Device for administering therapeutic drugs via the choroid

Abstract

To provide a device for delivering therapeutic drugs to the eye that allows access to the macula in a practical way. [Solution] The device for delivering therapeutic drugs to the eye includes a main body, a cannula 20, a needle 30, and an actuation assembly. The cannula extends distally from the main body and is sized and configured to be inserted between the choroid and sclera of the patient's eye. The actuation assembly acts the needle relative to the cannula, thereby driving the distal portion of the needle along an exit axis oriented at an angle of 5° to 30° with respect to the longitudinal axis of the cannula. The cannula can be inserted through a scleral incision to position its distal end between the choroid and sclera in the posterior region of the eye. The needle can be advanced through the choroid to deliver therapeutic drugs adjacent to the potential space between the neurosensory retina and the retinal pigment epithelium, adjacent to the geographic atrophy area.

Description

[Technical Field]

[0001] (Priority) This application claims priority to U.S. Provisional Patent Application No. 61 / 938,956, entitled “Suprachoroidal Approach,” filed on 12 February 2014, the disclosures of which are incorporated herein by reference.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 62 / 049,056, “Suprachoroidal Injector Design,” filed on 11 September 2014, the disclosures of which are incorporated herein by reference.

[0003] This application also claims priority to U.S. Provisional Patent Application No. 62 / 049,089, “Suprachoroidal Suture Measurement Template,” filed on 11 September 2014, the disclosures of which are incorporated herein by reference.

[0004] This application also claims priority to U.S. Provisional Patent Application No. 62 / 049,100, “Suprachoroidal Procedure Method,” filed on 11 September 2014, the disclosures of which are incorporated herein by reference.

[0005] This application also claims priority to U.S. Provisional Patent Application No. 62 / 049,128, “Suprachoroidal Manual Advance Injector and Third Arm,” filed on 11 September 2014, the disclosures of which are incorporated herein by reference.

[0006] This application also claims priority to U.S. Provisional Patent Application No. 62 / 104,295, filed on 16 January 2015, entitled “Method and Apparatus for Suprachoroidal Administration of Therapeutic Agent,” the disclosures of which are incorporated herein by reference.

[0007] (Statement regarding joint research) The subject matter disclosed in this application was developed and the invention described in the claims was created by one or more parties to a joint research agreement that was in effect prior to the effective filing date of the claimed invention, or for such parties. The claimed invention was created as a result of activities carried out within the scope of the joint research agreement. The parties to the joint research agreement include Ethicon Endo-Surgery, Inc. and Janssen Research & Development, LLC. [Background technology]

[0008] The human eye has several layers. The white outer layer is the sclera, which surrounds the choroidal layer. The retina is located inside the choroidal layer. The sclera contains collagen and elastic fibers and protects the choroid and retina. The choroidal layer contains a vascular system that supplies oxygen and nutrients to the retina. The retina contains photosensitive tissue such as rods and cones. The macula is located in the center of the retina at the back of the eye and is generally centered on the axis (i.e., the visual axis) that passes through the center of the lens and cornea of ​​the eye. The macula provides central vision, particularly through the cone cells.

[0009] Macular degeneration is a medical condition affecting the macula, and individuals with macular degeneration may experience loss or reduction of central vision while maintaining some degree of peripheral vision. Macular degeneration can be caused by various factors, including aging (also known as "AMD") and genetic factors. Macular degeneration can develop in a "dry" (non-exudative) form, where cellular debris, also known as drusen, accumulates between the retina and choroid, causing geographic atrophy. It can also develop in a "wet" (exudative) form, where blood vessels grow from the choroid behind the retina. While individuals with macular degeneration may maintain some degree of peripheral vision, loss of central vision can significantly impact their quality of life. Furthermore, the quality of remaining peripheral vision may deteriorate, and in some cases, it may even disappear. Therefore, treating macular degeneration may be desirable to prevent or reverse blindness caused by the condition. In some cases, it may be desirable to perform such treatment in a highly localized manner, for example, by delivering therapeutic substances to the subretinal layer (below the sensory nerve layer of the retina and above the retinal pigment epithelium) directly adjacent to the geographic atrophy area near the macula. However, because the macula is located in the fundus and beneath the vulnerable layers of the retina, accessing the macula in a practical manner can be difficult.

[0010] Although various surgical methods and instruments have been developed and used to treat the eyes, it is believed that no one had created or used the present invention as described in the attached claims prior to the present inventors. [Overview of the project] [Means for solving the problem]

[0011] A first embodiment of the present invention includes a device for delivering a therapeutic drug to the eye. The device includes a body, a cannula, a hollow needle, and an actuation assembly. The cannula extends distally from the body. The cannula is sized and configured to be insertable between the choroid and sclera of the patient's eye. The cannula defines a longitudinal axis. The needle is slidable relative to the cannula. The actuation assembly is capable of acting the needle relative to the cannula, thereby driving the distal portion of the needle along an exit axis oriented obliquely to the longitudinal axis of the cannula.

[0012] In some variations of the first embodiment, the actuation assembly includes an actuation member that is movable relative to the body in order to actuate the needle.

[0013] In some variations of the first embodiment, the actuating member is movable relative to the body in order to actuate the needle, and in some variations of the first embodiment, the actuating member is translatable relative to the body in order to actuate the needle.

[0014] In some variations of the first embodiment, the actuating member is movable relative to the body in order to actuate the needle, and in some variations of the first embodiment, the actuating member is rotatable relative to the body in order to actuate the needle.

[0015] In some variations of the first embodiment, where the actuating member is rotatable relative to the body to actuate a needle, the actuating assembly includes a threaded member associated with the actuating member. The threaded member is configured to engage with a threaded hole in the body and actuate the needle when the actuating member rotates relative to the body.

[0016] In some variations of the first embodiment, the needle has a sharp distal tip.

[0017] In some variations of the first embodiment, in which the needle includes a sharp distal tip, the sharp distal tip of the needle includes a first bevel, a second bevel, and a third bevel. The first, second, and third bevels are each oriented obliquely to one another.

[0018] In some variations of the first embodiment, the ejection axis is oriented at an angle of approximately 5° to approximately 30° with respect to the longitudinal axis of the cannula.

[0019] In some variations of the first embodiment, the ejection axis is oriented at an angle of approximately 7° to approximately 9° with respect to the longitudinal axis of the cannula.

[0020] In some variations of the first embodiment, the needle includes a blunt distal tip.

