Patent Description:
However, regardless of the particular procedure, a few different types of tools are generally employed. For example, an interventional tool that is tasked with directly engaging with and affecting a part of the eye will be utilized. A common example of such a tool is a vitrectomy probe utilized in a vitrectomy. A vitrectomy is the removal of some or all of the vitreous humor from a patient's eye. In some cases, where the surgery was limited to removal of clouded vitreous humor, the vitrectomy may constitute the majority of the procedure. However, a vitrectomy may accompany cataract surgery, surgery to repair a retina, to address a macular pucker or a host of other issues.

The vitreous humor itself is a clear fibrous gel that may be removed by an elongated probe when inserted through a pre-placed cannula at the eye. More specifically, the probe includes a central channel for removal of the vitreous humor. Further, the cannula provides a structurally supportive conduit strategically located at an offset location at the front of the eye, such as the pars plana. In this way, the probe may be guidingly inserted into the eye in a manner that avoids damage to the patient's lens or cornea.

Of course, in order to achieve a successful vitrectomy or other such intervention, some additional tools may be required. For example, visualization of the vitrectomy may be aided by the insertion of a light instrument. Similar to the vitrectomy probe, this may be guided by another pre-placed cannula that is again positioned at an offset location. Thus, a given eye surgery is likely to have multiple tools that reach interventionally into the eye.

One issue that emerges in advancing surgical tools through pre-placed cannulas as described, is visibility. Of course, utilizing a well-lit room to make sure that the surgeon can safely see both the cannula and the end of the tool that is being advanced into the cannula is an option. However, there are competing locations of interest for visibility. That is, competing locations of visibility may be involved in the surgery. For example, the retina within and at the back of the eye is often the target location for the eye surgery. However, if the operating room is too bright, there may not be sufficient contrast for good visibility of the retina to the surgeon.

As an alternative to the idea of a well-lit room, the room may be kept relatively dim while the surgeon utilizes a microscope light positioned over the patient's eye to illuminate the cannula and the end of the tool. In this way, as the end of the tool approaches the cannula, visibility of both may be sufficient to ensure safe advancement of the tool end into the cannula. Once this occurs, the surgeon may turn off or dim the microscope light to more closely match the illumination within the room. In theory, this may restore sufficient contrast to allow the surgeon to better see features within the eye such as the noted retina.

Because the surgeon's visibility may be dependent upon the surgeon's eyes which are themselves affected by fairly substantial changes in degrees of illumination, turning lights on and off, whether throughout the room or at a microscope light, may affect the surgeon's vision. Even the non-surgeon understands that when a bright light is turned down or off, it takes a few moments for visibility to return to a normal level as the eyes adjust to the change.

In the case of the described eye surgeries, this means that once the surgeon threads the end of the surgical tool into the cannula, the intense light is turned down and focus is then shifted to the interior of the eye to perform a procedure. However, due to the change in light conditions, the surgeon's vision may need to adjust to the change prior to continuing the surgery (which may cause some delay).

Reference is made to the documents <CIT>, <CIT>, <CIT>, <CIT>, and <CIT> which have been cited as relating to the background state of the art.

<CIT> discloses a system for adjusting illumination of a surgical microscope during an ophthalmic surgical procedure.

<CIT> discloses a surgical device for an ophthalmic surgery procedure, wherein the device comprises a switch for controlling the activation, light color, intensity, focus/diffusion, frequency, and strobing of external or internal means of illumination.

The scope of the invention is in accordance with the claims.

Accordingly, there is provided a surgical assembly as claimed in claim <NUM>. Further optional features are provided in accordance with the dependent claims. Embodiments, examples or aspects in the following disclosure, in particular methods, which do not fall under the scope of the claims are presented for illustration purposes only and do not form part of the invention.

The specification also includes description of a method of performing eye surgery, not being part of the invention. The method includes securing a fluorescent cannula at an eye surface. Low intensity light may be maintained within the operating room as an interventional device is advanced toward the fluorescent cannula. However, another light is directed at the device that is not the low intensity light. Rather, this other light is of a tailored light window range. The tailored light may be light that is between about <NUM>% and about <NUM>% illumination and/or light that is substantially monochromatic and less than about <NUM>,<NUM> (nanometers) in wavelength.

