Gripping structure for membrane removal

Abstract

An ophthalmic surgical instrument for peeling a retinal membrane includes a handpiece and an actuator attached to the handpiece. An outer tube has a proximal end attached to the handpiece. A gripping structure is extendable outward relative to the distal end of the outer tube in response to movement of the actuator. The gripping structure includes a cavity having an opening that faces the retinal membrane when in use. A blade extends along a portion of the opening, and a cushion defining a plurality of openings is positioned within the cavity. Vacuum pressure is applied to channels in the cushion and coupled to the openings to grip the retinal membrane, which can then be peeled from the retina.

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 can pull on the retina, causing conditions such as macular holes, macular pucker, vitreomacular traction syndrome, diabetic macular edema, and cystoid macular edema secondary to inflammation or venous occlusive disease, as well as other conditions. The epiretinal membrane (ERM) is a membrane that can form on the retina in response to injury to the retina, such as from a posterior vitreous detachment. [Background technology]

[0002] The ILM or ERM may need to be detached from the retina to prevent damage to the retina. Peeling of the ILM or ERM may also be required in preparation for a surgical procedure to be performed on the retina. To detach the ILM or ERM, a surgical instrument is inserted into the patient's eye through a cannula. Forceps or a specialized scraper are extended from the instrument and used to lift a flap of the ILM or ERM. The flap is then grasped with the forceps, and the ILM or ERM is detached from the retina using a circular motion. However, excessive force applied to the forceps may result in perforating the retina. Summary of the Invention [Problem to be solved by the invention]

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

[0004] FIELD OF THE DISCLOSURE The present disclosure relates generally to a grasping structure for peeling off retinal membranes.

[0005] Some aspects provide an ophthalmic surgical instrument for peeling a retinal membrane. The ophthalmic surgical instrument includes a handpiece and an actuator attached to the handpiece. An outer tube has a proximal end attached to the handpiece. A gripping structure is extendable outwardly relative to a distal end of the outer tube in response to movement of the actuator. The gripping structure defines a plurality of openings configured to be disposed in fluid communication with a vacuum pressure source.

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

[0007] The accompanying drawings, which illustrate certain aspects of one or more embodiments, are not to be considered as limiting the scope of the disclosure. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is an isometric view of a surgical instrument having a vacuum-activated grasping structure, in accordance with certain embodiments. [Figures 2A-2C] 2A-2C are cross-sectional views illustrating detachment of a retinal membrane using the vacuum-activated gripping structure of FIG. 1, according to certain embodiments. [Figure 3] FIG. 3 is an isometric view showing an ILM being peeled using the vacuum-activated gripping structure of FIG. 1, in accordance with certain embodiments. [Figure 4A] FIG. 4A is an isometric view of an alternative embodiment of a vacuum-actuated gripping structure, in accordance with certain embodiments. [Figure 4B] FIG. 4B is a bottom view of the vacuum-activated gripping structure of FIG. 4A, according to certain embodiments. [Figure 4C] FIG. 4C is an isometric view of another alternative embodiment of a vacuum-actuated gripping structure, in accordance with certain embodiments. [Figure 4D] FIG. 4D is a view of a distal end face of a vacuum-activated gripping structure, according to certain embodiments. [Figure 4E] FIG. 4E is an illustration of a vacuum-activated gripping structure engaging a membrane, according to certain embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0009] To facilitate understanding, the same reference numerals have been used, wherever possible, to indicate identical elements that are common between 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 for peeling a membrane from a patient's retina. Note that, as used herein, the distal end of a component refers to the end that is closer to the patient's body, while the proximal end of a component refers to the end that is away from the patient's body, or the end that is proximal to the handpiece of a surgical instrument, for example.

[0011] FIG. 1 illustrates a surgical instrument 100 including a handpiece 102 sized and contoured to be grasped by the hand of a surgeon performing an ophthalmic surgical procedure, such as peeling a membrane from the retina of a patient's eye, e.g., ILM or ERM, according to certain embodiments.

[0012] The gripping structure 104 is extendable relative to the distal end of an outer tube 106 connected to the handpiece 102. As described in more detail below, the gripping structure 104 is vacuum-actuated. The proximal end of the outer tube 106 is connected to the handpiece 102. One or more manual control structures may be attached to the handpiece 102. In the embodiment of FIG. 1, the manual control structure includes a slider 108. The slider 108 may be used to control the extension of the gripping structure 104 relative to the outer tube 106 and, in certain embodiments, may be replaced by a deformable basket. The vacuum supplied to the gripping structure 104 may additionally be controlled by a foot pedal 110 controlling airflow to the gripping structure 104, such as by supplying vacuum pressure from a vacuum generator 110a through a flexible tube 110b connecting the vacuum generator 110a to the handpiece 102. In other implementations, the airflow may be controlled by a button attached to the handpiece 102. The vacuum generator 110a may be implemented as part of a surgical console.