[0021] In some variations of the first embodiment, the cannula includes an inclined distal end. The inclined distal end has an inclination angle, which is approximately 10° to approximately 30°.

[0022] In some variations of the first embodiment, the cannula defines a plurality of lumens that extend longitudinally along the length of the cannula. At least one of the plurality of lumens is configured to slidably receive a needle.

[0023] In some variations of the first embodiment, the cannula is 0.7 × 10 -6 Nm 2 ~11.1×10 -6 Nm 2 It has bending rigidity.

[0024] In some variations of the first embodiment, the cannula is 2.0 × 10 -6 Nm 2 ~6.0×10 -6 Nm 2 It has bending rigidity.

[0025] In some variations of the first embodiment, the device further includes a valve assembly. The valve assembly is operable to provide a fluid connection between a fluid source and a needle. The valve assembly is configured to translate together with the needle relative to the body.

[0026] A second embodiment of the present invention includes a method for using a surgical instrument. The surgical instrument includes a cannula and a hollow needle movable relative to the cannula. The method includes the step of making a scleral incision by forming an incision in the patient's eye, the incision penetrating the scleral layer of the eye to provide access to the suprachoroidal space of the eye. The method further includes the step of inserting the cannula through the scleral incision. The method further includes the step of advancing the cannula between the choroid and the sclera to position the distal end of the cannula in the posterior region of the suprachoroidal space. The method further includes the step of advancing the needle relative to the cannula through the choroid to the subretinal space without perforating the retina. The method further includes the step of delivering a therapeutic agent into the subretinal space via the advanced needle.

[0027] In some variations of the second embodiment, the method further includes delivering a leading bleb of fluid via the forward needle before delivering a therapeutic agent via the forward needle.

[0028] In some variations of the second embodiment, the method further includes the step of attaching a suture loop to the patient's eye. The act of attaching the suture loop includes passing the suture through at least a portion of the patient's eye (e.g., the sclera) to form at least one loop defined by the suture. The act of inserting the cannula includes passing the cannula through the suture loop.

[0029] A third embodiment of the present invention includes a method for administering a therapeutic solution to a patient's eye via the choroid. The method includes passing a suture through at least a portion of the patient's eye (e.g., the sclera) to form at least one loop defined by the suture. The method further includes making an incision in at least a portion of the eye (e.g., the sclera) to provide access to the choroid of the eye. The method further includes guiding a cannula through the at least one loop defined by the suture into the incision formed by making an incision in at least a portion of the eye (e.g., the sclera). The method further includes advancing a needle through the cannula to penetrate the choroid and administer the therapeutic solution.

[0030] In some variations of the third embodiment, the method further includes the step of guiding the cannula to the injection site by direct visualization through the pupil. [Brief explanation of the drawing]

