External perfusion component and perfusion balloon catheter

Abstract

The present invention relates to the field of medical devices and discloses an external perfusion component and a perfusion balloon catheter; the external perfusion component is suitable for being sleeved and arranged on the outside of a balloon, and the external perfusion component includes a connecting unit and two elastic hoop; the connecting unit includes a deformation segment and a connecting segment. The present invention has a perfusion cavity independent of the balloon, and blood can continuously flow downstream through this channel, avoiding ischemic damage caused by traditional balloons blocking blood flow and extending the safe operation time; when the balloon contracts, the deformation segment is radially reset, and the elastic hoop and the connecting segment provide a restraining force to the deformation segment, so that the deformation segment automatically resets as the balloon contracts, which can avoid damage to blood vessels when the device is withdrawn, while enhancing the flexibility of positioning; compared with the complex one-piece molding process of traditional multi-cavity balloons, the present application sleeves a standard balloon with an independent external perfusion component, and the balloon expansion does not encroach on the blood circulation space, and the manufacturing process is separated, the structure is simplified and the process is optimized, thereby reducing production costs.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an external perfusion component and a perfusion balloon catheter. Background Art

[0002] Vascular disease is one of the major threats to human health. Percutaneous coronary intervention (PCI) has ushered in a new era in the treatment of coronary artery disease. Balloon dilatation catheters are commonly used in PCI procedures, but traditional balloon dilatation catheters can obstruct blood flow during expansion. External perfusion component balloons can be inflated for only a short time, as prolonged coronary artery occlusion can cause partial damage to the heart.

[0003] As a solution that allows for extended inflation time to completely treat stenosis, the perfusion balloon catheter provides a path for blood to flow through the balloon when the balloon is inflated. Blood can be supplied to the downstream area of ​​the inflated balloon, ensuring effective internal circulation of blood, thereby extending the operation time. Existing perfusion balloon catheters are mostly manufactured by forming a balloon with multiple balloon cavities, and the gaps surrounded by the multiple balloon cavities are used as blood flow channels. Although this design can establish a blood flow channel and extend the operation time, due to the complexity of the design structure, the actual manufacturing process is cumbersome. In terms of design, the multiple balloon cavities largely encroach on the radial space for blood circulation, reducing the blood circulation efficiency. Summary of the Invention

[0004] In view of this, the present invention provides an external perfusion component, a perfusion balloon catheter and an operation method to solve the problems raised by the above background technology.

[0005] In a first aspect, the present invention provides an external perfusion assembly, which is suitable for being sleeved and arranged on the outside of a balloon, and comprises a communication unit and two elastic hoops, wherein the two elastic hoops are respectively arranged at the proximal end and the distal end of the assembly;

[0006] There is at least one communication unit, each of which contains a perfusion cavity running through both ends, and both ends of the communication unit in the length direction are fixed to the elastic hoop at the proximal end and the elastic hoop at the distal end respectively;

[0007] The communication unit includes a deformation section and a connection section. The deformation section is extended outward by the radial expansion force when the balloon is inflated. The connection section is provided at both ends of the deformation section and is fixed to the two elastic hoops. The deformation section is connected to the connection sections at both ends to form the perfusion cavity.

[0008] When the balloon is inflated to a desired nominal pressure, the deformable segment expands outward to connect the perfusion cavity to the blood vessel, thereby establishing a continuous blood flow channel.

[0009] When the balloon is deflated, the deformable segment is radially reset.

[0010] Beneficial effects: The present application provides an external perfusion component that can be sleeved on the outside of the balloon, which includes a connecting unit and two elastic hoop. The deformation segment of the connecting unit passively extends outward when the balloon is inflated. When the balloon expands and blocks the blood vessel, a continuous blood flow channel is formed directly by the perfusion cavity established by the deformation segment and the connecting segment to ensure the continuity of blood flow. The present application has a perfusion cavity independent of the balloon, and blood can continuously flow downstream through this channel, avoiding ischemic damage caused by traditional balloons blocking blood flow and prolonging the safe operation time. When the balloon contracts, the deformation segment is radially reset, and the elastic hoop and the connecting segment provide a restraining force on the deformation segment, so that the deformation segment automatically resets as the balloon contracts. The elastic adaptive design can avoid damage to the blood vessel when the instrument is withdrawn, and at the same time enhances the flexibility of positioning. Compared with the complex one-piece molding process of traditional multi-cavity balloons, the present application sleeves a standard balloon with an independent external perfusion component, and the balloon expansion does not encroach on the blood circulation space. In addition, the manufacturing process is separated, the structure is simplified, and the process is optimized, thereby reducing production costs.

