An intraocular lens inserter for use during cataract surgery for delivering an intraocular lens (IOL) loaded into an IOL cartridge into a patient's eye. The inserter comprises an outer shell housing containing a hydraulic housing. A hydraulic piston positioned within the hydraulic housing defines an annular hydraulic chamber. The hydraulic chamber is filled with a fluid via a fill port. A high pressure compression spring constantly urges the piston forwardly to pressurize the fluid in the hydraulic chamber. During use, a valve element operatively connected to a depressible operation button, controls bleeding of fluid from the hydraulic chamber, whereupon the forward tip of the piston is moved forwardly to mechanically deliver the intraocular lens from the IOL cartridge into the patient's eye.

BACKGROUND OF THE INVENTION

Field of the Invention

This invention relates to intraocular lens inserters for inserting an intraocular lens (IOL) through a small clear corneal incision of an eye into the capsular opening (capsulorhexis) and to its final position within the capsular bag.

Description of the Background Art

Representative prior art IOL inserters include Published United States Patent Application 2014/0276901 and European Patent EP 0 937 443 B1, the disclosures of both of which are hereby incorporated by reference herein.

It is an object of this invention to provide an improvement which provides an improvement which is a significant contribution to the advancement of the IOL inserter art.

Another object of this invention is to provide a one-handed, spring-powered IOL inserter that operates hydraulically by a finger-operated operation valve to smoothly deliver the IOL continuously at a constant speed into the patient's eye while minimizing irregular movement that might otherwise result in the IOL being inserted too erratically into the eye or overshooting the IOL into the eye.

Another object to this invention is to provide an IOL inserter that is adaptable to use commercially available IOL folding and delivery chambers manufactured by IOL manufacturers.

Another object of this invention is to provide a spring-powered, hydraulically-operated IOL inserter that dispenses an initial amount of ophthalmic viscoelastic fluid into the IOL folding and delivery chamber to wet the chamber and smoothly fold of the IOL into position for delivery.

Another object of this invention is to provide a spring-powered, hydraulically-operated IOL inserter composed of biocompatible materials that is sufficiently economical to manufacture to be capable of being a single-use (i.e., disposable) IOL inserter.

The foregoing has outlined some of the pertinent objects of the invention. These objects should be construed to be merely illustrative of some of the more prominent features and applications of the intended invention. Many other beneficial results can be attained by applying the disclosed invention in a different manner or modifying the invention within the scope of the disclosure. Accordingly, other objects and a fuller understanding of the invention may be had by referring to the summary of the invention and the detailed description of the preferred embodiment in addition to the scope of the invention defined by the claims taken in conjunction with the accompanying drawings.

SUMMARY OF THE INVENTION

For the purpose of summarizing this invention, this invention comprises a spring-loaded piston that pushes an ophthalmic viscoelastic (OVD) fluid to achieve both restrained, constant IOL speed and lubrication, a single OVD filling port using about 0.5 ml OVD (per industry standard), and a third-party pre-loaded IOL delivery system having a lens folding and delivery chamber. In a first embodiment, the lens folding and delivery cartridge comprises the AcrySert C preloaded injector manufactured by Alcon, Inc. to insert Alcon's AcryS IQ IOL. In second and third embodiments, the lens folding and delivery cartridge comprises the Unfolder Platinum Series Cartridge manufactured by Abbott Medical Optics Inc. to insert Abbott's Tecnis 1-Piece Aspheric IOL. However, it shall be appreciated that other third-party delivery systems (e.g., Hoya Surgical Optics' iSert® 231/251 Preloaded IOL systems) may be alternatively employed without departing from the spirit and scope of this invention.

As shown inFIG. 1, the first embodiment of the IOL inserter of the invention comprises, a generally elongated outer shell including a spring chamber, an OVD filling port, a piston window, an operation button, a safety pin, and the AcrySert delivery system having a lens window and a tip for inserting into a 2.2 mm incision.

The interior of the IOL inserter of the first embodiment of the invention is shown inFIG. 2and comprises a spring, piston, hydraulic mechanism housing, operation button and AcrySert delivery system.

As shown inFIG. 3, the piston includes O-rings at both ends to prevent fluid leakage. In one embodiment of the invention, the properties of the spring may include those reflected inFIG. 3.

