US20050240116A1 - Device for sensing parameters of a hollow body organ - Google Patents
Device for sensing parameters of a hollow body organ Download PDFInfo
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- US20050240116A1 US20050240116A1 US11/145,497 US14549705A US2005240116A1 US 20050240116 A1 US20050240116 A1 US 20050240116A1 US 14549705 A US14549705 A US 14549705A US 2005240116 A1 US2005240116 A1 US 2005240116A1
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- Prior art keywords
- guidewire
- probe
- sensor
- temperature
- hollow body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
- A61B5/053—Measuring electrical impedance or conductance of a portion of the body
- A61B5/0538—Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
- A61B5/015—By temperature mapping of body part
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
- A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
- A61B5/1077—Measuring of profiles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09116—Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
Definitions
- This invention relates generally to invasive medical devices and more particularly to devices for sensing the profile of the interior wall of a hollow body organ such as a blood vessel.
- Angiography is one such procedure in which X-ray images of blood vessels are generated after a radio-opaque dye is injected into the blood stream. This procedure is capable of locating plaque in an artery, but is not capable of revealing whether the plaque is the inflamed, unstable type.
- the temperature at multiple locations along an arterial wall were measured in people with and without atherosclerotic arteries.
- the temperature was substantially homogeneous wherever measured: an average of 0.65 degrees F. above the oral temperature.
- the temperature of their plaques averaged 0.19 degrees F. above the temperature of their unaffected artery walls.
- the average temperature increase in people with unstable angina was 1.23 degrees F.
- the increase was 2.65 degrees F. in people who had just suffered a heart attack.
- temperature variation at different points at the plaque site itself was found to be greatest in people who had just had a heart attack. There was progressively less variation in people with unstable angina and stable angina.
- cavity wall profiling apparatus are comprised of temperature indicating probes such as thermocouples, thermistors, fluorescence lifetime measurement systems, resistance thermal devices and infrared measurement devices.
- a device for sensing the temperature profile of a hollow body organ.
- the device includes a hollow guidewire, a temperature sensor disposed on or within the guidewire, and an optional catheter through which the guidewire may be delivered.
- the guidewire has a relaxed configuration externally of the catheter that is formed to provide contact with the wall of the hollow body organ.
- the guidewire also has a contracted configuration internally of the catheter and is of a lesser diameter than the catheter.
- the device is used by contracting the guidewire elastically and constraining the guidewire within the catheter.
- the catheter and guidewire are advanced to a region of interest in a hollow body organ.
- the catheter is withdrawn to expose the distal portion of the guidewire which may then reconfigure into a relaxed configuration to make contact with the hollow body organ.
- the catheter may be held stationary relative to the hollow body organ and the guidewire may be advanced until the distal portion of the guidewire is exposed to reconfigure.
- the guidewire is moved longitudinally and rotated, continuously or continually, to sense the temperature of the hollow body organ at multiple locations.
- the catheter may be omitted entirely from the deployment procedure.
- the guidewire may simply be inserted and advanced within the hollow body organ to the tissue region of interest while in its relaxed configuration.
- an introducer and/or guide catheter may be positioned percutaneously through the skin into the body of a patient and the guidewire may simply be inserted without the use of a separate catheter directly into, e.g., the vasculature, via the introducer.
- the guidewire may be inserted into the body while the probe is in its relaxed configuration. Except when initially introduced or withdrawn through the introducer into the body, the probe may remain in its relaxed configuration.
- the probe or guidewire includes a hollow, flexible, elongate stem having proximal and mid portions and a distal end portion which terminates in a coil having at least a tip segment thereof biased away from the rotational axis of the probe at an angle between approximately 30° to 75° relative to the stem longitudinal axis, and more preferably between approximately 40° to 60°, and having a torque response of no more than about 0.4 ozf in.
- a transducer is mounted to the coil
- a connector is located at the proximal end portion of the stem, and at least one conductor connects the transducer to the connector.
- An elongate mandrel having a bent tip extends through the coil and provides the coil with its bent configuration.
- the probe may be configured such that the coil rotates about the proximal end portion of the stem in response to the rotation of an actuation shaft extending through the proximal end portion of the stem.
- the proximal end portion of the stem can also define a sheath slidable on the actuation shaft and operably coupled to the coil for allowing the axial reciprocal movement of the coil.
- An actuator may surround the proximal end portion of the stem and be adapted to provide both rotational and axial or longitudinal movement to the stem to allow the sensor to travel in a helical path through the desired body organ.
- the materials and/or shapes of the proximal, mid and distal end portions of the stem may be varied to provide a flexural rigidity ratio between the coil and the mid portion and the proximal end portion in the range of about 1:(4 to 4,400):(110 to 13,000), respectively, and more preferably 1:400:1200, respectively.
- various impedance measurement devices or sensors may also be provided in addition to the thermal sensors or transducers mounted in the tip segment.
- the actuator which controls the rotational and axial movement of the probe may be constructed as a handle.
- the probe may be attached via an optionally removable chuck to the handle and both the chuck and the probe may be electrically connected to an amplifier positioned within the handle.
- the amplifier is preferably configured to rotate while maintaining electrical contact with the probe.
- various motors under the control of a motor controller are used to control both the rotational and axial movement of the probe.
- a processor e.g., a computer, is used to not only track/control the positioning and movement of the probe, but is also used to process the signals acquired by the probe.
- the rate and pitch at which the vessel walls are scanned may be automatically varied by the processor to increase the measured sampling resolution upon the determination of a threshold measurement value being exceeded.
- an alternative embodiment may incorporate an intervening chuck and connector cable to allow for the manual manipulation of the probe.
- This embodiment utilizes a separate chuck which is used to receive the probe. The chuck may then be connected to the probe actuator via the connector cable.
- the intervening chuck and connector cable may remain attached to the probe actuator or they may be connected when manual manipulation is desired.
- the physician or surgeon may simply rotate and/or axially move the probe via the intervening chuck while maintaining the sterility of the probe and probe actuator.
- the intervening chuck may be omitted altogether and the probe may simply be attached to a connector cable which is configured to directly receive the probe connector.
- FIG. 1 is a perspective view of an embodiment of the present invention
- FIG. 2 is a longitudinal sectional view of an arterial hollow body organ in which the embodiment of FIG. 1 , also shown in longitudinal section, is deployed;
- FIG. 3A is a longitudinal sectional view of a guidewire probe variation in which the sensor is positioned off-center or off-axis;
- FIG. 3B is a cross-sectioned detail view of the probe of FIG. 3A ;
- FIG. 4A is a longitudinal sectional view showing an example of a mapping or scanning path in which the rotational and withdrawal rates are constant;
- FIG. 4B is a longitudinal sectional view showing an example of a mapping or scanning path in which the rotational and/or withdrawal rates may be varied to provide for regions of higher and lower measurement resolution;
- FIG. 5 is a longitudinal sectional view of an arterial hollow body organ in which another preferred embodiment of the present invention, also shown in longitudinal section, is deployed;
- FIG. 6 is a perspective view of yet another preferred embodiment of the present invention.
- FIG. 7 is a perspective view, partially in section, of a further preferred embodiment of the present invention.
- FIG. 8 is a perspective view of yet another preferred embodiment of the present invention.
- FIG. 9 is a longitudinal sectional view of an arterial hollow body organ in which another preferred embodiment of the present invention, shown in perspective, is deployed;
- FIG. 10 is a perspective view of a further preferred embodiment of the present invention.
- FIG. 11 is a longitudinal sectional view showing another variation of a guidewire having at least two bends
- FIG. 12 is a longitudinal sectional view showing another variation of a guidewire having multiple bends and at least two sensors;
- FIGS. 13A and 13B are longitudinal views showing alternative embodiments in which a guidewire probe may reconfigured by active actuation into a shape having a bend portion;
- FIGS. 14A and 14B are longitudinal views showing alternative embodiments in which a guidewire probe may reconfigured by active actuation into a shape having a radially extended portion;
- FIGS. 15A and 15B are longitudinal views showing alternative embodiments in which a guidewire probe may reconfigured by active actuation into a shape having at least two bend portions;
- FIG. 16 is a longitudinal view showing another embodiment in which guidewire probe may have at least two radially extended probes linearly spaced apart from one another;
- FIG. 17 is a perspective view of another preferred embodiment of the present invention.
- FIG. 18 is a longitudinal sectional view of an arterial hollow body organ in which yet another preferred embodiment of the present invention, shown in perspective, is deployed;
- FIG. 19 is a longitudinal sectional view showing a variation in which impedance measurements may be taken to determine whether sufficient contact exists between the guidewire and the vessel wall;
- FIG. 20 is a detailed view of the probe of FIG. 19 showing a variation on the dual-sensor location
- FIG. 21A is a perspective view of another device embodiment of the present invention.
- FIG. 21B is a schematic representation of a variation of a signal processor and controller connected to a probe actuator
- FIG. 22 is an exploded, broken perspective view of the probe of the device of FIG. 21A ;
- FIG. 23 is an exploded, broken perspective view of an alternate embodiment of the probe of the device of FIG. 21A ;
- FIG. 24 is an exploded, broken perspective view of yet another alternate embodiment of the probe of the device of FIG. 21A ;
- FIG. 25A is a cross-sectioned perspective view of a proximal end of a probe
- FIG. 25B is a side view of a variation on the probe in which the connector region is positioned near the mid-section of the wire;
- FIG. 26 is a schematic illustration of one variation of an actuator assembly which may be used to provide the rotational and axial movement for the probe;
- FIG. 27 is a side view of one embodiment of the probe actuator with the cover partially removed;
- FIG. 28 is a perspective view of the probe actuator of FIG. 27 with some components removed for clarity;
- FIG. 29 is a perspective view of an alternate embodiment of the probe actuator with the cover partially removed;
- FIG. 30A is a side view of an embodiment of the probe chuck
- FIG. 30B is an electrical schematic showing one variation of the chuck from FIG. 30A which may be self-calibrated;
- FIGS. 31A and 31B are perspective and end views, respectively, of an embodiment of a rotatable amplifier.
- FIG. 32 is a perspective view of an alternate embodiment having a manually manipulatable assembly.
- FIG. 1 shows a device 10 for profiling the wall of a hollow body organ.
- Device 10 includes a lumened catheter 12 having a central lumen 14 , a hollow guidewire 16 that defines a conduit comprising a metal wire 18 or the like in the shape of a coil defining a central lumen (not shown), and a thermal sensor 20 disposed at the terminal end of the distal portion of guidewire 16 .
- Conventional conductors or other signal carrying structures are provided to convey signals from the thermal sensor 20 along guidewire 16 and out of the proximal portion of guidewire 16 for connection to appropriate signal processing apparatus that converts the signals to a temperature indication.
- Thermal sensor 20 can be, e.g., a thermocouple, a thermistor, an infrared radiation sensor, fiberoptic oxygen sensor, ultrasonic transducer, impedance sensor, pH sensor, mechanical force sensor (e.g., strain gauge), etc., for example, and is secured by appropriate mechanical or adhesive means to the terminal end of guidewire 16 .
- radio-opaque materials e.g., platinum, gold, etc., may be formed in epoxy materials which may be used to attach sensor 20 to guidewire 16 .
- radio-opaque marker bands 19 may be formed proximally of sensor 20 along guidewire 16 to assist in denoting the location of sensor 20 during a measurement procedure.
- Typical thermocouples which can be used may include T-type thermocouples (Copper and Constantan) having thermoelectric conversion coefficients of about 40.3 ⁇ V/° C.
- Hollow guidewire 16 is made of thin wire 18 wound, for example around a mandrel, into small helical coils of desired diameter that lie tightly adjacent one another to form a hollow tube having a central passageway or lumen therethrough.
- Guidewire 16 may have an outer diameter which is uniform along its length; alternatively, the diameter may be varied, e.g., having diameter decrease proximally along the length of guidewire 16 or having sections of differing guidewire 16 diameters along the length.
- Guidewire 16 has an outer diameter somewhat less than the inner diameter of catheter 12 to permit guidewire 16 to slide freely within the lumen 14 of catheter 12 .
- guidewire 16 in its relaxed configuration, is shaped in the form of a bend 22 at the distal portion thereof, the bend 22 being spaced from the terminal end of guidewire 16 at which thermal sensor 20 is disposed. Consequently, thermal sensor 20 is displaced radially from the longitudinal axis 24 of guidewire 16 and catheter 12 when guidewire 16 is in the relaxed, bent configuration.
- guidewire 16 in the relaxed, bent configuration can be made to rotate about axis 24 , continuously or continually, depending on the response time for the sensor, thereby causing thermal sensor 20 to traverse a circumferential or helical path about axis 24 while providing temperature information.
- Guidewire 16 can be deformed elastically into a substantially straight configuration, i.e., without bend 22 , under force. When the force is removed, guidewire 16 returns to the relaxed, bent configuration.
- Guidewire 16 can be constructed of spring steel that can be deformed into a relatively straight configuration when withdrawn into catheter 12 , but which springs back to its bent configuration when extruded from catheter 12 and released from constraint. Another way is to construct guidewire 16 of superelastic nitinol and take advantage of the martensitic transformation properties of nitinol. Guidewire 16 can be inserted into catheter 12 in its straight form and kept cool within the catheter by the injection of cold saline through catheter 12 and over guidewire 16 . Upon release of guidewire 16 into the bloodstream, it will warm up and change to its austenite memory shape based on the well-known martensitic transformation by application of heat and putting the material through its transformation temperature.
- Guidewire 16 can also be made out of a composite such as a nitinol tube within the guidewire structure. In this fashion, the martensitic or superelastic properties of nitinol can be combined with the spring steel characteristics of the spring and lead to a desirable composition.
- Other suitable materials for guidewire 16 include copper, constantin, chromel or alumel.
- FIG. 2 shows device 10 deployed in a hollow body organ comprising an arterial blood vessel 26 having an endothelium 28 forming the inner wall thereof. Only the distal portion of guidewire 16 that extends beyond catheter 12 is shown. Electrical conductors 32 extend through lumen 30 of guidewire 16 . Conductor 32 is electrically insulated from the coils 18 of guidewire 16 so that guidewire 16 comprises one conductor and conductor 32 comprises another conductor or lead of the thermal sensor 20 which can be a thermocouple or thermistor. The conductors convey signals from the thermal sensor 20 to the proximal end of guidewire 16 for connection to appropriate signal processing apparatus that converts the received signals to a temperature indication.
- thermal sensor 20 is shown as extending along the center of the distal end of guidewire 16 , sensor 20 is preferably positioned off-center or off-axis from the longitudinal axis of the guidewire. As shown in FIG. 3A , as guidewire 11 traverses along wall 28 within vessel 26 , a lesion or obstruction 13 may force distal portion 23 to bend radially inward towards the longitudinal axis along bend 22 . Placement of thermal sensor 21 off-axis may allow for continuous contact and/or sensing between sensor 21 and wall 28 or lesion 13 despite having the center tip of distal portion 23 bent inwardly.
- FIG. 3B shows a cross-sectioned detail view of distal portion 23 where sensor 21 , connected to conductors 27 , is positioned off-axis near the distal tip.