[0011] In some optional embodiments, the two elastic hoops at the proximal end and the distal end are coaxially arranged; there are multiple connecting units, and all of the connecting units are centrally symmetrical or annularly distributed.

[0012] Beneficial effects: The two elastic hoops at the proximal and distal ends are coaxially arranged, which can provide stable restraint force to the connecting segment and the deformation segment. When the balloon is inflated, the expansion force can be evenly transmitted to each connected unit, preventing eccentric expansion of the balloon and reducing the risk of vascular damage; distributing multiple perfusion units symmetrically or in a ring shape is conducive to forming a uniform blood flow path, avoiding local blood flow deficiency caused by single-channel deviation, improving the stability of the blood flow channel, and enhancing blood flow efficiency.

[0013] In some optional embodiments, four communication units are provided.

[0014] Beneficial effects: The layout of the four interconnected units can minimize the impact on the balloon folding diameter while ensuring sufficient channel cross-sectional area, ensuring the passability of the device; in addition, the four symmetrically distributed interconnected units establish four channels that can reduce turbulence, maintain laminar flow, promote blood flow balance, and reduce the risk of thrombosis.

[0015] In some optional embodiments, the cross-section of the perfusion chamber is configured to be circular, rectangular or trapezoidal.

[0016] Beneficial effects: For the cross-section of the perfusion cavity, the circular cross-section can reduce the flow resistance; the rectangular cross-section and the trapezoidal cross-section can improve the structural stability and enhance the anti-collapse ability, and are suitable for the use scenarios of highly curved blood vessel segments to ensure an effective connectivity environment.

[0017] In some optional embodiments, the connecting unit is configured as a hollow long strip structure.

[0018] In some optional embodiments, the elastic hoop is made of elastic polymer material.

[0019] In some optional embodiments, the perfusion cavity has the same first cross-sectional area at the proximal inlet and the distal outlet; a variable cross-sectional flow channel is provided in the perfusion cavity, and the maximum cross-sectional area of ​​the variable cross-sectional flow channel is smaller than the first cross-sectional area.

[0020] Beneficial Effects: The cross-sectional area of ​​the perfusion chamber's entrance and exit is larger than the maximum cross-sectional area of ​​the deformable section. The perfusion chamber incorporates a variable-section flow channel. The large entrance and exit cross-sections help reduce local pressure loss. The variable diameter design of the perfusion chamber accelerates blood flow and improves blood flow efficiency, utilizing the Venturi effect to compensate for the reduced cross-sectional area. Furthermore, the variable-section design enhances the radial stiffness of the deformable section, resisting external tissue compression and improving the structural compressive strength, thereby maintaining channel patency and ensuring a reliable connection.

[0021] In some optional embodiments, the variable cross-section flow channel is configured as a venturi tube; the variable cross-section flow channel includes a gradually converging cone section and a gradually diverging cone section;

[0022] The tapered cone section is connected to the proximal inlet, and the inner cavity cross-sectional area of ​​the tapered cone section is gradually reduced in the direction from the proximal end to the distal end;

[0023] The gradually expanding cone section is connected to the distal outlet, and the inner cavity cross-sectional area of ​​the gradually expanding cone section is gradually expanded in the direction from the proximal end to the distal end.

[0024] Beneficial effects: The variable-section flow channel has a Venturi tube configuration; the blood flow is accelerated by the tapered cone section, and the pressure is restored by the tapered cone section, thereby reducing turbulent energy loss, maintaining downstream perfusion pressure, and optimizing blood flow efficiency; in addition, the high-speed flow inhibits the deposition of platelets on the channel wall, forming an anti-adsorption design and reducing the risk of acute thrombosis.

