EP2925222A2 - Système et procédé pour visualiser un positionnement de cathéter dans un système vasculaire - Google Patents

Système et procédé pour visualiser un positionnement de cathéter dans un système vasculaire

Info

Publication number
EP2925222A2
EP2925222A2 EP13857973.5A EP13857973A EP2925222A2 EP 2925222 A2 EP2925222 A2 EP 2925222A2 EP 13857973 A EP13857973 A EP 13857973A EP 2925222 A2 EP2925222 A2 EP 2925222A2
Authority
EP
European Patent Office
Prior art keywords
catheter
transceiver
recited
energy field
needle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
EP13857973.5A
Other languages
German (de)
English (en)
Other versions
EP2925222A4 (fr
Inventor
Nabil Dib
Robert Edward KOHLER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
DIB ULTRASOUND CATHETER LLC
Original Assignee
DIB ULTRASOUND CATHETER LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/691,220 external-priority patent/US20130102890A1/en
Application filed by DIB ULTRASOUND CATHETER LLC filed Critical DIB ULTRASOUND CATHETER LLC
Publication of EP2925222A2 publication Critical patent/EP2925222A2/fr
Publication of EP2925222A4 publication Critical patent/EP2925222A4/fr
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0062—Arrangements for scanning
    • A61B5/0066—Optical coherence imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6855—Catheters with a distal curved tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6869—Heart
    • 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
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided

Definitions

  • the present invention pertains generally to systems for advancing a needle or other secondary instrument through the vasculature of a patient to a treatment site at the heart. More particularly, the present invention pertains to systems that incorporate an imaging modality, such as ultrasound or Optical Coherence Tomography (OCT), to image a needle or other secondary instrument in the vasculature.
  • OCT Optical Coherence Tomography
  • the present invention is particularly, but not exclusively, useful as a system and method for bringing the energy field of an imaging modality into coincidence with the distal end of a catheter, to monitor the advancement of a needle, wire or other secondary instrument from the distal end of the catheter.
  • Imaging modalities For example, ultrasound technology is a well established imaging modality that has proven useful for many applications inside a body.
  • OCT Optical Coherence Tomography
  • These imaging modalities have their respective unique, operational limitations that must be accounted for.
  • the energy fields that are used by the imaging modalities must somehow be made incident on the target area that is to be imaged, and instruments to be used in the target area must be observable.
  • biologies e.g. cells, genes, protein and drugs
  • a needle injector For such an operation, however, it is essential to properly position the instrument that is being used (e.g. a needle injector).
  • the energy field of the imaging modality must be positioned to both cover the injection site, and intercept (i.e. become coincident with) the instrument.
  • a navigation system for use in advancing a needle or a wire (i.e. a guide wire) to an injection site at the heart of a patient which reconfigures a guide catheter to position its distal tip for visualization by an imaging unit.
  • Another object of the present invention is to provide a navigation system, for use when advancing a needle or wire through the vasculature of a patient, that provides for the movement of an imaging unit so its energy field will intercept the distal tip of a guide catheter for visualization of the catheter tip at an injection site.
  • Still another object of the present invention is to provide systems and methods for performing atrial septum procedures having the ability to image the catheter positioned in a forward looking position relative to the target tissue to reduce procedure time and increase success rate over traditional systems and methods.
  • Yet another object of the present invention is to provide a navigation system for use in advancing a needle or wire to an injection site in the vasculature or at the heart of a patient which is simple to manufacture, is easy to use, and is cost effective.
  • a system in accordance with the present invention is provided for advancing a needle to an injection site in the vasculature or at the heart of a patient.
  • the system essentially includes a guide catheter and an imaging unit that is associated with the guide catheter.
  • the guide catheter has a reflective distal tip, and the imaging unit radiates an energy field in a substantially radial direction from the axis of the guide catheter for the purpose of locating the tip.
  • a distal portion of the guide catheter is biased to bend into a predetermined configuration (i.e. the guide catheter may have a pre-bent portion).
  • this configuration will position the distal end of the catheter in the vasculature for interception by the energy field.
  • a coincidence of the reflective tip with the energy field can be established by manipulation of an actuator. Specifically, such a manipulation will move the energy field axially along the length of the guide catheter to intercept the reflective distal tip of the catheter. Once there is coincidence (i.e. when the reflective tip of the guide catheter is located and visualized in the energy field), the reflective tip will reflect a signal.
  • this reflective signal is useful for further positioning of the distal tip and for advancing the needle from the guide catheter and into the injection site.
  • the distal portion of the catheter can be steerable, rather than being pre-bent.
  • the guide catheter defines an axis and it has a proximal end and a distal end. It also has a lumen that extends between the proximal and distal ends of the guide catheter. Further, the lumen is dimensioned to receive either a needle injector that includes a needle for injection into the myocardium, or a wire that passes through the lumen of the catheter to navigate the vasculature, such as by crossing heart valves or septal defects.
  • An extracorporeal source of a fluid e.g. biologies: cells, genes, protein and drugs
  • the distal portion of the guide catheter is formed with a bendable section. Specifically, at least one part in the bendable section is biased to be bent through an angle ⁇ . In an alternate embodiment, there can also be a second part in the bendable section that is further biased to bend through an angle ⁇ . For the alternate embodiment, the center of rotation for the angle ⁇ is axially opposite the center of rotation for the angle ⁇ . Stated differently, the bendable section can be simultaneously bent in two different directions. Further, a reflective tip is attached to the bendable section at the distal end of the guide catheter, and a handle is affixed to the proximal end of the guide catheter.
  • the imaging unit includes a generator, a detector, and a transceiver that is mounted for axial movement on the guide catheter.
  • the imaging unit includes an actuator that is positioned in the handle of the guide catheter to move the transceiver axially along the guide catheter.
  • the actuator will typically have a dial that is mounted on the handle, and it will include an activation wire wherein a first end of the activation wire is attached to the transceiver and a second end is engaged with the dial. Manipulation of the dial will then produce an axial movement of the transceiver along the guide catheter.
  • the operative components of the actuator can be selected as any one of several well-known types, such as a rack and pinion, a lead screw or a reel.
  • the system of the present invention will use the generator, in combination with the transceiver, to radiate an energy field into the vasculature.
  • This radiation will typically be in a substantially radial direction from the axis of the guide catheter.
  • the generator will generate ultrasound energy, but, it is well known that OCT systems can also be effective for purposes of the present invention.
  • energy e.g. ultrasound energy
  • target tissue such as the heart.
  • a detector that is electronically connected to the transceiver will then receive and evaluate the signal of reflected energy to determine where exactly the reflective tip is located, relative to target tissue (e.g. heart), in the energy field.
  • the needle injector can then be advanced through the lumen of the guide catheter for extension of the needle beyond the reflective tip and from the distal end of the guide catheter for use at an injection site.