- the guidewire 16 and thermal sensor 20 of device 10 are inserted into the lumen 14 of catheter 12 from the proximal end, thereby constraining guidewire 16 in a substantially straight configuration with the thermal sensor 20 near the distal end of catheter 12 .
- access to the blood vessel 26 is obtained surgically.
- Catheter 12 with guidewire 16 and thermal sensor 20 disposed within, is advanced through the blood vessel 26 to the region of interest.
- Catheter 12 is slowly withdrawn while guidewire 16 is secured against movement relative to the patient such that guidewire 16 emerges from the distal end of catheter 12 and reverts to the relaxed, bent configuration within the blood vessel 26 .
- catheter 12 may be secured against movement relative to the patient and guidewire 16 may be advanced distally until it emerges from the distal end of catheter 12 .
- Guidewire 16 remains substantially fixed in the axial direction relative to the blood vessel 26 as catheter 12 is withdrawn, with the re-formed bent distal portion of guidewire 16 springing gently radially outwardly into contact with the vessel wall 28 .
- catheter 12 may be omitted entirely from the deployment procedure. Rather, guidewire 16 may simply be inserted into the patient while in its relaxed configuration and advanced within the hollow body organ to the tissue region of interest. With catheter 12 omitted, the guidewire 16 may be advanced in its relaxed configuration, as mentioned, or it may be inserted within the patient in its substantially straightened configuration and be allowed to reconfigure itself by heating up while being advanced.
- thermal sensor 20 With guidewire 16 exposed and thermal sensor 20 lying in contact with the wall 28 of blood vessel 26 , the thermal sensor 20 senses the localized temperature of the vessel wall 26 at the region where the thermal sensor 20 is situated.
- thermal sensor 25 can be made to traverse a helical path around the inner wall 28 of the blood vessel 26 , permitting temperature measurements to be taken at intervals of different regions of the vessel wall 28 .
- rotation can be intermittent or continuous, as needed.
- the location of the thermal sensor 20 relative to the distal end of the catheter 12 can be determined as a function of time, so that a temperature profile of the blood vessel 26 can be mapped, provided the response time of the thermal sensor is relatively short.
- mapping or scanning path 29 i.e., the path traced by sensor 21 against vessel wall 28 as guidewire 11 is rotated and withdrawn, may be formed at a uniform rate.
- the pitch of mapping or scanning path 29 may be tightened or shortened to provide for closer measurement readings, thereby producing a higher resolution profile.
- the device may be configured to automatically provide for lower resolution readings in non-critical areas and higher resolution readings in critical areas, e.g., where the temperature readings are elevated.
- One method of configuring the device may be to detect when a threshold temperature difference value between set variables, e.g., 0.05° to 0.5° C., is detected. When this threshold difference value is exceeded, this may be an indication of a lesion present within the tissue and the scanning path 29 of guidewire 11 may accordingly be tightened to produce the higher resolution profile.
- a threshold temperature difference value between set variables, e.g., 0.05° to 0.5° C.
- the guidewire 11 may be rotated and withdrawn at an initial constant pitch.
- scanning path 29 may provide for a relatively lower resolution temperature profile along region 31 .
- the pitch of scanning path 29 may be automatically reduced via a connected processor to produce the tightened scanning profile and thereby result in a higher resolution along region 33 .
- guidewire 11 may be configured to then automatically resume a lower resolution profile, as seen along region 35 .
- the guidewire 16 may be withdrawn fully into catheter 12 , re-sheathed and constrained in a substantially straight configuration, if catheter 12 is utilized.
- Catheter 12 or guidewire 16 alone can then either be withdrawn from the blood vessel 26 or repositioned to another region of interest within the hollow body organ for further mapping of the temperature profile at that region.
- FIG. 5 shows a second preferred embodiment of a device 10 ′ for profiling the wall of a hollow body organ.
- Device 10 ′ can be deployed in a hollow body organ in a manner similar to the embodiment of device 10 shown in FIGS. 1 and 2 and described above with respect to structure and use.
- Components of device 10 ′ that are similar in structure and function to corresponding components of device 10 of FIGS. 1 and 2 are designated by like primed numerals.
- the description of device 10 above applies also to device 10 ′ unless described otherwise below.
- Device 10 ′ includes a second thermal sensor 36 disposed at the outside of bend 22 ′ and exposed for contact with the inner wall 28 ′ of vessel 26 ′.
- a second electrical conductor 38 is electrically insulated the conductor 32 ′ and from the wire 18 ′ of guidewire 16 ′ so that guidewire 16 ′ comprises one conductor and conductor 38 comprises another conductor of the thermocouple or thermistor of thermal sensor 36 for conveying signals from the thermal sensor 36 to the proximal end of guidewire 16 for connection to appropriate signal processing apparatus that converts the signals to a temperature indication.
- Wire 18 ′ of guidewire 16 ′ is a conductor common to thermal sensors 20 ′ and 36 .
- Device 10 ′ of FIG. 5 can be used in a manner substantially similar to the manner of use described above with respect to the devices above, except that thermistors 20 ′ and 38 simultaneously traverse intertwined helical paths in contact with the inner wall 28 ′ of hollow body organ 26 ′. Consequently, the temperature profile of the inner wall 28 ′ can be mapped more quickly because data can be gathered from different locations simultaneously.
- FIG. 6 shows yet another preferred embodiment of a device 210 for profiling the wall temperature of a hollow body organ.
- Device 210 can be deployed in a hollow body organ in the manner described above with respect to the embodiments described above.
- Components of device 210 that are similar in structure and function to corresponding components of the devices above are designated by like reference numerals in the 200 series but having the same last two digits. The description of device 10 above applies also to device 210 unless described otherwise below.
- Device 210 of FIG. 6 includes one thermal sensor 40 disposed at the outside of a dogleg bend 42 that is spaced distally from bend 222 and from the terminal end of guidewire 216 .
- Thermal sensor 40 is exposed for contact with the inner wall 228 of vessel 226 .
- An electrical conductor (not shown) is electrically insulated from the wire 218 of guidewire 216 so that guidewire 216 comprises one conductor and the electrical conductor comprises another conductor of the thermocouple or thermistor of thermal sensor 40 for conveying signals from the thermal sensor 40 to the proximal end of guidewire 216 for connection to appropriate signal processing apparatus that converts the signals to a temperature indication.
- device 210 includes only a thermistor at bend 42 and no thermistor at the terminal end of guidewire 216 or at bend 222 .
- Device 210 of FIG. 6 can be used in a manner substantially similar to the manner of use described above with respect to the devices of FIGS. 1 to 5 .
- FIG. 7 shows a further preferred embodiment of a device 310 for profiling the wall temperature of a hollow body organ.
- Device 310 can be deployed in a hollow body organ in the manner described above with respect to the embodiments of the devices described above.
- Components of device 310 that are similar in structure and function to corresponding components of the above-described devices are designated by like reference numerals. The description of device 10 above applies also to device 310 unless described otherwise below.
- Device 310 of FIG. 7 rather than having externally exposed thermal sensors as in the embodiments above, includes a thermal sensor 50 disposed within the lumen 330 of hollow guidewire 316 and in thermal contact with the coiled wire 318 that comprises guidewire 316 .
- Thermal sensor 50 is located at bend 52 that is spaced between bend 322 and the distal end of guidewire 316 .
- Guidewire 316 also includes bend 54 between bend 52 and the distal end of guidewire 316 . Bends 322 , 52 and 54 together cause the distal portion of guidewire 316 to assume the shape of a question mark when in a relaxed configuration. In such a configuration, bend 52 and bend 54 contact opposite sides of the inner wall of the hollow body organ.
- guidewire 316 urges bend 52 in contact with the hollow body organ.
- Insulated electrical conductors 56 and 58 are operatively connected to the thermocouple or thermistor of thermal sensor 50 for conveying signals from the thermal sensor 50 to the proximal end of guidewire 316 for connection to appropriate signal processing apparatus that converts the signals to a temperature indication.
- Device 310 of FIG. 7 can be used in a manner substantially similar to the manner of use described above with respect to the devices.
- FIG. 8 shows another embodiment of a device 410 for profiling the wall temperature of a hollow body organ.
- Device 410 is an alternative configuration of the device 310 of FIG. 7 , in which bend 454 extends in a direction opposite to that of bend 54 , such that the terminal end portion of guidewire 416 extends axially away from catheter 412 .
- Bend 454 serves a purpose similar to that of bend 54 of device 310 of FIG. 7 , i.e., to assure that bend 452 , at which thermal sensor 450 is located, remains in contact with the inner wall of the hollow body organ when deployed therein.
- FIG. 9 shows yet another embodiment of the present invention.
- Temperature sensing device 510 is carried by hollow guidewire 516 which extends outwardly from the distal end of catheter 512 and includes thermal sensor 550 , e.g., a thermistor at bend 552 spaced from bend 522 which is situated between the sensor-carrying bend 552 and the distal end portion of catheter 512 .
- the distal end portion of guide wire 516 terminates in a generally crescent-shaped loop and is rotatable, continuously or continually, as desired, to sense the temperature of the endothelium 528 lining the wall of blood vessel 526 in the vicinity of plaque deposit 592 .
- FIG. 10 shows a further embodiment of a device 610 for profiling the wall temperature of a hollow body organ.
- Device 610 comprises another alternative configuration of the device 310 of FIG. 7 , in which guidewire 616 is shaped as a plurality of loops 60 with a plurality of thermal sensors 62 located within guidewire 616 at each location along the loops 60 that would contact the wall of the hollow body organ when disposed therein.
- FIG. 11 shows another embodiment of guidewire 618 which has two bends disposed within vessel 26 .
- Guidewire 618 may be formed into a device which is configured to securely place the distal sensing tip against vessel wall 28 .
- a contact region 621 is formed between guidewire 618 and vessel wall 28 by first bend 619 .
- Guidewire 619 may then be configured with second bend 620 to extend sensor 622 against wall 28 .
- sensor 622 may be placed securely against wall 28 during rotation and withdrawal.
- FIG. 12 shows a similar variation in guidewire 623 which may form first and second contact regions 624 , 625 between first and second sensors 626 , 627 , respectively, against vessel wall 28 .
- This variation may have at least two sensors 626 , 627 formed to simultaneously detect opposite sides of wall 28 during a sensing procedure.
- This configuration may also allow for guidewire 623 to ensure contact between wall 28 and sensors 626 , 627 since the two opposing contact regions 624 , 625 may press in opposing directions against wall 28 with a gentle force.
- FIGS. 13A to 15 B show alternative embodiments in which the guidewire probes may be configured to form their sensing configurations by active actuation alone or in addition to any reshaping which may occur by shape memory characteristics of the guidewires.
- guidewire 628 may be formed in a straightened configuration with sensor 629 positioned at some location proximal of the distal tip.
- Pullwire 630 may be disposed within guidewire 628 along its length and exposed exteriorly of guidewire 628 between exit port 631 and anchor region 632 .
- Sensor 629 is preferably positioned along guidewire 628 near the center portion between exit port 631 and anchor region 632 .
- Guidewire 628 may be inserted into, e.g., the vasculature, in its straightened configuration and placed near the tissue region to be examined.
- pullwire 630 may be pulled at its proximal end, preferably manipulated outside the body of the patient, such that a bend portion 633 is formed between exit port 631 and anchor region 632 .
- sensor 629 is preferably extended radially relative to the longitudinal axis of guidewire 628 such that contact between sensor 629 and the vessel wall may occur.
- exit port 631 and anchor region 632 are preferably defined on guidewire 628 opposite to where sensor 629 is located.
- FIGS. 14A and 14B show another alternative embodiment in guidewire 634 .
- Sensor 635 may be located near or at the distal end of guidewire 634 and pullwire 636 may be disposed within the length of guidewire 634 and anchored at anchor region 637 proximally of sensor 635 .
- pullwire 636 Prior to examination of the tissue region of interest, pullwire 636 may be manipulated to reconfigure the distal end of guidewire 634 to radially extend at bend region 638 .
- pullwire 636 may be relaxed and guidewire 634 may also be relaxed to reconfigure into its straightened shape.
- FIGS. 15A and 15B show an embodiment which is similar to that shown in FIG. 12 above.
- Guidewire 639 may be formed to have at least two sensors 640 spaced apart relative to one another along guidewire 639 .
- Pullwire 641 may be disposed within the length of guidewire 639 and exposed exteriorly preferably between exit ports 642 and anchored to guidewire 639 at anchor region 643 .
- sensors 640 are preferably located near the central portions between the exit ports 642 and anchor region 643 and pullwire 641 is preferably located along guidewire 639 oppositely of sensors 640 .
- pullwire 641 Prior to examination, pullwire 641 may similarly be manipulated at its proximal end to reconfigure guidewire 639 into first and second bend regions 644 , 645 , respectively.
- Sensors 640 are preferably located along the outer curvatures of bend regions 644 , 645 so guidewire 639 may undergo a torquing about its longitudinal axis to align sensors 640 accordingly as pullwire 641 is pulled.
- FIG. 16 shows another alternative embodiment in guidewire 646 which has linearly spaced probes separated by a distance D.
- first probe 647 has a distally located first sensor 649 at a first distance or radius R 1 relative to the guidewire 646 longitudinal axis and second probe 648 has a distally located second sensor 650 at a second distance R 2 .
- this embodiment shows two probes, any number of linearly spaced probes may be used as practicable.
- Probes 647 , 648 are preferably parallel with one another to ensure complete coverage during the scanning process, but they may alternatively be located at various angles relative to one another in the same plane or within different plane depending upon the desired configuration and application.
- the distance D between the probes 647 , 648 may also be varied depending upon the desired coverage during scanning.
- the radii may likewise be varied to suit the application.
- FIG. 17 shows yet another embodiment of a device 710 for profiling the wall temperature of a hollow body organ.
- Device 710 includes a lumened catheter 712 and a hollow guidewire 716 .
- the inner surface of lumen 730 of guidewire 716 is lined with a layer of black paint 70 which is in turn lined with a thermochromic material 72 that is sensitive to a change of temperature of the guidewire 716 .
- the color of the thermochromic material 716 varies as a function of temperature.
- thermochromic material 72 Disposed within lumen 730 of guidewire 716 , inwardly of thermochromic material 72 , is an optical probe 74 including an illuminating optical fiber 76 having a radially emitting diffuser 78 at the distal end thereof, and a sensing optical fiber 80 having a conically beveled distal end 82 for collecting light.
- An illuminating electromagnetic radiation source connected to the proximal end of illuminating optical fiber 76 provides illuminating radiation that is guided by optical fiber 76 to the region of interest within the hollow body organ, and diffused radially by diffuser 78 to illuminate the interior of lumen 730 , particularly thermochromic material 72 .
- the illuminating radiation can be in the visible, infrared or ultraviolet portions of the spectrum. Radiation from diffuser 78 is differentially absorbed and reflected by thermochromic material 72 , according to the color of material 72 which is indicative of the temperature of guidewire 716 in contact with the wall of the hollow body organ in the region of interest.
- thermochromic material 72 having wavelengths indicative of the color thereof, is collected by distal end 82 and directed toward the proximal end of sensing optical fiber 80 .
- An appropriate optical reflectance spectrometry device connected to the proximal end of sensing optical fiber 80 generates an electrical signal indicative of the color, and therefore temperature, of thermochromic material 72 .
