Ophthalmic retinal synchronized sealant mixing and illumination assembly

Abstract

A syringe having a plurality of chambers of an insulating composition for advancing into a mixing chamber to facilitate delivery to tissue within an eye of a patient. The syringe also includes a mixing mechanism in communication with the mixing chamber. In addition, the isolated chambers may be one of sequential or side-by-side / parallel depending on the type of components to be combined and other surgical preferences.

Description

Background Art

[0001] Over the years, there have been many significant advances in the field of eye surgery. Vitrectomy is one of the more common eye surgery procedures. Vitrectomy is the removal of some or all of the vitreous humor from a patient's eye. In some cases, if the surgery is limited to removing cloudy vitreous humor, then a vitrectomy may constitute the majority of the procedure. However, a vitrectomy may be performed in conjunction with cataract surgery, retinal repair surgery, surgery to treat macular pucker, or surgery to treat a number of other issues.

[0002] Typically, vitrectomy is performed with a variety of other procedures to address more specific eye features. That is, in addition to the vitrectomy described, other types of probes or instruments may be utilized to address specific eye problems. The scenario may involve a degree of vitrectomy followed by the use of instruments to interact directly with the eye features. For example, retinal tissue at the back of the eye may be repaired by various forceps, scissors, or other instruments utilized after a degree of vitrectomy. Vitrectomy may also be performed after retinal tissue repair to remove loose debris or stray tissue.

[0003] After retinal tissue repair and any accompanying vitrectomy procedures, measures are often taken to shield and protect the repaired retinal tissue to allow a period of isolated healing. One technique for shielding and / or protecting the repaired retinal tissue is to introduce silicone oil after repair. This viscous oil can be used to isolate the retina and allow a fairly extended shielded healing period. For example, the oil can be left in the eye for up to 90 days or possibly longer.

[0004] Alternative measures have been developed to protect and shield the repaired retina that may obviate the need for subsequent removal surgery. For example, gas tamponades of sulfur hexafluoride or other diluted medical gases may be used to promote healing of the repaired retina. Utilizing gas tamponades as an aid to long-term healing may require the patient to actively participate in the healing process, lying face down for some time to position the tamponade's bubble at the retinal healing site of the eye.

[0005] Another approach to applying wound isolation techniques to a repaired retina while avoiding subsequent removal surgery involves placing a retinal "patch" on the retina. In this way, isolation during the healing period is achieved using a more discrete placement of a degradable substance. Due to the degradable nature of the substance, removal surgery may not be required afterwards.

[0006] The "substance" constituting the retinal patch can include a mixture of different components, which can coagulate and solidify in a very short period of time when mixed. For example, a solid polyethylene powder mixture and a liquid polyethylene mixture combined may solidify in about 5 minutes. This means that the surgeon or surgical assistant is provided with a separate mixture, which must be combined, mixed and delivered to the surgical site at the back of the eye within a few minutes. Otherwise, the patch material may be stuck in the delivery needle or delivered in a blocky and undesirable manner that may affect the effectiveness of the patch performance. In fact, rather than taking the latter risk, it is quite common that the patch material mixed prematurely is stuck in the delivery needle or tool, resulting in inefficiency, requiring multiple mixing attempts and scrapped delivery tools to achieve appropriate patch delivery. Summary of the invention

[0007] A material delivery assembly for eye surgery is disclosed. The assembly may be a syringe and include separate chambers for containing separate isolated components. The components may be mixed together in one of the chambers or in a third separate mixing chamber. The assembly includes a needle in fluid communication with the chamber in which the components are mixed, the needle being positioned adjacent a tissue site in the eye to deliver the mixed components into the eye. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a side perspective view of an embodiment of a multi-chambered, isolated component syringe for use in eye surgery.

[0009] Figure 2A yes Figure 1 An enlarged view of a cross-section of the plunger of a syringe pushing a component through the membrane barrier of a first chamber and into a second chamber.

[0010] Figure 2B yes Figure 1 An enlarged view of a cross-section of a syringe in which a mixing mechanism is employed to induce mixing of the components.

