阅读说明：本技术 为Fontan病人提供循环动力的经导管植入柔性双腔辅助装置 (Transcatheter implanted flexible dual lumen accessory device for providing circulatory power to a Fontan patient ) 是由 王盛章 陈童 于 2021-08-26 设计创作，主要内容包括：本发明公开了一种为Fontan病人提供循环动力的经导管植入柔性双腔辅助装置,包括：外部支架,该外部支架为一柔性自膨胀支架,膨胀后用于装置的固定；转轴,该转轴上端与所述外部支架的上端可旋转地连接,所述转轴的下端连接动力单元；叶轮,该叶轮位于所述外部支架内,并安装在所述转轴上随其转动,所述叶轮的轮毂为流线型结构。柔性双腔辅助装置具有可压缩性,通过微创手术依靠输送导管经由股静脉植入病人体内,避免复杂开胸手术以及较大的手术创伤。叶轮旋转时,可为病人提供循环动力,同时辅助上、下腔静脉血液进入肺动脉,即使出现故障,叶轮处于静止状态,叶轮轮毂的流线型设计依然可以减少血液从腔静脉流入肺动脉所消耗的能量。(The invention discloses a transcatheter implanted flexible double-cavity auxiliary device for providing circulatory power for a Fontan patient, which comprises: an external stent, which is a flexible self-expanding stent and is used for fixing the device after being expanded; the upper end of the rotating shaft is rotatably connected with the upper end of the external bracket, and the lower end of the rotating shaft is connected with a power unit; the impeller is positioned in the external support and is arranged on the rotating shaft to rotate along with the rotating shaft, and a hub of the impeller is of a streamline structure. The flexible double-cavity auxiliary device has compressibility and is implanted into a patient through femoral veins by means of a delivery catheter through minimally invasive surgery, so that complex open chest surgery and large surgical trauma are avoided. When the impeller rotates, the impeller can provide circulating power for a patient, meanwhile, the upper vena cava blood and the lower vena cava blood are assisted to enter the pulmonary artery, and even if the impeller breaks down, the impeller is in a static state, and the energy consumed by the blood flowing into the pulmonary artery from the vena cava can be reduced due to the streamline design of the impeller hub.)

1. A transcatheter implantable flexible dual lumen assist device for providing circulatory power to a Fontan patient, comprising:

an external stent, which is a flexible self-expanding stent and is used for fixing the device after being expanded;

the upper end of the rotating shaft is rotatably connected with the upper end of the external bracket, and the lower end of the rotating shaft is connected with a power unit;

the impeller is positioned in the external support and is arranged on the rotating shaft to rotate along with the rotating shaft, and a hub of the impeller is of a streamline structure.

2. The device of claim 1, wherein the external frame is fixedly connected to a bearing housing at an upper end thereof, the bearing housing is provided with a bearing therein, and the upper end of the rotating shaft is connected to the bearing.

3. The flexible dual lumen access device of claim 2 wherein the bearing housing has an oval cross-sectional shape at its upper end.

4. The device of claim 2, wherein the outer stent is connected at its lower end to a constricting ring, said constricting ring being movably mounted on said shaft and being capable of moving axially along said shaft to effect expansion or contraction of said outer stent.

5. The device of claim 1, wherein the outer stent is a hollow cage-like structure, and the outer stent has two ends and a middle part which are arranged sparsely and the parts which are tightly attached to the vessel wall are arranged densely.

6. The flexible dual lumen access device of claim 4 wherein the outer stent is made of a wire alloy material.

7. The flexible dual lumen access device of claim 1 wherein the power unit comprises a motor, a cable, and the lower end of the shaft is connected to an output shaft of the motor.

8. The device of claim 1, wherein the impeller is a deformable symmetrical structure consisting of an outer layer of bladed units and an inner layer of non-bladed units, and the impeller is a spindle structure with a cross-section of spline shape at both upper and lower ends.

9. The device of claim 8, wherein the shaft has upper and lower splines, the upper spline has a shorter length and the lower spline has a longer length, the lower spline has a smaller size than the upper spline, the upper end of the impeller is fixed to the shaft by the splines, and the lower end of the impeller is sleeved to the shaft by a clearance fit of the splines and can move in the axial direction.

10. The flexible dual lumen access device for providing circulatory power to a Fontan patient as claimed in claim 8 wherein said impeller is made of a flexible material and the blades of said bladed unit are perpendicular to the hub surface of said impeller.