[0025] In some optional embodiments, the tapered cone sections and the gradually expanding cone sections are arranged alternately in the direction from the proximal end to the distal end; adjacent tapered cone sections and gradually expanding cone sections form a necking portion; at least two necking portions are arranged in series along the axial direction in the deformation section, and adjacent necking portions are connected with equal cross-section transitions.

[0026] Beneficial Effects: Arranging multiple constrictions in series with equal cross-sectional transitions between adjacent constrictions accelerates blood flow, while the gradually expanding conical section restores pressure. The multi-stage constriction creates a redundant design, allowing the remaining constrictions to maintain flow even when a single constriction is under pressure, enhancing resistance to external compression and improving channel reliability. The equal cross-sectional transition helps stabilize the flow pattern, create a uniform flow field, and avoid shear damage to the blood caused by sudden changes in flow velocity.

[0027] In some optional embodiments, the inner wall of the perfusion cavity is provided with a spiral guide portion, and the two ends of the inner cavity of the spiral guide portion are respectively connected to the proximal inlet and the distal outlet.

[0028] Beneficial effects: A spiral guide is provided on the inner wall of the perfusion chamber, which guides the blood to flow in a rotational manner through the spiral design, thereby suppressing turbulence and stagnation areas, forming an anti-eddy flow design, and reducing thrombosis; moreover, the rotating flow reduces the mechanical damage of the straight wall to the blood cells, thereby protecting the integrity of the red blood cells and platelets.

[0029] In a second aspect, the present invention provides a perfusion balloon catheter, comprising a balloon and the above-mentioned external perfusion component; the external perfusion component is sleeved and arranged on the outside of the balloon.

[0030] Beneficial effects: The external perfusion component is directly sleeved on the outside of the balloon, and has good compatibility; in actual use, there is no need to redesign the balloon body, and a standard balloon can be directly used for manufacturing and implementation; this application uses an independent external perfusion component to sleeve the standard balloon, and the balloon expansion does not encroach on the blood circulation space, and the manufacturing process is separated, the structure is simplified and the process is optimized, thereby reducing production costs.

[0031] In some optional embodiments, the perfusion balloon catheter also includes an inner tube, an outer tube and a catheter seat, the inner tube is fixedly inserted into the balloon, the proximal end of the inner tube is connected to the catheter seat, the outer tube is connected to the proximal part of the balloon, the catheter seat is provided with a filling port and a guide wire port, a filling channel is formed between the inner tube and the outer tube, the filling port is connected to the filling channel, and the guide wire port is connected to the inner tube; the deformed part of the balloon is sleeved on the outside of the inner tube, the proximal end of the deformed part is connected to the outer tube, and the distal end of the deformed part is connected to the inner tube.

[0032] Beneficial effects: A filling channel is formed between the inner tube and the outer tube, which is independent of the perfusion cavity to avoid pressure interference and space encroachment; the guidewire port is connected to the inner tube to ensure the passability of the guidewire; the inner tube fixes and supports the distal end of the balloon to prevent the external perfusion component from shifting. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0034] Figure 1 A schematic structural diagram of the external perfusion assembly provided by the present invention;

[0035] Figure 2 A schematic diagram of the external perfusion assembly and the balloon provided by the present invention being connected in a folded state;

[0036] Figure 3 A schematic diagram of the external perfusion assembly provided by the present invention and the balloon being connected in a filled state;

[0037] Figure 4 A schematic diagram of the external expansion of the external perfusion component of the balloon provided by the present invention when the balloon is in a filled state;

[0038] Figure 5 A schematic diagram of a first embodiment of a variable cross-section flow channel in an external perfusion assembly provided by the present invention;

[0039] Figure 6 A schematic diagram of a second embodiment of a variable cross-section flow channel in an external perfusion assembly provided by the present invention;

[0040] Figure 7 A schematic diagram of a third embodiment of a variable cross-section flow channel in an external perfusion assembly provided by the present invention;

[0041] Figure 8 This is a schematic diagram of the structure of the perfusion balloon catheter provided by the present invention when folded;

[0042] Figure 9 This is a schematic structural diagram of the perfusion balloon catheter provided by the present invention when it is filled.

