Biologic delivery system with positional sensing and force sensing

Patent metadata

Field	Value
Publication number	US-2020297239-A1
Application number	US-201716087804-A
Country	US
Kind code	A1
Filing date	Apr 5, 2017
Priority date	Apr 20, 2016
Publication date	Sep 24, 2020
Grant date	—

Abstract

Systems, apparatuses and methods are provided for identifying the position of a catheter relative to internal tissue and controlling injection of a therapeutic substance(s) into the internal tissue. In one embodiment, a catheter includes one or more position sensing electrodes disposed at or near a distal end of the catheter that allow identifying the position of the catheter relative to the internal tissue. The catheter also includes one or more contact sensors that provide an indication of contact and/or contact forces between the catheter and internal tissue before and after a therapy delivery needle is extended from the catheter into the internal tissue. Outputs of the contact sensor(s) allows for confirming insertion of the therapy delivery needle into the internal tissue to a desired depth. Once inserted to the desired depth, a therapeutic substance may be injected into the internal tissue at the desired depth.

First claim

What is claimed is:

1 . A system for internal delivery and injection of therapeutic substances into tissue within a body, comprising:
a catheter comprising:
a flexible elongate shaft with proximal and distal ends;
a lumen extending through at least a portion of said shaft and having an opening exiting proximate to said distal end of said shaft;
a first contact sensor attached to said catheter proximate to said distal end, said first contact sensor configured to generate contact outputs indicative of contact between said catheter and tissue;
a therapy delivery needle disposed within said lumen, said therapy delivery needle fluidly connected to a supply of therapeutic solution and being selectively moveable between a retracted position disposed within said catheter and an extended position where a tip of said needle is disposed a predetermined distance beyond said opening; and a control unit configured to compare a first contact output while said therapy delivery needle is disposed in said retracted position and a second contact output while said therapy delivery needle is disposed in said extended position and generate an output indicative of needle insertion based on said comparison.

2 . The system of claim 1 , wherein, based on said comparison, said control unit is configured to generate one of:
an output indicating said therapy delivery needle is fully inserted in the tissue; and an output indicating said therapy delivery needle is less than fully inserted in the tissue.

3 . The system of claim 1 , wherein said first contact sensor comprises an electrode, wherein said contact outputs comprise impedance related measurements.

4 . The system of claim 1 , wherein said first contact sensor comprises a force sensor configured to generate contact outputs indicative of mechanical force between said catheter and the tissue.

5 . The system of claim 1 , further comprising:
a first position sensor attached to said catheter proximate to said distal end, said first sensor configured to generate position outputs in response to applied signals; a navigation system configured to receive said position outputs from said first position sensor and locate said catheter within a coordinate system including the tissue; and a display operatively coupled to the navigation system and configured to display a representation of said catheter relative to a model of said tissue.

6 . The system of claim 5 , wherein said navigation system employs electric fields to detect the position of said first position sensor within said coordinate system, wherein said first position sensor comprises an electrode.

7 . The system of claim 5 , wherein said navigation system employs magnetic fields to detect the position of said first position sensor within said coordinate system, wherein said first position sensor comprises a coil.

8 . The system of claim 5 , wherein said display is further configured to display at least one target location on or within said model of said tissue.

9 . The system of claim 1 , further comprising:
a force sensor attached to said therapy delivery needle configured to generate force output indicative of forces applied to said tip of said therapy delivery needle.

10 . The system of claim 1 , further comprising:
a pump to controllable displace a dosage of said therapeutic solution through said therapy delivery needle.

11 . The system of claim 1 , further comprising:
a sensor attached to said shaft proximate to said opening configured to sense markings on said therapy delivery needle as said therapy delivery needle moves between said retracted position and said extended position and generate an needle extension output.

12 . A method for internally delivering and injecting therapeutic substances into tissue within a body, comprising:
receiving position outputs from position sensors attached proximate to a distal end of a catheter disposed proximate to a tissue region within a patient body; generating a display of the catheter relative to a model of to the tissue region; first identifying a first contact condition between the catheter and a target tissue within the tissue region based on a first output of a contact sensor attached proximate to the distal of the catheter; second identifying a second contact condition between the catheter and the target tissue based on a second output of the contact sensor, wherein said second output is received after advancement of a therapy needle a predetermined distance relative to the distal end of the catheter; determining a degree of needle insertion based on a comparison of said first contact condition and said second contact condition.

13 . The method of claim 12 , further comprising one of:
outputting an indication that the therapy delivery needle is fully inserted in the target tissue; and outputting an indication that the therapy delivery needle is less than fully inserted in the target tissue.

14 . The method of claim 13 , further comprising, upon the therapy delivery needle being fully inserted in the target tissue, injecting a therapeutic substance through the needle.

15 . The method of claim 13 , further comprising, upon the therapy delivery needle being less than fully inserted in the target tissue, adjusting the position of the distal end of the catheter.

16 . The method of claim 12 , further comprising:
adjusting a position of the distal end of the catheter based on said display to align the distal end of the catheter with the target tissue.

17 . The method of claim 12 , wherein said first and second identifying comprises receiving impedance related measurements from at least one electrode disposed proximate to the distal end of the catheter.

18 . The method of claim 12 , wherein said first and second identifying comprises receiving force measurements from at least one force sensor disposed proximate to the distal end of the catheter.

19 . The method of claim 12 , wherein said receiving position outputs comprises receiving outputs from electrodes disposed proximate to the distal end of the catheter.

20 . The method of claim 12 , wherein said receiving position outputs comprises receiving outputs from magnetic coils disposed proximate to the distal end of the catheter.

21 . The method of claim 12 , further comprising:
receiving a force output indicative of forces applied to a tip of the therapy delivery needle from a force sensor connected to the therapy delivery needle.

22 . A method for internally delivering and injecting therapeutic substances into tissue within a body, comprising:
displaying the position of a therapy delivery catheter relative to a model of internal patient tissue on a display of a catheter navigation system, wherein the position of the therapy delivery catheter is determined based on position outputs at least one position sensor attached proximate to a distal end of the therapy delivery catheter; using the display to position the therapy delivery catheter proximate to a target tissue displayed on said model; first identifying a first contact condition between the therapy delivery catheter and the target tissue based on a first output of a contact sensor attached proximate to the distal end of the therapy delivery catheter; advancing a therapy needle a predetermined distance relative to the distal end of the therapy delivery catheter and against the target tissue; second identifying a second contact condition between the therapy delivery catheter an

Assignees

• St Jude Medical Atrial Fibrillation Div Inc

Inventors

• Olson Richard J

Classifications

• A61M25/0084 Primary

  being one or more injection needles · CPC title

• A61B5/6885

  Monitoring or controlling sensor contact pressure · CPC title

• A61M2025/0166

  Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided · CPC title

• A61B5/4839

  combined with drug delivery · CPC title

• A61B5/6852

  Catheters · CPC title