In the following description, numerous details are set forth to provide an understanding of the present disclosure. However, it will be understood by those skilled in the art that the embodiments described may be practiced without these particular details. Further, numerous variations or modifications may be employed which remain contemplated by the embodiments as specifically described.

Embodiments are described with reference to certain types of vitrectomy probe surgical procedures. In particular, a procedure in which vitreous humor is removed to address vitreous hemorrhage is illustrated. However, tools and techniques detailed herein may be employed in a variety of other manners. For example, embodiments of a vitrectomy probe as detailed herein may be utilized to address retinal detachments, macular pucker, macular holes, vitreous floaters, diabetic retinopathy or a variety of other eye conditions. Regardless, so long as the surgical procedure is aided by the use of a tailored light window directed at the end of a surgical instrument as it is guided into the eye, appreciable benefit may be realized.

Referring now to <FIG>, an illustration of a surgical tool <NUM> approaching a preplaced fluorescent cannula <NUM> at an eye <NUM> is shown. The tool <NUM> may be a vitrectomy probe with a needle <NUM> wherein the objective is to guidingly insert the needle <NUM> through the cannula <NUM> for a vitrectomy procedure within the eye <NUM>. Notice that the procedure is taking place within the environment of an operating room <NUM> where generally low illumination ambient light, perhaps under about <NUM> lumen, is present. This is generally a non-light assisted environment where the visualization and contrasting aid techniques for the procedure are carried out as detailed further below. More specifically, in the embodiment illustrated in <FIG>, prior to reaching the interior of the eye <NUM>, a tailored window of light <NUM> may be used as a visualization aid for guiding the end of the needle <NUM> implement into the cannula <NUM>.

The tailored window of light <NUM> being directed at the needle <NUM> as a visualization aid is a beneficial in a variety of ways. For example, the low illumination of the operating room <NUM>, which is beneficial for surgery within the eye <NUM>, as described below, does not need to be altered. There is no need to operate a dimmer or a foot pedal or anything else to brighten the room <NUM>, followed by another attempt at re-finding the proper low level of illumination for the actual surgery within the eye. Instead, that general low level of illumination throughout the room <NUM> may be maintained because a different tailored light <NUM> is utilized as a visual aid for threading the needle <NUM> into the cannula <NUM>. Furthermore, because the overall intensity of light in the room <NUM> was not raised, the surgeon's own eyes may not need to undergo a period of constricted iris adjustment back open to the lower level illumination in the room <NUM> before proceeding with the surgery in the eye <NUM>. This is particularly beneficial because it may avoid a period of time where the surgeon attempts to hold still (possibly holding an implement inside the eye <NUM>) while the surgeon waits for his/her own visually impaired eyes to adjust back to the dimmer light of the room <NUM>.

Continuing with reference to <FIG>, the tailored light <NUM> itself may also be of a particular window of wavelengths. For example, the light <NUM> may be of between about <NUM>% and about <NUM>% illumination of a spectral output that is up to <NUM> lumens (other levels are also contemplated (e.g., <NUM> lumens, <NUM> lumens, <NUM> lumens, etc.) Just like avoiding brightening the light of the room <NUM> generally, limiting the illumination of the tailored light <NUM> to a narrow low level may avoid introducing a period of adjustment for the surgeon's own eyes as described above. Further, in another embodiment, the light <NUM> may alternately or additionally of a substantially monochromatic nature such as "amber" light. From a quantifiable standpoint, this may include substantially monochromatic light that is less than about <NUM>,<NUM> in wavelength. By way of more specific examples, this could include amber light of between <NUM>-<NUM>, near infrared (IR) of between about <NUM> and <NUM>,<NUM> and IR of up to <NUM>,<NUM>. Other wavelengths can also be used as required by the specific surgical needs.

