Needles for attachment to ophthalmic surgical handpieces

A cannula with a flexible member addresses the challenge of safely manipulating delicate ocular tissues by acting as a cushion and visual indicator, ensuring safe and effective tissue removal during ophthalmic surgeries.

JP2025535032APending Publication Date: 2025-10-22BAUSCH & LOMB IRELAND LIMITED
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Patent Information

Application Number
JP2025519154
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-10-04
Filing Date
2023-10-04
Publication Date
2025-10-22

AI Technical Summary

Technical Problem

Existing ophthalmic surgical needles face challenges in safely manipulating and removing delicate ocular tissues like the retina and posterior capsule without causing damage during procedures such as phacoemulsification, due to their proximity to sensitive eye parts.

Method used

The development of a cannula with a flexible member, such as a loop or button, coupled to the distal end, which acts as a cushion and visual indicator, ensuring gentle contact and providing a safe margin during tissue manipulation and emulsification, while allowing for tissue manipulation and aspiration.

Benefits of technology

Enhances safety by minimizing deformation and providing a visual warning when approaching sensitive tissues, facilitating safer and more effective tissue removal during ophthalmic surgeries.

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Abstract

The ultrasonic needle for attachment to an ophthalmic surgical handpiece includes a cannula having a proximal end and a distal end. The proximal end of the cannula is configured to be attached to the ophthalmic surgical handpiece. The distal end of the cannula includes a tip with at least one port in communication with a lumen extending through the cannula. A flexible member (e.g., a flexible loop, a flexible button, etc.) is coupled to the distal end of the cannula for tissue manipulation.
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Description

[Technical Field]

[0001] The present disclosure relates generally to needles and associated systems for attachment to ophthalmic surgical handpieces, and more particularly to needles that include structure for manipulating ocular tissue. [Background technology]

[0002] This section provides background information related to the present disclosure that is not necessarily prior art.

[0003] Ophthalmic surgery often involves resecting or emulsifying tissue that needs to be removed from the eye, such as cataract surgery. One known technique is phacoemulsification, which involves using high-frequency ultrasonic energy transmitted through a handpiece to a phacoemulsification needle to emulsify the affected tissue. The emulsified tissue is then removed from the eye through a suction channel. During surgery, the phacoemulsification needle may need to operate in close proximity to very delicate parts of the eye, such as the retina and posterior capsule, without damaging these parts of the eye. Summary of the Invention

[0004] This section provides an overview of the disclosure and is not a comprehensive disclosure of its entire scope or all of its functionality.

[0005] Exemplary embodiments of the present disclosure generally relate to a needle for attachment to an ophthalmic surgical handpiece. In one exemplary embodiment, the ultrasonic needle generally includes a cannula having a proximal end and a distal end. The proximal end of the cannula is configured to be attached to the ophthalmic surgical handpiece. The distal end of the cannula includes a tip with at least one port that communicates with a lumen extending through the cannula. A flexible member (e.g., a flexible loop, a flexible button, etc.) is coupled to the distal end of the cannula for tissue manipulation.

[0006] In another exemplary embodiment, an ophthalmic surgical handpiece is provided. The handpiece generally includes a housing having a distal end. A cannula is attached to the distal end of the housing and includes a distal tip having at least one suction port. A vibration source is disposed within the housing to vibrate the distal tip of the cannula. A flexible member (e.g., a flexible loop, a flexible button, etc.) is coupled to the distal tip of the cannula for tissue manipulation.

[0007] Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

[0008] The drawings described herein are for purposes of illustrating selected embodiments only, do not depict all possible implementations, and are not intended to limit the scope of the present disclosure. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a partial perspective view of an exemplary embodiment of a needle for attachment to an ophthalmic surgical handpiece; [Figure 2] FIG. 2 is another partial perspective view of the needle of FIG. [Figure 3] FIG. 2 is another partial perspective view of the needle of FIG. [Figure 4] 1 is a partial cross-sectional view of another exemplary embodiment of a needle for attachment to an ophthalmic surgical handpiece; [Figure 5] FIG. 2 is an elevational view of an exemplary embodiment of an ophthalmic surgical handpiece including the needle of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0010] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.

