CN116688351A - Intervention type blood pump and intervention type blood pump system - Google Patents
Intervention type blood pump and intervention type blood pump system Download PDFInfo
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- CN116688351A CN116688351A CN202210190781.XA CN202210190781A CN116688351A CN 116688351 A CN116688351 A CN 116688351A CN 202210190781 A CN202210190781 A CN 202210190781A CN 116688351 A CN116688351 A CN 116688351A
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- 210000004369 blood Anatomy 0.000 title claims abstract description 168
- 239000008280 blood Substances 0.000 title claims abstract description 168
- 239000000463 material Substances 0.000 claims description 29
- 230000005540 biological transmission Effects 0.000 claims description 12
- 239000003146 anticoagulant agent Substances 0.000 claims description 5
- 229940127219 anticoagulant drug Drugs 0.000 claims description 5
- 239000002184 metal Substances 0.000 claims description 5
- 229910052751 metal Inorganic materials 0.000 claims description 5
- 210000000709 aorta Anatomy 0.000 abstract description 10
- 208000007536 Thrombosis Diseases 0.000 abstract description 6
- 206010018910 Haemolysis Diseases 0.000 abstract description 5
- 230000015572 biosynthetic process Effects 0.000 abstract description 5
- 230000008588 hemolysis Effects 0.000 abstract description 5
- 239000012528 membrane Substances 0.000 description 11
- 239000002861 polymer material Substances 0.000 description 9
- 230000002861 ventricular Effects 0.000 description 8
- 238000000034 method Methods 0.000 description 6
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- 230000006378 damage Effects 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 210000001765 aortic valve Anatomy 0.000 description 4
- 210000005242 cardiac chamber Anatomy 0.000 description 4
- 238000010586 diagram Methods 0.000 description 4
- 230000017531 blood circulation Effects 0.000 description 3
- 210000005240 left ventricle Anatomy 0.000 description 3
- 238000005086 pumping Methods 0.000 description 3
- 229920002614 Polyether block amide Polymers 0.000 description 2
- 206010007625 cardiogenic shock Diseases 0.000 description 2
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- 229920005570 flexible polymer Polymers 0.000 description 2
- 238000009998 heat setting Methods 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 230000013011 mating Effects 0.000 description 2
- 229910001000 nickel titanium Inorganic materials 0.000 description 2
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- 230000004075 alteration Effects 0.000 description 1
- 210000002376 aorta thoracic Anatomy 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
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- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/205—Non-positive displacement blood pumps
- A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Mechanical Engineering (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- External Artificial Organs (AREA)
Abstract
The invention provides an intervention type blood pump and an intervention type blood pump system, wherein the intervention type blood pump comprises: a blood pump main body and a support part; the blood pump main body comprises a basket support; the supporting part is circumferentially arranged around the basket support and connected with the basket support, and the supporting part is converted between an expanding state and a contracting state along the radial direction of the basket support; the supporting part is in the contracted state under the limitation of the conveying device; the support is in the expanded state when unconstrained; wherein, in the expanded state, the support portion has a radial outer dimension along the basket support that is greater than a radial outer dimension of the basket support. So configured, the support portion is convertible to an expanded state to achieve fixation in the ventricle after intervention to the predetermined portion, thereby reducing the risk of shaking of the intervention blood pump in a suspended state in the ventricle, and reducing the formation of hemolysis and thrombus. In addition, the risk of the basket support and impeller falling from the ventricle into the ascending aorta is avoided.
Description
Technical Field
The invention relates to the technical field of medical appliances, in particular to an interventional blood pump and an interventional blood pump system.
Background
Percutaneous intervention blood pumps are mainly used for the first aid of cardiogenic shock and for the assisted circulation during high-risk PCI surgery. The blood pump arranged on the aortic valve can provide flow support of up to 4L/min, so that the blood pump function of the heart is replaced, the life of a cardiogenic shock patient can be saved, or the heart state is stabilized during the operation of a high-risk PCI patient, the occurrence of arrhythmia is reduced, the operation risk is reduced, and the success rate of the high-risk PCI operation is ensured.
The current percutaneous interventional blood pump products have a certain hidden trouble in technology. After the percutaneous interventional blood pump completes ventricular intervention, the head end part of the blood pump is in a suspended state in a ventricle in the operation stage, and at the moment, the change of blood flow in the ventricle caused by rotation of a rotor impeller can cause shaking of a blade and a basket in the operation process, so that blood cells are damaged, and hemolysis and thrombus are generated. In addition, in the stage that the blood pump starts to run, the runner membrane is washed away by blood flow, and as the outer diameter of the rotor impeller and the basket is smaller than the inner diameter of the runner membrane, the rotor impeller and the basket easily slide out of the ventricle into the aorta, so that the blood pump cannot continue to pump blood from the ventricle.
Disclosure of Invention
The invention aims to provide an interventional blood pump and an interventional blood pump system, which are used for solving the problems that the existing interventional blood pump is not effectively fixed after ventricular intervention is completed, damage is caused to blood cells, and a rotor impeller and a basket easily slide out.