[0043] Description of reference numerals:

[0044] 100, balloon; 101, proximal neck; 102, deformation portion; 103, distal neck;

[0045] 200, external perfusion assembly; 201, connecting unit; 2011, deformation section; 2012, connecting section; 2013, proximal inlet; 2014, distal outlet; 2015, tapered conical section; 2016, gradually expanding conical section; 2017, spiral guide portion; 202, elastic hoop;

[0046] 301, inner tube; 302, outer tube; 303, catheter seat; 3031, filling port; 3032, guidewire port. DETAILED DESCRIPTION

[0047] To make the purpose, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making creative efforts shall fall within the scope of protection of the present invention.

[0048] In related technologies, perfusion balloon catheters are mostly manufactured by forming a balloon with multiple balloon cavities, and utilizing the gaps formed in the middle of the multiple balloon cavities as blood flow channels. Although this design can establish a blood flow channel and prolong the operation time, the actual manufacturing process is cumbersome due to the complexity of the design structure. In terms of design, the multiple balloon cavities occupy more radial space for blood circulation, reducing the efficiency of blood circulation.

[0049] One of the technical objectives of the present invention is to solve the problems in related technologies, such as the complexity of the structure of the perfusion balloon catheter, the cumbersome actual production process, the high manufacturing cost, and the fact that multiple balloon cavities occupy a large amount of radial space for blood circulation, thereby reducing the blood circulation efficiency.

[0050] The following combination Figures 1 to 8 , describing embodiments of the present invention.

[0051] Example 1

[0052] According to an embodiment of the present invention, this embodiment provides an external perfusion component, see Figures 1 to 4 , Figure 1 A schematic structural diagram of the external perfusion assembly provided by the present invention; Figure 2 Schematic diagram of the external perfusion component provided by the present invention and the balloon in a folded state; the external perfusion component is suitable for being arranged on the outside of the balloon 100, and the external perfusion component includes a connecting unit 201 and two elastic hoops 202, and the two elastic hoops 202 are respectively arranged at the proximal end and the distal end of the component.

[0053] See also Figure 3 , Figure 3 Schematic diagram of the external perfusion component provided by the present invention and the balloon in a filled state; the balloon 100 includes a proximal neck 101, a deformation portion 102 and a distal neck 103, the deformation portion 102 is connected between the proximal neck 101 and the distal neck 103, and the deformation portion 102 is suitable for expanding and deforming when the balloon 100 is filled.

[0054] There are more than one communication unit 201 , and each communication unit 201 includes a perfusion cavity running through both ends. Both ends of the communication unit 201 in the length direction are fixed to the elastic hoop 202 at the proximal end and the elastic hoop 202 at the distal end, respectively.

[0055] See also Figure 4 , Figure 4 The diagram shows the external expansion of the external perfusion assembly of the balloon provided by the present invention when inflated. The connecting unit 201 includes a deformable segment 2011 and a connecting segment 2012. The deformable segment 2011 is expanded outward by the radial expansion force when the balloon 100 is inflated. The connecting segment 2012 is provided at both ends of the deformable segment 2011 and fixed to two elastic hoops 202. The deformable segment 2011 is connected to the connecting segments 2012 at both ends to form a perfusion cavity. The two elastic hoops 202 are respectively sleeved and mounted on the proximal neck 101 and distal neck 103 of the balloon 100. The deformable segment 2011 is provided corresponding to the deformable portion 102 of the balloon 100. Specifically, the deformable segment 2011 circumferentially covers the deformable portion 102. When the balloon 100 is inflated, the deformable portion 102 abuts against the deformable segment 2011, causing it to expand outward.

[0056] In this embodiment, when the balloon 100 is inflated to a desired nominal pressure, the deformable segment 2011 expands outward to connect the perfusion cavity to the blood vessel, thereby establishing a continuous blood flow channel; when the balloon 100 is deflated, the deformable segment 2011 is radially reset.

