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WO-2026091217-A1 - LEFT VENTRICULAR ASSIST DEVICE

WO2026091217A1WO 2026091217 A1WO2026091217 A1WO 2026091217A1WO-2026091217-A1

Abstract

Provided in the present invention is a left ventricular assist device, comprising: a drive control mechanism, which comprises a twisting-shell drive module and a core-shaft drive module; a transmission shaft, which comprises a twisting shell and a core shaft, the twisting shell being movably sleeved on the core shaft; and a micro pump head, which comprises a pump head impeller and a pump head transmission assembly, wherein the proximal end of the pump head impeller is in transmission connection with the twisting-shell drive module via the twisting shell, the distal end of the pump head transmission assembly is fixedly connected to the distal end of the pump head impeller, and the proximal end of the pump head transmission assembly is in transmission connection with the core-shaft drive module via the core shaft. The core-shaft drive module drives the core shaft and the twisting shell to rotate synchronously, so as to drive the distal end and the proximal end of the pump head impeller to rotate together, thereby enabling the pump head impeller to rotate while maintaining a fixed outer diameter. The twisting-shell drive module drives the twisting shell and the core shaft to rotate relative to each other, so as to drive the proximal end of the pump head impeller to rotate relative to the distal end, thereby enabling the pump head impeller to fold or unfold. The solution provided in the present invention can realize adjustment of the outer diameter of the micro pump head in the left ventricular assist device, thereby improving the operational efficiency and safety of the left ventricular assist device.

Inventors

  • ZHU, Zhenyan
  • TANG, Yichao

Assignees

  • 同济大学

Dates

Publication Date
20260507
Application Date
20241127
Priority Date
20241028

Claims (10)

