GB2607338A

GB2607338A - Ultraviolet instrument

Info

Publication number: GB2607338A
Application number: GB2108006.4A
Authority: GB
Inventors: Heng Jimmy Yang Teo; Nagtegaal Marno
Original assignee: Gyrus Medical Ltd
Current assignee: Gyrus Medical Ltd
Priority date: 2021-06-03
Filing date: 2021-06-04
Publication date: 2022-12-07
Anticipated expiration: 2041-06-04
Also published as: GB2607338B; GB202108006D0

Abstract

An ultraviolet instrument for radiating ultraviolet light within a body cavity of a human or animal subject comprises an axially extending probe 14 including an ultraviolet source 24 and a window 32 formed in the surface of the probe to permit UV light to exit and to be directed at tissue to be treated. The ultraviolet source 24 may output UV in two or more wavelengths, or alternatively, a plurality of UV sources may produce that effect. The probe 14 may have a window facing the axial direction or several windows 32 arranged radially. In one embodiment, the window is a single circumferential slot on the probe. Preferably, the instrument comprises an endoscope 22 to provide a view of the treatment site. An electrical power supply 26 may provide drive signals to the UV source. With treatment using ultraviolet radiation, bacteria and pathogens in the nasal cavity or sinuses or mouth can be reduced, thereby suppressing inflammation.

Description

Ultraviolet Instrument

Technical Field

The present invention relates to an ultraviolet (UV) instrument for the treatment of pathologies in the human or animal body, for example in the nasal and sinus cavity.

Backaround to the Invention

Rhinosinusitis is a condition in which the patient experiences inflammation or swelling of the nasal cavities, triggered by a known allergy, infection or other medical condition, which presents as symptoms of mucus drainage that leads to nasal congestion and difficulty breathing. Mahdavinia M. et al, in "A comprehensive review of the nasal microbiome in chronic rhinosinusitis (CRS)", Clinical and Experimental Allergy, 2016 January, 46(1):21- 41 describe the effects of the microbiomes and pathogens in the nasal activity that can lead to chronic rhinosinusitis.

There are many treatments such as the administration of drugs to suppress the inflammation or the use of antibiotics to manage the bacteria film or microbiome in the nasal cavity, however, these are not always effective and can be unsuitable for some patients. In some cases, an endoscopic sinus procedure may be required, in which a rigid or flexible endoscope with an attached light is inserted to the nasal cavity to explore the sinus passages and remove any tissue that may be causing nasal blockage.

Summary of the Invention

Examples of the present disclosure are intended to address problems in the treatment and management of the microbiome of the nasal cavity to provide relief to people who suffer nasal and sinus conditions such as rhinosinusitis, both chronic and acute, which present as showing symptoms of nasal tissue inflammation that leads to nasal congestion. In some cases, particularly where the condition is chronic and other treatments have been unsuccessful, endoscopic surgery such as functional endoscopic sinus surgery (FESS) may be required to remove tissue or widen the sinus passages. However, the upper respiratory endoscopes used in such treatments are reusable and very expensive, require capital equipment for the visualisation, and any tissue dissection can cause discomfort to the patient and damage to the walls of the sinus and nasal cavity. In order to address this problem, therefore, examples of the present disclosure provide an instrument that uses ultraviolet light to treat the nasal cavity in a minimally invasive way. Ultraviolet irradiation can have anti-microbial effects, and can thus be used to treat the microbiome and pathogens in the sinus and nasal cavity that is causing the inflammation, thereby managing and reducing the symptoms associated with rhinosinusitis and other inflammatory diseases. Furthermore, ultraviolet light of different wavelengths can be used to penetrate the tissue by varying amounts, thereby enabling the treatment of the microbiome to be delivered deep into the treatment area without any damage to the walls of the sinus or nasal cavity.

In view of the above, from one aspect the present disclosure provides an ultraviolet instrument for the application of ultraviolet light within a body cavity of the human or animal body, the ultraviolet instrument comprising an axially extending probe body shaped to allow insertion into a body cavity of a human or animal subject, the probe body including at least one ultraviolet source and having one or more windows formed in the surface thereof to permit ultraviolet light generated by the at least one ultraviolet source when in use to exit the probe body and to be directed at tissue to be treated.

