Ophthalmic Retinal Simultaneous Sealer Mixing and Illumination Assembly

Abstract

A syringe having a plurality of chambers of isolated components for advancing to a mixing chamber when promoting delivery to tissue within a patient's eye. The syringe also includes a mixing mechanism in communication with the mixing chamber. Additionally, the isolated chambers can be either in series or in parallel / parallel type, depending on the types of components to be combined and other surgical preferences.

Description

Background Art

[0001] Over the years, many dramatic advancements have occurred in the field of ophthalmic surgery. One of the more common ophthalmic surgical procedures is vitrectomy. Vitrectomy is the removal of some or all of the vitreous humor from a patient's eye. In the case of surgery limited to the removal of cloudy vitreous humor, in some cases, vitrectomy may account for the majority of the procedure. However, vitrectomy can be accompanied by cataract surgery, retinal repair surgery, macular patching, or many other surgeries to address problems.

[0002] Often, vitrectomy is accompanied by various other procedures to address more specific eye characteristics. That is, in addition to the vitrectomy described, other types of probes or instruments can be utilized to address specific eye problems. This scenario can involve some degree of vitrectomy followed by the use of instruments that directly interact with the eye's features. For example, the repair of retinal tissue in the back of the eye can be performed by various forceps, scissors, or other instruments used after a certain degree of vitrectomy. Vitrectomy can also be performed following retinal tissue repair to remove free fragments or deviated tissue.

[0003] After retinal tissue repair and the accompanying vitrectomy, often efforts are made to shield and protect the repaired retinal tissue and ensure an isolated healing period. One technique for shielding and / or protecting the repaired retinal tissue is to introduce silicone oil after repair. This viscous oil can serve to isolate the retina and enable a fairly long period of protective healing. For example, the oil can be left in the eye for 90 days or perhaps longer.

[0004] Alternative approaches for protecting and shielding a repaired retina that may obviate the need for subsequent removal surgery have been developed. For example, a gas tamponade of sulfur hexafluoride or other diluted medical gases can play a role in promoting the healing of the repaired retina. When utilizing a gas tamponade as an aid for long-term healing, the patient may need to actively participate in the healing process by positioning the face downward for a period of time to position the gas bubble of the tamponade over the retinal healing site of the eye.

[0005] Another approach for applying a wound isolation technique to the repaired retina while avoiding subsequent removal surgery involves the placement of a retinal "patch" onto the retina. In this way, a more discrete placement of a degradable substance is utilized to achieve isolation during the healing period. Due to the degradation characteristics of the substance, subsequent removal surgery may not be necessary.

[0006] The "substance" that constitutes the retinal patch can include a mixture of different components that can coagulate and solidify in a very short time when mixed. For example, a mixture of solid polyethylene powder combined with a liquid polyethylene mixture can typically solidify within about 5 minutes. This means that separate mixtures that must be combined, mixed, and delivered to the surgical site at the back of the eye within a few minutes are presented to the surgeon or surgical assistant. Otherwise, the patch material can clog within the delivery needle or be delivered in an undesirable lumpy shape that can affect patch performance. In fact, it is very common that rather than taking the risk of the latter, premature mixing of the patch material clogs within the delivery needle or tool, and multiple attempts at mixing and discarding of the delivery tool are inefficiently required before proper patch delivery can be achieved. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0007] A material delivery assembly for ophthalmic surgery is disclosed. The assembly can be a syringe and includes separate chambers for containing separate and isolated components. The components can be mixed with each other within one of the chambers or within a third separate mixing chamber. A needle in fluid communication with the chamber in which the components are mixed is attached to the assembly for positioning adjacent to an intraocular tissue site to deliver the mixed components to the tissue site.

Brief Description of the Drawings

[0008]

Figure 1

Figure 2A

Figure 2B

Figure 2C

Figure 3

Figure 4

Figure 5

Best Mode for Carrying Out the Invention

[0009] In the following description, numerous details are set forth in order to provide an understanding of the present disclosure. However, it will be understood by those skilled in the art that the described embodiments may be practiced without these specific details. Further, numerous variations or modifications may be employed that are still contemplated in the embodiments specifically described.

[0010] Embodiments are described in connection with a particular type of minimally invasive vitreoretinal procedure performed using a unique assembly or syringe. In particular, the procedure for using a syringe to mix and deliver a retinal patch mixture is shown and detailed. Of course, various other procedures may be performed using embodiments of the assemblies or syringes of the type detailed herein. In any event, significant benefits can be obtained as long as the syringe is equipped with an isolated component chamber and at least one improved mixing mechanism.

[0011] Referring now to FIG. 1, a side perspective view of an embodiment of a multi-chamber isolated component syringe 100 for ophthalmic surgery is shown. Syringe 100 includes a housing 130 having a plurality of chambers 133, 135, 137. In the illustrated embodiment, two chambers 135, 137 are provided for housing separate components 140, 160 in a separated manner from each other. Specifically, a substantially dry component 140 is housed within a dry chamber 135, and a substantially liquid component 160 is housed within a wet chamber 137. Another mixing chamber 133 is provided, and components 140, 160 can ultimately be introduced into mixing chamber 133 for mixing, as will be described in more detail below. However, in other embodiments, the use of this separate chamber 133 can be avoided.

[0012] Each of chambers 133, 135, 137 is separated from the other chambers by barriers in the form of conventional pressure-decomposable membranes 101, 105. Membranes 101, 105 can be medical foils or conventional rupture disks selected to rupture when exposed to a predetermined pressure. For example, in the illustrated embodiment, syringe 100 can be a 5 milliliter (ml) syringe having a proximal membrane 105 that receives a pressure of about 100 pounds per square inch (PSI) from plunger 110, as will be described below. This level of pressure is more than sufficient to rupture membrane 105 and facilitate the movement of liquid component 160 that begins to reach from wet chamber 137 into dry chamber 135.

[0013] Due to the above-mentioned rupture and movement of the liquid component 160, a process of mixing the liquid component 160 with the dry component 140 in the drying chamber 135 is initiated. This process can be facilitated by the mixing mechanism 115. In the illustrated embodiment, this mechanism 115 is an auger / propeller-type device that can rotate about an axis passing through the center of the syringe 100 when induced by the actuator 175. In fact, the depicted actuator 175 includes two separate depressors 180, 190, one of which, the depressor 180, can be utilized to trigger the movement of the plunger 110 described above, and the other depressor 190 can trigger the mixing mechanism 115 as described above. In the illustrated embodiment, these depressors 180, 190 are positioned together as the actuator 175 considering that the surgeon is likely to attempt to initiate mixing simultaneously with the movement of the plunger 110. However, this is not essential, and the surgeon can attempt to initiate mixing after the movement of the plunger 110. This possibility is considered due to the structure of the actuator 175. Alternatively, the mechanism 115, auger-type or otherwise, can be fixed such that swirling mixing promotion can be provided only by forward movement in the distal direction and can be non-rotating.

[0014] Continuing to refer to FIG. 1, the movement of the plunger 110 and the rotation of the mixing mechanism 115 described above are forcibly promoted by the air pressure locally provided by the pneumatic power cell 125. In some embodiments, the tube 191 can provide air pressure (e.g., pressurized air / fluid from a connected console or other pneumatic source) to move the plunger 110. Thus, a certain degree of accuracy is provided to the injection process that does not depend on the positioning of the surgeon's thumb or finger at the extension from the plunger. Such pneumatic actuation also serves to promote mixing through the illustrated mixing mechanism 115 or other types of mixing-promoting features described in more detail below. Of course, in other embodiments, more conventional plunger structures of this type can also be used. Additionally, in one embodiment, the mixing mechanism 115 is essentially telescopic and can maintain a physical connection with the associated depressor 190. Thus, as described below, even after the movement of the plunger 110 is completed, the surgeon can continue to repeatedly press and release the depressor 190 to continue rotating the mechanism 115 for mixing the components 140, 160. This can be assisted by a spring or other conventional return device associated with the depressor 190.

[0015] For the illustrated embodiment, the drying chamber 140 is defined by another membrane 101 on the distal side. This is not essential. However, it may be desirable to include another mixing chamber 133 with a dedicated void. Thus, after the plunger is advanced sufficiently to increase the pressure, a predetermined amount of the mixing chamber void remains due to the rupture of the distal membrane 101. This can be adjusted according to the amount and type of the components 140, 160 to be mixed. For example, a sufficient amount of inert air or argon gas can be utilized to enable the surgeon to effectively shake the syringe 100 to promote further mixing. Further, this can be done in a manner that holds the dry component 140 within the isolated region of the drying chamber 140 without prematurely exposing the components to the much larger surface area of the filter 107 or the inner wall of the housing 130 described below.

[0016] Upon mixing, the combined mixture can be pushed into the needle 170 through a filter 107 that is in front of the housing 130. The filter 107 can be utilized to prevent pieces of the membrane from reaching the interior of the needle. In the illustrated embodiment, a sleeve 150 is provided around the needle 170, and the sleeve 150 can serve to provide structural support, as will be further described below. The tip 181 of the needle 170 is shown as a sharp tip, although other tip structures can also be used. For example, the tip 181 can include a soft silicone tip, a brush applicator, or a blunt tip (e.g., a blunt stainless steel tip). The tip structure 112 can assist in applying the mixture to the injection site. For example, in some embodiments, the tip 181 can include a brush applicator that can function to "apply" the combined mixture to a retinal tear. In some embodiments, the combined mixture can be applied along a retinal tear in a bead structure to seal the tear. Thus, fluid entry behind the retina can be prevented by the seal (otherwise fluid can cause retinal detachment).

[0017] Referring to FIG. 2A, an enlarged cross-sectional view of the plunger 110 of the syringe 100 of FIG. 1 is shown, advancing the component 160 into the second dry chamber 135 past the membrane barrier 105 of the first liquid chamber 137. Only remnants of the membrane dividing the chambers 135, 137 remain, and the components 140, 160 begin to mix. In one embodiment, the mixture of the combined components 140, 160 constitutes a fast-drying retinal patch. Thus, the syringe 100 is an excellent tool for the rapid mixing and delivery of the patch mixture. In such one embodiment, the liquid component 160 is a polymer solution of less than about 2.0 ml, while the dry component 140 is another dry polymer reactant of less than 0.10 ml. Nevertheless, the mixture can become substantially solid in less than about 5 minutes from their contact with each other.

[0018] Referring specifically to FIG. 2B, an enlarged cross-sectional view of the syringe 100 of FIG. 1 is shown, with the mixing mechanism 115 illustrated as emerging from the plunger 110 of FIG. 2A. The mechanism 115 is used to more actively initiate the mixing of the components 140, 160 of FIG. 2A, as described above. Further, the mechanism 115 can serve to rupture the mentioned membrane 105. That is, the mechanism 115 can physically break the membrane 105 rather than relying solely on pressure.

[0019] For illustrative purposes, the syringes 100 of FIGS. 1 and 2A - 2C are shown in a horizontal orientation with a significant amount of void space throughout the housing 130. However, it should be noted that, as with other syringe applications, it is highly likely that the void space can be less than the amount shown, and the syringe 100 and housing 130 are highly likely to be held by the surgeon in a more vertical orientation. Thus, the air within each chamber 133, 135, 137 can rise, as shown in FIG. 3, before mixing and delivering the mixture. Additionally, if the mixing mechanism 115 is of the auger type, the auger features can extend further laterally towards the sidewalls of any given chamber 133, 135, 137 such that the mechanism 115 leaves a substantially minimal amount of clearance, if any, when present. Accordingly, mixing is further enhanced. In addition, the mechanism 115 can play a greater role in advancing the mixture in the distal direction.

[0020] Referring now to FIG. 2C, there is shown an enlarged cross-sectional view of the syringe 100 of FIG. 1 in which components 140, 160 are mixed within the mixing chamber 133 and advanced through the filter 107 to the needle 170. In fact, the flow 250 of the well-combined mixture 200 is shown as advancing through the needle 170. It should also be noted that all of the mixture 200 is filtered through the filter 107 before advancing to the needle 170. The main purpose of the filtration may be to prevent debris from the ruptured membranes 101, 105 from reaching the needle 170. However, the filter 107 may also be adjusted to prevent lumpy or larger, substantially dry component materials 140 (referred to herein as unmixed components) that have not been sufficiently or more appropriately mixed with the rest of the mixture 200 from reaching the needle 170. An optional sleeve 150 is also shown around the needle 170 as a structural aid for the surgical procedure described in more detail below.

[0021] Referring now to FIG. 3, there is shown an enlarged partial cross-sectional view of the needle 170 of the syringe 100 of FIGS. 1 and 2C during a minimally invasive vitreoretinal surgery reaching the retinal surface side above the optic nerve 360 within the eye 350. In this way, the mixture 200 of FIG. 2C can be delivered. Recall that the mixture 200 can be a fast-drying retinal patch that solidifies within about 5 minutes from mixing as described above. However, again as described above, by simply actuating the syringe 100 of FIG. 1, the mixture 200 can be obtained in a very short time without undue concern about premature solidification.

[0022] Continuing to refer to FIG. 3, the illustrated needle 170 can be 25 gauge or less and can be guided by cannula 315 and supported by stabilized sleeve 150 when reaching the interior 310 of the eye 350. There is also another pre - placed cannula 330 to guide and support the introduction of the focused working light instrument 325. In some embodiments, sleeve 150 can further include an optical fiber for illumination 312. This illumination can be in addition to the working light 325 or can be the only illumination used for the injection (e.g., when there is no separate working light instrument 325). The optical fiber illumination 312 is shown terminating at the sleeve, but in some embodiments, the optical fiber can extend further down the needle and provide illumination closer to the injection site. In some embodiments, the light can be provided at a location about 8 millimeters away from the injection site. Other distances are also contemplated (e.g., 1 millimeter, 10 millimeters, etc.). Cannulas 315, 330 can both be retractable to facilitate entry through their valves. Additionally, cannulas 315, 330 are positioned at a displaced location in the scleral tissue 370 to avoid contact with more sensitive features of the eye 350, such as the cornea 390 or the lens 380. In fact, the surgeon can directly visualize the interior 310 of the eye 350 through the cornea 390 and the lens 380 during the procedure, assisted by the light 340 from the instrument 325. However, more indirect visualization options can be employed. For example, a wide - angle visualization system with a microscope can be utilized.

[0023] Considering the space constraints, the aforementioned wide - angle visualization system can be relatively flexible and can be used with long, thick - gauge tubes. Additionally, cannula 315 can be articulated. In this way, 360 - degree visualization of the retina can be achieved and ergonomic access can be possible. In one embodiment, the end of the needle 170 can include an optical fiber vision enhancement to further assist visualization, especially as the needle 170 approaches the retina.

[0024] Continuing to focus on accessibility and referring further to FIG. 2C, in one embodiment, the needle 170 has a curved shape to facilitate a more ergonomic delivery of the mixture 200. For example, in one embodiment, the needle 170 can be constructed of a shape memory nickel-titanium alloy such as Nitinol. Thus, the needle 170 can be straightened to pass through the cannula 315 by being temporarily held within the sleeve 150 either directly or while passing through by the cannula 315. In either case, the needle 170 can return to its curved shape when it reaches the interior 310 of the eye 350.

[0025] Referring now to FIG. 4, an alternative embodiment of a multi-chamber, isolated-component syringe 400 for ophthalmic surgery is shown. In this figure, the syringe 400 is substantially the same as the embodiment of FIG. 1 in that it isolates the separate components 140, 160 prior to mixing them within the mixing chamber 433. However, here, the syringe 400 can rather be a dual-barrel structure in which the chambers 440, 460 are arranged such that the separate chambers 440, 460 are opened into the mixing chamber 433 substantially simultaneously with the rupture of the membrane 401. Thus, a path for continuously introducing the liquid 160 to the dry component 140 and then both the liquid 160 and the dry component 140 into the mixing chamber 433 can be avoided. This can be beneficial or can promote a more uniform dispersion of the final mixture, depending on the nature of the components 140, 160.

[0026] In addition to the different chamber structures, the syringe 400 of FIG. 4 includes additional mixing enhancement features. For example, the illustrated mixing mechanism 415 operates in the same manner as the mixing mechanisms of the embodiments of FIGS. 1 and 2B (see, e.g., 115). However, in this example, the mechanism 415 can be longer to provide more substantial mixing elements. Further, the mechanism 415 itself is shown in contact with the membrane 410 that defines the mixing chamber 433. Thus, the physical rupture of the membrane 401 can begin at the moment of forward movement of the plunger 110. In fact, in one embodiment, the separation element 405 can be sized to allow passage of the mechanism 405 by physical removal. In such an embodiment, the remaining portion of the membrane 401 can remain structurally sound as a solid wall barrier to minimize the amount of membrane shreds that may require filtration. In the illustrated embodiment, note that the mixing mechanism 415 is moving between the barrier walls of the chambers 440, 460 not shown for purposes of highlighting the mechanism 415. Further, for embodiments that utilize the separation element 405, these barrier walls are hermetically bonded to the element 405 prior to removal or separation.

[0027] With components 140, 160 introduced into the mixing chamber 433, the longer mechanism 415 can be from about half the length of the chamber 433 to the full length of the chamber 433 or even longer. Thus, the repeated reciprocation detailed above can provide a substantially greater effect in creating a more homogeneous mixture of the components 140, 160 combined within the chamber 433. In fact, in the illustrated embodiment, a baffle 450 is included that can further enhance mixing during this reciprocation. That is, the unique combination of the fixed baffle 450 can be utilized in conjunction with the moving and reciprocating mixing mechanism 415 with significantly beneficial effects.

[0028] In some embodiments, the mixing chamber 433 may be located adjacent to the tip 181 and, in some embodiments, the mixing chamber 433 may be small enough to safely enter the eye when the tip 181 is inserted into the eye. In this embodiment, the components 140, 160 are mixed within the mixing chamber 433 inside the eye immediately before entering the eye. For example, the components 140, 160 may be delivered to the mixing chamber 433 within the eye near the tip 181 along separate flow paths and mixed immediately before entering the eye. Thus, the mechanism 115 (e.g., an auger / propeller mechanism) may rotate near the tip 181 such that the components 140, 160 are mixed at the tip 181 immediately before entering the eye. In some embodiments, the components 140, 160 may further pass through the baffle 450 before exiting the tip for further mixing.

[0029] Referring now to FIG. 5, a flowchart summarizing an embodiment utilizing a multi-chamber isolated component syringe for ophthalmic surgery is shown. That is, the dry and wet components are supplied to isolated chambers of the syringe as shown at 510 and 530. Next, as described at 550, at least one barrier or membrane is ruptured to advance the components into a mixing chamber where the components are mixed internally (see 570). Thus, as shown at 590, the components may be delivered to the tissue within the patient's eye as a combined mixture.

[0030] The embodiments described above herein include apparatuses and techniques that enable an effective method for achieving reliable mixing of components for combinations of components that dry relatively rapidly in a very short time. This is accomplished using a single syringe in an ergonomically preferred manner that provides both enhanced mixing and improved efficiency.

[0031] The foregoing description has been presented with reference to current preferred embodiments. However, other embodiments and / or features of the embodiments that are disclosed but not detailed above may be employed. For example, various additional mixing facilitation features may be provided within the mixing chamber. This may include the use of piezoelectric actuators, helical or more circuitous paths fluidly coupled between the chamber and the needle, or many other structural features. In embodiments using a piezoelectric actuator, the actuator may be separately disposed within the mixing chamber or incorporated into a mixing mechanism associated with the plunger or any other part of the syringe such that the vibration effect is transmitted more throughout a given chamber or even the entire syringe. In some embodiments, an existing ultrasonic drive electronics from a connected console may be used to vibrate an ultrasonic crystal oscillation drive mixing element (e.g., a piezoelectric drive element). For example, the same ultrasonic drive electronics that drive a piezoelectric handpiece for crystal removal may also be used to vibrate a mixing element (such as a metal stirrer) within the syringe. Additionally, the syringe barrel may be vibrated for further mixing of the contents by the supplied vibration / oscillation. In some embodiments, a pneumatic drive stopper may drive the mixture using an ultrasonic crystal oscillation drive mixing element. Further, those skilled in the art to which these embodiments pertain will understand that still other alternative forms and modifications in the described structures and methods of operation may be implemented without significantly departing from the principles and scope of these embodiments. Additionally, the foregoing description should not be read as relating only to the exact structures described and shown in the accompanying drawings, but rather as being consistent with and supporting the following claims, which have the broadest and most appropriate scope thereof.