  1. A left ventricular assist device, characterized in that it comprises: The drive control mechanism (4) includes a twisting shell drive module (42) and a spindle drive module (43); The drive shaft (3) includes a twisting shell (32) and a spindle (33), wherein the twisting shell (32) is movably fitted over the spindle (33); and A miniature pump head (2) includes a pump head impeller (22) and a pump head drive assembly (23), wherein The proximal end of the pump head impeller (22) is connected to the twisting shell drive module (42) via the twisting shell (32), and the distal end of the pump head drive assembly (23) is fixedly connected to the distal end of the pump head impeller (22). The proximal end of the pump head drive assembly (23) is connected to the spindle drive module (43) via the spindle (33). The spindle drive module (43) drives the spindle (33) and the twisting shell (32) to rotate synchronously, thereby causing the distal and proximal ends of the pump head impeller (22) to rotate together, so that the pump head impeller (22) rotates with a fixed outer diameter; and the twisting shell drive module (42) drives the twisting shell (32) and the spindle (33) to rotate relative to each other, thereby causing the proximal end of the pump head impeller (22) to rotate relative to the distal end, so that the pump head impeller (22) folds or unfolds.
  2. The left ventricular assist device according to claim 1 is characterized in that the twisting shell (32) includes a twisting shell micro-pump head connecting section (322), a twisting shell flexible section (323), and a twisting shell drive control mechanism connecting section (324). The flexible section (323) of the twisted shell is fixedly connected to the connecting section (322) of the twisted shell micro pump head and the connecting section (324) of the twisted shell drive control mechanism by welding; wherein The distal end of the twisted shell micro pump head connecting section (322) is used to be fixedly connected to the proximal end of the pump head impeller (22), and the proximal end of the twisted shell drive control mechanism connecting section (324) is used to be drivenly connected to the twisted shell drive module (42).
  3. According to claim 2, the left ventricular assist device is characterized in that the drive shaft (3) further includes a protective sleeve (31), the protective sleeve (31) is movably sleeved on the outside of the twisting shell (32), the proximal end of the protective sleeve (31) is connected to the protective sleeve drive module (41) of the drive control mechanism (4), the distal end of the protective sleeve (31) is fixedly connected to the proximal end of the pump head protection assembly (21) of the micro pump head (2), and the drive control mechanism (4) controls the outer diameter of the pump head protection assembly (21) by controlling the protective sleeve (31) to slide on the twisting shell (32); Optionally, the left ventricular assist device (1) further includes a pressure sensor (5), the pressure sensor (5) includes an optical fiber (51), the protective sleeve (31) has an optical fiber hole (311), and the optical fiber (51) passes through the optical fiber hole (311). Optionally, the pressure sensor (5) further includes a fiber Bragg grating demodulator (52), and the optical fiber (51) is communicatively connected to the fiber Bragg grating demodulator (52) via a threaded connector; Optionally, the optical fiber (51) includes a pressure monitoring optical fiber (511) and a signal transmission optical fiber (512). The signal transmission optical fiber (512) is integrally formed with the pressure monitoring optical fiber (511). The near end of the signal transmission optical fiber (512) is fixed and communicatively connected to the fiber optic demodulator (52) through a threaded connector. Optionally, the protective sleeve (31) is made of medical Pebax tubing, the twisted shell (32) is made of multi-strand double-layer synchronous torque spring tubing, and/or the mandrel (33) is made of plastic-coated steel wire rope.
  4. The left ventricular assist device according to claim 1, characterized in that the pump head impeller (22) comprises: A foldable impeller (221), the distal end of which is fixedly connected to the spindle (33) via the pump head drive assembly (23); and A twisting connector (222) is provided, the distal end of which is engaged with the proximal end of the foldable impeller (221), and the proximal end of which is fixedly connected to the twisting shell (32).
  5. The left ventricular assist device according to claim 4, characterized in that the foldable impeller (221) comprises: An impeller frame (2211), the proximal end of which is fixedly connected to the twisting shell (32) via the twisting connector (222), and the distal end of which is fixedly connected to the mandrel (33) via the pump head drive assembly (23); and Impeller blade surface (2212), the impeller blade surface (2212) covers the outside of the impeller frame (2211); Optionally, the impeller frame (2211) includes: A proximal retaining ring (22113) is fixedly connected to the twisted shell (32) at its proximal end via the twisted connector (222); A distal retaining ring (22111), wherein the distal retaining ring (22111) is fixedly connected to the spindle (33) via the pump head drive assembly (23); and Impeller skeleton wire (22112), the impeller skeleton wire (22112) is spirally disposed between the proximal fixing ring (22113) and the distal fixing ring (22111); Optionally, the impeller skeleton wire (22112) is made of an elastic material; Optionally, the twisted connector (222) is provided with a plurality of rotation limiting bosses at its distal end, and the proximal outer edge of the proximal fixing ring (22113) is provided with a plurality of limiting grooves accordingly. The twisted connector (222) and the proximal fixing ring (22113) are rotated and limited by the insertion and cooperation of the rotation limiting bosses and the limiting grooves. Optionally, the distal and proximal ends of the impeller blade surface (2212) are respectively covered by the distal fixing ring (22111) and the proximal fixing ring (22113), and are pushed outward by the impeller skeleton wire (22112) to form an impeller.
