CN119075169A

CN119075169A - Fluid pumping catheter

Info

Publication number: CN119075169A
Application number: CN202310650698.0A
Authority: CN
Inventors: 请求不公布姓名; 唐智荣
Original assignee: Fengkaili Medical Instrument Shanghai Co ltd
Current assignee: Fengkaili Medical Instrument Shanghai Co ltd
Priority date: 2023-06-05
Filing date: 2023-06-05
Publication date: 2024-12-06

Abstract

The invention provides a fluid pumping catheter which comprises a first expansion body and a main body, wherein a fluid inflow channel is arranged at the distal end of the main body, a fluid outflow channel is arranged at the proximal end of the main body, and the first expansion body is arranged at the distal end of the main body. The flexible characteristic of the first expansion body buffers the contact force between the first expansion body and the inner wall of the tissue, and the first expansion body deforms to enlarge the contact area after contacting with the inner wall of the tissue, so that the tissue in the heart is not damaged, and structures such as a valve, chordae tendineae and the like are not hooked. The impact force on the inner wall of the tissue is effectively reduced, the problem of damaging the tissue in the heart is avoided, the safety of the instrument is effectively improved, and the occurrence probability of clinical adverse events is obviously reduced.

Description

Fluid pumping conduit

Technical Field

The invention relates to the technical field of medical instruments, in particular to a fluid pumping catheter.

Background

The pumping catheter is a blood auxiliary circulation device, and is used for introducing an instrument into the heart through PCI operation, providing stable blood flow circulation support for patients, improving coronary artery and remote organ perfusion, simultaneously relieving left ventricular burden, facilitating the stabilization of physical signs and postoperative rehabilitation of heart failure patients, cardiogenic shock patients and other serious patients, and promoting the recovery of cardiac functions of the patients. In the related art, the distal end of the pumping catheter is a J-shaped head or an annular head (pigtail) so as to increase the contact area between the head end of the catheter and the ventricular wall and reduce the damage of the head end of the pumping catheter to the ventricular wall. Because of valve chordae and myocardial fiber net in the ventricle, the head end of the J-shaped head and the annular head (pigtail) can hook the chordae or the fiber net, so that the instrument damages the tissue in the heart and even the instrument is difficult to withdraw from the heart. Furthermore, since the outer diameter of the J-head, annular head (pigtail) is typically smaller than the pumping catheter, the pumping catheter will rest against the ventricular wall, thereby drawing ventricular wall tissue into the pumping catheter, resulting in reduced pumping blood flow and even damage to the ventricular wall. Thus, there is a need for a safe and effective pumping catheter that reduces or eliminates the aforementioned clinical adverse events.

Disclosure of Invention

In order to overcome at least one of the problems in the related art, the present invention provides a fluid pumping catheter.

Wherein the fluid pumping conduit comprises a first inflatable body and a main body;

the distal end of the main body is provided with a fluid inflow channel, and the proximal end is provided with a fluid outflow channel;

the first expansion body is arranged at the distal end of the main body, and the volume of the first expansion body is adjustable.

In an alternative embodiment, the outer surface of the first expansion body is provided with a fluid flow gap.

In an alternative embodiment, the first expansion body includes a plurality of sub-regions;

Some of the sub-regions are in fluid communication with each other, or none of the sub-regions are in communication with each other.

In an alternative embodiment, the junction of the outer surfaces of adjacent ones of said sub-regions forms said fluid flow gap.

In an alternative embodiment, the distal end of the body is provided with a shaft extending axially of the body;

the first expansion body wraps the shaft rod and is connected with two ends of the shaft rod respectively.

In an alternative embodiment, the catheter further comprises a second inflation body disposed at the distal end of the main body, the second inflation body being disposed inside the first inflation body;

A first space is formed between the inner surface of the first expansion body and the outer surface of the second expansion body.

In an alternative embodiment, the first space is filled with a developing substance.

In an alternative embodiment, the catheter further comprises a third inflation body disposed outside the body and the interior of the first inflation body is in fluid communication with the interior of the third inflation body.

In an alternative embodiment, the third expansion body includes at least a first expansion state and a second expansion state, and when the internal pressure of the third expansion body is greater than or equal to the set pressure threshold, the third expansion body is switched from the first expansion state to the second expansion state.

In an alternative embodiment, a pressure measuring unit is provided on the surface of the first expansion body, which is arranged at the distal end of the main body.

In an alternative embodiment, a pacing unit is disposed on a surface of the first expansion body distal to the body.

The technical scheme of the invention has the following advantages or beneficial effects:

(1) The head end of the fluid pumping catheter adopts the first expansion body to replace the J-shaped head or the annular head in the prior art, the first expansion body is filled before the fluid pumping catheter enters the ventricle and completely wraps the head end of the catheter, the flexible characteristic of the first expansion body buffers the contact force between the first expansion body and the inner wall of the tissue, and the first expansion body deforms after contacting the inner wall of the tissue to enlarge the contact area, so that the tissue in the heart is not damaged, and structures such as a valve, a chordae tendineae and the like are not hooked. Effectively solves the problems of tendon cable hooking or fiber net hooking and the like of J-shaped heads or annular heads adopted in the prior art. The contact area of the first expansion body and the endocardial tissue is obviously larger than that of an end head structure in the prior art, so that the impact force on the inner wall of the tissue is effectively reduced, the problem of damaging the endocardial tissue is avoided, the safety of the instrument is effectively improved, and the occurrence probability of clinical adverse events is obviously reduced.