[0031] This specification concludes with claims that specifically identify and explicitly assert the rights to the present technology, which will be better understood by reading the following description of specific embodiments in conjunction with the accompanying drawings, in which similar reference numerals indicate the same elements. [Figure 1] This is a perspective view of an exemplary device for the choroidal administration of therapeutic drugs. [Figure 2] Another perspective view of the device shown in Figure 1, with a portion of the main body removed. [Figure 3] Figure 1 shows a detailed view of the distal end of the cannula of the device. [Figure 4] Figure 3 shows a cross-sectional view of the cannula, with the cross-section cut along line 4-4 in Figure 3. [Figure 5A] Figure 1 shows a detailed perspective view of the distal end of the needle of the instrument. [Figure 5B] Figure 1 shows a detailed elevation view of the distal end of the needle of the instrument. [Figure 5C] A detailed perspective view of the distal end of an exemplary alternative needle for use with the instrument in Figure 1 is shown. [Figure 5D] A detailed perspective view of the distal end of another exemplary alternative needle for use with the instrument in Figure 1 is shown. [Figure 5E] A detailed perspective view of the distal end of yet another exemplary alternative needle for use with the instrument in Figure 1 is shown. [Figure 5F] A detailed perspective view of the distal end of yet another exemplary alternative needle for use with the instrument in Figure 1 is shown. [Figure 5G] A detailed perspective view of the distal end of yet another exemplary alternative needle for use with the instrument in Figure 1 is shown. [Figure 5H] A detailed perspective view of the distal end of yet another exemplary alternative needle for use with the instrument in Figure 1 is shown. [Figure 5I] A detailed perspective view of the distal end of yet another exemplary alternative needle for use with the instrument in Figure 1 is shown. [Figure 6] Figure 1 shows a side view of the device. [Figure 7] Another side view of the device shown in Figure 1, with the locking member removed. [Figure 8] Another side view of the device shown in Figure 1 is displayed, with the working member advanced distally to extend the needle distally from the cannula. [Figure 9] Figure 1 shows a perspective view of an exemplary support assembly for use with the device shown. [Figure 10] Figure 9 shows a cross-sectional view of the support assembly. [Figure 11] Another perspective view of the support assembly in Figure 9 is shown, illustrating various axes of movement. [Figure 12] Figure 9 shows another perspective view of the support assembly with the device from Figure 1 positioned within the support assembly's cradle. [Figure 13] A perspective view of an exemplary suture measurement template used in an exemplary method for choroidal administration of therapeutic drugs is shown. [Figure 14A] This shows a plan view of the patient's eye, with the surrounding structures fixed and a chandelier installed. [Figure 14B] Figure 14A shows a plan view of the eye with the template from Figure 13 placed on top of the eye. [Figure 14C] Figure 14A shows a plan view of the eye with multiple markers placed above it. [Figure 14D] Figure 14A shows a plan view of the eye with the suture loop attached. [Figure 14E] Figure 14A shows a plan view of the eye where a scleral incision has been made. [Figure 14F] Figure 14A shows a plan view of the eye, with the instrument shown in Figure 1 inserted between the sclera and choroid of the eye through the scleral incision opening. [Figure 14G] Figure 14A shows a plan view of the eye, with the instrument shown in Figure 1 positioned between the sclera and choroid under direct visualization of the fundus. [Figure 14H] Figure 14A shows a plan view of the eye in which the needle of the instrument shown in Figure 1 is advanced under direct visualization of the fundus, and the outer surface of the choroid is pressed, causing the choroid to be "tented". [Figure 14I] Figure 14A shows a plan view of the eye, with the needle dispensing the leading bleb under direct visualization of the fundus, the needle positioned between the sclera and choroid, and the leading bleb in the subretinal space between the choroid and retina. [Figure 14J] Figure 14A shows a plan view of the eye, with the needle dispensing the drug into the eye between the sclera and choroid of the fundus. [Figure 15A] Figure 14A shows a cross-section of the eye, with the cross-section cut along the line 15A-15A in Figure 14A. [Figure 15B] Figure 14A shows a cross-section of the eye, and the cross-section is cut along the line 15B-15B in Figure 14E. [Figure 15C] Figure 14A shows a cross-section of the eye, and the cross-section is cut along the line 15C-15C in Figure 14F. [Figure 15D] Figure 14A shows a cross-section of the eye, and the cross-section is cut along the line 15D-15D in Figure 14G. [Figure 15E] Figure 14A shows a cross-section of the eye, and the cross-section is cut along the line 15E-15E in Figure 14H. [Figure 15F] Figure 14A shows a cross-section of the eye, and the cross-section is cut along the line 15F-15F in Figure 14I. [Figure 15G] Figure 14A shows a cross-section of the eye, and the cross-section is cut along the line 15G-15G in Figure 14J. [Figure 16A] Figure 14A shows a detailed strabismic view of the eye with the sutures initially inserted. [Figure 16B] Figure 16A shows a detailed perspective view of the eye and sutures, where the sutures have been further passed through the sclera of the eye to form a loop. [Figure 16C] Figure 16A shows a detailed perspective view of the eye and suture, with the two free ends of the suture tied together. [Figure 16D]Figure 16B shows a detailed perspective view of the eye and sutures in Figure 16A, with the second suture attached to the suture loop in Figure 16B. [Figure 16E] Figure 16A shows a detailed perspective view of the eye and sutures, with the second suture in Figure 16D cut and tied to the suture loop in Figure 16B. [Figure 17A] Figure 15E shows a detailed cross-sectional view of the eye in the state shown in Figure 14A. [Figure 17B] Figure 15F shows a detailed cross-sectional view of the eye in the state shown in Figure 14A. [Figure 17C] Figure 15G shows a detailed cross-sectional view of the eye in the state shown in Figure 14A. [Figure 18] An exaggerated perspective view of an alternative device for the choroidal administration of therapeutic drugs is shown. [Figure 19] Figure 18 shows another perspective view of the device with a portion of the main body removed. [Figure 20] Another perspective view of the device shown in Figure 18, with the operating member activated. [Figure 21] Figure 18 shows a perspective view of the distal end of the cannula of the device in which the needle is activated against the cannula. [Figure 22] Figure 1 shows a perspective view of the distal end of an exemplary alternative cannula for use with the device shown in Figure 1. [Figure 23] Figure 22 shows a perspective view of the distal end of the cannula needle. [Figure 24] Figure 1 shows a perspective view of the distal end of another exemplary alternative cannula for use with the device shown in Figure 1. [Figure 25] Figure 24 shows a perspective view of the distal end of the cannula needle. [Figure 26] Figure 1 shows a perspective view of the distal end of another exemplary alternative cannula for use with the device shown in Figure 1. [Figure 27] Figure 26 shows a cross-section of the cannula, with the cross-section cut along line 27-27 in Figure 26. [Figure 28] Figure 1 shows a perspective view of the distal end of an exemplary alternative cannula for use with the device shown in Figure 1. [Figure 29]Figure 28 shows a cross-section of the cannula, with the cross-section cut along line 29-29 in Figure 28. [Figure 30] Figure 1 shows a perspective view of the distal end of an exemplary alternative cannula for use with the device shown in Figure 1. [Figure 31A] Figure 30 shows a cross-section of the cannula, with the cross-section cut along line 31-31 in Figure 30. [Figure 31B] Figure 1 shows a cross-sectional view of an exemplary alternative cannula for use with the instrument shown in Figure 1. [Figure 31C] A cross-sectional view of another exemplary alternative cannula for use with the instrument in Figure 1 is shown. [Figure 31D] A cross-sectional view of yet another exemplary alternative cannula for use with the instrument in Figure 1 is shown. [Figure 32] An exaggerated perspective view of an alternative suture measurement template used in a method for administering therapeutic drugs via the choroid is shown. [Figure 33] A perspective view of another exemplary alternative suture measurement template used for a method of administering therapeutic drugs via the choroid is shown. [Figure 34] A perspective view of another exemplary alternative device for the suprachoroidal administration of therapeutic drugs is shown. [Figure 35] Figure 34 shows a cross-sectional perspective view of the device, with the cross-section cut along line 35-35 in Figure 34. [Figure 36] Figure 34 shows another cross-sectional perspective view of the device, with the cross section cut along line 36-36 in Figure 34. [Figure 37] Figure 34 shows a cross-sectional view of the main body of the device, with the cross-section cut along line 35-35 in Figure 34. [Figure 38] Figure 34 shows an exploded perspective view of the components of the drive assembly of the device. [Figure 39] Figure 38 shows a perspective view of the knob member of the drive assembly. [Figure 40] Figure 38 shows an exploded perspective view of the main screw member and nut member of the drive assembly. [Figure 41] Figure 38 shows an exploded perspective view of the clutch assembly of the drive assembly. [Figure 42] Figure 34 shows an exploded perspective view of the valve assembly of the device. [Figure 43] Figure 42 shows a cross-sectional perspective view of the valve assembly. [Figure 44A] Figure 42 shows a cross-sectional side view of the valve assembly in the first state. [Figure 44B] Figure 42 shows a cross-sectional side view of the valve assembly in the second state. [Figure 44C] Figure 42 shows a cross-sectional side view of the valve assembly in the third state. [Figure 45A] Figure 34 shows a partial cross-sectional side view of the device, with the cross section cut along line 35-35 in Figure 34, and the drive assembly in Figure 38 is in a non-operating state. [Figure 45B] Figure 34 shows a partial cross-sectional side view of the device, with the cross section cut along line 35-35 in Figure 34, and the drive assembly in Figure 38 is in the first partial operating state. [Figure 45C] Figure 34 shows a partial cross-sectional side view of the device, with the cross section cut along line 35-35 in Figure 34, and the drive assembly in Figure 38 is in a second partially operating state. [Figure 45D] Figure 34 shows a partial cross-sectional side view of the device, with the cross section cut along line 35-35 in Figure 34, and the drive assembly in Figure 38 is in a fully operational state. [Figure 46A] Figure 38 shows a partial plan view of the proximal components of the drive assembly in a non-operating state. [Figure 46B] Figure 38 shows a partial plan view of the proximal components of the drive assembly, where the drive assembly is in a first partially operating state. [Figure 46C] Figure 38 shows a partial plan view of the proximal components of the drive assembly, where the drive assembly is in a second partially operating state. [Figure 46D] Figure 38 shows a partial plan view of the proximal components of the drive assembly, with the drive assembly in a fully operational state. [Figure 47]Figure 34 shows a perspective view of an exemplary support assembly for use with the device. [Figure 48] Figure 47 shows a side view of the support assembly. [Figure 49] Another perspective view of the support assembly shown in Figure 47 is presented.

