CN119158163A - Percutaneous ventricular assist device - Google Patents
Percutaneous ventricular assist device Download PDFInfo
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- CN119158163A CN119158163A CN202310728654.5A CN202310728654A CN119158163A CN 119158163 A CN119158163 A CN 119158163A CN 202310728654 A CN202310728654 A CN 202310728654A CN 119158163 A CN119158163 A CN 119158163A
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- Prior art keywords
- transmission shaft
- flexible transmission
- perfusion
- sleeve
- assist device
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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
- A61M60/20—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
- A61M60/10—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
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
-
- 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
- A61M60/40—Details relating to driving
- A61M60/403—Details relating to driving for non-positive displacement blood pumps
- A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
- A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
- A61M60/416—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted directly by the motor rotor drive shaft
-
- 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
- A61M60/40—Details relating to driving
- A61M60/465—Details relating to driving for devices for mechanical circulatory actuation
- A61M60/47—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel
- A61M60/473—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel generated by an electromotor
-
- 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
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- 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)
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- Vascular Medicine (AREA)
- External Artificial Organs (AREA)
Abstract
The invention provides a percutaneous ventricular assist device which comprises a blood pump, an outer tube assembly, a flexible transmission shaft and a protection structure, wherein the outer tube assembly is connected with the blood pump, the flexible transmission shaft is accommodated in the outer tube assembly, the distal end of the flexible transmission shaft is connected with the blood pump, the proximal end of the flexible transmission shaft is used for being externally connected with a motor, the protection structure is arranged on the peripheral surface of the flexible transmission shaft, and the friction coefficient between the protection structure and the outer tube assembly is 0.04-0.20. According to the percutaneous ventricular assist device, the motor drives the flexible transmission shaft to rotate so as to transfer kinetic energy to the blood pump, and the friction coefficient between the protection structure and the sleeve is controlled within the preferred range, so that the friction resistance is smaller when the protection structure and the sleeve slide relatively, and abrasive dust generated after the protection structure and the sleeve touch the sleeve is reduced, so that the abrasive dust is prevented from entering a patient body after being accumulated in a large amount, and the physical health of the patient is prevented from being damaged.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a percutaneous ventricular assist device.
Background
The heart chamber auxiliary device is characterized in that a human hematopoietic pump is connected with the heart in parallel to simulate the function of ventricular ejection, and the ventricular blood is pumped into an arterial system to partially or completely replace the function of the heart. The blood pump is implanted in the patient, and the motor for providing kinetic energy to the blood pump is arranged outside the patient, so that the kinetic energy of the motor is usually transmitted to the blood pump in the body through a flexible shaft, and the kinetic energy is provided for the normal operation of the blood pump.
The flexible shaft is a stainless steel flexible shaft, can flexibly transfer torsion movement to a required position, one end of the flexible shaft for blood pump transmission is connected with an internal blood pump, the other end of the flexible shaft is connected with an external motor, and the kinetic energy of the motor is transferred to the internal blood pump. The outer periphery of the flexible shaft is provided with an outer sleeve, the flexible shaft is arranged in the sleeve in a penetrating way, and in the torsion transmission process of the flexible shaft, the flexible shaft inevitably contacts with the sleeve, namely the flexible shaft cannot always keep torsion at the central position of the sleeve.
When the twisted flexible shaft is contacted with the sleeve, the inner wall of the sleeve can be worn, the abrasion scraps are accumulated for a long time, and if the abrasion scraps particles enter the body of a patient, thrombus can be formed, so that the life and the health of the patient are endangered.