As shown inFIG. 4, the hydraulic mechanism comprises an OVD filling port check valve, allowing filling of an OVD chamber with OVD from a syringe filled with OVD, which flows from the OVD chamber through an opening into the valve cavity (see Section A).

As shown inFIG. 5, after filling of the OVD chamber via the syringe, OVD fluid flows through a conduit into the AcrySert lens chamber to fill the same.

The injector operation is summarized as follows. As shown inFIG. 6, in Step1the OVD chamber is filled with OVD via the OVD filling port check valve. During this step, the safety pin holds the valve open allowing the OVD fluid to flow via the conduit into the AcrySert delivery system. The syringe containing the supply of OVD fluid delivers sufficient fluid to fill the OVD chamber and the AcrySert delivery system via the conduit up to the indicated fill line in the tip of the system. The safety pin also locks the piston.

Referring toFIG. 7, Step2of the injector operation includes removing the safety pin whereupon the valve is released and moves upward by means of its spring to its closed position to close the conduit. Removal of the safety pin also releases the piston.

In Step3shown inFIG. 8, by depressing the operation button to partially open the valve, the IOL is advanced while folding it by means of the piston to its folded position. It is noted that the button includes stoppers to prevent the valve from moving all the way down. Continued depressing of the operation button then delivers the folded IOL into the eye.

The second embodiment of the IOL Inserter of the invention shown inFIG. 9comprises a design similar to the first embodiment. However, the second embodiment of the IOL Inserter is adapted to be used in conjunction with the IOL folding and delivery Cartridge known as the “Unfolder Platinum Series Cartridge” manufactured by Abbott Medical Optics Inc. to insert Abbott's Tecnis 1-Piece Aspheric IOL. The second embodiment further improves upon the first embodiment to operate in following manner.

First, as shown inFIG. 9, the surgical assistant loads the IOL into the IOL Cartridge wetted with OVD fluid. The surgical assistant fills the Hydraulic Housing via a Fill Port with OVD fluid. The IOL Cartridge is then inserted into the proximal end of a Slider of the IOL inserter. As shown inFIG. 10, the Slider is pushed inwardly into the proximal end of the Outer Shell Housing of the IOL Inserter and held into position by a catch. The inward movement of the Slider closes the Operation Switch.

The surgical assistant then snaps-off the Safety Clasp as shown inFIG. 11, which allows the Release Pin to move slightly forward in a slot in the Outer Shell Housing. The Release Pin is coupled to a spring-loaded Piston Housing (not shown) which moves forwardly to correspondingly move the Piston slightly forward. This slightly forward movement of the Piston forces the IOL into a folded condition in the IOL Cartridge, ready to be inserted into the patient's eye.

As shown inFIG. 12, the surgical assistant then moves the Release Pin off to the side, which internally functions to release the Piston to be subjected to the full force of a high-pressure spring entrained within the Piston Housing against the head of the Piston. The IOL inserter is now in its cocked position.

During the surgical procedure, as the surgeon pushes the Operation Button downwardly using finger pressure, its valve is opened allowing OVD fluid to bleed out of the Hydraulic Housing and thereby allowing the Piston under the force of the spring, to move progressively forwardly and deliver the IOL from the IOL Cartridge into the patient's eye (seeFIG. 13).

The third embodiment is illustrated inFIGS. 29-37. As shown inFIGS. 29-31, in the third embodiment, the IOL inserter includes an OVD fill port that is Luer compatible. A spring-loaded charging plunger is operatively positioned in the rear of the outer shell housing. A hydraulic tube (hypo tube) that encircles a portion of the piston fitted with O-rings to defines a hydraulic chamber. The chamber is fluidly connected to a hydraulic housing containing a valve.

As shown inFIGS. 31-32, the hydraulic chamber is fluidly connected to the fill port so that when an OVD-filled syringe is fitted to the Luer fitting of the fill port and OVD is injected therein, the hydraulic chamber is filled with OVD fluid. Also, excess OVD fluid is allowed to flow through a molded-in OVD conduit through a valve of a spring-loaded operation button being held open by a button latching rod. OVD fluid flowing through the open valve and OVD conduit fills the IOL cartridge, such as an AMO Tecnis iTec Preloaded Delivery and System Folder and Delivery Chamber.