[0057] This embodiment provides an external perfusion component that can be sleeved on the outside of the balloon 100, which includes a connecting unit 201 and two elastic hoop 202; the deformation segment 2011 of the connecting unit 201 is passively extended when the balloon 100 is inflated. When the balloon 100 expands and blocks the blood vessel, the perfusion cavity directly established by the deformation segment 2011 and the connecting segment 2012 forms a continuous blood flow channel to ensure the continuity of blood flow.

[0058] In some optional embodiments, the number of communication units 201 is 3-8; preferably, there are four communication units 201. The layout of the four communication units 201 can ensure sufficient channel cross-sectional area while minimizing the impact on the folded diameter of the balloon 100, ensuring the passability of the device. In addition, the four symmetrically distributed communication units 201 create four channels, which can reduce turbulence, maintain laminar flow, promote balanced blood flow, and reduce the risk of thrombosis.

[0059] In some structural embodiments, the connecting unit 201 is configured as a hollow long strip structure, so that the deformable segment 2011 has good outward expansion capability as the balloon 100 is filled and expanded, and is adapted to the complex lumen structure within the blood vessel.

[0060] Regarding the structural implementation of the perfusion chamber, the cross-section of the perfusion chamber is set to be circular; the circular cross-section can reduce flow resistance and accelerate blood circulation efficiency.

[0061] For other structural implementations of the perfusion chamber, the cross-section of the perfusion chamber is configured as a rectangle or a trapezoid. Rectangular and trapezoidal cross-sections can improve structural stability and enhance anti-collapse capabilities, making them suitable for use in highly curved blood vessels to ensure effective connectivity.

[0062] In some optional embodiments, the two elastic hoops 202 at the proximal and distal ends are coaxially arranged; the two elastic hoops 202 at the proximal and distal ends are coaxially arranged, which can provide a stable restraining force to the connecting segment 2012 and the deformation segment 2011. When the balloon 100 is inflated and expanded, the expansion force can be evenly transmitted to each connecting unit 201, preventing the balloon 100 from eccentrically expanding and reducing the risk of vascular damage.

[0063] In a further embodiment, a plurality of connecting units 201 are provided, and all connecting units 201 are arranged in a centrally symmetrical or annular distribution. The centrally symmetrical or annular distribution of the multiple connecting units 201 is conducive to forming a uniform blood flow path, avoiding local blood flow deficiency caused by single channel deviation, improving blood flow channel stability, and enhancing blood flow efficiency.

[0064] In an exemplary embodiment, see Figure 5 The perfusion cavity has the same first cross-sectional area at the proximal inlet 2013 and the distal outlet 2014; a variable cross-sectional flow channel is provided in the perfusion cavity, and the maximum cross-sectional area of ​​the variable cross-sectional flow channel is smaller than the first cross-sectional area S1.

[0065] In this embodiment, the cross-sectional area of ​​the perfusion chamber entrance and exit is larger than the maximum cross-sectional area of ​​the deformable section 2011. The deformable section 2011 incorporates a variable-cross-section flow channel. The large cross-section of the entrance and exit helps reduce local pressure loss. The variable diameter design of the deformable section 2011 helps accelerate blood flow and improve blood flow efficiency, utilizing the Venturi effect to compensate for the reduced cross-sectional area. Furthermore, the variable cross-sectional design enhances the radial stiffness of the deformable section 2011, resisting external tissue compression and improving the structural compressive strength, thereby maintaining a patency and ensuring a reliable connection.

[0066] In some optional embodiments, the minimum cross-sectional area S2 of the variable cross-sectional flow channel satisfies: 0.3≤S2 / S1≤0.7.

[0067] In a further embodiment, the variable cross-section flow channel is configured as a Venturi tube configuration; the variable cross-section flow channel includes a tapered cone section 2015 and a gradually expanding cone section 2016; the tapered cone section 2015 is connected to the proximal inlet 2013, and the inner cavity cross-sectional area of ​​the tapered cone section 2015 is gradually reduced in the direction from the proximal end to the distal end; the gradually expanding cone section 2016 is connected to the distal outlet 2014, and the inner cavity cross-sectional area of ​​the gradually expanding cone section 2016 is gradually expanded in the direction from the proximal end to the distal end.