In the prior art, the abrasive dust is washed by the perfusion liquid, but along with the continuous accumulation of the abrasive dust, the perfusion liquid can not bring a large amount of deposited abrasive dust out of the body, and a washing flow passage starts to be blocked. More seriously, as the flexible shaft does not always keep a straight line from outside the patient's body to inside the body, part of the section of the flexible shaft is bent in a certain radian, abrasive dust is more easily accumulated in the bent part of the flexible shaft, and the flushing flow channel becomes narrower. In the bending part of the flexible shaft, more and more abrasive dust is accumulated in the gap between the flexible shaft and the sleeve, the abrasive dust is not uniformly accumulated around the flexible circumference, the abrasive dust is accumulated on the inner side of the bending, and the flexible shaft continuously wears the inner wall of the sleeve on the outer side of the bending. Thus, the inner wall of the cannula outside the curve is worn out very quickly, which in turn leads to leakage of the perfusate and failure of the entire percutaneous ventricular assist device.
Disclosure of Invention
The invention aims to provide a percutaneous ventricular assist device, which solves the problems that in the prior art, a flexible shaft collides with an outer sleeve in the process of transmitting the kinetic energy of a motor to a blood pump to generate a large amount of abrasive dust so as to endanger the life health of a patient and shorten the effective operation time of the percutaneous ventricular assist device.
In order to solve the above technical problem, according to one aspect of the present invention, there is provided a percutaneous ventricular assist device comprising:
A blood pump;
an outer tube assembly connected to the blood pump;
The flexible transmission shaft is accommodated in the outer tube assembly, the distal end of the flexible transmission shaft is connected with the blood pump, and the proximal end of the flexible transmission shaft is used for being externally connected with a motor;
And the protection structure is arranged on the peripheral surface of the flexible transmission shaft, and the friction coefficient between the protection structure and the outer tube assembly is between 0.04 and 0.20.
Optionally, the protection structure comprises a coating and/or a heat-shrinkable tube, wherein the coating is coated and formed on the outer peripheral surface of the flexible transmission shaft, and the heat-shrinkable tube is heat-shrinkable and formed on the outer peripheral surface of the flexible transmission shaft.
Optionally, the thickness of the coating is between 5 microns and 10 microns.
Optionally, the material of the protective structure comprises FEP, PTFE or PEEK.
Optionally, the outer tube assembly includes a sheath tube and a sleeve tube, the sleeve tube is accommodated in the sheath tube, the flexible transmission shaft is accommodated in the sleeve tube, a radial gap between the sheath tube and the sleeve tube is configured as a perfusion inflow channel, a radial gap between the flexible transmission shaft and the sleeve tube is configured as a perfusion outflow channel, the blood pump is provided with a diversion channel, the perfusion inflow channel, the diversion channel and the perfusion outflow channel are sequentially communicated, and the diversion channel is used for diverting perfusion fluid into two paths, and one path of perfusion fluid flows to the perfusion outflow channel and the other path of perfusion fluid flows to the distal end of the blood pump.
Optionally, the sleeve material comprises FEP, PTFE, PEEK or PI.
Optionally, the outer tube assembly comprises a sheath tube, the flexible transmission shaft is positioned in the sheath tube, the flexible transmission shaft is in a hollow tubular shape, the inner cavity of the flexible transmission shaft is configured as a perfusion inflow channel, the blood pump is provided with a diversion channel, a radial gap between the sheath tube and the flexible transmission shaft is configured as a perfusion outflow channel, the perfusion inflow channel, the diversion channel and the perfusion outflow channel are sequentially communicated, and the diversion channel is used for diverting perfusion fluid into two paths, and one path of perfusion fluid flows to the perfusion outflow channel and the other path of perfusion fluid flows to the distal end of the blood pump.
Optionally, the sheath material comprises FEP, PTFE, PEEK or PI.
Optionally, a sealing tube is arranged between the flexible transmission shaft and the protection structure.
Optionally, a first ripple is arranged on the outer peripheral surface of the heat shrinkage tube, the first ripple is in a thread shape or an annular shape, the heat shrinkage tube comprises the first ripple in a thread shape and/or a plurality of first ripples in an annular shape which are axially arranged, and the spiral direction of the first ripple in the thread shape and the rotation direction of the flexible transmission shaft.
