External perfusion assembly and perfusion balloon catheter

Abstract

The invention relates to the field of medical instruments, and discloses an external perfusion assembly and a perfusion balloon catheter. The external perfusion assembly is suitable for being arranged on the outer side of the balloon in a sleeving mode and comprises a communication unit and two elastic hoops. The communication unit comprises a deformation section and a connection section. The device is provided with the perfusion cavity independent of the balloon, blood can continuously flow to the downstream through the channel, ischemic injury caused by blood flow blockage of a traditional balloon is avoided, and the safe operation time is prolonged; when the balloon contracts, the deformation section resets in the radial direction, the elastic hoop and the connecting section provide restraining force for the deformation section, so that the deformation section automatically resets along with contraction of the balloon, the situation that blood vessels are damaged when an instrument is withdrawn can be avoided, and meanwhile positioning flexibility is enhanced. Compared with a complex integrated forming process of a traditional multi-cavity balloon, the independent external perfusion assembly is connected with the standard balloon in a sleeving mode, the balloon does not occupy the circulation space of blood when expanded, the manufacturing process is separated, the structure is simplified, the process is optimized, and the production cost is reduced.

Description

Technical Field

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

[0002] Vascular diseases are one of the main diseases threatening human health. Percutaneous coronary intervention (PCI) has opened a new era for the treatment of coronary heart disease. Among them, the balloon dilatation catheter is a commonly used instrument in PCI surgery. However, the traditional balloon dilatation catheter will block blood flow during dilation. The balloon of the external perfusion assembly can be inflated for only a very short inflation time, because long-term occlusion of the coronary artery may cause damage to part of the heart.

[0003] As a solution that allows an 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 in the inflated state. Blood can be supplied to the downstream area of the inflated balloon, ensuring an effective internal circulation of blood, thereby extending the operation time. For existing perfusion balloon catheters, most are manufactured with multiple balloon cavities, and the gaps formed between the multiple balloon cavities are used as blood flow channels. This design, although it can establish a blood flow channel and extend the operation time, is cumbersome in actual manufacturing process due to the complexity of the design structure. In terms of design, the multiple balloon cavities occupy a relatively large radial space for blood flow, reducing the blood flow efficiency. Summary of the Invention

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

[0005] In a first aspect, the present invention provides an external perfusion assembly. The external perfusion assembly is adapted to be sleeved outside the balloon. The external perfusion assembly includes a communication unit and two elastic hoops, and the two elastic hoops are respectively arranged at the proximal end and the distal end of the assembly. There is at least one communication unit. Each communication unit contains a perfusion cavity penetrating through both ends. The two ends in the length direction of the communication unit are respectively fixed to the elastic hoop at the proximal end and the elastic hoop at the distal end. The communication unit includes a deformation section and a connection section. The deformation section expands outward under the action of a radial expansion force when the balloon is filled. The connection sections are arranged on both sides of the deformation section and are fixed to the two elastic hoops. The deformation section is communicated with the connection sections on both sides to form the perfusion cavity. When the balloon is filled to the desired nominal pressure, the deformation section expands outward to connect the perfusion cavity with the blood vessel, so as to establish a continuous blood flow channel.

[0006] When the balloon contracts, the deformed section radially resets.

[0007] Advantages: The present application provides an external perfusion component that can be sleeved outside the balloon, which includes a communication unit and two elastic hoops; the deformed section of the communication unit is passively abducted when the balloon is filled, and when the balloon expands to block the blood vessel, a continuous blood flow channel is directly formed by the perfusion cavity established by the deformed section and the connection section, ensuring 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 injury caused by traditional balloon blocking blood flow and prolonging the safe operation time; when the balloon contracts, the deformed section radially resets, and the elastic hoop and the connection section provide a binding force to the deformed section, so that the deformed section automatically resets with the contraction of the balloon. The elastic adaptive design can avoid damaging the blood vessel when the instrument is withdrawn, and at the same time enhances the flexibility of positioning; compared with the complex integral molding process of traditional multi-lumen balloons, in the present application, a standard balloon is sleeved with an independent external perfusion component. The expansion of the balloon does not occupy the blood circulation space, and the manufacturing process is separated, the structure is simplified and the process is optimized, reducing the production cost.