(2) When the device is used, an operator can flexibly adjust the volume of the expansion body according to the requirement, so that the volume of the expansion body is large enough to separate the fluid on the main body from the centrifugal chamber wall of the channel, and the problem that ventricular wall tissues are sucked into the channel in the prior art is effectively solved. Also, when the pumping conduit is proximate the ventricular wall, the operator may adjust the pumping flow of the conduit by adjusting the volume of the first inflation body. In addition, the outer surface of the expansion body is provided with a fluid flow gap, and the flow gap can guide the flow direction of the fluid, reduce or delay the phenomenon that the boundary layer is separated from the surface of the expansion body, reduce the resistance of the fluid flowing through the surface of the expansion body, and further improve the pumping flow.

(3) The first expansion body comprises a plurality of subregions, and part of subregions are communicated with fluid or are not communicated with each other. For the situation that the subareas are communicated, an operator only needs to control the air supply quantity of the air source at the near end to synchronously control the plurality of communicated subareas to synchronously expand or contract, and for the situation that the independent subareas exist, when the subareas in which direction are needed to be expanded by the user, the subareas in the corresponding direction are filled, and other subareas can not be filled. The uninflated subregion is in a contracted state to reduce the resistance to fluid flow on the surface of the first expansion body and thereby increase the fluid flow within the pumping conduit.

(4) The distal end of the present disclosure provides for nested two inflation bodies with the development substance filling in a double nested inflation body sandwich that constrains the distribution of the development substance. Compared with the scheme of directly filling the developing substance in the single-layer balloon, the developing substance in the scheme is more uniformly distributed in space, and the state of the expansion body in the body can be observed through the display device. The pumping catheter can be effectively compatible with the existing developing equipment, so that the learning cost of operators is reduced, and the pumping catheter can be faster to put on the catheter device of the present disclosure. In addition, the first space between the first expansion body and the second expansion body is filled with developer and/or a small amount of gas, so that the pressure in the first expansion body is smaller than that in the second expansion body, when the second expansion body is broken accidentally, the gas in the second expansion body can enter the first expansion body, the risk that the gas directly enters blood or an organ to form a gas plug is avoided, and the safety of the catheter is improved.

(5) By arranging two expansion bodies which are in fluid communication with each other in the body and the outside of the body, an operator does not need to develop substances, and does not need to observe the state of the expansion body in the body by means of additional display equipment, the state of the first expansion body in the body can be known by observing the state of the third expansion body in the body, the purpose of simply and conveniently observing the state of the pumping catheter is achieved, and various problems caused by misoperation of the expansion body in the body by the operator in the prior art are solved. Moreover, the device disclosed by the invention enables an operator to timely treat the emergency when observing that the third expansion body outside the body is abnormal, avoids the problems of leakage, embolism, and the like of the expansion body inside the body, effectively improves the use safety of the pumping catheter, and improves the efficiency of clinical medical treatment.

Drawings

The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention. Wherein:

FIG. 1 is a schematic illustration of a fluid pumping conduit according to an embodiment of the present invention;

FIG. 2 is a schematic illustration of a fluid pumping conduit in an indoor operating state according to an embodiment of the present invention;

FIG. 3 is a schematic cross-sectional view of a first inflatable body structure according to an embodiment of the present invention;

FIG. 4 is a schematic cross-sectional view of another first expansion body structure in accordance with an embodiment of the present invention;

FIG. 5 is a schematic cross-sectional view of yet another first expansion body structure in accordance with an embodiment of the present invention;

FIG. 6 is a schematic representation of a dual layer expansion body in an expanded state in accordance with an embodiment of the present invention;

FIG. 7 is a schematic representation of an instrument having an extracorporeal expansion body in accordance with an embodiment of the present invention;

FIG. 8 is a schematic view of a fold in a folded state according to an embodiment of the invention;

FIG. 9 is a schematic illustration of an inflatable body in a second inflated state according to an embodiment of the present invention;

FIG. 10 is a schematic illustration of an inflatable body in a third inflated state according to an embodiment of the present invention;

FIG. 11 is a schematic view of an instrument having a pressure measurement unit according to an embodiment of the invention;

Fig. 12 is a schematic view of an instrument with a pacing unit according to an embodiment of the present invention;

FIG. 13 is a schematic view of a prior art pump catheter in an indoor operating state;

FIG. 14 is a schematic view of a prior art pump catheter;

fig. 15 is a schematic view of a fluid pumping catheter with a shaft according to an embodiment of the present invention.

Detailed Description

Exemplary embodiments of the present invention will now be described with reference to the accompanying drawings, in which various details of the embodiments of the present invention are included to facilitate understanding, and are to be considered merely exemplary. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in this specification and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the term "and/or" as used herein refers to and encompasses any or all possible combinations of one or more of the associated listed items.