  6. The left ventricular assist device according to claim 5, characterized in that the pump head transmission assembly (23) comprises: A mandrel sleeve (236) passes through the impeller frame (2211). The distal end of the mandrel sleeve (236) is fixedly connected to the distal fixing ring (22111), and the proximal end of the mandrel sleeve (236) is sleeved inside the proximal fixing ring (22111) and fixedly connected to the mandrel (33). A top shaft (235) is fixedly embedded at the proximal end of the mandrel sleeve (236); A top shaft bearing (233) is sleeved on the far end of the top shaft (235), and the proximal end face of the top shaft bearing (233) contacts the far end face of the mandrel sleeve (236); A top shaft sleeve (232) is fixedly sleeved on the distal end of the top shaft (235), and the inner edge of the top shaft bearing (233) is limited between the distal end face of the mandrel sleeve (236) and the proximal end face of the top shaft sleeve (232); and A top sleeve (231) is fitted onto the far end of the top shaft (235) at its proximal end; Optionally, the mandrel sleeve (236) is fixedly sleeved with a mandrel collar (237) at its proximal end. The proximal end face of the mandrel collar (237) is flush with the proximal end face of the mandrel sleeve (236) and is limited to the proximal end of the proximal end fixing ring (22113) and the distal end of the twisted connector (222). Optionally, a top sleeve (234) is provided on the mandrel sleeve (236), the top sleeve (234) is sleeved on the far end of the mandrel sleeve (236), and the far end face of the top sleeve (234) is fixedly connected to the proximal end face of the top sleeve (231); Optionally, the proximal end of the top sleeve (231) is provided with an annular groove that is adapted to the top shaft bearing (233), the top shaft bearing (233) is embedded in the annular groove at the proximal end of the top sleeve (231), and the outer edge of the top shaft bearing (233) is limited between the annular groove at the proximal end of the top sleeve (231) and the top sleeve ring (234).
  7. The left ventricular assist device according to claim 3, characterized in that the micropump head (2) further includes: Pump head protection assembly (21) is coaxially mounted on the outside of the pump head impeller (22), and the near end of the pump head protection assembly (21) is connected to the protective sleeve drive module (41) in the drive control mechanism (4) through the protective sleeve (31), and the far end of the pump head protection assembly (21) is fixedly connected to the far end of the pump head drive assembly (23); Optionally, the pump head protection assembly (21) includes: An anchor bracket (212), the proximal end of which is fixedly connected to the distal end of the protective sleeve (31), and the distal end of which is sleeved and fixed to the distal end of the pump head transmission assembly (23); and Top sleeve tip (211), the top sleeve tip (211) is disposed at the far end of the anchor bracket (212), and the proximal end of the top sleeve tip (211) is fixedly connected to the far end of the pump head transmission assembly (23); Optionally, the pump head protection assembly (21) further includes a bracket protective sleeve connecting ring (213), the distal end of which is embedded and fixed to the annular proximal end of the anchor bracket (212), and the distal end face of the bracket protective sleeve connecting ring (213) is flush with the distal end face of the annular proximal end of the anchor bracket (212). The bracket protective sleeve connecting ring (213) is slidably sleeved on the outside of the twisted shell (32) and fixedly connected to the far end of the protective sleeve (31); Optionally, the top sleeve (231) is provided with an anchoring groove at its far end, and the top sleeve tip (211) is provided with an anchoring rod at its near end. The anchoring rod is inserted into the anchoring groove to fix the near end of the top sleeve tip (211) to the far end of the pump head transmission assembly (23). Optionally, the anchoring bracket (212) includes: An anchor bracket frame (2121), the proximal end of which is fixedly connected to the distal end of the protective sleeve (31), and the distal end of which is sleeved and fixed to the distal end of the pump head transmission assembly (23); and An anchoring support membrane (2122), which is sleeved over the anchoring support frame (2121); Optionally, the anchor support frame (2121) includes a proximal ring, a distal ring, and a plurality of anchor support frame wires arranged in parallel between the proximal ring and the distal ring. The anchor support frame wires bend outward when the proximal ring and the distal ring approach each other to expand the structure of the pump head protection assembly (21), and tighten inward when the proximal ring and the distal ring move away from each other to retract the structure of the pump head protection assembly (21). Optionally, the anchorage support skeleton wire is made of an elastic material.
  8. According to claim 1, the left ventricular assist device is characterized in that the drive control mechanism (4) further includes a housing (40); the twisting shell drive module (42) is disposed within the housing (40), and the distal end of the twisting shell drive module (42) is connected to the proximal end of the twisting shell (32); the mandrel drive module (43) is disposed within the housing (40) and arranged near the proximal end of the twisting shell drive module (42), the distal end of the mandrel drive module (43) is connected to the proximal end of the mandrel (33), and the distal end of the mandrel drive module (43) is detachably connected to the proximal end of the twisting shell drive module (42), wherein... When the mandrel drive module (43) is connected to the twisting shell drive module (42), the mandrel drive module (43) drives the mandrel (33) and the twisting shell (32) to rotate synchronously; and when the mandrel drive module (43) is separated from the twisting shell drive module (42), the twisting shell drive module (42) drives the twisting shell (32) to rotate relative to the mandrel (33).
  9. The left ventricular assist device according to claim 8, characterized in that the twisting shell drive module (42) comprises: A twisted shell connector (428) is fixedly connected to the twisted shell (32), and the proximal end of the twisted shell connector (428) is detachably connected to the distal end of the spindle drive module (43); and A twisting gear set is disposed at the distal end of the twisting shell connector (428) and is used to control the rotation of the twisting shell connector (428) when the distal end of the spindle drive module (43) is separated from the proximal end of the twisting shell drive module (42); Optionally, the twisting gear set includes: First twisting gear shaft (426); The first twisting gear (425) is sleeved on the first twisting gear shaft (426) and fixedly connected to the twisting shell connector (428) through the first twisting gear shaft (426); A first twisted gear shaft bearing (424) is disposed at the distal end of the first twisted gear shaft (426) and rotatably supports the first twisted gear shaft (426) within the housing (40); A twisted shell connector bearing (427) is disposed in the middle section of the twisted shell connector (428) and rotatably supports the twisted shell connector (428) within the housing (40); and The second gear set (421) is separable from and meshes with the first twisting gear (425). When the second gear set (421) meshes with the