CN107080871B

CN107080871B - Catheter sheath and ventricular assist circulation device

Info

Publication number: CN107080871B
Application number: CN201610087572.7A
Authority: CN
Inventors: 扈聪; 卢飞; 易博; 罗七一; 陈晓丽
Original assignee: Shanghai Microport Medical Group Co Ltd
Current assignee: CARDIOPOWER MEDTECH (SHANGHAI) Co.,Ltd.
Priority date: 2016-02-16
Filing date: 2016-02-16
Publication date: 2020-11-13
Anticipated expiration: 2036-02-16
Also published as: CN107080871A

Abstract

The invention provides a catheter sheath and a ventricular assist circulation device, wherein the catheter sheath comprises a catheter body, the catheter body is provided with an elastic part capable of restoring the shape, the elastic part is made of shape memory materials, and the elastic part is in a nonlinear shape. After the catheter sheath is placed in a body, the elastic part can be tightly attached to the inner tissue of the blood vessel wall, the left atrium or the right atrium through the shape recovery of the elastic part, so that the catheter sheath is fixed on the inner tissue of the blood vessel, the left atrium or the right atrium. The ventricular auxiliary circulation device comprises the catheter sheath, and the position of the catheter sheath can be fixed after the catheter sheath is placed in a body, so that accurate positioning can be realized, the stability of the blood flow direction is ensured, the risk problem caused by the fact that the position of the existing catheter is not fixed is avoided, and the use safety and the clinical applicability of the ventricular auxiliary circulation device are improved.

Description

Catheter sheath and ventricular assist circulation device

Technical Field

The invention belongs to the technical field of medical instruments, particularly relates to a ventricular assist circulation device for assisting heart blood circulation, and particularly relates to a catheter sheath which can be placed in a human body and has a blood channel.

Background

Heart failure is the leading cause of death in patients with cardiovascular disease, and its 5-year survival rate is similar to that of malignancies. Currently, the treatment of heart failure can be broadly divided into three categories, namely drug therapy, heart transplantation and mechanical assisted circulation. Among them, the drug therapy is often effective for patients with mild or moderate heart failure, but has little effect on patients with end-stage heart failure, and the estimated mortality rates are close to 30% and 60% in 1 year and 5 years, respectively. Heart transplantation is the best method for treating end-stage heart failure, but is not widely used due to donor involvement, e.g., more than 50000 patients who are registered in hospitals each year in the united states awaiting heart transplantation, but only 2000 can receive heart transplantation surgery.

For this reason, mechanically assisted circulation has increasingly become an essential means to save patients with severe heart failure. The mechanical auxiliary circulation is that the artificial mechanical device is used to partially or completely replace the blood pumping function of the heart and ensure the blood supply of tissues and organs of the whole body. Among them, the Percutaneous Left Ventricular Assist Device (PLVAD) has been widely used in the field of mechanical Assist circulation due to its advantages of small trauma, simple structure and easy operation.

The existing percutaneous left ventricle auxiliary device is used as a channel for blood circulation through a catheter which is placed in a human body, but the catheter cannot be fixed in a blood vessel, so that positioning deviation is easy to occur, the blood flow direction is deviated, the problems of bleeding, limb ischemia, artery bifurcation and the like are caused, and the application of the percutaneous left ventricle auxiliary device is greatly influenced.

Disclosure of Invention

The invention aims to provide an introducer sheath and a ventricular assist circulation device using the same, and aims to solve the problem that catheters used on a ventricular assist circulation device in the prior art cannot be fixed in blood vessels, the left atrium and the right atrium.

To achieve the above and other related objects, the present invention provides a catheter sheath including a catheter body having a shape-recoverable resilient portion made of a shape-memory material and having a non-linear shape.

Preferably, the catheter body is of an integrally formed structure.

Preferably, the elastic portion has a curled or spiral shape.

Preferably, the elastic part is made of a thermoplastic shape memory polymer material.

Preferably, the thermoplastic shape memory polymer material is polystyrene type or polycaprolactone type.

Preferably, an anticoagulant coating is arranged on the inner wall and/or the outer wall of the catheter body.

Preferably, the catheter body is made of a polymer material.

Preferably, the distal end of the catheter body is provided with a visualization point or ring.

Preferably, the catheter body is made of a contrast material.

In addition, the invention provides a ventricular assist circulation device, which comprises the catheter sheath and a blood pump connected with the catheter sheath.

Preferably, the blood pump comprises a housing, a paddle and a driver, the housing having a first chamber and a second chamber, the first chamber having an inlet and an outlet for fluid communication of the blood pump with the exterior, and the first chamber being fluidly isolated from the second chamber; the blade is located in the first cavity, at least one part of the driving piece is located in the second cavity, and the driving piece is used for driving the blade to rotate.

Preferably, the driving member at least comprises a motor stator, and the motor stator is arranged in the second chamber and used for driving the blades to rotate through magnetic force.

Preferably, the driving member further comprises a motor rotor, and the motor rotor is arranged in the first cavity; the motor rotor is connected with the paddle or arranged in the paddle.

Preferably, the paddle is made of a magnetic material.

Preferably, the driving member comprises a motor, the motor is detachably connected with the paddle through a motor shaft or a transmission shaft, the motor is located in the second chamber, and a sealing member is arranged between the first chamber and the second chamber.

Preferably, the blood pump further comprises a transition chamber disposed between the first chamber and the second chamber, the transition chamber being in fluid communication with the first chamber, the transition chamber being fluidly isolated from the second chamber, the motor shaft or the transmission shaft extending through the transition chamber into the first chamber.