  • a guide wire rather than the needle injector, may be advanced through the catheter.
  • a system for performing a procedure on targeted heart tissue of a patient with a secondary instrument includes a catheter formed with a lumen that has a pre-bent or actively bendable section that is located along a distal portion of the catheter.
  • the secondary instrument can be inserted into the lumen of the catheter for advancement therein to extend at least a portion of the secondary instrument beyond a distal end of the catheter.
  • the secondary instrument can be a needle injector, electrophysiology ablation catheter or a delivery catheter for delivering an embolic protection device or some other device.
  • an imaging unit transceiver is coupled with the catheter to radiate an energy field in a substantially radial direction from the axis. With this arrangement, the imaging unit is able to simultaneously image a reflective tip on the distal end of the catheter, the secondary instrument and the targeted heart tissue.
  • FIG. 1 is a schematic drawing of a system in accordance with the present invention
  • Fig. 2 is a cross sectional view of the distal portion of the guide catheter of the present invention as seen along the line 2-2 in Fig. 1 ;
  • Fig. 3A is a view of the distal portion of the guide catheter shown in its operational environment and configured with a single bend used for positioning the catheter's distal end at an injection site;
  • Fig. 3B is a view of the distal portion of the guide catheter shown in its operational environment and configured with a double bend used for positioning the catheter's distal end at an injection site;
  • Fig. 4A shows a rack and pinion arrangement for the actuator of the present invention
  • Fig. 4B shows a lead screw arrangement for the actuator of the present invention
  • Fig. 4C shows a reel arrangement for the actuator of the present invention
  • Fig. 5 is a view of the distal portion of another embodiment of a catheter, shown in its operational environment and configured with a double bend for positioning the catheter's distal end at a treatment site;
  • Fig. 6 is a view of the distal portion of another embodiment of a catheter, shown in its operational environment and configured with a single bend and an extended ultrasound transceiver for positioning the catheter's distal end at a treatment site;
  • Fig. 7 is a view of the distal portion of another embodiment of a catheter, shown in its operational environment and configured with a double bend and an extended ultrasound transceiver for positioning the catheter's distal end at a treatment site;
  • Fig. 8 is a sectional view as in Fig. 2 showing an injector having a needle, dilator and needle sheath;
  • Fig. 9 is a perspective view of an injection needle having a spiral pattern laser cut on its exterior surface to increase flexibility and / or ultrasound reflectivity
  • Fig. 10 is a view of the distal portion of another embodiment of a catheter, shown in its operational environment and configured with a pigtail bend for positioning the catheter's distal end at a treatment site and within the observable energy field of an ultrasound transceiver; and
  • Fig. 11 is a view of the distal portion of another embodiment of a catheter, shown in its operational environment and configured with a bend having a substantially straight portion between two curved portions for positioning the catheter's distal end at a treatment site and within the observable energy field of an ultrasound transceiver. DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • a system in accordance with the present invention is shown and is generally designated 10.
  • the system 10 includes a guide catheter 12 that has a reflective tip 14 at its distal end.
  • the system 10 also has a handle 16 that is mounted at the proximal end of the guide catheter 12, with a dial 18 and an actuator 20 being included as part of the handle 16.
  • the dial 18 is connected directly to the actuator 20 for manipulating the actuator 20 during an operation of the system 10.
  • Fig. 1 further indicates that the system 10 includes an energy generator 22 and a detector 24. More specifically, with cross reference to Fig. 2, it is to be appreciated that both the energy generator 22 and the detector 24 are electronically connected to a transceiver 26 via an activation wire 28. It is also to be appreciated that the activation wire 28 can be manipulated by the actuator 20 to move the transceiver 26.
  • the energy generator 22, detector 24 and the transceiver 26 are hereinafter sometimes referred to as an imaging unit.
  • the guide catheter 12 is to be used with a needle injector 30.
  • the needle injector 30 includes a needle wire 32 that has a needle 34 formed at its distal end (see Fig. 2).
  • a fluid source 36 is also provided for the injector 30, and this source 36 will typically hold a fluid that includes biologies (e.g. cells, genes, protein and drugs) for delivery through the injector 30.
  • access into the lumen 38 (see Fig. 2) of the guide catheter 12 for both the needle 34 and the needle wire 32 of the injector 30 is provided via a y-site 40.
  • a bendable section 42 at the distal portion of the guide catheter 12, can be considered as having at least one reconfigurable part 44.
  • a structure for the guide catheter 12 wherein there is no part 46 and, instead, only a part 44.
  • the bendable section 42 can be biased to bend around a center of curvature 48 to establish an angle ⁇ .
  • the angle ⁇ is measured relative to an axis 50 that is generally defined by the length of the guide catheter 12.
  • the bendable section 42 can be respectively biased to rotate through the angle ⁇ and, additionally, through an angle ⁇ around a center of curvature 52.
  • the angles ⁇ and ⁇ are measured in opposite directions with their respective centers of curvature 48 and 52 on opposite sides of the axis 50.
  • various devices have been proposed for bending or steering a catheter through the vasculature of a patient (not shown). For purposes of the present invention, any such device would be suitable for reconfiguring the guide catheter 12.
  • FIG. 2 Another structural aspect of the guide catheter 12 that is of more general importance for the entirety of the system 10 concerns the actuator 20. More specifically, the manipulation of the imaging unit and the consequent movement of the transceiver 26 is essential for the operation of the system 10. This aspect will be best appreciated by sequentially cross referencing Fig. 2 with Figs. 4A, 4B and 4C. Specifically, this aspect regards movements of the transceiver 26 along the axis 50 of the guide catheter 12. With reference to Fig. 2 it will be noted that, proximal to its bendable section 42, the guide catheter 12 is formed with a sleeve 54. Further, it is to be understood that the transceiver 26 is moveable inside the sleeve 54 by a manipulation of the actuator 20.