It should be understood that although the terms first, second, third, etc. may be used herein to describe various information, these information should not be limited by these terms. These terms are only used to distinguish one type of information from another. For example, first information may also be referred to as second information, and similarly, second information may also be referred to as first information, without departing from the scope of the application. The term "if" as used herein may be interpreted as "at..once" or "when..once" or "in response to a determination", depending on the context.

A blood pumping catheter is a type of blood-assisted circulation device. When the device is used, the device can be introduced into the heart through PCI operation, the blood can be pumped into the main artery from the left ventricle through the blood pumping catheter, so that stable blood flow circulation support is provided for a patient, coronary artery and remote organ perfusion are improved, meanwhile, left ventricle burden is lightened, the device is beneficial to the stabilization and postoperative rehabilitation of signs of heart failure patients, cardiogenic shock patients and other severe patients, and the recovery of heart functions of the patient is promoted. The distal end of the pumping catheter is a J-shaped head or an annular head (pigtail) commonly used in the prior art, so that the contact area between the catheter and the ventricular wall is increased, and the damage of the head end of the pumping catheter to the ventricular wall is reduced. Because of the valve chordae and myocardial fibrous webs in the ventricle, it has been found in some clinical studies that the head end of the J-head or ring-head (pigtail) can catch on the chordae or fibrous webs, resulting in damage to the tissue in the heart by the instrument and even difficult withdrawal of the instrument. The J-shaped head or the annular head (pigtail) can be made of polymer materials such as PEBAX, PVC, PU, PE, PP and the like, and is made through an extrusion process, a heat setting process, a tip forming process and the like. And then the connection and fixation are carried out by means of bonding, hot melting, thermal shrinkage, laser welding and the like. And its lumen may serve as a passage for a guidewire. Furthermore, as shown in fig. 14, since the outer diameter of the J-head, annular head (pigtail) is typically smaller than that of the pump catheter, it has been found in some clinical studies that the pump catheter may abut against the ventricular wall (as shown in fig. 13), and that the pump catheter may draw ventricular wall tissue into the pump catheter during operation, resulting in reduced pump blood flow and even damage to the ventricular wall.

To address at least one of the above problems, a first aspect of the present invention provides a fluid pumping conduit.

The fluid pumping catheter comprises a first expansion body and a main body, wherein a fluid inflow channel is arranged at the distal end of the main body, a fluid outflow channel is arranged at the proximal end of the main body, and the first expansion body is arranged at the distal end of the main body.

As shown in fig. 1 and 14, fig. 1 discloses a partial schematic structural view of a fluid pumping catheter of the present invention, and fig. 14 shows a schematic structural view of a blood pumping catheter. The fluid pumping conduit mainly comprises a main body portion and a first expansion body 101. In one embodiment, the first inflatable body may be formed as a fluid-filled balloon or an inflatable balloon. The fluid pumping catheter includes a distal end and a proximal end, wherein the distal end is the end distal from the operator and the proximal end is the end proximal to the operator, as viewed from the point of use. In actual use, the operator controls the fluid pumping catheter proximally, for example, to control inflation and deflation of the inflation body. The first expansion body is arranged at the distal end, is positioned in the human body when in use, and can undergo volume expansion in an inflated state. It should be noted that, in this embodiment, the head end of the fluid pumping catheter adopts the first expansion body instead of the J-shaped head or the annular head (pigtail) in the prior art, and before the fluid pumping catheter enters the ventricle, the first expansion body is filled and completely encloses the head end of the catheter, the flexible property of the first expansion body buffers the contact force between the first expansion body and the inner wall of the tissue, and the first expansion body deforms after contacting the inner wall of the tissue to increase the contact area, so that the tissue in the heart is not damaged, and structures such as a valve, a chordae tendineae and the like are not hooked. Effectively solves the problems of tendon cable hooking or fiber net hooking and the like of J-shaped heads or annular heads adopted in the prior art. The contact area of the first expansion body and the endocardial tissue is obviously larger than that of an end head structure in the prior art, so that the impact force on the inner wall of the tissue is effectively reduced, the problem of damaging the endocardial tissue is avoided, the safety of the instrument is effectively improved, and the occurrence probability of clinical adverse events is obviously reduced.