According to the percutaneous ventricular assist device, the motor drives the flexible transmission shaft to rotate so as to transfer kinetic energy to the blood pump, the protection structure is arranged on the flexible transmission shaft, the friction coefficient between the protection structure and the outer tube assembly is between 0.04 and 0.20, and the friction coefficient between the protection structure and the sleeve is controlled to be within the above preferred range, so that the friction resistance is small when the protection structure and the sleeve slide relatively, abrasive dust generated after touching the protection structure and the sleeve is reduced, and the abrasive dust is prevented from entering a patient body after being accumulated in a large amount to harm the physical health of the patient.
Drawings
It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. Wherein:
FIG. 1 is an axial cross-sectional view of a percutaneous ventricular assist device according to a first embodiment of the invention;
FIG. 2 is a radial cross-sectional view of a percutaneous ventricular assist device according to a first embodiment of the invention;
FIG. 3 is an axial cross-sectional view of a portion of the outer periphery of a flexible drive shaft according to a first embodiment of the invention;
FIG. 4 is a schematic view of a flexible drive shaft with a protective structure according to a first embodiment of the present invention;
FIG. 5 is a first schematic view of a first corrugation of a protective structure according to a first embodiment of the present invention;
FIGS. 6 and 7 are second schematic views of first corrugations of a protective structure according to a first embodiment of the present invention;
FIG. 8 is a third schematic view of a first corrugation of a protection structure according to a first embodiment of the present invention;
FIG. 9 is a fourth schematic view of a first corrugation of a protection structure according to a first embodiment of the present invention;
fig. 10 is an axial cross-sectional view of a percutaneous ventricular assist device according to a second embodiment of the invention.
In the accompanying drawings:
10-blood pump, 11-shell, 12-driving shaft;
20-an outer tube assembly, 21-a sheath tube, 22-a sleeve;
30-flexible transmission shaft, 31-steel wire;
40-protecting structure, 41-heat shrinking pipe and 42-first corrugation;
51-perfusion inflow channel, 52-shunt channel, 53-perfusion outflow channel.
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 a "first", "second", "third" or "a" may include, explicitly or implicitly, one or at least two such feature, one end "and" the other end "and" the proximal end "and" the distal end "generally refer to the respective two parts, including not only the endpoints, but also the terms" mounted "," connected "are to be interpreted broadly, e.g., as a fixed connection, as a removable connection, as a unitary body, as a mechanical connection, as an electrical connection, as a direct connection, as an indirect connection via an intermediary, as a communication between two elements, or as an interaction relationship between two elements. Furthermore, as used in this disclosure, an element disposed on another element generally only refers to a connection, coupling, cooperation or transmission between two elements, and the connection, coupling, cooperation or transmission between two elements may be direct or indirect through intermediate elements, and should not be construed as indicating or implying any spatial positional relationship between the two elements, i.e., an element may be in any orientation, such as inside, outside, above, below, or on one side, of the other element unless the context clearly indicates 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.
"Proximal" and "distal" are defined herein as "proximal" generally referring to the end of the medical device that is closest to the operator during normal operation, and "distal" generally referring to the end of the medical device that first enters the patient during normal operation.