[0068] The variable-section flow channel is configured as a Venturi tube, with the convergent cone section 2015 accelerating blood flow and the divergent cone section 2016 restoring pressure, thereby reducing turbulent energy loss, maintaining downstream perfusion pressure, and optimizing blood flow efficiency. In addition, the high-speed flow inhibits platelet deposition on the channel wall, forming an anti-adsorption design and reducing the risk of acute thrombosis.

[0069] In one embodiment, see Figure 5 The tapered conical section 2015 and the gradually expanding conical section 2016 of the variable cross-section flow channel are symmetrically arranged, and the perfusion cavity forms a flow channel structure with large ends and a small middle.

[0070] In a further embodiment, see Figure 6 , along the direction from the proximal end to the distal end, the tapered cone section 2015 and the gradually expanding cone section 2016 are arranged alternately; adjacent tapered cone sections 2015 and gradually expanding cone sections 2016 form a necking portion; more than two necking portions are arranged in series along the axial direction in the deformation section 2011, and adjacent necking portions are connected with equal cross-section transitions.

[0071] Multiple constrictions are arranged in series, with equal cross-sectional transitions between adjacent constrictions. The tapered conical section 2015 accelerates blood flow, while the diverging conical section 2016 restores pressure. The multi-stage constriction design provides redundancy, allowing flow to continue even when a single constriction is under pressure. This enhances resistance to external compression and improves channel reliability. The equal cross-sectional transitions stabilize the flow pattern and uniform the flow field, preventing shear damage to the blood caused by sudden changes in flow velocity.

[0072] In some alternative embodiments, see Figure 7 The inner wall of the perfusion cavity is provided with a spiral guide portion 2017, and the two ends of the inner cavity of the spiral guide portion 2017 are respectively connected to the proximal inlet 2013 and the distal outlet 2014.

[0073] A spiral guide portion 2017 is provided on the inner wall of the perfusion chamber. The spiral design guides the blood to flow in a rotational manner, which is beneficial to suppress turbulence and stagnation areas, form an anti-vortex design, and reduce thrombosis. In addition, the rotating flow reduces the mechanical damage of the straight wall to the blood cells, protecting the integrity of red blood cells and platelets.

[0074] In one embodiment, the spiral height is 0.05-0.2 mm, and the spiral pitch is 1-3 mm; the angle between the rotation direction of the spiral guide portion 2017 and the blood flow direction is 10°-30°. This design is conducive to increasing the tangential velocity of the fluid, thereby improving the blood circulation rate.

[0075] In some optional embodiments, the elastic hoop 202 is configured to be an elastic polymer material. Specifically, the elastic hoop 202 can be made of medical silicone or polyurethane with an elastic modulus of 0.1-5 MPa, which has both elasticity and fatigue resistance and can support multiple expansion and contraction cycles.

[0076] The external perfusion assembly provided in this embodiment is placed over the balloon 100 when loaded with the balloon 100, with the elastic cuffs 202 positioned at the proximal neck 101 and distal neck 103 of the balloon 100, respectively. When the balloon 100 is opened, the perfusion lumen also moves outward and expands until the balloon 100 is inflated to the nominal pressure. The balloon 100 then conforms to the blood vessel, and the perfusion lumen connects the blood at the proximal and distal ends of the balloon 100, achieving blood perfusion.

[0077] The external perfusion component provided in this embodiment has a perfusion cavity independent of the balloon 100. Blood can continue to flow downstream through this channel, avoiding ischemic damage caused by the traditional balloon 100 blocking blood flow and prolonging the safe operation time; when the balloon 100 contracts, the deformation segment 2011 is radially reset, and the elastic hoop 202 and the connecting segment 2012 provide a restraining force on the deformation segment 2011, so that the deformation segment 2011 automatically resets as the balloon 100 contracts. The elastic adaptive design can avoid damage to blood vessels when the instrument is withdrawn, while enhancing the flexibility of positioning.

[0078] Compared with the complex one-piece molding process of the traditional multi-chamber balloon 100, the present application uses an independent external perfusion component to connect the standard balloon 100. The expansion of the balloon 100 does not encroach on the blood circulation space, and the manufacturing process is separated, the structure is simplified and the process is optimized, thereby reducing production costs.