[0013] The gripping structure 104 may be connected to a hollow rod 112 that extends through the outer tube 106. In a first implementation, the hollow rod 112 is fixed relative to the handpiece 102, while the outer tube 106 is slidable relative to the handpiece 102 and is coupled to and actuated by a slider 108. In a second implementation, the hollow rod 112 is coupled to and actuated by the slider 108, while the outer tube 106 is fixed relative to the handpiece 102.

[0014] A longitudinal direction 114a may be defined as parallel to the axis of symmetry of the outer tube 106. A transverse direction 114b may be defined as perpendicular to the longitudinal direction 114a, and a vertical direction 114c may be defined as perpendicular to the longitudinal direction 114a and the transverse direction 114b.

[0015] The gripping structure 104 extends distally from the hollow rod 112 and increases in width in the transverse direction 114b such that the gripping structure 104 at its widest point in the transverse direction 114b is many times greater than the thickness of the gripping structure 104 perpendicular to the transverse direction 114b, e.g., more than 5, 10, 20, or 30 times the thickness. The width of the gripping structure 104 at its widest point may also be greater than the inner diameter of the outer tube 106, e.g., more than 1.1 or more than 2 times the inner diameter. Thus, when retracted within the outer tube 106, the gripping structure 104 may curl or bend to fit within the outer tube 106. The gripping structure 104 and hollow rod 112 may be made of a flexible material such as nitinol, spring steel, or a flexible polymer.

[0016] The gripping structure 104 may bend or curve in one or more cross-sectional planes. For example, the gripping structure 104 may bend or curve in a plane parallel to the longitudinal direction 114a and the vertical direction 114c (the "longitudinal-vertical plane"). The bending or curvature of the gripping structure 104 provides a distal portion 104a that is angled with respect to the longitudinal direction 114a and approaches parallel to the retinal membrane 116 that is grasped using the gripping structure 104. The flexibility of the gripping structure 104 may allow deformation of the gripping structure 104 such that the distal portion 104a overlies the retinal membrane 116. In practice, the gripping structure 104 is inserted through a trocar cannula on one side of the pupil of the patient's eye, while the retinal membrane 116 to be peeled is located behind the pupil. Thus, the longitudinal direction 114a is non-parallel to the normal of the retinal membrane 116 at the point of contact with the gripping structure 104. The angle 104c subtended by the distal portion 104a with respect to the longitudinal direction 114a in a longitudinal-perpendicular plane can describe this non-perpendicular angle. For example, the angle 104c can be between 85 degrees and 45 degrees, between 80 degrees and 50 degrees, or between 75 degrees and 55 degrees.

[0017] The distal portion 104a may be connected to the hollow rod 112 by a proximal portion 104b that may flare outward in a transverse direction 114b from the width of the hollow rod 112 to the width of the distal portion 104a. The distal portion 104a may be parallel to the longitudinal direction 114a except for the curved transition into an angled orientation of the distal portion 104a.

[0018] 2A-2C show the gripping structure 104 during use, as well as the internal structure of the gripping structure 104. The proximal portion 104b may define a channel 200 in fluid communication with the hollow rod 112, allowing vacuum pressure supplied from the vacuum generator 110a to the hollow rod 112 to be transmitted through the channel 200. The gripping structure 104 may define a cavity 202 in fluid communication with the channel 200 and accessible through an opening 204. The opening 204 may extend across substantially all (e.g., at least 90 percent) of the lower surface of the distal portion 104a (the side facing the retinal membrane 116) and may extend partially along the proximal portion 104b. The cavity 202 may be occupied by a cushion 206 made of a flexible material, such as silicone. The cushion 206 defines one or more channels 208 in fluid communication with the channel 200. The cushion 206 may extend into the channels 200 and may provide a seal that prevents fluid flow into the channels 200 other than through one or more of the channels 208. The one or more channels 208 connect to an array of openings 210 in the underside of the cushion 206 (the outward-facing surface through the openings 204). Although the openings 210 are shown distributed in one dimension, they may also be distributed in a two-dimensional array (ordered or random) across the underside of the cushion 206.

[0019] A blade 212 may extend across the distal end of the opening 204. The blade 212 extends downwardly beyond the lower surface of the cushion 206 a distance slightly less than the thickness of the retinal membrane 116 (typically about 4 microns). In the illustrated embodiment, the blade 212 is secured to the distal end of the distal portion 104a and defines the edge of the opening 204 opposite the proximal portion 104b. When the cushion 206 is pressed against the retinal membrane 116, the blade 212 may extend downwardly into the membrane by 0.6 to 0.9 times the thickness of the retinal membrane 116, e.g., 1 to 3.6 microns, e.g., 2.4 to 3.6 microns.