[0032] The drawings are not intended to limit anything in any sense, and various embodiments of the Art may be carried out in various other ways, including those not necessarily shown in the drawings. The accompanying drawings incorporated herein and forming part of this specification illustrate some aspects of the Art and, together with the description thereof, are helpful in illustrating the principles of the Art, but it should be understood that the Art is not limited to the exact arrangements shown. [Modes for carrying out the invention]

[0033] The following description of specific examples of the present technology should not be used to limit the scope of the invention. Other examples, features, aspects, embodiments, and advantages of the present technology will be apparent to those skilled in the art from the following description, which, as an example, represents one of the best modes conceived for carrying out the present technology. As should be understood, all the technologies described herein are possible in various obvious forms without departing from the present technology. Accordingly, the drawings and specification should be considered illustrative and not restrictive.

[0034] It should be further understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the teachings, expressions, embodiments, examples, etc. described below should not be considered separately from one another. Various suitable ways of combining the teachings herein will be apparent to those skilled in the art. Such modifications and variations are included within the claims.

[0035] For clarity of this disclosure, the terms “proximal” and “distal” are defined herein with respect to a surgeon or other operator holding a surgical instrument having a distal surgical end effector. The term “proximal” refers to the location of an element closer to the surgeon or other operator, while the term “distal” refers to the location of an element closer to the surgical end effector of the surgical instrument and further away from the surgeon or other operator.

[0036] I. Exemplary device having a slider joint mechanism Figures 1 and 2 show an exemplary instrument (10) configured for use in a procedure to administer a therapeutic drug to a patient's eye via the choroid. The instrument (10) includes a flexible cannula (20), a body (40), and a sliding part (60). The cannula (20) extends distally from the body (40) and has a substantially rectangular cross-section. The cannula (20) is generally configured to support a needle (30) that is slidable within the cannula (20), as will be described in more detail later.

[0037] In this embodiment, the cannula (20) contains a flexible material such as polyether block amide (PEBA), which may be manufactured under the trade name PEBAX. Naturally, any other suitable material or combination of materials can be used. Furthermore, in this embodiment, the cannula (20) has a cross-sectional outer dimension of approximately 2.0 mm × 0.8 mm and a length of approximately 80 mm. Alternatively, any other suitable dimensions may be used.

[0038] As will be described in more detail below, the cannula (20) has sufficient flexibility to fit precisely with a particular structure and contour of a patient's eye, but the cannula (20) also has sufficient column strength to be advanced between the sclera and choroid of the patient's eye without buckling the cannula (20). Several factors can contribute to the suitable flexibility of the cannula (20). For example, the durometer of the material used to construct the cannula (20) at least somewhat characterizes the flexibility of the cannula (20). By way of mere example, the material used to form the cannula (20) can have a Shore hardness of about 27D, about 33D, about 42D, about 46D, or any other suitable Shore hardness. It is to be understood that the Shore hardness can be within the range of about 27D to about 46D, or more specifically within the range of about 33D to about 46D, or more specifically within the range of about 40D to about 45D. The particular cross-sectional shape of the cannula (20) can also at least somewhat characterize the flexibility of the cannula (20). In addition, the rigidity of the needle (30) disposed within the cannula (20) can at least somewhat characterize the flexibility of the cannula (20).

[0039] In this embodiment, the flexibility of the cannula (20) can be quantified by calculating the bending rigidity of the cannula (20). The bending rigidity is calculated by the product of the elastic modulus and the moment of inertia of the area. By way of mere example, one exemplary material that can be used to form the cannula (20) has a Shore hardness D27, an elastic modulus (E) of 1.2×10 7 N / m 2 , and a moment of inertia of the area (I x ) of 5.52×10 -14 m 4 , and the calculated bending rigidity about the x-axis is 0.7×10 -6 Nm 2 . Another exemplary material that can be used to form the cannula (20) has a Shore hardness D33, an elastic modulus (E) of 2.1×10 7 N / m 2 , and a moment of inertia of the area (I x ) of 5.52×10 -14 m 4It may have a bending stiffness of 1.2 × 10⁻¹⁰, and the calculated bending stiffness around the x-axis is 1.2 × 10⁻¹⁰. -6 Nm 2 This is the result. Another exemplary material that can be used to form the cannula (20) is a Shore hardness D42, elastic modulus (E) 7.7 × 10 7 N / m 2 , and the moment of inertia of the area (I x ) 5.52 × 10 -14 m 4 It may have a bending stiffness of 4.3 × 10⁻¹⁰. -6 Nm 2 This is the result. Another exemplary material that can be used to form the cannula (20) is a Shore hardness D46, elastic modulus (E) 17.0 x 10 7 N / m 2 , and the moment of inertia of the area (I x ) 5.52 × 10 -14 m 4 It may have a bending stiffness of 9.4 × 10⁻¹⁰. -6 Nm 2 Therefore, as a simple example, the bending stiffness of the cannula (20) is approximately 0.7 × 10⁻⁶. -6 Nm 2 ~Approx. 9.4×10 -6 Nm 2 Within the range, or more specifically, about 1.2 × 10 -6 Nm 2 ~Approx. 9.4×10 -6 Nm 2 Within the range, or more specifically, about 2.0 × 10 -6 Nm 2 ~Approx. 7.5×10 -6 Nm 2 Within the range, or more specifically, about 2.0 × 10 -6 Nm 2 ~Approx. 6.0×10 -6 Nm 2 Within the range, or more specifically, approximately 3.0 × 10 -6 Nm 2 ~Approx. 5.0×10 -6 Nm 2 Within the range, or more specifically, approximately 4.0 × 10 -6 Nm 2 ~Approx. 5.0×10 -6 Nm 2 It may be within the range.

