Endothelium-in DMEK injector and loading system and related systems and methods

Abstract

A modular multi-piece corneal transplant system for the collection of endothelium-in endothelial keratoplasty (EK) corneal allografts. The system has a detachable tissue injector and a coupling funnel and is configured for the collection of allografts in the detachable injector from a punch block, where the detachable injector is disposed at an ergonomic angle. The fluid-filled injector containing the allograft can then be detached and fitted to a syringe for insertion into a micro corneal incision for placement in a patient in need thereof.

Description

ENDOTHELIUM-IN DMEK INJECTOR AND LOADING SYSTEM AND RELATED SYSTEMS ANDMETHODSCross-References & Related Applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 529,870 filed July 31 , 2023, which is hereby incorporated by reference in its entirety under 35 U.S.C. §119(e).Technical Field

[0002] This disclosure relates to a modular corneal transplant system used to access, collect and load corneal endothelial cell allografts, including endothelial keratoplasty (EK) tissues such as Descemet Membrane Endothelial Keratoplasty (DMEK) allografts, into an injector which is used to transplant the collected cells into a patient in need thereof. In various implementations, the system comprises a tissue injector that connects to a syringe to deliver the corneal allograft into the eye, and a coupling or loading funnel that couples the injector to a corneal punch block and is configured at a trajectory that provides for an ergonomic angle of approach to load the injector by manually transferring the allograft with micro-forceps from the corneal punch block into the injector after it has been manipulated into an endothelium-in configuration.BACKGROUND

[0003] There is a need in the art for improved endothelium-in EK devices having improved dimensions and form factors.BRIEF SUMMARY OF THE INVENTION

[0004] Described herein are various implementations relating to devices, systems and methods for a modular endothelium-in EK allograft injection system and corresponding devices and methods of use.

[0005] In Example 1 , a modular multi-piece corneal transplant system comprising a detachable tissue injector comprising an injector lumen; and a coupling funnel comprising a funnel lumen, wherein the funnel lumen and injector lumen are in fluidic communication and are configured to accept an endothelium-in endothelial keratoplasty (EK) corneal allograft

[0006] In Example 2, the system of Example 1 , wherein the coupling funnel comprises a body configured for secure placement adjacent to a punch block.

[0007] In Example 3, the system of Example 1 or 2, wherein the coupling funnel comprises a funnel opening comprising a ramp portion configured for placement adjacent to an upside-down corneoscleral rim for accepting the endothelium-in EK corneal allograft or equivalent.

[0008] In Example 4, the system of any of Examples 1-3, wherein the coupling funnel is configured to dispose the detachable tissue injector at an angular trajectory.

[0009] In Example 5, the system of any of Example 4, wherein the angular trajectory approximates the angle of a peripheral upward-facing surface of an upside-down corneoscleral rim or corneoscleral rim equivalent resting on a concave punch block.

[0010] In Example 6, the system of any of Examples 1-5, wherein the tissue injector is an elongate tube comprising several injector segments.

[0011] In 7, the system of any of Examples 1-6, wherein the tissue injector comprises three segments comprising a first end segment, a second end segment and a central segment, and the second end segment has a width that is configured for use with a micro-corneal incision.

[0012] In Example 8, the system of any of Examples 1-7, wherein the tissue injector comprises three segments comprising a first end segment, a second end segment and a central segment, and the second end segment has a width that is between about 1 ,5mm and about 4.5mm.

[0013] In Example 9, the system of any of Examples 1-8, wherein the injector lumen comprises a plurality of lumen segments disposed therethrough corresponding to various injector segments.

[0014] In Example 10, the system of any of Examples 1-9, wherein the EK allografts are Descemet membrane endothelial keratoplasty (DMEK) allografts, Descemet stripping automated endothelial keratoplasty (DSAEK) allografts, pre-Descemet endothelial keratoplasty (PDEK), cultured allografts or biosynethic allografts.

[0015] In Example 11 , the system of any of Examples 1-10, wherein the injector comprises glass, medical plastic, elastomer, rubber, latex, synthetic rubber and coated variants thereof

[0016] In Example 12, the system of any of Examples 1-11 , wherein the injector comprises medical plastic, elastomer, rubber, latex, synthetic rubber and coated variants thereof

[0017] In Example 13, a modular multi-piece corneal transplant system, comprising a detachable tissue injector comprising an injector lumen; and a coupling funnel comprising a funnel lumen, wherein the funnel lumen and injector lumen are in fluidic communication and are configured to accept an endothelium-in endothelial keratoplasty (EK) corneal allograft, and the tissue injector comprises at least one segment is configured for introduction into a microincision.

