Phacoemulsification Infusion Sleeve

Abstract

The ophthalmic surgical handpiece includes a needle for insertion through an incision in the eye and an ultrasonic energy generator for delivering ultrasonic energy to the needle to emulsify tissue within the eye. The ophthalmic surgical handpiece also includes a sleeve surrounding at least a portion of the needle, the sleeve including an insertion portion for delivering injectate to the eye and a compressible portion for sealing the incision in the eye by pressing against the outer surface of the eye at the incision.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to phacoemulsification infusion sleeves, and more particularly to phacoemulsification infusion sleeves in which the phacoemulsification needle is movable independently of the infusion sleeve. [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 (e.g., coaxial phacoemulsification). This technique involves using high-frequency ultrasonic energy to transmit through a handpiece to a phaco needle to emulsify the diseased tissue within the eye and aspirating the emulsified tissue through the phaco needle and out of the eye. During surgery, an injectate (e.g., saline) is introduced into the eye through the handpiece to maintain the eye under pressure and aid in aspirating the emulsified tissue. Specifically, the injectate enters the eye through an infusion sleeve positioned around (e.g., coaxial with) the phaco needle. Both the infusion sleeve and the phaco needle are inserted into the eye through an incision in the eye. Summary of the Invention [Means for solving the problem]

[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 an infusion sleeve for an ophthalmic surgical instrument (e.g., a phacoemulsification handpiece, etc.). In one exemplary embodiment, the ophthalmic surgical instrument includes a needle for insertion through an incision in the eye and an ultrasonic energy generator for delivering ultrasonic energy to the needle to emulsify tissue within the eye. The ophthalmic surgical handpiece also includes a sleeve surrounding at least a portion of the needle, the sleeve having a distal insertion portion for delivering infusion fluid to the eye and a more proximal compressible portion for sealing the incision in the eye by pressing against the outer surface of the eye at the incision.

[0006] In another exemplary embodiment, the infusion sleeve generally includes an insertion portion for insertion into an incision in the eye and a more proximal compressible portion for sealing against the outer surface of the eye at the incision, the insertion portion having a first diameter and the compressible portion having a second diameter greater than the first diameter.

[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 an infusion sleeve partially surrounding a phacoemulsification needle; [Figure 2] FIG. 1 is a cross-sectional elevation view of another exemplary embodiment of an infusion sleeve partially surrounding a phacoemulsification needle, with the tip of the infusion sleeve and phaco needle inserted to a first depth within the eye, compared to an example of a prior art example. [Figure 3] FIG. 3 is a cross-sectional elevation view of the injection sleeve of FIG. 2, with the needle tip inserted to a second depth within the eye; [Figure 4] Cross-sectional elevation view of the injection sleeve of Figure 2, with the tip of the phaco needle fully inserted into the eye to a depth of 3. DETAILED DESCRIPTION OF THE INVENTION

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

[0011] Exemplary embodiments of the present disclosure generally relate to a phacoemulsification infusion sleeve handpiece that delivers infusate into the eye from a fixed location relative to the incision site, as well as a structure that seals the incision site to prevent or minimize incision leakage, regardless of the size of the incision. Traditionally, infusion sleeves have been designed to have an interference fit with the phaco needle and move parallel to the phaco needle during surgery (e.g., both the phaco needle and the infusion sleeve move back and forth together). As a result, infusate enters the eye near the tip of the phaco needle, near the location where the phaco needle aspirates emulsified tissue from the eye. However, injecting fluid from the infusion sleeve near the tip of the phaco needle can be counterproductive, for example, because the infusate may push tissue fragments that are intended to be emulsified and aspirated away from the tip of the phaco needle. Additionally, infusate leakage from the incision can cause a drop in intraocular pressure (IOP), potentially leading to serious problems such as intraocular tissue collapsing on the vibrating phaco needle. To prevent such leakage, infusion sleeves have traditionally been designed primarily to accommodate the size of the incision (e.g., by sealing the incision by eliminating the space between the sleeve and the incision site). This necessitates different sizes of infusion sleeves for different incision sizes. Furthermore, during a typical phacoemulsification procedure, the phaco needle and infusion sleeve move back and forth along the incision an average of 50 times. As the phaco needle moves back and forth, the sleeve can rub against the inner surface of the incision, causing tissue damage (e.g., corneal burns) and potentially adversely affecting postoperative healing. Furthermore, the sleeve can move with the phaco needle during surgery, potentially compromising visibility of the needle and the surgical field.

