Gripping structure for ophthalmic surgery

Abstract

An ophthalmic surgical instrument for peeling a retinal membrane includes a handle and an actuator attached to the handle. A first arm and a second arm extend outward from a distal end of an outer tube attached to the handle. The first arm includes a first pulling surface and a first gripping surface, and the second arm includes a second pulling surface and a second gripping surface. The pulling surface of each arm is substantially perpendicular to the gripping surface of each arm, and the gripping surfaces of the arms face each other. When the outer tube is extended over the first arm and the second arm to lift a flap of retinal membrane that is subsequently gripped between the first gripping surface and the second gripping surface, the first pulling surface and the second pulling surface move toward each other.

Description

[Technical Field]

[0001] The internal limiting membrane (ILM) is a thin, transparent membrane located between the vitreous and retina of the eye. The ILM plays a role during eye development but is not necessary for proper function of the adult eye. The ILM pulls on the retina, causing conditions such as macular holes secondary to inflammation or venous occlusive disease and other conditions, macular atrophy, vitreomacular traction syndrome, diabetic macular edema, and cystoid macular edema. An epiretinal membrane (ERM) is a membrane that can form on the retina in response to damage to the retina, such as from posterior vitreous detachment. [Background technology]

[0002] The ILM or ERM may need to be peeled away from the retina to prevent damage to the retina. Peeling away the ILM or ERM may also be required in preparation for a surgical procedure to be performed on the retina. To peel away the ILM or ERM, a surgical instrument is inserted into the patient's eye through a cannula (e.g., a trocar cannula). Forceps or a specialized scraper extend from the instrument and are used to lift a flap of the ILM or ERM. The lifted flap is then grasped by the forceps, and the ILM or ERM is peeled away from the retina using a circular motion. However, if excessive force is applied to the forceps, the retina may be punctured. Summary of the Invention [Problem to be solved by the invention]

[0003] Therefore, reducing the risk of retinal damage resulting from ILM or ERM detachment would be an advancement in the art. [Means for solving the problem]

[0004] The present disclosure relates generally to structures for grasping the internal limiting membrane (ILM) or epiretinal membrane (ERM) during ophthalmic surgery.

[0005] An ophthalmic surgical instrument for peeling a retinal membrane includes a handle and an actuator attached to the handle. The outer tube has a proximal end attached to the handle. A first arm extends outward from the distal end of the outer tube and includes a first pulling surface and a first gripping surface substantially perpendicular to the first pulling surface. A second arm extends outward from the distal end of the outer tube and includes a second pulling surface and a second gripping surface substantially perpendicular to the second pulling surface. The second gripping surface faces the first gripping surface. The actuator is configured to retract the first arm and the second arm into the outer tube, thereby moving the first pulling surface and the second pulling surface toward each other. As the first and second pulling surfaces move toward each other, a flap of retinal membrane is lifted between the first and second gripping surfaces and gripped between the first and second gripping surfaces.

[0006] The following description and the annexed drawings set forth in detail certain illustrative features of the one or more embodiments.

[0007] The accompanying drawings depict certain aspects of one or more embodiments and therefore should not be considered as limiting the scope of the present disclosure. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is an isometric view of a surgical instrument having a gripping structure including a pulling surface and a gripping surface, in accordance with certain embodiments. [Figure 2A] FIG. 10 is an isometric view of a gripping structure in an open configuration, according to certain embodiments. [Figure 2B] FIG. 10 is an isometric view of a gripping structure in a closed configuration, according to certain embodiments. [Figure 2C] 12A is a cross-sectional view of a gripping structure in a retracted configuration, according to certain embodiments. FIG. [Figure 3A-3C] 10A-10C are cross-sectional views illustrating an exemplary method of gripping a membrane using a gripping structure, according to certain embodiments. [Figure 4]FIG. 10 is an isometric view illustrating an ILM being peeled away using a gripping structure, according to certain embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0009] To facilitate understanding, the same reference numerals will be used wherever possible to designate identical elements common to the figures. It is contemplated that elements and features of one embodiment may be beneficially incorporated in other embodiments without further recitation.

[0010] Aspects of the present disclosure provide a surgical instrument including a flexible loop for peeling a membrane from a patient's retina. Note that, as used herein, the distal end of a component refers to the end closer to the patient's body, while the proximal end of a component refers to the end away from the patient's body or, for example, the end proximal to the handle of a surgical instrument.

