Imaging tools to support ophthalmic surgery

Abstract

An imaging tool having a very small diameter tubular instrument for placement within a patient's eye and extending an image capture platform from it. The platform has a specific size to accommodate a thin film image sensor or the like within the lumen or inner diameter of the instrument. However, a microchip package having a bulk footprint that is too large for the inner diameter of the instrument can be displaced elsewhere in the tool, such as to an adjacent, larger handpiece or housing. Furthermore, the platform can expand as it is exposed inside the eye by extension, thus providing an increased surface area and number of pixels for imaging.

Description

Technical Field

[0001] Priority Claim This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 106,435, filed on October 28, 2020, entitled "Imaging Tool for Supporting Ophthalmic Surgery" (inventor: Paul R. Hallen), which is hereby incorporated by reference in its entirety.

Background Art

[0002] Over the years, there have been many dramatic advances in the field of ophthalmic surgery. However, regardless of the specific procedure, a few types of tools are generally adopted. For example, invasive tools tasked with directly engaging and acting on a part of the eye are utilized. A common example of such a tool is a vitrectomy probe used for vitrectomy. Vitrectomy is the removal of some or all of the vitreous humor from the patient's eye. When the surgery is limited to the removal of the cloudy vitreous humor, vitrectomy may account for most of the procedure. However, vitrectomy may be accompanied by surgeries for repairing the retina or cataract surgery to address hosts of macular folds or other problems.

[0003]

[0004] The vitreous humor itself is a clear gel and can be removed by an elongated probe when inserted through a cannula pre-positioned in the eye. Specifically, the probe includes a central flow path for the removal of the vitreous humor. Further, the cannula provides a structurally supportive conduit strategically placed at an offset position in the anterior part of the eye, such as the pars plana. In this way, the probe can be guided and inserted into the eye so as to avoid damaging the patient's lens or cornea.Naturally, some additional tools may be needed to successfully perform vitrectomy or other interventions of this type. For example, visualization of vitrectomy can be aided by the insertion of an illumination device. Similar to the vitrectomy probe, the illumination device can be guided by another pre-positioned cannula positioned at an offset location. Depending on the nature of the intervention and the target area of ​​the eye, external imaging of the procedure may be sufficient without further assistance. For example, if the probe is directed towards the posterior part of the eye to address the risk of bleeding, a camera that passes through the anterior part of the eye and is focused can adequately image the posterior part of the eye for the procedure.

[0005] Unfortunately, from an imaging perspective, surgical procedures are not always directed towards the posterior part of the eye. Furthermore, in standard situations, interventional tools and illumination equipment are available to reach inside the eye from a safer offset incision near the anterior part of the eye. In other words, visualizing and directly acting on the area near the anterior part of the eye can be challenging. The field of view available to the physician is limited.

[0006] To address the problem of limited field of view, surgical mirrors can be used to enlarge the field of view visible to the surgeon. Similar to dental mirrors, which are positioned in the patient's mouth to allow visibility of areas obscured by the absence of a mirror behind the teeth, ophthalmic surgical mirrors can be used. For example, a surgical mirror can be inserted into the eye at a third offset position. The mirror surface can be directed to adjacent offset positions and / or towards the front of the eye. In this way, the surgeon and external imaging equipment facing the front of the eye are given visualization of the anterior offset positions or posterior regions of the eye.

[0007] Surgical mirrors can be an effective aid for physician visualization, but their quality is still limited. The mirror itself represents an indirect, inverted image of the eye region to a camera located outside the patient's eye during surgery. Certainly, it might seem far more ideal to simply position the endoscopic imaging device directly inside the patient's eye and direct the device to an offset or anterior position. In fact, this might seem desirable for visualizing any region of the eye, even the posterior region.

