WO2010102794A1 - Apparatus for carrying out diagnostic and/or therapeutic procedures - Google Patents

Apparatus for carrying out diagnostic and/or therapeutic procedures Download PDF

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Publication number
WO2010102794A1
WO2010102794A1 PCT/EP2010/001479 EP2010001479W WO2010102794A1 WO 2010102794 A1 WO2010102794 A1 WO 2010102794A1 EP 2010001479 W EP2010001479 W EP 2010001479W WO 2010102794 A1 WO2010102794 A1 WO 2010102794A1
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WO
WIPO (PCT)
Prior art keywords
catheter
imaging device
tip
tissue
image
Prior art date
Application number
PCT/EP2010/001479
Other languages
French (fr)
Inventor
David Mceneaney
Original Assignee
Southern Health And Social Care Trust
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
Application filed by Southern Health And Social Care Trust filed Critical Southern Health And Social Care Trust
Priority to PL10709410T priority Critical patent/PL2410922T3/en
Priority to EP10709410.4A priority patent/EP2410922B1/en
Priority to ES10709410.4T priority patent/ES2440598T3/en
Priority to DK10709410.4T priority patent/DK2410922T3/en
Publication of WO2010102794A1 publication Critical patent/WO2010102794A1/en
Priority to HRP20131208AT priority patent/HRP20131208T1/en

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Classifications

    • 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
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter

Definitions

  • This invention relates to an apparatus for carrying out diagnostic and/or therapeutic procedures and in particular to an apparatus procedures and/or diagnosis comprising a hollow catheter for insertion into the body, an in particular to such an apparatus incorporating an imaging device adapted to provide an image of the tissue ahead of and lateral to the catheter tip.
  • the intrinsic rhythm of the heart is generated in the sino-atrial node, at the junction of the right atrium and superior vena cava.
  • a wave of activation passes over the upper heart chambers (atria), then is conveyed to the lower chambers of the heart (ventricles) by way of the atrio-ventricular node, His bundle and bundle branch/Purkinje fibres. This permits coordinated contraction of the atria and ventricles.
  • the electrical system of the heart is damaged dangerously slow or fast heart rhythms may ensue (bradyarrhythmias or tachyarrhythmias respectively). In many cases these abnormal heart rhythms may result in significant symptoms including dizzy spells or blackouts. In other circumstances arrhythmias may be fatal.
  • Electrodes By inserting electrodes into one or more of the chambers of the heart, via a large vein, it is possible to correct slow heart rhythms by delivering precisely controlled electrical impulses to the appropriate heart chamber. These impulses are generated by a battery and circuitry contained within a pacemaker generator. Power leads link the electrodes to a small hermetically sealed metal box, called the generator, that contains the battery and electronics. Implantable cardiovascular defibrillators have the added ability to deliver higher energy electrical shocks capable of correcting dangerous fast heart rhythms (tachycardias). .
  • cardiac leads typically terminate in a tined tip or screw for anchoring the lead into the muscle tissue of the heart (myocardium).
  • the leads are formed from materials chosen to be as inert as possible, tissue tends to grow over the leads, particularly where they are in contact with the walls of the veins through which they pass, leading to adhesion of the lead to the vessel
  • pacemaker/ICD leads The removal of pacemaker/ICD leads is typically achieved by advancing a sheath or catheter over the lead, the forward tip of the catheter cutting through adhesions of the tissue to the lead.
  • the lead can then be pulled back through the catheter and removed from the body, the catheter acting as a guide for removal of the lead.
  • the cutting action of the catheter can be enhanced by providing a concentric second sheath around the catheter that can advanced relative to the catheter.
  • optical fibres can be provided within the wall of the sheath by means of which laser energy can be used to cut through the tissue ahead of the catheter tip.
  • bipolar electrocautery electrodes are incorporated into the tip of the catheter for separating tissue ahead of the catheter tip using radiofrequency energy.
  • External imaging techniques are able to visualise dense structures within the body, such as bones (X-ray fluoroscopy).
  • X-ray fluoroscopy X-ray fluoroscopy
  • Such techniques do not permit visualisation of the point of contact of the catheter tip with adjacent soft tissues.
  • the pacemaker lead and catheter may thus be imaged using x-rays but the vessels and heart are not visible using this approach, thus the relationship of fibrosis and adhesions to the lead cannot be established.
  • Intravascular ultrasound imaging has been used in the past to provide a cross sectional image of a coronary artery by advancing a small imaging transducer ( ⁇ 1 mm diameter and length), placed at the end of a rotating driveshaft containing the signal cables, through a catheter and then slowly retracting the probe to provide an image of the cross section of the probe along the length of the artery.
  • a small imaging transducer ⁇ 1 mm diameter and length
  • the usual probe for coronary arteries uses 10-20Mhz.
  • the probe resides within a thin polythene tube (through which the sound waves can be transmitted and received by the transducer).
  • the probe can move longitudinally in the tube thus allowing sequential cross sections of the vessel to be obtained.
  • An example of such known ultrasonic imaging probe is the Atlantis SR pro imaging catheter produced by Boston Scientific.
  • an apparatus for carrying out diagnostic and/or therapeutic procedures comprising a hollow tubular catheter for insertion into the venous or arterial system or other body cavity of a patient, said catheter having a tip, an imaging device being associated with the tip of the catheter, said imaging device being adapted to provide an image of the tissue directly ahead of the catheter tip, wherein the imaging device is provided at a distal end of an elongate guide member guided within a guide passage to be axially translatable within the guide passage, a portion of the guide passage at or adjacent the tip of the catheter extending in a substantially helical and/or circumferential configuration around a distal region of the catheter whereby the imaging device can be reciprocated around the tip of the catheter to produce a toroidal or substantially toroidal image of the tissue immediately around and ahead of the catheter tip
  • the imaging device is adapted to provide forward and lateral visualisation of tissue adjacent the catheter tip.
  • said imaging device is adapted to distinguish between muscle, bone and blood and thus determine if the catheter is being advanced into areas where damage to tissue, such as the walls of veins and arteries, may occur.
  • the imaging device may comprise an ultrasonic imaging device comprising one or more ultrasonic transducers or any other suitable imaging device for imaging the tissue adjacent of the catheter tip, such an optical coherence tomography device.
  • Optical coherence tomography is an interferometric technique, typically employing near-infrared light.
  • the guide passage is provided within the catheter wall.
  • the guide member incorporates leads and/or a driveshaft for the imaging device.
  • the imaging device may be rotatable within the guide member as well as reciprocable therein.
  • the imaging device may be connected to a computer for producing an image of the tissue immediately around and ahead of the catheter tip.
  • the computer may be programmed to provide a three dimensional toroidal or substantially toroidal image made up from a series of two dimensional cross sectional views provided by the imaging device at intervals around the circumference of the catheter.