  • movements of the transceiver 26 by the actuator 20 are made on the guide catheter 12, through a range 56, in directions back and forth along the axis 50 indicated by arrows 66.
  • the real purpose here is to move an energy field 58 (i.e. transceiver 26) that is radiated from the transceiver 26.
  • the energy field 58 will be primarily oriented in a direction perpendicular to the axis 50, and will be radiated whenever the transceiver 26 is activated by the generator 22.
  • the generator 22 will preferably generate ultrasound energy, any other type of energy field that is known for use as an imaging modality is suitable (e.g. OCT). Further, although a two- dimensional field of ultrasound energy is typical, a three-dimensional ultrasound field may also be used.
  • Figs. 4A, 4B and 4C are only exemplary.
  • the components for the actuator 20 are shown to include a straight toothed rack 60 that is affixed to the activation wire 28.
  • a pinion 62 is shown engaged with the rack 60 and, with this engagement, the pinion 62 can be rotated by the dial 18 on handle 16 in the directions indicated by arrows 64. This rotation of the pinion 62 will then move the transceiver 26 axially along the guide catheter 12 in the directions of arrows 66.
  • FIG. 4A the components for the actuator 20 are shown to include a straight toothed rack 60 that is affixed to the activation wire 28.
  • a pinion 62 is shown engaged with the rack 60 and, with this engagement, the pinion 62 can be rotated by the dial 18 on handle 16 in the directions indicated by arrows 64. This rotation of the pinion 62 will then move the transceiver 26 axially along the guide catheter 12 in the directions of arrows 66.
  • a projection 68 is affixed to the activation wire 28.
  • a lead screw 70 is then engaged with the projection 68. Consequently, a rotation of the lead screw 70 by the dial 18 in directions indicated by arrows 72 will move the transceiver 26 axially along the guide catheter 12 in the directions of arrows 66.
  • a reel 74 is incorporated to take-up the activation wire 28. More specifically, with a rotation of the reel 74 in the directions indicated by arrows 76, the transceiver 26 will move axially along the guide catheter 12 in the directions of arrows 66.
  • the guide catheter 12 is positioned in the vasculature of a patient (not shown), and there it is reconfigured as shown in either Fig. 3A or Fig. 3B.
  • the transceiver 26 can then be moved by the actuator 20, as disclosed above, so that the energy field 58 radiated by the transceiver 26 will intercept the reflective tip 14 of the guide catheter 12.
  • a movement of the energy field 58 is shown in Fig. 3A where it can be seen that the energy field 58' has been moved axially along the guide catheter 12 to a new position for the energy field 58.
  • the reflective tip 14 of the guide catheter 12 is located in the energy field 58, and can be visualized with the detector 24 of the particular imaging modality being used), the reflective tip 14 can be further manipulated. Also, in this configuration the reflective tip 14 is positioned so that an advancement of needle 34 (or a guide wire) from reflective tip 14 will be seen as an axial movement of the needle 34. Further, because the energy field 58 will also see an injection site 78 on target tissue (e.g. the heart), advancement of the needle 34 can be made relative to the injection site 78 (target tissue). In particular, this additional manipulation may be necessary in order to properly position the reflective tip 14 at a predetermined injection site 78. The needle injector 30 can then be advanced through the guide catheter 12 to perform an injection with the needle 34 at the injection site 78.
  • target tissue e.g. the heart
  • Fig. 5 shows the distal end of another embodiment of a catheter 12' having a reflective tip 14' and bendable section 42'.
  • the bendable section 42' can be configured as a compound curve at the distal portion of the catheter 12'.
  • Fig. 5 further shows that a secondary instrument 80, such as the needle injector described above or some other type of secondary instrument (see below), can be extended from the lumen of the catheter 12' and beyond the distal end of the catheter 12' for interaction with target tissue 82.
  • the secondary instrument 80 can be an injection catheter as described above, a needle and or needle / dilator assembly (see Fig.
  • a stylet for example to puncture and or cross the atrial septum, a stylet, an electrophysiology ablation catheter or some other type of ablation catheter known in the pertinent art to ablate target tissue, a delivery catheter for delivering an embolic protection device, a snare or some other device or implant, a guidewire, for example, for crossing a heart valve, atrial septum or ventricular septum or any other secondary instrument known in the pertinent art.
  • the catheter 12' includes a transceiver 26', as described above, that is positioned on the catheter 12' proximal to the bendable section 42', for producing an energy field 58a.
  • the transceiver 26' can be a phased array transceiver having a plurality of individually controllable ultrasound transducers. With this arrangement, the shape, and in some cases the direction of the ultrasound energy field 58a emitted by the transceiver 26' can be controlled by activating the phased array transceiver 26' with the appropriate drive signal(s).
  • the transceiver 26' can be configured to produce a substantially cone shaped energy field 58a.
  • the ultrasound energy is able to look through and image behind standard catheter materials including braided materials.
  • the cone shaped energy field 58a can extend in a substantially radial direction relative to the catheter axis 50'.
  • the transceiver 26' can be moveable, as described above, back and forth along the axis 50' (see arrow 84) to selectively move the energy field 58a and intercept the reflective tip 14', secondary instrument 80 and target tissue 82 in a single image.
  • the transceiver 26' can be rotated about the axis 50' to selectively move the energy field 58a to a desired location.
  • a transceiver 26' producing another type of energy field known in the pertinent art for use as an imaging modality, such as OCT, may be used.
  • the bendable section 42' can be biased to establish an angle, ⁇ , measured relative to an axis 50' (i.e. the axis 50' is generally defined by the straight portion of the catheter 12' proximal to the bendable section 42'), and, additionally, biased to establish an angle ⁇ (as described above with reference to Fig. 3B).
  • the angle, ⁇ is typically in the range of 0 degrees ⁇ ⁇ ⁇ 90 degrees
  • the angle, ⁇ j> is typically in the range of 0 degrees ⁇ ⁇ j> ⁇ 90 degrees to place the reflective tip 14', secondary instrument 80 and target tissue 82 in the observable portion of the energy field 58a, as shown.
  • an angle, ⁇ greater than about 160 degrees and an angle, ⁇ greater than about 70 degrees is used for the embodiment shown in Fig. 5.