[0011] Figure 2C yes Figure 1 An enlarged view of a cross section of a syringe where the components are mixed in a mixing chamber and pushed through a filter to the needle.

[0012] Figure 3 yes Figure 1 and Figure 2C An enlarged partial cross-sectional view of the needle of a syringe extending toward the retinal surface within the eye to deliver a mixture of components.

[0013] Figure 4 An alternative embodiment of a multi-chambered, isolated component syringe for use in ocular surgery.

[0014] Figure 5 is a flow chart outlining an embodiment of utilizing a multi-chambered isolated component syringe for eye surgery. DETAILED DESCRIPTION

[0015] In the following description, many details are set forth to provide an understanding of the present disclosure. However, it will be appreciated by those skilled in the art that the described embodiments may be practiced without these specific details. Further, many variations or modifications may be employed that are still contemplated by the specifically described embodiments.

[0016] Embodiments are described with reference to certain types of minimally invasive vitreoretinal procedures performed with unique assemblies or syringes. In particular, procedures are shown and detailed in which a syringe is used to mix and deliver a retinal patch mixture. Of course, a variety of other procedures can be performed with the various types of assembly or syringe embodiments detailed herein. Regardless, significant benefits can be achieved as long as the syringe is equipped with isolated component chambers and at least one enhanced mixing mechanism.

[0017] Reference now Figure 1 , shows a side perspective view of an embodiment of a multi-chambered isolated component syringe 100 for eye surgery. The syringe 100 includes a housing 130 having a plurality of chambers 133, 135, 137. For the illustrated embodiment, two of these chambers 135, 137 are configured to house separate components 140, 160 in an isolated manner from one another. Specifically, a substantially dry component 140 is housed in the dry chamber 135, and a substantially liquid component 160 is housed in the wet chamber 137. Another mixing chamber 133 is provided, in which the components 140, 160 can ultimately be deposited for mixing, as described in further detail below. However, in other embodiments, the use of this separate chamber 133 can be avoided.

[0018] Each of the chambers 133, 135, 137 is separated from each other by a barrier in the form of a conventional pressure degradable membrane 101, 105. The membrane 101, 105 may be a medical foil or a conventional bursting disc selected to burst when exposed to a predetermined pressure. For example, in the illustrated embodiment, the syringe 100 may be a 5 milliliter (ml) syringe having a proximal membrane 105 that is subjected to approximately 100 pounds per square inch (PSI) from the plunger 110, as described below. This level of pressure may be sufficient to cause the membrane 105 to burst and facilitate the movement of the liquid component 160 from the wet chamber 137 to begin to reach the dry chamber 135.

[0019] The above-mentioned explosion and movement of the liquid component 160 begins the process of mixing the liquid component 160 with the dry component 140 in the dry chamber 135. This can be enhanced by the mixing mechanism 115. In the embodiment shown, the mechanism 115 is an auger / propeller type device that can rotate around an axis passing through the center of the syringe 100 when guided by the actuator 175. In fact, the actuator 175 depicted includes two independent presses 180, 190, one of which can be used to trigger the described plunger 110 movement, and the other press 190 can trigger the mixing mechanism 115 as described above. In the embodiment shown, given that the surgeon may try to start mixing while the plunger 110 moves, these presses 180, 190 are positioned together as the actuator 175. However, this is not required, and the surgeon may try to start mixing after the plunger 110 moves. The architecture of the actuator 175 will allow this possibility. Alternatively, the auger-type or other form of mechanism 115 may be stationary and non-rotating, such that distal advancement alone may generate a vortex-type mixing enhancement.