As shown inFIG. 32, during use, Step1comprises filling the hydraulic chamber with OVD fluid until OVD can be seen in front of the IOL to wet the IOL. During Step1, the valve is held open by means of the button latching rod (seeFIG. 33) so that OVD may flow into the IOL cartridge to fill the same to the desired level.

As shown inFIG. 34, Step2comprises pushing the charging plunger fully into the rear of the outer shell housing and locking it in place with an audible “click.” At the same time, the button latching rod likewise moves forward to release the button from being held in its open position. Upon being released, the button and hence the valve moves upwardly to a closed position, thereby activating the hydraulic valving system. As the charging plunger is pushed fully into the outer shell housing, the piston is advanced into in the IOL cartridge to push the IOL into the manufacturer's recommended 30 second to 10 minute location. It is noted that in this position, the spring of the charging piston is now constantly urging the piston forwardly; however, the piston remains stationary due to the OVD being captured within the hydraulic chamber. The piston may move forward under the force of the spring only when the captured OVD in the hydraulic chamber is bled therefrom by depressing the operation button to re-open the valve.

As shown inFIG. 35, Step3involves the surgeon's finger depressing the operation button to re-open the valve whereupon the IOL is moved forwardly into the manufacturer's recommend 1 minute maximum lens folding position in the IOL cartridge. As shown inFIG. 36, continued depressing of the operation button then further advances the piston until the IOL is deployed into the patient's eye.

Finally, as shown inFIG. 37, the third embodiment of the IOL inserter is intended to be co-developed with Abbott to be used with Abbott's IOL cartridge for its Tecnis 1-Piece Aspheric IOL (see alsoFIG. 9A). However, without departing from the spirit and scope of this invention, the IOL inserter may be adapted to be used with other IOL cartridges of other IOL manufacturers.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

First Embodiment

A more detailed description the first embodiment of the IOL inserter of the invention summarized above inFIGS. 1-8, is reflected in the mechanical drawings ofFIGS. 14-16, with the modification of redesigning the safety pin as a safety clasp positioned to the rear of the inserter as more particularly described below.

Referring toFIGS. 14-16, the first embodiment of the IOL inserter10of the invention comprises a hydraulic housing12positioned within an outer shell housing14and secured by screws15. The hydraulic housing12is operatively connected to an IOL cartridge16pre-loaded with an IOL18for delivery into a person's eye upon removal of a safety clasp20and depressing of an operation button22.

As better shown inFIG. 15A-A, a hydraulic piston24is positioned within a longitudinal bore26in the hydraulic housing12. The piston24includes a smaller-diameter portion28extending through the longitudinal bore26and a larger-diameter portion30extending into a longitudinal cylinder32formed in the outer shell housing14. Being smaller in diameter than the lumen of the longitudinal bore26, the smaller-diameter portion28defines an annular hydraulic chamber31.

The distal end of the piston24includes a piston head34dimensioned to slide within the longitudinal cylinder32. A high pressure compression spring36is entrained between the piston head34and the rear wall38of the longitudinal cylinder32to constantly urge the piston24forwardly.

The safety clasp20comprises resilient arms40that removably grasp around the rear of the outer shell housing14. The safety clasp20includes an inwardly extending safety pin42that extends through a pin opening44in the outer shell housing14to block the forward movement of the piston head34until removed.

The hydraulic housing12includes a fill port46connected in fluid communication with the hydraulic chamber31. The fill port46includes an elastomeric stopper48capable of being pierced by a hypodermic needle of a syringe filled OVD fluid. The hydraulic chamber31may be filled with OVD fluid by injection from the OVD-filled syringe. Once filled and the hypodermic needle is removed, the stopper48fully closes to prevent any leakage of OVD fluid from the chamber31.

A first O-ring50is positioned about the larger-diameter portion30of the piston24close to the transition to the smaller-diameter portion28. The first O-ring50functions to seal against the lumen of the longitudinal bore26as the piston24moves forwardly, thereby forcing the OVD fluid within the hydraulic chamber31through the operation button22(described hereinafter). It is noted that the front (proximal) end of the longitudinal bore26steps down to a reduced diameter equal to that of the small-diameter portion28of the piston24. A second O-ring52is positioned at the step54to sealingly engage around the smaller-diameter portion28of the piston24to prevent OVD fluid in the hydraulic chamber31from leaking therethrough.

