Methods and devices for transcarotid access

• US 9,241,699 B1
• Filed: 11/10/2014
• Issued: 01/26/2016
• Est. Priority Date: 09/04/2014
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Garrison, Michi E., Moreno, Marlon, Kume, Stewart M., Wallace, Michael P., Mendoza, Herbert
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US14/537,316
• Time in Patent Office: 442 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/0687 having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/24 Check- or non-return valves

Abstract

Disclosed is an arterial access sheath for introducing an interventional device into an artery. The arterial access sheath includes an elongated body sized and shaped to be transcervically introduced into a common carotid artery at an access location in the neck and an internal lumen in the elongated body having a proximal opening in a proximal region of the elongated body and a distal opening in a distal region of the elongated body. The internal lumen provides a passageway for introducing an interventional device into the common carotid artery when the elongated body is positioned in the common carotid artery. The elongated body has a proximal section and a distalmost section that is more flexible than the proximal section. A ratio of an entire length of the distalmost section to an overall length of the sheath body is one tenth to one half the overall length of the sheath body.

Claims

1. An arterial access sheath for introducing an interventional device into an artery, comprising:

an elongated body sized and shaped to be transcervically introduced into a common carotid artery at an access location in the neck;

an internal lumen in the elongated body having a proximal opening in a proximal region of the elongated body and a distal opening in a distal region of the elongated body, the internal lumen providing a passageway for introducing an interventional device into the common carotid artery when the elongated body is positioned in the common carotid artery;

wherein the elongated body has a proximal section and a distal most section that is more flexible than the proximal section, and wherein a ratio of an entire length of the distal most section to an overall length of the sheath body is one tenth to one half the overall length of the sheath body, and wherein the overall length of the elongated body is 20 cm to 30 cm.

2. A sheath as in claim 1, wherein the flexural stiffness of the distal most section is one third to one tenth the flexural stiffness of the remainder of the sheath body.

3. A sheath as in claim 1, wherein the distal most section has a flexural stiffness (E*I) in the range 50 to 300 N-mm2 and a remainder of the elongated body has a flexural stiffness in the range 500 to 1500 N-mm2, where E is the elastic modulus and I is the area moment of inertia of the elongated body.

4. A sheath as in claim 1, further comprising a transition section between the distal most section and the proximal section, wherein the flexibility of the transition section is between the flexibility of the distal most section and the flexibility of the proximal section.

5. A sheath as in claim 1, wherein the length of the distal most section is 3 cm to 4 cm.

6. A sheath as in claim 1, wherein the ratio of an entire length of the distal most section to an overall length of the sheath body is one fourth to one half the overall length of the sheath body.

7. A sheath as in claim 4, wherein the length of the distal most section is 2 cm to 4 cm, and the length of the transition section is 1 cm to 2 cm.

8. A sheath as in claim 1, wherein the overall length of the elongated body is 20 cm to 30 cm and wherein the distal most section is 2.5 cm to 5 cm.

9. A sheath as in claim 4, wherein the overall length of the elongated body is 20 cm to 30 cm, the length of the distal most section is 2.5 cm to 5 cm, and the length of the transition section is 2 cm to 10 cm.

10. A sheath as in claim 4, wherein the distal most flexible section and the transition section collectively form at least one fourth and at most one half the entire length of the sheath body.

11. A sheath as in claim 4, wherein the distal most flexible section and the transition section collectively form at least one sixth and at most one half the entire length of the sheath body.

12. A sheath as in claim 1, wherein the elongated body comprises:

an inner liner;

an outer jacket;

a reinforcement structure sandwiched between the inner liner and outer jacket.

13. A sheath as in claim 12, wherein a flexibility of the reinforcement structure varies along the length of the elongated body.

14. A sheath as in claim 12, wherein the reinforcement structure is a stainless steel or nitinol braid, a helical ribbon, a helical wire, a cut stainless steel or nitinol hypotube, or a cut rigid polymer.

15. A sheath as in claim 12, wherein the outer jacket is one or more of a group of materials including Pebax, thermoplastic polyurethane, or nylon.

16. A sheath as in claim 12, wherein the inner liner comprises a low friction material.

17. A sheath as in claim 16, wherein the low friction material is PTFE.

18. A sheath as in claim 1, further comprising a radiopaque marker on the elongated body.

19. A sheath as in claim 1, further comprising a connector structure at proximal end of the elongated body, and further comprising a proximal extension extending proximally from the connector structure.

20. A sheath as in claim 19, wherein the proximal extension is between 10 cm and 25 cm in length.

21. A sheath as in claim 19, wherein the proximal extension is between 15 cm and 20 cm in length.

22. A sheath as in claim 19, wherein the proximal extension has a length configured to provide a distance of between about 30 cm and 60 cm between a hemostasis valve on a proximal region of the sheath and a distal tip of the sheath body.

23. A sheath as in claim 19, wherein the proximal extension has an inner and outer diameter which is larger than the inner and outer diameter of the elongated body.

24. A sheath as in claim 19, wherein the connector structure includes a suture eyelet.

25. A sheath as in claim 19, further comprising a hemostasis valve on the proximal end of the proximal extension.

26. A sheath as in claim 19, further comprising a female Luer adaptor on the proximal end of the proximal extension.

27. A sheath as in claim 19, wherein the proximal extension is removable from the connector structure and wherein the connector structure further comprises a hemostasis valve such that the hemostasis valve is open when the proximal extension is attached to the connector structure but is sealed when the proximal extension is removed from the connector structure.

28. A sheath as in claim 1, wherein the sheath body has a distal section that is shaped in a curved or angled configuration.

29. A sheath as in claim 27, wherein the distal section is 0.5 cm to 1 cm and wherein the distal section is shaped in an angle from 10 to 30 degrees, as measured from the main axis of the sheath body.

30. A sheath as in claim 1, further comprising an elongated dilator sized to be positioned inside the lumen of the elongated body, wherein the elongated dilator has a distal most section that is flexible and that corresponds to the distal most section of the elongated body of the sheath.