Membrane removal device

Abstract

This disclosure relates in general to surgical instruments, and more specifically to ophthalmic surgical instruments and methods for manufacturing the same. In particular, a surgical instrument is provided. The surgical instrument includes a cannula. A spatula is formed at the end of the cannula. The spatula extends from the cannula at a non-zero angle to the outer surface of the cannula. The spatula defines at least partially the opening at the end of the cannula. An optical fiber extends along the interior of the cannula. The optical fiber is configured to direct laser light toward the spatula.

Description

Technical Field

[0001] In many microsurgical techniques, precise cutting and / or removal of various body tissues are required. For example, in retinal vitreous surgeries such as retinotomy, retinal resection, autologous retinal transplantation, membrane peeling, and vitrectomy, typically, cutting, removal, incision, membrane delamination, coagulation, and / or surgical operations of intraocular tissues such as the retina, vitreous humor, traction bands, and other membranous structures within the eye are necessary.

[0002] The retina, the innermost light-sensing layer that covers the back wall of the eye, plays a role in receiving, modulating visual stimuli from the external environment, and transmitting them to the optic nerve and ultimately to the visual cortex of the brain. Structurally, the retina is a complex and delicate tissue, with various types of cells arranged within multiple cell layers or membranes. Due to the role of the retina in vision and its fragility, if it is damaged, vision can be severely lost or even lead to permanent blindness. Therefore, in addition to the retina, cutting, removal, or surgical operations on the membranes and tissues attached to it must be carried out with great care to avoid unwanted retinal trauma.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Therefore, in the art, there is a need for improved surgical instruments for cutting, removing, and / or surgically operating on the retina and the membranes or tissues attached thereto.

Means for Solving the Problems

[0004] The present disclosure generally relates to surgical instruments, and more specifically, to ophthalmic surgical instruments and methods for manufacturing the same.

[0005] In a particular embodiment, a surgical instrument is provided. This surgical instrument includes a cannula. A spatula is formed at the end of the cannula. The spatula extends from the cannula at a non-zero angle to the outer surface of the cannula. The spatula defines at least partially the opening at the end of the cannula. An optical fiber extends along the inside or outside of the cannula. The optical fiber is configured to direct laser light toward the spatula.

[0006] The following description and related drawings detail specific exemplary features of one or more embodiments, including those described above.

[0007] To gain a more detailed understanding of the aforementioned features of this disclosure, a more specific description of the disclosure, which has been briefly summarized above, can be obtained by referring to embodiments, some of which are shown in the accompanying drawings. However, it should be noted that the accompanying drawings are only illustrative and should not be considered limiting in scope, as other similarly effective embodiments may also be possible. [Brief explanation of the drawing]

[0008] [Figure 1] Figure 1 shows an exemplary surgical instrument for use during ophthalmic surgery according to a particular embodiment of the present disclosure. [Figure 2A-D] Figures 2A to 2D show cross-sectional views of several examples of the cannula of Figure 1 according to a particular embodiment of the present disclosure. [Figure 3A-C] Figures 3A to 3C show perspective views of several examples of spatula geometric shapes according to a particular embodiment of the present disclosure. [Figure 4] Figure 4 shows a cross-sectional view of a cannula engaged with the membrane of the eye according to a particular embodiment of the present disclosure. [Modes for carrying out the invention]

[0009] For ease of understanding, the same reference numerals are used to indicate identical elements common to multiple drawings whenever possible. It is assumed that elements and features of one embodiment may be usefully incorporated into other embodiments without further mention.

[0010] In the following description, details are given as examples to facilitate understanding of the disclosed subject matter. However, it should be clear to those skilled in the art that the disclosed implementations are examples and do not encompass all conceivable implementations. Therefore, it should be understood that the references given are not intended to limit the scope of this disclosure. Any modifications and further alterations to the described devices, apparatus, and methods, as well as any further applications of the principles of this disclosure, are readily conceivable to those skilled in the art relating to this disclosure. In particular, features, components, and / or steps described in relation to one implementation are readily conceivable to be combined with features, components, and / or steps described in relation to other implementations of this disclosure.