The body has a fluid inflow channel 1404 at a distal end and a fluid outflow channel 1402 at a proximal end. In use, after the fluid pumping conduit reaches the target position, the fluid to be pumped is driven to flow through the drive device 1401 and into the fluid inflow channel, the fluid flows along the axial direction of the main body, and finally flows out of the pumping conduit from the fluid outflow channel. The drive means include, but are not limited to, a rotor. The rotor can be made of metal, polymer or composite materials of various materials. The rotor is usually designed into a spiral blade shape and is connected and fixed with the rotating shaft in a mechanical mode or an electromagnetic mode, and the rotating shaft drives the rotor to rotate through the rotation of the motor so as to drive fluid to flow in the pumping guide pipe. The fluid inflow channel and the fluid outflow channel may be made of stainless steel, nickel titanium, or other metal materials, for example, by machining, laser cutting, MIT, welding, or other processes. In one embodiment, a transvalve conduit 1403 is also provided between the fluid inflow and outflow channels. The transvalve catheter can be a metal tube, a polymer tube or a composite tube made of various materials. Preferably, the transvalve catheter has a certain bending angle, and the bending angle can be any angle between 0 and 150 degrees. The bending angle refers to an initial angle of the transvalve catheter when the transvalve catheter is not subjected to an external force. The bending angle ensures that the fluid pumping catheter has good pushing property, torsion control property, supporting property and bending flexibility, ensures that the fluid pumping catheter smoothly passes through an aortic arch and is inserted into an opening and closing opening of a valve, and ensures that a fluid inflow channel and a fluid outflow channel are respectively positioned below and above the valve so as to achieve the purpose of crossing the valve. The inner cavity of the transvalve catheter is a fluid circulation channel. In an alternative embodiment, the driving device 1401 is arranged in the fluid outflow channel, and one end of the fluid outflow channel is connected to the transvalve catheter, and the other end of the fluid outflow channel is connected to the main body catheter.

In an alternative embodiment, the volume of the first expansion body is adjustable. The end of the blood pumping catheter in the prior art adopts a J-shaped head or an annular head, and has the problem that the fluid inflow channel sucks in ventricular wall tissues. It will be appreciated that once the ventricular wall tissue is sucked in, it will block the fluid inflow channel, not only affecting the pumping efficiency of the fluid, but even causing problems in that the inflow channel over-squeezes the sucked-in ventricular wall tissue to damage said tissue. As shown in fig. 13, the J-head is not effective in supporting the body structure of the pump catheter, resulting in the fluid inflow channel abutting against the inner wall of the ventricle, with the risk of tissue being drawn into the inflow channel. Therefore, in one embodiment of the present invention, the volume of the first expansion body can be adjusted, and when in use, an operator can flexibly adjust the volume of the expansion body according to needs, so that the volume of the expansion body is large enough to separate the fluid inflow channel on the main body from the centrifugal chamber wall, thereby effectively solving the problem of the ventricular wall tissue suction inflow channel in the prior art. Furthermore, the operator can also adjust the volume of the first expansion body by means of the instrument observing the pump blood flow of the catheter or observing the distance between the catheter and the ventricular wall. It will be appreciated that when the distance is greater, fluid is able to enter the fluid inflow channel with low resistance, resulting in a greater fluid flow rate within the pumping conduit. Thus, when the pumping conduit is proximate the ventricular wall, the operator can adjust the pumping flow of the conduit by adjusting the volume of the first expansion body. Preferably, the outer diameter of the first expansion body is larger than that of the pumping catheter, so that the probability of the pumping catheter being attached to the wall of a ventricle is reduced, further, the size of the ventricle in practical use is considered when the first expansion body is regulated, and too large an outer diameter of the first expansion body occupies too much space in the ventricle to influence the blood flow in the ventricle and weaken the pumping function of the heart. The first expansion body can be made of natural latex, synthetic latex, silica gel, rubber, TPE, TPX, TPU, WPU, pebax and other materials, and is fixedly connected to the end part of the pumping catheter in a bonding, hot melting, heat shrinkage, laser welding and other modes.

In an alternative embodiment, the outer surface of the first expansion body is provided with a fluid flow gap. Generally, the first expansion body may be manufactured in a spherical structure to reduce production costs. With this configuration, fluid needs to pass over the surface of the sphere before entering the fluid inflow channel of the catheter. It will be appreciated that a larger ball's frontal area results in a greater resistance to fluid. In addition, when the fluid flows through the windward surface of the sphere, the boundary layer separation phenomenon can occur to generate larger turbulent flow, and when the laminar flow is changed into turbulent flow, the fluid is further influenced to enter the inflow channel, and the pumping flow is reduced. For this reason, in one embodiment of the present invention, a fluid flow gap is disposed on the outer surface of the expansion body, and the flow gap can guide the flow direction of the fluid, reduce or delay the separation of the boundary layer from the surface of the expansion body, and reduce the resistance of the fluid flowing through the surface of the expansion body, so as to improve the pumping flow. By way of example, in the embodiment shown in fig. 3-5, the first inflatable body includes a lobed configuration, such as 3 lobes or 4 lobes, and the like, and the number is not intended to limit the scope of the present invention. The valve-to-valve junction constitutes the flow gap 305. Preferably, the flow gap extends along the axial direction of the pumping conduit. When the fluid flows, the reverse fluid can flow along the flowing clearance, and the adjacent petal-shaped structures provide semi-open diversion channels for the fluid, so that the fluid can stably pass through the surface of the first expansion body with low resistance and then enter the fluid inflow channel.