As best shown inFIGS. 15B-Band16H-H, a first bleed channel56extends from the hydraulic chamber31to a vertically extending valve cylinder58. A second bleed channel60extends from the valve cylinder58to the IOL cartridge16. The second bleed channel60is at a higher level than the first bleed channel56.

A valve element62is positioned within the valve cylinder58. Upper and lower O-rings62U and62L are positioned on the valve element60and spaced apart along the length thereof such that when the O-rings62straddle the bleed channels56and60, fluid flow is established between the hydraulic chamber31and the IOL cartridge16(seeFIG. 15B-B). When the valve element62is positioned such that the lower O-ring62L is above the first bleed channel56, fluid flow from the hydraulic chamber31and the IOL cartridge16is blocked.

The operation button22is connected to the valve element62. A spring64is entrained underneath the button22and a notch66in the hydraulic housing12to constantly urge the button upwardly. However, while the IOL cartridge16inserted into the hydraulic housing12but not fully seated, the position of the button22is kept downwardly (i.e. open) by a catch so that the OVD fluid may flow from the hydraulic chamber31into the IOL cartridge16to fill the same. When the IOL cartridge16is fully inserted and seated in the hydraulic housing12, the button22is released and allowed to move upwardly to block (i.e., close) the fluid flow from the first bleed channel56to the second bleed channel60.

The ergonomic design of the IOL inserter10allows for one-handed operation by the surgeon. Depressing of the surgeon's finger on the button22against the resiliency of spring64moves the valve element62downwardly to the point where the O-rings62U and62L straddle the first bleed channel56. OVD fluid is thus bled from the hydraulic chamber31and into the IOL cartridge. As the OVD fluid is bled from the chamber31, the high pressure of the spring36forces the piston24forwardly in a smooth and deliberate speed. As the piston24moves forward, the tip68of the small-diameter portion38extends further into the IOL cartridge16to deliver the IOL18into the patient's eye. At any point during the forward travel of the piston24, the surgeon may release the button22whereupon spring64returns the button22to its upward position and valve element62moves to its closed position (seeFIG. 16H-H).

Second Embodiment

A more detailed description the second embodiment of the IOL inserter12of the invention summarized above inFIGS. 9-13, is reflected in the mechanical drawings ofFIGS. 14-28, with several modifications. It is noted that components in common with the first embodiment are numerically labeled with corresponding numbers prefixed by100sor200s. For example, the IOL inserter10of the first embodiment is labeled with numeral “10” whereas the IOL inserter of the second embodiment is correspondingly labeled with numeral “110.” It is noted that the description of the second embodiment110is largely the same as the first embodiment10and is therefore replicated, except of course where the second embodiment110is structurally different.

Referring toFIGS. 14-19, the first embodiment of the IOL inserter110of the invention comprises a hydraulic housing112positioned within an outer shell housing114and secured by screws115. The hydraulic housing112is operatively connected to an IOL cartridge116pre-loaded with an IOL118for delivery into a person's eye upon removal of a safety clasp120and depressing of an operation button122.

As better shown inFIGS. 18A-A, a hydraulic piston124is positioned within a longitudinal bore126in the hydraulic housing112. The piston124includes a smaller-diameter portion128extending through the longitudinal bore126and a larger-diameter portion130extending into a longitudinal cylinder132formed in a piston housing170positioned in the outer shell housing114. Being smaller in diameter than the lumen of the longitudinal bore126, the smaller-diameter portion128defines an annular hydraulic chamber131.

The distal end of the piston124includes a piston head134dimensioned to slide within the longitudinal cylinder132. A high pressure compression spring136is entrained between the piston head134and the rear wall138of the longitudinal cylinder132to constantly urge the piston124forwardly.

The safety clasp120comprises resilient arms140that removably grasp into corresponding depressions176formed on opposing sides of the rear of the outer shell housing114. A separate inwardly extending safety pin172extends through a pin opening174in the center of the clasp120and through a J-shaped slot180formed in the outer shell housing14and is permanently connected to the piston housing170by threads178. It is noted that only upon removal of the clasp120is the safety pin172allowed to move within the J-shaped slot180. Because the safety pin172is permanently connected to the piston housing170, movement of the piston housing170is defined by the configuration of the J-shaped slot180to first move longitudinally outwardly and then rotationally (compareFIGS. 11 and 12).