[0011] FIG. 1 illustrates a surgical instrument 100 including a handle 102 sized and contoured to be grasped by the hand of a surgeon performing an ophthalmic surgical procedure, such as peeling a membrane, e.g., an ILM or ERM, from the retina of a patient's eye, according to certain embodiments. A grasping structure 104 is extendable from a distal end of an outer tube 106 connected to the handle 102. A proximal end of the outer tube 106 is connected to the handle 102. The handle 102 may have a manual control structure attached thereto. In the embodiment of FIG. 1, the manual control structure includes a deformable basket 108. However, the manual control structure may also be implemented as a slider, a button, or any other manual control structure known in the art of ophthalmic surgical instruments.

[0012] The outer tube 106 is coupled to the deformable basket 108 and moves outward relative to the handle 102 in response to compression of the deformable basket 108 and moves inward into the handle in response to expansion of the deformable basket 108. In other embodiments, the deformable basket 108 is coupled to the gripping structure 104 such that the gripping structure moves relative to the outer tube 106 in response to compression and expansion of the deformable basket 108.

[0013] In FIG. 1 , the gripping structures 104 are embodied as arms 110a, 110b that pass through the outer tube 106 and are fixed relative to the handle 102, where the outer tube 106 is actuated by a deformable basket 108. In some embodiments, one or both of the arms 110a, 110b (arm 110a in the illustrated embodiment) can have a helical or twisted shape. In other embodiments, neither arm has a helical or twisted shape (e.g., as shown by arm 110b). The outer tube 106 defines a longitudinal direction 112a that is parallel to and collinear with the axis of symmetry of the outer tube 106. When extended relative to the outer tube 106, the arms 110a, 110b spring back to the illustrated position where the arms 110a, 110b are offset from one another along a transverse direction 112b that is perpendicular to the longitudinal direction 112a. The arms 110a, 110b may be symmetrical in that the arms 110a, 110b are biased outward to positions that are substantially the same distance (e.g., within 10%) from the axis of symmetry of the outer tube 106. The arms 110a, 110b may be asymmetrical in that the arms recoil to a position such that one arm 110a extends outward from the axis of symmetry of the outer tube 106 to a greater extent (e.g., at least 50 percent more) than the other arm 110b.

[0014] The distal portion of each arm 110a, 110b can include a vertical portion 114a, 114b that defines an inward-facing gripping surface 116a, 116b, respectively, oriented substantially parallel (e.g., within 10 degrees) to the longitudinal direction 112a and the vertical direction 112c.

[0015] The distal portion of each arm 110a, 110b may also include a horizontal portion 118a, 118b secured to the edge of the vertical portion 114a, 114b. The horizontal portion 118a, 118b may be implemented as a flange extending outward from the vertical portion 114a, 114b, or may be the underside of the vertical portion 114a, 114b itself. The horizontal portion 118a, 118b includes a downward-facing pulling surface 120a, 120b extending outward from the gripping surface 116a, 116b, respectively. The gripping surface 116a, 116b may be oriented substantially perpendicular (e.g., within 10 degrees) to the pulling surface 120a, 120b. In certain embodiments, there may be a rounded transition between the pulling surface and the gripping surface 116a, 116b.

[0016] Pulling surfaces 120a, 120b are oriented parallel to a plane that is substantially parallel to transverse direction 112b and at an angle 122 relative to longitudinal direction 112a. In certain embodiments, pulling surfaces 120a, 120b may have barbs 124a, 124b or similar features formed thereon. Barbs 124a, 124b may be an array of barbs forming a structure similar to the scales on sharkskin. Barbs 124a, 124b may be oriented inward, i.e., barbs 124a may face toward pulling surface 120b and barbs 124b may face toward pulling surface 120a. In this manner, barbs 124a provide greater resistance to relative movement of membrane 126 away from pulling surface 120b compared to movement of membrane 126 in the opposite direction. Similarly, barbs 124b provide greater resistance to relative movement of membrane 126 away from pulling surface 120a than to movement of membrane 126 in the opposite direction. Thus, when pulling surfaces 120a, 120b are urged toward one another, for example, by extending outer tube 106 over arms 110a, 110b or retracting arms 110a, 110b into outer tube 106, barbs 124a, 124b tend to pull membrane 126 inward, thereby lifting flap 128, which may then be grasped between gripping surfaces 116a, 116b.

[0017] In certain embodiments, barbs 124a, 124b extend outward from pulling surfaces 120a, 120b a distance that is less than the thickness of membrane 126. For example, barbs 124a, 124b can extend outward from pulling surfaces 120a, 120b by about 0.8 to about 8 microns, e.g., about 1 to about 6 microns, e.g., about 2 microns to about 4 microns.