[0008] In some alternative embodiments, the two elastic hoops at the proximal end and the distal end are coaxially arranged; a plurality of the communication units are provided, and all the communication units are arranged in a central symmetry or annular distribution.

[0009] Advantages: The two elastic hoops at the proximal end and the distal end are coaxially arranged, which can provide a stable binding force to the connection section and the deformed section. When the balloon is filled and expanded, the expansion force can be evenly transmitted to each communication unit, preventing the balloon from expanding eccentrically and reducing the risk of blood vessel injury; distributing a plurality of perfusion units in a central symmetry or annular shape is conducive to forming a uniform blood flow path, avoiding local blood flow insufficiency caused by single-channel deviation, improving the stability of the blood flow channel and enhancing the blood flow circulation efficiency.

[0010] In some alternative embodiments, four communication units are provided.

[0011] Advantages: The layout of four communication units can ensure a sufficient channel cross-sectional area while minimizing the impact on the folding diameter of the balloon, ensuring the passability of the instrument; in addition, the four channels established by the four symmetrically distributed communication units can reduce turbulence, maintain a laminar flow state, promote the balance of blood flow circulation, and reduce the risk of thrombus formation.

[0012] In some alternative embodiments, the cross-section of the perfusion cavity is circular, rectangular or trapezoidal.

[0013] Advantages: For the cross-section of the perfusion cavity, a circular cross-section can reduce the flow resistance; a rectangular cross-section and a trapezoidal cross-section can enhance the structural stability and anti-collapse ability, and are suitable for the use scenarios of highly curved blood vessel segments to ensure an effective communication environment.

[0014] In some alternative embodiments, the connecting unit is arranged as a hollow elongated structure.

[0015] In some alternative embodiments, the elastic hoop is made of an elastic polymer material.

[0016] In some alternative embodiments, the perfusion cavity has the same first cross-sectional area at the proximal inlet and the distal outlet; a variable cross-section flow channel is provided in the perfusion cavity, and the maximum cross-sectional area of the variable cross-section flow channel is smaller than the first cross-sectional area.

[0017] Advantageous effects: The cross-sectional areas of the inlet and outlet of the perfusion cavity are larger than the maximum cross-sectional area of the deformation section. The design of the perfusion cavity with a variable cross-section flow channel, the large cross-section at the inlet and outlet is beneficial to reducing local pressure loss. The variable diameter design of the perfusion cavity is conducive to accelerating the blood flow velocity and improving the blood flow circulation efficiency, using the Venturi effect to compensate for the influence of the reduced flow cross-sectional area. Moreover, the variable cross-section design can enhance the radial stiffness of the deformation section, resist external tissue extrusion, improve the structural compressive resistance, thus maintaining the patency of the channel and ensuring a reliable connection environment.

[0018] In some alternative embodiments, the variable cross-section flow channel is arranged in the configuration of a Venturi tube; the variable cross-section flow channel includes a converging cone section and a diverging cone section; The converging cone section is connected to the proximal inlet, and along the direction from proximal to distal, the inner cavity cross-sectional area of the converging cone section is gradually decreasing; The diverging cone section is connected to the distal outlet, and along the direction from proximal to distal, the inner cavity cross-sectional area of the diverging cone section is gradually increasing.

[0019] Advantageous effects: The variable cross-section flow channel is in the configuration of a Venturi tube; the blood flow is accelerated through the converging cone section, and the pressure is restored through the diverging cone section, reducing the turbulent energy loss, maintaining the downstream perfusion pressure, and optimizing the blood flow circulation 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.

[0020] In some alternative embodiments, along the direction from proximal to distal, the converging cone section and the diverging cone section are arranged alternately; an adjacent converging cone section and diverging cone section form a constriction neck; at least two constriction necks are arranged in series along the axial direction in the deformation section, and the adjacent constriction necks are connected by equal cross-section transition.

[0021] Advantageous effects: A plurality of constriction necks are arranged in series, and the adjacent constriction necks are connected by equal cross-section transition. The converging cone section of the constriction neck accelerates the blood flow, and the diverging cone section restores the pressure. The multi-stage constriction necks form a redundant design. When a single constriction neck is compressed, the other constriction necks can still maintain the flow, improving the anti-external extrusion ability and the reliability of the channel; the equal cross-section transition is beneficial to stabilizing the flow pattern and making the flow field uniform, avoiding the shear force damage to the blood caused by the sudden change of the flow velocity.