[0012] The infusion sleeve of the present disclosure is unique in that it includes an insertion portion that is inserted into the eye through the incision and a foldable or compressible portion that remains outside the eye and deforms (e.g., folds or accordions) as the phaco needle advances further into the eye. This two-part structure allows the infusion sleeve of the present disclosure to move the phaco needle back and forth within the eye as needed during surgery, while the infusion sleeve remains stationary, e.g., only the insertion portion of the infusion sleeve is positioned within the eye. Because the infusion sleeve remains stationary even when the phaco needle is moving, damage to the ocular tissue at the incision site is minimized or eliminated (e.g., the infusion sleeve does not continually rub against the ocular tissue at the incision site, such as during surgery). Additionally, the outer compressible portion of the infusion sleeve functions to seal the incision from the outside. As can be appreciated, this outer seal allows a single infusion sleeve and phaco needle combination to be used with a wide range of incision sizes.

[0013]

[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.

[0014] FIG. 1 illustrates an exemplary embodiment of an infusion sleeve 100 for an ophthalmic surgical instrument (e.g., a phacoemulsification handpiece, etc.) incorporating one or more aspects of the present disclosure, which is a handcrafted prototype sleeve. In the illustrated embodiment, the sleeve 100 generally includes an insertion portion 102 (broadly, a first or inner portion) and a compressible portion 104 (broadly, a second or outer portion). A needle 106 (e.g., a phaco needle, etc.) of an ophthalmic surgical instrument 108 (e.g., a phacoemulsification handpiece, etc.) is positioned within the sleeve 100. In the context of ophthalmic surgery, the insertion portion 102 of the sleeve 100 along with the needle 106 is inserted into an incision (broadly, an opening) in the eye, while the compressible portion 104 of the sleeve 100 remains outside the eye.

[0015] The sleeve 100 is generally formed as a hollow tube. In particular, the sleeve 100 includes a central opening for accommodating the needle 106 therein. During surgery, infusion fluid passes through the sleeve 100 and is delivered to the eye to maintain intraocular pressure. The infusion fluid enters the eye through one or more infusion ports 110 in the sleeve 100. In particular, in the illustrated embodiment, the insertion portion 102 of the sleeve 100 includes at least one infusion port 110 through which the infusion fluid is introduced into the eye. The infusion port 110 is formed proximal to the distal end of the sleeve 100. In the illustrated embodiment, the distal end of the insertion portion 102 of the sleeve 100 is tapered, for example, to facilitate insertion of the sleeve 100 into the eye through an incision.

[0016] In the illustrated embodiment, the diameter of the insertion portion 102 is smaller than the diameter of the compressible portion 104 of the sleeve 100. The diameter of the insertion portion 102 must be small enough to fit within the incision without stretching or tearing the incision, and large enough to accommodate the phaco needle 106 within the sleeve 100. In some embodiments, a lip 112 is present at the distal end of the compressible portion 104 due to the difference in diameter. In other embodiments, the transition between the different diameters of the insertion portion 102 and the compressible portion 104 is smooth, with no lip or step between the two portions 102, 104, but rather a flare from a smaller, first diameter to a larger, second diameter. The second diameter of the compressible portion 104 of the sleeve is sized large enough to avoid passing through the incision, and the compressible portion is configured to remain outside the eye during surgery. The insertion portion 102 of the sleeve 100 has a relatively small diameter, allowing it to enter the eye through the incision, while the compressible portion 104 of the sleeve 100 has a relatively large diameter, remaining outside the eye (e.g., lip 112 engages the outer surface of the eye and prevents the compressible portion 104 from entering the eye). Once the phaco needle is fully inserted into the eye (e.g., FIG. 4), the compressible portion 104 of the sleeve 100 is positioned outside the eye and is compressed (e.g., by uniaxial compression), reducing the effective length of the compressible portion 104. In some embodiments, the compressible portion 104 of the sleeve 100 includes folds or other structure to guide the shape of the compressible portion 104 when the sleeve 100 is compressed (e.g., causing the compressible portion 104 to deform like an accordion), as in the exemplary embodiment of FIGS. 2-4.

