Apparatus having stabilization members for percutaneously performing surgery and methods of use

Abstract

Apparatus and methods for performing surgery within an organ or vessel are provided. A catheter is provided having a longitudinal axis and an end region carrying an end effector, the end region movable to a series of positions along the longitudinal axis and with an selectable orientation relative to the longitudinal axis. The catheter includes elements for stabilizing the end region of the apparatus within an organ or vessel, and for counteracting reaction forces developed during actuation of the end effector.

What is claimed is: 
     
       1. Apparatus for treating an organ or vessel defining a cavity, the apparatus comprising:
 a catheter shaft adapted for insertion into the cavity, the catheter shaft having a distal region and a portion defining a groove,   a guide member including an end effector to treat an interior wall of the hollow-body organ, the guide member disposed in the groove for translation along the catheter shaft;   means for disposing the end effector at a selected orientation relative to the catheter shaft; and   a stabilization assembly, disposed in the distal region, that stabilizes the catheter shaft and guide member within the organ or vessel during actuation of the end effector.   
     
     
       2. The apparatus as defined in  claim 1  wherein the stabilization assembly comprises a band movable from a first position, wherein the band is disposed adjacent to an exterior surface of the catheter shaft, to a second position, wherein the band forms a plurality of loops extending from the exterior surface of the catheter shaft. Apparatus for treating an organ or vessel defining a cavity, the apparatus comprising:
 a catheter shaft adapted for insertion into the cavity, the catheter shaft having a distal region and a portion defining a groove, 
 a guide member carrying an end effector formed separately from the guide member to treat an interior wall of the organ or vessel, the guide member slidably engaged in the groove for selective translation along a longitudinal axis of the catheter shaft; 
 means for disposing the end effector at a selected orientation relative to the longitudinal axis of the catheter shaft; and 
 a stabilization assembly, formed separately from the catheter shaft and disposed in the distal region of the catheter shaft, that stabilizes the catheter shaft when activated within the organ or vessel during actuation of the end effector, wherein while the stabilization assembly is activated, the end effector is capable of making a plurality of treatment sites which are orthogonally disposed relative to a portion of the distal region of the catheter shaft, and which are placed longitudinally relative to the distal region of the catheter shaft, through translation of the guide member without repositioning at least a portion of the catheter shaft within the organ or vessel, wherein the stabilization assembly comprises a band movable from a first position, wherein the band is disposed adjacent to an exterior surface of the catheter shaft, to a second position, wherein the band forms a plurality of loops extending from the exterior surface of the catheter shaft. 
 
     
     
       3. The apparatus as defined in  claim 1  Apparatus for treating an organ or vessel defining a cavity, the apparatus comprising:
 a catheter shaft adapted for insertion into the cavity, the catheter shaft having a distal region and a portion defining a groove, 
 a guide member carrying an end effector formed separately from the guide member to treat an interior wall of the organ or vessel, the guide member slidably engaged in the groove for selective translation along a longitudinal axis of the catheter shaft; 
 means for disposing the end effector at a selected orientation relative to the longitudinal axis of the catheter shaft; and 
 a stabilization assembly, formed separately from the catheter shaft and disposed in the distal region of the catheter shaft, that stabilizes the catheter shaft when activated within the organ or vessel during actuation of the end effector, and wherein while the stabilization assembly is activated the end effector is capable of making a plurality of treatment sites which are orthogonally disposed relative to a portion of the distal region of the catheter shaft, and which are placed longitudinally relative to the distal region of the catheter shaft, through translation of the guide member without repositioning at least a portion of the catheter shaft within the organ or vessel, wherein the end effector comprises a rotating cutting head. 
 
     
     
       4. The apparatus as defined in  claim 3  wherein the end effector further comprises an electrode adapted to deliver RF energy. 
     
