Devices and methods for endovascular access and therapy

• US 10,124,144 B2
• Filed: 09/01/2016
• Issued: 11/13/2018
• Est. Priority Date: 12/07/2011
• Status: Active Grant

• Current Assignee: Traumatek Solutions, B.V.
• Original Assignee: Traumatek Solutions, B.V.
• Inventors: Avneri, Itzhak, Avneri, Ben-Ami, Avneri, Shahar, Avneri, Lior
• Primary Examiner(s): Orkin, Alexander
• Application Number:
  US15/254,803
• Publication Number:
  US 20170049991A1
• Time in Patent Office: 803 Days
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires

Abstract

The present invention provides for devices and methods for providing endovascular therapy, including facilitating establishment of vascular access, placement of endovascular sheaths, catheter tip localization, and administration of vascular occlusion. The inventions includes a vessel cannulation device, an expandable sheath, an occlusion catheter, and a localizer each of which may be provided separately or used as part of a system.

Claims

1. An expandable sheath comprising:

a sheath hub having a through lumen, a distal end, and a proximal end, wherein the through lumen is configured for passing a needle or a guidewire; and

an expandable sheath shaft connected to the distal end of the sheath hub, the expandable sheath shaft comprising a sheath body and sheath tip at the distal end of the sheath body,

wherein the expandable sheath shaft has a lumen and is configured for passing the needle or guidewire,

wherein the expandable sheath shaft comprises one or more beams connected by one or more strips each running longitudinally along a substantial portion of the shaft, wherein the one or more beams and the one or more strips extend parallel to a longitudinal axis at the sheath body and curve radially with respect to the longitudinal axis at the sheath tip,

wherein the one or more beams have a thickness greater than the one or more strips,

wherein the one or more beams and one or more strips comprise a same compliant material, and

wherein the expandable sheath is configured to expand radially.

2. The expandable sheath of claim 1, wherein the one or more beams are configured to confer longitudinal rigidity to the expandable sheath shaft.

3. The expandable sheath of claim 1, wherein the one or more strips are configured to confer radial expandability to the expandable sheath shaft.

4. The expandable sheath of claim 1, wherein the expandable sheath shaft is configured to be expandable from the proximal end of the expandable sheath shaft to the distal end of the expandable sheath shaft.

5. The expandable sheath of claim 1, wherein the expandable sheath shaft has a tapered region.

6. The expandable sheath of claim 5, wherein the sheath hub has an internal diameter and wherein the expandable sheath shaft has a crimped sheath internal diameter, and

wherein the tapered region of the expandable sheath shaft comprises a transition between the internal diameter of the sheath hub and the crimped sheath internal diameter.

7. The expandable sheath of claim 6, wherein the transition spans a longitudinal distance substantially equal to the distance of the internal diameter of the sheath hub.

8. The expandable sheath of claim 1, wherein a tip of the expandable sheath shaft is tapered.

9. The expandable sheath of claim 1, wherein a tip of the expandable sheath shaft is curved.

10. The expandable sheath of claim 1, further comprising a membrane covering a tip of the expandable sheath shaft.

11. The expandable sheath of claim 1, further comprising one or more of:

a hemostatic valve inside the sheath hub, wherein the hemostatic valve spans the lumen of the sheath hub;

a sheath hub adaptor to a needle hub, wherein the sheath hub adaptor is configured for connecting the sheath hub to the needle hub and for passing a needle; and

a fluid outlet connected to the through lumen of the sheath hub.

12. The expandable sheath of claim 1, wherein the distal tip of the expandable sheath shaft has an inner diameter having a close tolerance fit of the needle.

13. The expandable sheath of claim 1, wherein said sheath hub has an inner diameter larger than the inner diameter of the expandable sheath shaft.

14. The expandable sheath of claim 1, wherein the through lumen is configured for passing the needle and the guidewire.

15. The expandable sheath of claim 1, wherein the expandable sheath shaft has an inner diameter that is configured to have a close tolerance fit along most of its length with the needle or guidewire.

16. The expandable sheath of claim 1, wherein the expandable sheath shaft is configured to be preferentially expandable from the proximal end to the distal end.

17. An expandable sheath configured to be inserted into a patient'"'"'s body over a needle, the expandable sheath comprising:

a hub, a shaft, a tapered tip at a distal end of the shaft, and at least one longitudinal element, wherein;

the hub has an inner diameter equal to 2-5 times an outer diameter of the needle,

the expandable sheath has a crimped and an expanded state,

in the crimped state, the tapered tip and shaft have an inner diameter equal to the outer diameter of the needle,

the expandable sheath is configured to transition from its crimped state to its expanded state upon insertion of a large bore device into it, and

in the expanded state, the tapered tip and shaft have an inner diameter substantially equal to or larger than the inner diameter of the hub, wherein the inner diameter of the tapered tip and shaft in the expanded state are equal to 2-5 times the inner diameter of the tapered tip and shaft in the crimped state,

wherein the expandable sheath and the at least one longitudinal element are made from the same material.

18. The expandable sheath of claim 17, wherein the expandable sheath is further configured to preferentially expand from a proximal end to a distal end of the expandable sheath.

19. The expandable sheath of claim 17, wherein the distal end of the at least one longitudinal element curves gradually towards the distal end of the sheath such that each edge at the distal end of the at least one longitudinal element are approximately perpendicular to a longitudinal axis of the sheath.

20. The expandable sheath of claim 17, wherein the expandable sheath is configured to be inserted over the needle that is a 14 gauge to 23 gauge needle.

21. The expandable sheath of claim 17, wherein the distal end of the at least one longitudinal element curves gradually towards the distal end of the sheath.

22. The expandable sheath of claim 17, wherein the at least one longitudinal element comprises two or more longitudinal elements.