[0022] In some alternative embodiments, a spiral flow guiding portion is provided on the inner wall of the perfusion cavity, and both ends of the inner cavity of the spiral flow guiding portion are respectively communicated with the proximal inlet and the distal outlet.

[0023] Advantageous effects: A spiral flow guiding portion is provided on the inner wall of the perfusion cavity. Through the spiral design, the blood is guided to flow in a rotating manner, which is beneficial to suppressing turbulent flow and stagnant areas, forming an anti-vortex design, and reducing thrombus formation. Moreover, the rotating flow reduces the mechanical damage of the straight wall surface to blood cells and protects the integrity of red blood cells and platelets.

[0024] In a second aspect, the present invention provides a perfusion balloon catheter, which includes a balloon and the above-mentioned external perfusion assembly; the external perfusion assembly is sleeved outside the balloon.

[0025] Advantageous effects: The external perfusion assembly is directly sleeved outside the balloon, with 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. In this application, by sleeving a standard balloon with an independent external perfusion assembly, the expansion of the balloon does not occupy the blood flow space, and the separation manufacturing process simplifies the structure and optimizes the process, reducing the production cost.

[0026] In some alternative embodiments, the perfusion balloon catheter further includes an inner tube, an outer tube, and a catheter hub. The inner tube is fixedly disposed through the balloon, the proximal end of the inner tube is connected to the catheter hub, the outer tube is connected to the proximal portion of the balloon, the catheter hub 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 communicated with the filling channel, and the guide wire port is communicated with the inner tube; the deformable portion of the balloon is sleeved outside the inner tube, the proximal end of the deformable portion is connected to the outer tube, and the distal end of the deformable portion is connected to the inner tube.

[0027] Advantageous effects: A filling channel is formed between the inner tube and the outer tube. The filling channel is independent of the perfusion cavity, avoiding pressure interference and space occupation. The guide wire port is communicated with the inner tube to ensure the passing of the guide wire. The inner tube fixedly supports the distal end of the balloon, which can prevent the displacement of the external perfusion assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the following drawings are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0029] Figure 1 It is a schematic structural diagram of the external perfusion assembly provided by the present invention; Figure 2Schematic diagram of the external perfusion assembly provided by the present invention sleeved with the balloon in the folded state; Figure 3 Schematic diagram of the external perfusion assembly provided by the present invention sleeved with the balloon in the inflated state; Figure 4 Schematic diagram of the external expansion of the external perfusion assembly when the balloon of the present invention is in the inflated state; Figure 5 Schematic diagram of the first embodiment of the variable cross-section flow channel in the external perfusion assembly provided by the present invention; Figure 6 Schematic diagram of the second embodiment of the variable cross-section flow channel in the external perfusion assembly provided by the present invention; Figure 7 Schematic diagram of the third embodiment of the variable cross-section flow channel in the external perfusion assembly provided by the present invention; Figure 8 Schematic diagram of the structure of the perfusion balloon catheter when folded provided by the present invention; Figure 9 Schematic diagram of the structure of the perfusion balloon catheter when inflated provided by the present invention.

[0030] Explanation of reference numerals: 100. Balloon; 101. Proximal neck; 102. Deformation part; 103. Distal neck 200. External perfusion assembly; 201. Communication unit; 2011. Deformation section; 2012. Connection section; 2013. Proximal inlet; 2014. Distal outlet; 2015. Tapered section; 2016. Flared section; 2017. Spiral guide part; 202. Elastic hoop 301. Inner tube; 302. Outer tube; 303. Catheter hub; 3031. Inflation port; 3032. Guide wire port. Detailed implementation manners

[0031] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some but not all of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative efforts fall within the protection scope of the present invention.

[0032] In the related art, most perfusion balloon catheters are manufactured with multiple balloon cavities, and the gaps formed between 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 occupy more of the radial space for blood flow, reducing the blood flow efficiency.

[0033] One of the technical objectives of the present invention is to solve the problems in the related art, including the complexity of the structure of the perfusion balloon catheter, the cumbersome actual manufacturing process, the high manufacturing cost; and the fact that multiple balloon cavities occupy more radial space for blood flow, reducing the blood flow efficiency.

