Granted Patent B2

US 12,396,785 · App. 17/393,499 · Granted Aug 26, 2025

Inventors: Brock Miller (Toronto, CA); Matthew Gravett (Milton, CA); Kai-Lon Fok (Mississauga, CA); Rund Abou-Marie (Mississauga, CA)

Assignee: Boston Scientific Medical Device Limited

A61B18/1477A61B18/1206A61B2018/00083A61B2018/00351A61B2018/00755

Abstract

Claims (29)

1. A system for pericardial puncture comprising:

a medical assembly comprising,

an introducer having an elongate shaft extending between a proximal end and a distal end and defining a single lumen therethrough, the elongate shaft having a longitudinal axis extending between the proximal end and the distal end, the elongate shaft comprising:

an electrically conductive metallic tube;

a polymeric, electrically insulative sheathing on the metallic tube, the insulative sheathing having a tapered portion surrounding a distal portion of the electrically conductive metallic tube;

the introducer having a distally facing electrode at the distal end of the shaft, the electrode comprising a distal end portion of the metallic tube that is electrically exposed through the polymeric insulative sheathing, the electrode encircling the lumen and being coaxial with the longitudinal axis of the elongate shaft, and

an elongated puncture device disposed within the lumen and extendable from the distal end of the shaft;

an impedance meter electrically connectable with the electrode for measuring an impedance associated with the electrode; and

a display for displaying an indication of a position of the medical assembly device, wherein the indication of the position is based on of the impedance.

2. The system of claim 1 , wherein the indication of the position of the medical assembly is an indication of whether the medical is in contact with a target tissue.

3. The system of claim 1 , wherein the shaft comprises an electrical conductor extending proximally from the electrode for electrically connecting the electrode to the impedance meter.

4. The system of claim 1 , wherein

the puncture device is a radiofrequency puncture device; and

the system further comprises a radiofrequency generator electrically connectable with the electrode for delivering radiofrequency energy to the electrode.

5. The system of claim 1 , wherein the puncture device comprises a sharp tip.

6. The system of claim 1 , wherein the indication of a position of the medical assembly device includes an indication of whether or not the electrode is in contact with a pericardium of the heart.

7. The system of claim 6 , wherein the indication of whether or not the electrode is in contact with the pericardium of the heart is displayed text.

8. A method for pericardial puncture, comprising:

a. advancing an introducer towards a pericardium, the introducer having a distal end with a distalmost tip, the introducer having an elongate shaft, the elongate shaft having a longitudinal axis extending between the proximal end and the distal end, the elongate shaft comprising: an electrically conductive metallic tube; a polymeric, electrically insulative sheathing on the metallic tube, the insulative sheathing having a tapered portion surrounding a distal portion of the electrically conductive metallic tube; the introducer including a distally facing electrode at the distalmost tip, the electrode comprising a distal end portion of the metallic tube that is electrically exposed through the polymeric insulative sheathing, and the electrode being coaxial with the longitudinal axis of the elongate shaft;

b. advancing a puncture device through the introducer towards the pericardium, the puncture device including a puncturing tip having a puncturing tip electrode;

c. puncturing the pericardium with the puncture device; and

d. during at least one of step a., step b., and step c., measuring an impedance to assess a position of the introducer and a position of the puncture device, the impedance associated with the distally facing electrode and the puncturing tip electrode.

9. The method of claim 8 , wherein in step d., the position of the distal end of the introducer is assessed.

10. The method of claim 8 , wherein step d. comprises determining whether the distal end of the introducer is in contact with the pericardium.

11. The method of claim 8 , wherein step d. comprises determining whether the puncturing tip has punctured the pericardium.

12. The method of claim 8 , further comprising:

e. displaying an indication of the position of the introducer and/or the position of the puncture device.

13. The method of claim 12 , wherein step e. comprises displaying an indication of whether the introducer has contacted the pericardium, wherein the indication includes text, illumination, or light.

14. The method of claim 12 , wherein step e. comprises displaying an indication of whether the puncture device has punctured the pericardium, wherein the indication includes text, illumination, or light.

Assignments (2)

Continuity (2)

References Cited (319)