In another aspect, an ultraviolet instrument for the application of ultraviolet light within a body cavity of the human or animal body is provided, the ultraviolet instrument comprising an axially extending probe body shaped to allow insertion into a body cavity of a human or animal subject, the probe body including at least one ultraviolet source, and an endoscope, the probe body having one or more windows formed in the surface thereof to permit ultraviolet light generated by the at least one ultraviolet source when in use to exit the probe body and to be directed at tissue to be treated.

The at least one ultraviolet source may be configured to output ultraviolet light of two or more wavelengths. In some examples, the probe body may comprise a plurality of ultraviolet sources, each configured to output an ultraviolet light of a different wavelength. In other examples, the at least one ultraviolet source may comprise one or more filters for varying a wavelength of the ultraviolet light. The wavelength of the output ultraviolet light may be thus be varied depending on the depth of penetration required. In this respect, two or more wavelengths between lOnm and 400nm, preferably, around 250nm up to about 350nm, may be used, with longer wavelength providing deeper penetration of the treatment area.

In one example, the one or more windows include a window facing from a distal end of the probe in the axial direction.

In another example, the one or more windows include a window facing in a radial direction outwards from the longitudinal axis of the probe.

In further examples, there may be a plurality of windows equiangularly arranged facing in respective radial directions outwards from the longitudinal axis of the probe. For example, there may be from 2 to 8 windows equiangularly arranged facing in respective radial directions outwards from the longitudinal axis of the probe.

In other examples, the one or more windows may extend in the form of one or more slots extending circumferentially around the probe body. For example, at least one of the slots may extend around a majority portion of the circumference of the probe body, and at least one of the slots may extend around the whole of the circumference of the probe body, to thereby allow ultraviolet light to be emitted around the whole of the circumference of the probe.

In examples wherein an endoscope is provided, the endoscope generally provides a field of view facing from a distal end of the probe in the axial direction, although it will be appreciated that it could also provide a field of view facing in other directions.

A further aspect of the present disclosure provides an ultraviolet system for the generation of ultraviolet light, comprising an ultraviolet instrument in the form of an axially extending probe body mounting therein at least one ultraviolet source, the probe body having one or more windows formed in the surface thereof through which generated ultraviolet light may exit so as to impinge on tissue to be treated thereby, the system further including an electrical power supply to supply electrical drive signals to the at least one ultraviolet source.

In some examples of the system, the probe body also comprises an endoscope.

In some examples, a video display to display images captured by the endoscope may be provided.

In some examples the probe is adapted to be inserted through the nose into the nasal cavity. In such examples, the probe may be elongate with a diameter similar to that of known ENT endoscopes, for example with a diameter no larger than 5mm. In other examples the probe may be sized and adapted to be inserted into other body cavities and may further be adapted so as to be insertable through a trocar port.

Brief Description of the Drawings

Embodiments of the invention will now be further described by way of example only and with reference to the accompanying drawings, wherein like reference numerals refer to like parts, and wherein: Figure 1 is a system diagram of an ultraviolet system according to an example of the present disclosure; Figure 2 illustrates a first example of an ultraviolet probe according to the present disclosure; Figure 3 illustrates the operational modes of the ultraviolet probe according to the present invention Figure 4 is a diagram illustrating the use of an ultraviolet probe according to examples of

the present disclosure;

Figures 5A-5C further illustrate different examples of an ultraviolet probe according to the present disclosure; Figure 6 illustrates a further example of an ultraviolet probe according to the present

disclosure; and

Figure 7 illustrates yet a further example of an ultraviolet probe according to the present disclosure.

Detailed Description of the Embodiments

Embodiments of the present invention provide an ultraviolet instruments for the treatment of pathologies in human or animal body cavities, for example the nasal and sinus cavity.

In some examples of the present disclosure an ultraviolet instrument may be provided which is integrated with an ENT endoscope for guiding the ultraviolet light instrument to a treatment area in the human or animal body, either via a natural orifice, or via a trocar port. For example, the instrument may be adapted to be insertable through a nostril into the nasal sinus cavity of a patient. Once inserted, an ultraviolet source is used to deliver ultraviolet light to a treatment area. In this respect, the anti-microbial effect of ultraviolet radiation is used to reduce the microbes and pathogens in the nasal cavity that are causing inflammation. Kemeny L. et al, in "Ultraviolet light phototherapy for allergic rhinitis", Journal of Photochemistry and Photobiology B: Biology, Volume 87, Issue 1 (2007) describe the effects of ultraviolet radiation in the treatment of rhinitis and other inflammatory diseases through its anti-microbial effect. The wavelength of the ultraviolet light emitted by the instrument may be varied according to the treatment depth required, with longer wavelengths providing deeper penetration of the tissue. The instrument may be arranged to output ultraviolet light in any direction. For example, the beam of ultraviolet light may be output in a forward direction into the field of view of the endoscope.

