IP Library Granted Patent US 12,089,871
Granted Patent B2
US 12,089,871 · App. 17/411,877 · Granted Sep 17, 2024

Depth sensing dilator system

Inventors: Steven Howard (La Jolla, CA); Marshall L. Sherman (Cardiff By The Sea, CA); Randell Werneth (Rancho Santa Fe, CA); Bradley Klos (Solana Beach, CA)
Assignee: Cross Vascular, Inc.
A61B17/3421A61B18/1206A61B18/14A61B18/1477A61B2017/00026A61B2017/00128A61B2017/00199A61B2017/00247A61B2017/3433A61B2018/00077A61B2018/00083A61B2018/0016A61B2018/00357A61B2018/00577A61B2018/00875A61B2018/1226A61B2018/1425
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Quick Facts
Patent No.
US 12,089,871
App. No.
17/411,877
Granted
Sep 17, 2024
Kind
B2
Abstract

A depth sensing dilator system for dilating a penetration in a tissue plane includes an elongate flexible body, having a proximal end and a distal end. The body has a tapered dilator segment, and at least a first electrode on a distal end of the body. The system includes a processor and a user interface output device. The processor is configured to send a first signal to the output device when a change in impedance at the first electrode indicates that the first electrode has reached a predetermined relationship with the tissue plane.

Claims (30)

1. A depth sensing dilator system for dilating a penetration in a tissue plane, comprising:

an elongate flexible body, having a proximal end and a distal end;

a tapered dilator segment on the body;

at least a first and second electrode spaced axially apart on the body;

a processor; and

a feedback output,

wherein the processor is configured to send a first signal to the feedback output when the first electrode reaches a predetermined relationship with the tissue plane, and to send a second signal to the feedback output when the second electrode reaches the predetermined relationship with the tissue plane.

2. The depth sensing dilator system of claim 1 , wherein the predetermined relationship is when the first or second electrode contacts the tissue plane.

3. The depth sensing dilator system of claim 1 , wherein the predetermined relationship is when the first or second electrode has passed through and exited the tissue plane.

4. The depth sensing dilator system of claim 1 , wherein the feedback output comprises an audio output.

5. The depth sensing dilator system of claim 1 , wherein the feedback output comprises a visual output.

6. The depth sensing dilator system of claim 5 , wherein the feedback output is displayed on a graphical user interface display.

7. The depth sensing dilator system of claim 1 , wherein the feedback output comprises a tactile output.

8. The depth sensing dilator system of claim 1 , wherein at least one electrode is on the tapered dilator segment.

9. The depth sensing dilator system of claim 8 , wherein the first and second electrodes are spaced axially apart on the tapered dilator segment.

10. The depth sensing dilator system of claim 9 , further comprising a third electrode on the distal end.

11. The depth sensing dilator system of claim 10 , wherein the first, second and third electrodes are equally axially spaced apart.

12. The depth sensing dilator system of claim 1 , further comprising an RF generator configured to deliver RF energy to at least one of the first and second electrodes.

13. The depth sensing dilator system of claim 12 , configured to determine impedance at at least one of the electrodes.

14. The depth sensing dilator system of claim 12 , wherein the RF generator is battery powered.

15. The depth sensing dilator system of claim 1 , wherein the flexible body has an axially extending lumen, and further comprising a transseptal crossing needle axially advanceable through the lumen.

16. The depth sensing dilator system of claim 15 , wherein the needle has a distal electrode tip, and constant outside diameter for at least 2 cm proximally of the tip.

17. A depth sensing dilator system for dilating a penetration in a tissue plane, comprising:

an elongate flexible body, having a proximal end and a distal end;

a tapered dilator segment on the body;

at least a first electrode on a distal end of the body;

a processor;

a feedback output, wherein the processor is configured to send a first signal to the feedback output when a change in impedance at the first electrode indicates that the first electrode has reached a predetermined relationship with the tissue plane; and

a second electrode spaced proximally apart from the first electrode by a distance of x mm, wherein the processor is configured to determine that the depth of penetration is at least a thickness of the first electrode and less than the distance x.

18. A depth sensing dilator system as in claim 17 , wherein x is within the range of from 2 mm and 10 mm.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 22, 2021
From: HOWARD, STEVEN; SHERMAN, MARSHALL L; WERNETH, RANDELL; KLOS, BRADLEY
To: CROSS VASCULAR, INC.
Reel/Frame 058186/0273 →
Continuity (3)
Provisional Application 63195578 · Jun 1, 2021
Provisional Application 63070167 · Aug 25, 2020
Related Publication 20220061884A1 · Mar 3, 2022