[ Embodiment one ]
Fig. 1 is an axial sectional view of a percutaneous ventricular assist device according to a first embodiment of the invention, and fig. 2 is a radial sectional view of the percutaneous ventricular assist device according to the first embodiment of the invention. Referring to fig. 1 and 2, the present embodiment provides a percutaneous ventricular assist device that includes a blood pump 10, an outer tube assembly 20, a flexible drive shaft 30, and a protective structure 40. The blood pump 10 has a housing 11, a drive shaft 12, at least a portion of the drive shaft 12 being located within the housing 11, and an impeller (not shown) disposed at a distal end of the drive shaft 12. The outer tube assembly 20 is connected with the blood pump 10, specifically, the outer tube assembly 20 is connected with the housing 11 of the blood pump 10, further, the outer tube assembly 20 includes a sheath 21 and a sleeve 22, the sheath 21 is connected with the housing 11 of the blood pump 10, the sleeve 22 is accommodated in the sheath 21 and fixedly connected with the proximal end of the blood pump 10, and the flexible transmission shaft 30 is accommodated in the sleeve 22. The distal end of the flexible drive shaft 30 is connected to the blood pump 10, specifically, the distal end of the flexible drive shaft 30 is connected to the driving shaft 12 of the blood pump 10, the proximal end of the flexible drive shaft 30 is connected to the motor, and the flexible drive shaft 30 is made of stainless steel.
In this way, the motor drives the flexible transmission shaft 30 to rotate, so as to drive the driving shaft 12 to rotate, so that the impeller arranged at the far end of the driving shaft 12 rotates, and further, power is generated in the blood flow direction of the ventricle, blood is sucked out of the ventricle, and the heart is assisted to convey the blood to the whole body of the human body. I.e. the motor transmits torque to the impeller via the flexible drive shaft 30 and the drive shaft 12. Wherein the motor is disposed outside the patient's body.
Fig. 3 is an axial sectional view of a part of the outer periphery of a flexible drive shaft according to a first embodiment of the present invention. With respect to the specific structure of the flexible drive shaft 30, referring to fig. 3, the flexible drive shaft 30 includes a single helical layer or at least two helical layers disposed coaxially and in a stack. The spiral layer is configured such that a single wire 31 (stainless wire 31) is spirally wound, or such that at least two wires 31 are spirally wound.
Further, with continued reference to fig. 1,2 and 3, the percutaneous ventricular assist device of the present embodiment further includes a protection structure 40, where the protection structure 40 is disposed on the outer peripheral surface of the flexible transmission shaft 30 and completely covers the outer peripheral surface of the flexible transmission shaft 30, and a friction coefficient between the protection structure 40 and the outer tube assembly 20 is greater than or equal to 0.04 and less than or equal to 0.20. The outer tube assembly 20 comprises a sleeve 22 and a sheath 21 from inside to outside, and the friction coefficient between the outer peripheral surface of the protection structure 40 and the inner wall of the sleeve 22 is 0.04-0.20. During the transmission of the twisting motion by the flexible drive shaft 30, the flexible drive shaft 30 inevitably comes into contact with the sleeve 22, i.e., the flexible shaft cannot always remain twisted at the center position of the sleeve 22. The twisted flexible drive shaft 30 wears the inner wall of the sleeve 22 when it touches the outer sleeve 22, and the abrasive dust is accumulated for a long time, so that if the abrasive dust particles enter the body of the patient, thrombus is formed, the life and health of the patient are damaged, and a large amount of abrasive dust is difficult to wash out by the perfusate. The friction coefficient between the protection structure 40 and the sleeve 22 is between 0.04 and 0.20, and the friction coefficient between the protection structure and the sleeve is controlled within the above preferred range, so that the friction resistance is smaller when the protection structure and the sleeve slide relatively, and the abrasion dust generated after the protection structure and the sleeve touch the sleeve is reduced, thereby avoiding the abrasion dust from accumulating in a large amount and entering the body of a patient to harm the body health of the patient.