- FIG. 18 shows yet another embodiment of a device 810 suitable for profiling the impedance of the wall of a hollow body organ.
- Device 810 includes a catheter 812 within which is disposed a guidewire 816 having a bend in the distal portion thereof.
- Device 810 is similar in configuration to the embodiment of device 210 of FIG. 6 , and like components are indicated by like reference numerals in the 800 series but having the same last two digits.
- device 810 does not employ thermal sensing, but rather employs impedance sensing for profiling the wall of a hollow body organ.
- An electrode 90 at the outside of the bend of guidewire 816 is in electrical contact with guidewire 816 and in electrical contact with the inner wall 828 of the hollow body organ 826 .
- Guidewire 816 comprises a conductor operatively connected to an external impedance measuring device that has a ground terminal electrically connected to the body in which the hollow body organ is located. A small electrical current is applied via guidewire 816 and electrode 90 to the inner wall 828 at the region of contact therebetween. The impedance of the electrical path through the body, including through the region of interest in the hollow body organ 826 , can be measured and recorded. By moving guidewire 816 relative to the hollow body organ 826 as described above with respect to other embodiments, the impedance of the wall of the vessel 826 can be mapped. Any change of impedance along the wall 828 indicates the presence of an anomaly in the wall, such as a plaque 92 .
- impedance measurements may also be used to provide real-time feedback for contact between the guidewire probe and the vessel wall. For instance, when the impedance value rises above a preselected threshold, this may be an indication of lost contact against the vessel wall 828 since the surrounding fluids, e.g., blood, and/or tissue will likely have a higher impedance than the tissue being examined.
- One variation using impedance measurements for ensuring contact against the vessel wall is shown in FIGS. 19 and 20 .
- contact between guidewire 830 and plaque 92 or inner wall 828 may be ensured by monitoring the measured impedance.
- an impedance sensor 831 may be disposed within the distal tip of guidewire 830 in communication with power source 834 via connection 833 .
- Connection 833 may be any conventional electrical conductor or optical fiber if optical sensors are utilized.
- Power source 834 may be any type of power supply preferably capable of generating AC power.
- a first voltage may be applied through the body or vessel 826 , which is typically connected to electrical ground 832 either directly through, e.g., grounding straps, or indirectly through natural contact via the body of the patient.
- This first voltage, V 1 may be measured at voltage measurement location 835 and the resulting first current, I 1 , may be measured at current measurement location 836 , which is preferably taken between power source 834 and electrical ground 837 .
- a second voltage at a second current may be applied through the body or vessel 826 and the resulting voltage, V 2 , and current, I 2 , may be measured at voltage and current measurement locations 835 , 836 , respectively.
- FIG. 20 One detailed example of a dual-sensor probe is shown in FIG. 20 which may be used for impedance measurement.
- the distal end portion of guidewire 830 may have the thermal sensor 838 in the distal tip, as described above, in communication with a proximally located detector and processor via conductors 839 .
- a second sensor, impedance sensor 831 may be disposed adjacent or near thermal sensor 838 , and connected via connection 833 as shown.
- Impedance sensor 831 may detect contact via electrical impedance, as described above, but it may also detect via alternative methods, e.g., ultrasound, infrared, laser light, electrical conductivity, etc.
- connection 833 will be conductors, but if sensor 831 were configured to detect via optical methods, e.g., infrared or laser light, optical fibers may accordingly be used as connection 833 to detect and transmit the optical signals.
- optical methods e.g., infrared or laser light
- FIGS. 19 and 20 may be used with any of the various guidewire embodiments described herein.
- FIG. 21A shows a device embodiment 910 where a probe or guidewire 960 is adapted to be coupled to a detachable probe actuator 962 which, in turn, includes a cable 964 adapted to be coupled to a signal processing unit or the like.
- FIG. 21B shows schematically an example of an overall system for temperature sensing.
- probe actuator 962 may be connected via cable 964 directly to either the signal processor unit 963 or to the controller 965 .
- controller 965 which may be used to control and/or record the advancement or withdrawal of the motors or actuators contained within probe actuator 962 (discussed below in further detail) used for manipulating the guidewire 960 .
- Controller 965 may be connected via cable 967 to processor 963 , e.g., a computer, which may be used to process and display signals received from guidewire 960 as well as to control the movement of guidewire 960 within the vasculature.
- the probe system Prior to temperature acquisition, the probe system is preferably calibrated.
- the calibration may be performed through various methods.
- One example includes having two separate sensors for real-time calibration directly by a patient prior to use.
- One sensor may be placed in an orifice, e.g., the mouth, of the patient and an offset may be added to the measured value to estimate the core body temperature.
- the other sensor may be within the guidewire and used to acquire the temperature from the tissue region of interest.
- the system may be calibrated in the factory and a programmed calibration factor may be provided to the physician or technician for final calibration prior to use by the patient.
- a calibration slug or pod 969 may be provided along with the system.
- Such a slug 969 may be made from a material, e.g., plastics or polymers, which may be consistently and uniformly heated or cooled to a predetermined temperature, e.g., 37° C., preferably within a protective case prior to calibration.
- Slug 969 is preferably configured to define a channel or station for receiving and holding the guidewire after the slug 969 has been heated to the desired temperature. The guidewire may then be calibrated prior to each use as the slug 969 may be preferably reused multiple times to generate a consistent calibration temperature.
- FIG. 22 shows the structure of the probe or guidewire 960 which includes a stem 966 having a proximal end portion in the form of a hollow, elongate flexible proximal hypotube 968 , a mid portion in the form of a hollow, elongate, flexible mid hypotube 970 unitary with the tube 968 , and a distal end portion unitary with the tube 970 and being in the form of a hollow coiled end tube 972 which has a bent tip portion or segment 973 and is composed of thin wire 918 which has been wound into small helical coils in a manner similar to that described with respect to the coiled guidewire 16 of the device 10 shown in FIG. 2 .
- a transducer 920 is disposed within the interior of the terminal tip 973 of the distal coiled end tube 972 .
- the transducer 920 can take the form of a thermal sensor such as a thermocouple, thermistor, or a radiation sensor.
- the transducer 920 can also, however, take the form of an instrument adapted to respond to inputs other than temperature or radiation such as, for example, displacement or force.
- a radiopaque marker band 975 in the tip 973 of the distal end tube 972 allows the exact location of the probe 960 to be tracked during use.
- bent tip 973 of the distal end coiled tube 972 can be made of a material which is more radio-opaque than the material forming the remainder of the tube 972 to allow better visibility of the probe 960 as it is advanced through a blood vessel.
- the distal coiled end tube 972 includes an elongate shaping mandrel 974 extending through the interior thereof generally between the distal end of the mid tube 970 and the transducer 920 .
- the mandrel 974 comprises an elongate strip of metal or the like material having a distal tip portion 977 bent at an angle, a, generally between 10° to 90° relative to the longitudinal axis of the stem 966 .
- the distal tip portion 977 of the mandrel 974 is bent at an angle, ⁇ , generally between 30° to 70° and more preferably between 40° to 60° relative to the longitudinal axis of the stem 966 .
- the bent configuration of the mandrel 974 is, of course, imparted to the distal coiled end tube 972 of the stem 966 . It has also been determined that the guidewire 16 disclosed in FIG. 2 should preferably also be bent at the same angles as described above with respect to the mandrel 974 .
- the mandrel 974 of FIG. 22 is permanently bent into its angled configuration, it is understood that the mandrel 974 can be constructed from the same types of shape memory materials described above with respect to the guidewire 16 of FIG. 2 including, for example, spring steel or superelastic nitinol, so as to allow the mandrel 974 to move between straight and bent configurations in response to, for example, a change in temperature or the withdrawal of the coiled end tube 972 from a catheter 12 as shown in FIG. 2 .
- the mandrel 974 can alternatively take the shape of any of the coils described and shown herein. Additionally, it is understood that the present invention encompasses any one of several different mandrel embodiments depending upon the desired application of the device. For example, in applications where a soft and flexible tip portion 973 is desired, the length of the mandrel 974 can be shortened such that it terminates short of the tip portion 973 .
- the distal tip 977 of the mandrel 974 can be flattened and/or made of a material different than the remainder of the mandrel 974 .
- a plurality of spaced-apart parallel bands or rings of electrical connectors 978 surround the proximal tube 968 adjacent the proximal terminus thereof.
- the connectors 978 are separated from each other by a plurality of spaced-apart parallel bands or rings of insulative material 980 .
- the rings of connectors 978 and insulative material 980 respectively are flush with the outer surface of the tube 968 to assist in the alignment of the contacts 978 with cooperating contacts (not shown) in the actuator 962 .
- proximal tube 968 may incorporate a reduced diameter segment defining a groove in the proximal tube 968 and that the connector rings 978 can surround the reduced diameter segment to further assist in the alignment of the contacts with cooperating contacts in the actuator 962 .
- an elongate conductive wire 982 extends through the stem 966 between and in contact with the connectors 978 at one end and the transducer 920 at the opposite end for conveying appropriate signals from the transducer 920 to the connectors 978 and thereafter through the actuator 962 and the cable 964 and into the appropriate signal processing apparatus (not shown).
- An elongate strip of insulative material 984 extending through the stem 966 insulates the conductive wire 982 from the coils 918 and the tubes 968 and 970 .
- an elongate strip of insulative material 986 insulates the mandrel 974 from the coils 918 and the tubes 968 and 970 .
- Another elongate strip of insulative material 988 insulates the mandrel 984 from the conductive wire 982 .
- FIG. 23 depicts another probe embodiment 1060 which is similar in structure to the probe 960 of FIG. 22 .
- Components of probe or guidewire 1060 which are similar in structure and function to corresponding components of probe 960 are designated by like numerals in the 1000 series but have the same last two digits. The description of the probe 960 above applies equally to the probe 1060 unless described otherwise.
- the probe 1060 incorporates structure which allows the distal coiled tube 1072 to rotate relative to the mid-tube 1070 .
- the distal coiled tube 1072 is adapted to rotate about a rotary seal 1090 which separates the coiled tube 1072 from the mid-tube 1070
- the proximal and mid-tubes 1068 and 1072 respectively include an elongate actuation shaft 1092 extending therethrough and having a distal terminus (not shown) operably coupled for rotation to the proximal terminus (not shown) of the distal coiled tube 1072 .
- proximal terminus of proximal tube 1068 is adapted to be removably secured within the distal terminus of the actuator 962 shown in FIG. 21A and further that the actuator 962 incorporates motors therein (as described below) which is operably coupled to the proximal end of the shaft 1092 and adapted to impart a rotary and/or linear motion thereto which, in turn, is transferred to the distal coiled tube 1072 .
- This allows the transducer 1020 in the bent tip portion 1073 of stem 1066 to traverse a circular path around the inner wall of the blood vessel in a manner similar to that described with respect to the earlier embodiment.
- FIG. 24 depicts a further probe embodiment 1160 which is similar in structure to the probes 960 and 1060 .
- Component of probe 1160 which are similar in structure and function to corresponding components of probes 900 and 1060 are designated by like numerals in the 1100 series but having the same last two digits.
- the description of probes 960 and 1060 above applies equally unless described otherwise.
- the stem 1166 is mounted for axial sliding back and forth movement about the actuator shaft 1192 extending therethrough.
- the actuator shaft 1192 is hollow and, although not shown, it is understood that the elongate conductive wire 1182 extends through the distal coiled tube 1172 and then through the interior of the shaft 1192 .
- the probe 1160 also includes a plurality of spaced-apart, parallel bands or rings of electrical connectors 1178 surrounding the proximal end portion of the shaft 1192 .
- the connectors 1178 are separated from each other by a plurality of spaced-apart parallel bands or rings of insulative material 1180 .
- the connectors 1178 and bands of insulative material 1180 are flush with the outer surface of the rotating shaft 1192 , and although not shown, it is understood that the proximal end of the conductive wire 1182 is connected to the connectors 1178 .
- the probe 1160 and, more particularly, the proximal end portions of the shaft 1192 and the proximal tube 1168 are adapted to be removably fitted within the distal end of the actuator 962 ( FIG. 21A ) and further that the actuator 962 is adapted to incorporate, e.g., one or several motor-actuated screw drives, operably associated with the shaft 1192 and the stem 1166 to provide the combined rotational and axial probe movement which allows the transducer 1120 to traverse a helical path about the longitudinal stem axis in response to the activation of the actuator 962 to permit measurements to be taken at intervals of different regions of a vessel wall in the manner as described above with respect to the device 10 and FIG. 2 .
- the actuator 962 is adapted to incorporate, e.g., one or several motor-actuated screw drives, operably associated with the shaft 1192 and the stem 1166 to provide the combined rotational and axial probe movement which allows the transducer 1120 to traverse a helical path about the longitudinal stem
- each of the probe or guidewire embodiments described herein must be sufficiently flexible to be insertable within, for example, a blood vessel through a femoral artery access introducer and threaded into the coronary arteries and further that the various probe and guidewire embodiments must also have sufficient rigidity to ensure the rotation of the distal coiled tubes thereof in response to the rotation of the proximal end tubes thereof.
- the various probe and guidewire embodiments must provide support, i.e., directional control, for a catheter such as the catheter 12 shown in FIG. 2 .
- the probe and guidewire embodiments herein should preferably be constructed such that the bent distal coiled end tubes thereof preferably incorporate a torque response of no more than about 0.4 ounce force inches (ozf in), and more preferably no more than 0.3 ozf in, in response to the torque which is applied to the proximal end tubes of the respective probe and guidewire embodiments.
- This particular distal coiled end tube torque response can be achieved by varying the profile and/or material and/or coating of any one of the tube sections or the mandrel.
- the stiffness or flexibility of the various guidewire or probe embodiments can be adjusted or varied also by changing the shape, profile and/or material of any one of the tube sections or mandrel.
- the tubes 968 and 970 of the device 910 may, for example, be made from either nitinol or stainless steel and the tube 972 can be shaped into either a flat ribbon or a flat wide ribbon to obtain the desired stiffness ratio.
- the tubes 968 , 970 and 972 should be of a shape and/or material resulting in a relative stiffness ratio between the distal coiled tube 972 , the mid-tube 970 , and the proximal tube 968 of about 1:4,400:13,000, respectively.
- the tubes 968 , 970 and 972 should have such a shape and/or be constructed of such material sufficient to provide a ratio of about 1:4:110 between the distal, mid and proximal tubes 968 , 970 , and 972 , respectively.
- the preferred stiffness ratio between the respective distal, mid and proximal tubes forming the probe should be about 1:400:1200 to provide the desired distal end coiled tube torque response of no more than about 0.4 ounce force inches.
- the proximal end of the probe which has been cross-sectioned for clarity, preferably comprises a connector assembly 2000 which comprises shaft 2002 having multiple contacts near the proximal end, e.g., proximal contact 2006 and distal contact 2008 , which may be separated by indexing grooves 2004 .
- the sensor leads 2012 which extend down shaft 2002 to the sensor at the distal coiled tube, preferably terminate at each respective contact 2006 , 2008 .
- the proximal ends of the sensor leads 2012 may be electrically separated by any conventional insulative coating 2010 which may extend into indexing grooves 2004 to maintain the electrical separation.