Technical Field

The invention relates to the technical field of Fontan postoperative auxiliary treatment instruments, in particular to a transcatheter implanted flexible double-cavity auxiliary device for providing circulating power for a Fontan patient.

Background

Fontan surgery is the first choice for treating various complex congenital heart diseases such as tricuspid valve occlusion, single ventricle, aortic transposition, right ventricular and double outlet combined pulmonary artery stenosis and left ventricular dysplastic syndrome. The Fontan operation of the central and outer conduits is advocated for reducing atrial sutures and is widely used. After undergoing such surgery, the superior and inferior vena cava of the patient are directly connected to the pulmonary artery, forming a full vena cava-pulmonary artery connection structure (TCPC structure). Although the structure separates arteriovenous blood and solves the problem of hypoxia of organs of a patient, the patient still relies on a single ventricle to provide power for body and lung circulation. Various complications due to insufficient circulatory power can occur after surgery: the central venous pressure is too high, the pulmonary artery pressure is too low, the single ventricle preload is increased, the lung perfusion is insufficient, and the like, so the pulmonary resistance of a patient and the impedance of the whole blood vessel are increased, and finally the single ventricle heart failure is caused. The auxiliary device is used for providing circulating power for the patient, so that the postoperative pulmonary perfusion of the patient is increased, the load of a single ventricle is reduced, and the auxiliary device has great significance for improving the survival condition of the patient.

The invention patent with the patent application number of CN202110174888.0 discloses a serial axial flow pump auxiliary device for auxiliary treatment after Fontan operation, which pumps blood in superior and inferior vena cava to pulmonary artery respectively through two axial flow pump rotors which are connected on the same rotating shaft and face opposite directions. However, this device is complicated in structure, and when the operation is stopped due to a failure, the two axial flow pump rotors act as resistance to the entry of vena cava blood into pulmonary artery, and the load on the single ventricle is increased. In addition, such devices tend to be large in size, and when implanted into the body, they can easily cause surgical trauma and cause pain to the patient.

Disclosure of Invention

The invention aims to solve the problem that the existing device can block vena cava blood from entering pulmonary artery when in a static state, and provides a flexible double-cavity auxiliary device implanted through a catheter, which is used for providing circulation power for Fontan patients and improving the postoperative survival condition of the patients.

The purpose of the invention is realized by the following technical scheme:

a transcatheter implanted flexible dual lumen assist device for providing circulatory power to a Fontan patient, comprising:

an external stent, which is a flexible self-expanding stent and is used for fixing the device after being expanded;

the upper end of the rotating shaft is rotatably connected with the upper end of the external bracket, and the lower end of the rotating shaft is connected with a power unit;

the impeller is positioned in the external support and is arranged on the rotating shaft to rotate along with the rotating shaft, and a hub of the impeller is of a streamline structure.

When the impeller rotates, the device can provide circulating power for a patient and simultaneously assist superior and inferior vena cava blood to enter pulmonary arteries; when breaking down, the impeller is in quiescent condition, because impeller wheel hub's streamlined design, still can reduce the blood and flow into the energy that pulmonary artery consumed from vena cava, solve current device and exist when being in quiescent condition and hinder vena cava blood to get into pulmonary artery's problem.

The external support is from the inflation support, before the operation, the support can be compressed in carrying the pipe, and then whole device is implanted patient internal through the femoral vein through minimal access surgery, the device release back, the expansion of external support closely laminates with the vena cava inner wall, play the effect of fixed whole device, the design of this kind of flexible two-chamber auxiliary device has certain compressibility, rely on carrying the pipe to implant patient internal through the femoral vein through minimal access surgery, avoid complicated open chest operation and great operation wound.

Furthermore, the upper end of the external support is fixedly connected with a bearing seat, a bearing is arranged in the bearing seat, and the upper end of the rotating shaft is connected with the bearing.

Furthermore, the cross section of the upper end of the bearing seat is in an elliptical shape, so that energy loss when the superior vena cava blood flows into the device can be reduced.

Furthermore, the lower end of the external support is connected with a tightening ring, the tightening ring is movably sleeved on the rotating shaft and can axially move along the rotating shaft, and the external support is expanded or contracted.

The bunching ring provides attachment sites for the lower end of the outer support, is not in contact with the rotating shaft, can move along the axial direction, and is in a suspended state when the support is in an expanded state. When the bracket is in a compressed state, the constricting ring is in contact with the motor shell.