In one embodiment, the protective structure 40 is configured as a coating, which is formed on the outer peripheral surface of the flexible transmission shaft 30, and the coating may be an FEP coating (perfluoroethylene propylene copolymer coating), a PTFE coating (polytetrafluoroethylene coating), a PEEK coating (polyetheretherketone coating), and the thickness of the coating is greater than or equal to 5 micrometers and less than or equal to 10 micrometers. In an alternative embodiment, the protection structure 40 is configured as a heat-shrinkable tube, which is heat-shrunk and formed on the outer peripheral surface of the flexible transmission shaft 30, and the heat-shrinkable tube may be an FEP heat-shrinkable tube (perfluoroethylene propylene copolymer heat-shrinkable tube), a PTFE heat-shrinkable tube (polytetrafluoroethylene coating heat-shrinkable tube), or a PEEK heat-shrinkable tube (polyetheretherketone heat-shrinkable tube). The outer tube assembly 20 includes a sleeve 22 and a sheath 21 from inside to outside, the material of the sleeve 22 comprising FEP, PTFE, PEEK or PI. When the material of the protection structure on the surface of the flexible transmission shaft 30 is FEP, PTFE or PEEK and the material of the sleeve 22 is FEP, PTFE, PEEK or PI, the friction coefficient between the protection structure on the surface of the flexible transmission shaft 30 and the sleeve 22 is between 0.04 and 0.20, the friction resistance is small when the protection structure and the sleeve slide relatively, and the abrasive dust generated after the protection structure and the sleeve touch each other is reduced.
Specifically, the sleeve 22 may be a single-layer sleeve made of a single material, or may be a multi-layer composite sleeve, wherein the inner layer material of the multi-layer composite sleeve is preferably FEP, PTFE, PEEK or PI. For example, sleeve 22 is a three-layer composite sleeve having an inner layer of PTFE, an intermediate layer of stainless steel braid, and an outer layer of Pebax. The friction coefficient between the inner layer pipe of the sleeve and the protection structure is between 0.04 and 0.20, the friction resistance is small when the inner layer pipe and the protection structure slide relatively, abrasive dust generated after the inner layer pipe and the protection structure touch each other is reduced, the middle layer of the sleeve is a stainless steel woven layer, the stainless steel woven layer is elastically bent at the overbending part of an implantation path, the curvature radius of the elastic bending is between 20 and 40mm, the section of the sleeve at the overbending part is not obviously deformed, a flushing runner is kept smooth, the outer layer of the sleeve is Pebax, and the Pebax material has biocompatibility and is convenient to adhere to the middle stainless steel woven layer and the inner layer PTFE pipe.
In a preferred embodiment, the protection structure 40 includes a coating and a heat shrink tube, that is, a portion of the outer peripheral surface of the flexible transmission shaft 30 is provided with the coating, another portion of the outer peripheral surface of the flexible transmission shaft 30 is provided with the heat shrink tube, or the outer peripheral surface of the flexible transmission shaft 30 is entirely coated with the coating, and the heat shrink tube is further provided at a portion where a certain rigidity is required. In the clinical use process, different requirements may be imposed on the rigidity of each part section of the flexible transmission shaft 30, for example, a certain rigidity is required at the distal end of the flexible transmission shaft 30 to support the blood pump 10 implanted in the patient, a certain rigidity is required at the proximal end of the flexible transmission shaft 30 to push the shaft of the flexible transmission shaft 30 into the body, and a certain flexibility is required at the bending position of the implantation path of the flexible transmission shaft 30 in the patient, so that the flexible transmission shaft 30 can be smoothly bent. Thus, heat shrink tubing may be provided at both the distal and proximal portions of flexible drive shaft 30, with a coating provided at the middle portion (shown in FIG. 5).
Further, with continued reference to fig. 1, the sheath 21 and the cannula 22 have a gap in the radial direction, the radial gap between the sheath 21 and the cannula 22 is configured to perfuse the inflow channel 51, the flexible drive shaft 30 and the cannula 22 also have a gap in the radial direction, and the radial gap between the flexible drive shaft 30 and the cannula 22 is configured to perfuse the outflow channel 53. The blood pump 10 has a shunt channel 52, i.e. the shunt channel 52 is arranged in the housing 11 of the blood pump 10. The perfusion inflow channel 51, the shunt channel 52 and the perfusion outflow channel 53 are sequentially communicated, and the shunt channel 52 is used for shunting the perfusion fluid into two paths, and making one of the perfusion fluid flow to the perfusion outflow channel 53 and making the other perfusion fluid flow to the distal end of the blood pump 10. Thus, the perfusion fluid flows in from the perfusion inflow channel 51, and is split into two perfusion fluids after passing through the split channel 52, wherein one perfusion fluid flows to the far end of the blood pump 10, washes the impeller arranged on the driving shaft 12 to prevent blood from condensing on the impeller, and the other perfusion fluid flows to the perfusion outflow channel 53 to wash the abrasive dust generated between the flexible driving shaft 30 and the sleeve 22.