[0008] Unfortunately, the ability to use an endoscope for such procedures is not very desirable. A pre-positioned cannula is already set in an offset position. The cannula is safely positioned in an incision of a very limited size. In fact, the illumination equipment, vitrectomy probe, surgical mirror, and other instruments that reach into the eye are unlikely to exceed a diameter of approximately 0.70 mm to pass through and fit into the cannula. This may be too small to accommodate an angled endoscope due to the associated equipment. [Overview of the Initiative]

[0009] An imaging tool is provided to support ophthalmic surgery. The tool includes a housing for physical manipulation by the ophthalmologist. A tubular instrument with an outer diameter of approximately 0.7 mm or less extends from the distal end of the housing and reaches into the patient's eye during surgery. The housing accommodates a microchip with a bulk footprint larger than the inner diameter of the instrument. However, a thin-film imaging platform is housed within the annular instrument and can be extended from within the instrument for imaging of the eye. The platform is further configured to expand when extended in this manner from within the instrument. [Brief explanation of the drawing]

[0010] [Figure 1] Figure 1 is a perspective view of one embodiment of an imaging tool for ophthalmic surgery having a thin-film image acquisition platform. [Figure 2A]Figure 2A is a side cross-sectional view of the thin-film imaging sheet of the platform shown in Figure 1. [Figure 2B] Figure 2B is a side cross-sectional view of the microchip package inside the housing of the tool shown in Figure 1. [Figure 2C] Figure 2C is an enlarged side cross-sectional view of section 2-2 in Figure 2A, showing the sensor layer of the imaging sheet. [Figure 3] Figure 3 is a lateral cross-sectional view of a patient's eye during vitrectomy using the imaging tool shown in Figure 1. [Figure 4A] Figure 4A is a top view of the thin-film image acquisition platform of the tool in Figure 3, fully extended to facilitate maximum imaging for ophthalmic surgery. [Figure 4B] Figure 4B is a top view of the thin-film image acquisition platform as the tool retracts into the needle instrument. [Figure 4C] Figure 4C is a top view of the thin film image acquisition platform fully retracted into the needle instrument to withdraw the tool from the eye. [Figure 5] Figure 5 is a flowchart summarizing an embodiment in which ophthalmic surgery is performed with the help of imaging tools, as shown in Figures 1 and 3. [Modes for carrying out the invention]

[0011] In the following description, numerous details are given to facilitate understanding of this disclosure. However, those skilled in the art will see that the embodiments described can be implemented without these specific details. Furthermore, numerous changes or modifications can be adopted that are directly incorporated into the embodiments described.

[0012] Embodiments will be described with reference to specific types of vitrectomy probe surgical procedures. In particular, procedures for removing vitreous fluid to address vitreous hemorrhage will be illustrated. However, the tools and techniques detailed herein can be employed in a variety of other ways. For example, embodiments of vitrectomy probes detailed herein can be used to address retinal detachment, macular folds, macular holes, vitreous floatations, diabetic retinopathy, or a variety of other ocular conditions. Separately, appropriate advantages can be realized insofar as the surgical procedure is aided by the use of imaging tools having a thin-film imaging capture platform that is extendable and / or expandable into the ocular environment for direct imaging.

[0013] Figure 1 is a perspective view of one embodiment of the imaging tool 100. In a broad sense, the tool 100 can be fabricated for ophthalmic surgery as shown in Figure 3. Specifically, however, the tool 100 includes a thin-film image acquisition platform 101. As shown, the platform 101 extends from within a tubular needle instrument 150. This instrument 150 can have an outer diameter of approximately 0.7 mm or less. Therefore, practically, before extension (or during retraction), the platform 101 is configured to fold into the lumen of the instrument 150, which has an inner diameter of less than 0.7 mm (possibly less than approximately 0.9 mm). In this way, the larger profile of the extended and expanded platform 101 does not interfere with the minimal invasiveness of positioning the instrument 150 via a pre-positioned cannula 315 during surgery, as shown in Figure 3.

