Introducer sheath assembly for catheter systems and methods of using same

Patent metadata

Field	Value
Publication number	US-11969158-B2
Application number	US-202318325770-A
Country	US
Kind code	B2
Filing date	May 30, 2023
Priority date	May 1, 2019
Publication date	Apr 30, 2024
Grant date	Apr 30, 2024

Abstract

A catheter system includes a catheter, an introducer sheath, and a tubular plug. The catheter comprises an elongate body having an expandable medical device coupled with a distal end thereof. The introducer sheath comprises an elongate body defining a lumen therein. The introducer sheath is disposed over the catheter to form a gap therebetween. The tubular plug comprises an elongate body and extends through the lumen of the introducer sheath. The tubular plug is disposed between the catheter and the introducer sheath to occlude the gap. Further, the tubular plug is releasably fixed relative to the introducer sheath such that the tubular plug is removable from the lumen to allow the expandable medical device to pass therethrough.

First claim

What is claimed is:

1. A catheter system comprising:
a catheter comprising an elongate body having an expandable medical device coupled with a distal end thereof;
an introducer sheath comprising an elongate body defining a lumen therein, the introducer sheath disposed over the catheter to form a gap therebetween; and
a tubular plug comprising an elongate body, the tubular plug extending through the lumen of the introducer sheath, the tubular plug disposed between the catheter and the introducer sheath to occlude the gap, wherein the tubular plug is releasably fixed relative to the introducer sheath such that the tubular plug is removable from the lumen to allow the expandable medical device to pass therethrough.

2. The catheter system of claim 1 , wherein the catheter further comprises a retainer sheath disposed over the elongate body and having a proximal section and a retention section disposed over the expandable medical device to maintain the expandable medical device in a collapsed state.

3. The catheter system of claim 1 , wherein the catheter includes a reduced-diameter proximal portion having a smaller diameter than a distal end of the catheter, and wherein the introducer sheath is disposed along the reduced-diameter proximal portion of the catheter such that the tubular plug occludes the gap formed between the introducer sheath and the reduced-diameter proximal portion of the catheter.

4. The catheter system of claim 1 , further comprising a valve comprising a valve body defining an elongate passage therethrough, wherein the introducer sheath protrudes from a distal end of the valve body, and wherein the tubular plug extends through the elongate passage defined by the valve body.

5. The catheter system of claim 4 , wherein the valve engages a proximal portion of the tubular plug to seal a lumen defined between the tubular plug and the catheter.

6. The catheter system of claim 4 , wherein the valve body comprises a fluid port in fluid communication with the elongate passage, wherein the lumen is in fluid communication with the valve body fluid port, and wherein the tubular comprises a fluid port in fluid communication with the valve body fluid port.

7. The catheter system of claim 4 , wherein the valve comprises a rotatable actuator and a compressible valve member, wherein rotation of the rotatable actuator displaces the actuator towards the compressible valve member and compresses the valve member between the rotatable actuator and the valve body causing the valve member to deflect radially inward and apply a radial compressive force on the tubular plug to seal the lumen defined between the tubular plug and the catheter.

8. The catheter system of claim 4 , wherein the tubular plug comprises a handle coupled with a proximal end of the tubular plug and extends proximally from the valve.

9. The catheter system of claim 1 , wherein a distal end of the tubular plug has a relatively stiff construction as compared to a remainder of the tubular plug.

10. The catheter system of claim 1 , wherein a distal end of the tubular plug tapers radially inward towards a distal tip of the tubular plug.

11. The catheter system of claim 1 , wherein the expandable medical device comprises:
an expandable cannula; and
an impeller disposed within the expandable cannula and operable to draw fluid into the expandable cannula when rotated in the fluid.

12. An introducer sheath assembly comprising:
a valve comprising a valve body defining an elongate passage therethrough;
an introducer sheath protruding from the valve body distal end, the introducer sheath including an elongate body defining a lumen; and
a tubular plug extending through each of the elongate passage and the lumen of the introducer sheath, wherein a distal end of the tubular plug protrudes from a distal end of the introducer sheath, and wherein the tubular plug is releasably fixed relative to the introducer sheath such that the tubular plug is removable from the lumen.

13. The introducer sheath assembly of claim 12 , wherein the valve engages a proximal portion of the tubular plug.

14. The introducer sheath assembly of claim 12 , wherein the valve body comprises a fluid port in fluid communication with the elongate passage, wherein the lumen is in fluid communication with the valve body fluid port, and wherein the tubular plug comprises a fluid port in fluid communication with the valve body fluid port.

15. The introducer sheath of claim 12 , wherein the valve is operable to apply a radial compressive force on the tubular plug to seal a lumen defined between the plug and a catheter extending therethrough.

16. The introducer sheath assembly of claim 12 , wherein the valve comprises a rotatable actuator and a compressible valve member, wherein rotation of the rotatable actuator displaces the actuator towards the compressible valve member and compresses the valve member between the rotatable actuator and the valve body causing the valve member to deflect radially inward and apply the radial compressive force on the tubular plug.

17. The introducer sheath assembly of claim 12 , wherein the tubular plug comprises a handle coupled with a proximal end of the tubular plug and extends proximally from the valve.

18. The introducer sheath assembly of claim 12 , wherein a distal end of the tubular plug has a relatively stiff construction as compared to a remainder of the tubular plug.

19. The introducer sheath assembly of claim 12 , wherein a distal end of the tubular plug tapers radially inward towards a distal tip of the tubular plug.

20. The introducer sheath assembly of claim 12 , wherein the valve comprises an actuator, and wherein the plug comprises a handle releasably coupled to the actuator by an O-ring positioned within an annular recess defined by the actuator.

Assignees

• Tc1 Llc

Inventors

• Muller Paul
• Fitzgerald Keif
• Su Ted
• Butler Michael

Classifications

• A61B17/00234 Primary

  for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence) · CPC title

• A61M60/13

  by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system · CPC title

• A61M60/174

  discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system · CPC title

• A61M60/216

  including a rotating member acting on the blood, e.g. impeller · CPC title

• A61M60/414

  transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter · CPC title