first twisting gear (425), it controls the rotation of the first twisting gear (425). Optionally, the first twisting gear shaft (426) is configured as a shaft with a multi-stage stepped shape, and the proximal end of the first twisting gear shaft (426) is sleeved and fixed to the distal end of the twisting shell connector (428); Optionally, the twisting shell drive module (42) further includes a twisting shell bushing (423) and a twisting shell bushing bearing (422). The twisting shell bushing (423) is fitted with the twisting shell bushing bearing (422) at both ends. The twisting shell bushing (423) is fitted near the end of the twisting shell (32) and is located near the end of the first twisting gear shaft (426). Optionally, the second gear set (421) includes: Second twisting gear shaft (4214); The second twisting gear (4213) is sleeved on the second twisting gear shaft (4214) and can be disengaged from and meshed with the first twisting gear (425); The second twisting gear shaft bearing (4212) is disposed between the second twisting gear shaft (4214) and the second twisting gear (4213); The second twisting gear limiting member (4211) is respectively disposed at both ends of the second twisting gear shaft (4214) and fixedly connected to the second twisting gear shaft (4214). One side of the second twisting gear limiting member (4211) is inserted into the housing (40), and the other side of the second twisting gear limiting member (4211) extends out of the housing (40) and supports the second twisting gear (4213) on the outside of the housing (40); and The second twisting gear reset elastic element (4215) is disposed between the second twisting gear limiting element (4211) and the housing (40) and separates the second twisting gear (4213) from the first twisting gear (425).
  10. The left ventricular assist device according to claim 8, characterized in that the spindle drive module (43) comprises: A spindle connector (435) is sleeved on the outside of the spindle (33) and fixedly connected to the spindle (33); A coupling (437) is provided, the distal end of which is fixedly connected to the spindle connector (435), and the proximal end of which is fixedly connected to the drive motor (4310). A clutch (433), wherein the clutch (433) is disposed at the distal end of the spindle connector (435) and sleeved on the outside of the spindle (33), the clutch (433) is synchronously rotatably connected to the spindle connector (435), and the clutch (433) is detachably connected to the twisting shell connector (428); and A clutch reset elastic element (434) is disposed between the spindle connector (435) and the clutch (433); Optionally, the spindle drive module (43) further includes a spindle connector bearing (436), which is sleeved on the proximal end of the spindle connector (435) and rotatably supports the spindle connector (435) within the housing (40); Optionally, the spindle drive module (43) further includes: Braking assembly (438), the braking assembly (438) is arranged in pairs on both sides of the coupling (437) and is used to brake the coupling (437); Optionally, the braking assembly (438) includes: Brake slider (4381), the brake slider (4381) is disposed outside the housing (40); A brake element (4382) is disposed inside the brake element slider (4381). The large end of the brake element (4382) extends out of the housing (40) and is slidably connected to the brake element slider (4381). The small end of the brake element (4382) is inserted into the housing (40) and engages with the outer wall of the coupling (437). A pair of brake reset elastic elements (4383) are provided between the brake (4382) and the housing (40). One end of the pair of brake reset elastic elements (4383) is inserted into the corresponding mounting hole of the brake (4382), and the other end of the pair of brake reset elastic elements (4383) is inserted into the corresponding mounting hole of the housing (40). Optionally, the brake slider (4381) has a wedge-shaped bottom surface (43812), and the brake (4382) has a limiting groove (43821) at its large end. The wedge-shaped bottom surface (43812) and the two sides of the brake slider (4381) respectively contact the arc-shaped top surface and the two sides of the limiting groove (43821). Optionally, the spindle drive module (43) further includes: A clutch ring (432), which is slidably sleeved on the outside of the housing (40) and has a clutch fork mounting hole (4323) radially provided; and The clutch fork (431) is disposed in the clutch fork mounting hole (4323) and passes through the housing (40) to cooperate with the clutch (433), so that by operating the clutch ring (432), the clutch (433) can be driven to move, thereby separating or connecting the clutch (433) from the twisting shell connector (428); Optionally, the clutch ring (432) includes a first clutch ring (4321) and a second clutch ring (4322), wherein the first clutch ring (4321) and the second clutch ring (4322) are disposed opposite to each other to form a ring-shaped clutch ring (432). Optionally, the drive control mechanism (4) further includes: A protective sleeve drive module (41) is sleeved on the proximal end of the protective sleeve (31) and connected to the proximal end of the protective sleeve (31) for transmission. The protective sleeve (31) is driven to move through the protective sleeve drive module (41). Optionally, the protective sleeve drive module (41) includes a protective sleeve slider (411), a protective sleeve slider bearing (412), and a protective sleeve slider end cap (413). The protective sleeve slider (411) is sleeved on the proximal end of the protective sleeve (31) and fixedly connected to the protective sleeve (31). The protective sleeve slider bearing (412) is embedded in the proximal annular groove of the protective sleeve slider (411), and the outer edge of the protective sleeve slider bearing (412) is limited between the proximal annular groove of the protective sleeve slider (411) and the protective sleeve slider end cap (413). The protective sleeve slider end cap (413) is disposed on the proximal end of the protective sleeve slider (411) and fixedly connected to the protective sleeve slider (411). Optionally, the protective sleeve drive module (41) includes at least two protective sleeve slider bearings (412), the at least two protective sleeve slider bearings (412) being embedded in the proximal annular groove of the protective sleeve slider (411) such that the distal end face of the protective sleeve slider bearing (412) away from the protective sleeve slider end cap (413) contacts the proximal end face of the protective sleeve (31); Optionally, the protective cover slider (411) is provided with a protective cover slider locking member (4111), which cooperates with corresponding structures at different positions of the housing (40) to lock the protective cover slider (411) at different positions of the housing (40).