Preferably, the drive member comprises a motor and a drive magnet; at least one part of the driving magnet is connected with the motor and drives the paddle to rotate through magnetic force under the driving of the motor; at least a portion of the motor and the drive magnet are both located in the second chamber.

Preferably, the driving magnet comprises an active magnet and a passive magnet; the active magnet is connected with the motor and positioned in the second chamber, the passive magnet is connected with the paddle or arranged in the paddle, and the passive magnet is positioned in the first chamber.

Preferably, the magnetizing directions of the active magnet and the passive magnet are the same, and the active magnet is located in the magnetizing direction of the passive magnet.

Preferably, the driving magnet includes an active magnet connected to the motor and located in the second chamber, and the paddle is made of a magnetic material.

Preferably, the housing includes a first housing and a second housing, the first housing forming the first chamber, the second housing forming the second chamber, and the first housing and the second housing being detachably connected.

Compared with the prior art, the catheter sheath and the ventricular assist circulation device have the following beneficial effects:

1. after the catheter sheath is placed in a body, the elastic part can be tightly attached to the inner tissues of the blood vessel wall, the left atrium and the right atrium through the shape recovery of the elastic part, so that the catheter sheath is fixed in the blood vessel, the left atrium or the right atrium;

2. the ventricular auxiliary circulation device comprises the catheter sheath, and the position of the catheter sheath can be fixed after the catheter sheath is placed in a body, so that accurate positioning can be realized, the stability of the blood flow direction is ensured, the risk problem caused by the fact that the position of the existing catheter is not fixed is avoided, the use safety of the ventricular auxiliary circulation device is ensured, and the clinical applicability of the ventricular auxiliary circulation device is also improved;

3. the ventricle auxiliary circulation device comprises a detachable blood pump, wherein the blood pump comprises a paddle, a shell and a driving part, the shell comprises a first shell and a second shell which are detachably connected, the paddle is arranged in the first shell, so that each part of the blood pump is convenient to replace, and on the other hand, part of the driving part is not in contact with blood and can be repeatedly used to reduce the treatment cost;

4. the blood pump is directly driven by the motor or driven by a magnetic coupling or magnetic suspension mode, has few parts and simple structure, effectively reduces the quality and the using area of the device, and simplifies the driving process.

Drawings

FIG. 1 is a schematic view of a catheter sheath according to an embodiment of the present invention;

FIG. 2 is a schematic diagram of a magnetically coupled ventricular assist circulation device in accordance with an embodiment of the present invention;

FIG. 3 is a schematic diagram of a blood pump of the mechanically sealed ventricular assist circulation device in accordance with one embodiment of the present invention;

FIG. 4 is a schematic diagram of a blood pump of a magnetically coupled ventricular assist circulation device in accordance with an embodiment of the present invention;

FIG. 5 is a schematic diagram of a blood pump of a magnetic suspension type ventricular assist circulation device according to an embodiment of the present invention;

FIG. 6 is a schematic view of the configuration of an entry guide sheath without an entry dilator inserted therein in accordance with one embodiment of the present invention;

FIG. 7 is a longitudinal cross-sectional view of the entry sheath of FIG. 6 after insertion into the entry dilator;

FIG. 8 is a schematic view of the construction of an exit sheath without an exit dilator inserted therein in accordance with one embodiment of the present invention;

FIG. 9 is a longitudinal cross-sectional view of the exit sheath of FIG. 8 after insertion into the exit dilator;

FIG. 10 is a schematic structural view of an inlet expansion tube according to an embodiment of the present invention;

FIG. 11 is a schematic view of the outlet expansion tube of one embodiment of the present invention.

The drawings in the figures are illustrated as follows:

10-a ventricular assisted circulation device; 100-a catheter sheath; 110-a catheter body; 120-an elastic portion; 111-a body section; 112-bending section; 113-a necking section; 114-flow guiding holes; 1010-entry catheter sheath; 1020-an outlet catheter sheath; 1030-inlet dilation tube; 1031-first part; 1032-a second part; 1033-a throat structure; 1040-outlet dilation tube; 1041-a necked portion; 1050. 1060-quick joint; 200-blood pump; 2011-a housing; 2011 a-first housing; 2011 b-second housing; 2012-blade; 2013-a first chamber; 2014-a second chamber; 2015-inlet; 2016-outlet; 2017-a water suction chamber; 2018-a transition chamber; 2020-electric machine; 2021-motor shaft; 2022-a drive shaft; 2023-a seal; 2024-active magnet; 2025-passive magnet; 2026-isolation structures; 2027-a motor stator; 2028-electronic rotor; 2029-inlet line; 2030-outlet line.

Detailed Description

In order to make the contents of the present invention more clear and understandable, the sheath and the ventricular assist circulation device of the present invention are further described with reference to fig. 1 to 11 of the specification. The invention is of course not limited to this particular embodiment, and general alternatives known to those skilled in the art are also covered by the scope of the invention.

The present invention is described in detail with reference to the drawings, but these drawings are only for convenience of describing the present invention in detail and should not be construed as limiting the present invention. In this application, the term "distal" refers to the end that is farther from the operator, whereas "proximal" refers to the end that is closer to the operator.

First, please refer to fig. 1, which is a schematic view of a catheter sheath according to an embodiment of the present invention. The catheter sheath 100 includes a catheter body 110, and the catheter body 110 has a shape-recoverable resilient portion 120, the resilient portion 120 is made of a shape-memory material and the resilient portion 120 has a non-linear shape. When in use, the elastic part 120 can be deformed into other shapes under the action of external force; when the external force is removed, the elastic portion 120 can be restored to its original shape and size. Specifically, when the catheter sheath 100 is implanted, the elastic portion 120 may be constrained into other shapes by an external constraining device for facilitating the implantation; after placement, the elastic portion 120 may be restored to its original shape and size by removing the restraining device, so as to be closely attached to the inner tissue of the vessel wall, left atrium or right atrium, thereby achieving fixation of the introducer sheath 100 in the vessel, left atrium or right atrium.