[0018] In Example 14, the system of Example 14, wherein the micro-incision is between about 1.5mm and about 4.5mm.

[0019] In Example 15, the system of Example 13 or 14, wherein the coupling funnel comprises a body configured for secure placement adjacent to a punch block.

[0020] In Example 16, the system of any of Examples 13-15, wherein the coupling funnel comprises a funnel opening comprising a ramp portion configured for placement adjacent to an upside-down corneoscleral rim for accepting the endothelium-in EK corneal allograft or equivalent.

[0021] In Example 17, the system of any of Examples 13-16, wherein the coupling funnel is configured to dispose the detachable tissue injector at an angular trajectory.

[0022] In Example 18, the system of any of Examples 13-17, wherein the angular trajectory approximates the angle of a peripheral upward-facing surface of an upside-down corneoscleral rim or corneoscleral rim equivalent resting on a concave punch block.

[0023] In Example 19, the system of any of Examples 13-18, wherein the EK allografts are Descemet membrane endothelial keratoplasty (DMEK) allografts, Descemet stripping automated endothelial keratoplasty (DSAEK) allografts, pre-Descemet endothelial keratoplasty (PDEK), cultured allografts or biosynethic allografts.

[0024] In Example 20, a modular multi-piece corneal transplant system for the collection of endothelium-in endothelial keratoplasty (EK) corneal allografts, comprising a detachable tissue injector comprising an injector lumen; and a coupling funnel comprising a funnel lumen and a ramp and is configured to be operably coupled to a punch block wherein the detachable tissue injector and funnel lumen are configured to be in releasable fluidic communication with the punch block, and the ramp and funnel lumen are configured to intersect at a shallow angle with a peripheral upward-facing surface of an upside-down corneoscleral rim on the punch block.

[0025] In Example 21 , the system of Example 20, wherein the tissue injector is disposed at an ergonomic trajectory of between about 15° and about 75° from horizontal.

[0026] In Example 22, the system of Example 20 or 21 , wherein the tissue the tissue injector is configured for introduction into a micro-incision.

[0027] The modular endothelium-in EK allograft injection system described herein has numerous advantages over the prior art. Such non-limiting advantages include: that it has an integrated funnel that provides a gentle loading ramp on which the allograft can be pulled into an injector, that according to certain implementations it utilizes an endothelial-in system that can employ a fluid-filled injector to propel the tissue into the eye, that according to certain implementations it fits into a micro-corneal incision, such as an incision of less than 2.4mm, thataccording to certain implementations the injector is the substantially same diameter along its length so that it can be inserted to varying extents into and across the anterior chamber without affecting its seal with the corneal incision, and that according to certain implementations because the injector can be inserted across the anterior chamber, the injector can be used to deliver tissue by a combination of injection and tissue fixation with an instrument such as forceps. Further advantages will be apparent from the enclosed description.BRIEF DESCRIPTION OF DRAWINGS

[0028] FIG. 1 is a perspective view of the modular endothelium-in EK allograft injection system in use, according to one implementation.

[0029] FIG. 2A is a perspective view of the injector, according to one implementation.

[0030] FIG. 2B is a cross-sectional view of the injector of FIG. 2A.

[0031] FIG. 2C is a perspective view of the coupling funnel attached to a punch block, according to one implementation.

[0032] FIG. 3A is a perspective view of the coupling funnel, according to one implementation.

[0033] FIG. 3B is a side view of the coupling funnel, according to one implementation.

[0034] FIG. 3C is a cutaway perspective view of the coupling funnel, according to one implementation.

[0035] FIG. 3D is a cutaway side view of the coupling funnel, according to one implementation.

[0036] FIG. 3E is a top perspective view of the coupling funnel, according to one implementation.

[0037] FIG. 3F is a bottom view of the coupling funnel, according to one implementation.

[0038] FIG. 3G is a front view of the coupling funnel, according to one implementation.

[0039] FIG. 3H is a back view of the coupling funnel, according to one implementation.