[0040] In this example, the flexibility of the cannula (20) can also be quantified by the following formula.

[0041]

number

[0042] In the above equation, the bending stiffness (EI) is experimentally calculated by deflecting a cannula (20) with a constant total length (L) by a set distance and determining a predetermined deflection (δ). The amount of force (F) required for such deflection can then be recorded. For example, using such a method, the total length of the cannula (20) could be 0.06 m, and it could be deflected by a given distance. As a mere example, one exemplary material usable to form the cannula (20) requires a force of 0.0188 N to obtain a deflection of 0.0155 m, and the calculated bending stiffness around the x-axis is 5.5 × 10⁻⁶. -6 Nm 2 This could be the case. Another exemplary material that can be used to form the cannula (20) requires a force of 0.0205 N to obtain a deflection of 0.0135 m, and the calculated bending stiffness around the x-axis is 6.8 × 10 -6 Nm 2 This could be the case. Yet another exemplary material that can be used to form the cannula (20) requires a force of 0.0199 N to obtain a deflection of 0.0099 m, and the calculated bending stiffness around the x-axis is 9.1 × 10 -6 Nm 2 This could be the case. Yet another exemplary material that can be used to form the cannula (20) requires a force of 0.0241N to obtain a deflection of 0.0061m, and the calculated bending stiffness around the x-axis is 1.8 × 10⁻⁶. -6 Nm 2 This could be the case. Yet another exemplary material that can be used to form the cannula (20) requires a force of 0.0190 N to obtain a deflection of 0.0081 m, and the calculated bending stiffness around the x-axis is 1.0 × 10 -6 Nm 2This could be the case. Yet another exemplary material that can be used to form the cannula (20) requires a force of 0.0215N to obtain a deflection of 0.0114m, and the calculated bending stiffness around the x-axis is 8.4 × 10 -6 Nm 2 This could be the case. Yet another exemplary material that can be used to form the cannula (20) requires a force of 0.0193N to obtain a deflection of 0.0170m, and the calculated bending stiffness around the x-axis is 5.1 × 10 -6 Nm 2 This could be the case. Yet another exemplary material that can be used to form the cannula (20) requires a force of 0.0224 N to obtain a deflection of 0.0152 m, and the calculated bending stiffness around the x-axis is 6.6 × 10 -6 Nm 2 This could be the case. Yet another exemplary material that can be used to form the cannula (20) requires a force of 0.0183N to obtain a deflection of 0.0119m, and the calculated bending stiffness around the x-axis is 6.9 × 10 -6 Nm 2 This could be the case. Yet another exemplary material that can be used to form the cannula (20) requires a force of 0.0233N to obtain a deflection of 0.0147m, and the calculated bending stiffness around the x-axis is 7.1 × 10 -6 Nm 2 This could be the case. Yet another exemplary material that could be used to form the cannula (20) requires a force of 0.0192N to obtain a deflection of 0.0122m, and the calculated bending stiffness around the x-axis is 7.1 × 10 -6 Nm 2 This could be the case. Yet another exemplary material that can be used to form the cannula (20) requires a force of 0.0201 N to obtain a deflection of 0.0201, and the calculated bending stiffness around the x-axis is 4.5 × 10 -6 Nm 2 This is possible. Therefore, as a simple example, the bending stiffness of the cannula (20) is approximately 1.0 × 10⁻⁶. -6 Nm 2 ~Approx. 9.1×10 -6 Nm 2 It may be within the range. In other examples, just as an example, the bending stiffness of the cannula (20) is approximately 0.7 × 10⁻⁶. -6Nm 2 ~ about 11.1×10 -6 Nm 2 and can be within the range of, or more specifically, about 2.0×10 -6 Nm 2 ~ about 6.0×10 -6 Nm 2 It should be understood that it can be within the range.

[0043] The needle (30) can have a bending rigidity different from that of the cannula (20). By way of mere example, the needle (30) has a modulus of elasticity (E) of 7.9×10 10 N / m 2 , and a moment of inertia of the area (I x ) of 2.12×10 -17 m 4 and can be formed of a nitinol material with a calculated bending rigidity around the x-axis of 1.7×10 -6 Nm 2 By way of further mere example, the bending rigidity of the needle (30) can be within the range of about 0.5×10 -6 Nm 2 ~ about 2.5×10 -6 Nm 2 or more specifically within the range of about 0.75×10 -6 Nm 2 ~ about 2.0×10 -6 Nm 2 or more specifically within the range of about 1.25×10 -6 Nm 2 ~ about 1.75×10 -6 Nm 2 and can be within the range.

[0044] As can be seen from FIGS. 3 and 4, the cannula (20) has a generally rectangular cross-sectional shape. In some embodiments, such a rectangular shape can prevent the cannula (20) from rotating when the cannula (20) is inserted into the patient's eye. Of course, such a feature can be desirable since the needle (30) can exit the cannula (20) in a predictable direction. In other embodiments, the cannula (20) can have any other suitable cross-sectional shape that can generally prevent rotation, as will be apparent to those skilled in the art in view of the teachings herein.

[0045] The cannula (20) defines three lumens (22, 24), which extend longitudinally through the cannula (20) and terminate at an inclined distal end (26). Specifically, the lumens (22, 24) include two lateral lumens (22) and one central lumen (24). The lateral lumens (22) contribute to the flexibility of the cannula (20). Although the lateral lumens (22) are shown as opening at an inclined distal end (26), it should be understood that in some embodiments, the lateral lumens (22) may be closed at the inclined distal end (26) as needed. As will be described in more detail later, the central lumen (24) is configured to receive a needle (30) and an optical fiber (34).

[0046] The inclined distal end (26) is generally sloped to separate the scleral and choroidal layers, allowing the cannula (20) to be inserted between these layers without damaging either the scleral or choroidal layer. In this embodiment, the inclined distal end (26) is sloped at an angle of approximately 15° with respect to the longitudinal axis of the cannula (20) in this embodiment. In other embodiments, the inclined distal end (26) may have an inclination angle in the range of approximately 5° to approximately 50°, or more specifically, in the range of approximately 5° to approximately 40°, or more specifically, in the range of approximately 10° to approximately 30°, or more specifically, in the range of approximately 10° to approximately 20°.