In an alternative embodiment, the first expansion body comprises a plurality of sub-areas, and a part of the sub-areas are in fluid communication or none of the sub-areas are in communication. In practice, to facilitate control of inflation and deflation of the first inflatable body, one embodiment of the present invention divides the interior of the first inflatable body into a plurality of sub-regions. When a plurality of subareas are partially or fully communicated, the same air source can synchronously vent and control the volume change in the communicated subareas. And when part or all of the subareas are not communicated, an operator can independently control the air supply quantity of the areas which are not communicated so as to control the volume of the areas. Specifically, in the embodiment shown in fig. 3, the first inflation body is shown in a state in a blood vessel or endocardial tissue 302. The first expansion body comprises 3 petal-shaped structures 301, namely 3 subregions, and the 3 subregions are communicated with each other. The first expansion body is internally provided with an inner pipe 304, and the inner pipe is provided with an air injection opening 303 communicated with the inside of the first expansion body. When the first expansion body volume needs to be controlled, an operator can synchronously control the synchronous expansion or contraction of the 3 sub-areas only by controlling the air supply amount of the air source at the near end. Further, fig. 4 shows a schematic diagram with 4 lobe-shaped structures, where after the number of lobe-shaped structures is increased, the flow gap is correspondingly increased, and the flow rate of the fluid flowing through the surface of the first expansion body can be effectively improved by appropriately increasing the flow gap. In the embodiment shown in fig. 5, the subregions are not in communication with each other, so that a plurality of gas injection openings need to be provided in the inner tube, and each subregion is in communication with at least one gas injection opening. When the user needs to expand the subareas in which direction, the subareas in the corresponding direction are filled, and other subareas can be not filled. The uninflated subregion is in a contracted state to reduce the resistance to fluid flow on the surface of the first expansion body and thereby increase the fluid flow rate. In some embodiments, only one inner tube may be provided and the gas injection openings are all provided on the inner tube. In other embodiments, the number of the inner tubes may be greater than one, and the distribution of the gas injection openings on the inner tubes may be adjusted according to the distribution of the sub-regions.

In an alternative embodiment, as shown in fig. 15, the distal end of the main body is provided with a shaft 1501 extending along the axial direction of the main body, and the first expansion body is wrapped around the shaft and connected to both ends of the shaft, respectively, to reduce eccentricity of the first expansion body. It will be appreciated that if the first expansion body is attached at only one end to the distal end of the main body, the distal end of the first expansion body will be free and will undergo eccentric movement when subjected to external forces, such as swinging along the first expansion body to main body connection point, which increases the probability of the fluid pumping catheter coming into engagement with the ventricular wall. For this purpose, in this embodiment, a shaft extending in the axial direction of the main body is provided at the distal end of the main body, and both ends of the shaft are connected to the first expansion body, respectively, and the shaft can be covered when the first expansion body expands, so that both ends of the first expansion body are restrained by the shaft to avoid eccentric movement thereof. Preferably, the distal end and the proximal end of the first expansion body are connected to two ends of the shaft respectively. For example, when the first expansion body is spherical, the distal end and the proximal end of the first expansion body are located at two end points with the same diameter, and the two end points are respectively connected to the shaft rod, so that the first expansion body can be effectively restrained from eccentric movement caused by external force. When the first expansion body is in a revolving body structure, the distal end and the proximal end of the first expansion body are two endpoints positioned on the revolving axis. In an alternative embodiment, the shaft is provided with a vent, the vent is communicated with the interior of the first expansion body, and the vent is used for injecting or exhausting gas into or from the expansion body. In some embodiments, the shaft is disposed parallel to the inner tube 304 as described above, for example, the shaft is coaxially disposed with the inner tube, or the shaft is disposed side-by-side and non-coaxially with the inner tube. In some embodiments, the shaft may be the inner tube described above, which reduces the complexity of the structure and saves manufacturing costs.

In an alternative embodiment, the catheter further comprises a second expansion body disposed at the distal end of the main body and disposed within the first expansion body, wherein a first space is formed between the inner surface of the first expansion body and the outer surface of the second expansion body. Preferably, the first space is filled with a developing substance. At this time, the fluid pumping catheter is effectively compatible with a digital subtraction angiography Device (DAS) commonly used in the prior art, and an operator can observe the working state of the fluid pumping catheter in a human body through the digital subtraction angiography device.

Referring to fig. 6, there is shown a close-up view of the distal end of a fluid pumping catheter having a second inflation body. The first expansion body 101 and the second expansion body 602 may be formed in a balloon shape. The second expansion body is nested inside the first expansion body, and a first space 603 is formed between the inner surface of the first expansion body and the outer surface of the second expansion body. By means of the two expansion bodies which are arranged in a nested manner, when the second expansion body inside is broken and leaked due to excessive gas filling, the first expansion body on the outer layer can store the gas, so that the gas is prevented from entering the blood vessel or the organ.

Preferably, the first space is filled with a developing substance. The developing substance may be a contrast agent, or other substance having an equivalent function. The first space constrains the distribution of the developing substance as it fills the bilayer nested intumescent interlayer. The distribution of the developer in the space in this embodiment is more uniform than in the case of directly filling the developing substance inside the single-layer balloon, which is more advantageous for observing the state of the inflation body in the body through the display device. The first space between the first expansion body and the second expansion body is filled with developer and/or a small amount of gas, so that the pressure inside the first expansion body is smaller than the pressure inside the second expansion body. Therefore, when the second expansion body is accidentally broken, the gas in the second expansion body can enter the first expansion body, and the gas leaked by the second expansion body can be effectively contained under the smaller pressure condition of the first expansion body, so that the risk that the gas directly enters blood to form a gas plug is avoided, and finally the safety of the catheter is improved.