  • the computer may be programmed to provide a two dimensional projection of said three dimensional image.
  • the catheter is adapted to be advanced over a cardiac lead to assist removal of the lead.
  • One or more further tubes or catheters may be provided concentrically outside of or inside of the catheter to assist lead removal.
  • the catheter may be adapted to diagnose and/or treat obstructions in coronary arteries or other vessels, including chronic total occlusions. Additional lumens within or adjacent to the catheter whereby guide wires, stents, and/or balloons may be introduced for this and other therapeutic modalities. One or more additional lumens may be provided for the passage of other devices. One or more such additional lumens may be adapted for the passage of biopsy forceps for the purpose of tissue sampling, for example from the heart of a patient or other organ. One or more of such additional lumens may be adapted for the passage of electrode catheters including mapping and/or radiofrequency ablation catheters. Such mapping and/or radiofrequency ablation catheters may be used for the diagnosis and/or treatment of cardiac arrhythmias.
  • additional lumens may house guide wires or other catheters for use in other diagnostic and/or therapeutic procedures, such as for the puncture of an interarterial septum. This may allow access to the left atrium of the heart from the right atrium, permitting further diagnostic and therapeutic procedures.
  • diagnostic and/or therapeutic procedures such as for the puncture of an interarterial septum. This may allow access to the left atrium of the heart from the right atrium, permitting further diagnostic and therapeutic procedures.
  • Such procedures may include mapping and/or radiofrequency ablation of arrhythmias including arterial arrhythmias.
  • Figure 1 is a longitudinal sectional view through a cardiac lead removal apparatus according to an embodiment of the present invention.
  • Figure 2 is a sectional view on line A-A of Figure 1.
  • a cardiac lead removal apparatus comprises a sheath or catheter 10 adapted to be insertable into a vein 2 with the catheter concentrically arranged around a cardiac lead 4 whereby the catheter 10 can be advanced along the lead 4 such that the tip 12 of the catheter 10 effectively cuts through and separates the lead from surrounding tissue and provides a guide tube for removal of the cardiac lead 4 from the body.
  • an ultrasonic imaging device is incorporated into the catheter.
  • a polythene guide tube 14 is located within the wall of the catheter 10, within which is located a thin elongate cable (not shown) having one or more ultrasonic transducers located at a distal end thereof, leads for the or each transducer extending through the cable.
  • a thin elongate cable (not shown) having one or more ultrasonic transducers located at a distal end thereof, leads for the or each transducer extending through the cable.
  • suitable imaging devices such as an optical coherence tomography device, may be used.
  • the elongate cable is arranged to be rotatable and axially translatable within the guide tube 14.
  • the guide tube 14 runs longitudinally of the catheter 10, except for a distal portion X of the guide tube 14 at or adjacent the tip of the catheter 10, which extends in a substantially helical or circumferential configuration around a distal region of the catheter 10 whereby the ultrasonic transducer can be reciprocated around the circumference of the tip of the catheter, and optionally also rotated, to produce a toroidal image of the tissue immediately around and ahead of the catheter tip, as shown in Figure 1 (see region marked N), providing forward, medial and lateral imaging around the circumference of the catheter tip, visualising adjacent vascular structures and pacemaker/defibrillator lead.
  • the guide tube 14, and the ultrasonic imaging device located therein, are located entirely within the wall of the catheter 10 such that the inner and outer surfaces of the catheter 10 remain smooth, avoiding snagging on the walls of the vein 2 through which the catheter 10 is passed and preventing the cardiac lead 4 from snagging on the inner wall of the catheter 10.
  • the ultrasonic imaging device To image anterior and laterally to the tip of the catheter 10 requires the ultrasonic imaging device to be positioned perpendicular to the axis of the catheter and move circumferentially around (but within) it.
  • the image generated by the ultrasonic imaging device will be approximately toroidal so some processing will be needed to appropriately display this (e.g. in different cross sections or ideally 3D).
  • processing can be provided by a computer connected to the ultrasonic imaging device.
  • IVUS intravascular ultrasound
  • IVUS intravascular ultrasound
  • Suitable computer software will be required to reconstruct a 3D image of the end of sheath, adjacent vessel and pacemaker lead. It will be possible to orient the imaging plane using the varying relationship to the helical channel to the catheter tip as a marker (x-y etc).
  • the present invention permits other extraction apparatus to be used as a second sheath, either internal to or external to the catheter 10. If internal, the second sheath would lie between the pacemaker lead and the catheter 10.
  • the invention providing imaging of the point of contact of the catheter with body tissue, avoiding the prior art problems inherent with blind insertion of catheters, particularly in relation to intravascular catheters.
  • the helical arrangement of the guide tube at the catheter tip thus provides a series of 2 dimensional cross sectional views around the circumference of the catheter tip, and with suitable image manipulation, a 3 dimensional reconstruction of the tip of the catheter and adjacent structures as it is advanced through the body.
  • Additional lumens or catheters may be provided within or alongside the catheter 10, such additional lumens or catheters housing other diagnostic and/or therapeutic devices, such as guide wires, stents, balloons, biopsy forceps, electrode catheters, such as mapping and/or ablation catheters or any other similar device, wherein the image generated by the imaging device may facilitate the use of such devices and the accurate positioning of such devices within the body.
  • additional devices may be used for tissue sampling, in the case of biopsy forceps, the diagnosis and treatment of cardiac arrhythmias.