The rearward (distal) end of the piston housing170comprises a boss182that extends into rear of the outer shell housing114. A compression spring184is positioned concentrically over the boss182. As shown inFIG. 18J-J, inwardly extending guide fingers186center the boss182and spring184within the rear of the outer shell housing114. Being entrained between the piston housing170and the rear of the outer shell housing114, spring184constantly urges the piston housing170forwardly. When the safety clasp120is removed, the safety pin172is freed and is allowed to move within J-slot180. Spring184therefore moves the piston housing170forwardly a short distance equal to the length of the long leg of the J-slot180. Then, when the safety pin172is rotated over into the short leg of the J-slot180, the piston housing170correspondingly rotates in the same direction by the same rotational degree.

Rotational movement of the piston housing170while moving along the length of the long leg of the J-slot180as described above, is also prevented by means of opposing ears188emanating from the rear of the piston housing170that ride in a rails190(seeFIG. 18L-L).

Referring toFIGS. 20-22, the head134of the piston124comprises opposing parallel arms192extending longitudinally from the opposing sides of the head134. The arms192are dimensioned to longitudinally slide into the long legs194L of corresponding J-slots194formed in opposing sides of the piston housing170. The length of the arms192are dimensioned relative to the short leg194S of the J-slots194to fit therein when the piston housing170is rotated. As shown inFIG. 18K-K, the width of each of the arms192is greater that the depth of the J-slot194such that they protrude beyond the outer periphery of the piston housing170to ride in corresponding rails196extending inwardly from the inside of the outer shell housing14, thereby preventing any rotational movement of the piston24.

It is noted that in its at rest position as shown inFIG. 22, the arms192are engaged into the short legs194S and therefore longitudinal movement of the piston124relative to the piston housing170is prevented. However, as noted above, as the safety pin172is rotated into the short leg of the J-slot180, the piston housing170correspondingly rotates in the same direction by the same rotational degree. Because the piston194is itself prevented from rotation due to rails196, once the piston housing170is rotated as the safety pin172is rotated into the short leg of the J-slot180, the arms192rotate out of the short leg194S into the long leg190L of the J-slot190, thereby allowing the high pressure compression spring136to forcibly urge the piston124forwardly.

Similar to the function of the J-slot180, the head134of the piston124may include opposing radial tabs134T that extend into another J-slot134J in the piston housing170to provide addition support for keeping the spring136compressed until the piston housing170is rotated by the safety pin172.

The hydraulic housing112includes a fill port146connected in fluid communication with the hydraulic chamber131. The fill port146includes an elastomeric stopper148capable of being pierced by a hypodermic needle of a syringe filled OVD fluid. The hydraulic chamber131may be filled with OVD fluid by injection from the OVD-filled syringe. Once filled and the hypodermic needle is removed, the stopper148fully closes to prevent any leakage of OVD fluid from the chamber131.

A first O-ring150is positioned about the larger-diameter portion130of the piston124close to the transition to the smaller-diameter portion28. The first O-ring150functions to seal against the lumen of the longitudinal bore126as the piston124moves forwardly, thereby forcing the OVD fluid within the hydraulic chamber131through the operation button122(described hereinafter). It is noted that the front (proximal) end of the longitudinal bore126steps down to a reduced diameter equal to that of the small-diameter portion128of the piston124. A second O-ring152is positioned at the step154to sealingly engage around the smaller-diameter portion128of the piston124to prevent OVD fluid in the hydraulic chamber131from leaking therethrough.

As best shown inFIGS. 18B-Band19H-H, a first bleed channel156extends from the hydraulic chamber131to a vertically extending valve cylinder158. A second bleed channel160extends from the valve cylinder158to the IOL cartridge116. The second bleed channel160is at a higher level than the first bleed channel156.

A valve element162is positioned within the valve cylinder158. Upper and lower O-rings162U and162L are positioned on the valve element60and spaced apart along the length thereof such that when the O-rings162straddle the bleed channels156and160, fluid flow is established between the hydraulic chamber131and the IOL cartridge116(seeFIG. 18B-B). When the valve element162is positioned such that the lower O-ring162L is above the first bleed channel156, fluid flow from the hydraulic chamber131and the IOL cartridge116is blocked.