Alternatively, the beam of ultraviolet light may be directed radially to the sides of the end of the instrument, at right angles to the field of view of the ENT endoscope. The variable direction and treatment depth gives a number of different treatment options to the surgeon using the instrument.

Figure 1 illustrates an example ultraviolet (UV) system 10 according to examples of the disclosure. An ultraviolet instrument 14, also referred to herein as a probe, is provided, which integrates within its body an ENT endoscope comprising integrated optics for navigation and at least one ultraviolet source. The ultraviolet instrument 14 is connected to a handle 16 via cable 18, which provides electrical signals to the ultraviolet source, in order to generate and output ultraviolet light for treating the microbiome of the nasal or sinus cavity. In this respect, the handle 14 may comprise a power supply such as a battery, or be connectable to a separate power source. The ultraviolet instrument 14 may comprise multiple sources of ultraviolet radiation for delivering ultraviolet light of different wavelengths to the sinus or nasal cavity, for example, in the form of two or more ultraviolet light emitting diodes (LED). Alternatively, the ultraviolet source may comprise filters for varying the wavelength of the ultraviolet light output from the ultraviolet instrument 14.

Also integrated into the cable 18 is an optical fibre or other light waveguide forming party of the ENT endoscope that is integrated to the ultraviolet instrument 14. Images obtained via the ENT endoscope can be displayed on a display screen 12. Hence, the ultraviolet system of Figure 1 integrates an ultraviolet instrument with an ENT endoscope, in order to allow a surgeon to be guided via images obtained from the endoscope to a treatment site within the sinus or nasal cavity for the application of ultraviolet light to the site for treatment purposes. The ENT endoscope may also comprise articulating segments for navigating the ultraviolet instrument 14, the articulation extending along the cable 18 to the handle 16, which comprises controls for controlling the articulation of the ENT endoscope.

Figure 2 illustrates the ultraviolet instrument 14 in more detail. In this example, the instrument is for treatment of the microbiome in a nasal cavity. It will be seen that an ENT endoscope 22 is provided, extending along the length of the ultraviolet instrument 14, and projecting slightly from the end thereof so as to provide a field of view along the longitudinal axis of the instrument 14. As discussed above, this endoscope 22 may also comprise articulating segments (not shown) so that the instrument 14 can be navigated along the nasal cavity. Also integrated into the instrument 14 is an ultraviolet source 24, which is supplied with electrical power via wires 26 which run axially along the instrument 14, and back along the cable 18 to the handle 16. As described above, the ultraviolet source 24 may comprises two or more sources of ultraviolet light of different wavelengths, for example, in the form of two or more ultraviolet LEDs, or it may comprise a single ultraviolet source with a filter for varying the wavelength of the ultraviolet light that is output from the instrument 14. It will of course be appreciated that any suitable way of providing ultraviolet light of different wavelengths may be used.

In operation, the ultraviolet source 24 generates an ultraviolet light beam 28, which in this example is emitted from the front of the instrument 14, parallel to the axial long axis of the instrument and in the direction of the field of view of the ENT endoscope 22. The wavelength of the ultraviolet light 28 generated by the ultraviolet source 24 is selected depending on the treatment depth required. For example, as illustrated by Figure 3, an ultraviolet light from around 250nm up to about 350nm may be used, with the depth of penetration increasing with increasing wavelength. In this respect, the ultraviolet source 24 may be configured to output an ultraviolet light beam 28 having three different wavelengths, a first wavelength of 250nm for penetrating the stratum corneum, a second wavelength of 300nm for penetrating the epidermis and a third wavelength of 350nm for substantially penetrating the dermis. However, it will be appreciated that any suitable ultraviolet light with a wavelength from 1.0nm to 400nm may be used, depending on the depth of penetration required. To vary the wavelength of the ultraviolet light, it will be appreciated that the handle 16 will comprise suitable controls for switching between the different wavelengths.