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Abstract

An apparatus for carrying out diagnostic and/or therapeutic procedures and/or diagnosis, said apparatus comprising a hollow tubular catheter for insertion into the venous or arterial system or other body cavity of a patient, said catheter having a tip, an imaging device being associated with the tip of the catheter, said imaging device being adapted to provide an image of the tissue ahead of and lateral to the catheter tip, wherein the imaging device is provided at a distal end of an elongate guide member guided within a guide passage to be axially translatable within the guide passage, a portion of the guide passage at or adjacent the tip of the catheter extending in a substantially helical and/or circumferential configuration around a distal region of the catheter whereby the imaging device can be reciprocated around the tip of the catheter to produce a toroidal or substantially toroidal image of the tissue immediately around and ahead of the catheter tip.

Description

Apparatus for carrying out diagnostic and/or therapeutic procedures
This invention relates to an apparatus for carrying out diagnostic and/or therapeutic procedures and in particular to an apparatus procedures and/or diagnosis comprising a hollow catheter for insertion into the body, an in particular to such an apparatus incorporating an imaging device adapted to provide an image of the tissue ahead of and lateral to the catheter tip.
The intrinsic rhythm of the heart is generated in the sino-atrial node, at the junction of the right atrium and superior vena cava. A wave of activation passes over the upper heart chambers (atria), then is conveyed to the lower chambers of the heart (ventricles) by way of the atrio-ventricular node, His bundle and bundle branch/Purkinje fibres. This permits coordinated contraction of the atria and ventricles. If the electrical system of the heart is damaged dangerously slow or fast heart rhythms may ensue (bradyarrhythmias or tachyarrhythmias respectively). In many cases these abnormal heart rhythms may result in significant symptoms including dizzy spells or blackouts. In other circumstances arrhythmias may be fatal. By inserting electrodes into one or more of the chambers of the heart, via a large vein, it is possible to correct slow heart rhythms by delivering precisely controlled electrical impulses to the appropriate heart chamber. These impulses are generated by a battery and circuitry contained within a pacemaker generator. Power leads link the electrodes to a small hermetically sealed metal box, called the generator, that contains the battery and electronics. Implantable cardiovascular defibrillators have the added ability to deliver higher energy electrical shocks capable of correcting dangerous fast heart rhythms (tachycardias). .
750,000 pacemakers and implantable cardiovascular defibrillators are inserted annually in Europe and 850,000 implantable devices are inserted annually in the United States. As these devices increase in complexity, a greater number of implanted leads may be required, up to three in some cases. However, such cardiac leads may be prone to failure due to the mechanical stresses caused by movement or impact or they may require removal due to infection. Typically 4% to 7% of leads may require removal over the lifetime of a patient due to infection or malfunction, and studies have shown that up to 20% of cardiac leads may require replacement within ten years. Cardiac leads typically terminate in a tined tip or screw for anchoring the lead into the muscle tissue of the heart (myocardium). Removal of the lead can result in damage to the heart, particularly where fibrosis has occurred around the tip of the lead. Furthermore, while the leads are formed from materials chosen to be as inert as possible, tissue tends to grow over the leads, particularly where they are in contact with the walls of the veins through which they pass, leading to adhesion of the lead to the vessel
The removal of pacemaker/ICD leads is typically achieved by advancing a sheath or catheter over the lead, the forward tip of the catheter cutting through adhesions of the tissue to the lead. The lead can then be pulled back through the catheter and removed from the body, the catheter acting as a guide for removal of the lead. The cutting action of the catheter can be enhanced by providing a concentric second sheath around the catheter that can advanced relative to the catheter. In other versions, optical fibres can be provided within the wall of the sheath by means of which laser energy can be used to cut through the tissue ahead of the catheter tip. In another version, bipolar electrocautery electrodes are incorporated into the tip of the catheter for separating tissue ahead of the catheter tip using radiofrequency energy.
Many other intravascular and keyhole surgeries and diagnostic techniques involve the insertion of hollow catheters into the body and, in particular, into the venous and arterial systems.
A major problem with existing lead removal technology, and other techniques involving the insertion into the body of hollow catheters, is that the catheter is typically inserted under X- ray control, with no method of directly visualising the point of contact of the catheter with tissue immediately ahead of or adjacent to the catheter tip, leading to the risk of damage to tissue and the possible tearing and rupturing of the walls of blood vessels or the heart chambers. External imaging techniques are able to visualise dense structures within the body, such as bones (X-ray fluoroscopy). However, such techniques do not permit visualisation of the point of contact of the catheter tip with adjacent soft tissues. The pacemaker lead and catheter may thus be imaged using x-rays but the vessels and heart are not visible using this approach, thus the relationship of fibrosis and adhesions to the lead cannot be established.
