Navigation system for cardiac therapies

• US 8,060,185 B2
• Filed: 10/05/2009
• Issued: 11/15/2011
• Est. Priority Date: 11/19/2002
• Status: Expired due to Term

• Current Assignee: Medtronic Navigation Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Navigation Incorporated (Medtronic Plc)
• Inventors: Kelley, James F., Jascob, Bradley A., Verard, Laurent, Hunter, Mark W.
• Primary Examiner(s): Rozanski; Michael
• Application Number:
  US12/573,521
• Publication Number:
  US 20100022873A1
• Time in Patent Office: 771 Days
• Field of Search: 600/407, 600/424, 600/428, 600/433, 600/437
• US Class Current: 600/424
• CPC Class Codes: A61B 1/00071 Insertion part of the endoscope body A61B1/0055 takes precedence
• CPC Class Codes: A61B 1/0058 using shape-memory elements
• CPC Class Codes: A61B 1/012 characterised by internal passages or accessories therefor
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• 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 2034/252 indicating steps of a surgical procedure
• CPC Class Codes: A61B 2034/254 being adapted depending on the stage of the surgical procedure
• CPC Class Codes: A61B 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• CPC Class Codes: A61B 2090/367 creating a 3D dataset from 2D images using position information
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/062 : using magnetic field
• CPC Class Codes: A61B 5/7285 : for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: A61B 6/12 : Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/463 : characterised by displaying multiple images or images and diagnostic data on one display
• CPC Class Codes: A61B 6/541 : involving acquisition triggered by a physiological signal
• CPC Class Codes: A61M 2005/14292 : Computer-based infusion planning or simulation of spatio-temporal infusate distribution

Abstract

An image guided catheter navigation system for navigating a region of a patient includes an imaging device, a tracking device, a controller, and a display. The imaging device generates images of the region of the patient. The tracking device tracks the location of the catheter in the region of the patient. The controller superimposes an icon representing the catheter onto the images generated from the imaging device based upon the location of the catheter. The display displays the image of the region with the catheter superimposed onto the image at the current location of the catheter.

Claims

1. An image guided catheter navigation system for guiding a catheter through a region of a patient, said navigation system comprising:

an imaging device operable to generate image data of the region of the patient including a heart of the patient;

a plurality of discrete tracking devices, wherein each of the plurality of discrete tracking devices is operable to track a plurality of positions relating to each of the respective plurality of discrete tracking devices;

a catheter to which the plurality of discrete tracking devices are connected;

a controller in communication with the imaging device and the plurality of discrete tracking devices and operable to superimpose an icon representing the catheter onto the image data of the region of the patient, wherein the representation is based on determining a position of the catheter in the region of the patient based on the tracked plurality of positions relating to each of the respective plurality of discrete tracking devices;

a display operable to display the image data of the region of the patient with the superimposed icon of the catheter, wherein the image data of the region of the patient is free of image data of the catheter; and

a local delivery member for delivery of a therapy;

wherein the local delivery member is operable to be positioned at least with assistance of the catheter to provide a function to the region of the patient;

wherein the controller is operable to determine an iso-dose contour distribution map to be displayed on the display regarding the delivery of at least one of a pharmaceutical agent, a volume of cells, and a genetic therapy to illustrate how the at least one of the pharmaceutical agent, the volume of cells, and the genetic therapy is disbursed through the heart.

2. The image guided catheter navigation system of claim 1, further comprising:

at least one sensor connected directly to the catheter, wherein the at least one sensor includes an electrode for sensing myopotentials, an electrode for sensing action potentials, an absolute pressure sensor, an accelerometer, a temperature sensor, or an oxygen saturation sensor.

3. The image guided catheter navigation system of claim 2, further comprising:

an open lumen defined by the catheter to allow the delivery of a medical device; and

a medical lead operable to be passed through the open lumen.

4. The image guided catheter navigation system claim 2, further comprising:

an open lumen defined by the catheter to allow the delivery of an agent; and

a local delivery member for delivery of at least one of a pharmaceutical agent, a volume of cells, and a genetic therapy.

5. The image guided catheter navigation system of claim 4, further comprising:

an electrocardiogram device operable to measure a rhythm of the heart of the patient to determine an activation state or relaxation state of the heart of the patient to enable gating of the delivery of the pharmaceutical agent, the volume of cells, or the genetic therapy at an optimum time of the heart rhythm.

6. The image guided catheter navigation system of claim 5, wherein the controller is operable to suggest sites for delivery of at least one of the pharmaceutical agent, the volume of cells, and the genetic therapy and display an indication of the suggested site.

7. The image guided catheter navigation system of claim 2, further comprising:

a plurality of external dynamic reference frames, including at least a first external dynamic reference frame configured to be attached to a chest of the patient and a second external dynamic reference frame configured to be attached to a back of the patient;

wherein the catheter is operable to be navigated relative to the patient and the superimposed icon properly illustrated on the display with the controller that is able to determine both the position of the patient with the plurality of external dynamic reference frames and the position of the catheter with the plurality of tracking devices.

