Method for therapy of heart valves with a robot-based X-ray device

• US 8,252,049 B2
• Filed: 11/03/2008
• Issued: 08/28/2012
• Est. Priority Date: 11/03/2008
• Status: Expired due to Fees

• Current Assignee: Siemens Healthcare GMBH (Siemens AG)
• Original Assignee: Siemens AG
• Inventors: Maschke, Michael
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Swaminathan, Seema
• Application Number:
  US12/263,732
• Publication Number:
  US 20100114308A1
• Time in Patent Office: 1,394 Days
• Field of Search: 623/1.11, 623/1.15, 623/2.11, 623/2.17, 623/2.37, 606/108
• US Class Current: 623/2.11
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/4441 the rigid structure being a C-arm or U-arm
• CPC Class Codes: A61B 6/4458 the source unit or the detector unit being attached to robotic arms
• CPC Class Codes: A61B 6/4464 the source unit or the detector unit being mounted to ceiling
• CPC Class Codes: A61B 6/462 characterised by constructional features of the display
• CPC Class Codes: A61B 6/464 involving a plurality of displays
• CPC Class Codes: A61B 6/466 adapted to display 3D data
• CPC Class Codes: A61B 6/5247 combining images from an ionising-radiation diagnostic technique and a non-ionising radiation diagnostic technique, e.g. X-ray and ultrasound
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4416 related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter

Abstract

A method or workflow for heart valve replacement, or more precisely emplacement of a prosthetic heart valve, using minimally invasive procedures includes imaging of the patient'"'"'s heart during the procedure using a multi-access articulated x-ray imaging robot that allows a radiation detector carried by the robot to be moved in arbitrary paths around a patient in order to generate multiple projection exposures of the relevant region of the patient during the procedure. The imaging system is used to generate two dimensional image data during movement of the catheter and prosthetic heart valve into place and to generate three dimensional image data of the prosthetic heart valve within the patient'"'"'s heart. The two dimensional image data and the three dimensional image data are registered and superimposed for use in positioning of the prosthetic heart valve. Additional imaging may be performed once the prosthetic heart valve is in position.

Claims

1. A method for emplacement of a heart valve prosthesis in a patient'"'"'s heart, comprising the steps of:

positioning a patient on a table;

accessing the patient'"'"'s heart;

penetrating a wall of the patient'"'"'s heart to form an opening;

inserting a catheter having a prosthetic heart valve mounted in a compact state on the catheter into the opening including inserting the prosthetic heart valve into the patient'"'"'s heart;

imaging the patient'"'"'s heart using two dimensional imaging during insertion of the prosthetic heart valve to produce two dimensional image data;

imaging the patient'"'"'s heart using three dimensional imaging to produce three dimensional image data;

registering and superimposing the two dimensional image data and the three dimensional image data to generate superimposed image data;

imaging the patient'"'"'s heart using two dimensional imaging during a positioning imaging step;

positioning the prosthetic heart valve by positioning an image of the heart valve within the superimposed image data while imaging the patient'"'"'s heart in said positioning imaging step;

imaging the patient'"'"'s heart using two dimensional imaging during an opening imaging step;

opening the prosthetic heart valve to an expanded condition while in position in the patient'"'"'s heart within the superimposed image data while imaging the patient'"'"'s heart in said opening imaging step;

imaging the patient'"'"'s heart using three dimensional imaging to obtain a soft tissue image to determine a position of the prosthetic heart valve in the expanded condition in the patient'"'"'s heart, said imaging step using three dimensional imaging to obtain a soft tissue image being performed without use of a contrast agent;

imaging the patient'"'"'s heart using a contrast agent to obtain high contrast image data of the expanded prosthetic heart valve in the patient'"'"'s heart; and

comparing the soft tissue image of the prosthetic heart valve in position with the high contrast image data to determine at least one of attachment and functioning of the expanded prosthetic heart valve.

2. A method as claimed in claim 1, further comprising the steps of:

imaging the patient'"'"'s heart with the expanded prosthetic heart valve using ultrasound imaging.

3. A method as claimed in claim 1, wherein said step of accessing the patient'"'"'s heart includes:

making a surgical incision into a lateral chest area of the patient;

exposing a left ventricular apex of the patient'"'"'s heart; and

wherein said step of penetrating the wall of the patient'"'"'s heart penetrates the left ventricular apex.