In an alternative embodiment, the second inflatable body is made of an elastic material and/or the first inflatable body is made of a semi-compliant material. The elastic material comprises synthetic latex, silica gel, rubber, TPE, TPX, TPU, WPU and other high-elastic materials. In practice, the first expansion body is preferably made of high-elastic materials such as synthetic latex, thermoplastic elastomer (TPE), thermoplastic polyurethane elastomer (TPU), and the like, and compared with the scheme of manufacturing the balloon by using natural latex in the prior art, the high-elastic material can be compatible with the latex intolerant people, and the safety and the applicable crowd range of the pumping catheter are improved. In addition, the semi-compliant material may be PEBAX or the like. Wherein the material with the expansion ratio of 110-130% is a semi-compliant material.

In an alternative embodiment, the distal end of the main body is provided with a first air hole 606 and a second air hole 605, wherein the first air hole is communicated with the interior of the second expansion body, and the second air hole is communicated with the first space. As shown in fig. 6, in order to facilitate the respective inflation of the first space and the inner space 604 of the second expansion body and the respective control of the amount of the inflation gas, it is necessary to provide respective inflation passages for the first space and the inner space of the second expansion body.

In an alternative embodiment, the catheter further comprises a third inflation body disposed outside the body and the interior of the first inflation body is in fluid communication with the interior of the third inflation body. As shown in fig. 7, the pumping catheter includes a first inflation body 101 at the distal end and a third inflation body 702 near the proximal handle. And the interior of the first expansion body and the interior of the third expansion body are in fluid communication. In this embodiment, the first swelling body disposed at the distal end is not filled with the developing substance, and the developing agent is not added to the material of the first swelling body, so that the operator cannot observe the state of the first swelling body disposed in the body by a conventional developing device. Accordingly, to facilitate the operator's real-time understanding of the state of the first inflation body in the body, one embodiment of the present disclosure employs a dual inflation body design, with the third inflation body disposed proximally. In use, the first inflatable body is inserted into the human body along a blood vessel, and the third inflatable body is placed outside the body. Due to the fluid communication of the internal spaces of the first expansion body and the third expansion body, the internal pressures of the two expansion bodies are equal in real time. When the state parameters such as pressure, volume and the like of any expansion body are changed, the state parameters of the other expansion body are changed. That is, by the structural design of this embodiment of the present disclosure, when the first expansion body is located in the body and the third expansion body is located in the body, the volume change of the third expansion body can reflect the working state of the first expansion body. Therefore, the operator can know the state of the first expansion body in real time by observing the state of the third expansion body outside the body. Specifically, when the operator performs an inflation or deflation operation, the first inflatable body and the third inflatable volume will expand or contract simultaneously. Through connecting the inner spaces of the two expansion bodies in series, an operator does not need to develop substances, and does not need to observe the state of the expansion body in the body by means of additional display equipment, the state of the first expansion body in the body can be known only by observing the state of the third expansion body outside the body, the purpose of simply and conveniently observing the state of the pumping catheter is achieved, various problems caused by misoperation of the expansion body in the body by the operator in the prior art are solved, for example, the operation time is prolonged by repeated inflation and deflation confirmation, the risk of balloon rupture is increased, balloon leakage can lead to direct gas injection into blood and blood vessels, and the problems are all adverse events in clinic. Moreover, the device disclosed by the invention enables an operator to timely treat the emergency when observing that the third expansion body outside the body is abnormal, avoids the problems of leakage, embolism, and the like of the expansion body inside the body, effectively improves the use safety of the pumping catheter, and improves the efficiency of clinical medical treatment. It will be appreciated that the above-described extra-corporeal third inflatable body is equally applicable to a solution with nested inflatable bodies in the body, and for a solution with nested inflatable bodies in the body, it is preferred that said extra-corporeal third inflatable body is arranged in fluid communication with the innermost inflatable body in the body.

In an alternative embodiment, the outer diameters of the first expansion body and the third expansion body are equal in the non-compressed state of the first expansion body. Since the internal space of the blood vessel or organ of the human body is small, the outer diameters of the first and third inflation bodies are also small. Under such conditions, when the volume difference of the two inflatable bodies in the normal inflated state is large, especially when the outer diameter difference is large, and the volume or pressure change of the inflatable body in the body is slow, it will be difficult for the operator to find the volume change of the inflatable body in the body in time. Especially when the volume of the in vitro expansion is significantly larger than the volume of the in vivo expansion, the minor diameter change of the in vitro expansion is less visually apparent. In addition, when the outer diameters of the two expansion bodies are different, the operator has difficulty in knowing the real-time volume change of the expansion bodies in the body during the inflation process. For this purpose, in one embodiment of the present disclosure, the outer dimensions of the two expansion bodies are set to be identical, so that the dimensions, in particular the outer diameter, of the two expansion bodies are identical in the unaerated state and in the normally inflated state. When the first expansion body works normally in the body, that is, when the first expansion body is in a non-compressed state, the outer diameter of the first expansion body is equal to the outer diameter of the third expansion body. By the design, when an operator inflates or deflates the inflatable body, the outer diameter of the first inflatable body in the body can be known by observing the outer diameter of the third inflatable body in the body, and the inflation is stopped when the outer diameter of the third inflatable body reaches the target value, so that the outer diameter of the first inflatable body in the body is safely and efficiently controlled.