With added reference to <FIG>, in one embodiment, the tailored light <NUM> is introduced by the surgeon's use of a light instrument <NUM> such as a conventional chandelier as illustrated in <FIG>. This may be particularly beneficial where such an instrument <NUM> is already slated to be utilized in the procedure within the eye <NUM>. Indeed, note that there are multiple pre-placed cannulas <NUM>, <NUM> at offset locations of the sclera <NUM>, avoiding more delicate lens <NUM> and cornea <NUM> structure. Thus, as illustrated in <FIG>, a procedure within the eye <NUM> may eventually be carried out by both instruments <NUM>, <NUM>.

Notice that in addition to the tailored light <NUM> directed at the end of the needle <NUM>, there is additional light <NUM> emitting from the cannulas <NUM>, <NUM>. This additional light may be fluorescent light emanating from phosphor of the cannula structure. That is, in the embodiment shown, the cannulas <NUM>, <NUM> may be comprised of a conventional polycarbonate material with phosphorescent pigment mixed therein. Both the polycarbonate and pigment would be conventional biocompatible materials. In one embodiment, the pigment selected is based on strontium oxide aluminate chemistry. One advantage of utilizing phosphorescence to supply the light emitting component is the resulting "glow" or "glow-in-the-dark" nature supplied to the cannulas <NUM>, <NUM>. Thus, from the surgeon's perspective, the cannulas <NUM>, <NUM> will be visibly discrete while at the same time, the end of the needle <NUM> will be illuminated by a tailored light <NUM>. Therefore, the structures which are being brought together and mated are both suitably lit and visible within the otherwise dim light of the room <NUM>. It will be appreciated that other self-illuminating cannula types are also contemplated.

Referring now to <FIG>, an overview of the eye <NUM> of <FIG> is illustrated in the environment of the operating room <NUM> positioned below a microscope <NUM> for the surgery. In this view, lighting conditions of the room <NUM> in the context of an eye surgery that is about to commence may be better illustrated. For example, the surgeon may orient things by looking through eye pieces <NUM>, <NUM> with a sightline directed through a reduction lens <NUM> and a wide-angle lens <NUM>. In this way, particular focus is drawn to interior features of the eye <NUM> such as the optic nerve <NUM> and retina <NUM>. So, for example, visibility for removal of vitreous humor from an adjacent region <NUM> may be facilitated as discussed further below.

However, when attempting to advance surgical instruments to such a region <NUM>, visibility at the front of the eye <NUM> in the initial environment of the room <NUM> may not automatically be ideal. This may be of importance given the delicate nature of the cornea <NUM> and lens <NUM> in particular. Thus, as noted above, added measures may be taken to help ensure that other aspects near the front of the eye <NUM> are provided with visibility. As illustrated in <FIG>, fluorescent light <NUM> is emitted from the cannulas <NUM>, <NUM>. Therefore, the room <NUM> may be kept at a relatively dim level to provide contrast and visibility to features at the interior and back of the eye <NUM> as described while also allowing for cannula visibility near the front. With added reference to <FIG> and <FIG>, the same is true for the ends of instruments approaching the cannulas <NUM>, <NUM> at the front of the eye <NUM>. Specifically, tailored light <NUM> renders both a needle <NUM> of a vitrectomy probe <NUM> and the end of a light instrument <NUM> visible to the surgeon near the front of the eye <NUM>. In other words, sufficiently illuminated tool ends and cannulas <NUM>, <NUM> are visible to the surgeon in spite of the otherwise dim conditions of the room <NUM>.