4. A method as claimed in claim 1, wherein said two dimensional imaging and said three dimensional imaging are performed using a multi-axis articulated imaging system.

10. A method as claimed in claim 1, wherein said comparing step includes at least one of comparing, superimposing and subtracting the soft tissue image data and the high contrast image data.

5. A method for emplacement of a heart valve prosthesis in a patient'"'"'s heart, comprising the steps of:

positioning a patient on a table;

accessing the patient'"'"'s heart;

penetrating a wall of the patient'"'"'s heart to form an opening;

inserting a catheter having a prosthetic heart valve mounted in a compact state on the catheter into the opening including inserting the prosthetic heart valve into the patient'"'"'s heart;

imaging the patient'"'"'s heart using three dimensional imaging to produce three dimensional image data;

imaging the patient'"'"'s heart using two dimensional imaging during insertion of the prosthetic heart valve to produce two dimensional image data;

registering and superimposing the two dimensional image data and the three dimensional image data to generate superimposed image data;

position the prosthetic heart valve by positioning a current position of the prosthetic heart valve obtained by two-dimensional imaging within the superimposed image data;

opening the prosthetic heart valve to an expanded condition while in position in the patient'"'"'s heart;

imaging the patient'"'"'s heart using three dimensional imaging to obtain soft tissue image data to determine a position of the prosthetic heart valve in the expanded condition in the patient'"'"'s heart;

said imaging step using three dimensional imaging to obtain a soft tissue image being performed without use of a contrast agent

imaging the patient'"'"'s heart using a contrast agent to obtain high contrast image data of the expanded prosthetic heart valve in the patient'"'"'s heart; and

comparing the soft tissue image data and the high contrast image data to determine at least one of an attachment and functioning of the prosthetic heart valve in the patient'"'"'s heart.

6. A method as claimed in claim 5, further comprising the steps of:

imaging the patient'"'"'s heart with the expanded prosthetic heart valve using ultrasound imaging.

7. A method as claimed in claim 5, wherein said step of accessing the patient'"'"'s heart includes:

making a surgical incision into a lateral chest area of the patient;

exposing a left ventricular apex of the patient'"'"'s heart; and

wherein said step of penetrating the wall of the patient'"'"'s heart penetrates the left ventricular apex.

8. A method as claimed in claim 5, wherein said two dimensional imaging and said three dimensional imaging are performed using a multi-axis articulated imaging system.

11. A method as claimed in claim 5, wherein said comparing step includes at least one of comparing, superimposing and subtracting the soft tissue image data and the high contrast image data.

9. A system for emplacement of a heart valve in a patient'"'"'s heart, comprising:

an imaging system selected from the group consisting of an x-ray imaging system, a combination x-ray and PET (positron emission tomography) imaging system, a combination x-ray and CT (computed tomography) imaging system, a combination x-ray and SPECT (single photon emission computed tomography) imaging system, and a combination x-ray and MRI (magnetic resonance imaging) system;

the system being operable to perform the method steps of;

imaging the patient'"'"'s heart using two dimensional imaging during insertion of a prosthetic heart valve to produce two dimensional image data;

imaging the patient'"'"'s heart using three dimensional imaging to produce three dimensional image data, either prior to or following the two dimensional imaging step;

registering and superimposing the two dimensional image data and the three dimensional image data to generate superimposed image data;

imaging the prosthetic heart valve during positioning within the patient'"'"'s heart;

displaying the prosthetic heart valve within the superimposed image data during the positioning;

imaging the patient'"'"'s heart using three dimensional imaging to obtain soft tissue image data to determine a position of the prosthetic heart valve after the heart valve is in the expanded condition in the patient'"'"'s heart;

said imaging step using three dimensional imaging to obtain a soft tissue image being performed without use of a contrast agent

imaging the patient'"'"'s heart using a contrast agent to obtain high contrast image data to determine a position of the prosthetic heart valve after the heart valve is in the expanded condition in the patient'"'"'s heart; and

comparing the soft tissue image data and the high contrast image data to determine at least one of attachment and functioning of the prosthetic heart valve in the patient'"'"'s heart.

12. A system as claimed in claim 9, wherein said comparing step includes at least one of comparing, superimposing and subtracting the soft tissue image data and the high contrast image data.