[0011]

[0013] Exemplary embodiments will now be described in more detail with reference to the accompanying drawings. The description and specific examples contained herein are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

[0012] 1-3 illustrate an exemplary embodiment of a needle 100 (e.g., a phacoemulsification or fragmentation ultrasonic needle) for attachment to an ophthalmic surgical handpiece (e.g., an ultrasonic handpiece, a fragmentation handpiece, a phacoemulsification handpiece, a Bausch+Lomb Vitesse™ Hypersonic Vitrectomy handpiece, etc.) incorporating one or more aspects of the present disclosure. In the illustrated embodiment, the needle 100 includes a cannula 102 having a distal end 104 (e.g., a distal tip) and a proximal end 106. The needle 100 also includes a flexible member 108 (broadly, a tissue manipulation structure) coupled to the distal end 104 of the cannula 102 for tissue manipulation.

[0013] In the illustrated embodiment, the cannula 102 includes a port 110 in communication (e.g., fluid communication) with a lumen (not shown in these figures) extending through the cannula 102. Although only one port 110 is shown, in other embodiments, the cannula 102 may include additional ports within the scope of the present disclosure. As shown in FIG. 1 , the port 110 is positioned adjacent the distal end 104 of the cannula 102.

[0014] The proximal end 106 of the cannula 102 is configured (not shown) to be attached to an ophthalmic surgical handpiece (e.g., to the distal end of the handpiece) (see, for example, FIG. 5 ). For example, in some embodiments, the proximal end 106 includes a threaded connection for attachment to the handpiece. The handpiece generally includes a housing and a vibration source disposed within the housing to vibrate the distal tip 104 of the cannula 102 to aid in the removal of tissue (e.g., vitreous, other tissue, etc.) from a patient's eye. The vibration source can ultrasonically vibrate the distal end 104 of the cannula 102 (broadly, the needle 100) to emulsify the affected tissue. A suction source can be connected to the housing to apply negative pressure to the lumen and the suction port 110 to remove fluid and tissue from the eye. In this manner, the ophthalmic surgical handpiece provides ultrasonic emulsification and aspiration of tissue from the eye through the cannula 102.

[0015] As described above, the flexible member 108 of the needle 100 is coupled to the distal end 104 of the cannula 102. As shown in FIGS. 1-3, the flexible member 108 is configured as a loop of flexible material. In the illustrated embodiment, the distal end 104 of the cannula 102 includes an opening through which the flexible member 108 is inserted (e.g., an end of a loop is inserted into the opening, etc.). The flexible member 108 is secured within the opening in the distal end 104, and any gaps (e.g., within the opening between the flexible member 108 and the cannula 102) are filled to prevent fluid leakage. For example, the gap around the opening through which the flexible member 108 is attached can be filled with a suitable material, including a silicone sealant, etc. In some embodiments, the opening in the distal end 104 of the cannula 102 is added to the cannula 102 by a secondary process (e.g., after molding the cannula 102). Alternatively, in some embodiments, the cannula 102 is designed to be manufactured with an opening for the flexible member 108, which is manufactured during the primary manufacturing process. The flexible member 108 is formed from a soft and / or flexible material, including a polymer such as polyamide or silicone. The resilience and compact structure of the material of the flexible member 108 allows the needle 100 to be inserted into the eye with minimal deformation of the flexible member 108 (e.g., such that the flexible member 108 generally maintains its shape during insertion into the eye).