The original state of the stent is the expanded state. Prior to surgery, the stent is compressed within the delivery catheter with the aid of ice water. The entire device is then implanted into the patient via the femoral vein by minimally invasive surgery. After the device is released, the external support expands and is tightly attached to the inner wall of the vena cava, the whole device is fixed, the vena cava can be further propped open by the support, and the vena cava is prevented from collapsing due to local low pressure generated in the operation process of the device.

Further, the outer support be the cage-like structure of fretwork, outer support both ends and middle range are more sparse for blood receives less when being inhaled the device and being pumped to pulmonary artery from the device, arranges densely with the position that the vascular wall closely laminated, helps increasing the area of contact and the interact of support and vascular wall, makes the device can steady operation.

Furthermore, the outer support is made of alloy wires.

Furthermore, the power unit comprises a motor and a cable, the lower end of the rotating shaft is connected with an output shaft of the motor, and the motor is powered by the cable to provide power for the rotation of the rotating shaft and the impeller.

Furthermore, the impeller is of a deformable symmetrical structure and is formed by overlapping units with blades on the outer layer and units without blades on the inner layer, and the cross sections of the upper end and the lower end of the impeller are of a spindle body structure in a spline shape. Further, be equipped with upper and lower two splines in the pivot, upside spline length is shorter, and downside spline length is longer, and the size ratio of downside spline is little than the size of upside spline, the impeller upper end is fixed through the spline in the pivot, the lower extreme passes through spline clearance fit cover and establishes in the pivot to can remove along the axial. The design enables the upper end of the impeller to be tightly clamped in the spline on the upper side of the rotating shaft, meanwhile, the lower end of the impeller can move along the axial direction, and in addition, the impeller and the rotating shaft are connected through the spline, so that torque transmission is facilitated.

Further, the impeller is made of flexible materials, and the blades of the unit with the blades are perpendicular to the surface of the hub of the impeller. The outer layer is a unit with blades and mainly plays a role in rotating to do work; the inner layer is a unit without blades and is used for filling gaps between the outer layer units, and the design enables the distance between the outer layer units and the distance between the inner layer units to be changed, so that the compressibility of the impeller is realized.

The impeller is compressed in the conveying conduit before operation, the distance between the outer layer units and the distance between the inner layer units are smaller, the overlapped part of the inner layer and the outer layer is larger, the distance between the upper end and the lower end of the impeller is larger, and the maximum diameter of the impeller is smaller. After the device is released, the impeller is restored to the original state, the distance between the outer layer units and the distance between the inner layer units are larger, the overlapped part of the inner layer and the outer layer is smaller, the distances between the upper end and the lower end of the impeller are reduced, and the maximum diameter of the impeller is increased. When the impeller is in a static state, the streamline design of the hub can effectively avoid blood flow hedging of the upper vein and the lower vein, guide blood to flow to the pulmonary artery from the vena cava, and reduce the energy loss of the blood. When the impeller rotates, the symmetrical impeller structure can provide power for the upper and lower vena cava blood flow simultaneously. Thus, the impeller can relieve single ventricle load both when stationary and when rotating.

When the device is used in particular, the device is compressed and placed in a delivery catheter with the aid of ice water before surgery. The femoral vein is then opened, the device is advanced into the patient through a delivery catheter, and the location of release is determined by means of contrast agent and X-rays. After release, the stent expands and is tightly attached to the inner wall of the vena cava, the upper end and the lower end of the device are respectively positioned in the upper vena cava and the lower vena cava, and the impeller is positioned in the center of the TCPC. The stent filaments at the upper, lower and middle portions of the stent are relatively sparsely arranged and serve as the inlet and outlet of the device. The impeller is a work doing part, the motor is used for driving the rotating shaft and the impeller, and the cable supplies power to the motor. When the device is in operation, the symmetrical impellers rotate, and blood in the superior and inferior vena cava enters the device along the two ends of the stent and is pumped into the pulmonary artery. In the process, the impeller accelerates and pressurizes the blood, so that the pressure of the vena cava is reduced, the pressure of the pulmonary artery is increased, the load of a single ventricle is reduced, and the postoperative condition of a patient is improved.

The invention provides a transcatheter implanted flexible double-cavity auxiliary device for providing circulating power for Fontan patients, the diameters of an external bracket and an impeller can be adjusted, and blades can be curled. The overall device is compressed in the delivery catheter prior to surgery, the maximum diameter of the device is small, implantation via the femoral vein by minimally invasive surgery is facilitated, and major surgical trauma is avoided. After the release is finished, the impeller rotates to assist the superior vena cava blood and the inferior vena cava blood to enter the pulmonary artery. The impeller hub is of a unique streamline design, even if the impeller cannot rotate due to faults, the static impeller can also avoid the blood flow of the upper and lower vena cava from being flushed, the energy consumed by the vena cava blood entering the pulmonary artery is reduced, and the load of a single ventricle is reduced.

