Intravascular device delivery sheath

• US 10,661,052 B2
• Filed: 07/27/2017
• Issued: 05/26/2020
• Est. Priority Date: 07/29/2016
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories)
• Original Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories)
• Inventors: McNiven, Sean A., von Oepen, Randolf, Xie, Yongjin, Valencia, Francisco, Salvador, Ken C.
• Primary Examiner(s): Bouchelle, Laura A
• Application Number:
  US15/662,008
• Publication Number:
  US 20180126119A1
• Time in Patent Office: 1,034 Days
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0065 telescopic
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

An intravascular delivery system includes a delivery sheath capable of transmitting a predetermined tension or compression force in a longitudinal direction while maintaining flexibility to navigate tortuous anatomy. A method of delivering a medical device includes inserting an intravascular device delivery system including a delivery sheath having a continuous spine into a bodily lumen. A distal longitudinal force is applied to the delivery sheath. The distal force is transmitted through the continuous spine and across one or more slit cuts of the delivery sheath. A proximal longitudinal force is applied to the delivery sheath. The proximal longitudinal force is transmitted through the continuous spine of the delivery sheath.

Claims

1. A hybrid tubular member, the tubular member comprising:

a coil inner layer having a proximal end and a distal end, a longitudinal axis extending therebetween, an angle of the coil in relation to the longitudinal axis forming an inner layer angle; and

a hypotube, with a plurality of openings, forming an outer layer longitudinally overlapping the inner layer and positioned circumferentially outside and adjacent to the inner layer, the outer layer including one or more constituent elements having an outer layer angle relative to the longitudinal axis that is less than the inner layer angle; and

a braided contact layer disposed within the coil inner layer, the braided contact layer forming a lumen to receive an intravascular device, an inner surface of the braided contact layer being more continuous than a surface of the coil inner layer.

2. The tubular member of claim 1, wherein the inner layer has an outer diameter and the outer layer has an inner diameter, and the outer diameter of the inner layer is substantially equal to the inner diameter of the outer layer.

3. The tubular member of claim 1, wherein the inner layer has an outer diameter and the outer layer has an inner diameter, and the outer diameter of the inner layer is less than the inner diameter of the outer layer such that a gap is formed therebetween.

4. The tubular member of claim 1, wherein the inner layer and outer layer are longitudinally fixed relative one another at a proximal end and a distal end of the inner layer.

5. The tubular member of claim 1, wherein the inner layer angle and outer layer angle define a layer angle ratio between 1.1 and 5.0.

6. The tubular member of claim 1, further comprising one or more tensioning elements.

7. The tubular member of claim 6, wherein the one or more tensioning elements extend from the proximal end of the inner layer to the distal end of the inner layer.

8. An intravascular device delivery system, the system comprising:

an elongated member, the elongated member including;

a delivery catheter having a proximal end, a distal end, and a longitudinal axis extending therebetween;

a hybrid delivery sheath positioned radially outside and circumferentially about the delivery catheter and coaxial with the delivery catheter, the hybrid delivery sheath including;

a coil inner layer having a proximal end and a distal end, a longitudinal axis extending therebetween, an angle of the coil in relation to the longitudinal axis forming an inner layer angle; and

a hypotube, with a plurality of openings, forming an outer layer longitudinally overlapping the inner layer and positioned circumferentially outside and around the inner layer, the outer layer including one or more constituent elements having an outer layer angle relative to the longitudinal axis that is less than the inner layer angle; and

a braided contact layer disposed within the coil inner layer, the braided contact layer forming a lumen to receive an intravascular device, an inner surface of the braided contact layer being more continuous than a surface of the coil inner layer.

9. The system of claim 8, wherein the hybrid delivery sheath is moveable in a longitudinal direction relative to the delivery catheter.

10. The system of claim 8, wherein the hybrid delivery sheath is rotatable about the longitudinal axis relative to the delivery catheter.

11. The system of claim 8, wherein the hybrid delivery sheath is movable in at least two directions and relative to the delivery catheter.

12. The system of claim 8, wherein the outer layer and the coil inner layer are movable in at least two directions and relative to one another.

13. The system of claim 8, wherein at least one of the coil inner layer and the outer layer is movable in at least two directions and relative to the delivery catheter.

14. The system of claim 8, further comprising a handle connected to the elongated member at the proximal end of the elongated member, the handle configured to translate the hybrid delivery sheath longitudinally relative to the delivery catheter.

15. The system of claim 14, wherein the handle is configured to rotate the hybrid delivery sheath about the longitudinal axis during longitudinal translation of the hybrid delivery sheath relative to the delivery catheter.

16. The system of claim 8, wherein at least a portion of the hybrid delivery sheath is translatable distally beyond the distal end of the delivery catheter.

17. The system of claim 8, further comprising a friction-reducing layer located between at least part of the hybrid delivery sheath and the delivery catheter.