- Indexing grooves 2004 may be formed such that they are non-coextensive with an outer surface of shaft 2002 , i.e., grooves 2004 are formed such that they have diameters which are different, e.g., preferably less in diameter, than a diameter of shaft 2002 .
- the probe may further extend proximally with a proximal extension 2014 to any desired length.
- Proximal extension 2014 may be extended a short distance as shown in FIGS. 22-24 .
- another embodiment of the connector may include a probe having a length much longer than the lengths as shown in the figures above.
- probe 2016 may have a length with a mid-portion 2019 within which contacts 2017 and insulation 2018 may be situated.
- Contacts 2017 may be placed along the probe 2016 away from either the distal or proximal ends, and preferably near or at the mid-portion 2019 of probe 2016 . Placement of the contacts 2017 within mid-portion 2019 may then allow for a probe 2016 having a length much longer, e.g., twice the normal length, than a length typically used.
- the additional length may then allow for the use of rapid-exchange type catheters to be guided over the body of probe 2016 for advancement through the vasculature.
- Probe actuator 962 may not only provide for rotational movement of the guidewire probe, but it may also provide for longitudinal movement.
- Rail guide or frame 2081 may provide an internal frame for supporting the various components within the handle of actuator 962 .
- rotational shaft 2083 may be supported through interface 2082 .
- Chuck 2024 to which probe 2026 may be connected, may be rotatingly connected to the distal end of rotational shaft 2083 .
- rotational shaft 2083 may be connected to motor 2034 , e.g., DC motor, which may provide the rotational torquing force to rotate chuck 2024 and probe 2026 about its longitudinal axis through, e.g., a pulley and cable assembly 2084 , rotational gear assemblies, worm screw assemblies, etc.
- motor 2034 e.g., DC motor
- a second motor e.g., stepper motor 2032
- a second motor may be rotatingly connected via coupler 2087 to lead screw 2086 , or any other device which can translate rotational motion into linear motion, e.g., worm screw assemblies, rack or internal gear and pinion assemblies, etc.
- Coupler 2087 may comprise any conventional coupling device which can transmit the rotational torque from a motor with minimal loss to another device such as lead screw 2086 .
- a carriage assembly 2085 which is preferably connected to a proximal end of frame 2081 is preferably configured to receive lead screw 2086 .
- Lead screw 2086 is preferably received through carriage 2085 within a threaded hole such that rotation of lead screw 2086 in a first rotational direction translates carriage 2085 and frame 2081 in a first linear direction and rotation of lead screw 2086 in a second opposite rotational direction translates carriage 2085 and frame 2081 in a second opposite linear direction.
- a controlled linear motion of probe 2026 may be provided by controlled rotation of motor 2032 .
- Control of motors 2032 , 2034 may be provided by a processor and/or controller as described above.
- actuators are shown as motors, e.g., DC or stepper motors
- alternative actuators may include any type of practicable device which can be used to convert mechanical energy into rotational or longitudinal motion for the probes.
- screws or thumbscrews may be used to manually impart motion to the probe and guidewire apparatus.
- lead screw 2086 , rotational shaft 2083 , or chuck 2024 , or any other component may be manually manipulated to actuate movement of the probe without having to resort to the use of motors.
- FIGS. 27 to 29 show various embodiments which may incorporate actuator variation 2080 , or various embodiments thereof, to effect motion. Various features may be omitted from the figures only for clarity.
- FIG. 27 shows a side view of one variation on probe actuator 2020 with the cover removed for clarity.
- Probe actuator 2020 comprises handle 2022 having an optionally detachable probe or guidewire chuck 2024 .
- Guidewire chuck 2024 which is discussed in further detail below, is configured for mechanically and electrically receiving the proximal connection end of probe 2026 and chuck 2024 itself is in electrical communication with amplifier 2028 .
- Probe 2026 is configured to rotate about its longitudinal axis, and accordingly, chuck 2024 is also configured to rotate about its longitudinal axis. Because chuck 2024 rotates, amplifier 2028 is also configured to rotate about the same axis as chuck 2024 while remaining in electrical contact to receive the signals from sensor leads 2012 during probe 2026 rotation.
- amplifier 2028 As amplifier 2028 rotates, it is preferably electrically attached to a non-rotating platform 2030 having a plurality of concentric contacts for transmitting the signals to an externally located processor, e.g., processor 963 in FIG. 21B .
- An optional motor e.g., stepper motor 2032 , may be used to distally advance or proximally withdraw probe 2026 through a known longitudinal distance using, e.g., actuator variation 2080 above. The distance traveled may be controlled and/or recorded via processor 963 and controller 965 of FIG. 21B .
- Probe actuator 2020 may also contain within the handle 2022 a separate motor, e.g., DC motor 2034 , used for the rotational control of probe 2026 .
- the motor 2034 may rotate, e.g., in this variation the central shaft 2023 , which may also connect the chuck 2024 with probe 2026 .
- Each of the motors may have encoders (not shown) to determine both the rotational and axial position of the probe.
- Motor 2034 may also be controlled via the processor 963 and/or controller 965 through signal cable 2036 .
- FIG. 28 shows an isometric view of probe actuator 2020 of FIG. 27 with various components removed for clarity.
- Motor 2034 may be seen connected to the rotational shaft 2023 via a rotational gear 2035 .
- Shaft 2023 may also be seen optionally extending from the motor 2034 to the probe or guidewire chuck 2024 .
- FIG. 29 shows an isometric view of an alternative probe actuator 2040 which has had the cover partially removed for clarity.
- handle 2042 may contain the components as described above, e.g., chuck 2024 , amplifier 2028 , stepper motor 2032 , DC motor 2034 , etc.
- the variation 2040 seen has the DC motor 2034 positioned in-line with the other components in a collinear arrangement.
- motor 2034 may be aligned and mechanically connected via coupler 2044 to transfer the rotational motion via shafts 2046 to chuck 2024 .
- This arrangement allows for the compact packaging of the components within an ergonomically designed handle 2042 .
- the chuck 2024 which acts as the interface between the probe actuator and the probe itself is preferably removable as a separate unit from the probe actuator and may optionally be disposable. It may be provided as a package with the probe or guidewire for use with different probe actuators to maintain the sterility of the probe and the chuck between different patients.
- FIG. 30A shows a side view of a chuck 2024 which has been removed from the probe actuator.
- a probe insertion lumen 2050 is defined within the chuck 2024 for receiving the proximal end of the probe 2026 .
- Chuck 2024 may also be configured such that probe 2026 is mechanically seated securely within the insertion lumen 2050 . Ensuring a secure mechanical fit can ensure good signal transfer between probe 2026 and the amplifier 2028 . Moreover, the processor 963 may be configured whereby if the probe 2026 is not securely seated, any temperature readings will default to a null value or alternatively to a predetermined value which is well beyond normal readings to indicate a faulty connection in the system.
- the insertion lumen 2050 may further define a stop or a barrier within for halting the insertion of the probe 2026 within the lumen 2050 at the desirable position such that the contacts are fittingly aligned with one another.
- the electrical signals taken by the probe 2026 may be transferred through the chuck 2024 with minimal noise and interference.
- the proximal end of the chuck 2024 may define an attachment 2054 for connection to the probe actuator in which the attachment region 2054 defines several contact regions. These regions are configured to allow for the transfer of signals from contacts 2052 to an electrically connected amplifier while chuck 2024 rotates about its own longitudinal axis during signal acquisition.
- FIG. 30B shows one variation of an electrical schematic of chuck 2024 from FIG. 30A which may be self-calibrated.
- Chuck 2024 may be configured to have variable resistors 2090 , which may also be discrete resistors, in electrical communication between probe 2026 and attachment region 2054 .
- Variable resistors 2090 can be used to determine a calibration factor for a given probe which may be provided along with a chuck calibrated to the probe. For example, a resistor value of, e.g., 1 to 1000 ⁇ , can be selected to have 1000 discrete values.
- An arbitrary resistor value of, e.g., 500 ⁇ , may be selected as a neutral point and any probe having calibration errors above this neutral point may be used with a resistor having a value above 500 ⁇ and any probe having calibration errors below this neutral point may be used with a resistor having a value below 500 ⁇ .
- Variable resistors 2090 in any chuck 2024 may simply be adjusted accordingly to account for the calibration errors.
- the amplifier 2028 of FIGS. 27 and 29 are shown in isometric and end views in FIGS. 31A and 31B , respectively.
- the amplifier 2028 is used to amplify the acquired signals taken from the tissue by the probe while rotating about a longitudinal axis as seen by the rotational arrows in FIG. 31A .
- signals are electrically received by the amplifier circuitry 2060 , they may be transferred via a rotating platform 2062 which is in electrical communication with amplifier 2028 .
- the platform 2062 which is preferably circular in shape but may also be formed into other shapes, may have a plurality of contacts 2064 formed on one side of the platform 2062 .
- the contacts 2064 may be formed into any number of concentric circles depending upon the number of contacts needed to transfer the signal.
- the received signals may be transmitted through the contacts 2064 to brushes in corresponding contact without having to stop for signal transfer.
- Signal processing and probe manipulation are preferably done by processor 963 and/or controller 965 .
- manual operation of the probe may sometimes be desirable.
- an intervening chuck assembly, an intervening connector cable, or a combination of both may be utilized.
- FIG. 32 an isometric view of a manually actuated probe assembly 2070 is illustrated with an optional intervening chuck 2072 .
- the intervening chuck 2072 may be used to receive the probe 2026 in the same manner as described above and the chuck 2072 may have an optional connector 2074 for attachment to the intervening cable connector 2078 .
- the intervening connector cable 2076 is preferably made of a polymeric material which is flexible enough to assume various curves but is stiff enough to transmit a torquing force along the length of the connector cable 2076 . This can be accomplished through any variety of methods in constructing the connector cable 2076 ; for instance, metallic braids, reinforcing braids, or strands may be used in the construction of the cable. Alternatively, thermoset or thermoplastic polymers having a sufficient shear strength may be used alone or in combination with the various reinforcing methods.
- the intervening chuck 2072 and connector cable 2076 may be used merely as an extension of the chuck 2024 in normal operation.
- the physician or surgeon may manipulate the intervening chuck 2072 by hand to impart a rotational or longitudinal motion to the probe 2026 as necessary or desired.
- the intervening chuck assembly 2072 may be integrated directly with connector cable 2076 .
- the chuck 2072 may be maintained as a separate device, as currently shown in FIG. 32 , and attached separately to cable connector 2078 to maintain the sterility of the connector 2076 and handle 2022 prior to its use.
- chuck 2072 may be omitted entirely and cable connector 2078 may be configured to receive and hold probe 2026 directly. Manual manipulation of probe 2026 may, in this case, be accomplished by rotating cable 2076 , connector 2078 or probe 2026 directly.
Abstract
A device for sensing the profile of a hollow body organ includes a hollow guidewire or probe carrying a sensor. The hollow probe includes a distal coiled end tube with a tip bent at an angle between about 10° to 90° relative to the probe longitudinal axis and having a torque response of no more than about 0.4 ozf in. The flexural rigidity of the distal end tube relative to the mid and proximal end tubes forming the probe is generally in the range of about 1:(4 to 4,400):(110 to 13,000), respectively. An actuator is detachably secured to the probe and includes one or several motors which allow the sensor to travel in a rotational and axial path through the body organ.
Description
- This application is a continuation of U.S. patent application Ser. No. 10/146,014 filed May 14, 2002, which is a continuation-in-part of U.S. patent application Ser. No. 09/904,212 filed Jul. 12, 2001 (now abandoned).
- This invention relates generally to invasive medical devices and more particularly to devices for sensing the profile of the interior wall of a hollow body organ such as a blood vessel.
- Acute ischemic syndromes involving arterial blood vessels, such as myocardial infarction, or heart attack, and stroke, frequently occur when atherosclerotic plaque ruptures, triggering the formation of blood clots, or thrombosis. Plaque that is inflamed is particularly unstable and vulnerable to disruption, with potentially devastating consequences. Therefore, there is a strong need to detect and locate this type of plaque so that treatment can be initiated before the plaque undergoes disruption and induces subsequent life-threatening clotting.
- Various procedures are known for detecting and locating plaque in a blood vessel. Angiography is one such procedure in which X-ray images of blood vessels are generated after a radio-opaque dye is injected into the blood stream. This procedure is capable of locating plaque in an artery, but is not capable of revealing whether the plaque is the inflamed, unstable type.
- Researchers, acting on the theory that inflammation is a factor in the development of atherosclerosis, have discovered that local variations of temperature along arterial walls can indicate the presence of inflamed plaque. The temperature at the site of inflammation, i.e., the unstable plaque, is elevated relative to adjacent plaque-free arterial walls.
- Using a tiny thermal sensor at the end of a catheter, the temperature at multiple locations along an arterial wall were measured in people with and without atherosclerotic arteries. In people free of heart disease, the temperature was substantially homogeneous wherever measured: an average of 0.65 degrees F. above the oral temperature. In people with stable angina, the temperature of their plaques averaged 0.19 degrees F. above the temperature of their unaffected artery walls. The average temperature increase in people with unstable angina was 1.23 degrees F. The increase was 2.65 degrees F. in people who had just suffered a heart attack. Furthermore, temperature variation at different points at the plaque site itself was found to be greatest in people who had just had a heart attack. There was progressively less variation in people with unstable angina and stable angina.
- The temperature heterogeneity discussed above can be exploited to detect and locate inflamed, unstable plaque through the use of cavity wall profiling apparatus. Typically, cavity wall profiling apparatus are comprised of temperature indicating probes such as thermocouples, thermistors, fluorescence lifetime measurement systems, resistance thermal devices and infrared measurement devices.
- One problem with conventional cavity wall profiling apparatus is that they usually exert an undue amount of force on the region of interest. If the region of interest cannot withstand these forces, it may be damaged. The inside walls of a healthy human artery are vulnerable to such damage. Furthermore, if inflamed, unstable plaque is present it may be ruptured by such forces.
- Another problem with conventional cavity wall profiling apparatus is that they can only measure the temperature at one specific location. In order to generate a map of the cavity temperature variation, one would need to move the temperature indicating probe from location to location. This can be very tedious, can increase the risk of damaging the vessel wall or rupturing vulnerable plaque, and may not resolve temporal characteristics of the profile with sufficient resolution. An array of probes could be employed but that could be very big and heavy.
- According to one aspect of the invention, a device is provided for sensing the temperature profile of a hollow body organ. The device includes a hollow guidewire, a temperature sensor disposed on or within the guidewire, and an optional catheter through which the guidewire may be delivered. The guidewire has a relaxed configuration externally of the catheter that is formed to provide contact with the wall of the hollow body organ. The guidewire also has a contracted configuration internally of the catheter and is of a lesser diameter than the catheter.
- According to another aspect of the invention, the device is used by contracting the guidewire elastically and constraining the guidewire within the catheter. The catheter and guidewire are advanced to a region of interest in a hollow body organ. The catheter is withdrawn to expose the distal portion of the guidewire which may then reconfigure into a relaxed configuration to make contact with the hollow body organ. Alternatively, the catheter may be held stationary relative to the hollow body organ and the guidewire may be advanced until the distal portion of the guidewire is exposed to reconfigure. The guidewire is moved longitudinally and rotated, continuously or continually, to sense the temperature of the hollow body organ at multiple locations.