[0034] The following will describe the embodiments of the present invention in conjunction with Figures 1 to 8 ,

[0035] Embodiment 1 According to an embodiment of the present invention, this embodiment provides an external perfusion assembly. Refer to Figures 1 to 4 , Figure 1 , which is a schematic structural diagram of the external perfusion assembly provided by the present invention; Figure 2 is a schematic diagram of the external perfusion assembly provided by the present invention sleeved with the balloon in a folded state; the external perfusion assembly is adapted to be sleeved outside the balloon 100, and the external perfusion assembly includes 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 assembly.

[0036] Refer to Figure 3 , Figure 3 , which is a schematic diagram of the external perfusion assembly provided by the present invention sleeved with the balloon in a filled state; the balloon 100 includes a proximal neck 101, a deformation part 102 and a distal neck 103, the deformation part 102 is connected between the proximal neck 101 and the distal neck 103, and the deformation part 102 is adapted to expand and deform when the balloon 100 is filled.

[0037] There is more than one communication unit 201, and each communication unit 201 contains a perfusion cavity penetrating through both ends. The two ends in the length direction of the communication unit 201 are respectively fixed to the elastic hoop 202 at the proximal end and the elastic hoop 202 at the distal end.

[0038] Refer to Figure 4 , Figure 4 , which is an external expansion schematic diagram of the external perfusion assembly when the balloon is in a filled state provided by the present invention; the communication unit 201 includes a deformation section 2011 and a connection section 2012. The deformation section 2011 expands outward under the action of a radial expansion force when the balloon 100 is filled; the connection section 2012 is arranged on both ends of the deformation section 2011 and is fixed to the two elastic hoops 202; the deformation section 2011 and the connection sections 2012 on both ends are communicated to form a perfusion cavity. Among them, the two elastic hoops 202 are respectively sleeved on the proximal neck 101 and the distal neck 103 of the balloon 100, and the deformation section 2011 corresponds to the deformation part 102 of the balloon 100. Specifically, the deformation section 2011 circumferentially covers the deformation part 102, and when the balloon 100 is filled, the deformation part 102 abuts against the deformation section 2011 to expand outward.

[0039] In this embodiment, when the balloon 100 is inflated to the desired nominal pressure, the deformable section 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 section 2011 radially resets.

[0040] This embodiment provides an external perfusion component that can be sleeved outside the balloon 100, which includes a connection unit 201 and two elastic hoops 202; the deformable section 2011 of the connection unit 201 expands outward passively when the balloon 100 is inflated. When the balloon 100 expands to block the blood vessel, a continuous blood flow channel is directly formed by the perfusion cavity established by the deformable section 2011 and the connection section 2012, ensuring the continuity of blood flow.

[0041] In some alternative embodiments, the number of connection units 201 is 3 - 8; preferably, four connection units 201 are provided. The layout of the four connection units 201 can minimize the impact on the folding diameter of the balloon 100 while ensuring a sufficient channel cross-sectional area, ensuring the passageability of the device; in addition, the four channels established by the four symmetrically distributed connection units 201 can reduce turbulence, maintain a laminar flow state, promote balanced blood flow, and reduce the risk of thrombus formation.

[0042] In some structural embodiments, the connection unit 201 is arranged as a hollow long strip structure; this enables the deformable section 2011 to have good outward expansion ability when the balloon 100 is inflated, adapting to the complex lumen structure within the blood vessel.

[0043] For the structural embodiment of the perfusion cavity, the cross-section of the perfusion cavity is set as a circle; a circular cross-section can reduce the flow resistance and accelerate the blood flow efficiency.

[0044] For other structural embodiments of the perfusion cavity, the cross-section of the perfusion cavity is set as a rectangle or a trapezoid. A rectangular cross-section or a trapezoidal cross-section can enhance the structural stability, strengthen the anti-collapse ability, adapt to the usage scenario of highly curved blood vessel segments, and ensure an effective connection environment.

[0045] In some alternative embodiments, the two elastic hoops 202 at the proximal end and the distal end are coaxially arranged; coaxially arranging the two elastic hoops 202 at the proximal end and the distal end can provide a stable binding force to the connection section 2012 and the deformable section 2011. When the balloon 100 is inflated, the expansion force can be evenly transmitted to each connection unit 201, preventing the balloon 100 from expanding eccentrically and reducing the risk of blood vessel injury.

