EP-4734874-A1 - PACKAGING FOR BLOOD PUMPS

Abstract

Apparatus and methods are described for use with a device (20) that includes a delivery catheter (143), a proximal element (160), which is disposed proximally to the delivery catheter and is wider than the delivery catheter, an elongate element (142) passing through the proximal element and the delivery catheter, and a self-expandable element (27) coupled to the elongate element. Packaging (162) includes a tray (163), shaped to define a chamber (164) in which the self-expandable element (27) is packageable, and configured to stabilize the proximal element (160) while the self-expandable element (27) is retracted into the delivery catheter (143) via retraction of the elongate element (142). A securement piece (173) is coupled to the tray (163) adjacently to the chamber (164), and is configured to secure a distal end of the delivery catheter (143) while the self-expandable element (27) is retracted into the delivery catheter (143).

Inventors

• TUVAL, YOSI
• LARK, Tomer
• LUBINSKY, Gad
• SUDIN, YURI
• ROZENFELD, Avi
• MUSTACCHI, Shaul
• Tamir, Ran
• ZIPORY, YUVAL
• FRIEDMAN, Rinat
• KUSHNIR, Hadas

Assignees

• Magenta Medical Ltd.

Dates

Publication Date

20260506

Application Date

20241223

Claims (20)

1. 1. An apparatus for use with a device that includes: a delivery catheter, a proximal element, which is disposed proximally to the delivery catheter and is wider than the delivery catheter, an elongate element passing through the proximal element and through the delivery catheter, and a self-expandable element coupled to the elongate element distally to the elongate element and configured for percutaneous delivery to a portion of a body of a subject while the self-expandable element is in a radially-constrained configuration within the delivery catheter, the apparatus comprising: packaging, comprising: a tray, shaped to define a chamber in which the self-expandable element is packageable in a non-radially-constrained configuration, and configured to stabilize the proximal element while the self-expandable element is retracted into the delivery catheter via retraction of the elongate element; and a securement piece coupled to the tray adjacently to the chamber, and configured to secure a distal end of the delivery catheter while the self-expandable element is retracted into the delivery catheter.
2. 2. The apparatus according to claim 1, wherein: the delivery catheter of the device is coupled to an inlet port and the device additionally includes a purging-fluid bag containing purging fluid, and a purging-fluid tube, configured to connect the purging-fluid bag to the inlet port via an air-eliminating filter configured to remove air from the purging fluid; and the tray comprises a compartment configured to hold the air-eliminating filter in an upright position while the purging fluid flows from the purging-fluid bag, via the purging-fluid tube and aireliminating filter, into the inlet port.
3. 3. The apparatus according to claim 1, wherein the proximal element includes a fixation unit configured to fix a position of the elongate element relative to the delivery catheter.
4. 4. The apparatus according to claim 1, wherein a portion of the tray underneath the securement piece slopes downwardly in a direction of the chamber.
5. 5. The apparatus according to claim 1, wherein the device further includes an inlet port, wherein the delivery catheter is coupled to the inlet port, wherein the device is for use with: a purging-fluid bag containing purging fluid, and a purging-fluid tube, configured to connect the purging-fluid bag to the inlet port via an air-eliminating filter configured to remove air from the purging fluid, and wherein the tray comprises a compartment configured to hold the air-eliminating filter in an upright position while the purging fluid flows from the purging-fluid bag, via the purging-fluid tube and air-eliminating filter, into the inlet port.
6. 6. The apparatus according to any one of claims 1-5, wherein the tray is further shaped to define a track in which the delivery catheter is packageable.
7. 7. The apparatus according to claim 6, wherein the packaging further comprises a detachable element reversibly coupled to the tray over the track and configured to stabilize the proximal element when the proximal element is pushed against the detachable element.
8. 8. The apparatus according to claim 6, wherein the track comprises a widened portion configured to stabilize the proximal element when the proximal element is pushed against a wall of the widened portion.
9. 9. A method, comprising: removing a cover from a tray in which an intracorporeal device is packaged, the device including: a delivery catheter, a proximal element, which is disposed proximally to the delivery catheter and is wider than the delivery catheter, an elongate element passing through the proximal element and through the delivery catheter, and a self-expandable element coupled to the elongate element distally to the elongate element, packaged in a non-radially-constrained configuration, and configured for percutaneous delivery to a portion of a body of a subject while the self-expandable element is in a radially-constrained configuration within the delivery catheter; and stabilizing the proximal element using the tray, while retracting the elongate element so as to retract the self-expandable element into the delivery catheter.
10. 10. The method according to claim 9, wherein the proximal element includes a fixation unit configured to fix a position of the elongate element relative to the delivery catheter.
11. 11. The method according to claim 9, wherein the tray is shaped to define a track in which the delivery catheter is packaged.
12. 12. The method according to claim 11, wherein a detachable element is reversibly coupled to the tray over the track, and wherein stabilizing the proximal element comprises stabilizing the proximal element by pushing the proximal element against the detachable element.
13. 13. The method according to claim 11, wherein the track includes a widened portion, and wherein stabilizing the proximal element comprises stabilizing the proximal element by pushing the proximal element against a wall of the widened portion.
14. 14. The method according to any one of claims 9-13, wherein the device further includes a first component and a second component, and wherein the method further comprises, prior to retracting the elongate element, purging an interface between the first component and the second component by passing a purging fluid through the device.
15. 15. The method according to claim 14, wherein the device further includes an inflatable element, and wherein the method further comprises inflating the inflatable element with the purging fluid by passing the purging fluid through the device.
16. 16. The method according to claim 15, further comprising, subsequently to passing the purging fluid through the device and prior to retracting the elongate element, deflating the inflatable element by suctioning the purging fluid from the device.
17. 17. The method according to claim 15, wherein the inflatable element surrounds the elongate element.
18. 18. The method according to claim 17, wherein a wall of the elongate element is shaped to define one or more inflation-fluid openings, wherein the inflatable element surrounds the inflation-fluid openings, and wherein inflating the inflatable element comprises inflating the inflatable element via the inflation-fluid openings.
19. 19. The method according to claim 14, wherein the self-expandable element includes: a pump-outlet tube, which is configured for insertion, through an aorta of the subject, into a left ventricle of a heart of the subject such that a proximal portion of the pump-outlet tube is disposed within the aorta and a distal portion of the pump-outlet tube is disposed within the left ventricle, and an impeller configured to pump blood of the subject proximally through the pump- outlet tube, such that the blood exits the proximal portion of the pump-outlet tube, wherein the first component of the intracorporeal device includes an axial shaft coupled to the impeller and configured to rotate such that the impeller pumps the blood, and wherein the second component of the intracorporeal device includes at least one bearing configured not to rotate with the axial shaft.
20. 20. The method according to any one of claims 9-13, wherein the device defines a pressure-sensing channel, and wherein the method further comprises, prior to retracting the elongate element, flushing the pressure-sensing channel, with a flushing fluid, at a flow rate higher than a usual flow rate at which the flushing fluid flows through the pressure-sensing channel while the device is in use within the body of the subject.