  • the compound bend can be a single plane curve, as shown, or, a bi-plane curve may be used. With the arrangement shown, an image can be produced using the transceiver 26' in which the secondary instrument 80 is positioned in a forward looking position relative to the target tissue 82.
  • the compound curve can be established using a pre-bent section 42'.
  • the pre-bent section 42' can be delivered over a guidewire which straightens the section for navigation through the vasculature.
  • the section 42' will assume its pre-bent shape as the guidewire is retracted.
  • the section 42' can be actively deflected at the treatment site.
  • the catheter 12' can include a pair of wires (not shown) extending along the length of the catheter 12' and connected to respective anchor rings (not shown) located at the distal end of each curve making up the compound curve.
  • Fig. 6 shows the distal end of another embodiment of a catheter 12" having a reflective tip 14" and bendable section 42" that can be placed in a so-called “hockey stick” shape.
  • the bendable section 42" can be configured as a single curve at the distal portion of the catheter 12".
  • Fig. 6 further shows that a secondary instrument 80', such as the needle injector described above or some other type of secondary instrument (described above), can be extended from the lumen of the catheter 12" and beyond the distal end of the catheter 12" for interaction with target tissue 82'.
  • the catheter 12" includes a transceiver 26", as described above, for producing an energy field 58a' which, as shown, can be a substantially fan or coned shaped energy field 58a'. It is to be appreciated that within the cone, suitable imaging may be performed allowing for dynamic monitoring of the catheter 12", reflective tip 14" and target tissue 82'. Also shown in Fig. 6, the cone shaped energy field 58a' can extend in a substantially radial direction relative to the catheter axis 50". Fig. 6 shows that the transceiver 26" is integral with the catheter 12".
  • the transceiver 26" can extend from a lumen of the catheter 12", or both the catheter 12" and transceiver 26" can be delivered to the treatment site in a common guide catheter (not shown). For both cases, as shown, the transceiver 26" can be extended from a location proximal to the bendable section 42" and along axis 50" to a location spaced from the catheter 12". In some implementations the transceiver 26" can be moveable, as described above, back and forth along the axis 50" to selectively move the energy field 58a' and intercept the reflective tip 14", secondary instrument 80' and target tissue 82' in a single image.
  • the transceiver 26" can be rotated about the axis 50" to selectively move the energy field 58a' to a desired location.
  • a transceiver 26" producing another type of energy field known in the pertinent art for use as an imaging modality, such as OCT, may be used.
  • the bendable section 42" can be biased to establish an angle, ⁇ , (as described above with reference to Fig. 3A) measured relative to an axis 50" (i.e. the axis 50" is generally defined by the straight portion of the catheter 12" proximal to the bendable section 42").
  • the angle, ⁇ is typically in the range of 90 degrees ⁇ ⁇ ⁇ 180 degrees to distance the reflective tip 14" from the transceiver 26" and place the reflective tip 14", secondary instrument 80' and target tissue 82' in the observable portion of the energy field 58a', as shown.
  • an angle in the range of 125 degrees ⁇ ⁇ ⁇ 145 degrees is used for the embodiment shown in Fig. 6.
  • an image can be produced using the transceiver 26" in which the secondary instrument 80' is positioned in a forward looking position relative to the target tissue 82'.
  • the curve can be established using a pre-bent bendable section 42" or can be actively deflected at the treatment site.
  • Fig. 7 shows the distal end of another embodiment of a catheter 12"' having a reflective tip 14"' and bendable section 42"'.
  • the bendable section 42"' can be configured as a compound curve at the distal portion of the catheter 12"'.
  • Fig. 7 further shows that a secondary instrument 80", such as the needle injector (described above) or some other type of secondary instrument (described above), can be extended from the lumen of the catheter 12"' and beyond the distal end of the catheter 12"' for interaction with target tissue 82".
  • the catheter 12"' includes a transceiver 26"', as described above, for producing an energy field 58a" which, as shown, can be a substantially coned shaped energy field 58a". It is to be appreciated that within the cone, suitable imaging may be performed. Also shown in Fig. 7, the cone shaped energy field 58a" can extend in a substantially radial direction relative to the catheter axis 50"'.
  • the transceiver 26"' is integral with the catheter 12"'.
  • the transceiver 26"' can extend from a lumen of the catheter 12"' or both the catheter 12"' can both be delivered to the treatment site in a common guide catheter (not shown).
  • the transceiver 26"' can be extended from a location proximal to the bendable section 42"' and along axis 50"' to a location spaced from the catheter 12"'.
  • the transceiver 26"' can be moveable, as described above, back and forth along the axis 50"' to selectively move the energy field 58a" and intercept the reflective tip 14"', secondary instrument 80" and target tissue 82" in a single image.
  • the transceiver 26"' can be rotated about the axis 50"' to selectively move the energy field 58a" to a desired location.
  • a transceiver 26"' producing another type of energy field known in the pertinent art for use as an imaging modality, such as OCT may be used.
  • the bendable section 42"' can be biased to establish an angle, ⁇ , measured relative to an axis 50"' (i.e. the axis 50"' is generally defined by the straight portion of the catheter 12"' proximal to the bendable section 42"'), and, additionally, biased to establish an angle ⁇ (as described above with reference to Fig. 3B).
  • ⁇ measured relative to an axis 50"'
  • the axis 50"' is generally defined by the straight portion of the catheter 12"' proximal to the bendable section 42"'
  • ⁇ as described above with reference to Fig. 3B
  • the angle, ⁇ is typically in the range of 0 degrees ⁇ ⁇ ⁇ 90 degrees, and the angle, ⁇ is typically in the range of 0 degrees ⁇ ⁇ ⁇ 90 degrees to place the reflective tip 14"', secondary instrument 80" and target tissue 82" in the observable portion of the energy field 58a", as shown. More typically, as shown, an angle, ⁇ in the range of 35 degrees ⁇ ⁇ 55 degrees and an angle, ⁇ in the range of 30 degrees ⁇ ⁇ ⁇ 60 degrees is used for the embodiment shown in Fig. 7.
  • the compound bend can be a single plane curve, as shown, or, a bi-plane curve may be used.
  • an image can be produced using the transceiver 26"' in which the secondary instrument 80" is positioned in a forward looking position relative to the target tissue 82".
  • the compound curve can be established using a pre-bent bendable section 42"' or can be actively deflected at the treatment site.