As best shown inFIG. 23, the operation button122is connected to the valve element162. A spring164is entrained underneath the button122and a notch166in the hydraulic housing112to constantly urge the button122upwardly.

The second embodiment of the IOL injector110of the invention includes a slider200that interfaces the IOL cartridge116to the inserter110. As shown inFIG. 23, the slider comprises a front receptacle202adapted to receive the desired IOL cartridge116such as the Abbott's Tecnis 1-Piece Aspheric IOL identified above.FIG. 9Arepresents Abbott's instructions for use for its IOL cartridge.

As better shown inFIG. 18M-M, the slider200comprises a pair of rearwardly-extending parallel arms204having outer rails206that engage into corresponding longitudinal slots208formed on the inside sides of the outer shell housing114.

Referring toFIG. 23, the arm204on the opposite side of the valve element62comprises an interrupted inside rail210that fits into a longitudinal slot in the leg212of the button22to catch (i.e., hold) it in its downward, open position (FIG. 16H-H) allowing OVD fluid to flow into the IOL cartridge16.

Once the IOL18is loaded into the IOL cartridge116and the cartridge116snapped into the slider200(FIG. 24), the slider200may be pushed fully inward and held into position by a resilient catch214formed in the bottom of the outer shell housing14(FIG. 25). Once the slider200is snapped into position by catch214, leg212moves over the interrupted part of the rail210and the leg212and hence the button122and valve element162move upwardly to its closed position.

Accordingly, while the IOL cartridge116inserted into the slider200but not fully seated, the position of the button122is kept downwardly (i.e. open) so that the OVD fluid may flow from the hydraulic chamber131into the IOL cartridge116to fill the same (FIG. 24). When the IOL cartridge16is fully inserted and seated in the hydraulic housing112, the button122is allowed to move upwardly to block (i.e., close) the fluid flow from the first bleed channel156to the second bleed channel160(FIG. 25).

The ergonomic design of the IOL inserter10allows for one-handed operation by the surgeon. Depressing of the surgeon's finger on the button22against the resiliency of spring64moves the valve element62downwardly to the point where the O-rings62U and62L straddle the first bleed channel56. OVD fluid is thus bled from the hydraulic chamber31and into the IOL cartridge. As the OVD fluid is bled from the chamber31, the high pressure of the spring36forces the piston24forwardly in a smooth and deliberate speed. As the piston24moves forward, the tip68of the small-diameter portion38extends further into the IOL cartridge16to deliver the IOL18into the patient's eye. At any point during the forward travel of the piston24, the surgeon may release the button22whereupon spring64returns the button22to its upward position and valve element62moves to its closed position (seeFIG. 16H-H).

FIGS. 24-28respectfully correspond toFIGS. 9-13showing the start-to-finish use of the second embodiment of the IOL inserter110.

InFIG. 24, the IOL cartridge116, loaded with an OVD-wetted IOL118, has been snapped into the receptacle202of the slider200and the slider200has been partially inserted into the outer shell housing114. In this position, the valve element162is held open by means of the interrupted rail210. The surgical assistant fills the hydraulic chamber131with OVD via the fill port146with sufficient excess fluid flowing into the IOL cartridge116per the manufacturer's instructions for use.

As shown inFIG. 25, the slider200is pushed fully inward and snapped and held in position by the catch214. In this position, valve element162closes because of the interruption in the interrupted rail210.

As shown inFIG. 26, when surgical assistant removes the safety clasp120, the safety pin172(and therefore piston housing170and piston124) move forwardly the distance of the long portion of the J-slot180by means of spring184. This forward movement of the piston124advances the smaller-diameter portion128of the piston124further into the IOL cartridge116to advance and hence fold the IOL118further into the delivery portion of the cartridge116.

As shown inFIG. 27, the surgical assistant rotates the safety pin172whereupon the piston housing170also rotates to disengage the arms192of the piston124from the of the shorter legs194S of the J-slots194. This releases the full force of the high compression spring136against the head134of the piston124; however, the piston124does not move forward because the valve element162is closed, trapping the OVD fluid in the hydraulic chamber131. The IOL inserter110is now ready and the surgical assistant hands it to the surgeon.

As shown inFIG. 28, in the hands of the surgeon, depressing of the operation button122slowly and controllably bleeds OVD fluid from the hydraulic chamber131, whereupon the piston124moves steadily forwardly without pulsating or overshooting, to safely and deliberately deliver the IOL118into the patient's eye under precise control of the surgeon's finger.

