Catheter pump introducer systems and methods

• US 10,105,475 B2
• Filed: 04/15/2015
• Issued: 10/23/2018
• 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:
  US15/303,709
• Publication Number:
  US 20170035952A1
• Time in Patent Office: 1,287 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 impeller assembly disposed in the expandable cannula and including an impeller shaft and an impeller body including one or more impeller blades, the impeller blade(s) drawing fluid into the expandable cannula when rotated in the fluid;

a sheath having a cannula retention zone disposed over the expandable cannula and a separation zone, the cannula retention zone having a first configuration adapted to retain the expandable cannula in the delivery profile, the sheath further adapted to be advanced through a vasculature of a patient to deliver the expandable cannula to a target location within the vasculature where it is advanced distally out of the sheath; and

a separation device disposed on the catheter system proximal of the sheath at least when the cannula retention zone of the sheath is disposed over the expandable cannula, wherein, upon advancing the expandable cannula distally out of the sheath, the separation device is adapted to separate the separation zone of the sheath 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 portion so that the sheath can be removed from the elongate catheter body for operation of the impeller assembly.

2. The catheter system of claim 1, wherein the cannula retention zone comprises a first resistance to tearing, the sheath having an elongate zone proximal of the cannula retention zone and having a second resistance to tearing, the second resistance to tearing being lower than the first resistance to tearing.

3. The catheter system of claim 1, wherein the separation zone includes a composite seam.

4. The catheter system of claim 3, wherein the composite seam includes a first perforated segment disposed in the cannula retention zone and a second perforated segment disposed proximally of the cannula retention zone, the first perforated segment including perforations with less density than in the second perforated segment.

5. The catheter system of claim 1, wherein the separation zone includes a first portion and a second portion opposed to the first portion such that the sheath can be separated into two segments.

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

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

8. The catheter system of claim 1, wherein the separation device comprises at least one fin disposed on the elongate catheter body.

9. The catheter system of claim 1, wherein the sheath includes a side branch having a lumen.

10. The catheter system of claim 9, wherein the sheath includes an elongate sheath body comprising a pressure sensing lumen disposed therein and configured to detect fluid pressure at a distal end of the sheath.

11. The catheter system of claim 10, wherein the pressure sensing lumen is coupled in fluid communication with the lumen of the side branch.

12. A method, comprising:

advancing into a vasculature of a patient, to a target location within the vasculature, a catheter assembly including an elongate body, an expandable cannula having an expandable impeller disposed therein, and a sheath having a cannula retention portion disposed over the expandable cannula and the expandable impeller, the cannula retention portion retaining the expandable cannula and the expandable impeller in a low profile configuration;

providing relative motion between the sheath and the expandable cannula to expose the expandable cannula to permit the expandable cannula to expand to a high profile configuration, the high profile configuration having a larger width than the low profile configuration;

pulling a separation zone of the sheath into engagement with a separation device disposed on a proximal portion of the elongate body of the catheter assembly, the elongate body being coupled with the cannula at a distal portion thereof;

separating first and second portions of the sheath along a longitudinal portion thereof to create a gap therealong; and

passing the elongate body through the gap to cause the sheath to be removed from the catheter assembly for operation of the expandable impeller.

13. The method of claim 12, further comprising separating first and second portions of a handle assembly and pulling the first and second portion to extend a gap along the longitudinal direction of the sheath.

14. A method, comprising:

disposing an introducer sheath in a vasculature of a patient;

introducing a catheter assembly into a proximal end of the introducer sheath and into the vasculature through the introducer sheath, the catheter assembly including an elongate body having an expandable cannula coupled with a distal end thereof, the catheter assembly having an expandable impeller being journaled for rotation in the expandable cannula, the catheter assembly further comprising a retainer sheath disposed over the elongate body and the expandable cannula;

advancing the catheter assembly through the vasculature to a source of blood;

advancing the expandable cannula distally relative to and out of the retainer sheath, thereby expanding the expandable impeller for operation in the source of blood;

retracting the retainer sheath proximally into engagement with a separation device disposed on a proximal portion of the elongate body of the catheter assembly and separating the retainer sheath into first and second portions along a longitudinal portion thereof to create a gap therealong through which the catheter assembly passes;

retracting the elongate body into the introducer sheath such that the expandable cannula engages a distal end of the introducer sheath;

providing relative motion between the introducer sheath and the expandable cannula to compress the expandable cannula; and

removing the introducer sheath and the catheter assembly from the patient.

15. The method of claim 14, further comprising prior to retracting the elongate body into the introducer sheath, retracting the impeller into the elongate body of the catheter assembly to compress the impeller.

16. The method of claim 14, further retracting a retainer disposed over the expandable cannula and expandable impeller after introducing the catheter assembly to expand the expandable impeller.

17. The method of claim 16, wherein the retainer sheath comprises a separation zone disposed longitudinally there along, wherein the separation zone is separable into the first and second portions to create the gap through which the catheter assembly passes.

18. The method of claim 14 further comprising removing the first and second portions of the retainer sheath from the catheter assembly for operation of the expandable impeller to generate a flow of blood.