[0079] Example 2

[0080] According to an embodiment of the present invention, a perfusion balloon catheter is provided, comprising a balloon 100 and the external perfusion assembly 200 of Example 1; the external perfusion assembly 200 is sleeved and disposed on the outside of the balloon 100 .

[0081] The external perfusion component 200 is directly sleeved on the outside of the balloon 100, and has good compatibility; in actual use, there is no need to redesign the balloon 100 body, and the standard balloon 100 can be directly used for manufacturing and implementation; this application uses an independent external perfusion component 200 to sleeve the standard balloon 100, and the expansion of the balloon 100 does not encroach on the blood circulation space, and the manufacturing process is separated, the structure is simplified and the process is optimized, thereby reducing production costs.

[0082] In some alternative embodiments, see Figure 3 、 Figure 8 and Figure 9 The perfusion balloon catheter also includes an inner tube 301, an outer tube 302 and a catheter seat 303. The inner tube 301 is fixedly inserted into the balloon 100, the proximal end of the inner tube 301 is connected to the catheter seat 303, the outer tube 302 is connected to the proximal end of the balloon 100, and the catheter seat 303 is provided with a filling port 3031 and a guide wire port 3032. A filling channel is formed between the inner tube 301 and the outer tube 302, the filling port 3031 is connected to the filling channel, and the guide wire port 3032 is connected to the inner tube 301; the deformation part 102 of the balloon 100 is sleeved on the outside of the inner tube 301, the proximal end of the deformation part 102 is connected to the outer tube 302, and the distal end of the deformation part 102 is connected to the inner tube 301.

[0083] In this embodiment, a filling channel is formed between the inner tube 301 and the outer tube 302. The filling channel is independent of the perfusion cavity to avoid pressure interference and space encroachment; the guidewire port 3032 is connected to the inner tube 301 to ensure the passability of the guidewire; the inner tube 301 fixes and supports the distal end of the balloon 100 to prevent the external perfusion component 200 from shifting.

[0084] When using the above-mentioned perfusion balloon catheter, after the balloon 100 and the external perfusion assembly 200 are assembled, the balloon 100 is first placed in a folded and deflated state and transported to the lesion site. Then, fluid is injected into the balloon 100 to inflate the balloon 100. The perfusion cavity provides a path for blood to flow through the balloon 100, allowing blood to flow to the downstream area of ​​the balloon 100, thereby preventing prolonged vascular occlusion and partial damage to human tissue. When it is necessary to remove the balloon 100 dilation catheter from the body, the balloon 100 is depressurized and deflated, allowing the balloon 100 to be removed from the body.

[0085] Example 3

[0086] According to an embodiment of the present invention, this embodiment provides a perfusion method for a perfusion balloon catheter, using the perfusion balloon catheter of Example 2, comprising the following steps:

[0087] When the balloon 100 is folded, the external perfusion assembly 200 is fixed on the outside of the balloon 100;

[0088] The balloon 100 and the external perfusion assembly 200 are delivered to the location of the vascular lesion and then the balloon 100 is inflated to establish a blood flow channel in the perfusion cavity;

[0089] After the pressure is released, the balloon 100 and the external perfusion assembly 200 are withdrawn synchronously.

