OPTICAL ENERGY DELIVERY AND SENSING APPARTUS
20180333205 ยท 2018-11-22
Inventors
Cpc classification
A61B18/18
HUMAN NECESSITIES
A61B2018/2261
HUMAN NECESSITIES
A61N2005/063
HUMAN NECESSITIES
G02B6/32
PHYSICS
G02B6/262
PHYSICS
G01K11/3206
PHYSICS
International classification
A61B18/18
HUMAN NECESSITIES
G02B6/32
PHYSICS
G01K11/32
PHYSICS
Abstract
Optical energy delivery apparatus for ablation or embolization includes an optical fibre having a distal end which is provided a light directing element, such as a lens. The light directing element is configured to direct optical energy beyond the distal end of the optical fibre. The optical fibre includes at least one Bragg grating proximate the distal end for sensing a change in the optical fibre during its operation. The apparatus includes a control unit configured to drive an optical source and to obtain signals from a sensor unit. The controller may also drive the energy source at a sensing wavelength. The structure provides a single optical fibre supply optical energy and sense changes in optical fibre. The optical fibre may have a tapering diameter towards its distal tip for increased flexibility at its distal end.
Claims
1. Optical energy delivery embolization and/or ablation apparatus for medical applications including: an optical fibre having a length, a proximal end and a distal end, the distal end including a light directing element configured to direct optical energy for embolization and/or ablation beyond the distal end of the optical fibre; the proximal end of the optical fibre being configured to be coupled to a source of optical energy; the optical fibre including a plurality of sensing lattice structures disposed at spaced intervals along the length thereof; the optical fibre being a combined device for delivery of optical energy and for sensing changes in the optical fibre; the apparatus including a sensing unit coupled to detect changes in light reflected from the lattice structures and to determine therefrom changes in temperature.
2. Apparatus according to claim 1, wherein the lattice structures are spaced from one another by around 1 mm to around 5 mm.
3. Apparatus according to claim 1, including two or more lattice structures physically positioned so that they either experience same change in temperature with varying strain or same strain with varying change in temperature.
4. Apparatus according to claim 1, wherein the at least one lattice structure is an inscribed micro-lattice structure.
5. Apparatus according to claim 1, wherein the at least one lattice structure is a Bragg grating.
6. Apparatus according to claim 1, wherein the light directing element at the distal end of the optical fibre is or includes a lens.
7. Apparatus according to claim 6, wherein the lens is: a concave lens; a concave axicon lens; or a combination lens in the form of one of: a double convex axicon lens and a double concave axicon lens.
8. Apparatus according to claim 1, wherein the light directing element at the distal end of the optical fibre is or includes at least one angled surface configured to direct light at an angle out of the distal end of the optical fibre.
9. Apparatus according to claim 8, wherein the light directing element at the distal end of the optical fibre includes at least two angled surfaces configured to direct light in at least two directions out of the distal end of the optical fibre.
10. Apparatus according to claim 8, wherein each angled surface directs light forwardly and radially out of the distal end of the optical fibre.
11. Apparatus according to claim 1, wherein the optical fibre has a varying diameter along its length.
12. Apparatus according to claim 1, wherein the optical fibre has a varying stiffness along its length.
13. Apparatus according to claim 12, wherein the optical fibre has a reducing diameter along its length in the direction of its distal end.
14. Apparatus according to claim 12, wherein the optical fibre includes a stiffening structure in a proximal portion thereof.
15. Apparatus according to claim 1, including a control unit coupled to the source of optical energy and operable to drive the source of optical energy to generate light energy at a plurality of wavelengths.
16. Apparatus according to claim 15, wherein the control unit is operable to utilize different wavelengths for different functions.
17. Apparatus according to claim 16, wherein the control unit is operable to use a first generated wavelength for power transfer.
18. Apparatus according to claim 17, wherein the first wavelength is between 600 nm and 1400 nm.
19. Apparatus according to claim 17, wherein the first wavelength is around 970 nm.
20. Apparatus according to claim 15, wherein the control unit is operable to use a second generated wavelength for sensing.