Third Embodiment

A more detailed description the third embodiment of the IOL inserter312of the invention summarized above inFIGS. 29-37, is reflected in the mechanical drawings ofFIGS. 38-55. It is noted that components in common with the first embodiment are numerically labeled with corresponding numbers prefixed by300sand400s. For example, the IOL inserter10of the first embodiment is labeled with numeral “10” whereas the IOL inserter of the third embodiment is correspondingly labeled with numeral “310.”

As shown inFIG. 38, the third embodiment of the IOL inserter310comprises an outer shell housing314into which is loaded an IOL cartridge316having a clear window316W for visualizing the IOL318and OVD fluid therein. The IOL inserter310further includes a fill-port346for filling with OVD fluid.

As better shown inFIG. 39, the fill-port346is fluidly connected to a hydraulic tube326in which is positioned the smaller diameter portion328of a hydraulic piston324. It is noted that leakage about the periphery of the hydraulic tube326is precluded by O ring352positioned about the forward most end of the tube326which seals within the valve housing362H. The forward end of the hydraulic tube326extends into a valve housing362H and sealed by second O-ring352. The tip368of the piston324extends out of the hydraulic tube326within the valve housing362H and extends into the IOL cartridge316. Another O-ring362H prevents leakage between the tip368and the housing362H.

The annular space between the outer surface of the smaller diameter portion328of the hydraulic piston324and the lumen of the hydraulic tube326define a hydraulic chamber331. As shown inFIG. 40, when OVD fluid is injected into the IOL inserter310by means of an OVD-filled syringe422, the OVD fluid flows through the fill port346into the hydraulic chamber331and then, as explained later in greater detail, into the valve housing362H containing the valve362, through the valve362and into the IOL cartridge316. Valve362is similar to the first and second embodiments62and162and comprises a valve element362having upper and lower O-rings362U and362L installed within a valve cylinder358.

Preferably, fill port346comprises a Luer fitting. As better shown inFIG. 41, the fill port346comprises a generally circular bore346B. The rearward end326R of the hydraulic tube326is sealingly inserted into the forward portion of the bore at346B. A first O-ring350is positioned in an O-ring slot formed at the juncture between the smaller diameter portion328and the larger diameter portion330of the piston324to form a seal with the rear portion of the bore346B.

When the OVD-filled syringe is connected to the fill port346as shown inFIG. 41, fluid flows through the upper portion of the port346and into the hydraulic chamber331to fill the same and to then through the valve housing362H to fill the IOL cartridge316. After removal of the syringe, and charging of the IOL inserter310(described hereafter), the piston324moves forwardly whereupon O-ring350moves into the rearward end of the hydraulic tube326, thereby forming a seal therewith.

Returning toFIG. 39, the operation button322is operatively connected to the leg312and is spring-loaded upwardly by a spring364. The operation button322and hence the valve362are held in their “down” or “open” position by means of a latching/unlatching mechanism410that fits into a side slot412S in the leg312of the button322. Functioning similar to the interrupted rail210of the second embodiment, the end of the unlatching mechanism410includes a cut out portion428that allows the valve362to move upwardly within the valve cylinder358of the valve housing362H when the mechanism410is slid forwardly with the cut out portion428in alignment with the slot412S.

As shown inFIGS. 40-46illustrating Step1of the intended use, so long as the valve element362is latched open by the mechanism410, its lower O ring362L is positioned in a frustro-conical portion430FC of a bleed channel430where the lower O ring362L is no longer being sealed inside the circular-cylindrical valve cylinder358, thereby allowing OVD fluid to bleed around the O ring362L and into the lower circular-cylindrical portion430CC of the channel430. Channel430is fluidly connected to a horizontal channel432. The forward most end of the channel432comprises a nipple434that is sealingly mated with a corresponding port formed in the IOL cartridge316.

FIG. 45illustrates the first bleed channel356inside the valve housing362H that fluidly connects the end of the hydraulic tube326to the valve cylinder358

FIG. 46better illustrates the IOL cartridge316and its visualization window316W which allows the visualization of the IOL318and the OVD fluid filling the cartridge316to the desired, manufacturers' suggested level. Step two involves charging the IOL inserter310.

