Methods and apparatus for guided transluminal interventions using vessel wall penetrating catheters and other apparatus

• US 20040147837A1
• Filed: 03/12/2004
• Published: 07/29/2004
• Est. Priority Date: 02/06/2001
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Lamson, Theodore C., Beckey, Brian R., Makower, Joshua, Kim, Isaac Han Joon, Macaulay, Patrick E
• Granted Patent: US 7,966,057 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• 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 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• 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 2090/3954 magnetic, e.g. NMR or MRI
• 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 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 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: A61B 5/6886 Monitoring or controlling distance between sensor and tissue
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/508 for non-human patients
• 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 8/5238 : for combining image data of patient, e.g. merging several images from different acquisition modes into one image for image registration algorithms G06T7/30
• CPC Class Codes: A61M 25/0105 : Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0662 : Guide tubes

Abstract

Electro-anatomically navigated catheters (e.g., mapping catheters, tissue penetrating catheters, delivery catheters and/or sheaths) and associated methods whereby devices or substances may be delivered to specific locations within a patient'"'"'s body and/or penetration tracts or passageways are formed at specific locations between anatomical structures. The catheters are equipped with sensors and a sensing field is created around the body of the patient. The sensor-equipped catheters are then inserted into the patient'"'"'s body and the position of the catheter-mounted sensor(s) is/are observed on a display representing the sensing field. Apparatus may be included for propelling the catheter(s) to specific locations and/or specific rotation orientations, within the patient'"'"'s body.

Claims

1. A navigable tissue penetrating catheter system comprising:

a field generator for generating a sensing field about at least a portion of the body of a human or veterinary patient;

a tissue penetrating catheter comprising a) a catheter body, b) a penetrator that is advanceable from the catheter body so as to penetrate outwardly through the wall of an anatomical conduit in which the catheter body is positioned to a target location and c) a sensor located on or in the catheter body in known positional relation to the penetrator, for sensing components of the sensing field and emitting signals indicative of the position and/or rotational orientation of the sensor within the sensing field; and

,

a sensor monitor which receives signals from the sensor and provides, on the basis of those signals, a prediction of the path upon which the penetrator will advance from the catheter.

2. A navigable tissue penetrating catheter system according to claim 1 wherein the field generator comprises at least one apparatus selected from the group consisting of:

at least one magnetic apparatus for creating a magnetic sensing field;

at least one ultrasound generating device for creating an ultrasonic sensing field;

at least one infrared apparatus for generating an infrared sensing field;

at least one x-ray device for creating an x-ray field;

at least one light-emitting device for creating a light energy field;

at least one microwave device for creating a microwave field;

at least one radiofrequency device for creating a radiofrequency field;

at least one microcurrent device for generating a microcurrent sensing field; and

,

possible combinations thereof.

3. A navigable tissue penetrating catheter system according to claim 1 wherein the sensor is mounted on or in the catheter body in fixed longitudinal position and fixed rotational orientation relative to the trajectory on and/or direction in which the penetrator will advance from the catheter body, thereby enabling the operator to use the indicia provided by the processing and indicia-providing means to position and rotationally orient the catheter within the patient'"'"'s body such that, when the penetrator is subsequently advanced from the catheter body, the penetrator will penetrate outwardly through the wall of the anatomical conduit in which the catheter body is positioned and to the target location.

4. A system comprising a navigable tissue penetrating catheter according to claim 1 further in combination with a sensor-equipped mapping catheter, said sensor-equipped mapping catheter comprising an elongate, flexible catheter body having a sensor positioned on or in the catheter body, said mapping catheter being movable through the target location such that the sensor of the mapping catheter may be used to obtain data points mapping the target location or to act as a marker of the target location.

5. A system according to claim 4 wherein the mapping catheter further comprises a centering apparatus for centering a portion of the mapping catheter in or on which the sensor is located within an anatomical conduit.

6. A system according to claim 5 wherein the centering apparatus comprises a centering balloon.

7. A system according to claim 4 wherein the centering apparatus comprises a plurality of centering arms that deploy from the mapping catheter body to center said portion of the mapping catheter within the anatomical conduit.

24. A navigable catheter system according to claims 1 or 15 wherein the sensor mounted on the catheter comprises an an emitter or transmitter and the sensor monitor comprises at least one detector capable of detecting signals from the emitter or transmitter and determining the 3 dimensional position and/or rotational orientation of the catheter within the patient'"'"'s body.

25. A navigable tissue penetrating catheter system according to claim 1 or 15 wherein the sensor is positioned on the catheter body.

26. A navigable tissue penetrating catheter system according to claim 1 or 15 wherein the sensor is positioned on the tissue penetrator.

27. A navigable tissue penetrating catheter system according to claim 1 or 15 wherein the sensor is positioned on an apparatus that is inserted through or into the catheter.

28. A navigable tissue penetrating catheter system according to claim 27 wherein the sensor is positioned on a guidewire that is insertable into or through the catheter.