[0047] As described above, the needle (30) and the optical fiber (34) are positioned within the central lumen (24). Specifically, the needle (30) is slidably positioned within the central lumen (24) so ​​that it can be advanced distally from the inclined distal end (26). In this embodiment, the optical fiber (34) is fixedly mounted within the central lumen (24), but in other embodiments, the optical fiber (34) may be slidable relative to the inclined distal end (26), similar to the needle (30).

[0048] The needle (30) and the optical fiber (34) both pass through a guide member (36) disposed within the central lumen (24). The guide member (36) is configured to guide the needle (30) when it is advanced distally relative to the inclined distal end (26). Specifically, in this embodiment, the guide member (36) is configured to guide the needle (30) along the longitudinal axis of the cannula (20) so that the needle (30) advances obliquely relative to the inclined distal end (26). Alternatively, in another embodiment, the guide member (36) may be configured to guide the needle (30) along a path other than the longitudinal axis of the cannula (20). For example, the guide member (36) in such an embodiment may include a curved channel (not shown) that can bend the needle (30) as it advances through the guide member (36). In this case, the needle (30) can be advanced along a path oriented at an oblique angle to the longitudinal axis of the cannula (20). As just one example, the guide member (36) may bias the needle (30) so that it exits the cannula (20) along a path oriented at an angle of about 7° to about 9° with respect to the longitudinal axis of the cannula (20). As just another example, the guide member (36) may bias the needle (30) so that it exits the cannula (20) along a path oriented at an angle within the range of about 5° to about 30° with respect to the longitudinal axis of the cannula (20), or more specifically within the range of about 5° to about 20° with respect to the longitudinal axis of the cannula (20), or more specifically within the range of about 5° to about 10° with respect to the longitudinal axis of the cannula (20). Although the guide member (36) is shown as a separate component from the cannula (20), please understand that in other embodiments, the guide member (36) may be integrated with the cannula (20).

[0049] The needle (30) of this embodiment includes a nitinol subcutaneous injection needle that is small enough to deliver the therapeutic agent while being small enough to form a self-sealing wound when the needle (30) penetrates the tissue structure of the patient's eye, as will be described in more detail later. As merely an example, the needle (30) may be 35 gauge (100 μm inner diameter), but other suitable sizes may be used. For example, the outer diameter of the needle (30) may be in the range of 27 gauge to 45 gauge, or more specifically in the range of 30 gauge to 42 gauge, or more specifically in the range of 32 gauge to 39 gauge. As another merely exemplary embodiment, the inner diameter of the needle (30) may be in the range of about 50 μm to about 200 μm, or more specifically in the range of about 50 μm to about 150 μm, or more specifically in the range of about 75 μm to about 125 μm.

[0050] As is best seen in Figures 5A and 5B, the needle (30) has a sharp distal end. The distal end (32) in this embodiment has a tri-bevel shape. Specifically, several bevels (31, 33, 35) converge to form the distal end. The distal end (32) is first formed by grinding or laser cutting the first bevel (31) of the needle (30) at an oblique angle with respect to the longitudinal axis (LA) of the needle (30). As just one example, the first bevel (31) may be oriented at an angle of about 30° with respect to the longitudinal axis (LA) of the needle (30). Next, a pair of laterally opposing second bevels (33) are ground or laser cut into the needle (30) at an oblique angle with respect to the longitudinal axis (LA) of the needle (30). As a mere example, each of the second inclined surfaces (33) may be oriented at an angle of approximately 35° with respect to the longitudinal axis (LA) of the needle (30).

[0051] Finally, a pair of third bevels (35) are ground or laser-cut onto the needle (30) at an oblique angle to the first bevel (31) and the second bevel (33). The second bevels (33) and the third bevels (35) are cut into a portion of the first bevel (31), leaving at least a portion of the first bevel (31) intact. All the bevels (31, 33, 35) converge at the distal end of the needle to form the tip. Since the needle (30) is a subcutaneous injection needle, the bevels (31, 33, 35) intersect with the opening (37) at the distal end of the needle (30). As can be seen from the figure, as the bevels (31, 33, 35) intersect with the opening (37), the opening (37) tapers, forming a further cut edge that further increases the sharpness of the needle (30). Although the needle (30) is shown having a specific number and arrangement of bevels (31, 33, 35), in other embodiments the distal end (32) may include any other suitable number of bevels. For example, the distal end (32) may include a single bevel, two bevels, or more than three bevels. As just a further example, the distal end (32) may include bevels formed at angles in the range of about 5° to about 50°, or more specifically in the range of about 15° to about 40°, or more specifically in the range of about 15° to about 30°, or in the range of about 25° to about 35°.

[0052] Figures 5C to 5I show several simply exemplary alternative needles (2730, 2830, 2930, 3030, 3130, 3230, 3330, 3430) that can be used with the instrument (10) instead of the needle (30). As can be seen from Figure 5C, one simply exemplary alternative needle (2730) may be a Touhy needle (2730). The needle (2730) includes a sharp distal end (2732) that is slightly curved. The needle (2730) further includes an opening (2737) at the distal end (2732). The opening (2737) is cut into the needle (2730) at an angle that gives sharpness to the distal end (2732).

[0053] Figure 5D shows another exemplary alternative needle (2830) that can be used with the instrument (10) instead of needle (30). Needle (2830) is substantially identical to needle (30) described above, except that needle (2830) is a Franseen needle (2830). As can be seen from the figure, needle (2830) has a sharp distal tip (2832) with four divided tips. Each tip is oriented in a symmetrical pattern with respect to the other tips. Parabolic inclined regions are located between each tip. These inclined regions, together with each tip, define an opening (2837) for fluid delivery.

[0054] Figure 5E shows yet another alternative needle (2930) that can be used with the instrument (10) instead of needle (30). Needle (2930) is substantially identical to needle (30) described above, except that needle (2830) is a Whitacre needle (2830). As can be seen from the figure, needle (2930) has a sharp conical distal tip (2932), and a lateral opening (2937) is located proximal to the distal tip (2937). The distal tip (2932) can be tilted at any angle suitable for perforating tissue, similar to the tilt angle described above. The opening (2937) may be located at any suitable distance proximal to the distal tip (2932).

[0055] Figure 5F shows yet another alternative needle (3030) that can be used with the instrument (10) instead of needle (30). Needle (3030) is substantially identical to needle (30) described above, except that needle (3030) is a Cornand needle (3030). As can be seen from the figure, needle (3030) has a sharp distal tip (3032) having an opening (3037) defined by an inclined rim. The inclined rim forms two different inclined surfaces, namely a proximal surface and a distal surface. Each inclined surface has a different angle of inclination. For example, the proximal surface is inclined at a generally small angle with respect to the longitudinal axis of needle (3030), while the distal surface is inclined at a generally large angle with respect to the longitudinal axis of needle (3030). It should be understood that these surfaces may be inclined at any preferred angle, as will be apparent to those skilled in the art in light of the teachings herein.