Fig. 5 is a first schematic view of a first corrugation of a protection structure according to a first embodiment of the present invention. Preferably, referring to fig. 5, when the protective structure 40 is configured as a heat shrink tube, the heat shrink tube 41 is provided with first corrugations 42 on its outer circumferential surface. The heat shrink tube 41 and the first corrugation 42 may be integrally formed, for example, by applying a torsion moment to the heat shrink tube during the heat shrink process to form a thread-like fold (i.e., the first corrugation 42). In addition, a wire is wound around the surface of the flexible drive shaft 30, and then a heat shrinkage process is performed. The metal wires are embedded between the heat shrinkage tube and the flexible transmission shaft, so that the surface of the heat shrinkage tube is not smooth, and folds (namely, the first corrugations 42) are formed. The shape of the corrugations (i.e., the first corrugations 42) depends on the winding path of the wire on the surface of the flexible drive shaft.
Fig. 6 and 7 are second schematic views of first corrugations of a protection structure according to a first embodiment of the present invention. In an embodiment, referring to fig. 5, 6 and 7, the first corrugation 42 is in a thread shape, and the spiral direction of the first corrugation 42 is the same as the rotation direction of the flexible transmission shaft 30, for example, the rotation direction of the flexible transmission shaft 30 is clockwise, and then the first thread is spirally wound on the outer circumferential surface of the heat shrinkage tube 41 in the clockwise direction. The effect of this arrangement is that, on the one hand, when the flexible drive shaft 30 rotates, the surrounding perfusion fluid is driven to follow the rotation under the drainage effect of the first corrugation 42 in the same direction, so that the perfusion fluid flows more smoothly, a more smooth perfusion fluid flow channel can be formed, and the abrasive dust can be better washed out. On the other hand, when the flexible transmission shaft 30 transmits the larger torque of the motor, the flexible transmission shaft 30 has a unwinding trend (the steel wire 31 has a unwinding trend), and the heat shrinkage tube provided with the first corrugation 42 has a holding force on the flexible transmission shaft 30, so that the unwinding of the flexible transmission shaft 30 can be effectively resisted. The first thread-like corrugation 42 may have one thread (shown in fig. 5) extending from the proximal end to the distal end of the heat shrink tubing 41, and preferably the first thread-like corrugation 42 has at least two threads (shown in fig. 6 and 7), the greater the number of threads, the stronger the flow guiding effect on the perfusate, improving the flow capacity of the perfusate. The helix shape of at least two threads remains consistent, the at least two threads extending in parallel from the proximal end to the distal end.
Fig. 8 is a third schematic view of the first corrugation of the protection structure according to the first embodiment of the present invention. In another embodiment, referring to fig. 8, the first corrugation 42 is closed in a ring shape along the circumferential direction of the heat shrinkage tube 41, and the heat shrinkage tube 41 includes a plurality of first corrugation 42 in a ring shape axially aligned. Fig. 9 is a fourth schematic view of the first corrugation of the protection structure of the first embodiment of the present invention, and in an alternative embodiment, referring to fig. 9, the heat shrinkable tube 41 includes both the first corrugation 42 having a ring shape and the first corrugation 42 having a thread shape.