[0016] When configured as a loop, the flexible member 108 may be formed in a generally circular or oval shape. In the illustrated embodiment, the flexible member 108 is formed as a teardrop-shaped loop, with the tip of the teardrop coupled to the distal end 104 of the cannula 102. In particular, the flexible member 108 comprises a strand of material, with each end of the strand coupled to the distal end 104 of the cannula 102 (e.g., each end of the strand coupled into and sealed at an opening in the distal end 104 of the cannula 102, as described above). In some embodiments, the flexible member 108 is pre-fabricated in the desired shape (e.g., teardrop-shaped) and then attached to the cannula 102 (e.g., a closed loop is first formed and then attached to the cannula 102). Although in this embodiment, the flexible member 108 is shown as a loop, it should be understood that in other embodiments, the flexible member 108 may have shapes and / or configurations other than a loop, including, for example, a button (see, e.g., FIG. 3 ), etc., based on the desired tissue manipulation function of the flexible member 108. Furthermore, the flexible member 108 is formed to a specific size, and the size of the flexible member 108 is not adjustable (e.g., the circumference of the loop is not adjustable). In the illustrated embodiment, the flexible member 108 is positioned parallel to the cannula 102. In particular, the flexible member 108 extends from the distal end 104 of the cannula 102 in a direction parallel to the central longitudinal axis of the cannula 102. It should be understood that in other embodiments, the flexible member 108 may be positioned in other orientations, such as at an angle, perpendicular to the central longitudinal axis, etc., within the scope of the present disclosure.

[0017] The flexible member 108 is an additional structure disposed at the distal end 104 of the cannula 102 that acts as a cushion between the cannula 102 and retinal tissue within the eye during vibration of the needle 100. In this manner, the flexible member 108 enhances the safety of the needle 100, for example, when the needle 100 is in close proximity to sensitive areas of the eye, such as the retina and posterior capsule. In particular, because the flexible member 108 is formed from a soft, flexible material, the flexible member 108 acts very gently when contacting the retina, regardless of whether the cannula 102 is vibrating. Furthermore, the flexible member 108 serves as a visual indicator of the distance between the distal end 104 of the cannula 102 and the target tissue. For example, the flexible member 108 provides a visual indicator to the surgeon manipulating the needle 100 that the cannula 102 is approaching the retina. In particular, when the flexible member 108 contacts the retina, the flexible member 108 deforms in a manner that is visible or perceptible to the surgeon. The visual or perceptible deformation of the flexible member 108 relative to the retina serves as a warning that special care must be taken during the surgical procedure. In some embodiments, the flexible member 108 is formed in a color that is easily recognizable during surgery, such as blue or black (e.g., to contrast with the retina and red blood cells commonly present in many posterior chamber pathologies). The flexible member 108 also allows for manipulation of the patient's ocular tissue during surgery, for example, as a lasso to grasp target and / or diseased tissue. Additionally, when the cannula 102 is not energized (e.g., when the needle 100 is not vibrating), the flexible member 108 allows for the peeling of the retinal membrane, the pushing of the detached retinal tissue into a desired location, and easier and safer tissue removal by suction.

[0018] FIG. 4 illustrates another exemplary embodiment of a needle 200 (e.g., an ultrasonic needle) for attachment to an ophthalmic surgical handpiece (e.g., an ultrasonic handpiece, a phacoemulsification handpiece, etc.) according to the present disclosure. The needle 200 of this embodiment is similar to the needle 100 previously described and shown in FIGS. 1-3. For example, the needle 200 of this embodiment also includes a cannula 202 having a distal end 204 (e.g., a distal tip) and a proximal end 206. The needle 200 also includes a flexible member 208 (broadly, a tissue manipulation structure) coupled to the distal end 204 of the cannula 202 for tissue manipulation.

[0019] In the illustrated embodiment, cannula 202 includes a port 210 in communication (e.g., fluid communication) with a lumen 212 extending through cannula 202. Although only one port 210 is shown, in other embodiments, cannula 202 may include additional ports within the scope of the present disclosure. As shown in FIG. 4, port 210 is positioned adjacent to the distal end 204 of cannula 202.