[0056] Figure 5G shows yet another alternative needle (3130) that can be used with the instrument (10) instead of needle (30). Needle (3130) is substantially the same as needle (30) described above, except that needle (3130) is a Mengini needle (3130). As can be seen from the figure, needle (3130) has a sharp distal tip (3132) having an opening (3137) defined by an inclined edge. The inclined edge has an inclination angle that is continuously adjusted from one end of the inclined edge to the other. For example, the inclined edge first cuts needle (3130) along a plane perpendicular to the longitudinal axis of needle (3130). As the inclined edge extends downward, it cuts needle (3130) in a plane that becomes increasingly parallel to the longitudinal axis of needle (3130).

[0057] Figure 5H shows yet another alternative needle (3230) that can be used with the instrument (10) instead of needle (30). Needle (3230) is substantially the same as needle (30) described above, except that needle (3230) is a back-cut bevel needle (3230). As can be seen from the figure, needle (3230) has a sharp distal tip (3232) having an opening (3237) defined by an upper bevel. The distal tip (3232) also includes two opposing bevels on the underside of needle (3230), which intersect with the tip bevel, thereby forming the sharp distal tip (3232).

[0058] Figure 5I shows yet another alternative needle (3330) that can be used with the instrument (10) instead of the needle (30). The needle (3330) is substantially the same as the needle (30) described above, except that the needle (3330) is a Dos Santos needle (3330). As can be seen from the figure, the needle (3330) has a sharp distal tip (3332) with a flat bevel. The needle (3330) further includes two openings (3337) located proximal to the distal tip, which are configured to allow fluid from the needle (3330) to communicate. The bevel can be tilted at an angle suitable for perforating tissue, as with the tilt angle described above. As will be apparent to those skilled in the art in view of the teachings herein, the openings (3337) may be located at any suitable proximal distance from the distal tip (3332).

[0059] The optical fiber (34) in this embodiment is a single optical fiber strand of polyimide-coated quartz glass. Although the optical fiber (34) is described herein as a single optical fiber strand, it should be understood that in other embodiments, the optical fiber (34) may consist of multiple fibers. Furthermore, the optical fiber (34) may consist of any suitable material such as sapphire or fluoride glass, plastic, and / or any other suitable material. As will be described in more detail later, the optical fiber (34) is generally configured to illuminate the area immediately in front of the needle (30) in order to assist in positioning the needle (30) and / or cannula (20) inside the patient's eye. The optical fiber (34) is entirely optional, and it should be understood that in other embodiments, the optical fiber (34) may be omitted.

[0060] Referring back to Figures 1 and 2, the body (40) is generally shaped as an elongated rectangle with a curved distal end. The specific shape of the body (40) shown is configured to be grasped by an operator. Alternatively, as will be described in more detail later, the body (40) may be attached to an assist device or robotic arm to facilitate the positioning of the instrument (10).

[0061] As is best seen in Figure 2, the interior of the body (40) includes a cannula mounting member (42), a bushing (44), and a needle advance member (46). The cannula mounting member (42) securely attaches the proximal end of the cannula (20) to the body (40), thereby preventing the cannula (20) from rotating or translating relative to the body (40). As described above, the needle (30) is slidably positioned inside the cannula (20). The proximal portion of the needle (30) extends through the body (40) and the bushing (44) and terminates in the advance member (46). The bushing (44) is configured to separate the needle (30) from the rest of the body (40). In some embodiments, the bushing (44) may be magnetized to allow selective attachment of the bushing (44) to a support device or any other ferromagnetic surface.

[0062] The needle advance member (46) includes a bushing engagement portion (48) and a body engagement portion (50). The bushing engagement portion (48) slidably engages with the proximal end of the bushing (44) to position the bushing engagement portion (48) relative to the bushing (44). The body engagement portion (50) slidably engages with the inside of the body (40) to position the advance member (46) relative to the body (40). As will be described in more detail later, the body engagement portion (50) further extends through the proximal end of the body (40) and is attached to the operating assembly (60). The body (40) and the advance member (46) may further include one or more pairs of complementary mechanisms configured to prevent the advance member (46) from rotating relative to the body (40) but to allow the advance member (46) to translate relative to the body (40). Complementary mechanisms include keys and keyways, pins and slots, and hexagonal mechanisms.

[0063] In this embodiment, the main body engagement portion (50) includes a fluid connecting member (not shown) disposed within the main body engagement portion (50). Specifically, the bushing engagement portion (48) may be hollow, i.e., have a lumen, so that the needle (30) can extend proximal to the fluid connecting member of the main body engagement portion (50) by passing through the bushing engagement portion (48). As will be described in more detail later, the fluid connecting member of the main body engagement portion (50) connects the needle (30) to the supply tube (64) so ​​that the supply tube (64) is in fluid communication with the lumen of the needle (30). In addition, the fluid connecting member of the main body engagement portion (50) connects the needle (30) to the main body engagement portion (50) so that the needle (30) can advance through the main body (40) and the cannula (20). As merely an example, the fluid coupling member may include a mechanism overmolded around the proximal end of the needle, which is secured to the main engagement portion by screwing, interlocking, welding, adhesive, etc. Various preferred forms that the fluid coupling member can take will become apparent to those skilled in the art in light of the teachings herein.

[0064] The operating assembly (60) includes an operating member (62) and a locking member (66). The operating member (62) is fixed to the proximal end of the body engagement portion (50) of the forward member (46). In this embodiment, the operating member (62) is integral with the body engagement portion (50) of the forward member (46), but the forward member (46) and the body engagement portion (50) may be connected by any other suitable means. The shape of the operating member (62) is configured to be grasped by an operator. As will be described in more detail later, the operating member (62) is configured to translate relative to the body (40) to actuate the forward member (46) within the body (40), thereby advancing the needle (30) distally through the cannula (20). As will be described in even more detail later, in some variations, the operating member (62) may also be rotated relative to the body (40).