     
       5. The apparatus as defined in  claim 1  Apparatus for treating an organ or vessel defining a cavity, the apparatus comprising:
 a catheter shaft adapted for insertion into the cavity, the catheter shaft having a distal region and a portion defining a groove, 
 a guide member including an end effector to treat an interior wall of the organ or vessel, the guide member slidably engaged in the groove for selective translation along a longitudinal axis of the catheter shaft; 
 means for disposing the end effector at a selected orientation relative to the longitudinal axis of the catheter shaft; and 
 a stabilization assembly, formed separately from the catheter shaft and disposed in the distal region of the catheter shaft, that stabilizes the catheter shaft when activated within the organ or vessel during actuation of the end effector, and wherein while the stabilization assembly is activated the end effector is capable of making a plurality of treatment sites which are orthogonally disposed relative to a portion of the distal region of the catheter shaft, and which are placed longitudinally relative to the distal region of the catheter shaft, through translation of the guide member and without repositioning at least a portion of the catheter shaft within the organ or vessel, wherein the apparatus further comprises an outer sheath and the stabilization assembly comprises a plurality of wire hoops affixed to the catheter shaft, the plurality of wire hoops movable from a first position wherein the wire hoops are confined within the outer sheath, and a second position, wherein the wire hoops project outwardly from the catheter shaft to engage an interior surface of the organ or vessel. 
 
     
     
       6. The apparatus as defined in  claim 5  wherein the end effector comprises a rotating cutting head. 
     
     
       7. The apparatus as defined in  claim 6  wherein the end effector further comprises an electrode adapted to deliver RF energy. 
     
     
       8. Apparatus for treating an organ or vessel comprising:
 an outer sheath; 
 a guide member extending from the outer sheath, the guide member including carrying an end effector formed separately from the guide member for treating an interior region of an the organ or vessel, an end region of the guide catheter movable to dispose the end effector at a selected orientation and position relative to the a longitudinal axis of a catheter shaft; and 
 a stabilization assembly, which is formed separately from the outer sheath, comprising a plurality of bands extending from within the outer sheath, each one of the plurality of bands terminating in a spool that contacts is adapted to be in contact with an interior wall of the organ or vessel, the stabilization assembly stabilizing the guide member during actuation of the end effector. 
 
     
     
       9. The apparatus as defined in  claim 8  wherein the end effector further comprises an electrode adapted to deliver RF energy to the treatment site. 
     
     
       10. Apparatus for performing transmyocardial revascularization, the apparatus comprising:
 a catheter shaft adapted for insertion into a patient's left ventricle, the catheter shaft having a distal region including a portion adapted to engage an interior wall in a vicinity of an apex of the patient's left ventricle;   a guide member having an end effector to treat the interior wall of the left ventricle, the guide member disposed for translation along the catheter shaft; and   a stabilization assembly, disposed in the distal region, that stabilizes the catheter shaft and guide member within the left ventricle during actuation of the end effector.   
     
     
       11. The apparatus as defined in  claim 10  Apparatus for performing transmyocardial revascularization, the apparatus comprising:
 a catheter shaft adapted for insertion into a patient's left ventricle, the catheter shaft having a distal region including a portion adapted to engage an interior wall in a vicinity of an apex of the patient's left ventricle; 
 a guide member carrying an end effector formed separately from the guide member to treat the interior wall of the left ventricle, the guide member disposed for selective translation along a longitudinal axis of the catheter shaft; and 
 a stabilization assembly, formed separately from the catheter shaft and disposed in the distal region of the catheter shaft, to alternate between a retracted position and an expanded position, that stabilizes the catheter shaft within the left ventricle during actuation of the end effector, wherein the stabilization assembly comprises a band movable from a first position, wherein the band is disposed adjacent to an exterior surface of the catheter shaft, to a second position, wherein the band forms a plurality of loops extending from the exterior surface of the catheter shaft. 
 
     
     
       12. The apparatus as defined in  claim 10  Apparatus for performing transmyocardial revascularization, the apparatus comprising:
 a catheter shaft adapted for insertion into a patient's left ventricle, the catheter shaft having a distal region including a portion adapted to engage an interior wall in a vicinity of an apex of the patient's left ventricle; 
 a guide member carrying an end effector formed separately from the guide member to treat the interior wall of the left ventricle, the guide member disposed for selective translation along a longitudinal axis of the catheter shaft; and 
 a stabilization assembly, formed separately from the catheter shaft and disposed in the distal region of the catheter shaft, to alternate between a retracted position and an expanded position, that stabilizes the catheter shaft within the left ventricle during actuation of the end effector, wherein the stabilization assembly comprises a wire movable from a first position, wherein the wire is partially retracted within a lumen of the catheter shaft, to a second position, wherein the wire forms a plurality of sinusoidal bends that contact and support the catheter shaft. 
 
     
     
       13. The apparatus as defined in  claim 10  Apparatus for performing transmyocardial revascularization, the apparatus comprising:
 a catheter shaft adapted for insertion into a patient's left ventricle, the catheter shaft having a distal region including a portion adapted to engage an interior wall in a vicinity of an apex of the patient's left ventricle; 
 a guide member carrying an end effector formed separately from the guide member, wherein a distal portion of the end effector is configured for selective bending at an angle relative to a main body of the guide member to treat the interior wall of the left ventricle, the guide member disposed for selective translation along a longitudinal axis of the catheter shaft; and 
 a stabilization assembly, formed separately from the catheter shaft and disposed in the distal region of the catheter shaft to alternate between a retracted position and an expanded position, that stabilizes the catheter shaft within the left ventricle during actuation of the end effector, and wherein while the stabilization assembly is expanded the end effector is capable of making a plurality of treatment sites which are orthogonally disposed relative to a portion of the distal region of the catheter shaft, and which are placed longitudinally relative to the distal region of the catheter shaft, through translation of the guide member without repositioning at least a portion of the catheter shaft within the left ventricle, wherein the end effector comprises a rotating cutting head. 
 
     
     
       14. The apparatus as defined in  claim 12  wherein the end effector further comprises an electrode adapted to deliver RF energy. 
     
     
       15. A method of treating an interior region of an organ or vessel comprising:
 providing apparatus having a catheter shaft adapted for insertion into an organ or vessel, a guide member mounted in a groove on the catheter shaft and having an end effector for treating an interior region of the organ or vessel, and a stabilization assembly mounted on the catheter shaft;   inserting the apparatus within an organ or vessel;   deploying the stabilization assembly to stabilize the catheter shaft and guide member within the organ or vessel;   translating the guide member within the groove of the catheter shaft to dispose the end effector at a selected location relative to the catheter shaft; and   actuating the end effector to form a channel in an interior region of the organ or vessel.   
     
     
       16. The method as defined in  claim 15  further comprising A method of treating an interior region of an organ or vessel comprising:
 providing an apparatus having a catheter shaft adapted for insertion into the organ or vessel, a guide member slidably mounted in a groove on the catheter shaft and carrying an end effector formed separately from the guide member for treating an interior region of the organ or vessel, and a stabilization assembly mounted on the catheter shaft and formed separately from the catheter shaft; 
 inserting the apparatus within the organ or vessel; 
 deploying the stabilization assembly to stabilize the catheter shaft within the organ or vessel; 
 slidably translating the guide member within the groove of the catheter shaft to dispose the end effector at a selected position relative to a longitudinal axis of the catheter shaft; 
 actuating the end effector to form a channel in an interior region of the organ or vessel; and  
 delivering RF energy to the channel to create a controlled depth of necrosis. 
 
     
     
       17. The method as defined in  claim 15  further comprising, following actuating the end effector:
 translating the guide member in the groove relative to the catheter shaft to relocate the end effector; and 
 repeating actuation of the end effector. 
 
     
     
       18. The method as defined in  claim 15  A method of treating an interior region of an organ or vessel comprising:
 providing an apparatus having a catheter shaft adapted for insertion into the organ or vessel, a guide member slidably mounted in a groove on the catheter shaft and carrying an end effector formed separately from the guide member for treating an interior region of the organ or vessel, and a stabilization assembly formed separately from the catheter shaft and mounted on the catheter shaft, wherein the stabilization assembly comprises a band movable from a first position, wherein the band is disposed adjacent to an exterior surface of the catheter shaft, to a second position, wherein the band forms a plurality of loops extending from the exterior surface of the catheter shaft, and deploying the stabilization assembly to stabilize the catheter shaft and guide member within the organ or vessel further comprises moving the band from the first position to the second position ; 
 inserting the apparatus within the organ or vessel; 
 deploying the stabilization assembly to stabilize the catheter shaft within the organ or vessel, wherein deploying the stabilization assembly comprises moving the band from the first position to the second position; 
 slidably translating the guide member within the groove of the catheter shaft to dispose the end effector at a selected position relative to a longitudinal axis of the catheter shaft; 
 actuating the end effector to form a channel in an interior region of the organ or vessel. 
 
     
     
       19. The method as defined in  claim 15  A method of treating an interior region of an organ or vessel comprising:
 providing an apparatus having a catheter shaft adapted for insertion into the organ or vessel, a guide member slidably mounted in a groove on the catheter shaft and carrying an end effector formed separately from the guide member for treating an interior region of the organ or vessel, and a stabilization assembly mounted on the catheter shaft and formed separately from the catheter shaft; 
 inserting the apparatus within the organ or vessel; 
 deploying the stabilization assembly to stabilize the catheter shaft within the organ or vessel; 
 slidably translating the guide member within the groove of the catheter shaft to dispose the end effector at a selected position relative to a longitudinal axis of the catheter shaft; and 
 actuating the end effector to form a channel in an interior region of the organ or vessel, wherein actuating the end effector comprises rotating a cutting head. 
 
     
     
       20. The method as defined in  claim 15  A method of treating an interior region of an organ or vessel comprising:
 providing an apparatus having a catheter shaft adapted for insertion into the organ or vessel, a guide member slidably mounted in a groove on the catheter shaft and carrying an end effector formed separately from the guide member for treating an interior region of the organ or vessel, and a stabilization assembly, formed separately from the catheter shaft and mounted on the catheter shaft, wherein the stabilization assembly comprises a plurality of wire hoops affixed to the catheter shaft, the plurality of wire hoops movable from a first position wherein the wire hoops are confined within the outer sheath, and a second position, wherein the wire hoops project outwardly from the catheter shaft to engage an interior surface of the organ or vessel, and deploying the stabilization assembly to stabilize the catheter shaft and guide member within the organ or vessel further comprises retracting the outer sheath; 
 inserting the apparatus within the organ or vessel; 
 deploying the stabilization assembly to stabilize the catheter shaft within the organ or vessel; 
 slidably translating the guide member within the groove of the catheter shaft to dispose the end effector at a selected position relative to a longitudinal axis of the catheter shaft; and 
 actuating the end effector to form a channel in an interior region of the organ or vessel. 
 
     
     
       21. The method as defined in  claim 15  A method of treating an interior region of an organ or vessel comprising:
 providing an apparatus having a catheter shaft adapted for insertion into the organ or vessel, a guide member slidably mounted in a groove on the catheter shaft and carrying an end effector formed separately from the guide member for treating an interior region of the organ or vessel, and a stabilization assembly, formed separately from the catheter shaft and mounted on the catheter shaft, wherein the stabilization assembly comprises a wire movable from a first position wherein the wire is partially retracted within the catheter shaft, and a second position, wherein the wire forms a plurality of interconnected bends that engage an interior surface of the organ or vessel, and deploying the stabilization assembly to stabilize the catheter shaft and guide member within the organ or vessel, and the method further comprises extending the wire so that it resumes a preformed shape; 
 inserting the apparatus within the organ or vessel; 
 deploying the stabilization assembly to stabilize the catheter shaft within the organ or vessel; 
 slidably translating the guide member within the groove of the catheter shaft to dispose the end effector at a selected position relative to a longitudinal axis of the catheter shaft; 
 actuating the end effector to form a channel in an interior region of the organ or vessel. 
 
     
     
       22. A method of treating an interior region of an organ or vessel comprising:
 providing an apparatus having an outer sheath, a guide member extending from the outer sheath, the guide member including carrying an end effector formed separately from the guide member for treating an interior region of the an organ or vessel; and a stabilization assembly, which is formed separately from the outer sheath, comprising a plurality of bands extendable from within the outer sheath, each one of the plurality of bands terminating in a spool that contacts an interior wall of the organ or vessel when extended; 
 inserting the apparatus within an organ or vessel; 
 extending the plurality of bands from the outer sheath to form spools, each spool contacting an interior wall of the organ or vessel to stabilize the guide member within the organ or vessel; 
 translating the guide member to dispose the end effector at a selected location position relative to a longitudinal axis of the apparatus; and 
 actuating the end effector to form a channel in an interior region of the organ or vessel. 
 
     
     
       23. An apparatus for performing transmyocardial revascularization, the apparatus comprising:
 a catheter shaft adapted for insertion into a patient's left ventricle;   a guide member carrying an end effector formed separately from the catheter shaft to treat an interior wall of the left ventricle, the end effector disposed for selective translation relative to a longitudinal axis of the catheter shaft; and   a stabilization assembly, formed separately from the catheter shaft and disposed in a distal region of the catheter shaft to alternate between a retracted position and an expanded position, that stabilizes the catheter shaft within the left ventricle during actuation of the end effector, wherein the stabilization assembly comprises a band movable from a first position, wherein the band is disposed adjacent to an exterior surface of the catheter shaft, to a second position, wherein the band forms a plurality of loops extending from the exterior surface of the catheter shaft.   
     
     
       24. An apparatus for performing transmyocardial revascularization, the apparatus comprising:
 a catheter shaft adapted for insertion into a patient's left ventricle;   a guide member carrying an end effector formed separately from the catheter shaft to treat an interior wall of the left ventricle, the end effector disposed for selective translation relative to a longitudinal axis of the catheter shaft; and   a stabilization assembly, formed separately from the catheter shaft and disposed in a distal region of the catheter shaft, to alternate between a retracted position and an expanded position, that stabilizes the catheter shaft within the left ventricle during actuation of the end effector, wherein the stabilization assembly comprises a wire movable from a first position, wherein the wire is partially retracted within a lumen of the catheter shaft, to a second position, wherein the wire forms a plurality of sinusoidal bends that contact and support the catheter shaft.   
     
     
       25. An apparatus for improving ischemic cardiac tissue, the apparatus comprising:
 a catheter shaft adapted for insertion into a patient's left ventricle;   a member carrying an end effector formed separately from the catheter shaft, wherein the end effector comprises a needle, to treat an interior wall of the left ventricle, the end effector disposed for selective translation relative to a longitudinal axis of the catheter shaft; and   a stabilization assembly, formed separately from the catheter shaft and disposed in a distal region of the catheter shaft, to alternate between a retracted position and an expanded position, that stabilizes the catheter shaft and member within the left ventricle during actuation of the end effector, wherein the stabilization assembly comprises a band movable from a first position, wherein the band is disposed adjacent to an exterior surface of the catheter shaft, to a second position, wherein the band forms a plurality of loops extending from the exterior surface of the catheter shaft.   
     
     
       26. An apparatus for improving ischemic cardiac tissue, the apparatus comprising:
 a catheter shaft adapted for insertion into a patient's left ventricle;   a member carrying an end effector formed separately from the catheter shaft, wherein the end effector comprises a needle, to treat an interior wall of the left ventricle, the end effector disposed for selective translation relative to a longitudinal axis of the catheter shaft; and   a stabilization assembly, formed separately from the catheter shaft and disposed in a distal region of the catheter shaft, to alternate between a retracted position and an expanded position, that stabilizes the catheter shaft and member within the left ventricle during actuation of the end effector, wherein the stabilization assembly comprises a wire movable from a first position, wherein the wire is partially retracted within a lumen of the catheter shaft, to a second position, wherein the wire forms a plurality of sinusoidal bends that contact and support the catheter shaft.   
     
     
       27. An apparatus for improving ischemic cardiac tissue, the apparatus comprising:
 a catheter shaft adapted for insertion into a patient's left ventricle;   a member carrying an end effector formed separately from the catheter shaft, wherein the end effector comprises a needle, to treat an interior wall of the left ventricle, the end effector disposed for selective translation relative to a longitudinal axis of the catheter shaft; and   a stabilization assembly, formed separately from the catheter shaft and disposed in a distal region of the catheter shaft, to alternate between a retracted position and an expanded position, that stabilizes the catheter shaft and member within the left ventricle during actuation of the end effector, wherein while the stabilization assembly is expanded, the end effector is capable of making a plurality of treatment sites through transition of the member without repositioning at least a portion of the catheter shaft within the left ventricle, wherein the stabilization assembly comprises at least one inflatable hoop member.