[0018] Pulling surfaces 120a, 120b lie flat, substantially flat, or at least nearly flat on membrane 126 so that barbs 124a, 124b can grip membrane 126 and a large area of ​​pulling surfaces 120a, 120b contacts the membrane during use to reduce the risk of puncturing membrane 126 and the underlying retina. Angle 122 can encourage bending of arms 110a, 110b in response to pressing of pulling surfaces 120a, 120b against membrane 126 so that pulling surfaces 120a, 120b lie flat on membrane 126. Angle 122 can be any angle between 0 and 45 degrees.

[0019] As can be seen in FIG. 1, the outer peripheries of the vertical portions 114a, 114b and horizontal portions 118a, 118b may be rounded to both (a) reduce the risk of puncturing the retina and (b) allow the vertical portions 114a, 114b and horizontal portions 118a, 118b to slide smoothly in and out of the outer tube 106 during use.

[0020] The gripping structure 104 may be made of a highly flexible material, such as, for example, Nitinol (a nickel-titanium alloy), spring steel, or other surgical-grade material. The high flexibility allows the gripping structure 104 to elastically deform when retracted into the outer tube 106, thus facilitating the larger dimensions of the horizontal portions 118a, 118b and, in certain embodiments, the vertical portions 114a, 114b. When extended from the outer tube 106, the horizontal portions 118a, 118b may expand to a width in the transverse direction 112b that is many times the inner diameter of the outer tube 106, and possibly many times the outer diameter of the outer tube, e.g., 1.5 times, 2 times, 4 times, 8 times, etc. For example, the height of the gripping surfaces 116a, 116b perpendicular to the vertical direction 112c can be 0.2 to 0.5 millimeters, the width of the pulling surfaces 120a, 120b in the transverse direction 112b can be 0.1 to 0.4 millimeters, and the length of the gripping surfaces 116a, 116b and pulling surfaces 120a, 120b in the longitudinal direction 112a can be 0.2 to 0.8 millimeters.

[0021] 2A-2C illustrate the gripping structure in open, closed, and retracted configurations, respectively, according to certain embodiments. As shown in FIG. 2A, in use, the outer tube 106 is retracted or the arms 110a, 110b are pushed outward from the outer tube 106 such that at least a portion of the arms 110a, 110b are extended outward relative to the outer tube 106. When extended, the arms 110a, 110b are biased such that the gripping surfaces 116a, 116b are separated in the transverse direction 112b by a gap 200 due to the recoil of the arms 110a, 110b. The gap 200 can be as large as the height of the flap 128 to be lifted, e.g., at least 10 times, at least 100 times, or at least 200 times the typical thickness of the membrane 126. For example, the ILM typically has a thickness of 1 micron to 10 microns.

[0022] 2B , outer tube 106 may then be extended, or arms 110a, 110b may be pulled inward within outer tube 106, thereby pulling arms 110a, 110b inward against outer tube 106 and, optionally, against a portion of one or both of vertical portions 114a, 114b and horizontal portions 118a, 118b. This causes barbs 124a, 124b to pull on membrane 126, moving pulling surfaces 120a, 120b together such that flap 128 between gripping surfaces 116a, 116b is lifted. As arms 110a, 110b approach each other, flap 128 is securely gripped between gripping surfaces 116a, 116b. The surgeon may then move the surgical instrument in a circular motion to peel away a portion of membrane 126.

[0023] 2C , before and after peeling away membrane 126, arms 110a, 110b, vertical portions 114a, 114b, and horizontal portions 118a, 118b may be pulled into outer tube 106 when passed through a trocar cannula. Vertical portions 114a, 114b and horizontal portions 118a, 118b may resiliently curl and / or fold to fit within outer tube 106. Alternatively, vertical portions 114a, 114b and horizontal portions 118a, 118b may be sized to fit within outer tube 106 without curling or folding, or may be sized to fit through a trocar cannula, e.g., may not extend outward from the outer diameter of outer tube 106.

[0024] 3A-3C further illustrate the process of peeling membrane 126 using gripping structure 104. As shown in FIG. 3A, pulling surfaces 120a, 120b rest on membrane 126, and barbs 124a, 124b partially penetrate membrane 126 without penetrating the underlying retina 300. The extension of barbs 124a, 124b from pulling surfaces 120a, 120b is preferably less than the thickness of membrane 126, such as 0.5 to 0.75 times the thickness of membrane 126. Outer tube 106 is then extended, thereby pulling pulling surfaces 120a, 120b together, as shown in FIG. 3B. FIG. 3B illustrates the case where arms 110a, 110b are asymmetric, causing pulling surface 120a to move toward pulling surface 120b while pulling surface 120b remains substantially stationary. As pulling surfaces 120a, 120b are pulled together, flap 128 of membrane 126 is lifted and ultimately securely grasped between gripping surfaces 116a, 116b. As shown in Figure 3C, the surgeon may then pull gripping structure 104 away from retina 300, thereby tearing membrane 126. As shown in Figure 4, the surgeon may move gripping structure 104 in a circular motion to peel a portion of membrane 126 from retina 300.