[0040] FIG. 4A is a perspective view of the coupling funnel fitted to a punch block, according to one implementation.

[0041] FIG. 4B is a cutaway side view of the coupling funnel fitted to a punch block, according to one implementation.

[0042] FIG. 5 is a perspective view of the modular endothelium-in EK allograft injection system in use, according to one implementation.

[0043] FIG. 6 is a perspective view of the modular endothelium-in EK allograft injection system after it has been inserted into a corneal incision of a human cadaveric cornea that has beenmounted to an artificial anterior chamber to simulate ophthalmic surgery with the endothelial keratoplasty allograft in its lumen, according to one implementation.

[0044] FIG. 7 is a close-up view of the injector in use, according to one implementation.DETAILED DESCRIPTION

[0045] The disclosed modular endothelium-in EK allograft injection system 10 overcomes limitations in the prior art and is configured for delivering an endothelial keratoplasty (EK) corneal allograft into the eye in an endothelium-in configuration through the use of an injector 20 and coupling funnel 30, as is further described herein.

[0046] In various implementations, the endothelium-in EK allografts can be of various types, certain non-limiting examples being Descemet membrane endothelial keratoplasty (DMEK) allografts, Descemet stripping automated endothelial keratoplasty (DSAEK), pre-Descemet endothelial keratoplasty (PDEK), cultured allografts, biosynethic allografts and the like as would be understood.

[0047] As is shown in the implementation of FIG. 1 , the system 10 comprises one or more components, which can be a detachable tissue injector 20 and a coupling funnel 30 or loading funnel 30 that is configured to couple to the injector 20 while affixed or otherwise in operational communication with a corneal punch block 40 for the loading of endothelium-in EK allografts, as would be appreciated by those of skill in the art.

[0048] In various implementations, and as shown in FIGS. 1 and 2A-2B, the tissue injector 20 is an elongate tube that may comprise several injector segments 20A, 20B, 20C. As will be understood, the injector 20 according to these implementations is configured for use as an fluid- filled endothelial-in injector 20 that is configured to load an allograft into the injector 20 while mounted on a funnel 30, and then subsequently be removed from the funnel 30 with the sample, be mounted to a syringe, be primed with fluid that is then used to propel the endothelial-in EK allograft tissue into the eye via a micro-incision, such as via an incision of about 2.2mm or smaller. That is, in certain implementations the injector 20 is initially filled with air and then loaded with the allograft and then subsequently primed with liquid for the injection of the sample through an incision and into the eye of a patient.

[0049] As to the incision, it is understood that an incision that is less than about 2.4mm is generally considered to be a micro-incision, but that in certain use cases of the described system 10 a variety of incision sizes are possible, ranging from about 1.5mm or less to about4.5mm or more. One of skill in the art would appreciate that these approximate sizes and ranges are in no way intended to be limiting.

[0050] Continuing with the implementations of FIGS. 1 and 2A-2B, the injector 20 has an injector body 22 having a first end 24 configured for operable communication with the coupling funnel 30 and a second end 26 that is optionally angled 0, as well, so as to be configured to accommodate the introduction of various tools and subsequently be used for entrance through a corneal incision followed by the injection of the collected sample, as described herein. It will be appreciated that the first end 24 of the injector is distal to the user during the loading of the allograft and then subsequently becomes the proximal end when fitted to a syringe for use during injection of the sample into the eye.

[0051] Further, in various implementations like those of FIGS. 1 and 2A-2B, the injector has a first end width (reference arrow C) at the first end 24 and a second end width (reference arrowA) at the second end 26, and the central segment 20B having a transition width (reference arrowB) that transitions between the first end C and second end A widths. The first end width C facilitates coupling of the injector to the coupling funnel 30, as described herein, and the second end width A facilitates insertion into a micro-corneal incision.

[0052] Continuing with the implementations of FIGS. 1 and 2A-2B, the second end 26 segment has a width B that is between about 1.5mm and about 4.5mm. Further, in certain implementations, the second width B is less than about 2.1 mm so that it is therefore adapted to fit into a 2.2 mm corneal incision. In further implementations, both the first A and second B widths are less than about 2.1 mm. In yet further, alternate implementations, both the first A and second B widths are greater than 2.1 mm.