[0014] Platform 101 can be supported by a flexibly expandable substrate of nitinol, biocompatible elastomer, or other suitable base support. However, it is the thin-film imaging sensor feature of platform 101 that uniquely benefits the entire tool 100 for use in minimally invasive surgery. See also Figure 2, the thin-film imaging sensor is not only foldable as suggested above and further detailed below, but in the illustrated embodiment, the microchip imaging assembly 240 can be displaced from its location on platform 101. That is, such an assembly 240, which has a bulk footprint that is too large to be positioned within the instrument 150, can be displaced to another location, such as within the housing 125 held by the physician during the procedure, as shown in Figure 3.

[0015] Furthermore, as can be seen in Figure 2, unlike conventional endoscopes, thin-film image sensors, such as those used in platform 101 in Figure 1, can be electrically coupled to the microchip imaging assembly 240 by conventional cable wiring or by thin-film circuits with conductive traces. Separately, the use of the thin-film platform 101 makes it practical to displace the assembly 240, which has a larger bulk footprint, to a nearby practical location. Thus, the foldable platform 101 can be extended and expanded from within the instrument 150 as instructed using the actuator 175. Specifically, the positioning of the platform can be manipulated by moving the mandrel or actuation rod within the instrument 150, which is physically connected to the actuator 175 and platform 101, forward or backward using the actuator 175. In this way, the platform 101 with an extended profile can be deployed for visualization once positioned within the patient's eye 350, and then retracted into the instrument 150 to remove the tool 100 (Figure 3).

[0016] Next, Figure 2A is a side cross-sectional view of the thin-film image acquisition platform 101 of Figure 1. Specifically, the thin-film image sensor sheet portion of the platform is shown at its minimum thickness (t). That is, the underlying substrate is not depicted. The sheet has a thickness (t) of less than approximately 0.05 mm, and would likely remain unchanged even with the aforementioned substrate added. Therefore, the ability to store the foldable platform 101 within the apparatus 150 before use, as shown in Figure 4C, is practically guaranteed.

[0017] Next, referring to Figure 2B in addition to Figure 1, a side cross-sectional view of the microchip package 240 is shown. The package 240 contains a chip 208 with sufficient memory to store image capture data from the platform 101 in Figure 2A. The package 240 may also include other features that contribute to the overall bulk footprint, which would be too large to accommodate in a conventional encapsulation material 230, circuit board 205, and fixture 150. Unlike the folding platform 101, the package 240 is rigid and includes a thickness (T) and width (W), each possibly exceeding 1 mm. Nevertheless, there is sufficient available space within the housing 125 of the tool 100 to displace the package 240 away from the location of the thin-film platform 101 in order to house it in the housing 125. The chip 208 can be electronically coupled to the platform 101 using conventional wiring or a thin-film circuit with metal traces running from the platform 101 through the fixture 150 to the housing 125.

[0018] Looking at Figure 2B in addition to Figure 1, the package 240 can be a conventional CMOS (complementary metal-oxide-semiconductor) package well suited for image data management. A "off-the-shelf" package 240 may be suitable for use without the need to specifically configure a package 240 of a shape or size suited to the purpose. Furthermore, the package 240 may include a wireless data transmitter to facilitate image data management and processing on a nearby mainframe. Thus, the tool 100 may include conventional wireless equipment for a physician, from which images are generated and presented on a nearby screen.

[0019] FIG. 2C is an enlarged side cross-sectional view taken along line 2-2 of FIG. 2A, showing the sensor layers 225, 250, 275 of the thin film platform 101. This illustrates an embodiment of image capture. Specifically, a first layer 225 made to capture blue image data, a second layer 250 made to capture green image data, and a third layer 275 made to capture red image data are utilized, employing a Faveon sensor architecture. This stack acquires data when light 210 reaches and is absorbed by each layer. Depending on the total surface area of the fully deployed platform 101 of FIG. 1, practically, data capture of 10,000 to 100,000 pixels can be achieved. Of course, it is not necessary to employ a Faveon stack architecture. For example, a non-stack Bayer sensor architecture may be preferred in some cases.