Referring now to <FIG>, a perspective view of the surgical tool <NUM> of <FIG> is shown in the form of a vitrectomy probe. However, in addition to the probe <NUM>, a light instrument <NUM> is also shown which is utilized to direct the tailored window of light <NUM> toward the probe <NUM>. More specifically, a light emitting diode (LED) <NUM> or other light source of the instrument is utilized to direct the light <NUM> at the needle <NUM> of the probe <NUM> near a port <NUM> discussed further below. That is, the probe <NUM> includes a variety of other features at other locations, such as a tapered handle <NUM>, housing <NUM> and/or removable shell <NUM>. However, it is the end of the needle <NUM> that is of visibility concern when it comes to pairing and threading of the probe <NUM> relative the cannula <NUM> and into the eye <NUM> as illustrated in <FIG>. In this regard, the light <NUM> may be of a tailored window of full spectrum, low illumination or of a substantially monochromatic nature as described hereinabove.

Continuing with reference to <FIG>, it is worth noting that the tailored window of light <NUM> may include light that is outside of the visible spectrum in terms of the surgeon's own naked eye, for example. That is, in certain circumstances, visibility for the surgeon is provided indirectly by way of a video screen. Thus, light that is visible to video instrumentation, even if not visible to the surgeon may be sufficient. By way of a specific example, substantially monochromatic light that is below about <NUM> in wavelength may be outside of the surgeon's own visible spectrum and nevertheless sufficient for generating decipherable imaging by way of a video screen presented to the surgeon.

In some embodiments, the light provided by the instrument <NUM> may be switched between the tailored light <NUM> and a light preferred for illumination of the interior of the eye. For example, the surgeon may switch the instrument <NUM> to the tailored light while the light is outside of the eye and then switch the instrument provided light to a brighter (or dimmer) light for illuminating the interior of the eye once the instrument <NUM> has been inserted into the eye (e.g., through cannulas <NUM>, <NUM>). In some embodiments, other characteristics of the light may also be changed after the light is inserted into the eye (e.g., independent levels of red, green, and blue LEDs providing the light may be adjusted). In some embodiments, blue light may be omitted entirely once the instrument <NUM> is inserted into the eye.

Input to trigger switching between the tailored light and internal eye light may be provided by the surgeon, for example, through pressing a button on a foot pedal, pressing a button on a surgical console, pressing a button on the side of the instrument <NUM>, etc.) In some embodiments, the instrument <NUM> may include an optical sensor near an end of the probe that provides detected light levels to a surgical console to assist the console in determining if the instrument <NUM> is inside or outside of the eye (and the tailored light may be switched on (out of the eye) or off (inside the eye in which case a different type of light may be emitted), accordingly. Other detection means are also contemplated (e.g., the console may analyze images of the surgical site taken through a camera to determine if the instrument <NUM> is inside or outside the eye and switch the light accordingly).

In some embodiments, the tailored light may be emitted from, for example, a microscope part that is not configured to enter the eye. In this case, the console may determine when a surgical implement (e.g., a vitrectomy probe) is outside of the eye (e.g., using an optical sensor on the vitrectomy probe or analyzing images of the surgical site to determine a location of the vitrectomy probe) and emit a tailored light from the microscope part. Further, when the console determines (through, for example, the optical sensor or image analysis, etc.) that the vitrectomy probe is inside the eye (e.g., inserted through cannulas <NUM>, <NUM>) the console may switch the light emitted from the microscope part to light with different characteristics (e.g., intensity, frequency, etc.) according to, for example, a surgeon preference for the light once the vitrectomy probe is located in the eye.

Referring now to <FIG>, a perspective overview of the tool <NUM> and light instrument <NUM> of <FIG> are shown advanced to within the eye <NUM> of <FIG> and <FIG> for a surgical procedure therein. During the procedure, the needle <NUM> is inserted through a preplaced cannula <NUM> and directed toward a region <NUM> where vitreous humor is to be removed. Specifically, a suction is applied and the port <NUM> is used for the uptake of the vitreous humor or other substances. For example, in the procedure illustrated, a hemorrhage may be taking place in the region <NUM> such that blood is drawn into the port <NUM> along with the vitreous humor. Regardless, of the particulars of the procedure itself, however, the visibility of the ends of the tool <NUM> and instrument <NUM> is enhanced by a uniquely tailored window of light <NUM> that does not compromise the given light of the room <NUM> (see <FIG>). Thus, these devices (<NUM>, <NUM>) may reach the depicted destination without sacrifice to visibility and potential harm to portions of the eye <NUM> at its front. Once more, this same light <NUM> may be used to further aid visibility in performing the surgery as illustrated in <FIG>. However, in an alternate embodiment, the light <NUM> may emerge from another source such as the microscope <NUM> of <FIG>. In this way, the surgeon may control a foot pedal, utilize voice activation, a wearable sensor or other means of light actuation, thereby freeing up another hand during the surgical procedure.