The catheter sheath 100 of the present embodiment is particularly suitable for a ventricular assist circulation device for assisting the blood circulation of the heart, and can function as a blood passage. In addition, the constraint mode of the elastic part 120 is not particularly limited in the present invention, for example, when performing the implantation, another tube may be inserted into the catheter body 110 to constrain the elastic part 120 to another shape; after insertion, the other tube can be removed and the resilient portion 120 can return to its original shape and size.

In this embodiment, the elastic portion 120 is made of a thermoplastic shape memory polymer material, such as a polystyrene type thermoplastic shape memory polymer material or a polycaprolactone type thermoplastic shape memory polymer material.

Optionally, the catheter body 110 is of an integrally formed structure, and is simple in process and convenient to process. The elastic portion 120 has a non-linear shape in a free state (i.e., an undeformed state), for example, a curled shape or a spiral shape, and the present invention is not limited thereto. The elastic portion 120 shown in fig. 1 has a spiral shape, and the specific number of the spiral can be set as desired.

In this embodiment, the catheter body 110 is a single lumen tube for blood flow. Preferably, the catheter body 110 comprises a main body segment 111 and a bending segment 112 forming an angle with the main body segment 111, wherein the elastic part 120 connects the main body segment 111 and the bending segment 112. The introducer sheath 100 is easily placed into the body by the bend section 112.

Further, one end (i.e. the distal end) of the catheter body 110 is provided with a reduced section 113, the reduced section 113 comprises an inlet and an outlet, the inlet is connected with the distal end of the catheter body 110, and the cross-sectional area of the reduced section 113 is gradually reduced from the inlet to the outlet. The inlet of the throat section 113 shown in fig. 1 is connected to one end of the bend section 112, so that the throat section 113 forms a part of the bend section 112. In this application, the term "distal" refers to the end that is distal to the user, whereas "proximal" refers to the end that is proximal to the user, the same applies below.

With continued reference to fig. 1, one or more baffle holes 114 may be disposed in the outer wall of the catheter body 110, and preferably, the number of baffle holes 114 is plural. A plurality of baffle holes 114 are spaced axially along the conduit body 110. More preferably, the baffle holes 114 are distributed at the distal end of the catheter body 110, such as at the bend 112. The flow guide holes 114 can reduce the fluid resistance, so that the blood can be conveyed more smoothly.

Further, anticoagulant coatings are arranged on the inner wall and/or the outer wall of the catheter body 110 to prevent blood from coagulating due to the action of the blood and the catheter body 110 and affecting the normal transportation of blood. The catheter body 110 is made of a material with good biocompatibility, such as a polymer material. The high polymer material can be block polyether amide resin (PEBAX), nylon and other high polymer materials.

Further, the distal end of the catheter body 110 is provided with a visualization point or ring. Fig. 1 shows the distal end of catheter body 110, i.e., the distal end of bending section 112. Or the catheter body 110 is made of a contrast material. By arranging the developing point or the developing ring or adopting developing materials to manufacture the catheter sheath 100, the average-square physician can directly observe the position of the catheter sheath 100 in the blood vessel or the atrium after the catheter sheath 100 is placed in the body, thereby improving the accuracy and the safety of the operation, shortening the time of the operation and reducing the risk of infection of the patient.

In a preferred embodiment, the catheter body 110 has a dense anti-coagulation coating, such as heparin coating, on the inner wall thereof to prevent cavitation. The outer wall of the catheter body 110 may further be provided with a hydrophilic coating to increase the smoothness of the catheter sheath 100, thereby facilitating the smooth insertion of the catheter sheath 100.

Next, referring to fig. 2 to 11, the present invention further provides a ventricular assist circulation device 10 for functioning as a substitute for the blood pumping function of the heart, which includes the catheter sheath 100 of the above embodiment and a blood pump 200 connected to the catheter sheath 100, wherein the catheter sheath 100 is configured to be placed in the body to form a blood flow channel, and the blood pump 200 is configured to provide pressure to the blood in the blood flow channel for circularly delivering the blood.

The ventricular assist circulation device 10 of the embodiment can fix the position of the catheter sheath 100 after being placed into the body, so that accurate positioning can be realized, the stability of the blood flow direction is ensured, the risk problem caused by unfixed position of the existing catheter is avoided, the use safety of the ventricular assist circulation device is ensured, and the clinical applicability of the ventricular assist circulation device is also improved.

In particular, referring to fig. 3-5 in combination with fig. 2, fig. 2 is a schematic structural diagram of a magnetically coupled ventricular assist circulation device according to an embodiment of the present invention. The blood pump 200 includes a housing 2011 having a first chamber 2013 and a second chamber 2014 that are fluidly isolated, a paddle 2012, and a driver; the blade 2012 is located in the first chamber 2013, and at least a portion of the drive member is located in the second chamber 2014, the drive member being configured to drive the blade 2012 to rotate. Preferably, the paddle 2012 is made of a material with good biocompatibility, such as medical grade high molecular material.