[0011] Where used herein, the term "approximately" may refer to a variation of + / - 10% from the nominal value. It should be understood that such variation may be included in any value provided herein.

[0012] Certain embodiments disclosed herein provide surgical instruments for cutting and removing tissue from a surgical site, more specifically, surgical instruments for cutting and removing membranes adjacent to the retina.

[0013] Various conditions affecting the retina can be treated by cutting and removing membranes that cover or are adjacent to the retina. For example, an epiretinal membrane (ERM) is a thin layer of scar tissue that can form at the vitreoretinal interface on the inner surface of the retina. ERMs typically localize on the macula, the photosensitive tissue in the center of the retina responsible for fine vision. This scar tissue (membrane) can cause varying degrees of distortion and blurring of the patient's central visual field, and therefore, its treatment typically requires removal of the membrane. ERMs can be either idiopathic (primary) or secondary. In idiopathic ERMs, cell proliferation can occur after posterior vitreous detachment (PVD) and rupture of the internal limiting membrane (ILM). Secondary ERMs, on the other hand, can result from pre-existing eye conditions such as proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), hypertensive retinopathy, intraocular inflammation, retinal vein occlusion, retinal detachment (RD), and traumatic eye injury.

[0014] Currently, various microsurgical instruments can be used to excise the epiretinal membrane (ERM) from a patient's retina. Such instruments include vitreous cutters (or vitrectomy probes), scissors, forceps, and surgical knives. However, the use of such instruments may induce undesirable traction on the retina adjacent to the target membrane cutting site, which can cause retinal tears and even retinal detachment, or it may require the use of both hands by the surgeon. In addition, in order to excise the epiretinal membrane using a vitreous cutter, there must already be a gap or tear between the epiretinal membrane and the retina.

[0015] The embodiments of surgical instruments described herein are advantageous in that they address the shortcomings of certain existing instruments and reduce the risk of causing undesirable damage to peripheral retinal tissue when cutting and / or removing ERM and other membranes, by providing a cannula having a spatula formed at the end of the cannula to facilitate mechanically lifting / separating the membrane at the target surgical site, as well as an optical fiber that directs a laser beam onto the lifted / separated membrane to cut the membrane, with a low risk of damage to peripheral tissue.

[0016] Figure 1 shows a perspective view of an improved surgical instrument 100 according to a specific embodiment described herein. As shown in Figure 1, the surgical instrument 100 comprises a cannula 110 and a base unit 120. The cannula 110 is positioned longitudinally in part within the distal end 121 of the base unit 120 and can be directly or indirectly attached thereto within the internal chamber of the base unit 120. Note that, as described herein, the distal end or distal portion of a component refers to the end or part closer to the patient's body during use of that component. In addition, the proximal end or proximal portion of a component refers to the end or part further away from the patient's body.

[0017] In some embodiments, the base unit 120 is a handpiece having an outer surface configured to be held by a user, such as a surgeon. For example, the base unit 120 may have an ergonomic contour to fit substantially to the user's hand. In some embodiments, the outer surface may be textured or have one or more gripping features formed thereon, such as one or more grooves and / or ridges. The base unit 120 may be made from any material commonly used in such instruments and suitable for ophthalmic surgery. For example, the base unit 120 may be formed from lightweight aluminum, stainless steel, thermoplastic polymer, or other suitable material. In some embodiments, the base unit 120 may be configured to be sterilized and used in two or more surgeries, or the base unit 120 may be a single-use device.

[0018] In some embodiments, the base unit 120 may include a control interface 124. The control interface 124 may include buttons, sliders, switches, haptic feedback, conductive elements, touch elements, etc., to facilitate the detection of inputs on the base unit 120. Although the control interface 124 is shown to be located close to the distal end 121 of the base unit 120, the control interface 124 may also be located in other positions and orientations along the length of the base unit 120.

[0019] The base unit 120 further provides one or more ports 123 at its proximal end 125 for extending one or more supply lines into the internal chamber of the base unit 120 (for example, one port 123 is shown in Figure 1). For example, a port 123 may provide a connection point between the base unit 120 and a vacuum line of a vacuum source for suction / aspiration. A port 123 may also provide a conduit for an optical fiber extending between the cannula 110 and one or more light sources in order to provide laser light to the cannula 110. In some embodiments, the optical fiber may extend from the port 123 into an optical fiber cable configured to protect the optical fiber from the external environment and to facilitate coupling the optical fiber with a light source and / or a surgical console in which the light source may be housed.