[0020] 2B , in use, the outer tube 106 is inserted through a trocar cannula and the gripping structures 104 are extended relative to the outer tube 106 by either withdrawing the outer tube 106 or pushing the gripping structures 104 from the outer tube 106. The cushion 206 presses against the retinal membrane 116 and the blade 212 presses against the retinal membrane 116, thereby forming an incision 220 in the retinal membrane 116. Vacuum pressure is supplied through the hollow rod 112 and the channel 200 to one or more channels 208, thereby inducing a vacuum at the opening 210.

[0021] 2C, vacuum pressure at opening 210 adheres distal portion 104a and a portion 116a of cushion 206 to retinal membrane 116. The gripping structure 104 can then be lifted away from retina 214, thereby separating that portion 116a of retinal membrane 116 from retina 214.

[0022] 3, the gripping structure 104 may then be moved in a circular motion to remove the separated portion of the retinal membrane 116 from the retina. The gripping structure 104 may then be retracted into the outer tube 106, and the gripping structure 104 and outer tube 106 may be withdrawn through the trocar cannula. Vacuum pressure may continue to be supplied to the opening 210 as the gripping structure 104 is withdrawn so that the peeled portion of the membrane 116 is also withdrawn through the trocar cannula.

[0023] 4A and 4B illustrate an alternative implementation of a surgical instrument 100 for peeling a membrane, such as an ILM or ERM, from the retina of a patient's eye, according to certain embodiments.

[0024] As shown, the vacuum-actuated gripping structure 400 includes a tube 402 that is extendable relative to the outer tube 106 by actuation of a slider 108 or alternative manual control structure. Similar to the previous embodiment, the outer tube 106 can be actuated by the slider 108 and the tube 402 can be fixed relative to the handpiece 102, or the tube 402 can be actuated by the slider 108 and the outer tube 106 can be fixed relative to the handpiece 102. In the embodiment of FIG. 4A, the supply of vacuum pressure to the tube 402 is controlled by a button 110c on the handpiece 102. The button 110c may control the supply of power to a vacuum generator 110a or may actuate a valve that couples vacuum pressure to the tube 402 when the button 110c is pressed or otherwise actuated. The button 110c may also be used in place of the foot pedal 110 in the embodiments of FIGS. 1-2C.

[0025] The distal end of the tube 402 may include a distal end face 410 having a perforated cover 404 with a plurality of openings 406 (shown in FIG. 4B). The perforated cover 404 may be made of the same material as the tube 402, for example, nitinol. Alternatively, the tube 402 may be made of nitinol while the cover 404 is made of a flexible material such as silicone or other polymer.

[0026] The distal end surface 410 of the tube 402 may be at an angle relative to the longitudinal direction 114a. For example, as shown in FIG. 4A, the distal end surface 410 of the tube 402 may be at an angle in a plane perpendicular to the longitudinal direction. For example, the angle may be between 85 degrees and 45 degrees, between 80 degrees and 50 degrees, or between 75 degrees and 55 degrees. This angle may facilitate the distal end surface 410 of the tube 402 and the cover 404 being positioned flat against the membrane 116.

[0027] In use, the outer tube 106 may be inserted through a trocar cannula, the tube 402 may be extended relative to the outer tube 106, the cover 404 may be placed against the membrane 116, and the button 110c may be actuated to supply vacuum pressure through the tube 402 to the opening 406. The membrane 116 may then be pulled against the cover 404. The surgeon may then pull on the handpiece 102 to peel the membrane 116 from the retina 214. The surgeon may then move the gripping structure 400 in a circular motion to remove a portion of the membrane 116, as shown in FIG. 3 . The gripping structure 400 may then be retracted into the outer tube 106, and the gripping structure 104 and outer tube 106 may be withdrawn from the trocar cannula. Vacuum pressure may continue to be supplied to the opening 406 as the gripping structure 104 is withdrawn so that the peeled portion of the membrane 116 is also withdrawn through the trocar cannula.

[0028] 4C and 4D, in some embodiments, teeth 420 may be provided on at least a portion of the distal end face 410 for cutting the membrane 116. For example, the teeth 420 may be arranged circumferentially around at least a portion of the cover 404 and / or opening 406 (e.g., a 180-degree to 90-degree sector). The teeth 420 may have a height from about 2 microns to about 20 microns from the surface of the distal end face 410, e.g., a height from about 5 microns to about 15 microns from the surface of the distal end face 410, e.g., a height from about 10 microns from the surface of the distal end face 410. In certain embodiments, the teeth 420 may be angled at an angle from about 30 degrees to about 90 degrees relative to the longitudinal direction 114a, e.g., an angle from about 45 degrees to about 75 degrees relative to the longitudinal direction 114a.

[0029] Referring to FIG. 4E, the gripping structure 400 of the embodiment of FIGS. 4A-4D can be modified as shown to achieve the illustrated gripping structure 400a. The gripping structure 400a can be used in the same manner as the gripping structure 400 of FIGS. 4A-4D. In the gripping structure 400a, the distal portion 408 secured to or formed by a portion of the tube 402 can be flared, such as horn- or cone-shaped. In such an embodiment, the diameter of the distal end face 410 of the distal portion 408 can be larger than the inner diameter of the outer tube 106, requiring the distal portion 408 to fold or otherwise deform in order to fit into the outer tube 106. The distal portion 408 can be made of a different material than the tube 402. For example, the distal portion 408 can be made of silicone or other elastomer, while the remainder of the tube 402 is made of nitinol. As shown in the embodiment of FIG. 4B, a cover 404 having an opening 406 may extend across at least a portion of the distal end surface 410 of the distal portion 408. If the distal portion 408 is made of the same material as the cover 404, the distal portion and cover 404 may be monolithically formed, such as by co-molding. As shown in the embodiment of FIGS. 4C-4D, teeth may be provided around a portion of the circumference of the distal end of the tube 402. The flexibility of the distal portion 408 may allow the distal portion 408 to compensate for differences in orientation between the cover 404 and the membrane 116 and reduce the amount of force transmitted from the handpiece 102 to the membrane 116. In the embodiment of FIG. 4E, a foot pedal 110 is used to control the supply of vacuum pressure to the tube 402. However, as shown in the embodiment of FIG. 4A, a button 110c may also be used.

[0030] The above description is provided to enable those skilled in the art to practice the various embodiments described herein. Various modifications to these embodiments will be readily 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: A handpiece and an actuator attached to the handpiece; an outer tube having a proximal end attached to the handpiece; a gripping structure extendable outwardly relative to the distal end of the outer tube in response to movement of the actuator, the gripping structure defining a plurality of openings configured to be placed in fluid communication with a vacuum pressure source; 1. An ophthalmic surgical instrument, comprising:

2. 2. The ophthalmic surgical instrument of claim 1, wherein the gripping structure defines a cavity having an opening configured to face the retinal membrane, and the gripping structure further includes a blade positioned along a portion of the opening.

3. The ophthalmic surgical instrument of claim 2 , wherein the blade extends outward from the opening by 1 to 3.6 microns.

4. The ophthalmic surgical instrument of claim 2 further comprising a cushion positioned within the cavity.

5. 5. The ophthalmic surgical instrument of claim 4, wherein the cushion defines a channel configured to be disposed in fluid communication with the vacuum pressure source and a plurality of openings in a lower surface of the cushion, the plurality of openings in fluid communication with the channel, and the lower surface facing outward from the cavity.

6. The ophthalmic surgical instrument of claim 5 , wherein the cushion extends into the channel.

7. The ophthalmic surgical instrument of claim 5 , wherein the cushion comprises silicone.

8. 6. The ophthalmic surgical instrument of claim 5, further comprising a hollow tube connecting the gripping structure to the handpiece, the hollow tube in fluid communication with the channel and configured to be placed in fluid communication with the vacuum pressure source.

9. 9. The ophthalmic surgical instrument of claim 8, wherein the gripping structure includes a proximal portion secured to the hollow tube and defining the channel, and a distal portion secured to the proximal portion and angled relative to the proximal portion, the proximal portion defining the cavity and having the blade secured thereto.

10. The ophthalmic surgical instrument of claim 1 , further comprising a button attached to the handpiece and configured to control the supply of vacuum pressure from the vacuum source to the gripping structure.

11. 10. The ophthalmic surgical instrument of claim 1, further comprising a foot pedal coupled to the vacuum source and the gripping structure, the foot pedal configured to control the supply of vacuum pressure from the vacuum source to the gripping structure.

12. 1. A method for detaching a membrane from a retina, comprising: pressing a lower surface of a gripping structure against the membrane, the lower surface defining a plurality of openings; applying a vacuum pressure to the plurality of openings; A method comprising:

13. 13. The method of claim 12, further comprising removing a portion of the membrane from the retina by pulling the grasping structure away from the retina.

14. The method of claim 12 , wherein the gripping structure includes a blade configured to cut the membrane when the lower surface of the gripping structure is pressed against the membrane.

15. the gripping structure includes a cushion positioned within the cavity and defining the plurality of openings; The method of claim 13 , wherein pressing the lower surface of the gripping structure against the membrane comprises pressing a lower surface of the cushion against the membrane.

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