29. A navigable tissue penetrating catheter system according to claim 1 or 15 wherein the sensing field and the sensor monitor are adapted to propel the catheter body, penetrator or a device that has been inserted through or around the tissue penetrator, to a specific 3-dimensional location within the patient'"'"'s body.

30. A navigable tissue penetrating catheter system according to claim 1 or 15 wherein the sensing field and the sensor monitor are adapted to propel the catheter body, penetrator or a device that has been inserted through or around the tissue penetrator, to a specific rotational orientation within the patient'"'"'s body.

31. A navigable tissue penetrating catheter system according to claim 1 or 15 wherein the sensor is mounted in substantially fixed spacial relation to the penetrator.

32. A navigable tissue penetrating catheter system according to claim 31 wherein the penetrator is initially positioned in a penetrator housing within the catheter and wherein the sensor is attached to the penetrator housing such that the penetrator housing and sensor are maintained in substantially fixed spacial relation to one another.

33. A navigable tissue penetrating catheter system according to claim 1 or 15 further comprising an imaging apparatus for imaging anatomical structures.

34. A navigable tissue penetrating catheter system according to claim 33 further comprising a monitor for displaying an image received form the imaging apparatus along with an indication of the sensor position within the sensing field.

35. A navigable tissue penetrating catheter system according to claim 33 wherein the inaging apparatus comprises an intravascular ultrasound imaging transducer.

8. A method for using a navigable tissue penetrating catheter system in a human or veterinary patient to penetrate from a location within the lumen of a luminal anatomical conduit that has a wall, outwardly through the wall of the anatomical conduit and to a target location, said method comprising the steps of:

(A) providing a navigable tissue penetrating catheter system comprising i) a field generator for generating a sensing field about at least a portion of the body of a human or veterinary patient;

ii) a tissue penetrating catheter comprising a) a catheter body, b) a penetrator that is advanceable from the catheter body so as to penetrate outwardly through the wall of an anatomical conduit in which the catheter body is positioned to a target location and c) a sensor mounted on or in the catheter body for sensing components of the sensing field and emitting signals indicative of the position and/or rotational orientation of the sensor within the sensing field; and

, iii) a sensor-monitor adapted to receive signals from the sensor and to provide, on the basis of those signals, indicia of the position and/or rotational orientation of the sensor within the sensing field.

(B) using the field generator to create a sensing field;

(C) positioning at least the portion of the patient'"'"'s body in which the target location is located within the sensing field;

(D) inserting the tissue penetrating catheter into the patient'"'"'s body and advancing the catheter into an anatomical conduit located within the sensing field;

(E) actuating the sensor of the tissue penetrating catheter such that signals from the sensor are received by the sensor monitor;

(F) using the indicia provided by the sensor monitor to position and/or rotationally orient the catheter body within the anatomical conduit such that, when the penetrator is subsequently advanced from the catheter body, it will penetrate outwardly through the wall of the anatomical conduit in which the catheter body is positioned and to the target location; and

,

(G) advancing the penetrator from the catheter body, through the wall of the anatomical conduit in which the catheter body is positioned and to the target location.

9. A method according to claim 8 wherein the anatomical conduit in which the catheter body is positioned is an artery;

vein;

urethra;

ureter;

fallopian tube;

esophagus;

trachea;

lymphatic;

nasal passage;

GI tract;

chamber of the heart;

ventricle of the brain or a man made interstitial space, channel, tunnel or pocket.

10. A method according to claim 8 wherein the target location is selected from the group consisting of:

an artery;

a vein;

a location within the parenchyma of an organ;

a cavity within an organ;

a body cavity;

an aberrant anatomical structure

an anatomical malformation;

a location to which a drug, substance, flow of energy or apparatus is to be delivered; and

,

a location from which a sample, reading, image or diagnostic information is to be obtained.

11. A method according to claim 8 further comprising the steps of:

providing a sensor-equipped mapping catheter; and

,

using the sensor equipped mapping catheter to map or mark the target location.

12. A method according to claim 11 further comprising the step of:

displaying the map of the target location to the operator.

13. A method according to claim 12 wherein the map of the target location is displayed by the sensor monitor along with the indicia received from the sensor of the tissue penetrating catheter.

14. A method according to claim 8 further comprising the steps of:

positioning a body-mounted sensor in or on the patient'"'"'s body in a known positional relationship to an anatomical landmark,

obtaining a three dimensional scan of at least the portion of the patients body in which the body-mounted sensor and the target location are located;

displaying the three dimensional scan to the operator; and

,

actuating the body-mounted sensor during performance of Steps F-G of the method, thereby enabling the operator to discern the position the body-mounted sensor and to ascertain the position of the target location within the sensing field on the basis of the previously obtained three dimensional scan.