  • Fig. 8 shows an embodiment of a secondary instrument 80a for use in any of the embodiments described above (i.e. Figs. 3A, 3B and 5-7) to pierce and dilate target tissue 82a such as an atrial or ventricular septum.
  • the secondary instrument 80a includes a needle 34a that extends distally from the reflective tip 14a of catheter 12a.
  • Secondary instrument 80a also includes a dilator 86 and sheath 88.
  • the needle including injection needles and puncturing needles, can include a needle tip that is straight, curved (not shown) or can include a one or more pre-defined bends (not shown).
  • the sheath 88 may be shaped as a tube and made of a polymer, a reinforced polymer or metal.
  • the distal end of the catheter 12a is positioned relative to the target tissue. With the catheter 12a positioned, the sheath 88 can be advanced distally, telescoping out from the distal end of catheter 12a until the sheath contacts the target tissue 82a.
  • the needle 34a can be advanced distally to puncture the target tissue 82a, (e.g.
  • the sheath 88 protects the needle 34a against damage to the needle 34a or collateral (i.e. non-target) tissue.
  • the dilator 86 can be distally advanced through the hole made by the needle 34a to dilate the hole to a desired size. It is to be appreciated that the sheath 88 described herein can also be used with the injector systems (described above) to deliver a medicament or cell therapy to target tissue.
  • the integration of the transceiver 26" with the needle 34a allows the user to see the depth of the needle 34a in the tissue 82a in relation to anatomical landmarks and boundaries, and allows the user to see the interaction of the needle sheath 88 and needle 34a with the anatomic wall of the heart or other anatomical structure. This helps the user watch the impact of the pressure against the wall (i.e. condensing / displacing tissue) and helps reduce the risk of puncturing through a wall. It also helps the user see penetration and depth of needle 34a to insure injection of stem cells / biologic material to the right target area. In some cases, the needle may not be hollow all the way through, but may have a solid core until the tip, allowing for more pushability and control.
  • the needle and / or needle sheath may have some steering mechanism and also may be preshaped and deflectable to help align the needle in the field of view of the imaging window.
  • the injector can include a plurality of needles coming out as a bundle for infusion.
  • Fig. 9 shows an injection needle 34b that has been treated to increase the needle 34b's reflection of ultrasonic energy, and thus, increase the observability of the needle 34b when used with the imaging units described herein.
  • the relatively thin needles used for treating heart tissues having a thickness of about AWG 27-28 and made of stainless steel or nitanol, are often difficult to observe using ultrasound.
  • the needle 34b is observable when advancing, penetrating and injecting inside the tissue / organ / muscle.
  • a pattern 90 can be scribed on the exterior surface 92 of needle 34b to increase the surface area and increase the amount of needle surface area that reflects energy back, along a particular angle, to a transceiver (not shown).
  • the pattern 90 may be scribed onto the surface using a laser, a suitable machining process or cut with another similar process. As shown, the pattern 90 may consist of a spiral that extends along a portion of the needle 34b, near the sharp distal tip 94. Other suitable patterns can include one or more spaced apart rings formed on the surface 92 (not shown). In addition, surface features may be established on the surface 92 of the needle 34b to increase the flexibility of the needle 34b, allowing the needle 34b to navigate through the vasculature. Alternatively, or in addition to the scribed pattern 90, a coating can be applied to a portion or all of the surface 92 of the needle 34b (not shown) to increase ultrasound reflectivity and observability. For example, an echogenic polymer coating manufactured by (STS Biopolymers, Henrietta, NY) which produces a polymer film having a porous microstructure that entraps microbubbles of air may be used to increase needle observability.
  • Fig. 10 shows the distal end of another embodiment of a catheter 12b having a reflective tip 14b and bendable section 42b.
  • the bendable section 42b can be configured as a so-called "pigtail curve" creating a full loop at the distal portion of the catheter 12b.
  • Fig. 10 further shows that a secondary instrument 80b, such as the needle injector (described above) or some other type of secondary instrument (described above), can be extended from the lumen of the catheter 12b and beyond the distal end of the catheter 12b for interaction with target tissue 82b.
  • the catheter 12b includes a transceiver 26b, as described above, for producing an energy field 58b which, as shown, can be a substantially coned shaped energy field 58b. It is to be appreciated that within the cone, suitable imaging may be performed. Also shown in Fig. 10, the cone shaped energy field 58b can extend in a substantially radial direction relative to the catheter axis 50b. Fig. 10 shows that the transceiver 26b is mounted on the catheter 12b proximal to the bendable section 42b and is thus integral with the catheter 12b.
  • the transceiver 26b can be moveable, as described above, back and forth along the axis 50b to selectively move the energy field 58b and intercept the reflective tip 14b, secondary instrument 80b and target tissue 82b in a single image.
  • the transceiver 26b can be rotated about the axis 50b to selectively move the energy field 58b to a desired location.
  • a transceiver 26b producing another type of energy field known in the pertinent art for use as an imaging modality, such as OCT may be used.
  • the bendable section 42b is biased to bend greater than 180 degrees such that the distal end of the catheter 12b approaches or crosses a portion of the catheter 12b proximal to the bendable section 42b to position the reflective tip 14b, secondary instrument 80b and target tissue 82b in the observable portion of the energy field 58b, as shown.
  • the pigtail curve can be established using a pre-bent bendable section 42b or can be actively deflected at the treatment site.
  • Fig. 10 shows the distal end of another embodiment of a catheter 12b having a reflective tip 14b and bendable section 42b.
  • the bendable section 42b can be configured as a so-called "pigtail curve" creating a full loop at the distal portion of the catheter 12.
  • Fig. 10 further shows that a secondary instrument 80b, such as the needle injector (described above) or some other type of secondary instrument (described above), can be extended from the lumen of the catheter 12b and beyond the distal end of the catheter 12b for interaction with target tissue 82b.
