INTRAVASCULAR DEVICE DELIVERY SHEATH

• US 20180126119A1
• Filed: 07/27/2017
• Published: 05/10/2018
• Est. Priority Date: 07/29/2016
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Randolf von Oepen
• Inventors: McNiven, Sean A., von Oepen, Randolf, Xie, Yongjin, Valencia, Francisco, Salvador, Ken C.
• Granted Patent: US 10,661,052 B2
• Time in Patent Office: 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:

an inner layer having a proximal end and a distal end, a longitudinal axis extending therebetween, the inner layer including one or more constituent elements having an inner layer angle relative to the longitudinal axis; and

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.

2. The tubular member of claim 1, wherein the inner layer is a spiral coil.

3. The tubular member of claim 1, wherein the outer layer is a braided sleeve.

4. 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.

5. 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.

6. The tubular member of claim 1, wherein the outer layer is a cut hypotube.

7. 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.

8. 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.

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

10. The tubular member of claim 9, wherein the one or more tensioning elements extend from the proximal end of the inner layer to the distal end of the inner layer.

11. 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;

an inner layer having a proximal end and a distal end, the longitudinal axis extending therebetween, the inner layer including one or more constituent elements having an inner layer angle relative to the longitudinal axis; and

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.

12. The system of claim 11, wherein the hybrid delivery sheath is moveable in a longitudinal direction relative to the delivery catheter.

13. The system of claim 11, wherein the hybrid delivery sheath is rotatable about the longitudinal axis relative to the delivery catheter.

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

15. The system of claim 11, wherein the outer layer and the inner layer are movable in at least two directions and relative to one another.

16. The system of claim 11, wherein at least one of the inner layer and the outer layer is movable in at least two directions and relative to the delivery catheter.

17. The system of claim 11, 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.

18. The system of claim 17, 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.

19. The system of claim 11, wherein at least a portion of the hybrid delivery sheath is translatable distally beyond the distal end of the delivery catheter.

20. The system of claim 11, further comprising a friction-reducing layer located between at least part of the hybrid delivery sheath and the delivery catheter.

21. A method of delivering a medical device, the method including:

inserting an intravascular device delivery system including a hybrid delivery sheath having an inner layer and an outer layer into a bodily lumen;

applying a distal longitudinal force to the hybrid delivery sheath;

moving the inner layer of the hybrid delivery sheath relative to the outer layer of the hybrid delivery sheath;

transmitting the distal force through the inner layer of the hybrid delivery sheath;

applying a proximal longitudinal force to the hybrid delivery sheath;

moving the outer layer of the hybrid delivery sheath relative to the inner layer of the hybrid delivery sheath; and

transmitting the proximal longitudinal force through an outer layer of the hybrid delivery sheath.

22. The method of claim 21, wherein transmitting the distal force through the inner layer of the hybrid delivery sheath further comprises changing a transverse dimension of the hybrid delivery sheath less than 25%.

23. The method of claim 21, wherein transmitting the proximal force through an outer layer of the hybrid delivery sheath further comprises changing a transverse dimension of the hybrid delivery sheath less than 25%.

24. The method of claim 21, further comprising steering the hybrid delivery sheath with a steerable delivery catheter positioned radially within the hybrid delivery sheath.

25. The method of claim 24, further comprising moving the hybrid delivery sheath longitudinally relative to the steerable delivery catheter.

26. The method of claim 25, further comprising rotating the hybrid delivery sheath relative to the steerable delivery catheter while moving the hybrid delivery sheath longitudinally relative to the steerable delivery catheter.

27. The method of claim 21, wherein moving the outer layer of the hybrid delivery sheath relative to the inner layer of the hybrid delivery sheath comprises contracting the outer layer of the hybrid delivery sheath around the inner layer of the hybrid delivery sheath.

28. The method of claim 21, wherein transmitting the distal force through the inner layer of the hybrid delivery sheath comprises foreshortening a transverse dimension of the hybrid delivery sheath by up to about 300%.