15. A navigable delivery catheter system for delivering a radially expandable implantable device to a target location within the body of a human or veterinary patient, said system comprising:

a field generator for generating a sensing field about at least a portion of the body of the patient, said sensing field comprising field components that are detectable by a sensor;

a delivery catheter comprising a) a catheter body and b) a sensor mounted on or in the catheter body sensing components of the sensing field and emitting signals indicative of the position and/or rotational orientation of the sensor within the sensing field;

an implantable article mounted in or on the delivery catheter and deployable from the catheter such that it separates from and is free of the catheter body; and

,

a signal monitor which receives signals from the sensor and provides, on the basis of those signals, indicia of the position and/or rotational orientation of the sensor within the sensing field.

16. A navigable delivery catheter system according to claim 15 wherein the field generator comprises one or more field generating apparatus selected from the group consisting of:

at least one magnet for creating a magnetic sensing field;

at least one ultrasound generating device for creating an ultrasonic sensing field;

at least one infrared apparatus for generating an infrared sensing field;

at least one x-ray device for creating an x-ray field;

at least one light-emitting device for creating a light energy field;

at least one microwave device for creating a microwave field;

at least one radiofrequency device for creating a radiofrequency field;

at least one microcurrent device for generating a microcurrent sensing field; and

,

possible combinations thereof.

17. A navigable delivery catheter system according to claim 15 wherein the implantable article comprises a radially expandable implantable device.

18. A navigable delivery catheter system according to claim 17 wherein the radially expandable implantable device comprises a stent.

19. A navigable delivery catheter system according to claim 17 wherein the radially expandable implantable device comprises stent-graft.

20. A navigable delivery catheter system according to claim 17 wherein the radially expandable implantable device comprises a connector that is implantable between openings formed in the walls of two blood vessels to maintain a blood flow channel between the blood vessels.

21. A navigable delivery catheter system according to claim 17 wherein the radially expandable implantable device comprises a radially expandable tube graft.

22. A navigable delivery catheter system according to claim 16 wherein the implantable article comprises a substance delivery device.

23. A method for using a navigable delivery catheter system to implant a radially expandable, implantable device in a predetermined rotational orientation at a target location within the patient'"'"'s body, said method comprising the steps of:

(A) providing a navigable delivery catheter system that comprises i) a field generator for generating a sensing field about at least a portion of the body of the patient, said sensing field comprising field components that are detectable by a sensor;

ii) a delivery catheter comprising a) a catheter body and b) a sensor mounted on or in the catheter body sensing components of the sensing field and emitting signals indicative of the position and/or rotational orientation of the sensor within the sensing field;

iii) a radially expandable implantable device mounted in or on the delivery catheter in a radially collapsed configuration and deployable from the catheter such that it will assume a radially expanded configuration free of the catheter body; and

, iv) a signal monitor which receives signals from the sensor and provides, on the basis of those signals, indicia of the position and/or rotational orientation of the sensor within the sensing field.

(B) using the field generator to create a sensing field;

(C) positioning at least the portion of the patient'"'"'s body in which the target location is located within the sensing field;

(D) inserting the navigated delivery catheter with the radially expandable device mounted thereon or therein, into the patient'"'"'s body and advancing it into an anatomical conduit located within the sensing field;

(E) actuating the sensor mounted on or in the catheter body such that signals from the sensor are received by the sensor monitor;

(F) using the indicia provided by the sensor monitor to position the catheter at the target location and/or to rotationally orient the catheter such that, when the radially expandable device is subsequently deployed from the catheter it will assume its radially expanded configuration and will become implanted at the target location in the desired rotational; and

,

(G) deploying the radially expandable implantable device from the delivery catheter such that it radially expands and becomes implanted at the target location in the desired rotational orientation.

36. A sensor-equipped sheath for guiding the insertion of an elongate catheter or apparatus said sensor-equipped sheath comprising:

an elongate, flexible, tubular sheath body having a side wall and at least one lumen extending longitudinally through at least a portion thereof;

a side aperture formed in the side wall of the sheath body and communicating with the lumen of the sheath;

an anchoring apparatus for anchoring the portion of the sheath body wherein the side aperture is located in a substantially fixed position within the lumen of a body conduit;

a rotation inhibiting surface associated with the sheath lumen such said rotation inhibiting surface engages an elongate catheter or apparatus that has been inserted into the sheath lumen and advanced to a position adjacent the side aperture, thereby preventing the catheter or apparatus from undergoing substantial rotational movement relative to the sheath.

37. A sensor-equipped sheath according to claim 36 having a plurality of said sensors.

38. A sensor-equipped sheath according to claim 36 wherein the anchoring apparatus comprises an inflatable balloon.

39. A system comprising a sensor-equipped sheath according to claim 36 in combination with an elongate catheter or apparatus that is insertable into the sheath lumen and advanced to a position adjacent the side aperture, said elongate catheter or apparatus being configured such that it engages the rotation inhibiting surface and is thereby prevented from undergoing substantial rotational movement relative to the sheath.

40. A system according to claim 39 wherein the elongate catheter or apparatus comprises a tissue penetrating catheter having an elongate catheter body configured to engage the rotation inhibiting surface and a tissue penetrator that is advanceable through the side aperture of the sheath.