Intravascular ultrasound imaging has been used in the past to provide a cross sectional image of a coronary artery by advancing a small imaging transducer (<1 mm diameter and length), placed at the end of a rotating driveshaft containing the signal cables, through a catheter and then slowly retracting the probe to provide an image of the cross section of the probe along the length of the artery. There are various sizes and frequency spectrum characteristics of probes. The usual probe for coronary arteries uses 10-20Mhz. For coronary arteries the probe resides within a thin polythene tube (through which the sound waves can be transmitted and received by the transducer). The probe can move longitudinally in the tube thus allowing sequential cross sections of the vessel to be obtained. An example of such known ultrasonic imaging probe is the Atlantis SR pro imaging catheter produced by Boston Scientific.
However, such known ultrasonic probes are only able to produce cross sectional images of the artery and cannot provide a forward looking image of the leading tip of a catheter. Furthermore, such probes are advanced and retracted coaxially through the centre of a guide catheter, therefore the catheter cannot serve a further purpose, such as cardiac lead removal.
According to the present invention there is provided an apparatus for carrying out diagnostic and/or therapeutic procedures, said apparatus comprising a hollow tubular catheter for insertion into the venous or arterial system or other body cavity of a patient, said catheter having a tip, an imaging device being associated with the tip of the catheter, said imaging device being adapted to provide an image of the tissue directly ahead of the catheter tip, wherein the imaging device is provided at a distal end of an elongate guide member guided within a guide passage to be axially translatable within the guide passage, a portion of the guide passage at or adjacent the tip of the catheter extending in a substantially helical and/or circumferential configuration around a distal region of the catheter whereby the imaging device can be reciprocated around the tip of the catheter to produce a toroidal or substantially toroidal image of the tissue immediately around and ahead of the catheter tip
Preferably the imaging device is adapted to provide forward and lateral visualisation of tissue adjacent the catheter tip.
Preferably said imaging device is adapted to distinguish between muscle, bone and blood and thus determine if the catheter is being advanced into areas where damage to tissue, such as the walls of veins and arteries, may occur.
The imaging device may comprise an ultrasonic imaging device comprising one or more ultrasonic transducers or any other suitable imaging device for imaging the tissue adjacent of the catheter tip, such an optical coherence tomography device. Optical coherence tomography is an interferometric technique, typically employing near-infrared light.
Preferably the guide passage is provided within the catheter wall. Preferably the guide member incorporates leads and/or a driveshaft for the imaging device.
The imaging device may be rotatable within the guide member as well as reciprocable therein.
Preferably the imaging device may be connected to a computer for producing an image of the tissue immediately around and ahead of the catheter tip. The computer may be programmed to provide a three dimensional toroidal or substantially toroidal image made up from a series of two dimensional cross sectional views provided by the imaging device at intervals around the circumference of the catheter. The computer may be programmed to provide a two dimensional projection of said three dimensional image.
In one embodiment, the catheter is adapted to be advanced over a cardiac lead to assist removal of the lead. One or more further tubes or catheters may be provided concentrically outside of or inside of the catheter to assist lead removal.
In an alternative embodiment the catheter may be adapted to diagnose and/or treat obstructions in coronary arteries or other vessels, including chronic total occlusions. Additional lumens within or adjacent to the catheter whereby guide wires, stents, and/or balloons may be introduced for this and other therapeutic modalities. One or more additional lumens may be provided for the passage of other devices. One or more such additional lumens may be adapted for the passage of biopsy forceps for the purpose of tissue sampling, for example from the heart of a patient or other organ. One or more of such additional lumens may be adapted for the passage of electrode catheters including mapping and/or radiofrequency ablation catheters. Such mapping and/or radiofrequency ablation catheters may be used for the diagnosis and/or treatment of cardiac arrhythmias. Similarly such additional lumens may house guide wires or other catheters for use in other diagnostic and/or therapeutic procedures, such as for the puncture of an interarterial septum. This may allow access to the left atrium of the heart from the right atrium, permitting further diagnostic and therapeutic procedures. Such procedures may include mapping and/or radiofrequency ablation of arrhythmias including arterial arrhythmias.