In an alternative embodiment, the first expansion body and the third expansion body are made of materials with the same expansion ratio. In order to enable parameters such as the volume and the outer diameter of one expansion body to synchronously and stably change along with the change of the other expansion body, especially to ensure that the outer diameters of the two expansion bodies are the same in the process of inflation or deflation, two expansion bodies are made of materials with the same expansion ratio in one embodiment of the present disclosure to solve the problem. Preferably, the same material is used for both expansion bodies. By way of example, the expansion body may be made of a highly elastic material such as synthetic latex, silicone rubber, TPE, TPX, TPU, WPU, etc. Compared with natural latex, the expansion body made of the material can be compatible with the latex intolerant people, and the use safety and the applicable crowd range of the pumping catheter are improved.

In an alternative embodiment, the third expansion body includes at least a first expansion state and a second expansion state, and when the internal pressure of the first expansion body is greater than or equal to the set pressure threshold, the third expansion body is switched from the first expansion state to the second expansion state. In the implementation shown in fig. 8 to 10, the third expansion body includes three expansion states, that is, a first expansion state shown in fig. 8, a second expansion state shown in fig. 9, and a third expansion state shown in fig. 10. In each expansion state, the outer diameter of the expansion body is in discontinuous and discrete distribution, namely, the diameter OD1 shown in fig. 8 needs to be stepped to the OD2 shown in fig. 9 when a preset pressure is met, and the diameter OD2 shown in fig. 9 needs to be stepped to the OD3 shown in fig. 10 when another preset pressure is met. It should be noted that the number of expansion states is merely an example, and may be reasonably set according to the use requirement in practice. In practice, the working state of the first expansion body in the body is reflected by setting different expansion states. For example, the safety pressure threshold is taken as the set pressure threshold, and since the first expansion body is positioned in the blood vessel or the organ, the expansion of the volume is restrained by the blood vessel or the organ. When the first expansion body is continuously inflated, the blood vessel or organ presses the first expansion body so that the volume of the first expansion body cannot be increased, the external pressure applied to the first expansion body is increased, the internal pressure is also increased gradually, and when the internal pressure of the first expansion body is greater than or equal to a safety pressure threshold value, the third expansion body is stepped from a first expansion state shown in fig. 8 to a second expansion state shown in fig. 9. The outer diameter of the secondary expansion state is obviously larger than that of the primary expansion state, and an operator can obviously find out the outer diameter change of the third expansion body outside the body and confirm that the internal pressure of the first expansion body inside the body reaches a safety threshold. More advantageously, when the third expansion body is stepped to the second expansion state, the volume change of the third expansion body greatly reduces the internal pressure, so that the internal pressure of the first expansion body is reduced to be within a safe range, the outer diameter of the third expansion body is correspondingly reduced, the problems of bursting and the like are avoided, the time for processing the internal pressure of the expansion body is enough for an operator, and the use safety of the instrument is further improved. Of course, when the pressure of the inflation body is within the safety threshold, the maximum outer diameter of the inflation body is OD1 shown in fig. 8.

In an alternative embodiment, the third inflatable body includes an undeployed section, wherein the undeployed section is opened to effect a switch from the primary inflation state to the secondary inflation state when the internal pressure of the first inflatable body is greater than or equal to the set pressure threshold. In an alternative embodiment, the unexpanded section includes a fold. To achieve the previously described step change in the outer diameter of the inflation body between the different inflation states, one embodiment of the present disclosure addresses this problem by providing an undeployed section on the inflation body. The undeployed parts can be arranged at a plurality of positions of the expansion body, and the number of the undeployed parts can be also a plurality of, and the undeployed parts can be matched with the corresponding pressure threshold values by reasonably controlling the connection strength of the undeployed parts so as to realize the deployment under different pressure threshold values. Preferably, the undeployed section is disposed radially of the third inflatable body and is configured to cause a significant change in outer diameter upon deployment. As shown in fig. 8 to 10, the third expansion body is folded in the diameter direction with a first folded portion 401 and a second folded portion 402, and the expansion pressures of the two folded portions are different. When the internal pressure of the first expansion body reaches a first pressure threshold, the first folding part 401 is unfolded, the second folding part 402 is not unfolded, the outer diameter of the third expansion body is stepped from OD1 to OD2, and when the internal pressure of the first expansion body is further increased and reaches a second pressure threshold, the second folding part 402 is unfolded, and the outer diameter of the third expansion body is stepped from OD2 to OD3. The folding portion may be folded on one side as shown in fig. 8, or may be folded on both sides (not shown). The above-mentioned folding modes are examples, and are not limiting to the scope of the present disclosure. It will be appreciated that the folded or unfolded portion may take other forms than those described in the embodiments of the present disclosure, and need only be unfolded at a predetermined pressure.

