The present invention relates to a magnetic guidance system for guiding a medical device within a patient, in the preferred embodiment for guiding a guide wire, catheter or other endoluminal device through the vasculature of a patient, particularly for neurological applications.
Endoluminal medical procedures are commonly practiced for a variety of medical procedures, such as for vessel or valve repair, angioplasty procedures, treatment of aneurysms, implantation of medical devices, localized delivery of medicinal products and so on. Most of these procedures involve the insertion of an elongate element from a remote percutaneous entry point of the patient, into a vessel of the patient and then the feeding of the device through the patient's vasculature to the treatment point. A variety of techniques are known, a commonly used procedure being the well-known Seldinger technique.
The process of feeding a medical assembly through a patient's vasculature is a specialized technique but commonly practiced. Where insertion must be carried out through tortuous or delicate vessels, the procedure can be complicated. Difficulties arise particularly in neurological applications, where the cerebral vessels are very delicate, very tortuous and prone to vessel spasm. It can often take several hours to position a guide wire for an endoluminal neurological procedure. In such a case, the physician must carefully guide the distal end of the guide wire through the vessels, often removing the guide wire to adjust its curvature to pass through a particular vessel curve or bifurcation. Despite these time and technical difficulties, an endoluminal procedure is still much more preferable over open surgery.
Attempts have been made to provide guidance systems for guiding a guide wire through a patient's vasculature. Examples can be found in US-2007/0016006, US-2006/0142632, US-2004/0019447, US-2003/0040737, U.S. Pat. No. 6,296,604, US-2013/0131503. In general terms, these documents disclose magnetic guidance systems for guiding a guide wire having a magnet at its distal end. The systems use a framework of permanent or electromagnets arranged around the patient, at least some of which are movable relative to the patient during the procedure. The magnets provide an attractive force on the distal tip of the guide wire which can be used to direct the guide wire through the patient's vasculature. The systems generally provide a user input, which may for instance be in the form of a joystick or the like. The user input is used to move the location of the guiding magnets and the magnetic force applied to the distal end of the guide wire through the patient's vessels. Once the guide wire has been positioned as required, the subsequent medical procedure can be conducted in conventional manner.
There are a number of shortcomings with these systems which it is believed limit their practical application. The systems are large and complex; they envelop a patient, restricting access to the patient and leading to patient anxiety; and also require training and additional manipulation by the physician.
The present invention seeks to provide an improved magnetic guidance system for guiding a medical device within a patient, in the preferred embodiment for guiding a guide wire, catheter or other endoluminal device through the vasculature of a patient, particularly for neurological applications.
According to an aspect of the present invention there is provided a medical magnetic guidance system for guiding a medical device deployed in a patient, the system including:
a patient support;
a magnet assembly disposed adjacent the patient support, the magnet assembly including a movable magnet support and one or more magnets attached to the support, the magnet support being mounted on a guide element having a single plane;
a drive mechanism coupled to the magnet support to move the magnet support and the one or more magnets attached thereto in the guide element in said single plane.
In a preferred embodiment, the medical magnetic guidance system is designed for guiding a medical neurological device deployed in a patient, the system including: a patient support including a patient head zone and a patient body zone; a magnet assembly disposed adjacent the patient head zone, the magnet assembly including a movable magnet support and one or more magnets attached to the support; a drive mechanism coupled to the magnet support and operable to move the magnet support and the one or more magnets attached thereto in a single plane relative to the patient head zone of the patient support.
This aspect of the present invention provides a system in which the magnets are maintained in a single plane relative to a patient's body. This provides the advantage of keeping the patient's body accessible to the physician, for imaging purposes, and also avoids enveloping the patient in machinery, which can be stressful and not conducive to smooth operating conditions. This is particularly beneficial also for neurological applications.
In the preferred embodiment, the drive mechanism is operable to move the magnet support in a rotary, reciprocating or vibratory motion in said single plane. As is explained below, this provides an effective mechanism for controlling the movement of a medical device within the patient and which can also avoid complex control inputs by the physician or other medical staff.
The drive mechanism is preferably operable to move the magnet support in a repetitive periodic motion in said single plane. As is set out below in the specific description of the preferred embodiments, this feature enables the physician to move the endoluminal medical device under the influence of the periodic, and repetitive, moving magnetic field without the need for any other control input.
The single plane may be lateral, above or below the patient support. In a preferred embodiment, the single plane may be lateral, above or below the patient head zone of the patient support. Most preferably, the single plane is at or adjacent a crown end of the patient head zone. This is closest to the cerebral vessels, requiring therefore a smaller magnetic field, and can in practice allow the apparatus to be visually hidden from the patient.
According to another aspect of the present invention, there is provided a medical magnetic guidance system for guiding a medical device deployed in a patient, the system including:
a patient support;
a magnet assembly disposed adjacent the patient support, the magnet assembly including a movable magnet support, and one or more magnets attached to the support; the movable magnet support being mounted on a guide element;
a drive mechanism coupled to the magnet support to move the magnet support and the one or more magnets attached thereto in the guide element in a repetitive periodic motion.
As with the first aspect disclosed above, the magnet assembly may include a rotary coupling to magnet support, the drive mechanism being operatively connected to the rotary coupling so as to move the magnet support in a rotary motion. The magnet assembly may include a linear coupling to magnet support, the drive mechanism being operatively connected to the linear coupling so as to move the magnet support in a reciprocating motion.
In an embodiment, the magnet assembly includes a vibratory coupling to magnet support, the drive mechanism being operatively connected to the vibratory coupling so as to move the magnet support in a reciprocating vibratory motion.
As with the previous aspect, and all other aspects, the apparatus is preferably for neurological applications, in which case the patient support preferably includes a patient head zone and a patient body zone and said magnet assembly is disposed adjacent the patient head zone.
According to another aspect of the present invention, there is provided a medical magnetic guidance system for guiding a medical device deployed in a patient, the system including:
a patient support;
a magnet assembly disposed adjacent the patient support, the magnet assembly including a movable magnet support and one or more magnets attached to the support, the magnet support being mounted on a rotatable axle;
a drive mechanism coupled to the axle of the magnet support and operable to rotate the magnet support and the one or more magnets attached thereto about the axle.
The magnet support is preferably rotatable in a single plane.
All aspects of the present invention may include on or more of the following features.
The patient support may lie in a plane and the at least one magnet is disposed substantially perpendicular to the plane of the patient support. For this purpose, the at least one magnet may be disposed at or adjacent a top of head position of the patient support, in some embodiments in a plane tangential to a top of head position of the patient support.
Advantageously, the one or more magnets are positioned off-center relative to the patient head zone of the patient support.
The drive mechanism is preferably operable to move the magnet support in a periodic motion 1 rpm or less, or 1/50 or 1/60 Hertz or less for non-rotary reciprocating motion.
The one or more magnets preferably move within a range of a few millimeters up to around 20 centimeters. As described in detail below, the magnet may also be angled towards the patient during the procedure.
The systems preferably include an elongate medical device, the medical device including a distal end magnetized distal tip having a given magnetic polarization at the distal end, the one or more magnets having a front surface, which front surface has the same magnetic polarization as that of the distal end of the medical device such that the one or more magnets exert a magnetic repulsive force on the distal end of the medical device.
As is explained below, the inventors have discovered that using repulsive magnetic forces can in practice provide much simpler guidance, in particular by reducing the movement required of the magnets to produce movement of the tip of the elongate medical device. This is a significant departure from earlier published systems.
The medical device may be a guide wire, a catheter or any other endoluminal medical device, including for instance another component of an introducer assembly, a probe or other medical tool.
Preferably, the magnet assembly is adjustable in yaw or pitch. Such adjustment can usefully be effected before the magnet(s) are put into motion, although in some embodiments the yaw and/or pitch of the magnet(s) could be adjusted while they are being operated, as a fine adjustment particularly for very tortuous vessels or at difficult vessel bifurcations.
Other features, aspects and advantages of the teachings herein will become apparent from the specific description which follows.
Embodiments of the present invention are described below, by way of example only, with reference to the accompanying drawings, in which:
It is to be appreciated that the drawings show various features of the embodiments of the system taught herein in schematic form only. Moreover, not all of the features which would be included in such a device are shown in the drawings, which are intended to depict only the primary features of the disclosed system.
The preferred embodiments described below are directed to a neurological guidance system but it is to be understood that the teachings are not limited to neurological applications only. Other systems could readily be designed for other parts of the body of a patient. The principles and basic components of the apparatus can remain the same.
Moreover, the embodiments described below use a guide wire having a magnetic tip. The teachings herein, however, are not restricted to guiding a guide wire and are equally applicable to other endoluminal medical devices. One example is a catheter having a magnetic tip. A catheter of such a nature could be deployed through the vasculature of a patient without needing to use a guide wire.
The embodiments described herein may use permanent magnets or electromagnets. Both have relative advantages which are well-known to the person skilled art and therefore will not be discussed herein in detail.
Referring first to
In this location, the magnet unit 20 is not visible to the patient during use and it can also be hidden, for example in a casing or behind a partition screen or curtain.
Referring now to
The magnet unit 20 depicted in schematic form of
With reference now to
The guidewire 70 differs from conventional guidewires in having a magnetic tip 74, which in this example has its south pole at the distal end of the guidewire 70 and its north pole proximal to that. The magnetic element of the tip 74 could have the opposite polarity to that shown in
Referring now to
The principles are used in the preferred embodiments of the magnetic driving system disclosed herein.
With reference first to
With reference to
The intention of these adjustments of the magnet unit 20 is to position this appropriately with respect to the crown 42 of the patient's head 40, to what one could describe as alignment with a center point of the patient's head. This provides a useful starting location of the magnet unit 20 for driving a guidewire into the patient's neurological vessels. Typically, in such procedure, the guidewire would be inserted from a patient's neck typically through the jugular vein.
An arrangement having the characteristics of
The magnet or magnets 150 are also, in this embodiment, able to slide along the arm 142, so as to adjust its/their position relative to the center of rotation 144 and as a result relative to the centerline through the patient's cranium. This can adjust the relative position of the magnet(s) 150 relative to the guide wire 70. The physician can adjust the position of the magnets manually, although in other embodiments this may be done by the control system, in which case the apparatus will be provided with a drive mechanism such as a motor or solenoid for moving the magnet along the arm 142.
With reference now to
The apparatus shown in
The apparatus disclosed herein is, in the preferred embodiments, able to move the magnets in a repetitive periodic motion, in the case of rotational movement at a uniform rate of rotation. The rate of movement could be fixed although in some embodiments could be adjustable, for instance by the physician, in order to alter the rate and movement of the magnetic field in the zone of interest created by the magnet(s). It is to be understood that other embodiments may move the magnets linearly rather than rotationally, and/or in one or more directions of movement. The aim, in the preferred embodiments, is to create a periodically moving, for instance rotating, magnetic field which creates a repetitive pattern of movement of the end of a guide wire or other medical device deployed in a patient. The movement of the magnet(s) 20 is preferably in a single plane, which assists in providing a regular and predictable movement of the end of the medical device or tool, as well as simplifying the apparatus and optimizing access to the patient.
Advantageously, the periodic motion of the magnets of the device is at a relatively low frequency in order that the distal end of the elongate medical device, such as a guidewire or catheter, will move slowly enough that a physician can maneuver the medical device through the vasculature of the patient in reasonable time and with reasonable efficiency. Typically, the periodic motion may be around 1 rpm or less or 1/50 or 1/60 Hertz or less for linear reciprocal motion. Movement of the magnet is preferably also relatively small. In the case of a rotating magnet arrangement, the radius of rotation may be in the region of around 70 mm to around 100 mm, but can be as low as 5 mm, in dependence on the position of the distal end of the guide wire and the tortuosity of the vasculature in which the guide wire is located. The radius can be adjusted as the guide wire is moved during the procedure. In the case of a linear motion (in one or more directions) the magnets may move within a range of 100 mm to around 200 mm. As explained above, it is not necessary to move the magnets over large distances in order to be able to direct the distal tip of the medical device as a result of the preferred arrangement disclosed herein.
With reference now to
With reference first to
With reference to
The tip 74 of the guidewire 70 can be made to follow a variety of orientations in this manner and as a result to pass through tortuous vasculature and side branches within a network of vessels.
The inventors believe that the system disclosed herein can enable the placement of a guidewire or other medical device in the cerebral vessels of a patient within a matter of minutes, compared to the hours that it currently takes with a conventional guidewire. This is a significant advantage of current medical procedures.
In the preferred embodiments, the physician is able to move the endoluminal medical device under the influence of the periodic, and repetitive, moving magnetic field without the need for any other control input. This is considered a significant advantage in that the apparatus can be made less complex with less control inputs and can also provide a mechanism which quickly becomes intuitive and simple for the physician to implement.
The teachings herein are not limited to the provision of a guidewire as they can be used with a variety of other elongate medical devices, including probes, tools, catheters and so on. With these other embodiments, the medical device will be provided with a magnet at its distal end, similar to that disclosed above. Advantageously, the medical device would also be provided with a more flexible distal end, again in a manner similar to the guidewire depicted in
Although the embodiments described above are directed to apparatus suitable for guiding a medical device within the cerebral zone of a patient, the skilled person will appreciate that the system could be designed for other body parts of a patient. The principles of such other embodiments are the same as those described herein.
It is not necessary for the magnets to be placed adjacent the crown of a patient's head or even in the orientation shown. Other embodiments are envisaged, with the magnets being positioned laterally of the patient's head, and even above and below. However, the arrangement described above and depicted in the drawings is the preferred at least for the reasons given above.
The magnet(s) could, instead of moving in a rotary motion, move in a linear motion, for instance backwards and forwards, or in at least two directions, such as in two orthogonal directions or even in a greater number of directions.
The system may be entirely automated but may also allow for some fine adjustment such as described above and also during operation, for instance in terms of the speed of movement, the period of movement, distance of movement and also be temporarily stopped and started if desired. As such changes can be relatively simple, they could be controlled by a simple input such as a foot pedal, a hand dial and so on.
It will be appreciated that the magnet arrangement can be located quite close to a patient's body, particularly in light of the single plane movement of the preferred embodiments and also the relatively small movement required by the magnets in order to move a guidewire or other medical device. This can also result in a system which requires weaker magnets as the guiding magnet(s) can be located much closer to the area of interest, which has further advantages in terms of effects on the patient, imaging and size in complexity of the apparatus.
All optional and preferred features and modifications of the described embodiments and dependent claims are usable in all aspects of the invention taught herein. Furthermore, the individual features of the dependent claims, as well as all optional and preferred features and modifications of the described embodiments are combinable and interchangeable with one another.
While the above description constitutes the preferred embodiments of the present invention, it will be appreciated that the invention is susceptible to modification, variation and change without departing from the proper scope and fair meaning of the accompanying claims.
The disclosure in the abstract accompanying this application is incorporated herein by reference.
Number | Date | Country | Kind |
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1603636.0 | Mar 2016 | GB | national |