[0090] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. An external perfusion component, characterized in that: The external perfusion component (200) is suitable for being sleeved and arranged on the outside of the balloon (100), and the external perfusion component (200) comprises a communication unit (201) and two elastic hoops (202), and the two elastic hoops (202) are respectively arranged at the proximal end and the distal end of the component; At least one communication unit (201) is provided, and each communication unit (201) includes a perfusion cavity running through both ends, and both ends of the communication unit (201) in the length direction are fixed to elastic hoops (202) at the proximal end and the distal end respectively; The communication unit (201) comprises a deformation section (2011) and a connection section (2012); the deformation section (2011) is extended outward by the radial expansion force when the balloon (100) is filled; the connection section (2012) is arranged at both ends of the deformation section (2011) and is fixed to the two elastic hoops (202); the deformation section (2011) is connected to the connection sections (2012) at both ends to form the perfusion cavity; When the balloon (100) is inflated to a desired nominal pressure, the deformable segment (2011) expands outward to connect the perfusion cavity to the blood vessel, thereby establishing a continuous blood flow channel; When the balloon (100) contracts, the deformable segment (2011) is radially reset; The perfusion cavity has the same first cross-sectional area at the proximal inlet (2013) and the distal outlet (2014); a variable cross-sectional flow channel is provided in the perfusion cavity, and the maximum cross-sectional area of ​​the variable cross-sectional flow channel is smaller than the first cross-sectional area; The variable cross-section flow channel is configured as a Venturi tube; the variable cross-section flow channel comprises a gradually converging cone section (2015) and a gradually diverging cone section (2016); The tapered cone section (2015) is connected to the proximal inlet (2013), and the inner cavity cross-sectional area of ​​the tapered cone section (2015) is gradually reduced in the direction from the proximal end to the distal end; The gradually expanding cone section (2016) is connected to the distal outlet (2014), and the inner cavity cross-sectional area of ​​the gradually expanding cone section (2016) is gradually expanded in the direction from the proximal end to the distal end; In the direction from the proximal end to the distal end, the tapered conical sections (2015) and the gradually expanding conical sections (2016) are arranged in a staggered manner; adjacent tapered conical sections (2015) and gradually expanding conical sections (2016) form a constricted portion; at least two constricted portions are arranged in series along the axial direction in the deformation section (211), and adjacent constricted portions are connected with equal cross-section transitions; The inner wall of the perfusion cavity is provided with a spiral guide portion (2017), and the two ends of the inner cavity of the spiral guide portion (2017) are respectively connected to the proximal inlet (2013) and the distal outlet (2014).

2. The external perfusion assembly (200) according to claim 1, characterized in that: The two elastic hoops (202) at the proximal end and the distal end are coaxially arranged; a plurality of the communication units (201) are provided, and all the communication units (201) are centrally symmetrical or annularly distributed.

3. The external perfusion assembly (200) according to claim 2, characterized in that: Four communication units (201) are provided.

4. The external perfusion assembly (200) according to claim 1, characterized in that The cross section of the perfusion cavity is configured to be circular, rectangular or trapezoidal; and / or, The communication unit (201) is configured as a hollow long strip structure; and / or, The elastic hoop (202) is made of elastic polymer material.

5. A perfusion balloon catheter, characterized in that: It comprises a balloon (100) and an external perfusion component (200) according to any one of claims 1 to 4; the external perfusion component (200) is sleeved and arranged on the outside of the balloon (100).

6. The perfusion balloon catheter according to claim 5, characterized in that: The perfusion balloon catheter further comprises an inner tube (301), an outer tube (302) and a catheter seat (303), wherein the inner tube (301) is fixedly inserted into the balloon (100), the proximal end of the inner tube (301) is connected to the catheter seat (303), the outer tube (302) is connected to the proximal end of the balloon (100), the catheter seat (303) is provided with a filling port (3031) and a guide wire port (3032), and the inner tube (301) is fixedly inserted into the balloon (100), the proximal end of the inner tube (301 ... outer tube (302) is connected to the proximal end of the balloon (100), the catheter seat (303) is provided with a filling port (3031) and a guide wire port (3032), and the inner tube (301) is fixedly inserted into the balloon (100), the proximal end of the inner tube (301) is connected to the proximal end of the balloon (100), the proximal end of the inner tube (301) is connected to the proximal end of the balloon (100), the proximal end of the inner tube (301) is connected to the proximal end of the balloon (100), the proximal end of the inner tube (301) is connected to the proximal end of the inner tube (301), the proximal end of the inner tube (301) is connected to the proximal end of the inner tube (301), the proximal end of the outer tube (302) is connected to 1) and the outer tube (302), a filling channel is formed between the filling port (3031) and the filling channel, and the guide wire port (3032) is connected to the inner tube (301); the deformation portion (102) of the balloon (100) is sleeved outside the inner tube (301), the proximal end of the deformation portion (102) is connected to the outer tube (302), and the distal end of the deformation portion (102) is connected to the inner tube (301).

Images