[0053] Continuing with the implementations of FIGS. 1 and 2A-2B, the injector 20 also has a lumen 28 defined therethrough, wherein the lumen 28 may have several lumen segments 28A, 28B, 28C disposed therethrough and corresponding to the various injector segments 20A, 20B, 20C. These lumen segments 28A, 28B, 28C are in sealed fluidic communication with one another, as would be readily apparent.

[0054] In various implementations, and as discussed above and shown in FIG. 2B, the segments 20A, 20B, 20C can comprise various segment widths A, B, C. Correspondingly, the lumens 28A, 28B, 28C can comprise various lumen widths DA, DB, Dchaving diameters that can be determined by the wall thickness and / or the width of the various injector segments 20A, 20B, 20C so as to result in a variety of configurations, as would be appreciated. In certainimplementations, the wall thickness can be made thinner to widen the lumen diameter widths DA, DB, DCrelative to the segment widths A, B, C. In further implementations, the wall thickness can be held constant such that altering the lumen diameters widths DA, DB, DC changes the widths A, B, C of the injector segments 20A, 20B, 20C, as would be understood. In yet further implementations, the wall thickness can vary between lumen segments 28A, 28B, 28C with or without changing the widths of the injector segments 20A, 20B, 20C.

[0055] Further, in various implementations, and as will be readily apparent from the drawings, the system 10 is constructed and arranged such that the injector 20 is disposed at an ergonomic trajectory that approximates the angle of the peripheral upward-facing surface of a corneoscleral rim resting on a concave punch block 40 for the collection of the endothelium-in EK corneal allograft or equivalent. This allows for an angle of approach that will permit the introduction of microforceps or other surgical tools, as described here. In various implementations, for example, the angle of approach and corresponding trajectory (designated variously throughout as 0) is about 45° from the horizon, though it would be readily apparent that in various implementations the trajectory 0 can be from about 15° to about 75° from horizontal, or anywhere from about 0° to about 90° from horizontal. The implementations of the coupling funnel 30 shown in FIGS. 3A-3H and FIGS. 4A-4B variously depict the ergonomical trajectory 0 further. It is of course appreciated that many ergonomical trajectories 0 are of course possible.

[0056] Continuing with the implementations of the coupling funnel 30 shown in FIGS. 2C and FIGS. 3A-3H, the coupling funnel 30 is configured to be seated into a punch block 40. The coupling funnel 30 defines an opening 32 and lumen 34 that is configured to accommodate the microforceps through the injector 20 and funnel 30, as would be understood.

[0057] The coupling funnel 30 according to these implementations comprises a body 36, and as shown in FIG. 2C and 3A-H, in certain implementations of the coupling funnel 30, at the distal opening 32 the body 36 further features a ramp portion 46 including a flared 46A distal extension and that is adjacent to the opening 32 and lumen 34 and is configured to accommodate the introduction and use of a surgical tool 2 such as a small microforceps 2 for use in the collection of the allograft via the ramp portion 46.

[0058] The ramp portion 46 according to these implementations is configured to intersect at a shallow angle with the peripheral upward-facing surface 80 of an upside-down corneoscleral rim 80 resting on the concave punch block 40 when the rim 80 has been positioned under the bottom free edge of the ramp portion 46 and provide ergonomic and clear access to the samplevia the ergonomic trajectory 0 of the lumen 34, as would be appreciated. Further, in certain implementations the inner portion 36A of the body 36 is correspondingly curved or otherwise adapted to be fitted around the punch block 40, as would be understood.

[0059] In various implementations, the mating portion 44 comprises adjacent mating portions 44A, 44B disposed at about a 90° angle to one another, though other configurations are of course possible.

[0060] The coupling funnel 30 further has a coupler body 36 and receiving nipple 38 and recession 42 that are configured for coupling with the distal first end 24 of the injector 20 in a fluidic seal such that the lumen 34 of the coupling funnel 30 and the lumen(s) 28 of the injector 20 are in sealed fluidic communication for use in the collection of the EK corneal allograft in an endothelium-in configuration for subsequent use, as would be understood. That is, during use, the coupling funnel 30 is adapted for the coupling of the injector 20 for the loading of the endothelium-in EK cells from a specimen placed in the punch block 40, such as via the tool 2, as will be understood.