[0025] The foregoing description is provided to enable those skilled in the art to practice the various embodiments described herein. Various modifications to these embodiments will be apparent to those 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 are to be accorded the full scope consistent with the language of the claims.

Claims

1. An ophthalmic surgical instrument for peeling off a membrane of the retina, comprising: The handle and an actuator attached to the handle; an outer tube having a proximal end attached to the handle; a first arm extending outwardly relative to the distal end of the outer tube and including a first pulling surface and a first gripping surface substantially perpendicular to the first pulling surface; a second arm extending outwardly relative to the distal end of the outer tube and including a second pulling surface and a second gripping surface substantially perpendicular to the second pulling surface, the second gripping surface facing the first gripping surface; wherein the actuator is configured to retract the first arm and the second arm into the outer tube, thereby moving the first pulling surface and the second pulling surface toward each other to lift a flap of retinal membrane between the first gripping surface and the second gripping surface and grip the flap between the first gripping surface and the second gripping surface.

2. The ophthalmic surgical instrument of claim 1 , wherein the actuator is configured to extend the outer tube over the first arm and the second arm relative to the handle in response to movement of the actuator in a first direction.

3. 3. The ophthalmic surgical instrument of claim 2, wherein the actuator is configured to retract the outer tube from over the first arm and the second arm in response to movement of the actuator in a second direction opposite the first direction.

4. 2. The ophthalmic surgical instrument of claim 1, wherein the first arm and the second arm are configured to extend outward from an outer diameter of the outer tube when extended outwardly relative to the distal end of the outer tube.

5. 2. The ophthalmic surgical instrument of claim 1, wherein the first and second arms are biased to spring outward when extended from the distal end of the outer tube such that the first and second arms extend outward to at least twice a diameter of the outer tube.

6. The ophthalmic surgical instrument of claim 1 , wherein the first arm and the second arm are configured to resiliently deform sufficiently to fit within the outer tube.

7. The ophthalmic surgical instrument of claim 6 , wherein the first arm and the second arm each comprise nitinol.

8. 10. The ophthalmic surgical instrument of claim 1, wherein the first pulling surface includes a first barb configured to grip the retinal membrane, and the second pulling surface includes a second barb configured to grip the retinal membrane.

9. The ophthalmic surgical instrument of claim 8, wherein the first barb and the second barb have a length of between 0.8 and 8 microns.

10. 2. The ophthalmic surgical instrument of claim 1, wherein the first pulling surface is formed on a first flange extending outward from the first gripping surface, and the second pulling surface is formed on a second flange extending outward from the second gripping surface.

11. 1. A method of detaching a membrane from a retina of a patient's eye, comprising: inserting a distal end of an outer tube through a cannula into the patient's eye; extending a first arm and a second arm outwardly relative to the distal end of the outer tube; engaging the membrane with a first pulling surface on the first arm and a second pulling surface on the second arm; bringing the first arm and the second arm together so that a flap is lifted and gripped between a first gripping surface on the first arm and a second gripping surface on the second arm, the first gripping surface being substantially perpendicular to the first pulling surface and the second gripping surface being substantially perpendicular to the second pulling surface; A method comprising:

12. 12. The method of claim 11, further comprising pulling the flap, effective to detach a portion of the membrane from the retina.

13. the outer tube is attached to a handle having an actuator attached thereto and coupled to the outer tube; extending the first arm and the second arm from the distal end of the outer tube includes moving the actuator in a first direction; and 12. The method of claim 11, wherein bringing the first arm and the second arm together comprises moving the actuator in a second direction opposite the first direction to pull the first arm and the second arm into the outer tube.

14. The method of claim 11 , wherein the first arm and the second arm extend outwardly from an outer diameter of the outer tube when extended from the distal end of the outer tube.

15. 12. The method of claim 11, wherein the first arm and the second arm are biased outwardly from the outer tube when extended from the distal end of the outer tube such that the first arm and the second arm extend outwardly to at least twice the diameter of the outer tube.

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