[0046] In a further embodiment, a plurality of communication units 201 are provided, and all the communication units 201 are arranged in central symmetry or annular distribution. Arranging the plurality of communication units 201 in central symmetry or annular distribution is beneficial to forming a uniformly distributed blood flow path, avoiding local blood flow insufficiency caused by single-channel offset, improving the stability of the blood flow channel, and enhancing the blood flow circulation efficiency.

[0047] In an exemplary embodiment, referring to 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-section flow channel is provided in the perfusion cavity, and the maximum cross-sectional area of the variable cross-section flow channel is smaller than the first cross-sectional area S1.

[0048] In this embodiment, the design is such that the cross-sectional areas of the inlet and outlet of the perfusion cavity are larger than the maximum cross-sectional area of the deformation section 2011, and the deformation section 2011 includes a variable cross-section flow channel. The large cross-section at the inlet and outlet is beneficial to reducing local pressure loss, and the variable diameter design of the deformation section 2011 is conducive to accelerating the blood flow velocity, enhancing the blood flow circulation efficiency, and compensating for the influence of the reduced flow cross-sectional area by using the Venturi effect. Moreover, the variable cross-section design can enhance the radial stiffness of the deformation section 2011, resist external tissue extrusion, improve the structural compressive resistance, thereby maintaining the patency of the channel and ensuring a reliable communication environment.

[0049] In some alternative embodiments, the minimum cross-sectional area S2 of the variable cross-section flow channel satisfies: 0.3 ≤ S2 / S1 ≤ 0.7.

[0050] In a further embodiment, the variable cross-section flow channel is arranged in the configuration of a Venturi tube; the variable cross-section flow channel includes a converging cone section 2015 and a diverging cone section 2016; the converging cone section 2015 is connected to the proximal inlet 2013, and along the direction from proximal to distal, the inner cavity cross-sectional area of the converging cone section 2015 is gradually reduced; the diverging cone section 2016 is connected to the distal outlet 2014, and along the direction from proximal to distal, the inner cavity cross-sectional area of the diverging cone section 2016 is gradually increased.

[0051] With the variable cross-section flow channel in the configuration of a Venturi tube, the blood flow is accelerated through the converging cone section 2015, the pressure is restored by the diverging cone section 2016, the turbulent energy loss is reduced, the downstream perfusion pressure is maintained, and the blood flow circulation efficiency is optimized; 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.

[0052] In one embodiment, referring to Figure 5 , the converging cone section 2015 and the diverging cone 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.

[0053] In a further embodiment, referring to Figure 6, in the proximal-to-distal direction, the tapered sections 2015 and the expanded sections 2016 are arranged alternately; an adjacent tapered section 2015 and an expanded section 2016 form a constricted neck; more than two constricted necks are arranged in series along the axial direction within the deformation section 2011, and the adjacent constricted necks are connected by equal cross-section transitions.

[0054] Arrange multiple constricted necks in series, and the adjacent constricted necks are connected by equal cross-section transitions. The tapered section 2015 of the constricted neck accelerates blood flow, and the expanded section 2016 restores pressure. The multi-stage constricted necks constitute a redundant design. When a single constricted neck is compressed, the other constricted necks can still maintain blood flow, improving the anti-external extrusion ability and the reliability of the channel; the equal cross-section transition is beneficial to stabilizing the flow state and uniform flow field, and avoiding shear force damage to the blood caused by sudden changes in flow velocity.

[0055] In some alternative embodiments, refer to Figure 7 , a spiral guide portion 2017 is provided on the inner wall of the perfusion cavity, and both ends of the inner cavity of the spiral guide portion 2017 are respectively communicated with the proximal inlet 2013 and the distal outlet 2014.

[0056] A spiral guide portion 2017 is provided on the inner wall of the perfusion cavity. By means of the spiral design, the blood is guided to flow in a rotating manner, which is beneficial to suppressing turbulence and stagnant areas, forming an anti-vortex design, and reducing thrombus formation; moreover, the rotational flow reduces the mechanical damage of the straight wall surface to blood cells and protects the integrity of red blood cells and platelets.

[0057] In one embodiment, the spiral height is 0.05 - 0.2 mm, and the spiral pitch is 1 - 3 mm; the included angle between the spiral direction of the spiral guide portion 2017 and the blood flow direction is 10° - 30°. This design is beneficial to increasing the tangential velocity of the fluid, thereby increasing the blood flow velocity.

