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

• US RE43,300 E1
• Filed: 04/18/2002
• Issued: 04/03/2012
• Est. Priority Date: 12/02/1996
• Status: Expired due to Term

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Saadat, Vahid, Ream, John H.
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US10/126,295
• Time in Patent Office: 3,638 Days
• Field of Search: 606/1, 606/108, 606/167, 606/170, 606/171, 606/180, 606/185, 606/2, 606/159, 606/7, 606/15, 606/181
• US Class Current: 606/159
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00208 actively driven, e.g. by a motor
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00738 : Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00839 : Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00916 : with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/1435 : Spiral
• CPC Class Codes: A61B 2018/1437 : whereby the windings of the spiral touch each other such as to create a continuous surface
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/034 : abutting on parts of the device itself
• CPC Class Codes: A61B 2090/0811 : for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration
• 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 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61M 25/0084 : being one or more injection needles

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.

Claims

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.