[0020] Figures 2A–D show longitudinal cross-sectional views of several examples of the cannula 110 of Figure 1 according to specific embodiments of the present disclosure. As shown in the figures, the cannula 110 may generally include an elongated hollow structure. For example, in some embodiments, the cannula 110 may have a cylindrical geometric shape. However, in other embodiments, the cannula 110 may have a non-cylindrical geometric shape (for example, it may have cross-sections including shapes such as elliptical, triangular, or rectangular). The cannula 110 may be formed in whole or in part from stainless steel, nickel-titanium alloy, aluminum, or other metals or combinations of metals. In some embodiments, the cannula 110 may be formed in part from a thermoplastic polymer. In some embodiments, the cannula 110 may include coatings, film deposition, or other surface treatments. For example, at least part of the cannula 110 may have a roughened or laser-etched surface. Generally, the gauge sizes of the cannula 110 are 29, 27, 25, 23, etc. However, other gauges and / or sizes are also possible.

[0021] In Figure 2A, the cannula 110 is shown to have a spatula 202 formed at its distal end 203. In some embodiments, the spatula 202 may be integral with the cannula 110. In other words, the spatula 202 may be formed by changing the material of the distal end 203 of the cannula 110 to alter the geometry at the distal end 203 of the cannula 110. For example, the spatula 202 may be formed by bending, press-fitting, or otherwise manipulating the distal end 203 of the cannula 110 through an additive process. In some embodiments, the spatula 202 may be bonded to the cannula 110 through an additive process.

[0022] The spatula 202 facilitates the manipulation of materials such as ocular tissue. In some embodiments, the spatula 202 can be used to detach the retinal membrane from the retina. The spatula 202 can have a variety of geometric shapes. For example, in some embodiments, the spatula 202 may extend from the cannula 110 at a non-zero angle 204 with respect to the outer surface 206 of the cannula 110. In some embodiments, the non-zero angle 204 is between 30 and 80 degrees. In other embodiments, the non-zero angle 204 is less than 30 degrees or greater than 80 degrees. The spatula 202 has a flat (e.g., planar) or substantially flat geometric shape, and is shown such that the distal surface 205 of the spatula 202 forms a constant relative angle 204, but other embodiments may include geometric shapes in which the angle 204 with respect to the outer surface 206 of the cannula 110 is variable. For example, curved or gradually changing geometric shapes, as shown in Figure 2C, are also possible. In some embodiments, the distal surface 205 may have a surface texture, treatment, or feature. For example, the distal surface 205 may be coated, injected with a lubricating fluid, polished, etched, roughened, patterned, etc. The surface texture, treatment, or feature on the distal surface 205 may make it easier to increase or decrease the traction force for the spatula 202 when manipulating the membrane or other structure in the surgical site or environment.

[0023] In some embodiments, an opening 208 is formed in the cannula 110 proximal to and adjacent the spatula 202. The opening facilitates entry of substances into the interior 210 of the cannula 110. For example, the opening 208 may be sized to draw in substances by applying a negative pressure or vacuum to draw substances from the opening 208 into the interior 210 of the cannula 110. In some embodiments, a portion of the perimeter of the opening 208 corresponds to the outer edge of the spatula 202. In other words, the opening 208 may be at least partially defined by the edge of the spatula 202.

[0024] In some embodiments, a vacuum source 212 is in fluid communication with the cannula 110 via a port 123 of the base unit 120 to apply a negative pressure or vacuum to the cannula 110 to draw substances into the interior of the cannula 110 from the opening 208. In such embodiments, the interior 210 of the cannula 110 may be configured to allow the drawn substances to freely pass along the interior 210 of the cannula 110, e.g., into the base unit 120. The vacuum source 212 may be a stand-alone vacuum source or may be incorporated into or operatively coupled to the surgical console.