[0017] The compressible portion 104 of the sleeve 100 acts as a compressible seal against the incision, which is sealed by the portion of the sleeve 100 that is outside the eye (i.e., the compressible portion 104). Notably, the sleeve 100 acts as a cap that seals the incision (e.g., by pressing against the outside of the incision), rather than a plug that seals the incision (e.g., by pressing against the inside of the incision). In particular, the compressible portion 104 of the sleeve 100 compresses against the outer surface of the eye, and when compressed, the compressible portion 104 presses against the outer surface of the eye at and around the incision, effectively sealing the incision. To achieve the seal, the diameter of the compressible portion 104 is larger than the incision, such that when the compressible portion 104 is folded, it completely covers the incision from outside the eye (e.g., it does not fill the incision from the inside). In some embodiments, the lip 112 of the compressible portion 104 has a diameter large enough to seal the incision, e.g., like a cap, regardless of the diameter of the compressible portion 104 when compressed. In these embodiments, the lip 112 can be considered a flange at the distal end of the compressible portion 104, which is of a diameter large enough to surround the incision (and, additionally or alternatively, has a larger diameter than the remainder of the compressible portion 104 when compressed). For example, the distal surface of such a flange seals against the outer surface of the eye, sealing the incision. As will be appreciated, a single infusion sleeve 100 and phaco needle 106 combination can be used for a wide range of incision sizes, for example, due to the different diameters of the insertion portion 102 and the compressible portion 104, as well as the sealing mechanism of the sleeve 100 (e.g., sealing the incision from the outside). Additionally, the compressible portion 104 of the sleeve 100 can improve fluid stability by sealing the incision on the outer surface of the eye, and the larger diameter of the compressible portion 104 can provide enhanced infusion into the eye compared to typical prior art sleeves that have a substantially constant diameter.

[0018] The compressible portion 104 of the sleeve 100 is preferably formed of a compressible biocompatible material that seals against the incision from the outside when the insertion portion 102 of the sleeve 100 (and the phaco needle) is inserted through the incision. The compressible section 104 of the sleeve 100 is intended to be easily deformed or compressed, and therefore, the compressible section 104 can be described as flexible, compressible, resilient, pliable, and / or deformable. For example, the compressible section 104 can be formed of a compressible material, including, but not limited to, silicone, rubber, plastic, polymer, nylon, polyether, polyurethane, and the like. If the sleeve 100 is constructed of two joined pieces, the insertion portion 102 can be formed of a harder, more rigid material to allow for easier insertion through the incision. It should be appreciated that the compressible section 104 can be formed of any material and / or combination of materials useful in lens surgery.

[0019] Figures 2-4 illustrate the insertion of a phaco handpiece 108 and a phaco needle 106 attached to an infusion sleeve 200 into an eye through an incision. In particular, Figure 2 illustrates the phaco needle 106 inserted to an initial or first depth into the eye 201. Figure 3 illustrates the phaco needle 106 inserted to a second, deeper depth, and Figure 4 illustrates the phaco needle 106 fully inserted to a third, deepest depth. For comparison purposes, an identical phaco needle 106 with a conventional infusion sleeve 10, labeled Prior Art, is shown at each corresponding depth in Figures 2-4 above the infusion sleeve 200 of the present disclosure.

[0020] As shown in FIG. 2 , when the phaco needle 106 is initially inserted into the eye, the distal insertion portion 202 of the sleeve 200 is positioned within the eye and the compressible portion 204 is located outside the eye. At least a second diameter of the compressible portion 204 is at least larger than the first diameter of the insertion portion 202 (and larger than the incision in the eye 201), so that the compressible portion 204 does not enter the eye and prevents further entry of the sleeve 200 into the eye 201. The diameter of the compressible portion of the sleeve is sized large enough so that it does not pass through the incision, and the compressible portion is also configured to remain outside the eye during surgery. As shown in FIG. 3 , once the phaco needle 106 is advanced into the eye (e.g., to a second depth), the sleeve 200 does not further advance within the eye. Notably, the insertion portion 202 of the sleeve 200 remains in the same position within the incision. The first diameter of the insertion portion of the sleeve is sized to be inserted through the incision and not seal against the incision in the eye. To allow for advancement of the phaco needle 106 without advancing the sleeve 200, the effective length of the compressed portion 20 of the sleeve 200 is reduced, as indicated by arrows 212, 214, and 216. In contrast, as shown in FIG. 3 , when the phaco needle 106 is advanced into the eye to a second depth, the conventional sleeve 10 is also advanced into the eye. This creates friction against the incision as the conventional sleeve 10 moves back and forth between the first depth and the second depth, etc., scraping against the incision.

[0021] Similarly, in FIG. 4 , phaco needle 106 is fully inserted to a third depth. Again, insertion portion 202 of sleeve 200 remains in the same position relative to the outer surface of the eye (e.g., as shown in FIGS. 2 and 3 ). In this manner, phaco needle 106 can be inserted to a greater depth independently of sleeve 200, improving its ability to emulsify the lens material as desired (e.g., improved crushing and frangibility, increased retention, etc.). In contrast, once phaco needle 106 is fully inserted, conventional sleeve 10 is also fully inserted. Comparing sleeve 200 to conventional sleeve 10, sleeve 200 is inserted into eye 201 over a relatively short length (e.g., only insertion portion 202 of sleeve 200). This shorter insertion length allows for easier insertion through an incision without buckling due to the greater structural strength available compared to conventional sleeve 10, which has a much longer, uniform cross-section. Furthermore, because infusion sleeve 200 remains fixed in position during surgery (e.g., regardless of movement of phaco needle 106), infusion fluid can be introduced into the eye through injection port 210 at a constant location relative to the incision site. Notably, compared to conventional infusion sleeves 10, injection occurs at a greater distance from the tip of phaco needle 106, except for the initial insertion depth. This can facilitate emulsification and aspiration of tissue from the eye, since tissue is not pushed or removed from the tip of phaco needle 106 by fluid exiting port 210, as is the case with conventional sleeves 10.

[0022] The infusion sleeve of the present disclosure has a unique two-part structure, including an insertion portion that is inserted into the eye through an incision and an outer portion that remains outside the eye and is compressed to seal the incision from outside the eye as the phaco needle advances through the eye. This two-part structure allows the infusion sleeve of the present disclosure to move the phaco needle back and forth within the eye as needed during surgery, while the infusion sleeve remains stationary, e.g., only the insertion portion of the infusion sleeve is positioned within the eye. Because the infusion sleeve remains stationary even when the phaco needle is moving, damage to the ocular tissue at the incision site is minimized or eliminated (e.g., the risk of corneal burns is reduced because the infusion sleeve does not continually rub against the ocular tissue at the incision site, such as during surgery).