8. An image guided catheter navigation system for guiding a catheter through a region of a patient, said navigation system comprising:

a catheter operable to be moved into the region of the patient including a heart, the catheter including,

a plurality of discrete tracking devices, wherein each of the plurality of discrete tracking devices is connected to the catheter and operable to track a plurality of positions relating to each of the respective plurality of discrete tracking devices, and

a pressure sensor,

wherein the catheter is operable to provide a function to the region of the patient;

a display operable to display an image representative of the region of the patient; and

a controller in communication the plurality of discrete tracking devices and the pressure sensor;

wherein the controller is operable to execute instructions to determine reference points in the heart of the patient based on a measured pressure with the pressure sensor and a tracked location of the catheter by tracking at least one of the plurality of discrete tracking devices, wherein the controller is further operable to match a model of a heart to match the determined reference points at least by shrinking, stretching, and rotating the model;

wherein the controller is further operable to execute instructions to determine a position of at least a portion of the catheter and superimpose an icon representing the catheter onto the image representative of the region of the patient;

wherein the icon representation is based on determining a position of the catheter in the region of the patient based on the tracked plurality of positions relating to each of the respective plurality of discrete tracking devices;

wherein the controller is further operable to determine an iso-dose contour map for display on the display regarding how at least one of a pharmaceutical agent, a volume of cells, or a genetic therapy is disbursed through the heart;

wherein the display is further operable to display the iso-dose contour on the model.

9. The image guided catheter navigation system of claim 8, further comprising:

an imaging device operable to generate two-dimensional (2D) image data of the region of the patient including a heart of the patient;

wherein the controller is operable to superimpose the model as a three-dimensional (3D) model on the 2D image data based on the reference points identified in the heart.

10. The image guided catheter navigation system of claim 9, wherein the icon representing the catheter is operable to be superimposed on at least one of the 3D model and the 2D image data.

11. The image guided catheter navigation system of claim 10, wherein the 3D model is based on at least one of a recalled atlas heart model and an actual physiological image data.

12. The image guided catheter navigation system of claim 8, further comprising:

wherein attached to the catheter, in addition to the pressure sensor, is at least one of an electrode for sensing myopotentials, an electrode for sensing action potentials, an accelerometer, or an oxygen saturation sensor.

13. A method for guiding a catheter through a region of a patient with an image guided catheter navigation system, the method comprising:

generating a model of the region of the patient including a heart of the patient;

tracking a tracking device of a catheter, wherein the catheter further includes at least one sensor, while moving the catheter within the region of the patient;

measuring a pressure with the at least one sensor of the region of the patient as the catheter is moved within the region of the patient;

determining locations of reference points within the region of the patient based on the measured pressure and tracking the tracking device included with the catheter;

executing instructions with a processor system to match the model to the region of the patient by stretching, rotating, and aligning the model at the determined reference points to match the model to the determined reference points;

displaying the matched model;

determining a distribution map as an iso-dose contour map of a delivery of at least one of a pharmaceutical agent, a volume of cells, and a genetic therapy through an open lumen defined by the catheter; and

displaying the iso-dose contour map regarding the delivery of at least one of the pharmaceutical agent, the volume of cells, and the genetic therapy to illustrate how the at least one of the pharmaceutical agent, the volume of cells, and the genetic therapy is disbursed through the heart on the displayed model.

14. The method of claim 13, further comprising:

registering the region of the patient with the matched model; and

superimposing an icon representing a position of at least a portion of the catheter on the displayed and registered matched model.

15. The method of claim 14, further comprising:

passing a medical instrument through an open lumen defined by the catheter to the region of the patient.

16. The method of claim 14, further comprising:

attaching an internal dynamic reference frame directly to a wall of the heart of the patient with a temporary lead;

wherein the internal dynamic reference frame is operable to track a regional motion of the heart and maintain the registration of the region of the patient with the matched model.

17. The method of claim 13, further comprising:

measuring a rhythm of the heart of the patient with an electrocardiogram device operable to determine an activation state or relaxation state of the heart of the patient to enable gated delivery of at least one of the pharmaceutical agent, the volume of cells, or the genetic therapy delivery, at an optimum time of the heart rhythm.

18. The method of claim 17, further comprising:

executing instructions with the processor system to determine a suggested site for delivery of the at least one of the pharmaceutical agent, the volume of cells, and the genetic therapy; and

displaying an indication of the suggested site;

wherein the processor system is included with the image guided catheter navigation system.

19. The method of claim 13, wherein determining reference points within the region of the patient based on the measured pressure further includes basing reference points on at least one of an electrical signal morphology change or a pressure signal morphology change.

20. The method of claim 19, wherein the reference points include transition points in the heart of the patient including a transition from the superior vena cava to the right atrium, passing the tricuspid valve and into the right ventricle, and a left ventricular apex.

21. The method of claim 13, wherein determining reference points is determined solely by a user.