  • the catheter 12b includes a transceiver 26b, as described above, for producing an energy field 58b which, as shown, can be a substantially coned shaped energy field 58b. It is to be appreciated that within the cone, suitable imaging may be performed. Also shown in Fig. 10, the cone shaped energy field 58b can extend in a substantially radial direction relative to the catheter axis 50b. Fig. 10 shows that the transceiver 26b is mounted on the catheter 12b proximal to the bendable section 42b and is thus integral with the catheter 12b.
  • the transceiver 26b can be moveable, as described above, back and forth along the axis 50b to selectively move the energy field 58b and intercept the reflective tip 14b, secondary instrument 80b and target tissue 82b in a single image.
  • the transceiver 26b can be rotated about the axis 50b to selectively move the energy field 58b to a desired location.
  • a transceiver 26b producing another type of energy field known in the pertinent art for use as an imaging modality, such as OCT may be used.
  • the bendable section 42b is biased to bend greater than 180 degrees such that the distal end of the catheter 12b approaches or crosses a portion of the catheter 12b proximal to the bendable section 42b to position the reflective tip 14b, secondary instrument 80b and target tissue 82b in the observable portion of the energy field 58b, as shown.
  • the pigtail curve can be established using a pre-bent bendable section 42b or can be actively deflected at the treatment site.
  • Fig. 1 1 shows the distal end of another embodiment of a catheter 12c having a reflective tip 14c and bendable section 42c. As shown, for this embodiment, the bendable section 42c can create a full loop at the distal portion of the catheter 12c.
  • Fig. 11 further shows that a secondary instrument 80c, such as the needle injector (described above) or some other type of secondary instrument (described above), can be extended from the lumen of the catheter 12c and beyond the distal end of the catheter 12c for interaction with target tissue 82c.
  • a secondary instrument 80c such as the needle injector (described above) or some other type of secondary instrument (described above)
  • the catheter 12c includes a transceiver 26c, as described above, for producing an energy field 58c which, as shown, can be a substantially coned shaped energy field 58c (field is oriented into the plane of the page). It is to be appreciated that within the cone, suitable imaging may be performed. Also shown in Fig. 11 , the cone shaped energy field 58c can extend in a substantially radial direction relative to the catheter axis 50c. Fig. 11 shows that the transceiver 26c is mounted on the catheter 12c proximal to the bendable section 42c and is thus integral with the catheter 12c.
  • the transceiver 26c can be moveable, as described above, back and forth along the axis 50c to selectively move the energy field 58c and intercept the reflective tip 14c, secondary instrument 80c and target tissue 82c in a single image.
  • the transceiver 26c can be rotated about the axis 50c to selectively move the energy field 58c to a desired location.
  • a transceiver 26c producing another type of energy field known in the pertinent art for use as an imaging modality, such as OCT may be used.
  • the bendable section 42c includes portions 96, 98 and 100. As shown, portions 96 and 100 are curved portions and portion 98 is substantially straight. As further shown, portion 96 can be biased to establish an angle, ⁇ , measured relative to an axis 50c (i.e. the axis 50c is generally defined by the straight portion of the catheter 12c proximal to the bendable section 42c), and, additionally, portion 100 can be biased to establish an angle ⁇ j> (as described above with reference to Fig. 3B). For the embodiment shown in Fig.
  • the angle, ⁇ is typically in the range of 0 degrees ⁇ ⁇ ⁇ 90 degrees, and the angle, ⁇ is typically in the range of 0 degrees ⁇ ⁇ ⁇ 180 degrees to place the reflective tip 14c, secondary instrument 80c and target tissue 82c in the observable portion of the energy field 58c, as shown. More typically, as shown, an angle, ⁇ in the range of 35 degrees ⁇ ⁇ ⁇ 55 degrees and an angle, ⁇ in the range of 45 degrees ⁇ ⁇ ⁇ 90 degrees is used for the embodiment shown in Fig. 10,
  • the compound bend can be a single plane curve with a small out of plane curve to allow the secondary instrument 80c to cross the catheter 12c, as shown, or, a more pronounced bi-plane curve may be used.
  • the curve can be established using a pre-bent bendable section 42c or can be actively deflected at the treatment site.
  • Atrial septum procedures include puncturing the atrial septum, crossing the atrial septum with a wire (for example, to perform mitral valve repair or atrial ablation), atrial septal defect (ASD) closure and patent foramen ovale (PFO) closure.
  • ASD atrial septal defect
  • PFO patent foramen ovale
  • Additional applications of the systems described above include crossing the aortic valve, delivering cells, such as stem cells, or other medicaments to the endocardium (see description above), crossing the ventricular septum and repairing or replacing a heart valve.
  • the systems described herein are compatible with other imaging systems found in a modern cathlab and can be used together with one or more of these other imaging systems to accurately deliver and view the needle or other secondary instrument as it is introduced into the heart or other tissue.
  • These other imaging systems include, but are not limited to, 2D ultrasound, 3D ultrasound, MRI, MRI integrated picture, the NOGA mapping system (Cordis), angiography, CT, PET / nuclear imaging, a 3D mapping system, 3D left ventricle angiogram and 3D echocardiogram.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Human Computer Interaction (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un système pour avancer une aiguille à travers un système vasculaire jusqu'à un site d'injection au niveau du cœur d'un patient, qui comprend un cathéter-guide ayant une pointe distale réfléchissante. L'invention concerne également une unité d'imagerie qui est montée sur le cathéter pour émettre un champ d'énergie. De façon structurale, une partie distale du cathéter est sollicitée pour se plier dans une configuration prédéterminée qui positionnera l'extrémité distale du cathéter de façon à ce que celle-ci soit interceptée par le champ d'énergie. Si nécessaire, une coïncidence de la pointe réfléchissante avec le champ d'énergie est établie par déplacement du champ d'énergie le long du cathéter-guide. Au moyen de cette coïncidence, la pointe réfléchissante réfléchit un signal qui est utile pour faire avancer l'aiguille 34b du cathéter-guide au site d'injection.
EP13857973.5A 2012-11-30 2013-10-16 Système et procédé pour visualiser un positionnement de cathéter dans un système vasculaire Ceased EP2925222A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13/691,220 US20130102890A1 (en) 2010-05-26 2012-11-30 System and Method for Visualizing Catheter Placement in a Vasculature
PCT/US2013/065261 WO2014084975A2 (fr) 2012-11-30 2013-10-16 Système et procédé pour visualiser un positionnement de cathéter dans un système vasculaire

