Cataract removal device and integrated tip
10052227 ยท 2018-08-21
Assignee
Inventors
Cpc classification
A61F9/00736
HUMAN NECESSITIES
A61M1/774
HUMAN NECESSITIES
A61B5/0036
HUMAN NECESSITIES
A61B5/0084
HUMAN NECESSITIES
A61M1/00
HUMAN NECESSITIES
A61B90/30
HUMAN NECESSITIES
International classification
A61F9/00
HUMAN NECESSITIES
A61B1/00
HUMAN NECESSITIES
A61B5/00
HUMAN NECESSITIES
A61B90/00
HUMAN NECESSITIES
A61B90/30
HUMAN NECESSITIES
Abstract
The present invention is directed to an apparatus and method for assisted removal of the cortex, capsule polishing and destruction and/or removal of other intraocular structures. More particularly, the present invention is directed to a surgical apparatus configurable for removal of the cortex and the polishing of the capsule during cataract extraction surgery.
Claims
1. An ophthalmic surgical instrument for use at a surgical site, comprising: an endpiece configured to be operable with a handpiece having at least one axis, said endpiece configured to oscillate about the at least one axis; wherein the endpiece is configured with an inner channel there through, at least one polishing surface, a portion of the at least one polishing surface, where a portion of the polishing surface is in communication with the inner channel and configured with a plurality of recessed channels, at least a portion of the polishing surface is equipped with an abrading element extending from at least a portion of the polishing surface in a first direction, and at least one aspirating surface, where a portion of the aspirating surface is in communication with the inner channel and equipped with recessed channels; wherein a portion of the aspirating surface is configured to emulsify intraocular structures and at least a portion of the aspirating surface is configured to extend in a direction orthogonal to the first direction; and an inlet defined by the portion of the polishing surface and aspirating surface in communication with the inner channel and wherein said polishing surface is configured to polish the lens capsule of the eye.
2. The ophthalmic instrument of claim 1, wherein the emulsification surface and polishing surface have rounded faces.
3. The ophthalmic instrument of claim 1, wherein said endpiece is configured to oscillate so as to induce cavitation within a fluid present in the surgical site.
4. The ophthalmic instrument of claim 1, wherein said apparatus has the ability to selectively extract material from the eye.
5. The ophthalmic instrument of claim 1, wherein the endpiece having at least one of said polishing surface and emulsification surface is configured to selectively oscillate along three axis.
6. The ophthalmic instrument of claim 5, wherein at least one of said polishing surfaces and emulsification surfaces has the ability to rotate around a central axis of the endpiece.
7. The ophthalmic instrument of claim 6, wherein at least a portion of the endpiece is configured to oscillate at a variable frequency setting.
8. The ophthalmic instrument of claim 7, wherein the endpiece is selectively removable from the handpiece.
9. The ophthalmic apparatus of claim 1 further including; a selectable power source for generating the oscillation of the endpiece.
10. The ophthalmic instrument of claim 9 wherein the endpiece is equipped with a plurality of emulsification and polishing surfaces, each surface configured to be selectably oscillated independently of any other surface.
11. The ophthalmic instrument of claim 1, wherein the abrading element is a compressible, porous material having suitable durability to abrade the interior of a capsular bag.
12. The ophthalmic instrument of claim 9, further comprising a sheath surrounding the endpiece, the sheath being equipped with at least one outlet to introduce material to, or remove material from the eye.
13. The ophthalmic instrument of claim 12, wherein the endpiece is formed of a solid resilient material.
14. The ophthalmic instrument of claim 9, wherein the endpiece further includes a fiber-optic imaging instrument configured to transmit images from the surgical site to the operator of the surgical instrument.
15. The ophthalmic instrument of claim 11, wherein the volume of the porous material is dependent on ambient temperature.
16. The ophthalmic instrument of claim 9, wherein the endpiece is configured to articulate in three directions about a longitudinal axis of the handpiece.
17. The ophthalmic surgical instrument of claim 1, wherein a diameter of the inlet of the endpiece is variable.
18. The ophthalmic surgical instrument of claim 1, wherein the endpiece is formed of a flexible material.
19. The ophthalmic surgical instrument of claim 14 wherein the fiber-optic imaging instrument includes a fiber optic cable equipped to transmit images to a monitor.