[0025] In some embodiments, an optical fiber 214 extends along the interior 210 of the cannula 110. In other embodiments, the optical fiber 214 extends along the outside of the cannula 110. The optical fiber 214 may be configured to direct a laser beam 216 toward the proximal face 207 of the spatula 202. The optical fiber 214 may be fixed to the interior 210 or outer sidewall 215 of the cannula 110 or the optical fiber 214 may not be fixed within the interior 210 of the cannula 110. For example, in some embodiments, the optical fiber 214 may be fixed to the sidewall 215 by an adhesive. In other embodiments, the optical fiber 214 may be disposed within a rigid or semi-rigid sleeve extending along the interior 210, which may or may not contact the sidewall 215.

[0026] In some embodiments, the spatula 202 and / or a portion of the spatula 202 may be aligned with an optical fiber 214 so that the laser beam 216 is directed towards the spatula 202 during use. In such embodiments, the cavitation force, heating, and other effects from the laser beam 216 may be contained or otherwise shielded by the spatula 202 so as not to damage surrounding tissue or other structures. For example, positioning the spatula 202 may reduce damage to surrounding retinal tissue when removing epiretinal membranes.

[0027] The optical fiber 214 may or may not have a cladding. In some embodiments, the optical fiber 214 is a sapphire fiber or another light-transmitting material. In some embodiments, the optical fiber 214 may have a uniform material composition along its length. In other embodiments, the optical fiber 214 may have a first region having a first material composition and a second region having a second material composition, wherein the first and second material compositions differ from each other in one or more respects. In some embodiments, the optical fiber 214 may be a single-core fiber. In other embodiments, the optical fiber 214 may be a multi-core fiber.

[0028] In some embodiments, the light source 218 communicates optically with the optical fiber 214 via port 123 of the base unit 120, supplying optical energy into the optical fiber 214 as laser light 216 for propagation to the spatula 202. The light source 218 may be a standalone light source, or it may be integrated with or operably coupled to a surgical console. The light source 218 may be configured to generate one or more types of optical energy. In some examples, the light source 218 may generate laser light 216 having a pulse rate in the range of about 100 Hz to about 10 kHz. In some embodiments, the laser source 218 may generate and propagate laser light 216 having a pulse rate in the range of about 10 kHz to about 500 kHz or about 1 kHz to about 1500 Hz. In some embodiments, the laser source 218 may generate laser light 216 having a frequency of about 100 Hz to about 5 kHz. In other embodiments, the laser source 218 may generate laser light 216 having a frequency of about 100 Hz to about 1 kHz. In some embodiments, the laser source 218 may generate laser light 216 having a frequency of about 100 Hz to about 500 Hz. Other pulse rate ranges are also possible. In some examples, the laser source 218 generates a first laser beam 104 of nanosecond, picosecond, or femtosecond duration.

[0029] In some embodiments, the light source 218 may be configured to generate therapeutic laser light 216 configured to excise, cut, and / or remove material with the spatula 202. In this case as well, the spatula 202 and / or a portion of the spatula 202 may be aligned with the optical fiber 214 (for example, positioned immediately downstream or distal to its distal end) so that cavitation forces, heating, and other effects from the therapeutic laser light 216 do not damage tissue such as eye tissue adjacent to the distal end 203 of the cannula. Thus, the spatula 202 may function as a “backstop” for the therapeutic laser light 216 propagated distally by the optical fiber 214. In some embodiments, the proximal surface 207 of the spatula 202 may be patterned or roughened to absorb or scatter the therapeutic laser light 216. For example, the proximal surface 207 may include a laser etching pattern configured to scatter the therapeutic laser light 216 to the greatest extent possible, so that the majority of the propagated therapeutic laser light 216 is not directed towards any single region or tissue.

[0030] In some embodiments, the light source 218 may also be configured to generate non-therapeutic laser light (e.g., a aiming laser, illumination light, etc.) that does little or no alteration to the material in the spatula 202 (in addition to the therapeutic laser light 216), but can assist with illumination, tracking, aiming, etc. In such embodiments, the light source 218 may be configured to provide one or more different types of optical energy to different cores of the optical fiber 214, or to provide one or more different types of optical energy to one core of the optical fiber 214.

