Dual lumen sheath for arterial access

• US 10,737,008 B2
• Filed: 08/17/2015
• Issued: 08/11/2020
• Est. Priority Date: 08/17/2015
• Status: Active Grant

• Current Assignee: Abiomed, Inc. (Johnson & Johnson)
• Original Assignee: Abiomed, Inc. (Johnson & Johnson)
• Inventors: Corbett, Scott C., Fantuzzi, Glen Robert, Murphy, John, Kirchhoff, Frank, Brousseau, David, Siess, Thorsten
• Primary Examiner(s): Marlen, Tammie K
• Application Number:
  US14/827,741
• Publication Number:
  US 20170049947A1
• Time in Patent Office: 1,821 Days
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0286 anchored in the skin by suture or other skin penetrating devices
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0662 Guide tubes
• 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 60/135 inside a blood vessel, e.g. using grafting
• 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 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/422 the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps

Abstract

A sheath assembly for the insertion of a percutaneous pump includes a tubular sheath body dimensioned for insertion into a blood vessel through a vessel aperture. The tubular sheath body includes a wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, an inner surface defining a first lumen substantially parallel to the longitudinal axis, and a second lumen disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion to the distal end portion. The first lumen is dimensioned to allow passage of a portion of the percutaneous pump, and the second lumen is dimensioned for passage of a guidewire. A stylet is removably positioned to substantially occlude the second lumen. The stylet has a proximal end releasably secured to the sheath assembly.

Claims

1. An assembly for insertion of a percutaneous intravascular blood pump and a guidewire, the assembly comprising:

a guidewire having proximal and distal ends;

a stylet having proximal and distal ends;

a tubular sheath body dimensioned for insertion into a blood vessel through a vessel aperture, and for receiving and delivering an intravascular blood pump, the sheath body including;

a wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, and an inner surface defining a first lumen substantially parallel to the longitudinal axis, wherein the first lumen is dimensioned to allow passage of at least a portion of the intravascular blood pump; and

a second lumen disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion to the distal end portion; and

a hub coupled to the tubular sheath body and having a port in fluid communication with the second lumen, wherein the second lumen is sized to receive, individually, (1) the distal end of the guidewire and (2) the distal end of the stylet, and

wherein when the stylet is positioned within the second lumen, the distal end of the stylet substantially occludes the second lumen and the stylet forms a liquid tight seal across the port.

2. The assembly of claim 1, the stylet and the second lumen each having a length, and wherein the length of the stylet is substantially equal to the length of the second lumen.

3. The assembly of claim 1, wherein the second lumen has a proximal section having a proximal section diameter and a distal section having a distal section diameter, and wherein the proximal section diameter is greater than the distal section diameter.

4. The assembly of claim 3, wherein the distal section diameter is about equal to an outer diameter of the stylet.

5. The assembly of claim 1, wherein the second lumen is coated with an antithrombogenic agent.

6. The assembly of claim 1, wherein the hub is coupled to the proximal end portion of the sheath body, the port is a second port on the hub, and wherein the hub further comprises:

a first port in fluid communication with the first lumen, and wherein the second port is configured to secure the proximal end of the stylet.

7. The assembly of claim 6, wherein an outer diameter of the distal end of the stylet is approximately equal to an inner diameter of the second port.

8. The assembly of claim 1, wherein the outer surface of the wall includes at least one of a hydrophilic coating and a coating to reduce tissue adhesion.

9. The assembly of claim 1, wherein the outer surface of the wall includes markings for determining a depth of insertion.

10. The assembly of claim 1, wherein the distal end portion of the sheath body is tapered and includes a tapered surface extending to a distal end face, the distal end face being substantially orthogonal to the longitudinal axis of the sheath body.

11. The assembly of claim 10, wherein the second lumen has an outlet extending through the tapered surface of the distal end portion of the sheath body.

12. The assembly of claim 1, further comprising a stabilizing structure rotatably coupled to the tubular sheath body.

13. The assembly of claim 12, wherein the stabilizing structure is rotatable about the longitudinal axis.

14. The assembly of claim 13, wherein the stabilizing structure includes a feature configured for suturing to a patient.

15. The assembly of claim 14, wherein the stabilizing structure includes a pair of suture wings, each wing having a plurality of ribs for securing sutures.

16. The assembly of claim 1, wherein the sheath body is dimensioned to be introduced through a percutaneous access site of about 20 Fr (6.67 mm) or less.

17. The assembly of claim 1, further comprising the intravascular blood pump.

18. The assembly of claim 1, wherein the stylet is dimensioned to reduce a risk of blood clot formation in the second lumen.

19. The assembly of claim 1, wherein the intravascular blood pump is a percutaneous intracardiac blood pump assembly.

20. The assembly of claim 1, wherein the first lumen comprises a first cross-sectional area that is larger than a second cross-sectional area of the second lumen.

21. The assembly of claim 20, wherein the first cross-sectional area is between about 120 mm² and about 140 mm² in a proximal section of the first lumen.

22. The assembly of claim 20, wherein the second cross-sectional area is between about 0.75 mm² and about 1 mm² in a proximal section of the second lumen.

23. The assembly of claim 1, wherein the first lumen has a proximal section having a first diameter and a distal section having a second diameter that is less than the first diameter.

24. A method, comprising:

positioning, via a blood vessel aperture, an intravascular blood pump within vasculature of a patient;

inserting a sheath assembly through the blood vessel aperture, over the positioned intravascular blood pump, and into the vasculature of the patient, the sheath assembly comprising;

a wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, and an inner surface defining a first lumen substantially parallel to the longitudinal axis, wherein the positioned intravascular blood pump is within the first lumen after the sheath assembly is inserted; and

a second lumen disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion to the distal end portion, wherein a stylet is positioned within and substantially occludes the second lumen during insertion of the sheath assembly;

removing the stylet from the second lumen;

positioning a guidewire within the second lumen after the stylet is removed, while the sheath assembly is within the vasculature of the patient; and

removing, over the guidewire, the intravascular blood pump and the sheath assembly through the blood vessel aperture, such that the guidewire remains within the vasculature.