Description

PACKAGING FOR BLOOD PUMPS CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims priority from US Provisional Application 63/615,377 to Tuval et al., entitled “Inlet guards for blood pumps,” filed December 28, 2023, which is incorporated herein by reference, US Provisional Application 63/566,681 to Tuval et al., entitled “Inlet guards for blood pumps,” filed March 18, 2024, which is incorporated herein by reference, and US Provisional Application 63/692,734 to Tuval et al., entitled “Inlet guards for blood pumps,” filed September 10, 2024, which is incorporated herein by reference. FIELD OF EMBODIMENTS Some embodiments relate generally to medical devices, and specifically to blood pumps, e.g., for ventricular assist devices. BACKGROUND Ventricular assist devices are mechanical circulatory support devices designed to assist and unload cardiac chambers in order to maintain or augment cardiac output. They are used in patients suffering from a failing heart and in patients at risk for deterioration of cardiac function during percutaneous coronary interventions. Most commonly, a left-ventricular assist device is applied to a defective heart in order to assist left-ventricular functioning. In some cases, a right-ventricular assist device is used in order to assist right-ventricular functioning. Such ventricular assist devices are either designed to be permanently implanted or mounted on a catheter for temporary placement. SUMMARY Some embodiments of the present disclosure include packaging for an intracorporeal device, such as a ventricular assist device. The device includes a delivery catheter, a proximal element, which is disposed proximally to the delivery catheter and is wider than the delivery catheter, an elongate element passing through the proximal element and through the delivery catheter, and a selfexpandable element coupled to the elongate element distally to the elongate element and configured for percutaneous delivery to a portion of a body of a subject while the self-expandable element is in a radially-constrained configuration within the delivery catheter. The packaging includes a tray shaped to define a chamber in which the self-expandable element is packageable in a non-radially- constrained configuration. The tray is configured to stabilize the proximal element while the self- expandable element is retracted into the delivery catheter via retraction of the elongate element. The packaging further includes a securement piece coupled to the tray adjacently to the chamber, and configured to secure the distal end of the delivery catheter while the self-expandable element is retracted into the delivery catheter. Other embodiments include a cartridge for facilitating the setup of an intracorporeal device, the device including an inlet port, an outlet port, and a pressure-sensing port. The cartridge, which in some embodiments is packaged with the device in the aforementioned packaging, includes a first port, a second port, and a third port, and holds multiple tubes. The tubes include (a) a purging-fluid tube, configured to connect a purging-fluid bag, which contains purging fluid, to the inlet port, (b) a waste tube, configured to connect a waste bag to the outlet port, (c) a flushing tube, configured to connect a flushing-fluid bag, which contains flushing fluid, to a first sensor port of a pressure sensor, and (d) a pressure-sensing tube, configured to connect a second sensor port of the pressure sensor to the pres sure- sensing port of the intracorporeal device such that the flushing fluid flows, via the pressure sensor, into the pressure-sensing port. Typically, to facilitate properly connecting the tubes, the cartridge holds the tubes such that respective proximal portions of the purging-fluid tube, the waste tube, and the flushing tube pass through the first port, respective distal portions of the purging-fluid tube, the waste tube, and the pressure-sensing tube pass through the second port, and a distal portion of the flushing tube and a proximal portion of the pressure-sensing tube pass through the third port. Alternatively or additionally, the cartridge is configured for insertion into a console such that the cartridge and the console interact with one another. For example, in some embodiments, the cartridge comprises pumps configured to pump the purging fluid through the purging-fluid tube and waste tube, and the console comprises motors configured to drive the pumps. Other embodiments include a blood pump including an inlet guard. The inlet guard includes a main body, which is typically frustoconical and is shaped to define one or more blood-inlet openings configured to allow passage of blood therethrough. The inlet guard further includes multiple proximal flaps extending proximally from the main body. The blood pump further includes a frame including a proximal portion, a central portion, and a distal portion, an inner lining that lines at least part of the central portion