[0031] Figure 2B shows another example of the cannula 110. In the embodiment shown in the figure, the opening 208 is larger and more open than the opening 208 of the cannula 110 shown in Figure 2A. In other words, the opening 208 may extend more proximal along the length of the cannula 110 and / or more radially around the cannula 110 toward the base of the spatula 202. In some embodiments, the curvature of the opening 208 may affect the shape and usefulness of the spatula 202. For example, in the embodiment shown in the figure, the spatula 202 may be longer to allow engagement with and manipulation of thicker material (e.g., a membrane on the retina) than the cannula 110 in Figure 2A. In some embodiments, a more open opening 208 may make it easier to give the spatula 202 a wider geometric shape, thereby reducing the concentration of force and allowing for gentler separation of material, thus avoiding undesirable tearing or shearing at the surgical site.

[0032] Figure 2C shows yet another example of a cannula 110 in which the spatula 202 has a curved geometric shape. In some embodiments, the radius of curvature of the spatula 202 may be uniform along the length of the spatula 202, or the radius of curvature may vary along the length of the spatula 202. In the embodiment shown in Figure 2C, the optical fiber 214 is further retracted in the interior 210 away from the opening 208. Although relative proximity is shown in the examples of Figures 2A-D, the optical fiber 214 may be positioned to extend to different positions relative to the opening 208. For example, the optical fiber 214 may terminate proximal to the proximal edge of the opening 208, or terminate at the proximal edge of the opening 208, or extend distally beyond the proximal edge of the opening 208 into the opening 208. In some embodiments, multiple optical fibers 214 or fiber cores may be included, which terminate at different positions relative to the opening 208.

[0033] Figure 2D shows yet another example of the cannula 110. In the embodiment shown in the figure, an extendable tongue-shaped portion 220 is located inside the cannula 110. The extendable tongue-shaped portion 220 may be configured to extend along the spatula 202 to reach further or to facilitate the mechanical manipulation of material in the spatula 202. In some embodiments, the extendable tongue-shaped portion 220 is translationally movable along its length 222 by the user. For example, the user may operate a slide, trigger, or other control unit (e.g., the control interface 124 in Figure 1) on the base unit 120 to extend or retract the tongue-shaped portion 220 into the cannula 110. In some embodiments, the tongue-shaped portion 220 is flexible along its length. In other embodiments, the tongue-shaped portion 220 has a flexible portion and a rigid or less flexible portion.

[0034] In some embodiments, the cannula 110 may include a flexible portion. For example, the cannula 110 may include a laser-etched area that allows the user to bend the cannula 110. In some embodiments, the flexibility of the cannula 110 may allow the user to guide the cannula 110 around structures to reach the surgical site.

[0035] Figures 3A–C show perspective views of exemplary spatula geometric shapes according to specific embodiments of the present disclosure. In the embodiment shown in Figure 3A, the spatula 202 is shown with a rounded geometric shape. In some embodiments, having a rounded geometric shape reduces the possibility of unintentional tissue damage by the spatula 202 at the surgical site.

[0036] Figure 3B shows an example of a spatula 202 having a pointed geometric shape. In some embodiments, the pointed geometric shape of the spatula 202 allows for more precise lifting of materials such as membranes on the retina for removal by laser light 216 from the optical fiber 214. For example, the spatula 202 may be positioned with respect to the optical fiber 214 such that the laser light emitted from the optical fiber 214 strikes the spatula 202 without interruption.

[0037] Figure 3C shows an example of a spatula 202 having a flat edge. In some embodiments, different spatula geometry 202 may be more effective in engaging different materials (e.g., films) having different thicknesses, degrees of adhesion, or different adjacent structures.