In order to solve the above technical problems, the present invention provides an interventional blood pump, comprising: a blood pump main body and a support part;
the blood pump main body comprises a basket support; the supporting part is circumferentially arranged around the basket support and connected with the basket support, and the supporting part is converted between an expanding state and a contracting state along the radial direction of the basket support;
the supporting part is in the contracted state under the limitation of the conveying device; the support is in the expanded state when unconstrained;
wherein, in the expanded state, the support portion has a radial outer dimension along the basket support that is greater than a radial outer dimension of the basket support.
Optionally, in the interventional blood pump, the basket support has an inflow end and an outflow end opposite to each other along an axial direction of the basket support, and one end of the support part is connected with the inflow end of the basket support; when the supporting portion is in the expanded state, at least a portion of the supporting portion expands in an outer direction of the basket support.
Optionally, in the interventional blood pump, the supporting part includes a plurality of supporting wires circumferentially distributed around the basket support, one end of the supporting wires is connected with the inflow end of the basket support, the other end of the supporting wires is a free end, and when the supporting part is in the expanded state, the free end extends and expands towards the external direction of the blood pump main body.
Optionally, in the interventional blood pump, an end of the supporting wire connected with the basket support extends along an axial direction of the basket support, the supporting wire is concave towards a proximal direction, and a normal direction of the concave is towards an outer portion of the basket support.
Optionally, in the interventional blood pump, the supporting wire and the inflow end of the basket support are integrally formed; or the supporting wires are welded with the inflow end of the basket support.
Optionally, the interventional blood pump comprises an inflow end bearing part axially connected with the inflow end of the basket support, and the supporting part comprises a plurality of supporting wires circumferentially distributed around the inflow end bearing part; one end of the supporting wire is connected with the inflow end bearing part, the other end of the supporting wire is a free end, and when the supporting part is in the expanded state, the free end extends and expands to the external direction of the blood pump main body.
Optionally, the interventional blood pump comprises a contact part, one end of the contact part is connected with the inflow end bearing part, and the supporting wire is connected with the inflow end bearing part through the contact part.
Optionally, in the interventional blood pump, an end of the supporting wire connected with the inflow end bearing portion extends along a radial direction of the basket support, the supporting wire is concave towards a proximal direction, a normal direction of the concave faces the inside of the basket support, and an extending direction of the free end faces the outflow end.
Optionally, in the interventional blood pump, the other end of the supporting wire is provided with a buffer part, and/or the other end of the supporting wire is coated with an anticoagulant.
Optionally, in the interventional blood pump, the supporting part includes a sliding ring movable along an axial direction of the blood pump main body and a plurality of supporting wires circumferentially distributed around the sliding ring, one end of each supporting wire is connected with an inflow end of the basket support, and the other ends of the plurality of supporting wires are converged on the sliding ring; when the support part is in the expanded state, the middle part of the support wire is raised and expands towards the external direction of the blood pump main body.
Optionally, the interventional blood pump comprises a contact part, one end of the contact part is connected with the inflow end bearing part, and the sliding ring is movably sleeved on the contact part.
Optionally, in the interventional blood pump, the material of the support wire and/or the material of the basket support comprises a memory metal.
Optionally, the interventional blood pump comprises a contact part, wherein the contact part is connected with the distal end of the basket support; the supporting part is arranged on the contact part and is connected with the basket support through the contact part.
Optionally, in the interventional blood pump, the supporting portion includes a plurality of branches, one end of each branch is connected to the contact portion, the other end of each branch is a free end, and when the supporting portion is in the expanded state, the other end of each branch extends to an external direction of the blood pump main body.
Optionally, in the interventional blood pump, the material of the support part and/or the material of the contact part comprises a flexible polymer material.
Optionally, in the interventional blood pump, the material of the support part and/or the material of the contact part further comprises a developing material.
In order to solve the technical problems, the invention also provides an interventional blood pump system, which comprises the interventional blood pump, a transmission assembly and a driving assembly; the interventional blood pump is connected with the driving assembly through the transmission assembly, and the driving assembly drives the impeller of the interventional blood pump to act through the transmission assembly.
In summary, in the interventional blood pump and the interventional blood pump system provided by the present invention, the interventional blood pump includes: a blood pump main body and a support part; the blood pump main body comprises a basket support; the supporting part is circumferentially arranged around the basket support and connected with the basket support, and the supporting part is converted between an expanding state and a contracting state along the radial direction of the basket support; the supporting part is in the contracted state under the limitation of the conveying device; the support is in the expanded state when unconstrained; wherein, in the expanded state, the support portion has a radial outer dimension along the basket support that is greater than a radial outer dimension of the basket support.
So configured, the supporting part is inserted to the preset position and then can be converted to an expanded state to realize fixation in the heart chamber, and the basket support is connected with the supporting part, so that the basket support is also fixed relatively, the shaking risk of the inserted blood pump in the suspended state in the heart chamber is reduced, and the formation of hemolysis and thrombus is reduced. In addition, because the basket support is also relatively fixed in the ventricle, the risk that the basket support and the impeller drop to the ascending aorta from the ventricle can also be avoided, the reliability of the interventional blood pump in the operation period is improved, and serious faults such as stalling, failure and the like are avoided.