Publications (2)

Publication Number Publication Date
EP2925222A2 true EP2925222A2 (fr) 2015-10-07
EP2925222A4 EP2925222A4 (fr) 2016-07-13

Family

ID=50828581

Family Applications (1)

Application Number Title Priority Date Filing Date
EP13857973.5A Ceased EP2925222A4 (fr) 2012-11-30 2013-10-16 Système et procédé pour visualiser un positionnement de cathéter dans un système vasculaire

Country Status (2)

Country Link
EP (1) EP2925222A4 (fr)
WO (1) WO2014084975A2 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU4131793A (en) * 1992-06-26 1994-01-06 Critikon, Inc. Catheter with extensible, two-piece needle guard
DE60223794T2 (de) * 2001-04-27 2008-10-30 C.R. Bard, Inc. Elektrophysiologie-katheter zur mapping und ablation
US6997938B2 (en) * 2002-02-12 2006-02-14 Scimed Life Systems, Inc. Embolic protection device
CN101809459B (zh) * 2007-09-27 2013-07-31 皇家飞利浦电子股份有限公司 用于全矩阵阵列的机械平移的***和方法
US9332973B2 (en) * 2008-10-01 2016-05-10 Covidien Lp Needle biopsy device with exchangeable needle and integrated needle protection
US8798721B2 (en) * 2010-05-26 2014-08-05 Dib Ultrasound Catheter, Llc System and method for visualizing catheter placement in a vasculature

Also Published As

Publication number Publication date
WO2014084975A2 (fr) 2014-06-05
EP2925222A4 (fr) 2016-07-13
WO2014084975A3 (fr) 2014-11-06

Similar Documents

Publication Publication Date Title
US20130102890A1 (en) System and Method for Visualizing Catheter Placement in a Vasculature
US8798721B2 (en) System and method for visualizing catheter placement in a vasculature
JP5778585B2 (ja) 経頸静脈的肝内門脈大循環短絡術の方法、システム及び装置
US11160532B2 (en) Method of employing a medical apparatus with translatable imaging device for real-time confirmation of interception of target tissue
US20090131790A1 (en) Systems and methods for deploying echogenic components in ultrasonic imaging fields
US20130190609A1 (en) Echogenic medical device
JP6263131B2 (ja) 閉塞アクセスシステム
JP6283128B2 (ja) 基準マーカ留置のためのねじ駆動式ハンドルおよびシステム
JP6122476B2 (ja) 基準マーカー配備システム
WO2009151478A1 (fr) Cathéter d'injection à aiguille
JP2009533175A (ja) 磁気共鳴画像を使用した組織穿刺カテーテルの生体内における位置特定および追跡
JP2016500532A (ja) 湾曲針を備える医療器具
US11950805B2 (en) Sharp turning steerable needle
US20180085027A1 (en) Mr compatible puncture catheter
Henken et al. Manually controlled steerable needle for MRI-guided percutaneous interventions
CN112041016B (zh) 用于介入手术用装置的装置转向、跟踪和导航的***
EP2593172B1 (fr) Procédé et appareil d'injection per-opératoire dans tissu cardiaque
WO2014084975A2 (fr) Système et procédé pour visualiser un positionnement de cathéter dans un système vasculaire
EP4359051A1 (fr) Dispositifs médicaux détachables, composants et leurs procédés d'utilisation
US11864791B2 (en) Handle assembly for medical devices
US10213187B1 (en) Method and apparatus for percutaneous superficial temporal artery access for carotid artery stenting
US20120083653A1 (en) Guided procedural treatment device and method

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20150324

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

AX Request for extension of the european patent

Extension state: BA ME

DAX Request for extension of the european patent (deleted)
A4 Supplementary search report drawn up and despatched

Effective date: 20160609

RIC1 Information provided on ipc code assigned before grant

Ipc: A61B 8/12 20060101ALI20160603BHEP

Ipc: G01T 1/161 20060101ALI20160603BHEP

Ipc: A61B 5/05 20060101AFI20160603BHEP

Ipc: A61B 6/00 20060101ALI20160603BHEP

Ipc: G01T 1/00 20060101ALI20160603BHEP

Ipc: A61B 18/00 20060101ALI20160603BHEP

Ipc: A61B 18/18 20060101ALI20160603BHEP

Ipc: A61B 5/06 20060101ALI20160603BHEP

RIN1 Information on inventor provided before grant (corrected)

Inventor name: KOHLER, ROBERT EDWARD

Inventor name: DIB, NABIL

17Q First examination report despatched

Effective date: 20170518

REG Reference to a national code

Ref country code: DE

Ref legal event code: R003

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN REFUSED

18R Application refused

Effective date: 20180419