[0038] Figure 4 shows a cross-sectional view of a cannula 110 engaged with a retinal membrane 402 in a patient's eye, according to a particular embodiment of the present disclosure. In the example shown, the retinal membrane 402 may include, for example, an epiretinal membrane formed on the retina 406. As shown in the figure, the cannula 110 is positioned to remove the retinal membrane 402. The cannula 110 is configured to remove the retinal membrane 402 by engaging the retinal membrane with a spatula 202 to lift the retina 402 and then fracturing the retina 402 with a laser beam 216 emitted from an optical fiber 214 inside the cannula 110. The fragments 404 of the retinal membrane 402 removed by the laser beam 216 are drawn into the cannula 110 through an opening 208 to be removed from the retina 406. In some embodiments, the emission of the laser beam 216 can be coordinated with a negative pressure applied inside the cannula 110 210 to attract fragments 404 of the retinal membrane 402. For example, the attraction may be performed before, simultaneously with, or after the emission of the laser beam 216.

[0039] As used herein, the phrase “at least one of” in an item list refers to any combination of these items, including a single member. For example, “at least one of a, b, or c” includes a, b, c, ab, ac, bc, and abc, as well as any combination of multiple identical elements (e.g., aa, aaa, aab, aac, abb, acc, bb, bbb, bbc, cc, and ccc, or any other ordering of a, b, and c).

[0040] The above description is provided so that any person skilled in the art can carry out the various embodiments described herein. Various modifications to these embodiments will be readily apparent to a person skilled in the art, and the general principles defined herein may be applied to other embodiments. Accordingly, the claims are not intended to be limited to the embodiments shown herein, but the entire scope consistent with the language of the claims should be recognized.

[0041] Where an element is referred to in the singular in a claim, unless otherwise explicitly stated, it is intended to mean "one or more" and not "one and only one." Unless otherwise explicitly stated, the term "several" refers to one or more. All structural and functional equivalents of elements in various forms described throughout this disclosure, known or to those skilled in the art, are expressly incorporated by reference in this application and are intended to be encompassed by the claims. Furthermore, nothing disclosed in this application is intended to be dedicated to the public, whether such disclosure is expressly enumerated in the claims or not. No element of a claim shall be construed under Section 112(f) of the United States Patent Act unless the element is expressly described using the phrase "means for," or, in the case of a method claim, using the phrase "steps for." In this specification, the term "exemplary" is used to mean "serving as an example, illustration, or diagram." Any embodiment described as “exemplary” in this specification should not be construed as necessarily preferable or advantageous to any other embodiment.

Claims

1. A surgical instrument for membrane removal, Cannula and, A spatula formed at the distal end of the cannula, extending from the distal end of the cannula at a non-zero angle to the outer surface of the cannula, and at least partially defining the opening of the distal end of the cannula. An optical fiber extending along the cannula, configured to direct the laser beam toward the surface of the spatula, Surgical instruments, including those mentioned above.

2. The surgical instrument according to claim 1, wherein the non-zero angle of the spatula with respect to the outer surface of the cannula is 30 to 80 degrees.

3. The surgical instrument according to claim 1, wherein the outer edge of the spatula has a curved geometric shape.

4. The surgical instrument according to claim 1, wherein the outer edge of the spatula has a pointed geometric shape.

5. The surgical instrument according to claim 1, wherein the opening is sized to allow a substance to be aspirated from the membrane into the inside of the cannula.

6. The surgical instrument according to claim 1, wherein the cannula is at least partially flexible.

7. The surgical instrument according to claim 1, further comprising an extendable tongue-shaped portion that is positioned within the cannula and extends to reach a position outside the spatula.

8. The surgical instrument according to claim 1, wherein the proximal surface of the spatula is patterned to redirect the laser light from the optical fiber.

9. The surgical instrument according to claim 1, wherein the distal surface of the spatula is patterned to facilitate traction on the membrane.

10. The surgical instrument according to claim 1, wherein the laser light includes a therapeutic laser light for separating eye tissue.

11. The surgical instrument according to claim 10, wherein the laser light further includes non-therapeutic laser light.

12. The surgical instrument according to claim 11, wherein the spatula provides a stopper for pulsed laser light.

13. The surgical instrument according to claim 1, wherein the optical fiber extends along the inside of the cannula.

14. The surgical instrument according to claim 1, wherein the optical fiber extends along at least a portion of the outside of the cannula.

15. The surgical instrument according to claim 1, further comprising a vacuum source that is in fluid communication with the cannula to facilitate the aspiration of a substance from the opening into the inside of the cannula.

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