In an alternative embodiment, the undeployed section is maintained in an undeployed state by at least one of bonding, heat staking, heat shrinking, or welding. Taking the folded state shown in fig. 8 as an example, in practice, it is necessary to design the connection strength of the folded portion according to a predetermined unfolding pressure. The folded position may be glued, heat fused, heat shrunk or welded to obtain sufficient connection strength. Wherein, the welding mode can be laser welding. Parameters such as specific connection positions and connection areas of the folding parts can be flexibly adjusted according to requirements.

In an alternative embodiment, a pressure measurement unit 1101 is provided on the surface of the first inflation body disposed at the distal end of the main body. In practice, the pumping catheter collides with human tissues in the process of intervention, and how to accurately measure the impact load of the front end of the catheter on the human tissues is an important precondition for ensuring the safety of the intervention process. To this end, in one embodiment of the invention the problem is solved by providing a pressure measuring unit at the surface of the expansion body. For the case of a solution in which only one expansion body is provided in the body, the pressure measuring unit is provided on the surface of the expansion body, and for the case of a solution with a plurality of expansion bodies in the body, the pressure measuring unit is provided on the surface of the expansion body of the outermost layer. Preferably, the pressure measuring unit is disposed on an outer surface of the expansion body. The pressure measuring unit can measure the received pressure load, when the expansion body collides with human tissues, the measured value of the pressure measuring unit greatly rises, and the measured value can be transmitted to the display unit through the sensor connector 1102 arranged at the proximal end, so that an operator can know the pressure-bearing state of the expansion body in real time.

In an alternative embodiment, a pacing unit 1201 is provided on the surface of the first expansion body disposed at the distal end of the body. Preferably, the pacing unit is a pacing electrode, and a pacing electrode joint 1202 electrically connected to the pacing electrode is further disposed at the handle of the apparatus. When a patient conduction block is encountered during surgery, the operator can rapidly pace the heart chamber through the pacing electrode. For the case of a solution where only one expansion body is provided in the body, the pacing unit is provided on the surface of the expansion body, while for the case of a solution with a plurality of expansion bodies in the body, the pacing unit is provided on the surface of the expansion body of the outermost layer. Preferably, the pacing unit is disposed on an outer surface of the expansion body.

The above embodiments do not limit the scope of the present application. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the disclosed technology. This application is intended to cover any adaptations, uses, or adaptations of the disclosure following, in general, the principles of the disclosure and including such departures from the present disclosure as come within known or customary practice within the art to which the disclosure pertains. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the disclosure being indicated by the following claims.

It is to be understood that the present disclosure is not limited to the precise arrangements and instrumentalities shown in the drawings, and that various modifications and changes may be effected without departing from the scope thereof. The scope of the present disclosure is limited only by the appended claims.

Claims

1. A fluid pumping catheter which is capable of pumping fluid,

The method is characterized in that:

the catheter comprises a first expansion body and a main body;

2. The fluid pumping catheter of claim 1, wherein the fluid pumping catheter is configured to pump fluid,

The outer surface of the first expansion body is provided with a fluid flow gap.

3. The fluid pumping catheter of claim 2, wherein the fluid pumping catheter is configured to pump fluid,

The first expansion body comprises a plurality of sub-areas;

4. A fluid pumping catheter as defined in claim 3, wherein,

The junction of the outer surfaces of adjacent sub-regions forms the fluid flow gap.

5. The fluid pumping catheter of claim 1, wherein the fluid pumping catheter is configured to pump fluid,

The distal end of the body is provided with a shaft extending along the axial direction of the body;

6. The fluid pumping catheter of any of claims 1-5,

The catheter also comprises a second expansion body which is arranged at the distal end of the main body and is arranged inside the first expansion body;

7. The fluid pumping catheter of claim 6, wherein the fluid pumping catheter is configured to pump fluid,

The first space is filled with a developing substance.

8. The fluid pumping catheter of claim 1, wherein the fluid pumping catheter is configured to pump fluid,

The catheter further includes a third inflation body disposed external to the body and in fluid communication with the interior of the first inflation body and the interior of the third inflation body.

9. The fluid pumping catheter of claim 8, wherein the fluid pumping catheter is configured to pump fluid,

The third expansion body at least comprises a primary expansion state and a secondary expansion state, and when the internal pressure of the third expansion body is larger than or equal to a set pressure threshold value, the third expansion body is switched from the primary expansion state to the secondary expansion state.

10. A fluid pumping catheter according to any of claims 1 to 5, wherein a pressure measurement unit is provided on a surface of the first inflation body disposed at the distal end of the main body.

11. The fluid pumping catheter of any of claims 1-5,

A pacing unit is disposed on a surface of the first expansion body disposed at the distal end of the body.