20. An ophthalmic surgical instrument for use at a surgical site, comprising: an endpiece configured with an inner channel there through, at least one polishing surface, a portion of the at least one polishing surface, where a portion of the polishing surface is in communication with the inner channel and configured with a plurality of recessed channels, at least a portion of the polishing surface is equipped with an abrading element extending from at least a portion of the polishing surface in a first direction, and at least one aspirating surface, where a portion of the aspirating surface is in communication with the inner channel and equipped with recessed channels; wherein a portion of the aspirating surface is configured to emulsify intraocular structures and at least a portion of the aspirating surface is configured to extend in a direction orthogonal to the first direction; and an inlet defined by the portion of the polishing surface and aspirating surface in communication with the inner channel and a fiber optic imaging instrument integral to the endpiece.
21. The ophthalmic instrument of claim 20 wherein, the endpiece is configured to illuminate the surgical site.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The foregoing and other features of the present invention will be more readily apparent from the following detailed description and drawings of an exemplary arrangement of the elements of the instrument described in which:
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DETAILED DESCRIPTION OF THE INVENTION
(21) The present invention is directed to the assisted removal of the cortex, capsule polishing and destruction/removal of other intraocular structures. By way of overview and introduction, the instrument and method disclosed herein provides for a configuration selectable instrument which allows one of ordinary skill in the art to remove the cortex and polish the lens capsule using an instrument configured to oscillate. For example, the described instrument employs the use of an ultrasonic energy transducer to oscillate the instrument. Specifically, the instrument and method of the present invention are configured to use an oscillator to vibrate an endpiece portion of the instrument to ensure the disruption of the cortex during a cataract removal procedure, as well as the dislodging of epithelial cells from the lens capsule. Furthermore, the present invention is directed to the use of an oscillating abrasion tip, surface or feature which is integral to the endpiece of the described invention. In one configuration, this polishing surface is configured in order to achieve the purposes of polishing the capsule during a cataract removal procedure.
(22) The present invention described provides for an instrument which reduces the possibility of damaging the delicate structures of the ocular cavity, by preventing compete occlusion of an inlet by intraocular tissues. Furthermore, the instrument described reduces the need to repeatedly insert and remove various instruments and devices into the eye during a surgical procedure. As such, through the use of the described instrument and method, the incidence of post-surgical infection is significantly reduced.
(23) While the instrument herein described is envisioned in one operative mode to engage in oscillation at ultrasonic frequencies, the present invention may also operate at frequency ranges lower than ultrasonic or higher than ultrasonic. For example, the present invention may operate at a frequency range from below 10 HZ to above 40 KHz.
(24) In the illustrated embodiments, the instrument depicted is equipped with elements that enable the instrument to accomplish both a cortex degrading function, as well as a capsule polishing function, with an optionally removable endpiece. In one configuration, the endpiece is used for degrade the cortex and/or nucleus and capsule polishing or any combination thereof. In this arrangement, the endpiece is of solid body construction and does not incorporate an inlet or aspiration port.
(25) Those skilled in the art will quickly appreciate that the endpiece which incorporates, the functions of both the cortex removal or the combined cortex removal and capsule polishing are separable and can be undertaken as discrete independent instruments. Those skilled in the art will recognize that the endpiece can be configured as an arrangement of elements, each element designed to perform or undertake a specific function. For example, the endpiece of the described instrument is configurable with removable surfaces, tips, or structures to assist in performing the desired functions. The invention as provided is in no way limited to the description as provided in the figures and the subject matter thereof is applicable to any obvious modification and arrangements of those described.
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(27) As illustrated in
(28) As further illustrated in
(29) In one arrangement of elements, the aspiration surface 112 is used to polish the capsule by operating on a low oscillation setting. In this configuration the instrument provides for oscillations at the low end of the frequency and amplitude range. The instrument described is arranged such that the cortex, as well as the remaining epithelial cells on the capsule surfaces, is removed by suction.
(30) In a further arrangement of elements, both the aspiration surface 112 and the polishing surface 104 are equipped with rounded faces such that no angled surfaces are presented near the suction inlet 114. The tips 112, 104 are configured so as to avoid pointed or jagged edges that could penetrate the posterior capsule causing the capsule to fail and resulting in complications with the procedure.
