EXPANDABLE SHEATH FOR INTRODUCING AN ENDOVASCULAR DELIVERY DEVICE INTO A BODY

• US 20140379067A1
• Filed: 07/07/2014
• Published: 12/25/2014
• Est. Priority Date: 10/10/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Duy, Nguyen, Kim D., Nguyen, Thanh V.
• Granted Patent: US 9,301,841 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: Y10T 156/1026 with slitting or removal of material at reshaping area prior to reshaping

Abstract

Embodiments of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such embodiments can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some embodiments can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some embodiments include an elastic outer cover positioned outside the outer layer. Embodiments of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.

Claims

1. A method of inserting a prosthetic device into a blood vessel of a patient, the method comprising:

inserting a sheath at least partially into the blood vessel of the patient, the sheath comprising an inner layer defining a lumen therethrough and at least one longitudinal pleat, the sheath further comprising an outer layer having a circumferentially discontinuous portion extending at least partially along the length of the outer layer to facilitate radial expansion of the sheath, the circumferentially discontinuous portion having a first longitudinal edge portion and a second longitudinal edge portion; and

advancing a prosthetic device through the lumen of the sheath so as to cause the sheath to locally expand from the non-expanded configuration to the expanded configuration from the outwardly directed radially force of the prosthetic device exerted against the inner layer, and then locally contract at least partially back to the non-expanded configuration as the prosthetic device passes through the lumen.

2. The method of claim 1, wherein the at least one longitudinal pleat of the inner layer extends between the first and second longitudinal edge portions at least in a non-expanded configuration of the sheath.

3. The method of claim 1, wherein when the sheath is in the non-expanded configuration, the first longitudinal edge portion overlaps the second longitudinal edge portion with the at least one longitudinal pleat of the inner layer disposed between the first and second longitudinal edge portions.

4. The method of claim 3, wherein when the sheath is in the non-expanded configuration, the at least one longitudinal pleat extends circumferentially over the second longitudinal edge portion and the first longitudinal edge portion extends circumferentially over the at least one longitudinal pleat.

5. The method of claim 1, wherein the lumen is cylindrical in the non-expanded configuration and the expanded configuration.

6. The method of claim 1, wherein the sheath comprises an elastic outer cover extending at least partially over the outer layer, which outer cover locally expands and contracts as the prosthetic device is advanced through the lumen.

7. The method of claim 1, wherein the prosthetic device is mounted in a radially crimped state on a delivery apparatus, and the act of advancing the prosthetic device through the lumen of the sheath comprises advancing the delivery apparatus and the prosthetic device through lumen of the sheath and into the vasculature of the patient.

8. The method of claim 7, wherein the prosthetic device comprises a prosthetic heart valve and the method further comprises implanting the prosthetic heart valve at a treatment site within the patient.

9. The method of claim 8, wherein the prosthetic heart valve is mounted on a balloon catheter of the delivery apparatus as the prosthetic heart valve is advanced through the sheath.

10. The method of claim 7, wherein the sheath comprises an introducer housing coupled to proximal ends of the inner and outer layers, the housing having one or more seals for forming a seal around an outer surface of the delivery apparatus, and wherein the delivery apparatus is inserted through the one or more seals in the housing.

11. The method of claim 1, wherein the sheath is inserted into a femoral artery of a patient.

12. The method of claim 1, wherein the sheath comprises a tip portion and advancing the prosthetic device through the tip portion causes a score line in the tip portion to separate, allowing the tip portion to expand from the radially force of the prosthetic device.

13. A method of inserting a prosthetic device into a blood vessel of a patient, the method comprising:

providing a sheath comprising an inner layer defining a lumen therethrough, the inner layer having at least one longitudinal pleat, the sheath also comprising an outer layer having a circumferentially discontinuous portion extending at least partially along the length of the outer layer to facilitate radial expansion of the sheath, the circumferentially discontinuous portion having an overlapping portion and an underlying portion, wherein the outer layer is configured so that the overlapping portion overlaps the underlying portion and at least a portion of the longitudinal pleat of the inner layer is positioned between the overlapping and underlying portions when the sheath is in a rest configuration;

inserting the sheath at least partially into the blood vessel of the patient; and

advancing a prosthetic device through the lumen of the sheath so as to cause the sheath to locally expand from the rest configuration to an expanded configuration from the outwardly directed radially force of the prosthetic device exerted against the inner layer, and then locally contract at least partially back to the rest configuration as the prosthetic device passes through the lumen.

14. The method of claim 13, wherein the prosthetic device is mounted in a radially crimped state on a delivery apparatus, and the act of advancing the prosthetic device through the lumen of the sheath comprises advancing the delivery apparatus and the prosthetic device through lumen of the sheath and into the vasculature of the patient.

15. The method of claim 14, wherein the prosthetic device comprises a prosthetic heart valve and the method further comprises implanting the prosthetic heart valve at a treatment site within the patient.

16. The method of claim 15, wherein the prosthetic heart valve is mounted on a balloon catheter of the delivery apparatus as the prosthetic heart valve is advanced through the sheath.

17. The method of claim 13, wherein the lumen is cylindrical in the rest configuration and the expanded configuration.

18. The method of claim 13, wherein the sheath comprises a tip portion and advancing the prosthetic device through the tip portion causes a score line in the tip portion to separate, allowing the tip portion to expand from the radially force of the prosthetic device.

19. The method of claim 13, wherein the sheath comprises an elastic outer cover extending at least partially over the outer layer, which outer cover locally expands and contracts as the prosthetic device is advanced through the lumen.

20. The method of claim 13, wherein the inner layer comprises a tubular portion having a substantially cross-sectional profile and defining a longitudinally extending seam, the longitudinal pleat having first and second fold portions extending radially outwardly from respective portions of the tubular portion on opposite sides of the seam when the sheath is in the rest configuration.

21. The method of claim 13, wherein the prosthetic device is advanced through a distal opening of the sheath at a terminal distal end of the sheath in an axial direction extending lengthwise of the sheath.