[0061] Further, on the opposite side of the body 36, and as shown in FIG. 2C, in certain implementations of the coupling funnel 30, the body further features a flared distal extension and ramp portion 46 that is adjacent to the lumen 34 and is configured to accommodate the introduction and use of a surgical tool 2 such as microforceps 2 for use in the loading procedure via the ramp portion 46, which is configured to intersect at a shallow angle with the peripheral upward-facing surface 81 of an upside-down corneoscleral rim 80 resting on the concave punch block 40 when the rim 80 has been positioned under the bottom free edge of the ramp portion 46.

[0062] It is further appreciated that the funnel lumen 34 and various injector lumen segments 24A, 24B, 24C are configured to accommodate the tool 2 such as the microforceps 2 at its distal end 4 to grasp and manipulate corneal allograft tissue on the corneal punch block 40 adjacent to the opening 32 and ramp portion 46, and subsequently pull or otherwise load the allograft gently into the injector via the ramp portion 46, as would be appreciated by those of skill in the art.

[0063] The coupling funnel 30 according to certain implementations is also adapted or otherwise configured to be in operational communication with or otherwise be supported by a corneal punch block 40, such as by way of a defined mating portion 44 which is configured toallow the coupling funnel 30 to be disposed in the outer trough 48 of the punch block 40, as would be readily understood.

[0064] In various implementations, the body 36 of the coupling funnel 30 optionally comprises one or more body projections 52 surrounding a defined central opening 54 which provides for an improved form-factor and allows for stability of the body 36 within the outer trough 48 without additional weight or inducing unnecessary friction when placing the body 36 in the outer trough 48 or rotating it about the punch block 40, as would be understood. It is readily apparent that the body 36, mating portion 44, and body projections 52 can be otherwise configured to be in operational communication with a punch block of varying size and shape, with or without an outer trough.

[0065] In use, and as shown in FIGS. 5-7, the injector 20 is connected to the coupling funnel 30, which is seated securely on the punch block 40.

[0066] In these implementations, EK tissue is tri-folded into a conventional endothelium-in configuration as an allograpft 60 and positioned on a corneoscleral donor rim 80 for collection. As is shown in FIG. 5, the corneoscleral donor rim 80 is correspondingly positioned such that it is adjacent to the opening 32, coupling funnel lumen 34 and ramp 46, as would be readily understood. In these implementations, a surgical tool 2 such as microforceps 2 is introduced via the injector lumen 28 and funnel lumen 34 to the corneoscleral donor rim 80, where the EK allograft 60 is grasped with the microforceps 2 and passaged into the injector lumen 28, where it is held for subsequent use.

[0067] The injector 20 containing the allograft 60 can then be disconnected from the coupling funnel 30 by the user, and then connected to a syringe 82 that has been pre-filled with balanced salt solution or other appropriate liquid for injection, as is shown in FIGS. 6-7. That is, the first end 24 of the injector 20 is coupled to the syringe and the second end 26 is now distal to the user and is inserted into the eye 6 of the patient in need thereof and used to inject the allograft 60 tissue, as would be understood and as is shown in FIGS. 6-7.

[0068] It is appreciated that in various implementations the injector 20 has been primed with fluid and is then used to propel the endothelial-in EK allograft tissue into the eye via a microincision, such as via a 2.2mm incision or a smaller incision. In certain implementations the injector 20 is initially filled with air and then loaded with the allograft and then subsequently primed with liquid for the injection of the sample through an incision and into the eye of a patient.

[0069] In various implementations, the injector 20 is made of glass and / or inert medical plastic or other suitable surgical material. Likewise, in various implementations, the loading funnel 30 is made of medical plastic or other materials, including but not limited to medical metals or other polymers commonly used in such application. In various implementations, the loading funnel 30 is adapted to attach to commercially available corneal punch blocks 40 of various sizes and shapes via press-fitting or is alternately integrated into a standalone corneal punch block 40 or other device fulfilling the purpose of such a block, which is to hold a corneoscleral rim 80 securely for EK tissue preparation as described herein.

[0070] Although the disclosure has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the disclosed apparatus, systems and methods.

Claims

ClaimsWhat is claimed is:

1. A modular multi-piece corneal transplant system comprising: a. a detachable tissue injector comprising an injector lumen; and b. a coupling funnel comprising a funnel lumen, wherein the funnel lumen and injector lumen are in fluidic communication and are configured to accept an endothelium-in endothelial keratoplasty (EK) corneal allograft.