- Alternatively, the catheter may be omitted entirely from the deployment procedure. Rather than using a catheter or sheath to restrain the distal portion of the guidewire during deployment, the guidewire may simply be inserted and advanced within the hollow body organ to the tissue region of interest while in its relaxed configuration. For instance, an introducer and/or guide catheter may be positioned percutaneously through the skin into the body of a patient and the guidewire may simply be inserted without the use of a separate catheter directly into, e.g., the vasculature, via the introducer. During insertion, the guidewire may be inserted into the body while the probe is in its relaxed configuration. Except when initially introduced or withdrawn through the introducer into the body, the probe may remain in its relaxed configuration.
- In accordance with yet another aspect of the present invention, the probe or guidewire includes a hollow, flexible, elongate stem having proximal and mid portions and a distal end portion which terminates in a coil having at least a tip segment thereof biased away from the rotational axis of the probe at an angle between approximately 30° to 75° relative to the stem longitudinal axis, and more preferably between approximately 40° to 60°, and having a torque response of no more than about 0.4 ozf in. Moreover, a transducer is mounted to the coil, a connector is located at the proximal end portion of the stem, and at least one conductor connects the transducer to the connector. An elongate mandrel having a bent tip extends through the coil and provides the coil with its bent configuration.
- The probe may be configured such that the coil rotates about the proximal end portion of the stem in response to the rotation of an actuation shaft extending through the proximal end portion of the stem. The proximal end portion of the stem can also define a sheath slidable on the actuation shaft and operably coupled to the coil for allowing the axial reciprocal movement of the coil. An actuator may surround the proximal end portion of the stem and be adapted to provide both rotational and axial or longitudinal movement to the stem to allow the sensor to travel in a helical path through the desired body organ.
- Moreover, and depending upon the particular desired application, the materials and/or shapes of the proximal, mid and distal end portions of the stem may be varied to provide a flexural rigidity ratio between the coil and the mid portion and the proximal end portion in the range of about 1:(4 to 4,400):(110 to 13,000), respectively, and more preferably 1:400:1200, respectively.
- To ensure contact between the probe and the vessel wall, various impedance measurement devices or sensors may also be provided in addition to the thermal sensors or transducers mounted in the tip segment.
- The actuator which controls the rotational and axial movement of the probe may be constructed as a handle. The probe may be attached via an optionally removable chuck to the handle and both the chuck and the probe may be electrically connected to an amplifier positioned within the handle. The amplifier is preferably configured to rotate while maintaining electrical contact with the probe. Moreover, various motors under the control of a motor controller, are used to control both the rotational and axial movement of the probe. A processor, e.g., a computer, is used to not only track/control the positioning and movement of the probe, but is also used to process the signals acquired by the probe. During the measurement or scanning process, the rate and pitch at which the vessel walls are scanned may be automatically varied by the processor to increase the measured sampling resolution upon the determination of a threshold measurement value being exceeded.
- While the processor and/or controller may be used to control the movement of the probe, an alternative embodiment may incorporate an intervening chuck and connector cable to allow for the manual manipulation of the probe. This embodiment utilizes a separate chuck which is used to receive the probe. The chuck may then be connected to the probe actuator via the connector cable. During normal operation, the intervening chuck and connector cable may remain attached to the probe actuator or they may be connected when manual manipulation is desired. To accomplish the manipulation, the physician or surgeon may simply rotate and/or axially move the probe via the intervening chuck while maintaining the sterility of the probe and probe actuator. Alternatively, the intervening chuck may be omitted altogether and the probe may simply be attached to a connector cable which is configured to directly receive the probe connector.
- Further aspects and advantages of the present invention are apparent from the following description of the preferred embodiments referring to the drawings.
- In the drawings,
-
FIG. 1 is a perspective view of an embodiment of the present invention; -
FIG. 2 is a longitudinal sectional view of an arterial hollow body organ in which the embodiment ofFIG. 1 , also shown in longitudinal section, is deployed; -
FIG. 3A is a longitudinal sectional view of a guidewire probe variation in which the sensor is positioned off-center or off-axis; -
FIG. 3B is a cross-sectioned detail view of the probe ofFIG. 3A ; -
FIG. 4A is a longitudinal sectional view showing an example of a mapping or scanning path in which the rotational and withdrawal rates are constant; -
FIG. 4B is a longitudinal sectional view showing an example of a mapping or scanning path in which the rotational and/or withdrawal rates may be varied to provide for regions of higher and lower measurement resolution; -
FIG. 5 is a longitudinal sectional view of an arterial hollow body organ in which another preferred embodiment of the present invention, also shown in longitudinal section, is deployed; -
FIG. 6 is a perspective view of yet another preferred embodiment of the present invention; -
FIG. 7 is a perspective view, partially in section, of a further preferred embodiment of the present invention; -
FIG. 8 is a perspective view of yet another preferred embodiment of the present invention; -
FIG. 9 is a longitudinal sectional view of an arterial hollow body organ in which another preferred embodiment of the present invention, shown in perspective, is deployed; -
FIG. 10 is a perspective view of a further preferred embodiment of the present invention; -
FIG. 11 is a longitudinal sectional view showing another variation of a guidewire having at least two bends; -
FIG. 12 is a longitudinal sectional view showing another variation of a guidewire having multiple bends and at least two sensors; -
FIGS. 13A and 13B are longitudinal views showing alternative embodiments in which a guidewire probe may reconfigured by active actuation into a shape having a bend portion; -
FIGS. 14A and 14B are longitudinal views showing alternative embodiments in which a guidewire probe may reconfigured by active actuation into a shape having a radially extended portion; -
FIGS. 15A and 15B are longitudinal views showing alternative embodiments in which a guidewire probe may reconfigured by active actuation into a shape having at least two bend portions; -
FIG. 16 is a longitudinal view showing another embodiment in which guidewire probe may have at least two radially extended probes linearly spaced apart from one another; -
FIG. 17 is a perspective view of another preferred embodiment of the present invention; -
FIG. 18 is a longitudinal sectional view of an arterial hollow body organ in which yet another preferred embodiment of the present invention, shown in perspective, is deployed; -
FIG. 19 is a longitudinal sectional view showing a variation in which impedance measurements may be taken to determine whether sufficient contact exists between the guidewire and the vessel wall; -
FIG. 20 is a detailed view of the probe ofFIG. 19 showing a variation on the dual-sensor location; -
FIG. 21A is a perspective view of another device embodiment of the present invention; -
FIG. 21B is a schematic representation of a variation of a signal processor and controller connected to a probe actuator; -
FIG. 22 is an exploded, broken perspective view of the probe of the device ofFIG. 21A ; -
FIG. 23 is an exploded, broken perspective view of an alternate embodiment of the probe of the device ofFIG. 21A ; -
FIG. 24 is an exploded, broken perspective view of yet another alternate embodiment of the probe of the device ofFIG. 21A ; -
FIG. 25A is a cross-sectioned perspective view of a proximal end of a probe; -
FIG. 25B is a side view of a variation on the probe in which the connector region is positioned near the mid-section of the wire; -
FIG. 26 is a schematic illustration of one variation of an actuator assembly which may be used to provide the rotational and axial movement for the probe; -
FIG. 27 is a side view of one embodiment of the probe actuator with the cover partially removed; -
FIG. 28 is a perspective view of the probe actuator ofFIG. 27 with some components removed for clarity; -
FIG. 29 is a perspective view of an alternate embodiment of the probe actuator with the cover partially removed; -
FIG. 30A is a side view of an embodiment of the probe chuck; -
FIG. 30B is an electrical schematic showing one variation of the chuck fromFIG. 30A which may be self-calibrated; -
FIGS. 31A and 31B are perspective and end views, respectively, of an embodiment of a rotatable amplifier; and -
FIG. 32 is a perspective view of an alternate embodiment having a manually manipulatable assembly. -
FIG. 1 shows adevice 10 for profiling the wall of a hollow body organ.Device 10 includes alumened catheter 12 having acentral lumen 14, ahollow guidewire 16 that defines a conduit comprising ametal wire 18 or the like in the shape of a coil defining a central lumen (not shown), and athermal sensor 20 disposed at the terminal end of the distal portion ofguidewire 16. Conventional conductors or other signal carrying structures (not shown) are provided to convey signals from thethermal sensor 20 alongguidewire 16 and out of the proximal portion ofguidewire 16 for connection to appropriate signal processing apparatus that converts the signals to a temperature indication.Thermal sensor 20 can be, e.g., a thermocouple, a thermistor, an infrared radiation sensor, fiberoptic oxygen sensor, ultrasonic transducer, impedance sensor, pH sensor, mechanical force sensor (e.g., strain gauge), etc., for example, and is secured by appropriate mechanical or adhesive means to the terminal end ofguidewire 16. Moreover, radio-opaque materials, e.g., platinum, gold, etc., may be formed in epoxy materials which may be used to attachsensor 20 to guidewire 16. Alternatively, one or several radio-opaque marker bands 19, preferably made of biocompatible materials such as those listed above, may be formed proximally ofsensor 20 alongguidewire 16 to assist in denoting the location ofsensor 20 during a measurement procedure. Typical thermocouples which can be used may include T-type thermocouples (Copper and Constantan) having thermoelectric conversion coefficients of about 40.3 μV/° C. -
Hollow guidewire 16 is made ofthin wire 18 wound, for example around a mandrel, into small helical coils of desired diameter that lie tightly adjacent one another to form a hollow tube having a central passageway or lumen therethrough.Guidewire 16 may have an outer diameter which is uniform along its length; alternatively, the diameter may be varied, e.g., having diameter decrease proximally along the length ofguidewire 16 or having sections of differingguidewire 16 diameters along the length.Guidewire 16 has an outer diameter somewhat less than the inner diameter ofcatheter 12 to permitguidewire 16 to slide freely within thelumen 14 ofcatheter 12. In addition, guidewire 16, in its relaxed configuration, is shaped in the form of abend 22 at the distal portion thereof, thebend 22 being spaced from the terminal end ofguidewire 16 at whichthermal sensor 20 is disposed. Consequently,thermal sensor 20 is displaced radially from thelongitudinal axis 24 ofguidewire 16 andcatheter 12 whenguidewire 16 is in the relaxed, bent configuration. Through external manipulation, guidewire 16 in the relaxed, bent configuration can be made to rotate aboutaxis 24, continuously or continually, depending on the response time for the sensor, thereby causingthermal sensor 20 to traverse a circumferential or helical path aboutaxis 24 while providing temperature information.Guidewire 16 can be deformed elastically into a substantially straight configuration, i.e., withoutbend 22, under force. When the force is removed, guidewire 16 returns to the relaxed, bent configuration. -
Guidewire 16 can be constructed of spring steel that can be deformed into a relatively straight configuration when withdrawn intocatheter 12, but which springs back to its bent configuration when extruded fromcatheter 12 and released from constraint. Another way is to constructguidewire 16 of superelastic nitinol and take advantage of the martensitic transformation properties of nitinol.Guidewire 16 can be inserted intocatheter 12 in its straight form and kept cool within the catheter by the injection of cold saline throughcatheter 12 and overguidewire 16. Upon release ofguidewire 16 into the bloodstream, it will warm up and change to its austenite memory shape based on the well-known martensitic transformation by application of heat and putting the material through its transformation temperature. -
Guidewire 16 can also be made out of a composite such as a nitinol tube within the guidewire structure. In this fashion, the martensitic or superelastic properties of nitinol can be combined with the spring steel characteristics of the spring and lead to a desirable composition. Other suitable materials forguidewire 16 include copper, constantin, chromel or alumel. -
FIG. 2 showsdevice 10 deployed in a hollow body organ comprising anarterial blood vessel 26 having anendothelium 28 forming the inner wall thereof. Only the distal portion ofguidewire 16 that extends beyondcatheter 12 is shown.Electrical conductors 32 extend throughlumen 30 ofguidewire 16.Conductor 32 is electrically insulated from thecoils 18 ofguidewire 16 so thatguidewire 16 comprises one conductor andconductor 32 comprises another conductor or lead of thethermal sensor 20 which can be a thermocouple or thermistor. The conductors convey signals from thethermal sensor 20 to the proximal end ofguidewire 16 for connection to appropriate signal processing apparatus that converts the received signals to a temperature indication. - Although
thermal sensor 20 is shown as extending along the center of the distal end ofguidewire 16,sensor 20 is preferably positioned off-center or off-axis from the longitudinal axis of the guidewire. As shown inFIG. 3A , asguidewire 11 traverses alongwall 28 withinvessel 26, a lesion orobstruction 13 may forcedistal portion 23 to bend radially inward towards the longitudinal axis alongbend 22. Placement ofthermal sensor 21 off-axis may allow for continuous contact and/or sensing betweensensor 21 andwall 28 orlesion 13 despite having the center tip ofdistal portion 23 bent inwardly.FIG. 3B shows a cross-sectioned detail view ofdistal portion 23 wheresensor 21, connected toconductors 27, is positioned off-axis near the distal tip. - In one use, the
guidewire 16 andthermal sensor 20 ofdevice 10, as shown inFIGS. 1 and 2 , are inserted into thelumen 14 ofcatheter 12 from the proximal end, thereby constrainingguidewire 16 in a substantially straight configuration with thethermal sensor 20 near the distal end ofcatheter 12. Using conventional percutaneous insertion techniques, access to theblood vessel 26 is obtained surgically.Catheter 12, withguidewire 16 andthermal sensor 20 disposed within, is advanced through theblood vessel 26 to the region of interest. -
Catheter 12 is slowly withdrawn whileguidewire 16 is secured against movement relative to the patient such that guidewire 16 emerges from the distal end ofcatheter 12 and reverts to the relaxed, bent configuration within theblood vessel 26. Alternatively,catheter 12 may be secured against movement relative to the patient and guidewire 16 may be advanced distally until it emerges from the distal end ofcatheter 12.Guidewire 16 remains substantially fixed in the axial direction relative to theblood vessel 26 ascatheter 12 is withdrawn, with the re-formed bent distal portion ofguidewire 16 springing gently radially outwardly into contact with thevessel wall 28. - In another use,
catheter 12 may be omitted entirely from the deployment procedure. Rather, guidewire 16 may simply be inserted into the patient while in its relaxed configuration and advanced within the hollow body organ to the tissue region of interest. Withcatheter 12 omitted, theguidewire 16 may be advanced in its relaxed configuration, as mentioned, or it may be inserted within the patient in its substantially straightened configuration and be allowed to reconfigure itself by heating up while being advanced. - With
guidewire 16 exposed andthermal sensor 20 lying in contact with thewall 28 ofblood vessel 26, thethermal sensor 20 senses the localized temperature of thevessel wall 26 at the region where thethermal sensor 20 is situated. By slowly withdrawingguidewire 16, either intocatheter 12 or simply withdrawing distally, while simultaneously rotatingguidewire 16 about its longitudinal axis, thermal sensor 25 can be made to traverse a helical path around theinner wall 28 of theblood vessel 26, permitting temperature measurements to be taken at intervals of different regions of thevessel wall 28. Depending upon the response time ofthermal sensor 20, which is preferably on the order of milliseconds, e.g., between 10 to 100 msec. and preferably less than 50 msec., rotation can be intermittent or continuous, as needed. By withdrawing and rotating theguidewire 16 at constant rates, e.g., at a scanning rate of about 50 mm/min with a linear or pull-back rate of between 0.3 to 10 mm/sec. and preferably 1 mm/sec. and at a rotational rate of between 1 to 100 rpm, and preferably between 10 to 100 rpm, and more preferably about 25 rpm, the location of thethermal sensor 20 relative to the distal end of thecatheter 12 can be determined as a function of time, so that a temperature profile of theblood vessel 26 can be mapped, provided the response time of the thermal sensor is relatively short. - One variation of a mapping procedure is shown in
FIG. 4A where the rotational and withdrawal rates are maintained constant. The mapping orscanning path 29, i.e., the path traced bysensor 21 againstvessel wall 28 asguidewire 11 is rotated and withdrawn, may be formed at a uniform rate. To provide higher resolution measurements, the pitch of mapping orscanning path 29 may be tightened or shortened to provide for closer measurement readings, thereby producing a higher resolution profile. Yet to optimize the scanning profile and minimize the time involved in profiling a region of tissue, the device may be configured to automatically provide for lower resolution readings in non-critical areas and higher resolution readings in critical areas, e.g., where the temperature readings are elevated. One method of configuring the device may be to detect when a threshold temperature difference value between set variables, e.g., 0.05° to 0.5° C., is detected. When this threshold difference value is exceeded, this may be an indication of a lesion present within the tissue and thescanning path 29 ofguidewire 11 may accordingly be tightened to produce the higher resolution profile. - For example, during a mapping procedure as shown in
FIG. 4B , theguidewire 11 may be rotated and withdrawn at an initial constant pitch. During this sensing period, scanningpath 29 may provide for a relatively lower resolution temperature profile alongregion 31. When a temperature of thevessel wall 28 is measured bysensor 21 to exceed the predetermined threshold temperature difference, the pitch of scanningpath 29 may be automatically reduced via a connected processor to produce the tightened scanning profile and thereby result in a higher resolution alongregion 33. As thescanning path 29 progresses, once the measured or sensed temperature difference value falls below the preselected threshold value, guidewire 11 may be configured to then automatically resume a lower resolution profile, as seen alongregion 35. - Once the mapping is completed, the
guidewire 16 may be withdrawn fully intocatheter 12, re-sheathed and constrained in a substantially straight configuration, ifcatheter 12 is utilized.Catheter 12 orguidewire 16 alone can then either be withdrawn from theblood vessel 26 or repositioned to another region of interest within the hollow body organ for further mapping of the temperature profile at that region. -
FIG. 5 shows a second preferred embodiment of adevice 10′ for profiling the wall of a hollow body organ.Device 10′ can be deployed in a hollow body organ in a manner similar to the embodiment ofdevice 10 shown inFIGS. 1 and 2 and described above with respect to structure and use. Components ofdevice 10′ that are similar in structure and function to corresponding components ofdevice 10 ofFIGS. 1 and 2 are designated by like primed numerals. The description ofdevice 10 above applies also todevice 10′ unless described otherwise below. -
Device 10′ includes a second thermal sensor 36 disposed at the outside ofbend 22′ and exposed for contact with theinner wall 28′ ofvessel 26′. A secondelectrical conductor 38 is electrically insulated theconductor 32′ and from thewire 18′ ofguidewire 16′ so that guidewire 16′ comprises one conductor andconductor 38 comprises another conductor of the thermocouple or thermistor of thermal sensor 36 for conveying signals from the thermal sensor 36 to the proximal end ofguidewire 16 for connection to appropriate signal processing apparatus that converts the signals to a temperature indication.Wire 18′ ofguidewire 16′ is a conductor common tothermal sensors 20′ and 36. -
Device 10′ ofFIG. 5 can be used in a manner substantially similar to the manner of use described above with respect to the devices above, except that thermistors 20′ and 38 simultaneously traverse intertwined helical paths in contact with theinner wall 28′ ofhollow body organ 26′. Consequently, the temperature profile of theinner wall 28′ can be mapped more quickly because data can be gathered from different locations simultaneously. -
FIG. 6 shows yet another preferred embodiment of adevice 210 for profiling the wall temperature of a hollow body organ.Device 210 can be deployed in a hollow body organ in the manner described above with respect to the embodiments described above. Components ofdevice 210 that are similar in structure and function to corresponding components of the devices above are designated by like reference numerals in the 200 series but having the same last two digits. The description ofdevice 10 above applies also todevice 210 unless described otherwise below. -
Device 210 ofFIG. 6 includes onethermal sensor 40 disposed at the outside of adogleg bend 42 that is spaced distally frombend 222 and from the terminal end ofguidewire 216.Thermal sensor 40 is exposed for contact with the inner wall 228 of vessel 226. An electrical conductor (not shown) is electrically insulated from thewire 218 ofguidewire 216 so thatguidewire 216 comprises one conductor and the electrical conductor comprises another conductor of the thermocouple or thermistor ofthermal sensor 40 for conveying signals from thethermal sensor 40 to the proximal end ofguidewire 216 for connection to appropriate signal processing apparatus that converts the signals to a temperature indication. Unlike the embodiments of the devices of FIGS. 1 to 5,device 210 includes only a thermistor atbend 42 and no thermistor at the terminal end ofguidewire 216 or atbend 222. -
Device 210 ofFIG. 6 can be used in a manner substantially similar to the manner of use described above with respect to the devices of FIGS. 1 to 5. -
FIG. 7 shows a further preferred embodiment of adevice 310 for profiling the wall temperature of a hollow body organ.Device 310 can be deployed in a hollow body organ in the manner described above with respect to the embodiments of the devices described above. Components ofdevice 310 that are similar in structure and function to corresponding components of the above-described devices are designated by like reference numerals. The description ofdevice 10 above applies also todevice 310 unless described otherwise below. -
Device 310 ofFIG. 7 , rather than having externally exposed thermal sensors as in the embodiments above, includes athermal sensor 50 disposed within thelumen 330 ofhollow guidewire 316 and in thermal contact with the coiledwire 318 that comprisesguidewire 316.Thermal sensor 50 is located atbend 52 that is spaced betweenbend 322 and the distal end ofguidewire 316.Guidewire 316 also includesbend 54 betweenbend 52 and the distal end ofguidewire 316.Bends guidewire 316 to assume the shape of a question mark when in a relaxed configuration. In such a configuration, bend 52 and bend 54 contact opposite sides of the inner wall of the hollow body organ. The spring nature ofguidewire 316 urges bend 52 in contact with the hollow body organ. Insulatedelectrical conductors thermal sensor 50 for conveying signals from thethermal sensor 50 to the proximal end ofguidewire 316 for connection to appropriate signal processing apparatus that converts the signals to a temperature indication. -
Device 310 ofFIG. 7 can be used in a manner substantially similar to the manner of use described above with respect to the devices. -
FIG. 8 shows another embodiment of adevice 410 for profiling the wall temperature of a hollow body organ.Device 410 is an alternative configuration of thedevice 310 ofFIG. 7 , in which bend 454 extends in a direction opposite to that ofbend 54, such that the terminal end portion ofguidewire 416 extends axially away fromcatheter 412.Bend 454 serves a purpose similar to that ofbend 54 ofdevice 310 ofFIG. 7 , i.e., to assure thatbend 452, at whichthermal sensor 450 is located, remains in contact with the inner wall of the hollow body organ when deployed therein. -
FIG. 9 shows yet another embodiment of the present invention.Temperature sensing device 510 is carried byhollow guidewire 516 which extends outwardly from the distal end ofcatheter 512 and includesthermal sensor 550, e.g., a thermistor atbend 552 spaced frombend 522 which is situated between the sensor-carryingbend 552 and the distal end portion ofcatheter 512. The distal end portion ofguide wire 516 terminates in a generally crescent-shaped loop and is rotatable, continuously or continually, as desired, to sense the temperature of theendothelium 528 lining the wall ofblood vessel 526 in the vicinity ofplaque deposit 592. -
FIG. 10 shows a further embodiment of adevice 610 for profiling the wall temperature of a hollow body organ.Device 610 comprises another alternative configuration of thedevice 310 ofFIG. 7 , in which guidewire 616 is shaped as a plurality ofloops 60 with a plurality ofthermal sensors 62 located withinguidewire 616 at each location along theloops 60 that would contact the wall of the hollow body organ when disposed therein. -
FIG. 11 shows another embodiment ofguidewire 618 which has two bends disposed withinvessel 26.Guidewire 618 may be formed into a device which is configured to securely place the distal sensing tip againstvessel wall 28. Acontact region 621 is formed betweenguidewire 618 andvessel wall 28 byfirst bend 619.Guidewire 619 may then be configured withsecond bend 620 to extendsensor 622 againstwall 28. With this variation,sensor 622 may be placed securely againstwall 28 during rotation and withdrawal. -
FIG. 12 shows a similar variation inguidewire 623 which may form first andsecond contact regions second sensors vessel wall 28. This variation may have at least twosensors wall 28 during a sensing procedure. This configuration may also allow forguidewire 623 to ensure contact betweenwall 28 andsensors contact regions wall 28 with a gentle force. - The following
FIGS. 13A to 15B show alternative embodiments in which the guidewire probes may be configured to form their sensing configurations by active actuation alone or in addition to any reshaping which may occur by shape memory characteristics of the guidewires. As seen inFIGS. 13A and 13B , guidewire 628 may be formed in a straightened configuration withsensor 629 positioned at some location proximal of the distal tip.Pullwire 630 may be disposed withinguidewire 628 along its length and exposed exteriorly ofguidewire 628 betweenexit port 631 andanchor region 632.Sensor 629 is preferably positioned alongguidewire 628 near the center portion betweenexit port 631 andanchor region 632.Guidewire 628 may be inserted into, e.g., the vasculature, in its straightened configuration and placed near the tissue region to be examined. Prior to examination, pullwire 630 may be pulled at its proximal end, preferably manipulated outside the body of the patient, such that abend portion 633 is formed betweenexit port 631 andanchor region 632. Asbend portion 633 is formed,sensor 629 is preferably extended radially relative to the longitudinal axis ofguidewire 628 such that contact betweensensor 629 and the vessel wall may occur. To help ensure thatsensor 629 is extended on the outer curvature ofbend portion 633,exit port 631 andanchor region 632 are preferably defined onguidewire 628 opposite to wheresensor 629 is located. -
FIGS. 14A and 14B show another alternative embodiment inguidewire 634.Sensor 635 may be located near or at the distal end ofguidewire 634 and pullwire 636 may be disposed within the length ofguidewire 634 and anchored atanchor region 637 proximally ofsensor 635. Prior to examination of the tissue region of interest, pullwire 636 may be manipulated to reconfigure the distal end ofguidewire 634 to radially extend atbend region 638. At the end of the examination procedure, pullwire 636 may be relaxed and guidewire 634 may also be relaxed to reconfigure into its straightened shape. -
FIGS. 15A and 15B show an embodiment which is similar to that shown inFIG. 12 above.Guidewire 639 may be formed to have at least twosensors 640 spaced apart relative to one another alongguidewire 639.Pullwire 641 may be disposed within the length ofguidewire 639 and exposed exteriorly preferably betweenexit ports 642 and anchored to guidewire 639 atanchor region 643. As above,sensors 640 are preferably located near the central portions between theexit ports 642 andanchor region 643 and pullwire 641 is preferably located alongguidewire 639 oppositely ofsensors 640. Prior to examination, pullwire 641 may similarly be manipulated at its proximal end to reconfigureguidewire 639 into first andsecond bend regions Sensors 640 are preferably located along the outer curvatures ofbend regions sensors 640 accordingly aspullwire 641 is pulled. -
FIG. 16 shows another alternative embodiment inguidewire 646 which has linearly spaced probes separated by a distance D. As shown,first probe 647 has a distally locatedfirst sensor 649 at a first distance or radius R1 relative to theguidewire 646 longitudinal axis andsecond probe 648 has a distally locatedsecond sensor 650 at a second distance R2. Although this embodiment shows two probes, any number of linearly spaced probes may be used as practicable.Probes probes -
FIG. 17 shows yet another embodiment of adevice 710 for profiling the wall temperature of a hollow body organ.Device 710 includes alumened catheter 712 and ahollow guidewire 716. The inner surface oflumen 730 ofguidewire 716, at abend 742 similar to bend 42 ofdevice 210 ofFIG. 6 , is lined with a layer ofblack paint 70 which is in turn lined with athermochromic material 72 that is sensitive to a change of temperature of theguidewire 716. The color of thethermochromic material 716 varies as a function of temperature. - Disposed within
lumen 730 ofguidewire 716, inwardly ofthermochromic material 72, is anoptical probe 74 including an illuminatingoptical fiber 76 having a radially emittingdiffuser 78 at the distal end thereof, and a sensingoptical fiber 80 having a conically beveleddistal end 82 for collecting light. An illuminating electromagnetic radiation source connected to the proximal end of illuminatingoptical fiber 76 provides illuminating radiation that is guided byoptical fiber 76 to the region of interest within the hollow body organ, and diffused radially bydiffuser 78 to illuminate the interior oflumen 730, particularlythermochromic material 72. The illuminating radiation can be in the visible, infrared or ultraviolet portions of the spectrum. Radiation fromdiffuser 78 is differentially absorbed and reflected bythermochromic material 72, according to the color ofmaterial 72 which is indicative of the temperature ofguidewire 716 in contact with the wall of the hollow body organ in the region of interest. - The light reflected from
thermochromic material 72, having wavelengths indicative of the color thereof, is collected bydistal end 82 and directed toward the proximal end of sensingoptical fiber 80. An appropriate optical reflectance spectrometry device connected to the proximal end of sensingoptical fiber 80 generates an electrical signal indicative of the color, and therefore temperature, ofthermochromic material 72. -
FIG. 18 shows yet another embodiment of adevice 810 suitable for profiling the impedance of the wall of a hollow body organ.Device 810 includes acatheter 812 within which is disposed aguidewire 816 having a bend in the distal portion thereof.Device 810 is similar in configuration to the embodiment ofdevice 210 ofFIG. 6 , and like components are indicated by like reference numerals in the 800 series but having the same last two digits. Unlikedevice 210 ofFIG. 6 ,device 810 does not employ thermal sensing, but rather employs impedance sensing for profiling the wall of a hollow body organ. Anelectrode 90 at the outside of the bend ofguidewire 816 is in electrical contact withguidewire 816 and in electrical contact with theinner wall 828 of thehollow body organ 826.Guidewire 816 comprises a conductor operatively connected to an external impedance measuring device that has a ground terminal electrically connected to the body in which the hollow body organ is located. A small electrical current is applied viaguidewire 816 andelectrode 90 to theinner wall 828 at the region of contact therebetween. The impedance of the electrical path through the body, including through the region of interest in thehollow body organ 826, can be measured and recorded. By moving guidewire 816 relative to thehollow body organ 826 as described above with respect to other embodiments, the impedance of the wall of thevessel 826 can be mapped. Any change of impedance along thewall 828 indicates the presence of an anomaly in the wall, such as aplaque 92. - Aside from detecting anomalies in the wall of the vessel, impedance measurements may also be used to provide real-time feedback for contact between the guidewire probe and the vessel wall. For instance, when the impedance value rises above a preselected threshold, this may be an indication of lost contact against the
vessel wall 828 since the surrounding fluids, e.g., blood, and/or tissue will likely have a higher impedance than the tissue being examined. One variation using impedance measurements for ensuring contact against the vessel wall is shown inFIGS. 19 and 20 . Similarly toFIG. 18 above, contact betweenguidewire 830 andplaque 92 orinner wall 828 may be ensured by monitoring the measured impedance. In this variation, animpedance sensor 831 may be disposed within the distal tip ofguidewire 830 in communication withpower source 834 viaconnection 833.Connection 833 may be any conventional electrical conductor or optical fiber if optical sensors areutilized. Power source 834 may be any type of power supply preferably capable of generating AC power. - In operation, a first voltage may be applied through the body or
vessel 826, which is typically connected toelectrical ground 832 either directly through, e.g., grounding straps, or indirectly through natural contact via the body of the patient. This first voltage, V1, may be measured atvoltage measurement location 835 and the resulting first current, I1, may be measured atcurrent measurement location 836, which is preferably taken betweenpower source 834 andelectrical ground 837. A second voltage at a second current may be applied through the body orvessel 826 and the resulting voltage, V2, and current, I2, may be measured at voltage andcurrent measurement locations impedance sensor 831 andplaque 92 orvessel wall 828, a consistent impedance value may be maintained and used as an indicator of contact between the two. Yet if contact were broken, then the impedance value will vary and this may be used as an indicator of lost contact betweenguidewire 830 and the tissue. - One detailed example of a dual-sensor probe is shown in
FIG. 20 which may be used for impedance measurement. As shown, the distal end portion ofguidewire 830 may have thethermal sensor 838 in the distal tip, as described above, in communication with a proximally located detector and processor viaconductors 839. A second sensor,impedance sensor 831, may be disposed adjacent or nearthermal sensor 838, and connected viaconnection 833 as shown.Impedance sensor 831 may detect contact via electrical impedance, as described above, but it may also detect via alternative methods, e.g., ultrasound, infrared, laser light, electrical conductivity, etc. Ifimpedance sensor 831 were configured to detect electrical impedance or conductivity,connection 833 will be conductors, but ifsensor 831 were configured to detect via optical methods, e.g., infrared or laser light, optical fibers may accordingly be used asconnection 833 to detect and transmit the optical signals. The methods for impedance detection ofFIGS. 19 and 20 may be used with any of the various guidewire embodiments described herein. -
FIG. 21A shows adevice embodiment 910 where a probe orguidewire 960 is adapted to be coupled to adetachable probe actuator 962 which, in turn, includes acable 964 adapted to be coupled to a signal processing unit or the like.FIG. 21B shows schematically an example of an overall system for temperature sensing. As seen,probe actuator 962 may be connected viacable 964 directly to either thesignal processor unit 963 or to thecontroller 965. The example shows theprobe actuator 962 connected tocontroller 965, which may be used to control and/or record the advancement or withdrawal of the motors or actuators contained within probe actuator 962 (discussed below in further detail) used for manipulating theguidewire 960.Controller 965 may be connected viacable 967 toprocessor 963, e.g., a computer, which may be used to process and display signals received fromguidewire 960 as well as to control the movement ofguidewire 960 within the vasculature. - Prior to temperature acquisition, the probe system is preferably calibrated. The calibration may be performed through various methods. One example includes having two separate sensors for real-time calibration directly by a patient prior to use. One sensor may be placed in an orifice, e.g., the mouth, of the patient and an offset may be added to the measured value to estimate the core body temperature. The other sensor may be within the guidewire and used to acquire the temperature from the tissue region of interest.
- Alternatively, the system may be calibrated in the factory and a programmed calibration factor may be provided to the physician or technician for final calibration prior to use by the patient. Another alternative may be to provide a calibration slug or
pod 969 along with the system. Such aslug 969 may be made from a material, e.g., plastics or polymers, which may be consistently and uniformly heated or cooled to a predetermined temperature, e.g., 37° C., preferably within a protective case prior to calibration.Slug 969 is preferably configured to define a channel or station for receiving and holding the guidewire after theslug 969 has been heated to the desired temperature. The guidewire may then be calibrated prior to each use as theslug 969 may be preferably reused multiple times to generate a consistent calibration temperature. -
FIG. 22 shows the structure of the probe orguidewire 960 which includes astem 966 having a proximal end portion in the form of a hollow, elongate flexibleproximal hypotube 968, a mid portion in the form of a hollow, elongate, flexiblemid hypotube 970 unitary with thetube 968, and a distal end portion unitary with thetube 970 and being in the form of a hollowcoiled end tube 972 which has a bent tip portion orsegment 973 and is composed ofthin wire 918 which has been wound into small helical coils in a manner similar to that described with respect to the coiledguidewire 16 of thedevice 10 shown inFIG. 2 . Atransducer 920 is disposed within the interior of theterminal tip 973 of the distalcoiled end tube 972. As described above with reference to thedevice 10 ofFIG. 2 , thetransducer 920 can take the form of a thermal sensor such as a thermocouple, thermistor, or a radiation sensor. Thetransducer 920 can also, however, take the form of an instrument adapted to respond to inputs other than temperature or radiation such as, for example, displacement or force. Aradiopaque marker band 975 in thetip 973 of thedistal end tube 972 allows the exact location of theprobe 960 to be tracked during use. Moreover, it is understood that thebent tip 973 of the distal end coiledtube 972 can be made of a material which is more radio-opaque than the material forming the remainder of thetube 972 to allow better visibility of theprobe 960 as it is advanced through a blood vessel. - The distal
coiled end tube 972 includes anelongate shaping mandrel 974 extending through the interior thereof generally between the distal end of themid tube 970 and thetransducer 920. Themandrel 974 comprises an elongate strip of metal or the like material having adistal tip portion 977 bent at an angle, a, generally between 10° to 90° relative to the longitudinal axis of thestem 966. In accordance with the preferred embodiment of theprobe 960, thedistal tip portion 977 of themandrel 974 is bent at an angle, α, generally between 30° to 70° and more preferably between 40° to 60° relative to the longitudinal axis of thestem 966. The bent configuration of themandrel 974 is, of course, imparted to the distalcoiled end tube 972 of thestem 966. It has also been determined that theguidewire 16 disclosed inFIG. 2 should preferably also be bent at the same angles as described above with respect to themandrel 974. - Although the
mandrel 974 ofFIG. 22 is permanently bent into its angled configuration, it is understood that themandrel 974 can be constructed from the same types of shape memory materials described above with respect to theguidewire 16 ofFIG. 2 including, for example, spring steel or superelastic nitinol, so as to allow themandrel 974 to move between straight and bent configurations in response to, for example, a change in temperature or the withdrawal of thecoiled end tube 972 from acatheter 12 as shown inFIG. 2 . - Although not shown in
FIG. 22 , it is also understood that themandrel 974 can alternatively take the shape of any of the coils described and shown herein. Additionally, it is understood that the present invention encompasses any one of several different mandrel embodiments depending upon the desired application of the device. For example, in applications where a soft andflexible tip portion 973 is desired, the length of themandrel 974 can be shortened such that it terminates short of thetip portion 973. Moreover, in applications where thetip portion 973 must have a particular stiffness or in applications where it would be desirable to be able to bend or flex thetip portion 973 to help direct the probe into tight openings, thedistal tip 977 of themandrel 974 can be flattened and/or made of a material different than the remainder of themandrel 974. - A plurality of spaced-apart parallel bands or rings of
electrical connectors 978 surround theproximal tube 968 adjacent the proximal terminus thereof. Theconnectors 978 are separated from each other by a plurality of spaced-apart parallel bands or rings ofinsulative material 980. In accordance with one embodiment of the invention, the rings ofconnectors 978 andinsulative material 980 respectively are flush with the outer surface of thetube 968 to assist in the alignment of thecontacts 978 with cooperating contacts (not shown) in theactuator 962. Although not shown, it is also understood that theproximal tube 968 may incorporate a reduced diameter segment defining a groove in theproximal tube 968 and that the connector rings 978 can surround the reduced diameter segment to further assist in the alignment of the contacts with cooperating contacts in theactuator 962. - Also, an elongate
conductive wire 982 extends through thestem 966 between and in contact with theconnectors 978 at one end and thetransducer 920 at the opposite end for conveying appropriate signals from thetransducer 920 to theconnectors 978 and thereafter through theactuator 962 and thecable 964 and into the appropriate signal processing apparatus (not shown). An elongate strip ofinsulative material 984 extending through thestem 966 insulates theconductive wire 982 from thecoils 918 and thetubes insulative material 986 insulates themandrel 974 from thecoils 918 and thetubes insulative material 988 insulates themandrel 984 from theconductive wire 982. -
FIG. 23 depicts anotherprobe embodiment 1060 which is similar in structure to theprobe 960 ofFIG. 22 . Components of probe or guidewire 1060 which are similar in structure and function to corresponding components ofprobe 960 are designated by like numerals in the 1000 series but have the same last two digits. The description of theprobe 960 above applies equally to theprobe 1060 unless described otherwise. - Specifically, the
probe 1060 incorporates structure which allows the distal coiledtube 1072 to rotate relative to themid-tube 1070. Particularly, the distal coiledtube 1072 is adapted to rotate about arotary seal 1090 which separates the coiledtube 1072 from the mid-tube 1070, and the proximal and mid-tubes 1068 and 1072 respectively include anelongate actuation shaft 1092 extending therethrough and having a distal terminus (not shown) operably coupled for rotation to the proximal terminus (not shown) of the distal coiledtube 1072. Additionally, it is understood that the proximal terminus ofproximal tube 1068 is adapted to be removably secured within the distal terminus of theactuator 962 shown inFIG. 21A and further that theactuator 962 incorporates motors therein (as described below) which is operably coupled to the proximal end of theshaft 1092 and adapted to impart a rotary and/or linear motion thereto which, in turn, is transferred to the distal coiledtube 1072. This, of course, allows thetransducer 1020 in thebent tip portion 1073 ofstem 1066 to traverse a circular path around the inner wall of the blood vessel in a manner similar to that described with respect to the earlier embodiment. -
FIG. 24 depicts a further probe embodiment 1160 which is similar in structure to theprobes probes 900 and 1060 are designated by like numerals in the 1100 series but having the same last two digits. The description ofprobes stem 1166 is mounted for axial sliding back and forth movement about theactuator shaft 1192 extending therethrough. Moreover, in the probe 1160, theactuator shaft 1192 is hollow and, although not shown, it is understood that the elongateconductive wire 1182 extends through the distal coiledtube 1172 and then through the interior of theshaft 1192. - The probe 1160 also includes a plurality of spaced-apart, parallel bands or rings of
electrical connectors 1178 surrounding the proximal end portion of theshaft 1192. Theconnectors 1178 are separated from each other by a plurality of spaced-apart parallel bands or rings ofinsulative material 1180. Theconnectors 1178 and bands ofinsulative material 1180 are flush with the outer surface of therotating shaft 1192, and although not shown, it is understood that the proximal end of theconductive wire 1182 is connected to theconnectors 1178. - It is understood that the probe 1160 and, more particularly, the proximal end portions of the
shaft 1192 and theproximal tube 1168 are adapted to be removably fitted within the distal end of the actuator 962 (FIG. 21A ) and further that theactuator 962 is adapted to incorporate, e.g., one or several motor-actuated screw drives, operably associated with theshaft 1192 and thestem 1166 to provide the combined rotational and axial probe movement which allows thetransducer 1120 to traverse a helical path about the longitudinal stem axis in response to the activation of theactuator 962 to permit measurements to be taken at intervals of different regions of a vessel wall in the manner as described above with respect to thedevice 10 andFIG. 2 . - Although not shown, it is also understood that each of the probe or guidewire embodiments described herein must be sufficiently flexible to be insertable within, for example, a blood vessel through a femoral artery access introducer and threaded into the coronary arteries and further that the various probe and guidewire embodiments must also have sufficient rigidity to ensure the rotation of the distal coiled tubes thereof in response to the rotation of the proximal end tubes thereof. In addition, the various probe and guidewire embodiments must provide support, i.e., directional control, for a catheter such as the
catheter 12 shown inFIG. 2 . - For example, because the balance between flexibility and rigidity is important to the effective operation of the various probe embodiments, it has been determined that the probe and guidewire embodiments herein should preferably be constructed such that the bent distal coiled end tubes thereof preferably incorporate a torque response of no more than about 0.4 ounce force inches (ozf in), and more preferably no more than 0.3 ozf in, in response to the torque which is applied to the proximal end tubes of the respective probe and guidewire embodiments. This particular distal coiled end tube torque response can be achieved by varying the profile and/or material and/or coating of any one of the tube sections or the mandrel.