Compared with the prior art, the invention has the following beneficial effects:

1. compared with the prior art, the device has simple structure, and the impeller can lighten the load of the single ventricle when in static and rotating states. The problem of prior art when stopping because of the trouble, inside complicated structure hinders blood to flow to the pulmonary artery from the vena cava on the contrary is solved.

2. The device has compressibility, can be implanted through femoral vein through minimally invasive surgery without destroying the built TCPC structure, and avoids bringing great surgical trauma and complex open chest surgery process to the very fragile patient.

Drawings

FIG. 1 is a front view (released configuration) of a flexible dual chamber assist device in accordance with an embodiment of the present invention;

FIG. 2 is a front view (compressed configuration) of a flexible dual chamber assist device in accordance with an embodiment of the present invention;

FIG. 3 is an enlarged partial cross-sectional view of a bearing and a cinch ring of a flexible dual chamber assist device in accordance with an embodiment of the present invention;

FIG. 4 is an elevation, plan and close-up view of an impeller in a flexible dual chamber assist device in accordance with an embodiment of the present invention;

FIG. 5 is a front and left side view of two components (a bladed unit and an un-bladed unit) of an impeller in a flexible dual chamber assist device in accordance with an embodiment of the present invention;

FIG. 6 is an elevation view and a section view of a shaft in a flexible dual chamber assist device in accordance with an embodiment of the present invention;

FIG. 7 is a schematic view of an impeller and a rotating shaft in a flexible dual-chamber auxiliary device according to an embodiment of the present invention in an operating state and a cross-sectional view showing spline-fitting of upper and lower ends of the impeller to upper and lower sides of the rotating shaft;

FIG. 8 is a sectional view and a partially enlarged view of an impeller and a rotating shaft of a flexible dual chamber auxiliary device according to an embodiment of the present invention in an operating state;

FIG. 9 is a schematic view of an impeller and a shaft in a compressed state and an enlarged partial cross-sectional view of the upper and lower ends of the impeller in a flexible dual chamber assist device in accordance with an embodiment of the present invention;

FIG. 10 is a schematic view of a flexible dual chamber accessory of an embodiment of the present invention in operation within a TCPC;

description of reference numerals:

1-a bearing seat; 2-a rotating shaft; 3-an external scaffold; 4-an impeller; 5-a bundling ring; 6, a motor; 7-a cable; 8-inferior vena cava; 9-superior vena cava; 10-pulmonary artery; 11-a bearing; 41-bladed units; 42-unit without vanes.

Detailed Description

The invention is described in detail below with reference to the figures and specific embodiments.

1-10, a transcatheter implantable flexible dual lumen accessory device for providing circulatory power to a Fontan patient, comprising: bearing seat 1, rotating shaft 2, external support 3, impeller 4, bundling ring 5, motor 6, cable 7 and bearing 11

The two ends of the external bracket 3 are respectively connected with the housing of the bearing seat 1 and the constricting ring 5 (as shown in figure 3). The impeller 4 is designed in a symmetrical structure, one end of the impeller is fixed in a spline on the upper side of the rotating shaft 2, and the other end of the impeller can move in the spline on the lower side of the rotating shaft 2 along the axial direction. One end of the rotating shaft 2 is connected with a bearing 11 in the bearing seat 1 (as shown in fig. 3), and the other end is connected with an output shaft of the motor 6. The motor 6 is connected to a cable 7.

The outer support 3 is made of nickel-titanium alloy, the upper end of the outer support is connected with the outer shell of the bearing seat 1, and the lower end of the outer support is connected with the contraction ring 5. The bearing block 1 is fixed and the collar 5 is movable in the axial direction, so that the holder 3 can be contracted and expanded. The original state of the stent 3 is the expanded configuration. Before the operation, the stent 3 is compressed in the delivery catheter by means of ice water (fig. 2 is a contracted state). The entire device is then implanted into the patient via the femoral vein by minimally invasive surgery. After the device is released, the external support 3 expands and is tightly attached to the inner wall of the vena cava to play a role in fixing the whole device, and the support 3 can also prop open the vena cava to prevent the vena cava from collapsing caused by local low pressure generated in the operation process of the device. The alloy wires at both ends and in the middle of the stent 3 are relatively sparse in arrangement, so that blood is less obstructed from being drawn into the device from the vena cava and pumped from the device to the pulmonary artery. The alloy wires at the part tightly attached to the vessel wall are densely arranged, which is helpful for increasing the contact area and the interaction force of the stent 3 and the vessel wall, so that the device can stably operate.