(31) As depicted in the illustrated arrangement, the inlet 114 is set back from the distal surface of the endpiece 100, which in this case is the distal end of primary polishing surface 114 and the polishing surface 112, such that the capsule tissue is prevented from being sucked directly into the inlet 114 during aspiration or polishing. Likewise, the inlet is equipped with secondary ports, ridges, divots, ports or small communications or openings into the channel 106, or other structures designed to prevent complete occlusion of the inlet by membranous tissues. In a further arrangement of elements, the inlet is configured with mechanisms designed to allow the shape and size of the inlet to be configured by a user. For example, the inlet is equipped with a plurality of baffles actuated by a motor or other mechanism which can alter the diameter of the inlet. In another configuration, a series of elements are provided to selectively alter shape of the inlet by covering portions of the inlet.
(32) This is in contrast to existing ultrasonically powered instruments, which are configured to use ultrasound to cut intraocular structures as opposed to the present invention which is configured to emulsify intraocular structures.
(33) In the present description of the invention, the term emulsify can be used to describe any agitation, disruption, destruction, liquefaction, disintegration, or other destruction of an intraocular structure Through the use of the rounded, recessed inlet 114, the present instrument is configured to avoid puncturing or otherwise lacerating the intraocular structures of the eye.
(34) In one particular arrangement, the position of the inlet 114 is such that the vacuum pressure exerted by the pump is negligible in the area immediately outside inlet 114. In this arrangement, the suction is such that only ambient particles of cortex or epithelial cells in close proximity to the inlet are drawn into the channel 106. Through this configuration, intraocular structures are not significantly deformed if the instrument comes into close proximity. Additionally, by providing minimal suction beyond the surface of the instrument the delicate cells located within the interior of the ocular cavity are not disturbed by large pressure gradients.
(35) In an alternative arrangement, the aspiration surface 112, inlet 114 and channel 106 are each configured with groves, voids, divots, ports or small communications or openings into the channel 106, or other arrangements that prevent complete occlusion by the capsule of the of the inlet. As a result of the vibratory energy, complete occlusion is not necessary to extract the material from the capsule. Thus a safer design of the tip is achieved.
(36) As further illustrated in
(37) As shown, each surface 104, 112 is supported by a shaft 108, 110 respectively, designed to transmit oscillating vibrations from an oscillator (not shown) located in a base station or the hand-tool itself. In one arrangement the oscillator is an ultrasonic transducer. In another arrangement, the oscillator is a motor. In one arrangement, the motor is electrically powered. In a further arrangement, the motor is operable by compressed fluid such as air or hydraulic fluid. In a particular arrangement of the present invention, the shafts 108, 110 are vibrated such that the corresponding tips 104, 112 are caused to oscillate within as many as 3-axial directions as well as rotate about said axis. In this arrangement, oscillations of the endpiece induce cavitations within the ocular cavity such that the cortex particles are degraded into smaller portions. Alternatively, the cavitations are used to dislodge cells lining the lens capsule.
(38) In the illustrated embodiment the endpiece of the instrument 100 is positioned and secured as an attachment or adaptor to a conventional handpiece A (such as a phacoemulsion tool) such that the endpiece is able to rotate freely about a central axis as well as being configured to be able to laterally slide within a given range along the same axis. In the described configuration, the induced vibrations are sufficient to cause a complete oscillation of the endpiece, or a portion of the endpiece about the 3 axis. Those skilled in the art will appreciate that the vibrations and oscillation rates are configurable for a given situation. As such, it is envisioned that a user will have access to a control mechanism that provides specific oscillation frequencies, period and intensities.
(39) The ultrasonic handpiece from a conventional phacoemulsification technique is configurable to generate the necessary vibrations in the depicted endpiece 100 so as to accomplish the goals provided. In this configuration, the instrument of the present invention is coupled to the handpiece through a screw-thread arrangement, magnetic attraction, pressure valve, spring clasp or any similar mechanism for securing the instrument to the handpiece. In a further arrangement, the conventional phacoemulsification needle is removable, and the instrument of the present invention is inserted in its place. In an arrangement wherein the instrument of the present invention replaces the phacoemulsification tip it, is desirable to match the mass of the instrument to the specific ultrasonic instrument used in the phacoemulsion. In this way, the ultrasonic apparatus does not need to be tuned or otherwise calibrated for the specific instrument.