After filling with OVD fluid in Step1(FIGS. 40-46), in Step2(FIGS. 47-49) involve charging the inserter310by means of the charging plunger420which is forcibly pushed into the rear of the outer shell housing314as shown by arrow440(FIG. 47) up to a depth indicated by a charge indication line442. ComparingFIG. 39withFIG. 48, it is seen that the charging plunger420comprises mating left and right portions420L and420R each having forwardly extending flat thin legs444that reciprocate in grooves446formed in the left and right sides of the outer shell housing314. The outside surface of the legs444include a catch448that snap over corresponding protrusions450formed on the inner wall of the outer shell housing314. The catches/protrusions448/450allow the legs444to be snapped into position shown inFIG. 39, allowing forward movement but precluding any backward rearward movement.

The high pressure spraying336is positioned over the end of a boss382extending rearwardly from the head334of the piston324. In this position shown inFIG. 39, a pair of inwardly extending pawls452engage under the head334of the piston324to keep the spring336compressed within the charging plunger420. However, once the charging plunger420is forcibly pushed (seeFIG. 47) fully into the rear of the inserter310(FIG. 48), the pawls452are spread apart by tabs454inwardly extending from the outer shell housing314. The pawls452engage and spread the pawls452outwardly apart as shown inFIG. 48as the charging plunger452is forced inwardly, thereby releasing the head334of the piston324. It is noted that the pawls452are allowed to expand outwardly by tabs454by virtue of the space between the legs444and the inner lumen of the outer shell housing314. It is also noted that additional protrusions456are aligned with the fully-inward position of the charging plunger420to allow catches448to snap over and be retained thereby to securely hold the charging plunger420in its charging position shown inFIG. 48. It is also noted that when the charging plunger420is in its fully-inward position, the indicator line442is no longer visible because it is moved inside the rear of the housing314, thereby visually indicating that the plunger420has been pushed the desired distance into the rear of the housing314.

Simultaneously with forcibly pushing the plunger420into the rear of the housing314, one of the legs444engages and slides forward the unlatching mechanism410which moves its cut out portion428in alignment with the slot412S in the leg412of the button320, thereby allowing the button320to pop up to its closed position. It is noted that in the closed position, the lower O-ring362L has moved upwardly from the frustro-conical portion430FC into the circular cylindrical valve cylinder358to seal therewith, thereby precluding any OVD fluid flow therethrough.

Also simultaneously with forcing the plunger420into the rear of the housing314, the piston324is likewise forced forwardly. Upon forward movement of the piston324, the first O ring350moves into the hydraulic tube326to form a seal with its inner lumen entrapping OVD fluid therein while at the same time precluding any leakage back through the fill port346.

As shown inFIGS. 50-52, Step3comprises deploying the IOL318into the patient's eye. Deployment occurs by depressing upon the button322to open the valve362(seeFIG. 43) allowing OVD fluid to flow from hydraulic chamber331inside the hydraulic tube326into the valve housing362H through the first bleed channel356into the valve cylinder358, around the periphery of the valve element362and lower O-ring362L and the valve cylinder358, then over the surface of the lower O ring362L and into the channel432. It is noted that due to the frustro-conical portion430FC, further depressing of the button322increases the flow rate of the OVD fluid as the lower O ring362L moves downwardly along the length of the frustro-conical portion430FC, thereby allowing the surgeon to have precise control over the rate of delivery of the IOL318into the patient's eye.

As the OVD fluid is bled from the hydraulic chamber331by depressing button322, the piston324is allowed to move forward under pressure from spring336. Such forward movement of the piston324causes the tip368of the piston to fully deliver the IOL318into the patient's eye. It is noted that the OVD fluid being bled from the hydraulic chamber331flows into the IOL cartridge316.

As noted above and illustrated inFIGS. 53 and 54, the IOL inserter310of the invention may be adapted to be used with a variety of IOL cartridges316(AMO is merely illustrative). In this regard, the manufacturer's IOL cartridge316will have to be adapted to fit into the forward end of the outer shell housing314such as including locating and retention features (i.e., notches). Further, the tip368of the piston324would be optimally designed according to the manufacturer's specifications to properly engage that manufacturer's IOL318for proper folding of the IOL318in the IOL cartridge316and delivery into the patient's eye.

Now that the invention has been described,