[0020] The proximal end 206 of the cannula 202 is configured to be attached to an ophthalmic surgical handpiece (e.g., to the distal end of the handpiece). For example, in some embodiments, the proximal end 206 includes a threaded connection (not shown) for attachment to the handpiece (not shown). The handpiece generally includes a housing and a vibration source disposed within the housing to vibrate the distal tip 204 of the cannula 202 to aid in the removal of tissue (e.g., vitreous, other tissue, etc.) from a patient's eye. The vibration source can ultrasonically vibrate the distal end 204 of the cannula 202 (broadly, the needle 200) to emulsify the affected tissue. A suction source can be connected to the housing to apply negative pressure to the lumen and the suction port 210 to remove fluid and tissue from the eye. In this manner, the ophthalmic surgical handpiece provides ultrasonic emulsification and aspiration of tissue from the eye through the cannula 202.

[0021] As described above, the flexible member 208 of the needle 200 is coupled to the distal end 204 of the cannula 202. As shown in FIG. 4 , the flexible member 208 is configured as a button of flexible material (e.g., a generally flat, circular protrusion protruding from the distal end 204 of the cannula 202). In particular, the flexible member 208 includes a first surface 214 (e.g., a distal face) that is disposed generally perpendicular to the cannula 202 (i.e., disposed perpendicular to the central longitudinal axis of the cannula 202). In the illustrated embodiment, the first surface 214 is curved, although it should be understood that in other embodiments, the first surface 214 of the flexible member 208 may be flat, concave, faceted, or the like. The flexible member 208 also includes a second surface 216 that, in the illustrated embodiment, is conical or tapered from the first surface 214 toward the distal end 204 of the cannula 202. In particular, the intersection of the first surface 214 and the second surface 216 of the flexible member 208 forms a lip (e.g., a rounded edge) that aids in tissue manipulation (e.g., lifting a membrane from the retinal surface, etc.) It should be understood that in other embodiments, the second surface 216 may be flat, generally parallel to the first surface 214, etc., to form a lip without departing from the scope of the present disclosure.

[0022] The flexible member 208 also includes a base 218 that is inserted into an opening at the distal end 204 of the cannula 202. The base 218 of the flexible member 208 is secured within the opening at the distal end 204, and any gaps (e.g., within the opening between the flexible member 208 and the cannula 202) are filled to prevent fluid leakage. For example, the gap around the opening to which the flexible member 208 is attached can be filled with a suitable material, including a silicone sealant or the like. The flexible member 208 is formed of a soft and / or flexible material, including a polymer such as polyamide or silicone. The resilience of the material of the flexible member 208 and its compact structure allow the needle 200 to be inserted into the eye without or with minimal deformation of the flexible member 208 (e.g., so that the flexible member 208 generally maintains its shape during insertion into the eye).

[0023] Similar to flexible member 108, flexible member 208 is an additional structure disposed at the distal end 204 of cannula 202 that acts as a cushion between cannula 202 and retinal tissue within the eye during vibration of needle 200. In this manner, flexible member 208 enhances the safety of needle 200, for example, when needle 200 is in close proximity to sensitive areas of the eye, such as the retina and posterior capsule. In particular, because flexible member 208 is formed from a soft, flexible material, flexible member 208 is very gentle when contacting the retina, regardless of whether cannula 202 is vibrating. Furthermore, flexible member 208 serves as a visual indicator of the distance between distal end 204 of cannula 202 and the target tissue. For example, flexible member 208 provides a visual indicator to the surgeon manipulating needle 200 that cannula 202 is approaching the retina. In particular, when the flexible member 208 contacts the retina, the flexible member 208 deforms in a manner that is visible or perceptible to the surgeon. The visual or perceptible deformation of the flexible member 208 relative to the retina serves as a warning that special care must be taken during the surgical procedure. In some embodiments, the flexible member 208 is formed in a color that is easily recognizable during surgery, such as blue or black (e.g., to contrast with the retina and red blood cells commonly present in many posterior chamber pathologies). The flexible member 208 also allows for manipulation of the patient's eye tissue, such as, for example, retinal membrane separation or pushing detached retinal tissue into a desired location.

[0024] FIG. 5 illustrates an exemplary embodiment of an ophthalmic surgical handpiece 300 (e.g., an ultrasound handpiece, a fragmentation handpiece, a phacoemulsification handpiece, a Bausch+Lomb Vitesse™ hypersonic vitrectomy handpiece, etc.) having attached thereto a needle 100 (having a flexible member 108) in accordance with the present disclosure. While FIG. 5 illustrates the needle 100 attached to the handpiece 300, in other embodiments, other needles, such as needle 200, may be attached to the handpiece 300. The handpiece 300 includes a distal end 320 and a proximal end 322. As illustrated, the needle 100 is attached to the distal end 320 of the handpiece 300. For example, in some embodiments, the distal end 320 of the handpiece 300 may include a threaded connection for attachment to the needle 100. The handpiece generally includes a housing 324 and a vibration source 326 disposed within the housing 324 to vibrate the needle 100 (e.g., the distal tip 102 of the cannula, etc.) to aid in the removal of tissue (e.g., vitreous, other tissue, etc.) from a patient's eye. The vibration source 326 ultrasonically vibrates the needle 100, for example, to emulsify the affected tissue. The handpiece 300 includes an aspiration path 328, and by connecting an aspiration source to the aspiration path 328, negative pressure can be applied to the aspiration port 110 of the needle 100 to remove fluid and tissue from the eye through the aspiration path 328. In this manner, the handpiece 300, in combination with the needle 100, provides ultrasonic emulsification and aspiration of tissue from the eye.

[0025] The exemplary embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope to those skilled in the art. Numerous specific details are described, such as examples of specific components, devices, and methods, to provide a thorough understanding of the embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, and that the exemplary embodiments can be embodied in many different forms, none of which should be construed as limiting the scope of the present disclosure. In some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0026] The specific dimensions, materials, and / or shapes disclosed herein are exemplary in nature and do not limit the scope of the present disclosure. The disclosure herein of a particular value and range of values ​​for a given parameter does not exclude other values ​​and ranges of values ​​that may be useful in one or more examples disclosed herein. Furthermore, it is contemplated that any two specific values ​​for a particular parameter described herein can define the endpoints of a range of values ​​that may be suitable for that given parameter (i.e., disclosure of a first and a second value for a given parameter can be interpreted as disclosing that any value between the first and second values ​​may also be employed for the given parameter). For example, if parameter X is exemplified herein as having a value A and also as having a value Z, it is contemplated that parameter X may have a range of values ​​from about A to about Z. Similarly, the disclosure of two or more ranges of values ​​for a parameter (whether such ranges are nested, overlapping, or distinct) is contemplated to encompass all possible combinations of the ranges of values ​​that may be claimed using the endpoints of the disclosed ranges. For example, if a parameter X is exemplified herein as having a value in the range of 1 to 10, or 2 to 9, or 3 to 8, it is contemplated that the parameter X may have other ranges of values, including 1 to 9, 1 to 8, 1 to 3, 1 to 2, 2 to 10, 2 to 8, 2 to 3, 3 to 10, and 3 to 9.

[0027] The terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. As used herein, the singular forms "a," "an," and "the" may be intended to include the plural forms unless the context clearly dictates otherwise. The terms "comprise," "comprising," "containing," and "having" are inclusive and thus specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. The method steps, processes, and operations described herein should not be construed as necessarily requiring performance in the particular order discussed or illustrated, unless specifically identified as such. It is also understood that additional or alternative steps may be employed.

[0028] When an element or layer is referred to as being "on," "engaged," "connected," or "coupled" to another element or layer, it may be directly on, engaged with, connected, or coupled to the other element or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being "directly on," or "directly connected to," or "directly coupled" to another element or layer, there may be no intervening elements or layers present. Other words used to describe relationships between elements should be interpreted similarly (e.g., "between" and "directly between," "adjacent" and "directly adjacent," etc.). As used herein, the terms "and / or" and "at least one" include any and all combinations of one or more of the associated listed items.

[0029] Terms such as "first," "second," and "third" may be used herein to describe various elements, components, regions, layers, and / or sections, but these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or section from another region, layer, or section. Terms such as "first," "second," and other numerical terms, when used herein, do not imply an order or sequence unless clearly indicated by context. Thus, a first element, component, region, layer, or section discussed below could be referred to as a second element, component, region, layer, or section without departing from the teachings of the exemplary embodiments.

[0030] For ease of description, spatially relative terms such as "inside," "outside," "below," "below," "downward," "above," and the like may be used herein to describe the relationship of one element or feature shown in the figures to another element(s) or feature(s). Spatially relative terms may be intended to encompass various orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if the device in the figures were turned over, elements described as "below" or "below" other elements or features would be oriented "above" the other elements or features. Thus, the exemplary term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein would be interpreted accordingly.

[0031] The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended that the disclosure be exhaustive or limiting of the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, may be interchangeable and used in selected embodiments even if not specifically shown or described. The same may also be modified in various ways. Such variations should not be considered a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure. [Explanation of symbols]

[0032] 100,200 stitches 102,202 Cannula 104,204,320 Distal end 106,206,322 Proximal end 108,208 Flexible member 110,210 ports 212 lumens 214 First Surface 216 Second Surface 218 Base 300 Ophthalmic Surgical Handpiece 324 Case 326 Vibration source 328 Suction Path

Claims

1. 1. An ultrasonic needle for attachment to an ophthalmic surgical handpiece, the ultrasonic needle comprising: a cannula having a proximal end and a distal end, the proximal end configured to be attached to an ophthalmic surgical handpiece, the distal end including a tip with at least one port in communication with a lumen extending through the cannula; and a flexible member coupled to the distal end of the cannula for tissue manipulation. Including, ultrasonic needles.

2. The ultrasonic needle of claim 1 , wherein the flexible member is a loop of flexible material.

3. The ultrasonic needle of claim 2 , wherein the loop comprises a strand having a first end and a second end, the first end and the second end being coupled to the distal end of the cannula.

4. The ultrasonic needle of claim 2 , wherein the loop is parallel to a central longitudinal axis of the cannula.

5. The ultrasonic needle of claim 2 , wherein the loop is teardrop shaped.

6. The ultrasonic needle of claim 1 , wherein the flexible member is a button of flexible material.

7. The ultrasonic needle of claim 6 , wherein the button includes a distal surface, a tapered surface, and a lip between the distal surface and the tapered surface.

8. The ultrasonic needle of claim 7 , wherein the distal surface is perpendicular to a central longitudinal axis of the cannula.

9. The ultrasonic needle of claim 1 , wherein the flexible member is polyamide.

10. The ultrasonic needle of claim 1 , wherein the flexible member is silicone.

11. 1. An ophthalmic surgical device comprising: a housing having a distal end; a cannula attached to the distal end of the housing and having a distal tip with at least one suction port; a vibration source disposed within the housing for vibrating the distal tip of the cannula; and a flexible member coupled to the distal tip of the cannula for tissue manipulation. An ophthalmic surgical device comprising:

12. The ophthalmic surgical device of claim 11 , wherein the flexible member is a loop of flexible material.

13. The ophthalmic surgical device of claim 12, wherein the loop comprises a strand having a first end and a second end, the first end and the second end being coupled to the distal end of the cannula.

14. The ophthalmic surgical device of claim 12 , wherein the loop is parallel to a central longitudinal axis of the cannula.

15. The ophthalmic surgical device of claim 12 , wherein the loop is teardrop shaped.

16. The ophthalmic surgical device of claim 11 , wherein the flexible member is a button of flexible material.

17. The ophthalmic surgical device of claim 16 , wherein the button includes a distal surface, a tapered surface, and a lip between the distal surface and the tapered surface.

18. The ophthalmic surgical device of claim 17 , wherein the distal surface is perpendicular to a central longitudinal axis of the cannula.

19. The ophthalmic surgical device of claim 11 , wherein the flexible member is polyamide and / or silicone.

20. The ophthalmic surgical device of claim 11 , wherein the housing and the vibration source are part of a phacoemulsification surgical handpiece.