Catheter pump introducer systems and methods

• US 10,709,829 B2
• Filed: 09/20/2018
• Issued: 07/14/2020
• Est. Priority Date: 04/15/2014
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories)
• Original Assignee: TC1 LLC (Abbott Laboratories)
• Inventors: Muller, Paul F.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US16/136,769
• Publication Number:
  US 20190015570A1
• Time in Patent Office: 663 Days
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/174 discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
• CPC Class Codes: A61M 60/211 using a jet, venturi or entrainment effect for pumping the blood
• CPC Class Codes: A61M 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/237 the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
• CPC Class Codes: A61M 60/411 generated by an electromotor
• CPC Class Codes: A61M 60/414 transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/508 Electronic control means, e.g. for feedback regulation
• CPC Class Codes: A61M 60/577 High-frequency driving
• CPC Class Codes: A61M 60/81 Pump housings
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body

Abstract

A catheter system for a catheter pump is disclosed. The system can include an elongate catheter body having a distal portion including an expandable cannula having an inlet and an outlet. The expandable cannula can have a delivery profile and an operational profile larger than the delivery profile. An impeller assembly can include an impeller shaft and an impeller body. A sheath can have a cannula retention zone disposed over the expandable cannula and a separation zone. The cannula retention zone can have a first configuration adapted to retain the expandable cannula in the delivery profile. The system can be adapted to separate the separation zone into a first portion and a second portion disposed across a gap. The gap can enable the elongate catheter body to pass between the first and second portion so that the sheath can be removed from the elongate catheter body.

Claims

1. A catheter system for a catheter pump, comprising:

an elongate catheter body having a distal portion including an expandable cannula having an inlet and an outlet, the expandable cannula having a delivery profile and an operational profile larger than the delivery profile;

an expandable impeller assembly disposed in the expandable cannula and including an impeller shaft and an impeller body including one or more impeller blades, the impeller blades drawing fluid into the expandable cannula when rotated in the fluid; and

a retainer sheath configured to be advanced through a vasculature of a patient while containing the expandable cannula and the expandable impeller assembly therein, to deliver the expandable cannula to a target location within the vasculature where it is advanced distally out of the retainer sheath, the retainer sheath comprising;

a distal cannula retention zone disposed over and compressing the expandable cannula and the expandable impeller assembly into the delivery profile, and having a first resistance to separation greater than an outward force generated by the expandable cannula and the expandable impeller assembly under compression, and

a proximal separation zone adjacent the distal cannula retention zone and disposed over the elongate catheter body, the proximal separation zone having a second resistance to a separation force, the second resistance less than the first resistance, wherein upon advancing the expandable cannula distally out of the retainer sheath, the proximal separation zone is configured to separate, under the separation force, into a first portion and a second portion disposed across a gap, the gap enabling the elongate catheter body to pass between the first and second portions to enable removal of the retainer sheath from the elongate catheter body for operation of the expandable impeller assembly.

2. The catheter system of claim 1, wherein the retainer sheath comprises a composite seam.

3. The catheter system of claim 2, wherein the composite seam includes a first perforated segment disposed in the distal cannula retention zone and a second perforated segment disposed in the proximal separation zone and including perforations with greater density than in the first perforated segment.

4. The catheter system of claim 2, wherein the retainer sheath comprises a first wall thickness in the distal cannula retention zone configured to provide the first resistance to separation greater than the outward force generated by the expandable cannula and the expandable impeller assembly under compression.

5. The catheter system of claim 1, wherein the proximal separation zone comprises a first portion and a second portion opposed to the first portion such that the retainer sheath is separable into two segments.

6. The catheter system of claim 5, wherein the first and second portions are disposed on opposite sides of the retainer sheath.

7. The catheter system of claim 1 further comprising handles disposed on a proximal end of the retainer sheath, the handles having a first configuration for providing relative motion between the retainer sheath and the elongate catheter body and a second configuration for changing the configuration of the retainer sheath from a tubular configuration to a sheet-like configuration.

8. The catheter system of claim 1 further comprising a separation device disposed on the catheter system proximal of the retainer sheath, wherein upon advancing the expandable cannula distally out of the retainer sheath, the separation devices is adapted to separate the distal separation zone.

9. The catheter system of claim 1, wherein the retainer sheath includes a side branch having a lumen, and an elongate sheath body comprising a pressure sensing lumen disposed therein and configured to detect fluid pressure at a distal end of the retainer sheath, wherein the pressure sensing lumen is coupled in fluid communication with the lumen of the side branch.

10. The catheter system of claim 1 further comprising an introducer sheath configured to be inserted percutaneously into the vasculature of the patient and configured to receive the retainer sheath and the elongate catheter body disposed therein.

11. A method of advancing a catheter pump to a target location within a vasculature of a patient, the method comprising:

disposing an expandable impeller assembly in an expandable cannula;

disposing an elongate catheter body in a proximal separation zone of a retainer sheath and the expandable cannula in a distal cannula retention zone of the retainer sheath to compress the expandable cannula and the expandable impeller assembly from an operational profile into a delivery profile smaller than the operational profile, the distal cannula retention zone adjacent to the proximal separation zone and having a first resistance to separation greater than an outward force generated by the expandable cannula and the expandable impeller assembly under compression;

advancing the retainer sheath through the vasculature of the patient to deliver the expandable cannula to the target location while containing the expandable cannula and the expandable impeller assembly within the retainer sheath;

advancing the expandable cannula distally out of the retainer sheath at the target location;

separating, under a separation force, the proximal separation zone of the retainer sheath into a first portion and a second portion disposed across a gap, the proximal separation zone having a second resistance to the separation force, the second resistance less than the first resistance; and

passing the elongate catheter body between the first portion and the second portion to remove the retainer sheath from the elongate catheter body for operation of the expandable impeller assembly.

12. The method of claim 11, wherein separating the proximal separation zone comprises separating the retainer sheath at a composite seam.

13. The method of claim 12, wherein separating the retainer sheath comprises separating the composite seam at a first perforated segment disposed in the distal cannula retention zone, and separating the composite seam at a second perforated segment disposed in the proximal separation zone and including perforations with greater density than in the first perforated segment.

14. The method of claim 11 further comprising inserting an introducer sheath percutaneously into the patient, the introducer sheath configured to receive the elongate catheter body.

15. The method of claim 14 further comprising retracting the expandable cannula and the expandable impeller assembly into the introducer sheath to compress the expandable cannula and the expandable impeller into the delivery profile.

16. The method of claim 14, wherein inserting the introducer sheath comprises advancing the introducer sheath to an abdominal aorta of the patient, and wherein advancing the retainer sheath to the target location comprises advancing the retainer sheath to a heart of the patient.

17. The method of claim 11, wherein separating the proximal separation zone comprises retracting the retainer sheath proximally into engagement with a separation device disposed on a proximal portion of the elongate body.

18. The method of claim 11 wherein separating the proximal separation zone comprises separating handles disposed on a proximal end of the retainer sheath, the handles having a first configuration for providing relative motion between the retainer sheath and the elongate catheter body and a second configuration for changing the configuration of the retainer sheath from a tubular configuration to a sheet-like configuration.

19. The method of claim 11 further comprising operating the expandable impeller assembly to generate a blood flow through the vasculature of the patient after the retainer sheath is removed from the vasculature.

20. The method of claim 11, wherein the retainer sheath includes a side branch having a lumen, and an elongate sheath body having a pressure sensing lumen disposed therein and in fluid communication with the lumen of the side branch, the method further comprising detecting a fluid pressure at a distal end of the retainer sheath.