[0020] Continue to refer Figure 1 , the described movement of the plunger 110 and the rotation of the mixing mechanism 115 are forced to promote by the pneumatic power unit 125 with locally generated pneumatic pressure. In some embodiments, the tube 191 can provide pneumatic pressure (e.g., pressurized air / fluid from a connected console or other pneumatic source) to move the plunger 110. In this way, a certain precision is introduced to the injection process, which does not depend on the positioning of the surgeon's thumb or finger at the extension of the plunger. This pneumatic actuation can also enhance the mixing effect by the mixing mechanism 115 shown or by other types of mixing enhancement features as further described below. Of course, in other embodiments, this type of more conventional plunger architecture can also be adopted. In addition, in one embodiment, the mixing mechanism 115 can be telescopic in nature and maintain a physical connection with the associated presser 190. Therefore, even after the plunger 110 movement is completed, as described below, the surgeon can continue to repeatedly push and release the presser 190 to allow the mechanism 115 to continue to rotate to mix the components 140, 160. This may be done with the aid of a spring or other conventional return means associated with the presser 190 .

[0021] For the embodiment shown, the dry chamber 140 is defined by another distal membrane 101. This is not necessary. However, it may be desirable to include another mixing chamber 133 with a dedicated air space. In this way, after sufficient plunger advancement and pressure rise, the explosion of the distal membrane 101 will leave a predetermined amount of mixing chamber air space. This can be customized for the amount and type of components 140, 160 to be mixed. For example, a sufficient amount of inert air or argon can be utilized to allow the surgeon to effectively shake the syringe 100 to promote additional mixing. Further, this can be accomplished in such a manner that the dry components 140 are maintained in an isolated area of ​​the dry chamber 140 without prematurely exposing the components to the much larger surface area of ​​the filter 107 described below or the inner wall of the housing 130.

[0022] Once mixed, the combined mixture can be forced through the filter 107 at the front of the housing 130 and into the needle 170. The filter 107 can be used to prevent any membrane fragments from reaching the interior of the needle. In the illustrated embodiment, a sleeve 150 is disposed around the needle 170, which can be used to provide structural support, as further described below. Although the tip 181 of the needle 170 is shown as a sharp point, 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 stainless steel blunt 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 be used to "paint" the combined mixture onto the retinal tear. In some embodiments, the combined mixture can be applied along the retinal tear in a beaded structure to seal the tear. Thus, the seal can prevent the fluid from flowing behind the retina (which otherwise could cause the retina to detach).

[0023] Reference now Figure 2A , showing Figure 1 100, which pushes the component 160 through the membrane 105 barrier of the first liquid chamber 137 and into the second dry chamber 135. Only the remnants of the membrane separating the chambers 135, 137 are left, and the components 140, 160 begin to combine. In one embodiment, the combined mixture of the components 140, 160 will constitute a fast-drying retinal patch. Therefore, the syringe 100 is a good tool for quickly mixing and delivering the patch mixture. In one such embodiment, the liquid component 160 is a polymer solution less than about 2.0 ml, and the dry component 140 is another dry polymer reactant less than 0.10 ml. However, within a time of less than about 5 minutes of exposure to each other, the mixture can become substantially solid.

[0024] Specific reference Figure 2B , showing Figure 1100, wherein the mixing mechanism 115 is now shown as being from Figure 2A The plunger 110 is pulled out. The mechanism 115 is used to more violently induce the above-mentioned Figure 2A The mixture of components 140, 160. In addition, the mechanism 115 can play a role in bursting the reference membrane 105. That is, the mechanism 115 can physically destroy the membrane 105, rather than relying solely on pressure.

[0025] For illustration purposes, Figure 1 and FIG. 2A to FIG. 2C The syringe 100 is shown in a horizontal manner with a significant amount of air space throughout the housing 130. However, it is worth noting that, as with other syringe applications, the air space may be less than the substantial amount shown, and the syringe 100 and housing 130 will be held by the surgeon in a more vertical orientation. In this manner, the air within each chamber 133, 135, 137 can be mixed and Figure 3 137. The mixing mechanism 115 is shown rising before delivering the mixture. Additionally, where the mixing mechanism 115 is of the auger variety, the auger feature can extend further laterally toward the sidewalls of any given chamber 133, 135, 137 so that the mechanism 115 leaves a substantially minimal amount of clearance, if any. Thus, mixing is further enhanced. Additionally, the mechanism 115 can play a greater role in propelling the mixture distally.