Drawings
Those of ordinary skill in the art will appreciate that the figures are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention. Wherein:
FIG. 1 is a schematic diagram of an interventional blood pump system in accordance with the present invention;
FIG. 2 is a schematic illustration of an interventional blood pump of the present invention being inserted into a ventricle;
FIG. 3 is a schematic illustration of an interventional blood pump according to a first embodiment of the present invention;
FIG. 4 is an axial cross-sectional schematic view of the interventional blood pump shown in FIG. 3;
FIG. 5 is a schematic view of a supporting portion according to a first embodiment of the present invention;
FIG. 6 is a schematic diagram of an interventional blood pump according to a second embodiment of the present invention;
fig. 7 is a schematic view of a supporting portion according to a second embodiment of the present invention;
FIG. 8 is a schematic diagram of an interventional blood pump according to a third embodiment of the present invention;
fig. 9 is a schematic view of a support portion of a third embodiment of the present invention;
fig. 10 is a schematic diagram of an interventional blood pump according to a fourth embodiment of the present invention.
In the accompanying drawings:
01-ascending aorta; 02-aortic valve; 03-left ventricle; 10-an interventional blood pump; 20-a transmission assembly; 21-an inner sheath; 22-flexible shaft; 30-a drive assembly; 40-a control assembly;
100-a blood pump body; 110-basket support; 111-inflow end; 112-outflow end; 113-basket coating; 120-impeller; 121-paddle; 122-rotating shaft; 131-inflow end bearing section; 1311—an inflow end connection; 1312—an inflow end bearing; 1312 a-a sliding bearing; 1312 b-plain bearing sleeve; 132-an outflow end bearing section; 1321-outflow end connector; 1322-outflow end bearing; 1322 a-slide bearings; 1322 b-plain bearing sleeve; 14-a flow channel membrane;
200-supporting parts; 210-supporting wires; 211-a buffer; 220-slip ring; 230-branching body; 300-contact;
Detailed Description
The invention will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.
As used in this disclosure, the singular forms "a," "an," and "the" include plural referents, the term "or" are generally used in the sense of comprising "and/or" and the term "several" are generally used in the sense of comprising "at least one," the term "at least two" are generally used in the sense of comprising "two or more," and the term "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying any relative importance or number of features indicated. Thus, a feature defining "first," "second," "third," or the like, may explicitly or implicitly include one or at least two such features, with "one end" and "another end" and "proximal end" and "distal end" generally referring to the corresponding two portions, including not only the endpoints. The terms "proximal" and "distal" are defined herein with respect to an interventional blood pump system having a drive assembly configured to mechanically and/or electrically couple the interventional blood pump to the proximal end. The term "proximal" refers to a position of an element closer to the drive assembly, and the term "distal" refers to a position of an element closer to the interventional blood pump and thus farther from the drive assembly. Alternatively, in a manual or hand-operated application scenario, the terms "proximal" and "distal" are defined herein with respect to an operator, such as a surgeon or clinician. The term "proximal" refers to a location of an element that is closer to the operator, and the term "distal" refers to a location of an element that is closer to the interventional blood pump and thus further from the operator. Furthermore, as used in this disclosure, "mounted," "connected," and "disposed" with respect to another element should be construed broadly to mean generally only that there is a connection, coupling, mating or transmitting relationship between the two elements, and that there may be a direct connection, coupling, mating or transmitting relationship between the two elements or indirectly through intervening elements, and that no spatial relationship between the two elements is to be understood or implied, i.e., that an element may be in any orientation, such as internal, external, above, below, or to one side, of the other element unless the context clearly dictates otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances. Furthermore, directional terms, such as above, below, upper, lower, upward, downward, left, right, etc., are used with respect to the exemplary embodiments as they are shown in the drawings, upward or upward toward the top of the corresponding drawing, downward or downward toward the bottom of the corresponding drawing.
The invention aims to provide an interventional blood pump, which solves the problems that the existing interventional blood pump is not effectively fixed after ventricular intervention is completed, damage is caused to blood cells, and a rotor impeller and a basket easily slide out.
The following description refers to the accompanying drawings.
Referring to fig. 1, there is shown an interventional blood pump system comprising: an interventional blood pump 10, a transmission assembly 20 and a drive assembly 30; the interventional blood pump 10 is connected with the driving assembly 30 through the transmission assembly 20, and the driving assembly 30 drives the impeller of the interventional blood pump 10 to act through the transmission assembly 20. Referring to fig. 4 in combination, in an exemplary embodiment, the interventional blood pump 10 has an impeller 120, the transmission assembly 20 includes an inner sheath 21 and a flexible shaft 22 rotatably penetrating the inner sheath 21, a distal end of the flexible shaft 22 is connected to the impeller 120, and a proximal end of the flexible shaft 22 is connected to the driving assembly 30. Thus, the driving assembly 30 can drive the impeller 120 to rotate through the flexible shaft 22. Alternatively, in some embodiments, the drive assembly 30 may be integrated into a handle. Optionally, the interventional blood pump system may further comprise a control assembly 40 for monitoring and controlling other components of the interventional blood pump system. The individual components of the interventional blood pump system will be understood by those skilled in the art and will not be described in detail herein.