21. Apparatus according to claim 20, wherein the second wavelength is around 1550 nm or around 800 nm.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] Embodiments of the present invention are described below, by way of example only, with reference to the accompanying drawings, in which:
[0032]
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DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0044] It is to be understood that the drawings are schematic only and not to scale. Often, only the principal components of the apparatus relevant for an understanding of the teachings herein are shown in the drawings and for the sake of clarity inessential elements commonplace in the art are not shown.
[0045] The embodiments described below relate to apparatus which can be passed from a remote percutaneous entry point endoluminally through the vasculature of a patient up to the point of treatment. The apparatus preferably has a small diameter at least at its distal end so as to be able to pass through and into small diameter vessels.
[0046] The apparatus may be used for embolization of blood, that is to create a blood clot which will then occlude a vessel. In other embodiments, the apparatus is configured to ablate a vessel, typically by heating the vessel wall at a plurality of discrete points around a circumference of the vessel or entirely around the vessel's circumference. Ablation causes contraction of the vessel and fusing of the vessel wall in a closed state, thereby to block the vessel. The apparatus can also be configured, by provision of suitable light directing elements at the distal end of the optical fibre, so as to carry out both ablation and embolization. Vessel ablation is generally considered better than blood embolization, for the reason that in the course of events the flow of blood will act to draw away heat generated by the device and therefore to temper the procedure. Where it is desired to use the apparatus to cause blood embolization, there can be provided a temporary vascular plug, such as the balloon shown in dotted outline in
[0047] In the case of vessel ablation, the system is preferably set up to heat and destroy the inner lining of the vessel wall, that is the endothelium of the tunica intima. For this purpose, a relatively low power is required, typically of less than 5 Watts.
[0048] Referring first to
[0049] The optical fibre 12 typically includes a core of glass or silica surrounded by a protective sheath. For the purposes of ablation and/or embolization the optical fibre preferably has a diameter of between 0.25 mm to 1.0 mm. The diameter of the fibre is related more to the diameter of the vessel to be treated.
[0050]
[0051] In
[0052] The distal end 14 of the optical fibre 12 is shown positioned generally in the centre of the lumen 26 of the vessel 24, and this may be achieved in any conventional or suitable manner, for instance by means of a supporting catheter, a supporting balloon disposed around the catheter, and so on. The dotted outline 28 shown in
[0053]
[0054] Referring now to
[0055] The embodiment of
[0056] Referring now to
[0057] As the skilled person will appreciate, the angle of the conical surface 62 relative to the flat fibre tip 14, and equally to the back surface 64 of the lens 60, can be varied in order to vary the angle of divergence of the beam 66. This affects, as a result, the point of impingement of the beam 66 onto a vessel wall 24 relative to the distal end of the fibre assembly, and also the length (in the longitudinal direction of the vessel 24) of the zones 68 which are subjected to the optical energy.
[0058] Referring now to
[0059] The optical fibre 12 has incorporated within its structure a sensing device, in this case a Bragg grating. In practice, this may be an inscribed micro-lattice structure formed into the surface of the fibre 12 in known manner. In one example this may be by UV light inscription into a UV sensitive fibre core (for instance made of silica) by laser light or through a mask, so as to form a series of regular circumferential rings spaced by a given spacing (desired reflection wavelength) relative to one another. It is to be understood, though, that the Bragg grating may be formed in different manners, one example being by way of a sandwich structure of different materials at the intended location of the or each grating.
[0060] With reference to
[0061] More specifically, a change in temperature of the fibre 12 will be caused by heating of the surrounding tissue and/or blood and this can as a result provide a reliable indication of temperature change within the organ being treated. A correlation between temperature and change in reflected wavelength from the Bragg grating 25 is given in equation 1 below. It can be taken that there will be no noticeable change in strain during the change in temperature, as the fibre 12 would not normally be moved during the ablation procedure or during each stage of the ablation procedure if carried out in multiple stages. In light of this, the equation linearly relates the measured change in wavelength to the temperature given the known constant coefficients, and the temperature can be determined by a suitable calibration routine with coefficients stored in a memory of the processor 40, for instance as a formula or as a look-up table.
[0067] In cases where is can be expected that strain will not be not constant during the ablation procedure, that is during the period of change in temperature, two or more fibre Bragg gratings may be used, physically positioned so that they either experience same change in temperature with varying strain or same strain with varying change in temperature. The temperature can then be derived by solving the linear system of two equations with two variables.
[0068] Referring to
[0069] It will be appreciated that different sets of Bragg gratings 25 can be configured to reflect different, non-overlapping frequencies so as to produce a plurality of such intensity curves.
[0070] As a result, the sensing unit 30 and processor 20 may be configured to measure intensity or maximum frequency for each set of Bragg gratings, as described above in connection with
[0071] In practice, once the fibre 12 has been positioned in a patient at the vessel location to be treated, the fibre is unlikely to incur any change further change in its state of strain. As a result, once positioned, the processor 40 can obtain a reference measurement from the or each Bragg grating 25 prior to initiation of the ablation or embolization process, that is prior to the generation of heat energy within the vessel. Heating will then be determined from a change in wavelength of the reflected light form the Bragg grating or gratings 25 relative to the reference measurement.
[0072] It is envisaged that in some embodiments there could be provided at least one second fibre (not shown in the drawings), also provided with one or more Bragg gratings, optimally adjacent the Bragg grating or gratings of the first fibre 12. This at least one second optical fibre can be used to obtain a second indication of strain for use in calibrating the measurements in light of overall strain. In practice, the second fibre can be arranged to incur the opposite strain to the first fibre 12, such as a compressive strain when the first fibre 12 incurs a stretching strain or vice versa, and thus provide a balancing reference measurement. This can be particularly useful for assemblies which have a curved, such as a J-shaped, distal end when unbiased.
[0073] In a practical embodiment, there may be provided a plurality of sets of Bragg gratings 25 at the distal end of the fibre 12 spaced from one another by, for example, by around 1 mm to around 5 mm. A plurality of sets of Bragg gratings can be used to measure different temperatures but also, or in the alternative, to measure the progress of the procedure for occluding the vessel. For instance, while the vessel is open and blood can flow therethrough, the blood will have a cooling effect such that it could be expected that there will be a temperature difference between different Bragg gratings. On the other hand, once the vessel has closed, there is no further blood flow to cool the fibre and the temperature measurement at the grating or gratings further down the fibre, in the proximal direction, will sense a rise in temperature which will be indicative of the successful occlusion of the vessel and therefore the end of the procedure. Thus, a plurality of sets of Bragg gratings 25 can provide a measure of operating characteristics along the length of the fibre 12. In some embodiments, though not necessary, there may be provided one or more Bragg gratings more proximally along the fibre relative to the zone at which ablation is effected, so as to obtain a measure of body temperature for use as a reference value. It is also not excluded that a proximal set of Bragg gratings may be provided to obtain a measure of ambient temperature.
[0074] It is to be appreciated that the sets of Bragg gratings spaced along the length of the fibre, for example each of the sets, can include groups of two or more lattice structures physically positioned so that they either experience same change in temperature with varying strain or same strain with varying change in temperature as discussed above, for example so that the temperatures at each of the lattice structures can be derived by solving the linear system of two equations with two variables. For example, each of the sets can include groups of two or more lattice structures physically positioned so that they experience same change in temperature with varying strain.
[0075] The apparatus 10, and in particular the control unit 40, may utilise several different wavelengths for different functions. For example, one wavelength may be selected for power transfer (for instance for embolization or ablation), which may be selected based on the absorption coefficient of blood and/or tissue. This has the advantage of targeting the delivery of power to the material intended to be ablated or caused to embolize, while minimising power delivery to other organs. With reference to
[0076] In a practical example, the control unit 40 is configured to generate in the region of 5 Watts or less of energy over a time period of less than 1 minute and preferably of between 5 to 30 seconds. Typically, though, the amount of energy to be generated and the length of time over which this should be supplied is dependent on the nature of the vessel and the of blood flow through the vessel. A vessel with thicker vessel walls will need greater energy to be ablated, compared to a smaller vessel or one with more delicate vessel walls. Similarly, a vessel experiencing higher blood flow will require the provision of more optical energy compared to a vessel experiencing lower blood flow. These parameters can be determined by the skilled person empirically by routine development processes.
[0077] The control unit 40 is also configured to operate the device at other wavelengths, or a spectrum of wavelengths, for use by the sensor unit 30 to detect the operating state of the optical fibre 12. These wavelengths will typically fall outside the range of wavelengths which would be absorbed by tissue or blood. For this purpose, in the preferred embodiments, the Bragg grating or gratings 25 have reflective wavelengths beyond the sensitive wavelengths of the vessel wall or blood and in the preferred embodiment around 1550 nm. Where a plurality of sets of Brag gratings 25 is provided, these may be spaced from one another in terms of wavelength by around 10 nm or more and in some cases up to around 25 nm. The wavelength spacing allows the sensor unit 30 to determine the status of each Bragg grating without interference, and preferably also without aliasing artefacts, from the other Bragg gratings in the fibre 12 and also allows for variation on the reflected wavelengths caused by strain or temperature changes in the fibre at the location of each Bragg grating 25.
[0078] In other embodiments, one or more Bragg gratings 25 may be formed to reflect light of around 800 nm wavelength.
[0079] The wavelengths used for sensing the state of the fibre 12 may be emitted at low power levels and the reflection pattern used to detect physical changes at the fibre Bragg grating zones 25. In one embodiment, two or a few specific wavelengths may be used instead of a spectrum, and the relative reflected intensities of these wavelengths used to detect physical changes at the zones of each Bragg grating 25
[0080] The power of light generated by the light source 20 for use in sensing is preferably in the region of 10 mW or less.
[0081] With reference now to
[0082] The Bragg gratings 25 may be configured to reflect the same wavelength or different wavelengths. These different wavelengths can be used for measuring changes during different modes of operation, for instance the state of the fibre 12 during different heating modes, such as heating tissue, heating blood, heating a combination of the two, and so on.
[0083]
[0084] As will be particularly apparent from
[0085] The control unit 40 may be configured to deliver optical energy and to sense simultaneously, making use of different optical frequencies for the purpose, but can equally be configured to operate in a multiplexed form, that is to cycle between heating and sensing. In practice, there may be provided a plurality of sensor modules or inputs, each tuned to a particular Bragg grating, in its expected range of operation. A plurality of sensor modules allow for continuous operation. However, a single sensing module 30 with a single input may be provided working in a multiplexed manner. The inventor has discovered that the apparatus can be operated at a multiplexing time frame which is much shorter that the time taken for any changes to be experienced in the surrounding blood, so any interruption in energy delivery is not expected to make any practical difference to the ablation process.
[0086] With reference now to
[0087] The fibre 140 may taper throughout its length or may taper for only a portion of its length, in which case it would have a proximal portion of substantially uniform diameter and then a distal portion of reducing diameter towards the distal tip 142. It is preferred that the taper is gradual, which minimises the risk of kinking, although it is not excluded that there could be a step change in outer diameter of the fibre to produce a more flexible distal portion.
[0088] With reference to
[0089] The embodiments of
[0090] In practice, a concave axicon lens may be preferable over a convex lens in order to avoid having a focal zone at the tip of the device in the centre of the blood stream when the device is configured to heat the vessel wall. However, where it is desired to heat blood plasma, in some embodiments a convex lens is used to focus light to a focal point beyond the tip 14 of the fibre 12.
[0091] The skilled person will also appreciate the precise properties of the light directing element (for instance lens) of the apparatus will be dependent of the choice of the material for the optical fibre.
[0092] 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.
[0093] The disclosure in the abstract accompanying this application is incorporated herein by reference.