(40) As seen in
(41) As further seen in
(42) In a further configuration, it is envisioned that the aspiration function of the instrument is selectable such that no material is extracted through the inlet 114. In an alternative arrangement, when engaged in abrading or dislodging un-needed tissue that needs to be removed from the eye, the channel 106 is used to direct fluid into the optical cavity. In a further configuration arrangement, the inflow of fluid is directed from the irrigating sleeve 116, or from a second instrument introduced into the eye through another incision during a procedure employing a bimanual technique. Alternatively, the fluid is withdrawn through the sleeve 116.
(43) In a still further alternative arrangement, the polishing surface 104 is fitted with a covering or enclosure designed to fit over the surface 112 or the inlet 114. In this configuration the covering (not shown) is equipped with a sponge or visco-elastic material deigned to gently remove material from the capsule surfaces. In an alternative configuration, the sponge surface is directly incorporated into the hand-piece previously described.
(44) In still a further configuration, the handpiece is configured so as to transmit and receive information through tactile means. For example, the handpiece so described is configured with a pressure sensor so as to increase or decrease the amount of vibratory energy and/or negative pressure transmitted to the tip based on the pressure exerted by the user on the grip. Likewise, the presence of materials within the eye is transmitted to the handpiece as a series of actuated nubs or nodules. For instance, the capsule in direct proximity to the tip is represented by an increased height of an actuated nub or ridge co-presence of the extensive with the handpiece. In one configuration, the handpiece is wirelessly connected to a control station using commonly understood wireless protocols.
(45) As described in the foregoing, the present invention is directed to an instrument and method for polishing lens capsule, cortex emulsification and emulsification of other tissues in need of removal from the eye, with or without irrigation and aspiration, and with or without mechanical agitation either by an operator or an agitation instrument.
(46) As seen in
(47) Upon activation, the movement of the aspiration surface 112 is used to agitate the cortex so as to break its structure down to render removal easier. In the given operation, the ultrasonically powered instrument first agitates the cortex to disrupt it, allowing for safer removal. Alternatively, the invention is configurable such that the aspiration surface 112 directs cortex material into the inlet 114, and then mechanically degrades, at ultrasonic speeds or otherwise degrades it prior to transporting the material through the channel 106 to the pump.
(48) In a further configuration, the present invention is directed to an embodiment that provides irrigation functions through a sleeve 116, and aspiration functions are provided through the center of the tip, e.g., inlet 114 as shown in
(49) As seen in
(50) As seen in
(51) With the configuration of
(52) As seen in
(53) In a further configuration, the endpiece is equipped with a volume variable material. This volumetric expansion or contraction can be due, in one embodiment, to changes in the temperature found at the surgical site. In another arrangement, the volumetric change is due to external force or pressure being applied or removed from the material. In a further arrangement external force or pressure can be exerted to reduce the volume of the material for easy extraction from the eye.
(54) In one arrangement, the instrument of the present invention is equipped with a sponge or a special design that it would allow it to expand. In this configuration, the reduced volume would allow for easier introduction into the eye. Once inserted, the expansion would make polishing and removal easier.
(55) In another configuration as shown in
(56) Furthermore, because the pupil is always smaller than the diameter of the lens, (in the case of cataract extraction, which involves the removal of the entire contents of the lens capsule: part of the anterior capsule, nucleus, cortex and capsule polishing), the surgeon cannot visualize the area under the iris, and is thus not able to see if the entire nucleus and cortex have been removed and the capsule is free of epithelial cells.
(57) After the cataract has been removed, an intraocular lens implant, known as an IOL or just lens implant, is placed in the capsular bag. Again, since the haptic, (haptic instrument elements are parts of the lens implant that extend into the capsular bag and into the area where the anterior and posterior capsule meet) extend under the iris, it is not possible to examine the exact placement and location of the IOL. Unable to perfectly and completely visualize the IOL, the surgeon may be lulled into believing that that IOL is in the proper position when in reality it may not be.
(58) During surgery in the posterior pole of the eye, that is surgery below or further and deeper into the eye, past the lens, the surgeon has to be able to see through the cornea and the lens (if it has not been previously removed) or the posterior capsule (if the patient had cataract surgery prior). If the cornea and lens are clear at the start of the operation, they often become cloudy during the operation, presenting serious challenges to the surgeon. Other structures that may also interfere with the surgeon ability to see are coagulated or fresh blood and vitreous strands and membranes.
(59) All of the above detail why having an alternative way of visualizing the contents of the eye during eye surgery is vital for a successful operation.