As shown in Figures 5A-5C, however, it is not essential that the ultraviolet light exits the instrument in the long axial direction of the probe 14, and instead the ultraviolet light can be directed radially to one side or the other side of the probe 14, or in a further example could be ejected from multiple directions. In one example, the ultraviolet light may be directed radially in all directions circumferentially around the probe 14.

Figures 6 and 7 illustrate example embodiments where the ultraviolet light is directed radially to one or both sides of the longitudinal axis of the probe 14. In the example of Figure 6, the ultraviolet source 24 is moved actually further back from the distal end of the probe 14 when compared to the example of Figure 2, and is positioned more centrally along the longitudinal axis of the probe 14. A substantially conical or pyramidal ultraviolet deflector 34 is provided mounted on the closed end of the probe body 14 with its point pointing axially along the longitudinal axis of the probe 14 back towards the proximal end thereof. The ultraviolet source 24 is arranged such that the ultraviolet light that is generated and emitted therefrom is directed onto the tip of the ultraviolet deflector 34, which deflects the ultraviolet light radially so as to exit outlets 32 cut in the sidewalk of the probe 14. It will be appreciated that as many outlets 32 as are needed may be provided. For example, two outlets 32 may be provided on opposite side of the probe body 14, or four outlets may be provided arranged equiangularly at 90 degrees around the circumference of the probe body 14. In a further embodiment, and in particular where a conical ultraviolet deflector 34 is provided, the opening 32 may be in the form of a circumferentially extending slot that allows ultraviolet light to exit the probe 14 all around the circumference of the probe body 14.

Figure 7 illustrates an alternative example. Here, instead of a conical or pyramidal optical deflector 34 which deflects the plasma in multiple directions, a triangular cross section ultraviolet deflector 44 is provided, which acts to deflect the ultraviolet light exiting the ultraviolet source 24 in a single radial direction out a window 42 formed in the sidewall of the probe 14. In embodiments of Figure 7, therefore, a single radially extending beam of ultraviolet light is obtained out of the sidewall of the probe 14 in a radial direction.

As will be understood from the arrangements shown in Figures 5A-5C, 6, and 7, either single beams of ultraviolet light may be obtained projecting axially out of the tip of the probe 14, or radially out of the sidewalls of the probe, or multiple beams of ultraviolet light may be obtained in different radial directions out of the sidewalk of the probe 14. Which probe is most useful for a particular procedure can often depend upon individual surgeon preference, or the treatment required.

Figure 4 illustrates a use of the ultraviolet probe 14 in the example of treatment within the nasal cavity. Here, it will be seen that the ultraviolet probe 14 may be inserted through a patient's nostril into the nasal cavity. The surgeon then guides the probe 14 to the appropriate area of the nasal cavity to which ultraviolet light is to be applied, using the endoscope built into the probe 14. Having inserted the probe 14 into the nasal cavity through the nostril, the surgeon then reviews the endoscope image on the screen 12, and guides the end of the probe 14 to the appropriate part of the nasal cavity to which ultraviolet light is to be applied. When the probe 14 is in the correct position, allowing for the direction of exit of the ultraviolet light from the probe 14, the surgeon uses the controls on the handle 16 to cause an ultraviolet light of the required wavelength to be emitted from the tip of the probe 14. The ultraviolet light then impacts the desired tissue treatment area, to thereby treat the inflamed tissue.

In other examples the probe may be adapted for insertion into other body cavities in which ultraviolet light may be used for treatment of the tissue therein. The length and width of the probe may be adapted depending on the intended cavity into which it is to be inserted. Moreover, insertion may be through a natural orifice such as the nose, mouth, anus, urethra or vagina, or via a trocar port.

Moreover, in further examples it is not necessary for the probe to be integrated with an endoscope, and whilst advantageous for navigation purposes as noted above, if navigation to the treatment site is possible via other means, for example using medical imaging such as x-ray fluoroscopy, or simply via surgeon knowledge then in further examples of the disclosure the probe need not be integrated with the endoscope, and can be a stand-alone ultraviolet treatment probe. For example, when treating the proximal section of the nasal tract near the nostrils, as shown in Figure 4, an endoscope may not be required to guide the probe 14.