The ventricular assist circulation device 10 of the present embodiment fluidly isolates the paddles 2012 from the driving member, so that the paddles 2013 in contact with blood can be directly replaced, and at least a portion of the driving member not in contact with blood can be reused, thereby improving the reusability of the ventricular assist circulation device 10 and reducing the treatment cost. In addition, the ventricular assist circulation device 10 performs circulation support on the heart through the blood pump 200, and compared with the medical treatment of diseases such as heart failure, the treatment effect is good. In addition, the ventricular assist circulation device 10 is inserted into the body through the catheter sheath 100, so that complicated operations such as thoracotomy are not required, the operation difficulty is reduced, the operation wound is reduced, rehabilitation of patients with chronic heart failure can be realized, and treatment can be performed for multiple times in a certain period. In addition, the ventricular assist circulation device 10 partially or completely serves as the blood pumping function of the heart through the blood pump 200, and the interventional therapy process is simple.

With continued reference to fig. 2, the catheter sheath 100 includes an inlet catheter sheath 1010 and an outlet catheter sheath 1020, the inlet catheter sheath 1010 preferably being removably coupled to an inlet 2015 of the blood pump 200, and the outlet catheter sheath 1020 being removably coupled to an outlet 2016 of the blood pump 200. After the inlet catheter sheath 1010 is placed in the body, blood can be led out to the blood pump 200, and under the conveying force of the blood pump 200, the blood flows into the body through the outlet catheter sheath 1020. Here, by using a detachable connection, it is convenient to replace the sheath 100 so that the ventricular assist circulation device 10 can be reused, further reducing the cost of treatment.

The entry sheath 1010 may be placed in the right atrium by femoral vein or superior extremity vein insertion, or in the left atrium by transseptal puncture. The exit sheath 1020 may be placed in the arterial system as desired, but is not limited to, the aorta, femoral artery, upper extremity artery, etc.

Further, as shown in fig. 6 to 7, fig. 6 is a schematic structural view of an inlet sheath without an inlet expansion tube inserted therein according to an embodiment of the present invention, and fig. 7 is a longitudinal sectional view of the inlet sheath shown in fig. 6 after being inserted into the inlet expansion tube. The catheter sheath 100 also includes an entry dilation tube 1030 and an entry guidewire (not shown in fig. 7), the entry dilation tube 1030 being disposed in the entry catheter sheath 1010 and the entry guidewire being disposed in the entry dilation tube 1030. The inlet dilation tube 1030 is configured to structurally support the inlet sheath 1010 such that the inlet sheath 1010 conforms to the inlet dilation tube 1030 such that the flexible portion 120 conforms to the inlet dilation tube 1030 in a substantially linear configuration to facilitate smooth placement of the inlet sheath 1010 within a blood vessel. The entry guide wire is used to guide the entry dilation tube 1030 and the entry guide sheath 1010 along the entry guide wire to a desired location.

Referring to fig. 8 to 9, fig. 8 is a schematic structural view of an outlet sheath without an outlet expansion tube inserted therein according to an embodiment of the present invention, and fig. 9 is a longitudinal sectional view of the inlet sheath shown in fig. 10 after the inlet sheath is inserted into the outlet expansion tube. The catheter sheath 100 also includes an exit dilation tube 1040 and an exit guidewire (not shown), the exit dilation tube 1040 being disposed within the exit catheter sheath 1020 and the exit guidewire being disposed within the exit dilation tube 1040. Based on the same principle, the outlet dilation tube 1040 also structurally supports the outlet sheath 1020 such that the outlet sheath 1020 conforms to the outlet dilation tube 1040 in shape, such that the flexible portion 120 conforms to the outlet dilation tube 1040 to a substantially linear configuration to facilitate smooth placement of the outlet sheath 1020 into the blood vessel. The exit guidewire also serves as a guide for the exit dilation tube 1040 and exit catheter sheath 1020 to reach a desired location along the exit guidewire.

With continued reference to fig. 2 in conjunction with fig. 3-5, the proximal ends of the inlet and

outlet sheath

1010, 1020 may be provided with a

quick connector

1050, 1060, respectively, the inlet sheath 1010 being connected to the inlet 2015 of the blood pump 200 via the quick connector 1050, and the outlet sheath 1020 being connected to the outlet 2016 of the blood pump 200 via the quick connector 1060. The present invention does not specifically limit the specific structure of the quick coupling, as long as it is easy to quickly mount and dismount.

Further, referring to fig. 10 to 11, fig. 10 is a schematic view of an inlet expanding tube according to an embodiment of the present invention, and fig. 11 is a schematic view of an outlet expanding tube according to an embodiment of the present invention. The inlet expansion tube 1030 comprises a first portion 1031 and a second portion 1032 extending from the first portion 1031 in a bent manner. When assembled, the second portion 1032 of the inlet dilation tube 1030 is configured to engage the bend section 112 of the inserted inlet sheath 1010 and the first portion 1031 of the inlet dilation tube 1030 is configured to engage the body section 111 of the inserted inlet sheath 1010. Preferably, the angle of bending of the second portion 1032 of the inlet dilation tube 1030 is equal to the angle of bending of the bending section 112 of the inlet sheath 1010. More preferably, one end (i.e., the distal end) of the inlet dilation tube 1030 is provided with a constriction 1033 to mate with the constriction 113 of the inlet sheath 1010 to ensure a good fit. Preferably, one end of the outlet expanding tube 1040 is correspondingly provided with a reduced portion 1041 which is matched with the reduced section 113 of the outlet catheter sheath 1020.

In this embodiment, the blood pump 200 includes a housing 2011, a paddle 2012 and a driving member, and the housing 2011, the paddle 2012 and a part of the driving member are all detachable structures, so that the detachable structures refer to that the blood pump can be directly replaced to achieve the purpose of repeated use. The blood pump is preferably a centrifugal pump, the centrifugal pump has large lift and good self-absorption capacity, and the use effect of the blood pump can be effectively ensured.