An embodiment of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:-
Figure 1 is a longitudinal sectional view through a cardiac lead removal apparatus according to an embodiment of the present invention; and
Figure 2 is a sectional view on line A-A of Figure 1.
As shown in the drawings, a cardiac lead removal apparatus according to an embodiment of the present invention comprises a sheath or catheter 10 adapted to be insertable into a vein 2 with the catheter concentrically arranged around a cardiac lead 4 whereby the catheter 10 can be advanced along the lead 4 such that the tip 12 of the catheter 10 effectively cuts through and separates the lead from surrounding tissue and provides a guide tube for removal of the cardiac lead 4 from the body.
In order to provide an image of the point of contact of the catheter with the tissue through which it is passed, an ultrasonic imaging device is incorporated into the catheter. A polythene guide tube 14 is located within the wall of the catheter 10, within which is located a thin elongate cable (not shown) having one or more ultrasonic transducers located at a distal end thereof, leads for the or each transducer extending through the cable. Alternatively other suitable imaging devices, such as an optical coherence tomography device, may be used.
The elongate cable is arranged to be rotatable and axially translatable within the guide tube 14. The guide tube 14 runs longitudinally of the catheter 10, except for a distal portion X of the guide tube 14 at or adjacent the tip of the catheter 10, which extends in a substantially helical or circumferential configuration around a distal region of the catheter 10 whereby the ultrasonic transducer can be reciprocated around the circumference of the tip of the catheter, and optionally also rotated, to produce a toroidal image of the tissue immediately around and ahead of the catheter tip, as shown in Figure 1 (see region marked N), providing forward, medial and lateral imaging around the circumference of the catheter tip, visualising adjacent vascular structures and pacemaker/defibrillator lead.
The guide tube 14, and the ultrasonic imaging device located therein, are located entirely within the wall of the catheter 10 such that the inner and outer surfaces of the catheter 10 remain smooth, avoiding snagging on the walls of the vein 2 through which the catheter 10 is passed and preventing the cardiac lead 4 from snagging on the inner wall of the catheter 10.
To image anterior and laterally to the tip of the catheter 10 requires the ultrasonic imaging device to be positioned perpendicular to the axis of the catheter and move circumferentially around (but within) it.
The image generated by the ultrasonic imaging device will be approximately toroidal so some processing will be needed to appropriately display this (e.g. in different cross sections or ideally 3D). Such processing can be provided by a computer connected to the ultrasonic imaging device.
IVUS (intravascular ultrasound) transducer technology is already available in various specifications which would need to be tailored to the device. IVUS as currently used in small arteries projects the ultrasound and receives the reflected images of arteries through a very thin plastic sheath - the transducer would thus can be contained within such a sheath at the catheter tip, so the rotation would not be evident viewed from outside the extraction sheath/catheter. Suitable computer software will be required to reconstruct a 3D image of the end of sheath, adjacent vessel and pacemaker lead. It will be possible to orient the imaging plane using the varying relationship to the helical channel to the catheter tip as a marker (x-y etc).
The present invention permits other extraction apparatus to be used as a second sheath, either internal to or external to the catheter 10. If internal, the second sheath would lie between the pacemaker lead and the catheter 10.
Current lead extraction technology, mechanical, electrocautery or laser, is compatible with the present invention.
While the embodiment of the present invention described above has been described in relation to a cardiac lead removal device, such can be equally applied to any other medical application wherein it is required to insert a hollow catheter into a body, the invention providing imaging of the point of contact of the catheter with body tissue, avoiding the prior art problems inherent with blind insertion of catheters, particularly in relation to intravascular catheters. The helical arrangement of the guide tube at the catheter tip thus provides a series of 2 dimensional cross sectional views around the circumference of the catheter tip, and with suitable image manipulation, a 3 dimensional reconstruction of the tip of the catheter and adjacent structures as it is advanced through the body.
Additional lumens or catheters may be provided within or alongside the catheter 10, such additional lumens or catheters housing other diagnostic and/or therapeutic devices, such as guide wires, stents, balloons, biopsy forceps, electrode catheters, such as mapping and/or ablation catheters or any other similar device, wherein the image generated by the imaging device may facilitate the use of such devices and the accurate positioning of such devices within the body. Such additional devices may be used for tissue sampling, in the case of biopsy forceps, the diagnosis and treatment of cardiac arrhythmias.
The invention is not limited to the embodiment(s) described herein but can be amended or modified without departing from the scope of the present invention.