As shown in fig. 4 and 5, the impeller 4 is made of a flexible material and can be deformed. Structurally, it consists of two basic cells (a bladed cell 41 and an unfladed cell 42) overlapped. The outer layer is a unit 41 with blades, and mainly plays a role in doing rotary work. The inner layer is a non-bladed cell 42 for filling the gap between the outer cells. The vertical areas of the upper and lower ends of all the basic units are connected with each other to form a whole with the cross section in the shape of an internal spline, but the middle parts of all the basic units are not connected. Such a design allows the distance between the outer layer elements and the distance between the inner layer elements to be varied, achieving compressibility of the impeller 4.

Referring to fig. 7 to 9, the upper end of the impeller 4 is in interference fit with the external spline on the upper side of the rotating shaft 2, and the upper end of the impeller 4 is tightly clamped on the rotating shaft 2. The lower end of the impeller 4 is in clearance fit with the external spline on the lower side of the rotating shaft 2, and the lower end of the impeller 4 can move along the axial direction. The original form of the impeller 4 is an expanded form, and before the operation, the impeller 4 is compressed in the delivery catheter, at the moment, the distance between the outer layer units and the distance between the inner layer units are smaller, the overlapping part of the inner layer and the outer layer is larger, the distance between the upper end and the lower end of the impeller 4 is larger, and the maximum diameter of the impeller 4 is smaller. After the device is released, the impeller 4 is restored to the original state, the distance between the outer layer units and the distance between the inner layer units are larger, the overlapping part of the inner layer and the outer layer is smaller, the distances between the upper end and the lower end of the impeller 4 are reduced, and the maximum diameter of the impeller 4 is increased. When the impeller 4 is in a static state, the streamline design of the hub can effectively avoid blood flow hedging of the upper vein and the lower vein, guide blood to flow to the pulmonary artery from the vena cava, and reduce the energy loss of the blood. When the impeller 4 rotates, the symmetrical impeller structure can simultaneously provide power for the superior and inferior vena cava blood flow. Thus, the impeller 4 can relieve single ventricle loads both when stationary and when rotating.

As shown in fig. 6, one end of the rotating shaft 2 is fixed in the bearing 11, and the other end is connected with the output shaft of the motor 6. The rotating shaft 2 is provided with an upper spline and a lower spline, the length of the upper spline is shorter, the length of the lower spline is longer, and the size (the major diameter, the minor diameter and the key width) of the lower spline is smaller than that of the upper spline. The design makes the upper end of the impeller 4 tightly clamped in the spline on the upper side of the rotating shaft 2 and the lower end of the impeller 4 can move along the axial direction. In addition, the impeller 4 and the rotating shaft 2 are connected through splines, so that torque transmission is facilitated.

As shown in fig. 3, the bearing housing 1 contains a bearing 11 for supporting one end of the rotating shaft 2. And the cross section of the bearing seat 1 is in an elliptical shape, so that the energy loss when the superior vena cava blood flows into the device can be reduced. The collar 5 provides an attachment point for the lower end of the outer support 3 and does not contact the shaft 2. The constricting ring (5) can move along the axial direction, and when the bracket (3) is in an expansion state, the constricting ring (5) is in a suspension state. When the bracket 3 is in a compressed state, the constricting ring 5 is in contact with the motor 6 housing. The motor 6 is powered by a cable 7 to provide power for the rotation of the rotating shaft 2 and the impeller 4.

FIG. 10 is a schematic view of a flexible dual lumen accessory device in operation in a TCPC, the present invention provides a transcatheter implanted flexible dual lumen accessory device for providing circulatory power to a Fontan patient for improving the post-operative condition of the patient, solving the problem of the prior art devices designed to be in a resting state that would otherwise block the entry of vena cava blood into the pulmonary artery, and simultaneously the device can be implanted via a delivery catheter through minimally invasive surgery to avoid major surgical trauma and complicated procedures.

The embodiments described above are described to facilitate an understanding and use of the invention by those skilled in the art. It will be readily apparent to those skilled in the art that various modifications to these embodiments may be made, and the generic principles described herein may be applied to other embodiments without the use of the inventive faculty. Therefore, the present invention is not limited to the above embodiments, and those skilled in the art should make improvements and modifications within the scope of the present invention based on the disclosure of the present invention.