Claims

1. A multi-chamber isolated component syringe for ophthalmic surgery, a first chamber for containing a first component, a second chamber adjacent to the distal side of the first chamber for containing a second component, a mixing chamber adjacent to the distal side of the second chamber, the mixing chamber for receiving the components for mixing therein, at least one mixing mechanism of the syringe for reaching the mixing chamber, and a needle in fluid communication with the mixing chamber for delivering the combined mixed components into a patient's eye A multi-chamber isolated component syringe comprising.

2. The syringe according to claim 1, wherein the chambers are isolated from each other by a barrier selected from the group consisting of medical foil, pressure-decomposable membrane and rupture disk.

3. The syringe according to claim 1, wherein the first chamber is a wet chamber, the first component is a liquid, the second chamber is a dry chamber, and the second component is a dry component.

4. The syringe according to claim 3, wherein the liquid component is a polymer solution of about 2.00 milliliters (ml), the dry component is a dry polymer reactant of about 0.10 ml, and the combined mixed components include a retinal patch.

5. The syringe according to claim 1, wherein the mixing chamber houses a dedicated void of a volume adjusted to the components for mixing.

6. The syringe according to claim 1, wherein the mixing mechanism is an auger-type instrument coupled to a plunger for breaking the barrier with the components.

7. The syringe according to claim 1, wherein the mixing chamber further includes one of a baffle and a piezoelectric actuator to facilitate mixing of the components.

8. The syringe according to claim 1, further including a dual depressor actuator at an external position of a housing containing the chambers, the dual depressor actuator configured to provide simultaneous surgical control over the mixing mechanism and a plunger for guiding the components into the mixing chamber.

9. A multi-barrel isolated component syringe for ophthalmic surgery, a first chamber for containing a first component, a second chamber parallel to the first chamber for containing a second component, A mixing chamber adjacent to the distal sides of the first and second chambers, the mixing chamber for receiving the components from the first and second chambers for mixing therein At least one mixing mechanism of the syringe for reaching the mixing chamber A needle in fluid communication with the mixing chamber for delivery of the combined mixed components into a patient's eye A multi-barrel isolated component syringe comprising

10. The syringe according to claim 9, wherein the mixing mechanism directly contacts a removable element for introducing the components into the mixing chamber substantially simultaneously

11. The syringe according to claim 9, wherein the mixing mechanism is configured to reciprocate within the mixing chamber, and the mixing chamber further comprises a baffle for facilitating the mixing during the reciprocation

12. A method of mixing a plurality of components within a syringe for delivery into a patient's eye, comprising Breaking at least one isolation barrier to advance the components from an isolated chamber into a mixing chamber Mixing the components within the mixing chamber using a mixing mechanism Delivering the combined mixture of the components into the patient's eye A method comprising

13. The method according to claim 12, wherein the component chamber is one of a series type that communicates with the mixing chamber for introducing the components into the mixing chamber in a partially combined manner and a parallel type for simultaneously introducing the components into the mixing chamber in a substantially uncombined manner

14. The method according to claim 12, further comprising filtering debris from the combined mixture within the mixing chamber, the debris being selected from the group consisting of barrier debris and unmixed components

15. The method according to claim 12, wherein the breaking, the mixing, and the delivering are induced by a pneumatic power cell device including a dual depressor actuator to enable a separate mixing operation apart from the breaking and the delivering

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