In particular, in order to achieve repeated use and reduce treatment cost, the parts of the blood pump 200 that are in contact with blood may be provided as replaceable structures (e.g., paddles 2012 and partial drives), while the parts that are not in contact with blood may be provided as reusable structures (e.g., partial drives).

With continued reference to fig. 2-5, housing 2011 includes a first housing 2011a and a second housing 2011b that are removably coupled, the first housing 2011a defining a first chamber 2013 and the second housing 2011b defining a second chamber 2014; the paddles 2012 are located in a first housing 2011a and at least a portion of the drive is located in a second housing 2011 b. Wherein the first housing 2011a has an inlet 2015 and an outlet 2016 for placing the blood pump 200 in fluid communication with the outside.

Preferably, a water suction chamber 2017 and a water pressing chamber (not shown in the figure) which are sequentially communicated are arranged in the first chamber 2013; wherein the pumping chamber 2017 is located before the paddle 2012 and the pumping chamber 2017 is located after the paddle 2012 according to the flowing direction of the blood in the first chamber 2013, the pumping chamber 2017 is used for introducing the liquid into the first chamber 2013 according to a certain condition, the pumping chamber is used for flowing out the liquid and converting a part of the kinetic energy of the liquid into pressure energy so as to guide the liquid to the outlet 2016 of the first housing 2011 a. The specific working principle is as follows: after flowing into the water suction chamber 2017 from the inlet 2015 of the first housing 2011a, the blood is thrown out to the pumping chamber by the centrifugal force of the blades 2012 and flows out from the outlet 2016 of the first housing 2011 a. Preferably, the scoops 2017 are straight tapered to ensure a uniform flow rate distribution of liquid into the first chamber 2013. The pumping chamber is preferably in an equidistant spiral structure so as to reduce hydraulic loss of liquid in the flowing process.

Next, the blood pump 200 of the present invention will be described in further detail by three ways, i.e., mechanical sealing, magnetic coupling, magnetic levitation, etc., and specifically refer to fig. 3 to 5. Fig. 3 is a schematic structural diagram of a blood pump of a mechanically sealed ventricular assist circulation device according to an embodiment of the present invention, fig. 4 is a schematic structural diagram of a blood pump of a magnetically coupled ventricular assist circulation device according to an embodiment of the present invention, and fig. 5 is a schematic structural diagram of a blood pump of a magnetically suspended ventricular assist circulation device according to an embodiment of the present invention.

As shown in fig. 3, the driving member drives the blade 2012 to rotate by a mechanical method, and includes a motor 2020, the motor 2020 is detachably connected to the blade 2012 by a motor shaft 2021 or a transmission shaft 2022 of the motor 2020, the transmission shaft 2022 is sleeved on the motor shaft 2021, and the blade 2012 rotates by the motor shaft 2021 or the transmission shaft 2022. The transmission shaft 2022 is adopted to be indirectly connected with the motor 2020, so that the service life of the motor 2020 can be prolonged, and the reliability of the motor 2020 is good. Preferably, the motor shaft 2021 is connected to the transmission shaft 2022 through a coupling, and is elastically connected to improve reliability.

In this embodiment, a transition chamber 2018 communicated with the first chamber 2013 is further disposed in the first housing 2011a, the transition chamber 2018 is configured to inject an anticoagulant medical fluid with a certain mass concentration or volume concentration, and preferably, the injection pressure of the anticoagulant medical fluid is greater than the pressure in the first chamber 2013, so that the liquid in the transition chamber 2018 automatically flows to the first chamber 2013, and the lubrication and cooling effects are achieved.

In this embodiment, the anticoagulant medication may be injected into the transition chamber 2018 through a lubrication feature. The lubricating member is for example a peristaltic pump.

In a mechanically sealed connection, if the paddle 2012 is connected to the drive shaft 2022, the injection of the anticoagulant medication may also act to lubricate the drive shaft 2022, i.e., at least a portion of the drive shaft 2022 is located within the first chamber 2013. In addition, the transition chamber 2018 may be located between the first chamber 2013 and the second chamber 2014, the motor shaft 2021 of the motor 2020 or the transmission shaft 2022 sleeved with the motor shaft 2021 may extend into the first chamber 2013 through the transition chamber 2018, at this time, a sealing member 2023 (shown in fig. 3) is disposed between the transition chamber 2018 and the motor 2020, and the sealing member 2023 may be a sealing sleeve, so as to seal the motor shaft 2021 or the transmission shaft 2022 and prevent the anticoagulant liquid medicine from leaking.

In the mechanical seal connection, the driving member further includes a manual control part (not shown in fig. 3) connected to the motor shaft 2021 or the transmission shaft 2022, and when the motor 2020 fails, the manual control part can drive the motor shaft 2021 or the transmission shaft 2022 to rotate, so as to rotate the blades 2012, thereby ensuring the device can work normally.

In the above embodiment, the components directly contacting with blood, such as the first housing 2011a, the paddle 2012, the transmission shaft 2022, the sealing member 2023, the inlet sheath 1010, the outlet sheath 1020, and the like, are all disposable consumables, that is, these components can be directly replaced after being used each time, so as to achieve the purpose that the device can be repeatedly used, and the rest components not directly contacting with blood can be reused without replacement, so that the treatment cost can be reduced.

Next, for example, in the magnetically coupled ventricular assist circulation device shown in fig. 2, the blood pump 200 drives the blades 2012 to rotate by magnetic coupling.

As shown in fig. 4, the driving member also includes a motor 2020 and a driving magnet, at least a portion of the driving magnet is connected to the motor 2020, and the blade 2012 is driven by the motor 2020 to rotate by magnetic force; and the motor 2020 and at least a portion of the drive magnet are located in the second housing 2011 b.

In this embodiment, the driving magnet includes an active magnet 2024 and a passive magnet 2025; the active magnet 2024 is connected to the motor 2020 and located in the second housing 2011b, the passive magnet 2025 is connected to the blade 2012 or disposed inside the blade 2012, and the passive magnet 2025 is located in the first housing 2011 a.

In another embodiment, the number of the driving magnets is one, and the paddle 2012 is made of a magnetic material for functioning as a passive magnet 2025. In any of the above embodiments, blade 2012 can be rotated by the magnetic force.

The magnetizing directions of the active magnet 2024 and the passive magnet 2025 are radial or axial, the magnetizing directions of the active magnet 2024 and the passive magnet 2025 are the same, and the active magnet 2024 is located in the magnetizing direction of the passive magnet 2025. For example, if the magnetization direction of the passive magnet 2025 is radial, the active magnet 2024 is arranged in the radial direction of the passive magnet 2025, and vice versa.

Preferably, an isolation structure 2026 is disposed between the active magnet 2024 and the passive magnet 2025, and the isolation structure 2026 is used to isolate the pair of driving magnets for sealing. The isolating structure 2026 may be an isolating plate, which is transversely disposed between the active magnet 2024 and the passive magnet 2025, and has simple structure and convenient installation.

The magnetic coupling blood pump 200 works according to the following principle: the motor 2020 drives the driving magnet 2024 to rotate, and because magnetic force exists between the driven magnet 2025 and the driving magnet 2024, the driven magnet 2025 rotates along with the magnetic force, and the blades 2012 are driven to rotate in the rotating process, so that the blood pump 200 can be operated.

In the magnetic coupling connection, the active magnet 2024 is preferably connected to a manual control unit (not shown in fig. 4), which can manually drive the blade 2012 to rotate when the motor 2020 fails, thereby ensuring that the device is operating normally. The manual control component can be a manual rocking handle which is fixed on the driving magnet 2024; the manual crank is arranged in parallel with the motor 2020 and the driving magnet 2024, and when the motor 2020 fails and cannot supply power, the driving magnet 2024 is rotated by manually rotating the manual crank, so as to drive the driven magnet 2025 to rotate.

Similarly, in the magnetic coupling connection, the components in direct contact with blood, such as the first housing 2011a, the paddle 2012, the inlet catheter sheath 1010 and the outlet catheter sheath 1020, are disposable consumables, and can be directly replaced, so that the device can be repeatedly used, and the rest components not in direct contact with blood can be repeatedly used without replacement, so that the treatment cost can be reduced.

In another embodiment, as shown in fig. 5, the blood pump 200 is rotated by magnetically levitated drive blades 2012. Specifically, the driving member includes at least one motor stator 2027, and the motor stator 2027 is disposed in the second housing 2011b and is configured to drive the blades 2012 to rotate by magnetic force, so that the motor stator 2027 does not directly contact with blood, and thus, the motor stator 2027 can be reused.

In this embodiment, the driving member further includes a motor rotor 2028, the motor rotor 2028 is disposed in the first housing 2011a, and the motor rotor 2028 is connected to the blade 2012, or the motor rotor 2028 is disposed in the blade 2012. In other embodiments, the drive includes only one motor stator 2027, and the blades 2012 are made of a magnetic material to act as a motor rotor 2028. Here, the person skilled in the art should know: when the magnetic field generated by the motor stator 2027 interacts with the magnetic field generated by the motor rotor 2028, the motor rotor 2028 is rotated, which in turn drives the blades 2012 to rotate.

Preferably, an isolation structure 2026 is disposed between the motor stator 2027 and the motor rotor 2028, which can perform a sealing isolation function.

In a magnetic levitation type connection, the motor rotor 2028 is in direct contact with blood, and thus can be provided as a disposable consumable for direct replacement. Similarly, in the magnetic suspension type connection, the parts such as the first housing 2011a, the blades 2012, the inlet catheter sheath 1010 and the outlet catheter sheath 1020 can also be directly replaced, and the motor stator 2027 and the second housing 2011b are not in contact with blood and do not need to be replaced, so that the purpose of repeatedly using the partial structure of the blood pump 200 is achieved.

In the above embodiment, the blood pump 200 drives the blades 2012 to rotate in a mechanical sealing, magnetic coupling or magnetic suspension manner, so that the configuration of parts is less, the structure is simple, the mass and the use area of the device are effectively reduced, and the driving process is simplified.

With continued reference to fig. 2, the blood pump 200 further includes an inlet conduit 2029 that connects the inlet sheath 1010 and the inlet 2015 of the blood pump 200, respectively, and an outlet conduit 2030 that connects the outlet sheath 1020 and the outlet 2016 of the blood pump 200, respectively. After the inlet sheath 1010 is connected to the inlet line 2029, a fastening mechanism (not shown in fig. 2), such as a bolt, may be used to secure and seal the inlet sheath 1010 and the inlet line 2029. Similarly, after the outlet sheath 1020 is connected to the outlet conduit 2030, the fixation and sealing are accomplished by another fastening mechanism.

Furthermore, a quick coupling (not shown in fig. 2) is provided at the inlet 2015 of the blood pump 200, through which the inlet 2015 is connected to the inlet line 2029, and is then secured and sealed by a fastening mechanism. A further quick coupling (not shown in fig. 2) is also provided at the outlet 2016 of the blood pump 200 and is connected to the outlet conduit 2030 via this quick coupling, after which the fixation and sealing can likewise be accomplished by means of a fastening mechanism. The quick connector is adopted to realize connection between pipelines, tool installation is avoided, and operation is convenient.

In a preferred embodiment, the ventricular assist circulation device further comprises a controller and a detection component connected to the controller; the controller is configured to send a corresponding control signal to the blood pump 200 according to the signal detected by the detecting portion to control the operation state of the blood pump 200, for example, the controller may perform functions of controlling the coil of the motor 2020 or the motor stator 2027, processing the signal, performing human-computer interaction, and the like.

The controller preferably comprises at least two control units which are connected in parallel and are respectively a main control unit and a standby unit so as to realize redundancy control; the master unit and the backup unit have the same function, wherein the switching from the master unit to the backup unit can be done manually, while the master unit can run in parallel with the backup unit, but only one of them is active during operation of the blood pump 200.

The controller is also provided with an alarm module to realize an alarm function. Specifically, when the actual index acquired by the detection component exceeds a preset range, an alarm can be given. The controller is also provided with an operation panel which can realize manual operation and is communicated with an upper computer to realize human-computer interaction. The controller and the upper computer can realize intelligent monitoring and automatically carry out system adjustment according to the condition of a patient.

The detection component at least comprises a flow detection module, a pressure detection module and a temperature detection module. The flow detection module can be an electromagnetic or ultrasonic flowmeter and is arranged in the blood flow channel to obtain the blood flow speed and is communicated with the controller, and the controller controls the working state of the blood pump 200 according to the measured blood flow speed. The pressure detection module may be a pressure detection component, such as a pressure sensor, disposed at the inlet 2015 or the outlet 2016 of the blood pump 200 to obtain the blood pressure at the inlet 2015 and the outlet 2016 and communicate with the controller. The temperature detection module can be a temperature detection component, is arranged in the blood flow channel to acquire the blood temperature and is communicated with the controller.

The controller and the detection part of the embodiment both adopt modular structures, so that the structure is simple, and the adjustment and the operation are convenient; and moreover, each module is adopted for detection and control, the intelligent degree is high, and the running state of the device is monitored in real time, so that the device can be adjusted in time according to the condition of a patient.

Of course, the detecting member of the present invention may be provided with other information members to detect other physiological indexes of blood, and the present invention is not particularly limited thereto, and may be added mainly according to actual needs.

Further, the ventricular assist circulation device further comprises an energy supply component connected with the blood pump 200, and the energy supply component is used for supplying electric energy. The energy supply part comprises a power plug to connect with an external power supply, and also comprises a battery slot capable of accommodating a storage battery, and preferably is arranged redundantly, namely simultaneously comprises the power plug and the battery slot, so that when the power supply by the external power supply is unavailable, the storage battery can be charged, and the energy supply requirement of the device is ensured.

Still further, the ventricular assist circulation device further includes an extension member for performing additional functions. The expansion component comprises but is not limited to an oxygenator, a filter, a manual control component, a temperature regulation component, a drug infusion component, a fixing component and the like, and is mainly arranged according to the actual treatment requirement.

The oxygenator, the filter, the temperature regulating component, and the drug infusion component may all be placed at the outlet 2016 end of the blood pump 200, between the outlet conduit 2030 and the outlet catheter sheath 1020. The fixing part is mainly used for fixing legs or fixing the body outside, and is specifically used according to the requirements of a patient, and the fixing part is connected with a shell 2011 of the blood pump 200 to realize the fixation of the legs or the fixation outside the body.

To ensure the implantation effect, the ventricular assist circulation device further comprises an exhaust (not shown) disposed at the proximal end of the

catheter sheaths

1010, 1020, which are connected to the proximal ends of the

catheter sheaths

1010, 1020 and the blood pump 200, respectively, for exhausting to purify the blood. The exhaust device is, for example, a three-way valve, and the present invention is not limited to this. Optionally, an exhaust is provided at both the inlet 2015 and/or outlet 2012 of the blood pump 200.

Next, with reference to the above embodiment and with reference to fig. 2, the present application will describe in detail the implementation of the ventricular assist circulation device of the present invention by taking the patient suffering from left heart failure as an example:

firstly, performing antegrade puncture of femoral vein, placing an entrance guide wire in the left atrium through interatrial puncture, taking out the entrance dilation tube 1030 after the entrance dilation tube 1030 and the entrance sheath 1010 enter the left atrium, and expanding the balloon 120 of the entrance sheath 1010 to fix the entrance sheath 1010 in the left atrium;

secondly, performing femoral artery puncture, placing an outlet guide wire in the contralateral femoral artery, enabling the outlet expansion tube 1040 and the outlet catheter sheath 1020 to enter the contralateral femoral artery, taking out the outlet expansion tube 1040, and inflating the balloon 120 of the outlet catheter sheath 1020 so as to fix the outlet catheter sheath 1020 in the contralateral femoral artery;

then, the controller (or an upper computer) controls the motor 2020 to start so as to drive the blood pump 200 to work; in the working process, each detection component monitors the running state of the ventricular assist circulation device and communicates with the controller, so that the device can be monitored in real time, and running adjustment can be realized through the controller.

The ventricular assist circulation device 10 of the present invention is mainly used for patients in need of ventricular assist or emergency treatment in the medium-short term (within about 30 days), including acute heart failure treatment, chronic heart failure rehabilitation, postoperative circulation support during operation, and is intended to be disposed in operating rooms, ICU wards, rescue rooms, and the like.

Compared with the prior art, after the introducer sheath 100 provided by the invention is placed in a body, the shape of the elastic part 120 can be restored, so that the elastic part 120 is tightly attached to the inner tissue of the blood vessel wall, the left atrium or the right atrium, and the catheter sheath 100 can be fixed in the blood vessel, the left atrium or the right atrium.

The ventricular assist circulation device 10 provided by the invention comprises the catheter sheath 100, and the position of the catheter sheath 100 can be fixed after being placed in a body, so that accurate positioning can be realized, the stability of the blood flow direction is ensured, the risk problem caused by the fact that the position of the existing catheter is not fixed is avoided, the use safety of the ventricular assist circulation device is ensured, and the clinical applicability of the ventricular assist circulation device is also improved.

In particular, the ventricular assist circulation device 10 of the present invention fluidly isolates the paddles 2012 from the drive member, such that the paddles 2012 in contact with blood can be directly replaced, while at least a portion of the drive member not in contact with blood can be reused, thereby improving the reusability of the ventricular assist circulation device 10 and reducing treatment costs.

In addition, the ventricular assisted circulation device 10 of the present invention includes a detachable blood pump 200, the blood pump 200 includes a housing 2011, a paddle 2012 and a driving member, the housing 2011 includes a first housing 2011a and a second housing 2011b, which are detachably connected, and the paddle 2012 is disposed in the first housing 2011a, so as to facilitate replacement of various components of the blood pump 200, and on the other hand, a part of the driving component is not in contact with blood and can be reused to reduce treatment cost.

In addition, the blood pump 200 is directly driven by the motor 2020 or driven by a magnetic coupling or magnetic suspension mode, so that the blood pump has the advantages of few parts, simple structure, effective reduction of the device quality and the use area, and simplification of the driving process.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

Claims

1. A catheter sheath is used for being connected with a blood pump and comprises a catheter body, wherein a blood flow channel is formed in an inner cavity of the catheter body, the catheter sheath is characterized in that the catheter body is provided with an elastic part capable of restoring in shape, the elastic part is made of shape memory materials and is in a nonlinear shape, the elastic part is made to cling to internal tissues of the left atrium through the shape restoring performance of the elastic part, so that the catheter sheath is fixed in the left atrium, the catheter body comprises a main body section and a bending section forming an included angle with the main body section, the elastic part is connected with the main body section and the bending section, a plurality of flow guide holes are formed in the outer wall of the catheter body, and the flow guide holes are distributed in the bending section.

2. The catheter sheath of claim 1, wherein the catheter body is of unitary construction.

3. The catheter sheath of claim 1, wherein the flexible portion is in a crimped or helical shape.

4. The catheter sheath of claim 1, wherein the flexible portion is a thermoplastic shape memory polymer material.

5. The catheter sheath of claim 4, wherein the thermoplastic shape memory polymer material is polystyrene-type or polycaprolactone-type.

6. The introducer sheath of claim 1, wherein the catheter body is provided with an anticoagulant coating on the inner and/or outer wall.

7. The catheter sheath of claim 1, wherein the distal end of the catheter body is provided with a visualization point or ring.

8. The catheter sheath of claim 1, wherein the catheter body is made of a contrast material.

9. A ventricular assisted circulation device for assisting the circulation of cardiac blood, comprising an introducer sheath as claimed in any one of claims 1 to 8 and a blood pump connected to the introducer sheath for providing pressure to blood in a blood flow path provided by the introducer sheath for circulatory delivery of the blood.

10. A ventricular assist circulation device as claimed in claim 9, wherein the blood pump includes a housing, a paddle, and a drive, the housing having a first chamber and a second chamber, the first chamber having an inlet and an outlet for fluid communication of the blood pump with the exterior, and the first chamber being fluidly isolated from the second chamber; the blade is located in the first cavity, at least one part of the driving piece is located in the second cavity, and the driving piece is used for driving the blade to rotate.

11. A ventricular assist circulation device as claimed in claim 10, wherein the drive member includes at least one motor stator disposed within the second chamber for magnetically driving the rotation of the blade.

12. A ventricular assist circulation device as claimed in claim 11, wherein the drive member further includes a motor rotor, the motor rotor being disposed within the first chamber; the motor rotor is connected with the paddle or arranged in the paddle.

13. A ventricular assist circulation device as claimed in claim 11, wherein the paddle is made of a magnetic material.

14. A ventricular assist circulation device as claimed in claim 10, wherein the drive member comprises a motor removably connected to the paddle via a motor shaft or drive shaft, the motor being located in the second chamber with a seal disposed between the first and second chambers.

15. A ventricular assist circulation device as claimed in claim 14, wherein the blood pump further includes a transition chamber disposed between the first chamber and the second chamber, the transition chamber being in fluid communication with the first chamber, the transition chamber being fluidly isolated from the second chamber, the motor shaft or drive shaft extending through the transition chamber into the first chamber.

16. A ventricular assist circulation device as claimed in claim 10, wherein the drive member includes a motor and a drive magnet; at least one part of the driving magnet is connected with the motor and drives the paddle to rotate through magnetic force under the driving of the motor; the motor and at least a portion of the drive magnet are located in the second chamber.

17. A ventricular assist circulation device as claimed in claim 16, wherein the drive magnet includes an active magnet and a passive magnet; the active magnet is connected with the motor and positioned in the second chamber, the passive magnet is connected with the paddle or arranged in the paddle, and the passive magnet is positioned in the first chamber.

18. A ventricular assist circulation device as claimed in claim 17, wherein the active and passive magnets have the same direction of magnetization and the active magnet is located in the direction of magnetization of the passive magnet.

19. A ventricular assist circulation device as claimed in claim 16, wherein the drive magnet includes an active magnet connected to the motor and located in the second chamber, and the paddle is made of a magnetic material.

20. A ventricular assist circulation device as claimed in claim 10, wherein the housing includes a first housing and a second housing, the first housing forming the first chamber and the second housing forming the second chamber, the first housing and the second housing being removably connected.