[0026] Reference now Figure 2C , showing Figure 1 1, 105, is an enlarged view of a cross-section of the syringe 100, wherein the components 140, 160 are mixed within the mixing chamber 133 and are pushed through the filter 107 to the needle 170. In fact, a stream 250 of the fully combined mixture 200 is shown being pushed through the needle 170. It is also worth noting that all of the mixture 200 is filtered through the filter 107 before being pushed into the needle 170. The primary purpose of the filtering may be to prevent any debris from the bursting disks 101, 105 from reaching the needle 170. However, the filter 107 may also be customized to prevent any agglomerated or larger, nearly dry component 140 materials (referred to herein as unmixed components) that have not been fully or more properly mixed with the rest of the mixture 200 from reaching the needle 170. An optional sleeve 150 is also shown, which surrounds the needle 170 as a structural aid for the surgical procedure described further below.

[0027] Reference now Figure 3 , showing Figure 1 and Figure 2CAn enlarged partial cross-sectional view of the needle 170 of the syringe 100 extending toward the retinal surface above the optic nerve 360 ​​in the eye 350 during minimally invasive vitreoretinal surgery. Figure 2C mixture 200. Recall that mixture 200 may be a quick-dry retinal patch that may cure within about five minutes of combination as described above. However, also as described above, by simply actuating Figure 1 The syringe 100 can obtain the mixture 200 in a moment without worrying about premature solidification.

[0028] Continue to refer Figure 3 , the needle 170 shown may be a 25 gauge or smaller needle and is supported by a sleeve 150 which is guidedly stabilized by a cannula 315 as it reaches the interior 310 of the eye 350. There is also another pre-placed cannula 330 to guidely support the introduction of a focused work light instrument 325. In some embodiments, the sleeve 150 may further include an illumination fiber 312. Such illumination may be in addition to the work light 325, or may be the only illumination used to deliver the injection (e.g., in the absence of a separate work light instrument 325). While the illumination fiber 312 is shown as terminating on the sleeve, in some embodiments, the fiber may extend further down the needle to provide illumination closer to the injection site. In some embodiments, the light may be positioned approximately 8 mm away from the injection site. Other distances are also contemplated (e.g., 1 mm, 10 mm, etc.). Both cannulae 315, 330 may be retractable to facilitate access through their valves. In addition, the cannulas 315, 330 are located at a position offset from 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 observe the interior 310 of the eye 350 through the cornea 390 and the lens 380 during the procedure with the aid of the light 340 from the instrument 325. However, more indirect viewing options can be used. For example, a wide-angle viewing system with a microscope can be utilized.

[0029] The wide angle viewing system described can be used with a relatively flexible and long large tube given the crowded space. Additionally, the cannula 315 can be articulated. In this way, up to 360 degrees of the retina can be visible and ergonomically accessible. In one embodiment, the end of the needle 170 includes a fiber optic visual enhancement to further assist in viewing, particularly when the needle 170 is brought closer to the retina.

[0030] Continue to focus on accessibility and refer to Figure 2CIn 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 nickel-titanium alloy (such as Nitinol) that has a memory shape. In this way, the needle 170 can be straightened to pass through the cannula 315, which can be achieved directly through the cannula 315, or temporarily retained within the sleeve 150 during passage. In either case, once reaching the interior 310 of the eye 350, the needle 170 can resume the curved shape.

[0031] Reference now Figure 4 , shows an alternative embodiment of a multi-chambered isolated component syringe 400 for eye surgery. In this illustration, the syringe 400 is similar to the syringe 400 in that it isolates the components 140, 160 before mixing them in the mixing chamber 433. Figure 1 4. However, the syringe 400 is now more of a dual-barrel configuration, with separate chambers 440, 460 arranged so that they will open substantially simultaneously to the mixing chamber 433 when the membrane 401 is ruptured. In this way, the route of sequentially introducing the liquid component 160 into the dry component 140 and then introducing both into the mixing chamber 433 can be avoided. Depending on the nature of the components 140, 160, this may be beneficial or promote a more evenly distributed final mixture.