[0020] FIG. 3 is a side cross-sectional view of a patient's eye 350 during vitrectomy using the imaging tool 100 of FIG. 1. In the illustrated surgery, instruments are positioned offset in the sclera 370. In this way, more delicate features located centrally in the rear part of the eye 350, such as the cornea 390 and lens 380 and the optic nerve 360 and retina 375, can be avoided. Specifically, the vitreous probe needle 325 is inserted through a pre-positioned cannula 330 and directed towards the region 310 where the vitreous humor is to be removed. In the illustrated situation, the region 310 is somewhat offset and closer to the front part of the eye 350, perhaps making it somewhat difficult for the doctor or external imaging equipment to image directly. Therefore, positioning the imaging tool 100 through another pre-positioned cannula 315 can be particularly advantageous in this situation. The lighting device can also be positioned through a pre-positioned cannula at another offset position of the eye 350 to assist visualization, as will be described below. Additionally, or alternatively, digital light can be supplied directly through the electronics of the thin film image capture platform 101 itself.

[0021] Continuing to refer to FIG. 3 in addition to FIG. 1, the actuator 175 of the tool 100 can be operated by a physician to extend the platform 101 out of the instrument 150. In the figure, the platform 101 is shown unfolded from its folded configuration to expose its surface towards the target region 310. Thus, imaging of the region 310 can be performed more directly. Once positioned at a predetermined location, suction can be applied through the vitreous needle 325 and its port 177 can be used to aspirate vitreous fluid or other substances in the region 310. The tool 100 and the platform 101 can provide direct visualization to the physician throughout this process.

[0022] FIG. 4A is a top view of the thin-film image capture platform 101 in its fully extended and expanded configuration to facilitate maximum imaging for the ophthalmic surgery of FIG. 3. By way of example only, the rectangular expanse of the platform 101 can be larger than about 0.16 mm 2 ,

[0023] , , That is, even if the inner diameter of the instrument 150 is limited to about 0.4 mm as described above, the platform 101 can unfold without any overlap to fit within a 0.4 mm inner diameter (e.g., along the Y axis). Of course, the platform 101 can expand and become even larger along the Y axis. Further, the X axis of the plane of the platform 101 can be made even larger at this size as long as there are no practical concerns regarding folding along this axis. In one embodiment, the X axis of the platform 101 can be made larger than 5.0 mm. Separately, for the example of an instrument 150 with an inner diameter of about 0.4 mm, each axis (X, Y) of the platform 101 can be at least about 0.4 mm, and thus the surface area is at least about 0.16 mm 2 This is more than sufficient to support the generation of 10,000 - 100,000 pixels with state-of-the-art thin-film sensors used as the platform 101.

[0023] Figure 4B is a top view of the thin-film image capture platform 101 retracting into the needle instrument 150. Looking at Figure 4A, we can see the flex edge 400 of the platform 101. The edge 400 can be structurally made to flex and bend inward or fold when it comes into contact with the boundary 450 of the instrument 150 as it is retracted as directed by the actuator 175 via the mandrel / actuating rod as described above (Figure 1). In one embodiment, in addition to the inclined flex shape shown in the figure, the flex edge 400 has a more robust edge configuration to facilitate flexing as shown, so as not to damage the platform 101 when it is forcibly retracted and made to contact the boundary 400.

[0024] Figure 4C is a top view of the completely flattened thin-film image acquisition platform 101. The platform 101 can be completely retracted into the needle instrument 150. In this way, the entire tool 100 of Figure 1 can be removed from the eye 350 of Figure 3 without concern of collision with the inner diameter of the pre-positioned cannula 315.

[0025] Figure 5 summarizes one embodiment of performing ophthalmic surgery with the assistance of an imaging tool, as shown in Figures 1 and 3. The surgical tool is positioned inside the eye as shown in 515. However, to assist in the positioning and use of this tool, an imaging instrument of another tool may also be positioned inside the eye as shown in 530. Once positioned, the thin-film imaging platform can be unfolded from within the instrument and exposed inside the eye (545). This may also include extending the platform from a folded or rolled-up form when extending the platform from the instrument (560).