- Additionally, the stiffness or flexibility of the various guidewire or probe embodiments can be adjusted or varied also by changing the shape, profile and/or material of any one of the tube sections or mandrel. Depending upon the desired performance requirements, the
tubes device 910 may, for example, be made from either nitinol or stainless steel and thetube 972 can be shaped into either a flat ribbon or a flat wide ribbon to obtain the desired stiffness ratio. - For example, where a
probe 910 with a soft and flexible coileddistal end tube 972 is desired, it has been determined that thetubes tube 972, the mid-tube 970, and theproximal tube 968 of about 1:4,400:13,000, respectively. It has also been determined that in applications where a probe with a stiff distal coiled tube is desired, thetubes proximal tubes - An example of the proximal end of a probe or guidewire, as shown in the various embodiments of
FIGS. 22-24 , is shown inFIG. 25A . The proximal end of the probe, which has been cross-sectioned for clarity, preferably comprises aconnector assembly 2000 which comprisesshaft 2002 having multiple contacts near the proximal end, e.g.,proximal contact 2006 anddistal contact 2008, which may be separated by indexinggrooves 2004. - The sensor leads 2012 which extend down
shaft 2002 to the sensor at the distal coiled tube, preferably terminate at eachrespective contact conventional insulative coating 2010 which may extend intoindexing grooves 2004 to maintain the electrical separation.Indexing grooves 2004 may be formed such that they are non-coextensive with an outer surface ofshaft 2002, i.e.,grooves 2004 are formed such that they have diameters which are different, e.g., preferably less in diameter, than a diameter ofshaft 2002. The probe may further extend proximally with aproximal extension 2014 to any desired length. -
Proximal extension 2014 may be extended a short distance as shown inFIGS. 22-24 . However, another embodiment of the connector may include a probe having a length much longer than the lengths as shown in the figures above. As seen inFIG. 25B ,probe 2016 may have a length with a mid-portion 2019 within whichcontacts 2017 andinsulation 2018 may be situated.Contacts 2017 may be placed along theprobe 2016 away from either the distal or proximal ends, and preferably near or at themid-portion 2019 ofprobe 2016. Placement of thecontacts 2017 within mid-portion 2019 may then allow for aprobe 2016 having a length much longer, e.g., twice the normal length, than a length typically used. The additional length may then allow for the use of rapid-exchange type catheters to be guided over the body ofprobe 2016 for advancement through the vasculature. -
Probe actuator 962, discussed above, may not only provide for rotational movement of the guidewire probe, but it may also provide for longitudinal movement. A schematic illustration of a variation ofactuator 2080 is shown inFIG. 26 . Rail guide orframe 2081 may provide an internal frame for supporting the various components within the handle ofactuator 962. At a distal end offrame 2081,rotational shaft 2083 may be supported throughinterface 2082.Chuck 2024, to whichprobe 2026 may be connected, may be rotatingly connected to the distal end ofrotational shaft 2083. The proximal end ofrotational shaft 2083 may be connected tomotor 2034, e.g., DC motor, which may provide the rotational torquing force to rotatechuck 2024 andprobe 2026 about its longitudinal axis through, e.g., a pulley andcable assembly 2084, rotational gear assemblies, worm screw assemblies, etc. - At a proximal end of
frame 2081, a second motor, e.g.,stepper motor 2032, may be rotatingly connected viacoupler 2087 to leadscrew 2086, or any other device which can translate rotational motion into linear motion, e.g., worm screw assemblies, rack or internal gear and pinion assemblies, etc.Coupler 2087 may comprise any conventional coupling device which can transmit the rotational torque from a motor with minimal loss to another device such aslead screw 2086. Acarriage assembly 2085 which is preferably connected to a proximal end offrame 2081 is preferably configured to receivelead screw 2086.Lead screw 2086 is preferably received throughcarriage 2085 within a threaded hole such that rotation oflead screw 2086 in a first rotational direction translatescarriage 2085 andframe 2081 in a first linear direction and rotation oflead screw 2086 in a second opposite rotational direction translatescarriage 2085 andframe 2081 in a second opposite linear direction. Thus, a controlled linear motion ofprobe 2026 may be provided by controlled rotation ofmotor 2032. Control ofmotors - Although the actuators are shown as motors, e.g., DC or stepper motors, alternative actuators may include any type of practicable device which can be used to convert mechanical energy into rotational or longitudinal motion for the probes. For instance, screws or thumbscrews may be used to manually impart motion to the probe and guidewire apparatus. Alternatively,
lead screw 2086,rotational shaft 2083, orchuck 2024, or any other component, may be manually manipulated to actuate movement of the probe without having to resort to the use of motors. - FIGS. 27 to 29 show various embodiments which may incorporate
actuator variation 2080, or various embodiments thereof, to effect motion. Various features may be omitted from the figures only for clarity.FIG. 27 shows a side view of one variation onprobe actuator 2020 with the cover removed for clarity.Probe actuator 2020 compriseshandle 2022 having an optionally detachable probe orguidewire chuck 2024.Guidewire chuck 2024, which is discussed in further detail below, is configured for mechanically and electrically receiving the proximal connection end ofprobe 2026 andchuck 2024 itself is in electrical communication withamplifier 2028.Probe 2026 is configured to rotate about its longitudinal axis, and accordingly,chuck 2024 is also configured to rotate about its longitudinal axis. Becausechuck 2024 rotates,amplifier 2028 is also configured to rotate about the same axis aschuck 2024 while remaining in electrical contact to receive the signals from sensor leads 2012 duringprobe 2026 rotation. - As
amplifier 2028 rotates, it is preferably electrically attached to anon-rotating platform 2030 having a plurality of concentric contacts for transmitting the signals to an externally located processor, e.g.,processor 963 inFIG. 21B . An optional motor, e.g.,stepper motor 2032, may be used to distally advance or proximally withdrawprobe 2026 through a known longitudinal distance using, e.g.,actuator variation 2080 above. The distance traveled may be controlled and/or recorded viaprocessor 963 andcontroller 965 ofFIG. 21B .Probe actuator 2020 may also contain within the handle 2022 a separate motor, e.g.,DC motor 2034, used for the rotational control ofprobe 2026. Themotor 2034 may rotate, e.g., in this variation thecentral shaft 2023, which may also connect thechuck 2024 withprobe 2026. Each of the motors may have encoders (not shown) to determine both the rotational and axial position of the probe.Motor 2034 may also be controlled via theprocessor 963 and/orcontroller 965 throughsignal cable 2036. -
FIG. 28 shows an isometric view ofprobe actuator 2020 ofFIG. 27 with various components removed for clarity.Motor 2034 may be seen connected to therotational shaft 2023 via arotational gear 2035.Shaft 2023 may also be seen optionally extending from themotor 2034 to the probe orguidewire chuck 2024. -
FIG. 29 shows an isometric view of analternative probe actuator 2040 which has had the cover partially removed for clarity. As shown, handle 2042 may contain the components as described above, e.g.,chuck 2024,amplifier 2028,stepper motor 2032,DC motor 2034, etc. Thevariation 2040 seen has theDC motor 2034 positioned in-line with the other components in a collinear arrangement. Thus,motor 2034 may be aligned and mechanically connected viacoupler 2044 to transfer the rotational motion viashafts 2046 to chuck 2024. This arrangement allows for the compact packaging of the components within an ergonomically designedhandle 2042. - The
chuck 2024 which acts as the interface between the probe actuator and the probe itself is preferably removable as a separate unit from the probe actuator and may optionally be disposable. It may be provided as a package with the probe or guidewire for use with different probe actuators to maintain the sterility of the probe and the chuck between different patients.FIG. 30A shows a side view of achuck 2024 which has been removed from the probe actuator. As seen by the dashed lines, aprobe insertion lumen 2050 is defined within thechuck 2024 for receiving the proximal end of theprobe 2026. Within theinsertion lumen 2050, there may be one orseveral contacts 2052 which are complementary to thecontacts probe 2026. -
Chuck 2024 may also be configured such thatprobe 2026 is mechanically seated securely within theinsertion lumen 2050. Ensuring a secure mechanical fit can ensure good signal transfer betweenprobe 2026 and theamplifier 2028. Moreover, theprocessor 963 may be configured whereby if theprobe 2026 is not securely seated, any temperature readings will default to a null value or alternatively to a predetermined value which is well beyond normal readings to indicate a faulty connection in the system. - Moreover, the
insertion lumen 2050 may further define a stop or a barrier within for halting the insertion of theprobe 2026 within thelumen 2050 at the desirable position such that the contacts are fittingly aligned with one another. When the contacts are desirably aligned, the electrical signals taken by theprobe 2026 may be transferred through thechuck 2024 with minimal noise and interference. The proximal end of thechuck 2024 may define anattachment 2054 for connection to the probe actuator in which theattachment region 2054 defines several contact regions. These regions are configured to allow for the transfer of signals fromcontacts 2052 to an electrically connected amplifier whilechuck 2024 rotates about its own longitudinal axis during signal acquisition. -
FIG. 30B shows one variation of an electrical schematic ofchuck 2024 fromFIG. 30A which may be self-calibrated. As seen, withprobe 2026 seated withinchuck 2024, electrical contact may be made betweencontacts 2052 andprobe 2026.Chuck 2024 may be configured to havevariable resistors 2090, which may also be discrete resistors, in electrical communication betweenprobe 2026 andattachment region 2054.Variable resistors 2090 can be used to determine a calibration factor for a given probe which may be provided along with a chuck calibrated to the probe. For example, a resistor value of, e.g., 1 to 1000 Ω, can be selected to have 1000 discrete values. An arbitrary resistor value of, e.g., 500 Ω, may be selected as a neutral point and any probe having calibration errors above this neutral point may be used with a resistor having a value above 500 Ω and any probe having calibration errors below this neutral point may be used with a resistor having a value below 500 Ω.Variable resistors 2090 in anychuck 2024 may simply be adjusted accordingly to account for the calibration errors. - The
amplifier 2028 ofFIGS. 27 and 29 are shown in isometric and end views inFIGS. 31A and 31B , respectively. Theamplifier 2028 is used to amplify the acquired signals taken from the tissue by the probe while rotating about a longitudinal axis as seen by the rotational arrows inFIG. 31A . As signals are electrically received by the amplifier circuitry 2060, they may be transferred via a rotating platform 2062 which is in electrical communication withamplifier 2028. The platform 2062, which is preferably circular in shape but may also be formed into other shapes, may have a plurality of contacts 2064 formed on one side of the platform 2062. The contacts 2064 may be formed into any number of concentric circles depending upon the number of contacts needed to transfer the signal. When theamplifier 2028 and the platform 2062 rotate during signal acquisition, the received signals may be transmitted through the contacts 2064 to brushes in corresponding contact without having to stop for signal transfer. - Signal processing and probe manipulation are preferably done by
processor 963 and/orcontroller 965. However, manual operation of the probe may sometimes be desirable. To allow for easy manual manipulation, an intervening chuck assembly, an intervening connector cable, or a combination of both may be utilized. As seen inFIG. 32 , an isometric view of a manually actuatedprobe assembly 2070 is illustrated with anoptional intervening chuck 2072. The interveningchuck 2072 may be used to receive theprobe 2026 in the same manner as described above and thechuck 2072 may have anoptional connector 2074 for attachment to the interveningcable connector 2078. The interveningconnector cable 2076 is preferably made of a polymeric material which is flexible enough to assume various curves but is stiff enough to transmit a torquing force along the length of theconnector cable 2076. This can be accomplished through any variety of methods in constructing theconnector cable 2076; for instance, metallic braids, reinforcing braids, or strands may be used in the construction of the cable. Alternatively, thermoset or thermoplastic polymers having a sufficient shear strength may be used alone or in combination with the various reinforcing methods. - The intervening
chuck 2072 andconnector cable 2076 may be used merely as an extension of thechuck 2024 in normal operation. When manual manipulation is desired, however, the physician or surgeon may manipulate theintervening chuck 2072 by hand to impart a rotational or longitudinal motion to theprobe 2026 as necessary or desired. The interveningchuck assembly 2072 may be integrated directly withconnector cable 2076. Alternatively, thechuck 2072 may be maintained as a separate device, as currently shown inFIG. 32 , and attached separately tocable connector 2078 to maintain the sterility of theconnector 2076 and handle 2022 prior to its use. Moreover,chuck 2072 may be omitted entirely andcable connector 2078 may be configured to receive and holdprobe 2026 directly. Manual manipulation ofprobe 2026 may, in this case, be accomplished by rotatingcable 2076,connector 2078 orprobe 2026 directly. - Although the present invention has been described in detail in terms of preferred embodiments, no limitation on the scope of the invention is intended. The scope of the subject matter in which an exclusive right is claimed is defined in the appended claims.
Claims (20)
1. An apparatus for measuring a parameter of vascular tissue, comprising:
a flexible body;
at least one biased projection extending from the body; and
a sensor disposed at a distal end of the at least one biased projection and a conductor for transmitting data from the sensor to a remote device;
wherein the at least one biased projection is adapted to adopt a deployed arcuate configuration relative to a longitudinal axis of the flexible body.
2. The apparatus of claim 1 wherein the flexible body comprises a coiled body.
3. The apparatus of claim 1 wherein the flexible body comprises a guidewire.
4. The apparatus of claim 1 wherein the at least one biased projection is adapted to adopt the arcuate deployed configuration at an angle between 10° to 90° relative to the longitudinal axis
5. The apparatus of claim 1 wherein the sensor comprises a thermistor.
6. The apparatus of claim 1 wherein the at least one biased projection comprises a superelastic material.
7. The apparatus of claim 1 further comprising a sheath adapted to constrain the at least one biased projection therein.
8. The apparatus of claim 7 wherein the sheath is retractable relative to the flexible body.
9. The apparatus of claim 7 wherein the at least one projection is adapted to adopt a low-profile configuration within the sheath and the deployed arcuate configuration externally of the sheath.
10. The apparatus of claim 1 wherein the remote device comprises a processor in communication with the sensor.
11. The apparatus of claim 10 wherein the processor comprises a computer.
12. A method of detecting a temperature variance in a hollow body lumen, comprising:
introducing a temperature detection apparatus into the hollow body lumen, the temperature detection apparatus having a flexible body, at least one biased projection adapted to extend from the body, and a sensor disposed at a distal end of the at least one biased projection and a conductor for transmitting data from the sensor to a remote device;
measuring at least a first temperature value at a first location along the hollow body lumen with the at least one biased projection in a deployed arcuate configuration relative to a longitudinal axis of the flexible body; and
determining a difference between the first temperature value and a reference temperature value.
13. The method of claim 12 further comprising diagnosing a presence of a lesion at the first location if the difference is between 0.05° to 0.5° C.
14. The method of claim 12 further comprising determining a reference temperature value prior to determining a difference.
15. The method of claim 14 wherein determining a reference temperature value comprises measuring a core body temperature.
16. The method of claim 14 wherein determining a reference temperature value comprises providing a predetermined calibration factor.
17. The method of claim 14 wherein determining a reference temperature value comprises measuring an external temperature calibration device.
18. The method of claim 12 further comprising measuring a plurality of temperature values along the hollow body lumen and determining the difference between each of the plurality of temperature values and the reference temperature value.
19. The method of claim 18 wherein measuring a plurality of temperature values comprises continuously measuring the temperature values along the hollow body lumen.
20. The method of claim 18 wherein measuring a plurality of temperature values comprises measuring individual temperature values along the hollow body lumen.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US11/145,497 US20050240116A1 (en) | 2001-07-12 | 2005-06-03 | Device for sensing parameters of a hollow body organ |
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Application Number | Priority Date | Filing Date | Title |
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US09/904,024 US20030013984A1 (en) | 2001-07-12 | 2001-07-12 | Method for sensing and mapping temperature profile of a hollow body organ |
US09/904,212 US20030013986A1 (en) | 2001-07-12 | 2001-07-12 | Device for sensing temperature profile of a hollow body organ |
US10/146,014 US6939313B2 (en) | 2001-07-12 | 2002-05-14 | Device for sensing parameters of a hollow body organ |
US11/145,497 US20050240116A1 (en) | 2001-07-12 | 2005-06-03 | Device for sensing parameters of a hollow body organ |
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US10/146,014 Continuation US6939313B2 (en) | 2001-07-12 | 2002-05-14 | Device for sensing parameters of a hollow body organ |
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US20050240116A1 true US20050240116A1 (en) | 2005-10-27 |
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Application Number | Title | Priority Date | Filing Date |
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US09/904,212 Abandoned US20030013986A1 (en) | 2001-07-12 | 2001-07-12 | Device for sensing temperature profile of a hollow body organ |
US10/146,014 Expired - Fee Related US6939313B2 (en) | 2001-07-12 | 2002-05-14 | Device for sensing parameters of a hollow body organ |
US11/145,497 Abandoned US20050240116A1 (en) | 2001-07-12 | 2005-06-03 | Device for sensing parameters of a hollow body organ |
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US10/146,014 Expired - Fee Related US6939313B2 (en) | 2001-07-12 | 2002-05-14 | Device for sensing parameters of a hollow body organ |
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Also Published As
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WO2003005895A1 (en) | 2003-01-23 |
US20030088187A1 (en) | 2003-05-08 |
US6939313B2 (en) | 2005-09-06 |
WO2003005895A9 (en) | 2003-08-07 |
US20030013986A1 (en) | 2003-01-16 |
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