(60) Therefore an instrument and method of visualization inside the eye, inside the capsular bag before and after the IOL has been placed inside the eye, visualization of the posterior pole through blood, vitreous strands and membranes, near the periphery of the retina would be of great value in making eye surgery safer, more successful, faster, and with fewer complications. Such visualization can be achieved through the use of a fiber-optic pipe to allow for illumination, visualization or oscillation, or a combination of all three functions.
(61) As shown in
(62) Furthermore, the fiber optic attachment is also equipped with a stand-off section or ring that prevents the fiber optic portion of the instrument from coming into direct contact with intraocular structures. In a further embodiment, the fiber-optic portion of the endpiece is fully integrated into the capsule polishing or cortex emulsification instrument as described previously. In a further configuration the stand-off ring can be used to degrade the cortex material or polish the capsule
(63) This imaging instrument can be either a fiber optic cable or an instrument configured to transmit images via a fiber optic conduit. In one configuration the image information and data is transmitted to a video display monitor. In another configuration, the data is converted and transmitted wirelessly from a transmitter integral in the handpiece to a properly equipped display instrument. In a further arrangement, control data is transmitted to control the power of the oscillations via the fiber optic conduit.
(64) The fiber-optic attachment can be used directly to emulsify the cortex or intraocular structures either through direct or mechanical emulsification. The fiber-optic instrument can be used to allow the user to view the posterior pole of the eye, and be used to breakdown blood, membranes and other tissues. The fiber optic instrument is configurable such that the images provided to the operator are electronically synchronized with the oscillations of the instrument. In this configuration, the operator is able to simultaneously observe intraocular structures and preform cutting or emulsification/destruction actions on intraocular structures. Furthermore, the fiber-optic attachment is configurable to provide a variable light intensity illumination to the surgical site without the need to provide visual information to the user.
(65) As shown in
(66) As shown in
(67) As shown in
(68) As shown in
(69) The described solid or hollow endpiece is equipped with any number of angles or bends such that a portion of the endpiece is able to access every portion of the capsular bag (for example, through 360 degrees of rotation).
(70) As further provided, the endpiece is configured to either be used in a power assisted or unassisted activation state. For example, the present invention can simply be engaged by manually dislodging material from the capsular bag. In the alternative, the described endpiece can be coupled to existing, or subsequently designed mechanical or ultrasonic instruments that allow the endpiece to be oscillated along the length of the probe and/or in along three additional axes.
(71) The porous material, while herein defined as a sponge material, can be formed from any material that is soft, pliable, porous and easily compressible. In one arrangement of elements, the probe is a hollow tube that allows fluid to be directed through the probe and out through the porous material through the use of a pump. Alternatively, the present instrument is equipped such that material may be withdrawn from the capsular bag through the porous material and directed out through the hollow probe through the use of a similar pumping instrument.
(72) In yet a further embodiment, the probe is a configured to be a solid shaft, but is equipped with an aspiration sleeve or cooling jacket, configured to direct or withdraw fluid into the capsular bag.
(73) Additionally, the invention so described can be applied in conjunction with or as a modification of, fiber-optic imaging instruments. It is important to note that during cataract surgery, the surgeon looks inside the eye through an operating microscope. The field of surgery is illuminated by light that is paracentral to the visual axis of the surgeon. The cornea often acts as a mirror causing glare and difficulty seeing inside the eye. Other structures such as drapes, conjunctivae, sclera can also cause reflective glare. Past studies and reports have demonstrated that prolonged exposure of the eye to the powerful microscope light can cause permanent damage to the macula, a vital structure for clear vision.
(74) Thus, in order to see inside the eye the surgeon has to have, first of all, a clear view through the cornea. However, because of age and disease, the cornea is or becomes cloudy during the operation and thus a major challenge to successful, safe surgery because the intraocular structures become difficult to see.
(75) As further shown in
(76) It should be understood that the fiber-optic instrument so described is configurable to perform illumination, visualization and emulsification or cutting functions, or some combination thereof.
(77) In any of the foregoing embodiments, it is envisioned that aspiration sleeves or irrigation mechanism can be integrated into the design so as to allow the described probe and tip to accomplish those same functions.
(78) It should be understood that various combinations, alternatives and modifications of the present invention could be devised by those skilled in the art. The present invention is intended to embrace all such alternatives, modifications and variances that fall within the scope of the appended claims.
(79) While the invention has been particularly shown and described with reference to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention.