This invention generally relates to surgical devices used in ocular surgery and more specifically to an irrigation sleeve used with a handpiece and needle tip in ocular surgery.
Phacoemulsification and irrigation/aspiration (FA) handpieces facilitate removal of the natural lens during cataract surgery. During cataract surgery, a phacoemulsification handpiece and/or an IA handpiece may be coupled to an irrigation source and an aspiration pump. The handpiece may include a needle tip and an irrigation sleeve, each comprising a distal tip. The distal tip of the irrigation sleeve may comprise one or more irrigation ports, which is coupled with an irrigation source via an irrigation line, and an aspiration port at the distal tip of the needle, which is coupled with an aspiration pump via an aspiration line. Fluid from the irrigation source, which is typically an elevated bottle of balanced salt solution, is irrigated into the eye via the irrigation line and the one or more irrigation ports, and the irrigation fluid and emulsified cataractic lens material are aspirated from the eye by the aspiration pump via the aspiration port at the distal tip of the needle and the aspiration line.
Before the operation begins, the irrigation sleeve is added to the distal end of the handpiece, covering at least a portion of a needle of the phacoemulsification handpiece (thus, exposing the distal tip of the needle). A distal portion of the needle and the sleeve are then inserted through an incision in the cornea of the eye to reach the cataractic lens.
In current irrigation sleeve designs, the irrigation ports may catch on smaller incisions. As such, it would be desirable to have irrigation ports with reduced potential for snagging on incisions. It would be further desirable to have an irrigation sleeve with increased irrigation outflow to optimize chamber stability of the eye.
Irrigation sleeves which maximize irrigation outflow and have a reduced potential for snagging on incisions are disclosed. More particularly, disclosed irrigation sleeves comprise webbed irrigation ports, crossed irrigation ports, axially stretched irrigation ports, and/or centering dimples. The disclosed irrigation sleeves may further provide optimal irrigation outflow for maintaining chamber stability of the eye.
An irrigation sleeve comprising at least one pair of irrigation ports located on a distal portion of the irrigation sleeve is disclosed. The at least one pair of irrigation ports may be separated by a web of material. A width of the web may be less than 0.012 inches or less than 1.5 times a wall thickness of the irrigation sleeve.
An irrigation sleeve comprising at least two pairs of irrigation ports located on a distal portion of the irrigation sleeve is disclosed. Each pair of irrigation ports may be located opposite each other on the irrigation sleeve.
An irrigation sleeve comprising at least two irrigation ports located on a distal portion of the irrigation sleeve is disclosed. At least one of the at least two irrigation ports may comprise an axial length along a longitudinal axis of the irrigation sleeve and a diametrical width normal to the longitudinal axis. At least one of the at least two irrigation ports may have a ratio of the axial length to the diametrical width of 3:2 or more.
An irrigation sleeve comprising at least two irrigation ports located on a distal portion of the irrigation sleeve is disclosed. The at least two dimples may be located on an inner surface of the irrigation sleeve. Each dimple may be located between adjacent irrigation ports. In some embodiments, the irrigation sleeve may comprise three dimples.
An irrigation sleeve comprising at least three irrigation ports located on a distal portion of the irrigation sleeve is disclosed. At least one irrigation port of the at least three irrigation ports may be non-rotationally symmetric relative to at least one of the other at least three irrigation ports. In some embodiments, at least one irrigation port of the at least three irrigation ports may comprise either a different port shape, port size, or axial position relative to the distal tip.
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
Improved irrigation sleeves for phacoemulsification and irrigation/aspiration (FA) handpieces are disclosed. All of the irrigation sleeves described below may be used with either phacoemulsification or I/A handpieces. Irrigation sleeves in accordance with the present disclosure may be made from any type of material, including, but not limited to, silicone, plastic, and/or rubber, and different sections may be made from different materials. For example, in some embodiments, the irrigations sleeve is made from silicone rubber. The irrigation sleeves may be manufactured using any manufacturing process. For example, silicone irrigation sleeves may be manufactured using silicone gum stock transfer molding and/or silicone liquid injection molding. Further, the irrigation and/or aspiration ports of irrigation sleeves in accordance with the present disclosure may be formed using various methods, including but not limited to punching, skiving, drilling, laser cutting, and/or molding.
In preparation for operation, irrigation sleeve 15 is added to the distal end of the handpiece, covering at least a portion of the needle (thus, exposing the distal tip of the needle), providing an irrigation pathway extending from the irrigation source to the irrigation port 17 via the irrigation line. The needle and a portion of the sleeve are then inserted through an incision in the cornea of the eye to reach the cataractic lens.
Improved irrigation sleeves for phacoemulsification and I/A handpieces are disclosed. Specifically, irrigation sleeves with reduced potential for catching the irrigation port on the incision and with increased irrigation outflow are disclosed. The manufacturing, materials and design of the irrigation sleeves are configured to optimize the amount of outflow while minimizing corneal snagging.
In the embodiment illustrated in
Irrigation sleeves in accordance with the present disclosure comprise irrigation ports which provide sufficient outflow. For example, in the embodiment illustrated in
In the embodiment illustrated in
For example,
Further,
Further, an irrigation sleeve in accordance with the present disclosure may comprise irrigation ports separated by webs that are horizontal, vertical, or diagonal, as discussed above. The embodiment illustrated in
In the embodiment illustrated in
Irrigation ports in accordance with the present disclosure, such as those discussed above, may be created using punches after an irrigation sleeve has been manufactured using a technique such as injection molding. Some embodiments may be manufactured using custom punches. Some embodiments, such as the embodiment illustrated in
Irrigation sleeves in accordance with the present disclosure may comprise more than two irrigation ports, as discussed above. In some embodiments, the irrigation sleeve comprises at least three irrigation ports. In on embodiment where the irrigation sleeve comprises three irrigation ports, the three irrigation ports are separated by 120 degrees. In some embodiments, the at least three irrigation ports are rotationally symmetric. In other embodiments, at least one of the at least three irrigation ports is non-rotationally symmetric to at least one of the other irrigation ports. In other words, at least one of the irrigation ports may be located at a different axial position relative to the other irrigation ports to maximize wall thickness in between two ports. In further embodiments, the at least one irrigation port that is non-rotationally symmetric may comprise a different port shape, port size, and/or axial position relative to the distal tip.
In other embodiments, the irrigation ports may comprise four crossed ports. For example, the embodiment illustrated in
In some embodiments, the crossed irrigation ports may have a reduced size as compared to current two port irrigation sleeves to reduce the potential for catching on corneal tissue while passing through an incision. However, the combined outflow of the four irrigation ports may be the same or greater than current irrigation sleeves with two standard-size ports. As such, irrigation sleeves in accordance with the present disclosure having more than two irrigation ports may provide sufficient outflow for maintaining chamber stability of the eye.
In the embodiment illustrated in
Irrigation sleeves in accordance with the present disclosure may comprise axially stretched ports. The potential for corneal incision snagging may increase as a higher percentage of radial circumference is removed to form side ports. Orienting total side port open area required for sufficient irrigation flow in a mostly axial direction and minimizing side port opening in a radial direction may reduce the potential for corneal incision snagging.
An irrigation sleeve in accordance with the present disclosure may comprise two or more axially elongated ports separated by a web. For example, in the embodiment illustrated in
An irrigation sleeve in accordance with the present disclosure may comprise crossed irrigation ports that are axially stretched. For example, irrigation sleeve 85 of
An irrigation sleeve with axially elongated ports may be of various shapes, as illustrated by
In some embodiments, a larger cross section of an opening is provided toward a proximal end of the irrigation sleeve. For example, in the embodiment illustrated in
In some embodiments, one or more irrigation ports are narrower in any dimension than the distal opening, for example, distal openings 79, 90, and 89 of
In the embodiments illustrated in
In any of the embodiments discussed above, one or more irrigation ports of the irrigation sleeve or a portion of the irrigation port may be of smaller size than a needle tip used in conjunction with the irrigation sleeve to prevent the needle tip from inadvertently going through an irrigation port when irrigation sleeve is added to the distal end of the handpiece.
In some embodiments, the irrigation sleeve may comprise three dimples in various orientations. In some embodiments, each of the three dimples are located between irrigation ports. For example, in some embodiments, two dimples may be located between two irrigation ports on a first side and one dimple may be located between the two irrigation ports on a second side opposite the first side. In some embodiments, the irrigation sleeve may comprise three dimples separated by 120 degrees.
In some embodiments, such as the embodiment illustrated in
In embodiments comprising irrigation ports separated by a web (e.g., embodiments illustrated in
An irrigation sleeve comprising at least one set of irrigation ports located on a distal portion of the irrigation sleeve, the at least set pair of irrigation ports comprising a first port and a second port, wherein the at least one set of irrigation ports are located on a single side of the irrigation sleeve and separated by a web of material.
The irrigation sleeve of example 1, wherein a width of the web is less than 0.012 inches or less than 1.5 times a wall thickness of the irrigation sleeve.
The irrigation sleeve of any one of examples 1-2, further comprising: a second set of irrigation ports located on the distal portion of the irrigation sleeve, wherein the first set of irrigation ports and the second set of irrigation ports are located opposite each other on the irrigation sleeve.
The irrigation sleeve of any one of examples 1-3, wherein the first set of irrigation ports and the second set of irrigation ports have a same size or have different sizes; and wherein the first set of irrigation ports and the second set of irrigation ports have a same shape or a different shape.
The irrigation sleeve of any one of examples 1-4, wherein at least one of the first port and the second port of the at least one set of irrigation ports comprise an axial length along a longitudinal axis of the irrigation sleeve and a diametrical width normal to the longitudinal axis, wherein the at least one of the first port and the second port has a ratio of the axial length to the diametrical width of 3:2 or more.
The irrigation sleeve of any one of examples 1-5, wherein the at least one set of irrigation ports have a shape of one selected from the group consisting of a half-circle shape, a rounded rectangular shape, a circular shape, a tear drop shape, and an oval shape.
The irrigation sleeve of any one of examples 1-6, wherein the at least one set of ports have a rounded rectangular shape, wherein a distal end of the at least one set of ports is narrower than a proximal end of the at least one set of ports along a longitudinal axis of the sleeve.
The irrigation sleeve of any one of examples 1-7, wherein the at least one set of irrigation ports further comprise a third port, wherein the third port is separated by a second web between the first port and the third port, and wherein the third port is separated by a third web between the second port and the third port.
The irrigation sleeve of any one of examples 1-8, wherein the first web is parallel with the longitudinal axis of the sleeve and the second web and third web are diagonal with respect to the longitudinal axis.
The irrigation sleeve of any one of examples 1-9, wherein the first web is parallel with the longitudinal axis of the sleeve.
The irrigation sleeve of any one of examples 1-10, wherein the first web is perpendicular to the longitudinal axis of the sleeve.
The irrigation sleeve of any one of examples 1-11, wherein the first port and the second port are the same size or are of different sizes.
The irrigation sleeve of any one of examples 1-13, wherein the first port and the second port have a same shape or have different shapes.
An irrigation sleeve, comprising: a first set of irrigation ports comprising a first port and a second port and a second set of irrigation ports comprising a third port and a fourth port, wherein the first and second set of irrigation ports are located on a distal portion of the irrigation sleeve, wherein the first port and second port are located on opposite sides of the irrigation sleeve and the third port and fourth port are located on opposite sides of the irrigation sleeve offset from the first set of irrigation portions, and wherein the first and second ports and the third and fourth ports are separated circumferentially from each other by a web of material.
The irrigation sleeve of example 14, wherein a width of the web is less than 0.012 inches or less than 1.5 times a wall thickness of the irrigation sleeve.
The irrigation sleeve of any one of examples 14-15, wherein the first set of irrigation ports and the second set of irrigation ports have a same size or have different sizes; and wherein the first set of irrigation ports and the second set of irrigation ports have a same shape or a different shape.
The irrigation sleeve of any one of examples 14-16, wherein at least one of the first port, the second port, the third port, and the fourth port comprise an axial length along a longitudinal axis of the irrigation sleeve and a diametrical width normal to the longitudinal axis, wherein the at least one of the first port and the second port has a ratio of the axial length to the diametrical width of 3:2 or more.
The irrigation sleeve of any one of examples 14-17, wherein at least one of the first set of irrigation ports and the second set of irrigation ports have a shape of one selected from the group consisting of: a half-circle shape, a rounded rectangular shape, a circular shape, a tear drop shape, and an oval shape.
The irrigation sleeve of any one of examples 14-18, wherein at least one of the first set of irrigation ports and the second set of irrigation ports have a rounded rectangular shape, wherein a distal end of the at least one of the first set of irrigation ports and the second set of irrigation ports are narrower than a proximal end of the at least one of the first set of irrigation ports and the second set of irrigation ports along a longitudinal axis of the sleeve.
The irrigation sleeve of any one of examples 14-19, wherein the web is parallel with the longitudinal axis of the sleeve.
The irrigation sleeve of any one of examples 14-20, wherein the first set of irrigation ports and the second set of irrigation ports have a same size or have different sizes; and wherein the first set of irrigation ports and the second set of irrigation ports have a same shape or a different shape.
An irrigation sleeve comprising: at least two irrigation ports located on a distal portion of the irrigation sleeve; and at least two dimples located on an inner surface of the irrigation sleeve, each dimple being located between adjacent irrigation ports.
The irrigation sleeve of example 22, wherein the at least two dimples comprise a first dimple, a second dimple, and a third dimple.
The irrigation sleeve of any one of examples 22-23, wherein the first dimple, the second dimple, and the third dimple are located between the at least two irrigation ports.
The irrigation sleeve of any one of examples 22-23, wherein the first dimple and the second dimple are located on a first portion between the at least two irrigation ports and the third dimple is located on a second portion between the at least two irrigation ports that is opposite the first portion.
The irrigation sleeve of any one of examples 22-25, wherein the first dimple, the second dimple, and the third dimple are separated by 120 degrees.
The irrigation sleeve of any one of examples 22-27, wherein a distal end of the sleeve comprises a bend, wherein the bend is located proximal to the at least two irrigation ports.
An irrigation sleeve comprising: at least three irrigation ports located on a distal portion of the irrigation sleeve; wherein at least one irrigation port of the at least three irrigation ports is non-rotationally symmetric relative to at least one of the other at least three irrigation ports.
The irrigation sleeve of example 28, wherein at least one irrigation port of the at least three irrigation ports comprises either a different port shape, port size, or axial position relative to the distal tip.
It should be understood that many variations are possible based on the disclosure herein. Although features and elements are described above in particular combinations, each feature or element can be used alone without the other features and elements or in various combinations with or without other features and elements.
This application claims priority to U.S. Provisional Application No. 63/365,080, filed on May 20, 2022, which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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63365080 | May 2022 | US |