It will also be understood that the probe 14 may be single use or reusable. In the former, the probe 15 may have connection port in the end opposite the treatment end for connecting to the cable 18 of the controller 16.

Various further modifications to the above described embodiments, whether by way of addition, deletion or substitution, will be apparent to the skilled person to provide additional embodiments, any and all of which are intended to be encompassed by the appended claims.

Claims

Claims 1. An ultraviolet instrument for the application of ultraviolet light within a body cavity of the human or animal body, the ultraviolet instrument comprising: an axially extending probe body shaped to allow insertion into a body cavity of a human or animal subject, the probe body including at least one ultraviolet source; the probe body having one or more windows formed in the surface thereof to permit ultraviolet light generated by the at least one ultraviolet source when in use to exit the probe body and to be directed at tissue to be treated.
2. An ultraviolet instrument according to claim 1, wherein the at least one ultraviolet source is configured to output ultraviolet light of two or more wavelengths.
3. An ultraviolet instrument according to claims 1 or 2, wherein the probe body comprises a plurality of ultraviolet sources, each configured to output an ultraviolet light of a different wavelength.
4. An ultraviolet instrument according to claims 1 or 2, wherein the at least one ultraviolet source comprises one or more filters for varying a wavelength of the ultraviolet light.
5. An ultraviolet instrument according to any preceding claim, wherein the one or more windows include a window facing from a distal end of the probe in the axial direction.
6. An ultraviolet instrument according to any of claims 1 to 4, wherein the one or more windows include a window facing in a radial direction outwards from the longitudinal axis of the probe.
7. An ultraviolet instrument according to claim 6, wherein there are a plurality of windows equiangularly arranged facing in respective radial directions outwards from the longitudinal axis of the probe.
8. An ultraviolet instrument according to claim 7, wherein there are from 2 to 8 windows equiangularly arranged facing in respective radial directions outwards from the longitudinal axis of the probe. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18.
An ultraviolet instrument according to any of claims 1 to 4, wherein the one or more windows extend in the form of one Or more slots extending circumferentially around the probe body.
An ultraviolet instrument according to claim 9, wherein at least one of the slots extends around a majority portion of the circumference of the probe body.
An ultraviolet instrument according to claim 10, wherein at least one of the slots extends around the whole of the circumference of the probe body, to thereby allow ultraviolet light to be emitted around the whole of the circumference of the probe.
An ultraviolet system for the generation of ultraviolet light, comprising an ultraviolet instrument in the form of an axially extending probe body mounting therein at least one ultraviolet source, the probe body having one or more windows formed in the surface thereof through which generated ultraviolet light may exit so as to impinge on tissue to be treated thereby, the system further including an electrical power supply to supply electrical drive signals to the at least one ultraviolet source.
An ultraviolet system according to claim 12, wherein the at least one ultraviolet source is configured to output ultraviolet light of two or more wavelengths.
An ultraviolet system according to claims 12 or 13, wherein the ultraviolet instrument comprises a plurality of ultraviolet sources, each configured to output an ultraviolet light of a different wavelength.
An ultraviolet system according to claims 12 or 13, wherein the at least one ultraviolet source comprises one or more filters for varying a wavelength of the ultraviolet light.
An ultraviolet system according to any of claims 12 to 15, wherein the probe body further comprises an endoscope.
An ultraviolet system according to claim 16, further comprising a video display to display images captured by the endoscope.
An ultraviolet system according to any of claims 12 to 17, wherein the one or more windows include a window facing from a distal end of the probe in the axial direction.
19. An ultraviolet system according to any of claims 12 to 17, wherein the one or more windows include a window facing in a radial direction outwards from the longitudinal axis of the probe.
20. An ultraviolet instrument for the application of ultraviolet light within a body cavity of the human or animal body, the ultraviolet instrument comprising: an axially extending probe body shaped to allow insertion into a body cavity of a human or animal subject, the probe body including: at least one ultraviolet source; and an endoscope; the probe body having one or more windows formed in the surface thereof to permit ultraviolet light generated by the at least one ultraviolet source when in use to exit the probe body and to be directed at tissue to be treated.
21. An ultraviolet system according to claim 20, wherein the endoscope provides a field of view facing from a distal end of the probe in the axial direction.