[0032] In addition to the different chamber architectures, Figure 4 The syringe 400 also includes additional mixing enhancement features. For example, the operation of the mixing mechanism 415 is shown to be similar to Figure 1 and Figure 2B The operation of the embodiment of the invention is the same (e.g., see 115). However, in this case, the mechanism 415 can be longer to provide a more significant mixing element. Further, the mechanism 415 itself is shown as contacting the membrane 410 that defines the mixing chamber 433. Therefore, the physical explosion of the membrane 401 can start from the moment when the plunger 110 is pushed. In fact, in one embodiment, the size of the separation element 405 can be customized so that the mechanism 405 is allowed to pass through by physically moving away. In one such embodiment, the remaining part of the membrane 401 can remain structurally intact such as a solid wall barrier to minimize the amount of membrane fragments that may potentially need to be filtered. It should be noted that for the embodiment shown, the mixing mechanism 415 will move between the barrier walls of the chambers 440 and 460, which are not shown in the figure, so as to focus on the mechanism 415. Further, for the embodiment utilizing the separation element 405, these barrier walls will be sealed and connected to the element before the element 405 is moved away or separated.

[0033] In the case of introducing the ingredients 140, 160 into the mixing chamber 433, the longer mechanism 415 can be from about half the length of the chamber 433 up to the full length or even longer. Thus, the repeated reciprocating motion as detailed above can have significantly greater effectiveness in producing a more uniform mixture of the combined ingredients 140, 160 within the chamber 433. Indeed, in the illustrated embodiment, a baffle 450 is included that can further enhance mixing during this reciprocating motion. That is, a unique combination of a fixed baffle 450 in combination with a moving and reciprocating mixing mechanism 415 can be utilized to obtain significantly beneficial effects.

[0034] In some embodiments, the mixing chamber 433 can be positioned adjacent to the tip 181, and in some embodiments, the mixing chamber 433 can 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 in the mixing chamber 433 within the eye just before entering the eye. For example, the components 140, 160 can be delivered to the mixing chamber 433 in the eye near the tip 181 along a separate channel and mixed just before entering the eye. Therefore, the mechanism 115 (e.g., an auger / propeller type mechanism) can rotate near the tip 181 so that the components 140, 160 are mixed at the tip 181 just before entering the eye. In some embodiments, the components 140, 160 can further pass through the baffle 450 for additional mixing before leaving the tip.

[0035] Reference now Figure 5 , a flow chart outlining an embodiment of utilizing a multi-chambered isolated component syringe for eye surgery is shown. That is, dry components and wet components are supplied to isolated chambers of the syringe, as indicated at 510 and 530. At least one barrier or membrane is then breached, as depicted at 550, to advance the components into a mixing chamber, where the components are mixed (see 570). Thus, as indicated at 590, the components can be delivered as a combined mixture to tissue within the patient's eye.

[0036] The embodiments described above include devices and techniques that allow reliable mixing of ingredients to be obtained in an efficient manner so that the combination of ingredients dries relatively quickly in a very short period of time. This is achieved in an ergonomically preferred manner with a single syringe that provides both mixing enhancement and efficiency enhancement.