Claims

Claims
1. An apparatus for carrying out diagnostic and/or therapeutic procedures, said apparatus comprising a hollow tubular catheter for insertion into the venous or arterial system or other body cavity of a patient, said catheter having a tip, an imaging device being associated with the tip of the catheter, said imaging device being adapted to provide an image of the tissue ahead of and lateral to the catheter tip, wherein the imaging device is provided at a distal end of an elongate guide member guided within a guide passage to be axially translatable within the guide passage, a portion of the guide passage at or adjacent the tip of the catheter extending in a substantially helical and/or circumferential configuration around a distal region of the catheter whereby the imaging device can be reciprocated around the tip of the catheter to produce a toroidal or substantially toroidal image of the tissue immediately around and ahead of the catheter tip.
2. An apparatus as claimed in claim 1 , wherein the imaging device is adapted to provide forward and lateral visualisation of tissue adjacent the catheter tip.
3. An apparatus as claimed in claim 1 or claim 2, wherein said imaging device is adapted to distinguish between muscle, bone and blood and thus determine if the catheter is being advanced into areas where damage to tissue, such as the walls of veins and arteries, may occur.
4. An apparatus as claimed in any preceding claim, wherein said imaging device comprises an ultrasonic imaging device comprising one or more ultrasonic transducers.
5. An apparatus as claimed in any preceding claim, wherein the guide passage is provided within the catheter wall.
6. An apparatus as claimed in any preceding claim, wherein the guide member incorporates leads and/or a driveshaft for the imaging device.
7. An apparatus as claimed in any preceding claim, wherein the imaging device is mounted to be reciprocated within the guide member.
8. An apparatus as claimed in claim 7, wherein the imaging device is rotatably mounted within the guide member.
9. An apparatus as claimed in any preceding claim, wherein the imaging device is connected to a computer for producing an image of the tissue immediately around and ahead of the catheter tip.
10. An apparatus as claimed in claim 9, wherein the computer is programmed to provide a three dimensional toroidal or substantially toroidal image made up from a series of two dimensional cross sectional views provided by the imaging device at intervals around the circumference of the catheter.
11. An apparatus as claimed in claim 9, wherein the computer is programmed to provide a two dimensional projection of said three dimensional image.
12. An apparatus as claimed in any preceding claim, wherein the catheter is adapted to be advanced over a cardiac lead to assist removal of the lead.
13. An apparatus as claimed in any preceding claim, wherein one or more further tubes or catheters are provided concentrically outside of or inside of the catheter to assist lead removal
14. An apparatus as claimed in any preceding claim, further comprising additional lumens or other tubular members within or adjacent to the catheter through which guide wires, stents, and/or balloons may be introduced for other therapeutic modalities, such as for the purpose of evaluating and/or treating coronary artery narrowings or occlusions.
15. An apparatus as claimed in claim 14, wherein one or more additional lumens or other tubular members may be provided for the passage of one or more of biopsy forceps, electrode catheters, including mapping and radiofrequency ablation catheters, or guide wires or any other device for use in other diagnostic and/or therapeutic procedure.
PCT/EP2010/001479 2009-03-11 2010-03-10 Apparatus for carrying out diagnostic and/or therapeutic procedures WO2010102794A1 (en)

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PL10709410T PL2410922T3 (en) 2009-03-11 2010-03-10 Apparatus for carrying out diagnostic and/or therapeutic procedures
EP10709410.4A EP2410922B1 (en) 2009-03-11 2010-03-10 Apparatus for carrying out diagnostic and/or therapeutic procedures
ES10709410.4T ES2440598T3 (en) 2009-03-11 2010-03-10 Apparatus for carrying out diagnostic and / or therapeutic procedures
DK10709410.4T DK2410922T3 (en) 2009-03-11 2010-03-10 DEVICE FOR PERFORMING DIAGNOSTIC AND / OR THERAPEUTIC PROCEDURES
HRP20131208AT HRP20131208T1 (en) 2009-03-11 2013-12-18 Apparatus for carrying out diagnostic and/or therapeutic procedures

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GBGB0904194.8 2009-03-11
GBGB0904194.8A GB0904194D0 (en) 2009-03-11 2009-03-11 Apparatus for carrying out intravascular procedures and/or diagnosis

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US10278616B2 (en) 2015-05-12 2019-05-07 Navix International Limited Systems and methods for tracking an intrabody catheter
US10709507B2 (en) 2016-11-16 2020-07-14 Navix International Limited Real-time display of treatment-related tissue changes using virtual material
WO2020152013A1 (en) * 2019-01-21 2020-07-30 Koninklijke Philips N.V. Vascular treatment systems and devices including intravascular imaging capabilities
US10828106B2 (en) 2015-05-12 2020-11-10 Navix International Limited Fiducial marking for image-electromagnetic field registration
US10881455B2 (en) 2015-05-12 2021-01-05 Navix International Limited Lesion assessment by dielectric property analysis
US10925684B2 (en) 2015-05-12 2021-02-23 Navix International Limited Contact quality assessment by dielectric property analysis
US11010983B2 (en) 2016-11-16 2021-05-18 Navix International Limited Tissue model dynamic visual rendering
US11284813B2 (en) 2016-11-16 2022-03-29 Navix International Limited Real-time display of tissue deformation by interactions with an intra-body probe
US11331029B2 (en) 2016-11-16 2022-05-17 Navix International Limited Esophagus position detection by electrical mapping
US11350996B2 (en) 2016-07-14 2022-06-07 Navix International Limited Characteristic track catheter navigation
US11622713B2 (en) 2016-11-16 2023-04-11 Navix International Limited Estimators for ablation effectiveness

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Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016071778A1 (en) 2014-11-07 2016-05-12 Medidata Sp. Z.O.O. Electrophysiological diagnostic catheter especially for obtaining of endomyocardial biopsy of heart tissue
US11039888B2 (en) 2015-05-12 2021-06-22 Navix International Limited Calculation of an ablation plan
US10881455B2 (en) 2015-05-12 2021-01-05 Navix International Limited Lesion assessment by dielectric property analysis
US10828106B2 (en) 2015-05-12 2020-11-10 Navix International Limited Fiducial marking for image-electromagnetic field registration
US10278616B2 (en) 2015-05-12 2019-05-07 Navix International Limited Systems and methods for tracking an intrabody catheter
US10925684B2 (en) 2015-05-12 2021-02-23 Navix International Limited Contact quality assessment by dielectric property analysis
US11350996B2 (en) 2016-07-14 2022-06-07 Navix International Limited Characteristic track catheter navigation
US11284813B2 (en) 2016-11-16 2022-03-29 Navix International Limited Real-time display of tissue deformation by interactions with an intra-body probe
US11010983B2 (en) 2016-11-16 2021-05-18 Navix International Limited Tissue model dynamic visual rendering
US10709507B2 (en) 2016-11-16 2020-07-14 Navix International Limited Real-time display of treatment-related tissue changes using virtual material
US11331029B2 (en) 2016-11-16 2022-05-17 Navix International Limited Esophagus position detection by electrical mapping
US11622713B2 (en) 2016-11-16 2023-04-11 Navix International Limited Estimators for ablation effectiveness
US11631226B2 (en) 2016-11-16 2023-04-18 Navix International Limited Tissue model dynamic visual rendering
US11793571B2 (en) 2016-11-16 2023-10-24 Navix International Limited Real-time display of treatment-related tissue changes using virtual material
US20220079614A1 (en) * 2019-01-21 2022-03-17 Koninklijke Philips N.V. Vascular treatment systems and devices including intravascular imaging capabilities
CN113329705A (en) * 2019-01-21 2021-08-31 皇家飞利浦有限公司 Vascular treatment system and device including intravascular imaging functionality
WO2020152013A1 (en) * 2019-01-21 2020-07-30 Koninklijke Philips N.V. Vascular treatment systems and devices including intravascular imaging capabilities

Also Published As

Publication number Publication date
ES2440598T3 (en) 2014-01-29
EP2410922A1 (en) 2012-02-01
EP2410922B1 (en) 2013-10-02
PL2410922T3 (en) 2014-02-28
DK2410922T3 (en) 2014-01-13
GB0904194D0 (en) 2009-04-22
PT2410922E (en) 2013-12-24
HRP20131208T1 (en) 2014-03-28

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