[0026] As shown in 575, image data can be acquired by the platform and relayed to an electronic package located at the displaced location (e.g., the handpiece or housing of the associated tool). This package may have a bulk footprint that is too large to accommodate within the instrument. However, because it is located at the displaced location, a complex redesign of the chipset is not required. In one embodiment, the platform not only acquires image data but also serves as a light source to enhance the acquired image data. Furthermore, in another embodiment, image data can be acquired from both sides or both sides of the extended platform. Apart from that, as shown in 590, once the data has been acquired and relayed, the data can be processed to provide the physician with real-time images to facilitate safe and effective surgery.

[0027] The embodiments described above include tools and techniques to support direct imaging of the inside of the patient's eye during surgery, without relying solely on indirect reversal imaging. This would be particularly advantageous when the surgical site includes offset peripheral locations that would otherwise be difficult to access visually. These tools and techniques allow the incision and pre-positioned support cannula to be kept to a limited size to facilitate rapid postoperative healing. Furthermore, image quality and / or control are not sacrificed. Rather, fairly large, modern tips and associated packages can be fully utilized.

[0028] For the purposes of the above description, several embodiments have been referenced. However, other embodiments and / or features of embodiments can be adopted, which are disclosed but not detailed above. Furthermore, those skilled in the art to which these embodiments belong will see that further modifications and changes to the described structures and operating methods can be made without departing significantly from the spirit and scope of these embodiments. Moreover, the above description should not be interpreted as relating only to the exact structures described and shown in the drawings, but rather as being consistent with and supporting the following claims, which have their full and reasonable scope.

Claims

1. An imaging tool for supporting ophthalmic surgery, wherein the imaging tool is A housing for the doctor to physically manipulate during surgery, A tubular instrument having a given inner diameter and extending from the housing to reach into the patient's eye during the surgery, wherein the housing contains a microchip having a bulk footprint larger than the inner diameter, A thin-film image acquisition platform housed within the tubular instrument, wherein the thin-film image acquisition platform is configured to extend from within the tubular instrument for image acquisition of the eye during surgery, and to expand when extended, An imaging tool equipped with these features.

2. Furthermore, the imaging tool according to claim 1, further comprising a thin-film image sensor of the thin-film image capture platform that is electronically coupled to the microchip via the tubular device.

3. The imaging tool according to claim 2, wherein the coupling is achieved by a thin-film circuit having a conductive trace.

4. The imaging tool according to claim 2, wherein the thin-film image sensor acquires image data of at least 10,000 pixels during the extension and expansion.

5. The imaging tool according to claim 2, wherein the thin-film image sensor occupies a length exceeding 5 mm within the inner diameter of the tubular device before being extended from the tubular device.

6. An imaging tool for supporting ophthalmic surgery, wherein the imaging tool is A housing for the physician to physically manipulate during the aforementioned ophthalmic surgery, A tubular instrument having a given inner diameter and extending from the housing to reach into the patient's eye during the ophthalmic surgery, A microchip housed in the aforementioned housing and having a bulk footprint larger than the given inner diameter, A thin-film image acquisition platform housed within the tubular instrument, wherein the thin-film image acquisition platform extends and expands from within the given inner diameter of the tubular instrument in order to acquire image data from the inside of the eye during ophthalmic surgery and relay it to the microchip, An imaging tool equipped with these features.

7. The imaging tool according to claim 6, wherein the thin-film image acquisition platform has a thickness of less than 0.05 mm and is equipped with a thin-film image sensor on a support substrate.

8. The imaging tool according to claim 6, wherein the given diameter of the tubular instrument is less than 0.9 mm.

9. The imaging tool according to claim 6, wherein the thin-film image capture platform is constructed to expand when extended to expose its surface to the eye region for the image data.

10. The imaging tool according to claim 9, wherein the thin film image capture platform is provided with an inclined flex edge to force contact with the boundary of the tubular instrument when the thin film image capture platform retracts into the tubular instrument of a given diameter, and the inclined flex edge facilitates the refolding of the thin film image capture platform while it is retracting.

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