2. The system of claim 1, wherein the coupling funnel comprises a body configured for secure placement adjacent to a punch block.

3. The system of claim 1 or 2, wherein the coupling funnel comprises a funnel opening comprising a ramp portion configured for placement adjacent to an upside-down corneoscleral rim for accepting the endothelium-in EK corneal allograft or equivalent.

4. The system of any of claims 1-3, wherein the coupling funnel is configured to dispose the detachable tissue injector at an angular trajectory.

5. The system of any of claim 4, wherein the angular trajectory approximates the angle of a peripheral upward-facing surface of an upside-down corneoscleral rim or corneoscleral rim equivalent resting on a concave punch block.

6. The system of any of claims 1-5, wherein the tissue injector is an elongate tube comprising several injector segments.

7. The system of any of claims 1-6, wherein the tissue injector comprises three segments comprising a first end segment, a second end segment and a central segment, and the second end segment has a width that is configured for use with a micro-corneal incision.

8. The system of any of claims 1-7, wherein the tissue injector comprises three segments comprising a first end segment, a second end segment and a central segment, and the second end segment has a width that is between about 1.5mm and about 4.5mm.

9. The system of any of claims 1-8, wherein the injector lumen comprises a plurality of lumen segments disposed therethrough corresponding to various injector segments.

10. The system of any of claims 1-9, wherein the EK allografts are Descemet membrane endothelial keratoplasty (DMEK) allografts, Descemet stripping automated endothelial keratoplasty (DSAEK) allografts, pre-Descemet endothelial keratoplasty (PDEK), cultured allografts or biosynethic allografts.

11. The system of any of claims 1-10, wherein the injector comprises glass, medical plastic, elastomer, rubber, latex, synthetic rubber and coated variants thereof.

12. The system of any of claims 1-11, wherein the injector comprises medical plastic, elastomer, rubber, latex, synthetic rubber and coated variants thereof.

13. A modular multi-piece corneal transplant system, comprising: a. a detachable tissue injector comprising an injector lumen; and b. a coupling funnel comprising a funnel lumen, wherein: i. the funnel lumen and injector lumen are in fluidic communication and are configured to accept an endothelium-in endothelial keratoplasty (EK) corneal allograft, andii. the tissue injector comprises at least one segment is configured for introduction into a micro-incision.

14. The system of claim 14, wherein the micro-incision is between about 1.5mm and about 4.5mm.

15. The system of claim 13 or 14, wherein the coupling funnel comprises a body configured for secure placement adjacent to a punch block.

16. The system of any of claims 13-15, wherein the coupling funnel comprises a funnel opening comprising a ramp portion configured for placement adjacent to an upside-down corneoscleral rim for accepting the endothelium-in EK corneal allograft or equivalent.

17. The system of any of claims 13-16, wherein the coupling funnel is configured to dispose the detachable tissue injector at an angular trajectory.

18. The system of any of claims 13-17, wherein the angular trajectory approximates the angle of a peripheral upward-facing surface of an upside-down corneoscleral rim or corneoscleral rim equivalent resting on a concave punch block.

19. The system of any of claims 13-18, wherein the EK allografts are Descemet membrane endothelial keratoplasty (DMEK) allografts, Descemet stripping automated endothelial keratoplasty (DSAEK) allografts, pre-Descemet endothelial keratoplasty (PDEK), cultured allografts or biosynethic allografts.

20. A modular multi-piece corneal transplant system for the collection of endothelium-in endothelial keratoplasty (EK) corneal allografts, comprising: a. a detachable tissue injector comprising an injector lumen; and b. a coupling funnel comprising a funnel lumen and a ramp and is configured to be operably coupled to a punch block, wherein:i. the detachable tissue injector and funnel lumen are configured to be in releasable fluidic communication with the punch block, and ii. the ramp and funnel lumen are configured to intersect at a shallow angle with a peripheral upward-facing surface of an upside-down corneoscleral rim on the punch block.

21. The system of claim 20, wherein the tissue injector is disposed at an ergonomic trajectory of between about 15° and about 75° from horizontal.

22. The system of claim 20 or 21 , wherein the tissue the tissue injector is configured for introduction into a micro-incision.

23. The system of any of claims 20-22, wherein the coupler body comprises a receiving nipple and recession that are configured for coupling with a distal end of the injector.

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