The first corrugation 42 has the advantage that the first corrugation 42 can scrape the abrasive dust on the inner peripheral wall of the sleeve 22 under the rotation of the flexible transmission shaft 30, especially at the overbending position of the flexible transmission shaft 30, the abrasive dust is easier to accumulate on the bending part of the flexible transmission shaft 30, the flushing flow passage becomes narrower, and the convex first corrugation 42 can scrape the abrasive dust like a brush under the rotation of the flexible transmission shaft 30, so that the abrasive dust is prevented from accumulating.
Preferably, the inner peripheral wall of the sleeve 22 is provided with a protruding second corrugation (not shown, refer to the first corrugation 42 in the shape of a thread in general), the second corrugation is in the shape of a thread, and the inner cavity of the sleeve 22 is also in the shape of a threaded hole, and the spiral direction of the second corrugation is in the same direction as the spiral direction of the first corrugation 42 in the shape of a thread, so that the spiral direction of the second corrugation, the spiral direction of the first corrugation 42 in the shape of a thread, and the rotation direction of the flexible transmission shaft 30 are in the same direction. The effect of this arrangement is that, on the one hand, under the drainage effect of the second corrugation in the lumen of the cannula 22, the perfusion fluid flows more smoothly and can better flush out the abrasive dust. On the other hand, the flexible transmission shaft 30 does not always enter the body from the outside of the patient and is not always kept in a straight line, namely, part of the shaft section of the flexible transmission shaft 30 is bent in a certain radian, the surface of the coating/heat shrinkage tube cannot avoid touching the inner peripheral wall of the sleeve 22 at the bent part of the flexible transmission shaft 30, compared with the flat structure of the surface of the coating/heat shrinkage tube and the inner peripheral wall of the sleeve 22, the contact area between the thread peak top of the first corrugation 42 and the thread peak top of the second corrugation is reduced, and the abrasive dust amount is further reduced. In other embodiments, the inner peripheral wall of sleeve 22 may also be flat, without the second corrugation being designed.
Preferably, a hydrophobic layer (not shown) is provided on the protective structure 40, and a hydrophobic layer may also be provided on the inner peripheral wall of the sleeve 22. The perfusate carries the abrasive dust to flow out, and abrasive dust amount piles up to increase, deposits on flexible drive shaft 30 surface easily, and the design of hydrophobic layer has less the pile up of abrasive dust, and the perfusate is convenient for wash out abrasive dust more smoothly through pouring outflow channel 53.
[ Example two ]
This embodiment only describes differences from the first embodiment, and the same or similar points are referred to the description of the first embodiment.
Fig. 10 is an axial cross-sectional view of a percutaneous ventricular assist device according to a second embodiment of the invention. Referring to fig. 10, in this embodiment, the outer tube assembly 20 includes only the sheath 21 and no sleeve 22. The flexible transmission shaft 30 is located in the sheath tube 21, the flexible transmission shaft 30 is in a hollow tubular shape, the inner cavity of the flexible transmission shaft 30 is configured to be perfused into the inflow channel 51, the blood pump 10 is provided with a shunt channel 52, namely, the shunt channel 52 is configured in the housing 11 of the blood pump 10, a radial gap between the sheath tube 21 and the flexible transmission shaft 30 is configured to be perfused into the outflow channel 53, the perfusion inflow channel 51, the shunt channel 52 and the perfusion outflow channel 53 are communicated in sequence, and the shunt channel 52 is used for shunting perfusate into two paths, and one path of perfusate flows into the perfusion outflow channel 53 and the other path of perfusate flows into the distal end of the blood pump 10. Thus, the perfusion fluid flows in from the perfusion inflow channel 51 (the inner cavity of the flexible transmission shaft 30), and is split into two perfusion fluids after passing through the split channel 52, wherein one perfusion fluid flows to the distal end of the blood pump 10, washes the impeller arranged on the driving shaft 12 to prevent blood from condensing on the impeller, and the other perfusion fluid flows to the perfusion outflow channel 53 to wash the abrasive dust generated between the flexible transmission shaft 30 and the sheath 21.