[0058] In some alternative embodiments, the elastic hoop 202 is made of 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, taking into account both elasticity and fatigue resistance, and supporting multiple expansion and contraction cycles.

[0059] For the external perfusion assembly provided in this embodiment, when loading the balloon 100, the external perfusion assembly is sleeved on the balloon 100, and the two end elastic hoops 202 are respectively located at the proximal neck 101 and the distal neck 103 of the balloon 100. When the balloon 100 is opened, the perfusion cavity also moves outward and expands deforming accordingly until the balloon 100 is filled to the nominal pressure, the balloon 100 fits with the blood vessel, and the perfusion cavity connects the blood at the proximal and distal parts of the balloon 100, realizing the function of blood perfusion.

[0060] The external perfusion assembly provided by this embodiment has a perfusion cavity independent of the balloon 100. Blood can continuously flow downstream through this channel, avoiding ischemic damage caused by the traditional balloon 100 blocking blood flow and extending the safe operation time. When the balloon 100 contracts, the deformed section 2011 radially resets. The elastic hoop 202 and the connecting section 2012 provide a binding force to the deformed section 2011, enabling the deformed section 2011 to automatically reset with the contraction of the balloon 100. The elastic adaptive design can avoid damaging blood vessels when the instrument is withdrawn and strengthen the flexibility of positioning at the same time.

[0061] Compared with the complex integral molding process of the traditional multi-lumen balloon 100, in this application, the standard balloon 100 is sleeved with an independent external perfusion assembly. When the balloon 100 expands, it does not occupy the blood circulation space, and the separated manufacturing process simplifies the structure and optimizes the process, reducing production costs.

[0062] Embodiment 2 According to an embodiment of the present invention, this embodiment provides a perfusion balloon catheter, including a balloon 100 and the external perfusion assembly 200 of Embodiment 1; the external perfusion assembly 200 is sleeved outside the balloon 100.

[0063] The external perfusion assembly 200 is directly sleeved outside the balloon 100, with 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. In this application, the standard balloon 100 is sleeved with an independent external perfusion assembly 200. When the balloon 100 expands, it does not occupy the blood circulation space, and the separated manufacturing process simplifies the structure and optimizes the process, reducing production costs.

[0064] In some alternative embodiments, refer to Figure 3 、 Figure 8 and Figure 9 , the perfusion balloon catheter further includes an inner tube 301, an outer tube 302, and a catheter hub 303. The inner tube 301 is fixedly disposed through the balloon 100. The proximal end of the inner tube 301 is connected to the catheter hub 303. The outer tube 302 is connected to the proximal part of the balloon 100. The catheter hub 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 communicated with the filling channel, and the guide wire port 3032 is communicated with the inner tube 301. The deformed part 102 of the balloon 100 is sleeved outside the inner tube 301. The proximal end of the deformed part 102 is connected to the outer tube 302, and the distal end of the deformed part 102 is connected to the inner tube 301.

[0065] 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, avoiding pressure interference and space occupation. The guide wire port 3032 is communicated with the inner tube 301 to ensure the passing of the guide wire. The inner tube 301 fixedly supports the distal end of the balloon 100, which can prevent the external perfusion assembly 200 from shifting.

[0066] When the above-mentioned perfusion balloon catheter is in use, after the balloon 100 and the external perfusion assembly 200 are assembled, first place the balloon 100 in a folded and contracted state and transport it to the lesion site. Then, inject fluid into the balloon 100 to make the balloon 100 expand and fill. The perfusion cavity provides a path for blood to flow through the balloon 100, and the blood can be supplied to the downstream area of the balloon 100, preventing partial damage to human tissues caused by long-term occlusion of blood vessels. When it is necessary to withdraw the balloon 100 dilation catheter from the body, the balloon 100 is depressurized and contracted, and then the balloon 100 dilation catheter can be withdrawn from the body.

[0067] Embodiment 3 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 Embodiment 2, the method includes the following steps: When the balloon 100 is in a folded state, the external perfusion assembly 200 is sleeved and fixed outside the balloon 100; After the balloon 100 and the external perfusion assembly 200 are jointly transported to the blood vessel lesion site, the balloon 100 is filled to establish a blood flow channel in the perfusion cavity; After depressurization, the balloon 100 and the external perfusion assembly 200 are withdrawn synchronously.