[0023] Furthermore, the infusion sleeve of the present disclosure remains fixed in position during surgery (e.g., independent of phaco needle movement, etc.), allowing for the introduction of injectate into the eye at a consistent location relative to the incision site. Notably, compared to conventional infusion sleeves, injectate is injected farther from the tip of the phaco needle during the majority of the procedure. This allows for efficient aspirating of emulsified or fragmented tissue from the eye without the fluid exiting the aspiration port pushing the emulsified or fragmented tissue away from the needle tip. Additionally, because the phaco needle can be inserted to a depth independent of the depth to which the infusion sleeve is inserted, the infusion sleeve of the present disclosure allows for the phaco needle to be embedded deeper into the lens material, improving visibility of the needle tip and tissue (since the sleeve is not within the target field of view), and therefore improving the ability to identify and emulsify the lens material as desired (e.g., improved fragmentation and breakability, improved retention, etc.). The independence of the phaco needle from the infusion sleeve also improves visibility of the phaco needle (and, more broadly, the surgical field) during surgery.

[0024] As will be appreciated, a single phaco needle and infusion sleeve combination of the present disclosure can be used for a wide range of incision sizes, for example, due to the different diameters of the insertion and compressible portions of the sleeve, as well as the sealing mechanism of the sleeve. Furthermore, fluid stability can be improved by sealing the incision from the outside to prevent fluid leakage from the incision, and by the larger diameter of the compressible portion of the sleeve (which delivers more infusion fluid closer to the eye than conventional sleeves). Furthermore, the relatively short length of the sleeve inserted into the eye of the present disclosure can provide greater structural strength and facilitate easier insertion. Furthermore, no modifications to existing surgical techniques are required to use the infusion sleeve of the present disclosure.

[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] 10 Conventional Infusion Sleeve 100,200 Infusion Sleeve 102,202 Insertion part 104,204 Compressible part 106 Needles / Phaco Needles 108 Ophthalmic surgical instruments 110 Injection port 112 Lip

Claims

1. 1. An ophthalmic surgical instrument comprising: a needle for insertion into the eye incision; an ultrasonic energy generator attached to the needle for delivering ultrasonic energy to the needle to emulsify tissue within the eye; and a sleeve surrounding at least a portion of the needle, the sleeve including a distal insertion portion for delivering infusion fluid into the eye and a compressible portion for sealing the incision in the eye by pressing against an outer surface of the eye at the incision. An ophthalmic surgical instrument comprising:

2. The ophthalmic surgical instrument of claim 1 , wherein the diameter of the insertion portion of the sleeve is smaller than the diameter of the compressible portion of the sleeve.

3. The ophthalmic surgical instrument of claim 1 , wherein the compressible portion of the sleeve includes a flange at a distal end thereof to enhance the seal at the incision.

4. The ophthalmic surgical instrument of claim 1 , wherein a first diameter of the insertion portion of the sleeve is sized to be inserted through the incision and not seal against the incision in the eye.

5. The ophthalmic surgical instrument of claim 1 , wherein the insert portion of the sleeve includes at least one injection port for supplying the injection fluid to the eye.

6. 10. The ophthalmic surgical instrument of claim 1, wherein the second diameter of the compressible portion of the sleeve is sized large enough to prevent it from passing through the incision and configured to remain outside the eye during surgery.

7. The ophthalmic surgical instrument of claim 1 , wherein the sleeve is configured to allow the needle to move within the eye independently of the sleeve.

8. 1. An infusion sleeve for a phacoemulsification handpiece, the infusion sleeve comprising: an insertion portion having at least a first diameter sized to be inserted through an incision in the eye and that does not seal against the incision in the eye; and a compressible portion for sealing against the outer surface of the eye at the incision, the compressible portion having a second diameter greater than the first diameter; Including, an infusion sleeve.

9. The infusion sleeve of claim 8 , wherein the insert portion includes at least one injection port for delivering an infusion fluid to the eye.

10. The infusion sleeve of claim 8 , wherein the compressible portion includes a flange at a distal end of the compressible portion for sealing the incision by pressing against the outer surface of the eye.

11. An infusion sleeve as described in embodiment 8, wherein the second diameter of the compressible portion of the sleeve is sized large enough to prevent it from passing through the incision and the compressible portion is configured to remain outside the eye during surgery.

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