The material of the protection structure 40 on the surface of the flexible transmission shaft 30 comprises FEP, PTFE or PEEK, the material of the sheath tube 21 comprises FEP, PTFE, PEEK or PI, the friction coefficient between the protection structure on the surface of the flexible transmission shaft and the sheath tube is between 0.04 and 0.20, the friction resistance is small when the protection structure and the sleeve relatively slide, and abrasive dust generated after the protection structure and the sleeve touch the abrasive dust is reduced.
Specifically, the sheath 21 may be a single-layer tube or a multi-layer composite tube, wherein the inner layer material of the multi-layer composite tube is preferably FEP, PTFE, PEEK or PI. For example, the sheath 21 is a three-layer composite tube, the inner layer of which is made of PTFE, the middle layer of which is made of stainless steel braid, and the outer layer of which is made of Pebax. The friction coefficient between the inner layer tube of the sheath tube 21 and the protective structure is between 0.04 and 0.20, the friction resistance is small when the inner layer tube and the protective structure slide relatively, abrasive dust generated after the inner layer tube and the protective structure touch each other is reduced, the middle layer of the sheath tube 21 is a stainless steel woven layer, the stainless steel woven layer is elastically bent at the overbending position of an implantation path, the curvature radius of the elastic bending is between 20 and 40mm, the section of the sheath tube 21 at the overbending position is not obviously deformed, a flushing runner is kept smooth, the outer layer of the sheath tube 21 is Pebax, and the Pebax material has biocompatibility and is convenient to adhere to the middle stainless steel woven layer and the inner layer PTFE tube.
On the one hand, in the present embodiment, the design of the perfusion inflow channel 51 and the perfusion outflow channel 53 can eliminate the sleeve 22 compared with the first embodiment, so that the radial dimension of the whole percutaneous ventricular assist device can be further reduced, and the percutaneous ventricular assist device can be conveniently implanted into the blood vessel of a patient. On the other hand, the inner cavity of the flexible transmission shaft 30 and the gap between the flexible transmission shaft 30 and the sheath 21 are filled with the perfusate, so that the perfusate plays a role in vibration buffering on the flexible transmission shaft 30 rotating at a high speed, and vibration isolation and noise reduction are facilitated.
Further, regarding the specific structure of the flexible drive shaft 30, the flexible drive shaft 30 includes a single spiral layer or at least two spiral layers coaxially and stacked. The spiral layer is configured such that a single wire 31 (stainless wire 31) is spirally wound, or such that at least two wires 31 are spirally wound. A sealing tube (not shown) is arranged between the flexible transmission shaft 30 and the protection structure 40, so that perfusate is prevented from seeping out from the inner cavity of the flexible transmission shaft 30. It should be noted that, the heat shrinkage tube may perform a sealing function, and the coating layer is sufficiently dense to perform a sealing function, and in this embodiment, the flexible transmission shaft 30 formed by spirally winding the steel wire 31 may be sealed by the heat shrinkage tube or the coating layer, so that no additional sealing tube is needed.
While the invention has been described in terms of preferred embodiments, the above embodiments are not intended to limit the invention. Many possible variations and modifications of the disclosed technology can be made by anyone skilled in the art without departing from the scope of the technology, or the technology can be modified to be equivalent. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.
Claims (10)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310728654.5A CN119158163A (en) | 2023-06-19 | 2023-06-19 | Percutaneous ventricular assist device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310728654.5A CN119158163A (en) | 2023-06-19 | 2023-06-19 | Percutaneous ventricular assist device |
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| Publication Number | Publication Date |
|---|---|
| CN119158163A true CN119158163A (en) | 2024-12-20 |
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| CN202310728654.5A Pending CN119158163A (en) | 2023-06-19 | 2023-06-19 | Percutaneous ventricular assist device |
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