[0068] Obviously, the above embodiments are merely examples for clear illustration and not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or variations can be made based on the above description. It is not necessary and impossible to enumerate all the implementation manners here. And the obvious changes or variations derived therefrom are still within the protection scope of the present invention.

Claims

1. An external perfusion component, characterized in that, The external perfusion assembly (200) is adapted to be sleeved outside the balloon (100). The external perfusion assembly (200) includes 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 assembly; At least one communication unit (201) is provided, and each communication unit (201) contains a perfusion cavity penetrating through both ends. The two ends in the length direction of the communication unit (201) are respectively fixed to the elastic hoops (202) at the proximal end and the distal end; The communication unit (201) includes a deformation section (2011) and a connection section (2012). The deformation section (2011) expands outward under the action of a radial expansion force when the balloon (100) is filled; the connection section (2012) is arranged on both side ends of the deformation section (2011) and is fixed to the two elastic hoops (202); the deformation section (2011) is communicated with the connection sections (2012) on both side ends to form the perfusion cavity; When the balloon (100) is filled to the desired nominal pressure, the deformation section (2011) expands outward to connect the perfusion cavity to the blood vessel to establish a continuous blood flow channel; When the balloon (100) contracts, the deformation section (2011) radially resets.

2. The external perfusion assembly (200) according to claim 1, wherein, The two elastic hoops (202) at the proximal end and the distal end are coaxially arranged; a plurality of communication units (201) are provided, and all the communication units (201) are arranged in a central symmetry or annular distribution.

3. The external perfusion assembly (200) according to claim 2, wherein 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 set to be circular, rectangular or trapezoidal; and / or, The communication unit (201) is set to be a hollow long strip structure; and / or, The elastic hoop (202) is made of an elastic polymer material.

5. The external perfusion assembly (200) according to any one of claims 1-4, characterized in that, The perfusion cavity has the same first cross-sectional area at the proximal inlet (2013) and the distal outlet (2014); a variable cross-section flow channel is arranged in the perfusion cavity, and the maximum cross-sectional area of the variable cross-section flow channel is smaller than the first cross-sectional area.

6. The external perfusion assembly (200) according to claim 5, characterized in that, The variable cross-section flow channel is set to a Venturi tube configuration; the variable cross-section flow channel includes a tapered section (2015) and a diffuser section (2016); The tapered section (2015) is connected to the proximal inlet (2013), and along the direction from the proximal end to the distal end, the inner cavity cross-sectional area of the tapered section (2015) is tapered; The diffuser section (2016) is connected to the distal outlet (2014), and along the direction from the proximal end to the distal end, the inner cavity cross-sectional area of the diffuser section (2016) is gradually expanded.

7. The external perfusion assembly (200) according to claim 6, characterized in that, Along the direction from the proximal end to the distal end, the tapered section (2015) and the diffuser section (2016) are arranged in an alternating manner; an adjacent tapered section (2015) and diffuser section (2016) form a constriction; at least two constrictions are arranged in series along the axial direction in the deformation section (2011), and the adjacent constrictions are connected in an equal cross-section transition.

8. The external perfusion assembly (200) according to claim 5, characterized in that, The inner wall of the perfusion cavity is provided with a spiral flow guiding part (2017), and both ends of the inner cavity of the spiral flow guiding part (2017) are respectively communicated with the proximal inlet (2013) and the distal outlet (2014).

9. An infusion balloon catheter, characterized in that, It includes a balloon (100) and the external perfusion assembly (200) according to any one of claims 1-8; the external perfusion assembly (200) is sleeved outside the balloon (100).

10. The infusion balloon (100) catheter according to claim 9, characterized in that, The perfusion balloon catheter further includes an inner tube (301), an outer tube (302) and a catheter hub (303). The inner tube (301) is fixedly disposed inside the balloon (100). The proximal end of the inner tube (301) is connected to the catheter hub (303). The outer tube (302) is connected to the proximal part of the balloon (100). The catheter hub (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 communicated with the filling channel. The guide wire port (3032) is communicated with the inner tube (301). The deformable part (102) of the balloon (100) is sleeved outside the inner tube (301). The proximal end of the deformable part (102) is connected to the outer tube (302). The distal end of the deformable part (102) is connected to the inner tube (301).

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