Referring to fig. 2, in use, the interventional blood pump 10 in a compressed state is inserted through the femoral artery by means of the delivery device, through the descending aorta and the ascending aorta 01, a portion of the distal end of the interventional blood pump 10 passes through the aortic valve 02 and enters the left ventricle 03, and after the delivery device is removed, the interventional blood pump 10 expands from the compressed state to an expanded state, and the impeller in the interventional blood pump 10 is driven (e.g., rotated) by the distal drive assembly 30, thereby pumping blood from the left ventricle 03 to the ascending aorta 01.
Based on the background, the inventor finds that the existing interventional blood pump 10 is mainly locked on the aortic valve 02 to achieve fixation, and the fixation effect is not good, so that on one hand, the shaking is large, the damage to blood cells is easy to occur, and on the other hand, the blood pump is easy to slip to the ascending aorta 01.
Based on the above-mentioned research, the present invention provides an interventional blood pump 10 to solve the problems that the existing interventional blood pump is not effectively fixed after ventricular intervention is completed, damage is caused to blood cells, and a rotor impeller and a basket easily slide out. The interventional blood pump 10 provided by the present invention will be described below in connection with several embodiments.
[ embodiment one ]
Referring to fig. 3 to 5, a first embodiment of the present invention provides an interventional blood pump 10, which includes: a blood pump main body 100 and a support 200; the blood pump body 100 includes a basket support 110; the supporting portion 200 is circumferentially arranged around the basket support 110 and connected to the basket support 110, and the supporting portion 200 is switched between an expanded state and a contracted state along a radial direction of the basket support 110; the supporting part 200 is in the contracted state under the restriction of the conveying device; the support 200 is in the expanded state when unconstrained; wherein, in the expanded state, the support 200 has a radial outer dimension along the basket support 110 that is greater than the radial outer dimension of the basket support 110. The radially outer dimension of the support portion 200 herein refers to the radially outer width of the support portion 200. If the outer peripheral contour of the support portion 200 is circular, the radially outer dimension thereof is the largest diameter of the circular shape. If the support portion 200 is formed of a plurality of support members (hereinafter, support wires or branches), the radially outer dimension thereof is the maximum diameter of the circumscribed circle of the plurality of support members. The definition of the radially outer dimension of the basket support 110 and the radially outer dimension of the runner membrane 14 will be understood with reference to the definition of the radially outer dimension of the support portion 200 described above.
In an exemplary embodiment, the basket support 110 is hollow, the basket support 110 is made of a memory metal such as nickel-titanium alloy, and the basket support 110 is manufactured by cutting a pipe by a laser carving technique, and then performing heat setting, sand blasting and polishing. The basket support 110 is in an expanded state when not limited, a cavity formed in the basket support 110 is used for forming a liquid passage for rotation of the impeller 120, and preferably, the basket support 110 is further covered with a basket covering film 113, and the basket covering film 113 is covered outside the basket support 110 through a heat shrinkage process and the like. Optionally, the hollow structure of the basket support 110 is diamond, which can provide enough supporting strength while ensuring the holding performance, so that the basket support 110 is not flattened and rubbed with the impeller 120 during blood pumping, and on the other hand, a sufficient connection area is provided for the basket coating 113, so that the quality and performance of the coated membrane surface are ensured.
Optionally, the blood pump body 100 further comprises an impeller 120, said impeller 120 being rotatably arranged within the basket support 110 about the axial direction of the basket support 110 for pumping blood by rotation in the axial direction of the basket support 110. In the example shown in fig. 3 and 4, the impeller 120 drives blood to flow from the left side to the right side in the drawing when it rotates. Thus, the opposite ends of the basket support 110 in the axial direction thereof define an inflow end 111 (left end in fig. 3 and 4) and an outflow end 112 (right end in fig. 3 and 4) according to the direction of blood flow.
Further, the interventional blood pump 10 includes an inflow end bearing portion 131 axially connected to the inflow end 111 of the basket support 110, and an outflow end bearing portion 132 axially connected to the outflow end 112 of the basket support 110. In one example, the inflow end bearing 131 includes an inflow end connector 1311 and an inflow end bearing 1312. The inflow end connector 1311 may be, for example, a plurality of circumferentially distributed rods of the same material as the basket support 110, which may be welded to the inflow end 111 of the basket support 110 or may be integrally formed with the basket support 110 extending distally. Preferably, when the interventional blood pump 10 is in the expanded state without external force from the delivery device, the rods of the inflow end connector 1311 enclose a truncated cone shape, which gradually contracts toward the distal end. The inflow end bearing 1312 includes a sliding bearing 1312a made of a wear-resistant polymer material and a sliding bearing sleeve 1312b made of a metal material, the sliding bearing sleeve 1312b being sleeved outside the sliding bearing 1312a, the sliding bearing 1312a having a bearing hole coaxially arranged with the basket support 110 for rotatably passing through the rotation shaft. The slide bearing sleeve 1312b is connected to the inflow end connector 1311 by welding or bonding, and thus the inflow end bearing 131 is fixed coaxially with respect to the basket support 110. The outflow end bearing portion 132 includes an outflow end connector 1321 and an outflow end bearing 1322.
