System and method for positioning an artificial heart valve at the position of a malfunctioning valve of a heart through a percutaneous route

Abstract

Method for positioning an artificial heart valve at the anatomic position of a malfunctioning heart valve of a heart of a patient, by employing a catheter bearing the artificial heart valve and a valve fixation device, at the tip of the catheter, the method including the procedures of receiving a marking input associated with an image of the heart, and respective of the anatomic position, in a medical positioning system (MPS) coordinate system, moving the tip toward the anatomic position, constantly detecting the current position of the artificial heart valve, and producing an indication when the current position substantially matches the anatomic position, thereby enabling the catheter to fix the malfunctioning heart valve in place, by the valve fixation device.

1 . Method for positioning an artificial heart valve at the anatomic position of a malfunctioning heart valve of a heart of a patient, by employing a catheter bearing said artificial heart valve and a valve fixation device, at the tip of the catheter, the method comprising:
 receiving a marking input associated with an image of said heart, and respective of said anatomic position, in a medical positioning system (MPS) coordinate system;   moving said tip toward said anatomic position;   constantly detecting the current position of said artificial heart valve; and   producing an indication when said current position substantially matches said anatomic position, thereby enabling said catheter to fix said malfunctioning heart valve in place, by said valve fixation device.   
     
     
         2 . The method according to  claim 1 , further comprising a preliminary procedure of producing said image. 
     
     
         3 . The method according to  claim 1 , further comprising providing said catheter, before performing said moving. 
     
     
         4 . The method according to  claim 1 , further comprising inducing cardiac arrest in said heart, before performing said moving, when said tip enters a heart chamber of said heart. 
     
     
         5 . The method according to  claim 1 , further comprising fixing in place said artificial heart valve at said anatomic position, by employing said valve fixation device, while said heart is in a state of cardiac arrest. 
     
     
         6 . The method according to  claim 1 , wherein said receiving is performed via a user interface. 
     
     
         7 . The method according to  claim 1 , wherein said valve fixation device comprises:
 an inflatable balloon located at said tip; and   a stent surrounding said inflatable balloon,   wherein said artificial heart valve is coupled with said stent, and   wherein said artificial heart valve is fixed in place at said anatomic position, by inflating said inflatable balloon.   
     
     
         8 . The method according to  claim 1 , wherein said catheter comprises an MPS sensor located at said tip, said MPS sensor being coupled with said MPS, and
 wherein said detecting is performed by said MPS, according to a position output produced by said MPS sensor.   
     
     
         9 . The method according to  claim 1 , wherein said moving is performed in a manner selected from the group comprising:
 automatically;   semi-automatically; and   manually.   
     
     
         10 . The method according to  claim 1 , wherein said indication is selected from the group comprising:
 aural;   visual; and   haptic.   
     
     
         11 . The method according to  claim 1 , wherein said malfunctioning heart valve is selected from the group comprising:
 a tricuspid valve;   an aortic valve;   a pulmonary valve; and   a mitral valve.   
     
     
         12 . The method according to  claim 1 , further comprising producing a current position representation respective of said current position, after said detecting. 
     
     
         13 . The method according to  claim 1 , further comprising producing an anatomic position representation respective of said anatomic position, after said detecting. 
     
     
         14 .- 22 . (canceled) 
     
     
         23 . The method according to  claim 1  wherein said receiving a marking input comprises:
 providing a user interface for receiving the marking input from a user, independent of a trajectory along which the catheter will move and respective of the anatomic position of the malfunctioning heart valve, the marking input comprising at least position information indicative of the anatomic position and a marking information indicating that the user has affirmatively designated the position information as indicative of the anatomic position. 
 
     
     
         24 . A method for positioning an artificial heart valve at the anatomic position of a malfunctioning heart valve of a heart of a patient, by employing a valve replacement catheter bearing the artificial heart valve and a valve fixation device, at the tip of the catheter, the method comprising:
 determining a trajectory along which the valve replacement catheter will move by acquiring position readings of a first medical positioning system (MPS) sensor disposed in a mapping catheter and coupled to the MPS;   providing a user interface for receiving the marking input from a user, independent of the trajectory and respective of the anatomic position of the malfunctioning heart valve, the marking input comprising at least position information indicative of the anatomic position and a marking information indicating that the user has affirmatively designated the position information as indicative of the anatomic position;   moving said tip of the valve replacement catheter towards the anatomic position;   constantly detecting the current position of said artificial heart valve according to an output of a second MPS sensor disposed in the valve replacement catheter; and   producing an indication when the determined current position substantially matches the anatomic position, thereby enabling the valve replacement catheter to fix the malfunctioning heart valve in place, by the valve fixation device.   
     
     
         25 . The method of  claim 24  wherein said providing the user interface includes receiving the marking input associated with an image of the heart in an MPS coordinate system, and wherein said constantly detecting the current position includes determining the current position in an MPS coordinate system. 
     
     
         26 . The method of  claim 24  further comprising determining the anatomic position in an MPS coordinate system according to the marking input. 
     
     
         27 . The method of  claim 24  further comprising:
 providing the valve fixation device to comprise an inflatable balloon located at the tip of the valve replacement catheter and a stent surrounding the inflatable balloon where the artificial heart valve is coupled to the stent; and 
 fixing the artificial heart valve in place at the anatomic position by inflating the inflatable balloon. 
 
     
     
         28 . The method of  claim 24  further comprising producing a current position representation respective of the current position. 
     
     
         29 . The method of  claim 24  further comprising producing an anatomic position representation respective of the anatomic position.