[0037] The foregoing description has been given with reference to the current preferred embodiment. However, other embodiments and / or features of embodiments disclosed above but not described in detail may be employed. For example, a variety of additional mixing enhancements may be provided in the mixing chamber. This may include the use of a piezoelectric actuator, a spiral or more circuitous path fluidically coupled between the chamber and the needle, or many other architectural features. In embodiments employing piezoelectric actuators, the actuators may be discretely disposed in the mixing chamber or incorporated into a mixing mechanism associated with the plunger or any other part of the syringe, so that the vibration effect is more transmitted throughout a given chamber or even throughout the syringe. In some embodiments, an existing ultrasonic driver electronics from a connected console may be used to vibrate an ultrasonic crystal oscillation driven mixing element (e.g., a piezoelectric driven element). For example, the same ultrasonic driver electronics that drives a piezoelectric handpiece for lens removal may also be used to vibrate a mixing element (such as a metal stirrer) in a syringe. In addition, the vibration / oscillation supplied may vibrate the syringe barrel to further mix the contents. In some embodiments, a pneumatically driven stopper may drive the mixture through an ultrasonic crystal oscillation driven mixing element. Furthermore, those skilled in the art and technology related to these embodiments will appreciate that other changes and variations may be made to the described structures and methods of operation without meaningfully departing from the principles and scope of these embodiments. In addition, the foregoing description should not be read as relating only to the precise structures described and shown in the drawings, but should be read as consistent with and as support for the appended claims, which will have their fullest and fairest scope.

Claims

1. A multi-chambered isolated component syringe for eye surgery, the syringe comprising: a first chamber, the first chamber being used to contain a first component; a second chamber distally adjacent to the first chamber for containing a second component; a mixing chamber distally adjacent to the second chamber to receive the components for mixing thereof in the mixing chamber; at least one mixing mechanism of the syringe, the at least one mixing mechanism being adapted to reach the mixing chamber; as well as A needle is in fluid communication with the mixing chamber for delivering the combined mixed components into an eye of a patient.

2. The syringe according to claim 1, wherein The chambers are isolated from each other by a barrier selected from the group consisting of: a medical foil, a pressure degradable membrane, and a bursting disc.

3. The syringe according to claim 1, wherein: The first chamber is a wet chamber and 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 about 2.00 milliliters (ml) of a polymer solution, the dry component is about 0.10 ml of a dry polymer reactant, and the combined mixed components include a retinal patch.

5. The syringe according to claim 1, wherein: The mixing chamber contains a dedicated air space whose volume is tailored to the components being mixed.

6. The syringe according to claim 1, wherein: The mixing mechanism is an auger device coupled to a plunger for passing the composition to disrupt the barrier.

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

8. The syringe of claim 1, further comprising: a dual-pressor actuator located at a location external to a housing containing the chamber, the dual-pressor actuator being configured to simultaneously provide surgical control of the mixing mechanism; and a plunger for directing the ingredients into the mixing chamber.

9. A multi-barreled isolated component syringe for use in eye surgery, the syringe comprising: a first chamber, the first chamber being used to contain a first component; a second chamber, the second chamber being parallel to the first chamber and configured to contain a second component; as well as a mixing chamber distally adjacent to the first chamber and the second chamber to receive the components therefrom for mixing thereof in the mixing chamber; at least one mixing mechanism of the syringe, the at least one mixing mechanism being adapted to reach the mixing chamber; as well as A needle is in fluid communication with the mixing chamber for delivering the combined mixed components into an eye of a patient.

10. The syringe according to claim 9, wherein: The mixing mechanism is in direct contact with the removable element to introduce the ingredients 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, the mixing chamber further comprising a baffle to enhance mixing during the reciprocating motion.

12. A method of mixing a plurality of components in a syringe for delivery to an eye of a patient, the method comprising: destroying at least one isolation barrier to advance the ingredients from the isolation chamber into the mixing chamber; mixing the ingredients in the mixing chamber using a mixing mechanism; as well as The combined mixture of the ingredients is delivered to the patient's eye.

13. The method of claim 12, wherein: The ingredient chambers are one of: sequentially leading to the mixing chamber for introducing the ingredients into the mixing chamber in a partially combined manner; and parallel for simultaneously introducing the ingredients into the mixing chamber in a substantially uncombined manner.

14. The method of claim 12, further comprising: During the delivering, debris selected from the group consisting of barrier debris and unmixed components is filtered from the combined mixture within the mixing chamber.

15. The method of claim 12, wherein: The disrupting, the mixing, and the delivering are directed by a pneumatic power pack device that includes a dual-pressor actuator to allow mixing actuation to be performed separately from the disrupting and delivering.

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