The outflow end connector 1321 is similar to the inflow end connector 1311 in structure, and more preferably, a double-layer rod is used to form a double-layer truncated cone-shaped structure, so as to improve radial stability, so that the impeller 120 is not pressed to deform by external force in the pressing and expanding stages. The outflow end bearing 1322 includes a sliding bearing 1322a made of a wear-resistant polymer material and a sliding bearing housing 1322b made of a polymer material. The outflow end bearing 1322 is similar in structure to the inflow end bearing 1312. The sliding bearing sleeve 1322b made of a polymer material can be conveniently connected with the inner sheath 21 in the transmission assembly 20 through adhesion, thermal shrinkage or thermal fusion. The sliding bearing sleeve 1322b is connected to the outflow end connector 1321 by heat shrinking or bonding, so that the outflow end bearing 132 is coaxially fixed with respect to the basket support 110.
Referring to fig. 4, the impeller 120 includes a blade 121 and a rotation shaft 122, the blade 121 is preferably made of an elastic material, and the rotation shaft 122 is fixedly connected to the blade 121 in an axial direction of the blade 121. The distal end of the shaft 122 rotatably penetrates into the inflow end bearing 1312 and the proximal end of the shaft 122 rotatably penetrates into the outflow end bearing 1322. So configured, the impeller 120 can rotate at high speed about the axis of the basket support 110 with the shaft centered in the basket support 110.
Further, the interventional blood pump 10 further comprises a flow channel membrane 14, wherein the distal end of the flow channel membrane 14 is connected with the basket covering membrane 113 by heat shrinkage or hot melting, the proximal end of the flow channel membrane 14 is connected with the inner sheath 21, a passage is formed in the flow channel membrane 14 after blood is pumped out of the blood pump main body 100, and the blood is pumped from the left ventricle 03 to the ascending aorta 01 through the aortic valve 02.
Referring to fig. 4 and 5, in the first embodiment, one end of the supporting portion 200 is connected to the inflow end of the basket support 110; when the support portion 200 is in the expanded state, at least a portion of the support portion 200 expands in the outer direction of the basket support 110. In one example, the support portion 200 includes a plurality of support wires 210 circumferentially distributed around the basket support 110, one end of the support wires 210 is connected to the inflow end 111 of the basket support 110, the other end of the support wires 210 is a free end, and when the support portion 200 is in the expanded state, the other end of the support wires 210 extends and expands in the external direction of the blood pump main body 100. One end of the support portion 200 may be connected to the inflow end of the basket support 110, either directly or indirectly.
In the example shown in fig. 4 and 5, the support wire 210 is curved toward the outside while being curved toward the proximal direction. Preferably, the end of the support wire 210 connected to the basket support 110 extends along the axial direction of the basket support, the support wire 210 is concave in the proximal direction, and the normal direction of the concave is toward the outside of the basket support 110. The arcuate shape of the support wire 210 is concave in a proximal direction to facilitate loading of the support wire 210 into the sheath of the delivery device. It will be appreciated that in other embodiments, the concavity of the support wire 210 may be not only curved, but also multi-fold, as the present embodiment is not limited in this regard. Further, the interventional blood pump 10 may be gradually loaded into the sheath of the delivery device from the proximal end to the distal end. The sheath of the delivery device can restrict the expansion of the support 200, causing the support 200 to transition to the contracted state, and the support wire 210 is straightened and retracted into the sheath. It should be noted that the conveying device is not particularly limited in this embodiment, and those skilled in the art may select to use according to the prior art.
Optionally, the supporting wires 210 are integrally formed with the inflow end 111 of the basket support 110, and are formed by extending the inflow end 111 of the basket support 110 distally, for example, by carving and heat setting; alternatively, the support wires 210 are welded to the inflow end 111 of the basket support 110. The shape design of the supporting wires 210 of the supporting portion 200 can refer to the structure of the human ventricle, so that each supporting wire 210 of the supporting portion 200 is unfolded outwards after the delivery device is withdrawn and contacts with the ventricle wall at a proper position, and the relative fixation of the ventricle wall and the supporting wires 210 is realized, thereby achieving the purpose of fixing the basket support 110 in the ventricle. Meanwhile, after the support portion 200 is expanded, the radial outer dimension of the support portion 200 is larger than the radial outer dimension of the basket support 110 and the runner membrane 14 after being flushed out, so that even if the support wires 210 of the support portion 200 are not completely fixed on the ventricle wall, the basket support 110 and the impeller 120 therein will not drop out of the ventricle due to the impact of blood.
Preferably, the other end of the support wire 210 (i.e., the end remote from the end connected to the basket support 110) has a buffer portion 211, and/or the other end of the support wire 210 is coated with an anticoagulant. The buffer portion 211 may be, for example, a blunt end, a sphere, a flexible ball, etc., and the buffer portion 211 may be, for example, made of a biocompatible material that is used to prevent damage to the ventricular wall when contacting the ventricular wall. The anticoagulants are gradually released into the blood during the deployment of the basket support 110 and the operation of the blood pump, so that the risk of thrombus formation can be reduced. Preferably, an anticoagulant may be further applied to the outer surface of the buffer portion 211.
Optionally, the material of the support wire 210 includes a memory metal, such as nitinol, which may be the same as or different from the material of the basket support 110, which is not limited in this embodiment.
Optionally, the interventional blood pump 10 further comprises a contact part 300, the contact part 300 being connected to the distal end of the blood pump body 100. In an alternative example, the contact 300 is a flexible tubular member having a proximal end coupled to the inflow end connector 1311, such as by heat shrinking or bonding, to the outside of the rods of the inflow end connector 1311. The contact 300 may be made of a polymer material having flexibility such as PEBAX. The distal end of the contact 300 is curled when unconstrained by an external force. The contact 300 is used to determine the location of the prototype implant during the implantation phase.
In the preoperative crimping and folding stage, the sheath of the delivery device may be pushed distally from the proximal end of the interventional blood pump 10 to flatten the curvature of the support wire 210 and thereby straighten the contact 300 into the sheath for loading.
The interventional blood pump system provided by the present embodiment includes the interventional blood pump 10 as described above, and thus has the advantageous effects brought about by the interventional blood pump 10 as described above. Please refer to the prior art for other component structures of the interventional blood pump system, which are not developed here.
In summary, after the intervention to the predetermined portion, the supporting portion 200 can be converted to an expanded state to achieve fixation in the ventricle, and the basket support 110 is connected to the supporting portion 200, so that the basket support 110 is also relatively fixed, thereby reducing the risk of shaking of the intervention blood pump 10 in a suspended state in the ventricle, and reducing the formation of hemolysis and thrombus. In addition, since the basket support 110 is also relatively fixed in the ventricle, the risk that the basket support 110 and the impeller 120 fall into the ascending aorta 01 from the ventricle can be avoided, the reliability of the interventional blood pump 10 during operation is improved, and serious faults such as stalling and failure are avoided.
[ example two ]
Referring to fig. 6 and 7, the interventional blood pump and the interventional blood pump system according to the second embodiment of the present invention are substantially the same as those of the first embodiment, and will not be described in detail, but only in terms of different points.
In the second embodiment, the structure of the supporting portion 200 and the connection manner thereof with the basket support 110 are different from those of the first embodiment. Specifically, in the second embodiment, the supporting portion 200 includes a plurality of supporting wires 210 circumferentially distributed around the inflow end bearing 131; one end of the support wire 210 is connected to the inflow end bearing 131, the other end of the support wire 210 is a free end, and when the support 200 is in the expanded state, the other end of the support wire 210 extends and expands in the external direction of the blood pump main body 100.
In one example, one end of the support wire 210 is connected to the sliding bearing housing 1312b of the inflow end bearing 131 by welding, which can secure the connection strength of the two. In the example shown in fig. 6 and 7, the other end of the support wire 210 is curved toward the outside while being curved in an arc shape toward the proximal direction.
Preferably, the end of the supporting wire 210 connected to the inflow end bearing 131 extends in the radial direction of the basket support 110, the supporting wire 210 is concave in the proximal direction, the normal direction of the concave is toward the inside of the basket support 110, and the extending direction of the free end is toward the outflow end 112. The arcuate shape of the support wire 210 is concave in a proximal direction to facilitate loading of the support wire 210 into the sheath of the delivery device. In addition, the concave shape of the supporting wire 210 facing the inside of the basket support 110 combines with the elasticity of the supporting wire 210, so that the interventional blood pump can be released first and then enter the ventricle, and the supporting wire 210 can expand and play a fixing role after entering the ventricle.
Further, the proximal end of the tubular contact portion 300 is sleeved outside the supporting wire 210 and the inflow end bearing portion 131, and is connected by heat shrinkage or bonding. So configured, the support 200 is of an independent structure, is convenient to process, and can be formed without the basket support 110, thereby reducing the process difficulty and the processing cost. In the preoperative crimping and folding stage, a section of inner sheath tube can be sleeved from the distal end of the contact part 300 to the free end beyond the supporting part 200, the supporting wire 210 is crimped therein, the outer sheath tube is pushed from the proximal end to the distal end of the interventional blood pump 10, and after at least exceeding the position of the supporting part 200, the inner sheath tube sleeved on the contact part 300 and the supporting part 200 is removed, so that the whole crimping of the interventional blood pump 10 is realized. It will be appreciated that during the withdrawal phase, the support wire 210 may be folded back distally by pushing the outer sheath distally from the proximal end of the interventional blood pump 10 directly, such that the support wire 210 is received within the outer sheath.
In another example, the support wire 210 may not be directly connected to the inflow end bearing 131, but indirectly connected to the inflow end bearing 131 through the contact part 300. Specifically, the supporting wire 210 may be connected to the contact portion 300 by heat shrinking or bonding, for example, bonding on the tubular proximal inner wall of the contact portion 300, and then sleeving the contact portion 300 on the inflow end bearing portion 131, and connecting by heat shrinking or bonding.
[ example III ]
Referring to fig. 8 and 9, the interventional blood pump and the interventional blood pump system according to the third embodiment of the present invention are substantially the same as those of the first embodiment, and will not be described again for the same parts, but only for different points.
In the third embodiment, the structure of the supporting portion 200 is different from that of the first embodiment. Specifically, in the third embodiment, the support portion 200 includes a sliding ring 220 that is movable along the axial direction of the blood pump main body 100, and a plurality of support wires 210 that are circumferentially distributed around the sliding ring 220, one end of the support wire 210 is connected to the inflow end 111 of the basket support 110, and the other ends of the plurality of support wires 210 are collected in the sliding ring 220; when the supporting portion 200 is in the expanded state, the middle portion of the supporting wire 210 is raised and expanded in the external direction of the blood pump main body 100.
The material of the support wire 210 is similar to the embodiment, and may be welded to the inflow end 111 of the basket support 110 after being formed independently, or may be integrally formed with the inflow end 111 of the basket support 110, and formed by extending the basket support 110 distally. Unlike the first embodiment, the other end of the support wire 210 is not outwardly expanded but is integrally connected to the sliding ring 220 when the support 200 is in an expanded state. And the supporting portion 200 is bulged at the middle of the supporting wire 210 when not constrained by the conveyor, so that the supporting portion 200 is formed to be bulged outwardly. During the pre-operative crimping and folding stage, the sheath may be used to push distally from the proximal end of the interventional blood pump 10, flattening the bulge of the support wire 210, as will be appreciated, with the sliding ring 220 moving distally.
Compared with the support portion 200 of the first and second embodiments, the potential contact between the structure of the support portion 200 of the third embodiment and the ventricular wall is changed from point contact to surface contact, and the possibility of puncturing the ventricular wall is reduced. And the process of putting the device into the conveying device is smoother.
Further, one end of the contact portion 300 is connected to the inflow end bearing portion 131, and the sliding ring 220 is movably sleeved on the contact portion 300. Preferably, the inner diameter of the sliding ring 220 is adapted to the outer diameter of the contact portion 300, and the sliding ring 220 moves distally along the contact portion 300 during crimping and folding stages when the sheath is flattening the bulge of the support wire 210.
Alternatively, the material of the sliding ring 220 includes a developing material, and the supporting portion 200 is positioned flush with a predetermined position (e.g., a head end) of the contact portion 300 when in the contracted state under the restriction of the conveying means. So configured, during implantation, the operator can clearly determine the location of the prototype implant by observing the position of the slip ring 220. And the contact part 300 can be processed without adopting a specific developing material, thereby reducing the cost.
[ example IV ]
Referring to fig. 10, the interventional blood pump and the interventional blood pump system according to the fourth embodiment of the present invention are substantially the same as those of the first embodiment, and will not be described again for the same parts, but only for different points.
In the fourth embodiment, the structure of the contact portion 300, the structure of the supporting portion 200, and the connection manner thereof with the basket support 110 are different from those of the first embodiment. Specifically, in the fourth embodiment, the contact portion 300 is a straight tube, and the distal end thereof is connected to the support portion 200 without forming a curl shape. The supporting portion 200 is disposed on the contact portion 300 and is connected to the basket supporting frame 110 through the contact portion 300.
In one example, the supporting portion 200 includes a plurality of branches 230, one end of the branches 230 is connected to the contact portion 300, the other end of the branches 230 is a free end, and the other end of the branches 230 extends toward the outside of the blood pump main body 100 when the supporting portion 230 is in the expanded state. Preferably, the branch body 230 is curved in an arc shape toward the outside while being directed toward the proximal direction. Preferably, the arcuate shape of the branch 230 is concave in a proximal direction to facilitate loading of the branch 230 into the sheath of the delivery device.
Optionally, the material of the supporting portion 200 and/or the material of the contact portion 300 includes a flexible polymer material. In one embodiment, the branch 230 is made of a polymer material such as PEBAX, which is softer than the material of the basket support 110 and the like, whereby the support 200 formed by the branch 230 is softer than the support 200 made of memory metal in the previous embodiment, reducing the risk of puncture to the inner wall of the ventricle.
Further, the material of the supporting portion 200 and/or the material of the contact portion 300 further include a developing material, for example, the supporting portion 200 and the contact portion 300 may be mixed with the developing material in a polymer material, and processed into a whole body for developing, so as to facilitate a doctor to monitor the position of the interventional blood pump 10 in the ventricle.
In summary, in the interventional blood pump and the interventional blood pump system provided by the present invention, the interventional blood pump includes: a blood pump main body and a support part; the blood pump main body comprises a basket support; the supporting part is circumferentially arranged around the basket support and connected with the basket support, and the supporting part is converted between an expanding state and a contracting state along the radial direction of the basket support; the supporting part is in the contracted state under the limitation of the conveying device; the support is in the expanded state when unconstrained; wherein, in the expanded state, the support portion has a radial outer dimension along the basket support that is greater than a radial outer dimension of the basket support. So configured, the supporting part is inserted to the preset position and then can be converted to an expanded state to realize fixation in the heart chamber, and the basket support is connected with the supporting part, so that the basket support is also fixed relatively, the shaking risk of the inserted blood pump in the suspended state in the heart chamber is reduced, and the formation of hemolysis and thrombus is reduced. In addition, because the basket support is also relatively fixed in the ventricle, the risk that the basket support and the impeller drop to the ascending aorta from the ventricle can also be avoided, the reliability of the interventional blood pump in the operation period is improved, and serious faults such as stalling, failure and the like are avoided.
It should be noted that the above embodiments may be combined with each other. The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the appended claims.
Claims (17)
1. An interventional blood pump, comprising: a blood pump main body and a support part;
the blood pump main body comprises a basket support; the supporting part is circumferentially arranged around the basket support and connected with the basket support, and the supporting part is converted between an expanding state and a contracting state along the radial direction of the basket support;
the supporting part is in the contracted state under the limitation of the conveying device; the support is in the expanded state when unconstrained;
wherein, in the expanded state, the support portion has a radial outer dimension along the basket support that is greater than a radial outer dimension of the basket support.
2. The interventional blood pump of claim 1, wherein the basket support has opposite inflow and outflow ends in an axial direction thereof, one end of the support being connected to the inflow end of the basket support; when the supporting portion is in the expanded state, at least a portion of the supporting portion expands in an outer direction of the basket support.
3. The interventional blood pump of claim 2, wherein the support section comprises a plurality of support wires circumferentially distributed around the basket support, one end of the support wires being connected to the inflow end of the basket support, the other end of the support wires being free ends, the free ends extending outwardly of the blood pump body when the support section is in the expanded state.
4. The interventional blood pump of claim 3, wherein an end of the support wire connected to the basket support extends in an axial direction of the basket support, the support wire is concave in a proximal direction, and a normal direction of the concave is toward an exterior of the basket support.
5. The interventional blood pump of claim 3, wherein said support wire is integrally formed with an inflow end of said basket support; or the supporting wires are welded with the inflow end of the basket support.
6. The interventional blood pump of claim 2, comprising an inflow end bearing portion axially connected to the inflow end of the basket support, the support portion comprising a plurality of support wires circumferentially distributed around the inflow end bearing portion; one end of the supporting wire is connected with the inflow end bearing part, the other end of the supporting wire is a free end, and when the supporting part is in the expanded state, the free end extends and expands to the external direction of the blood pump main body.
7. The interventional blood pump of claim 6, comprising a contact portion, one end of the contact portion being connected to the inflow end bearing portion, the support wire being connected to the inflow end bearing portion through the contact portion.
8. The interventional blood pump of claim 6, wherein an end of the support wire connected to the inflow end bearing portion extends in a radial direction of the basket support, the support wire is concave in a proximal direction, a normal direction of the concave is toward an interior of the basket support, and an extension direction of the free end is toward the outflow end.
9. The interventional blood pump of claim 3 or 6, wherein the other end of the support wire has a buffer and/or the other end of the support wire is coated with an anticoagulant drug.
10. The interventional blood pump according to claim 2, wherein the support part comprises a sliding ring movable along an axial direction of the blood pump main body and a plurality of support wires circumferentially distributed around the sliding ring, one end of the support wires is connected with an inflow end of the basket support, and the other ends of the plurality of support wires are converged on the sliding ring; when the support part is in the expanded state, the middle part of the support wire is raised and expands towards the external direction of the blood pump main body.
11. The interventional blood pump of claim 10, comprising a contact portion, one end of the contact portion being connected to the inflow end bearing portion, the sliding ring being movably sleeved on the contact portion.
12. An interventional blood pump according to any one of claims 3, 6, 10, wherein the material of the support wire and/or the material of the basket support comprises a memory metal.
13. The interventional blood pump of claim 1, comprising a contact portion connected to a distal end of the basket support; the supporting part is arranged on the contact part and is connected with the basket support through the contact part.
14. The interventional blood pump of claim 13, wherein the support comprises a plurality of branches, one end of the branches being connected to the contact portion, the other end of the branches being free, the other end of the branches extending in an outward direction of the blood pump body when the support is in the expanded state.
15. The interventional blood pump of claim 13, wherein the material of the support and/or the material of the contact comprises a flexible polymeric material.
16. The interventional blood pump of claim 15, wherein the material of the support and/or the material of the contact further comprises a developing material.
17. An interventional blood pump system, comprising an interventional blood pump according to any one of claims 1-16, further comprising a transmission assembly and a drive assembly; the interventional blood pump is connected with the driving assembly through the transmission assembly, and the driving assembly drives the impeller of the interventional blood pump to act through the transmission assembly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210190781.XA CN116688351A (en) | 2022-02-28 | 2022-02-28 | Intervention type blood pump and intervention type blood pump system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210190781.XA CN116688351A (en) | 2022-02-28 | 2022-02-28 | Intervention type blood pump and intervention type blood pump system |
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| Publication Number | Publication Date |
|---|---|
| CN116688351A true CN116688351A (en) | 2023-09-05 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210190781.XA Withdrawn CN116688351A (en) | 2022-02-28 | 2022-02-28 | Intervention type blood pump and intervention type blood pump system |
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| CN (1) | CN116688351A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2026012109A1 (en) * | 2024-07-08 | 2026-01-15 | 深圳核心医疗科技股份有限公司 | Cannula assembly and blood pump |
-
2022
- 2022-02-28 CN CN202210190781.XA patent/CN116688351A/en not_active Withdrawn
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2026012109A1 (en) * | 2024-07-08 | 2026-01-15 | 深圳核心医疗科技股份有限公司 | Cannula assembly and blood pump |
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Application publication date: 20230905 |