Description

Left ventricular assist device Technical Field This invention relates to the field of auxiliary device technology, and specifically to a left ventricular assist device. Background Technology In the past decade or so, the number of high-risk cardiovascular interventional surgeries both domestically and internationally has been increasing year by year. To reduce the risk of death caused by obstructed or stopped blood circulation during surgery, interventional left ventricular assist devices (LVADs) have been widely used in high-risk cardiovascular interventional procedures. An LVAD is a percutaneous mechanical circulatory support system that provides auxiliary blood flow to high-risk cardiovascular interventional patients during and after the procedure using a mechanical micropump. It can partially or completely assist the function of the left ventricle, helping the heart deliver oxygenated blood to the whole body. Existing LVADs mainly use micropump heads equipped with non-deformable rigid impellers. Due to the size limitations of the device, the auxiliary flow rate they can generate is relatively small. To meet the needs of maintaining blood circulation in high-risk interventional surgeries, the common solution for LVADs with fixed impeller sizes is to increase the impeller speed. However, high-speed impeller rotation inevitably causes excessive shear force within the blood, leading to changes in red blood cell permeability and irreversible cell damage, thus increasing the risk of hemolysis in patients. Therefore, there is an urgent need to design an interventional left ventricular assist device equipped with a high-folding-ratio active folding impeller that can simultaneously take into account the small size of the device, high blood flow, and low risk of hemolysis. Summary of the Invention The technical problem to be solved by the present invention is to provide a left ventricular assist device to improve the efficiency and safety of the left ventricular assist device. To solve the above-mentioned technical problems, the present invention provides a left ventricular assist device, comprising: Drive control mechanism, Includes a twisting shell drive module and a mandrel drive module; A drive shaft, comprising a twisting shell and a spindle, wherein the twisting shell is movably fitted over the spindle; and Miniature pump head, including pump head impeller and pump head drive assembly, wherein The proximal end of the pump head impeller is connected to the twisting shell drive module via the twisting shell, the distal end of the pump head drive assembly is fixedly connected to the distal end of the pump head impeller, and the proximal end of the pump head drive assembly is connected to the spindle drive module via the spindle. The mandrel drive module drives the mandrel and the twisting shell to rotate synchronously, thereby causing the distal and proximal ends of the pump head impeller to rotate together, so that the pump head impeller rotates with a fixed outer diameter; and the twisting shell drive module drives the twisting shell and the mandrel to rotate relative to each other, thereby causing the proximal end of the pump head impeller to rotate relative to the distal end, so that the pump head impeller folds or unfolds. In one embodiment, the twisting shell includes a twisting shell micro-pump head connecting section, a twisting shell flexible section, and a twisting shell drive control mechanism connecting section; The flexible section of the twisted shell is fixedly connected to the connecting section of the twisted shell micro-pump head and the connecting section of the twisted shell drive control mechanism by welding; wherein The distal end of the twisted shell micro pump head connecting section is used for fixed connection with the proximal end of the pump head impeller, and the proximal end of the twisted shell drive control mechanism connecting section is used for transmission connection with the twisted shell drive module; In one embodiment, the drive shaft further includes: A protective sleeve is movably fitted over the twisting shell. The proximal end of the protective sleeve is connected to the protective sleeve drive module of the drive control mechanism, and the distal end of the protective sleeve is fixedly connected to the proximal end of the pump head protection assembly of the micro pump head. The drive control mechanism controls the outer diameter of the pump head protection assembly by controlling the sliding of the protective sleeve on the twisting shell. Optionally, the left ventricular assist device further includes a pressure sensor, the pressure sensor including an optical fiber, the protective sleeve having an optical fiber hole, and the optical fiber passing through the optical fiber hole; Optionally, the pressure sensor further includes a fiber Bragg grating demodulator, and the optical fiber is communicatively connected to the fiber Bragg grating demodulator via a threaded c