As indicated, the surgery includes the probe <NUM> and a light instrument <NUM> reaching into the eye <NUM> through cannulas <NUM>, <NUM> positioned in an offset manner at the sclera <NUM>. In this way, the more delicate cornea <NUM> and lens <NUM> may be avoided. By the same token, the optic nerve <NUM> and retina <NUM> are also quite delicate. Therefore, given that the needle <NUM> is capable of reaching these delicate features, illuminating both the back of the eye <NUM> and the end of the needle <NUM> for the surgeon are of significant benefit. Once more, the manner in which this is achieved for the embodiments herein, do not require the surgeon to pause for any eye adjustment for sake of his/her own visibility.

Referring now to <FIG>, a flow-chart summarizing an embodiment of utilizing a tailored window of light to visually guide the end of a surgical tool into an eye of a patient is shown. Specifically, with a given light of the operating room set to highlight and contrast visibility at the interior of a patient's eye as indicated at <NUM>, another tailored window of light is directed at the end of a surgical tool (see <NUM>). This tool is then advanced through a cannula and into the eye as indicated at <NUM>. At this same time, light may also be emitted from the cannula itself as noted at <NUM>. Thus, visibility is provided at the front of the eye for the tool and optionally the cannula as well. This occurs without needing to alter the given light of the operating room. Therefore, as indicated at <NUM>, surgery may be performed with the tool reaching into the eye and without the surgeon needing to break for sake of his/her own eyes to re-adjust. Indeed, this surgery may even be further facilitated by the light instrument that supplied the tailored light, now being supplied within the eye. All the while, the desired given light of the operating room environment may be maintained for sake of visibility of the interior of the eye (see <NUM>).

Embodiments described hereinabove include techniques for performing eye surgery with an instrument advanced into an eye in a manner that does not present dramatic changes in light conditions. That is, there is no need to dramatically increase illumination, whether throughout the operating room or at a more central microscope location. Thus, the surgeon's own eyes are not presented with conditions that require any significant adjustment period between the time the instrument enters the eye and before the procedure commences within the eye. Rather, uniquely tailored windows of light that do not present cause for such adjustment periods are utilized to aid the surgeon in "threading the needle" that is guidance into a preplaced cannula at the eye for the procedure. As a result, the surgeon need not spend an inordinate amount of time remaining calm and still while holding a surgical tool within a patient's eye and waiting for a return to normal vision.

Claim 1:
A surgical assembly comprising: a surgical tool (<NUM>) with an implement for reaching into an eye of a patient during a surgical procedure in an operating room of a given light; and
a light instrument (<NUM>) for directing a tailored light (<NUM>) different from the given light at the implement to visibly facilitate the reaching of the implement into the eye;
and
a surgical console;
wherein light emitted from the light instrument (<NUM>) is switchable between the tailored light (<NUM>) when the implement is outside of the eye to a different light when the implement is located inside the eye;
wherein the tailored light (<NUM>) is substantially monochromatic light below <NUM> nanometers in wavelength such that the tailored light is not visible to a user's eyes but is visible to video instrumentation to be used to generate a decipherable image on a video screen presented to the user of the surgical tool;
wherein the assembly further comprises a detection means to determine if the surgical tool is inside the eye;
wherein the detection means comprises an optical sensor at an end of the surgical tool or a camera, and the console is configured to analyze images of a surgical site taken through the camera to determine if the surgical tool is inside the eye; and
wherein the console is configured to determine if the surgical tool is inside the eye and switch the light emitted from the light instrument accordingly based on the detection means.