[0065] In this embodiment, the actuarial member (62) includes a lumen (not shown) that extends longitudinally through the actuarial member (62). The lumen of the actuarial member (62) is configured to receive a supply tube (64). Specifically, the supply tube (64) is connected to a fluid connecting member of the main body engagement portion (50), extends proximal through the main body engagement portion (50), extends proximal through the actuarial member (62), and extends proximal from the proximal end of the actuarial member (62). Thus, the supply tube (64) defines a conduit through the actuarial member (62) to the needle (30), and as a result, fluid can be injected into the injection site via the supply tube (64) and through the needle (30). In this embodiment, the proximal end of the supply tube (64) is connected to a fluid source such as a syringe, an automatic or semi-automatic injector, or any other suitable fluid source. It should be understood that the proximal end of the supply pipe (64) may include a Luer fitting and / or any other suitable type of fitting that allows the supply pipe (64) to be removably connected to the fluid source.

[0066] The locking member (66) can be detachably attached to the main body engagement portion (50) between the main body (40) and the operating member (62). As will be described in more detail later, the locking member (66) fills the space between the main body (40) and the operating member (62) and prevents the operating member (62) from advancing distally relative to the main body (40). However, the locking member (66) can be removed in order to selectively allow the operating member (62) to advance distally relative to the main body (40).

[0067] Figures 6 to 8 show an exemplary operation of the instrument (10). Specifically, as can be seen in Figure 6, the needle (30) is initially retracted into the cannula (20), and the locking member (66) is positioned between the main body (40) and the operating member (62), thereby preventing the operating member (62) from moving forward. As will be described in more detail later, when the instrument (10) is in this configuration, the cannula (20) can be positioned inside the patient's eye.

[0068] After positioning the cannula (20) inside the patient's eye, the operator may wish to advance the needle (30) relative to the cannula (20). As can be seen in Figure 7, in order to advance the needle (30), the operator first removes the locking member (66) by pulling it away from the instrument (10). Once the locking member (66) is removed, the operator can move or translate the actuator (62) relative to the main body (40) to advance the needle (30) relative to the cannula (20). In this embodiment, the actuator (62) is configured only to translate the needle (30) and is not configured to rotate the needle (30). In other embodiments, it may be desirable to rotate the needle (30). Therefore, alternative embodiments may include a mechanism in the actuator (62) that rotates and translates the needle (30).

[0069] In this embodiment, advancing the operating member (62) to contact the main body (40) as shown in Figure 8 corresponds to advancing the needle (30) relative to the cannula (20) to a position where the needle (30) penetrates a certain amount into the inside of the patient's eye. In other words, the device (10) is configured such that the operator only needs to advance the operating member (62) to contact the main body (40) in order to properly position the needle (30) inside the patient's eye. In some embodiments, the predetermined amount of advancement of the needle (30) relative to the cannula (20) is in the range of approximately 0.25 mm to approximately 10 mm, or more specifically in the range of approximately 0.1 mm to approximately 10 mm, or more specifically in the range of approximately 2 mm to approximately 6 mm, or more specifically up to approximately 4 mm. In another embodiment, the contact between the operating member (62) and the main body (40) may not be particularly significant other than the maximum amount of advancement of the needle (30) relative to the cannula (20). Alternatively, the instrument (10) may be equipped with a specific tactile feedback mechanism to indicate to the operator the point in time when the needle (30) has advanced a certain distance relative to the cannula (20). Thus, the operator can determine the desired penetration depth of the needle (30) into the patient's eye based on direct visualization of a display on the instrument and / or tactile feedback from the instrument (10). Naturally, as will be apparent to those skilled in the art in view of the teachings herein, such a tactile feedback mechanism may be combined with this embodiment.

[0070] II. Exemplary Support Assembly Figures 9 to 12 show typical support assemblies (110) that can be used to structurally support the aforementioned apparatus. The support assembly (110) is generally configured to provide a selectively movable support surface on which an operator can removably connect the apparatus (10). The support assembly (110) includes a flex arm (112) and a rotating assembly (120). The flex arm (112) is generally made of a malleable material, so that an operator can bend the flex arm (112) as desired to a position on which the flex arm (112) can be maintained after the bending force is removed. As just one example, the flex arm (112) may include a malleable solid tube such as a malleable plastic or metal rod. In other embodiments, the flex arm (112) may be a hollow coil of metal or plastic. Naturally, as will be apparent to those skilled in the art in view of the teachings herein, the flex arm (112) may be made of any other suitable material or may have any other suitable configuration.

[0071] Regardless of the specific structure of the flex arm (112), the flex arm (112) includes a lower end (114) and an upper end (116). Although not shown, it should be understood that in some embodiments, the lower end (114) may have fasteners, brackets, or other mounting mechanisms that allow the support assembly (110) to be attached to an operating table or other structure used in surgical procedures. As just one example, the lower end (114) may include one or more mechanisms configured to selectively fix the lower end (114) to a conventional wrist rest used in ophthalmic surgery.

[0072] The upper end (116) is fixedly attached to the rotating assembly (120). As is best seen in Figure 10, the upper end (116) of the flex arm (112) is fixedly attached to the rotating assembly (120) by a threaded weld stud (118). Specifically, the threaded weld stud (118) engages with threads cut into the inner radius of the base (122) of the rotating assembly (120) and the upper end (116) of the flex arm (112). In this embodiment, the base (122) is configured to rotate relative to the flex arm (112) and the threaded weld stud (118). Alternatively, the base (122) may simply be fastened to the flex arm (112) without having the ability to rotate relative to the flex arm (112). The base (122) is configured to receive the clamp sleeve (124) and the connecting rod (126). Specifically, the clamp sleeve (124) is configured to receive the connecting rod (126) so as to allow the clamp sleeve (124) to maintain a position perpendicular to the upper end (116) of the flex arm (112), while also allowing the clamp sleeve (124) to rotate about its longitudinal axis. As can be seen in the figure, the clamp sleeve (124) includes a hole (123) configured to receive a spring (125). As will be described in more detail later, the spring (125) pushes the clamp sleeve (124) away from the base (122), thereby creating a compressive force between the washer (128) and a hole (not shown) at the opposing end of the connecting rod (126).

[0073] The rotating assembly (120) further includes a cradle (130) supported by a sparring pin (132). The sparring pin (132) passes through a hole in the clamp sleeve (124) and a hole (not shown) in the connecting rod (126). The connecting rod (126), together with a spring (125), compresses the clamp sleeve (124) and the sparring pin (132). This compressive force is strong enough to maintain the position of the compression sleeve (124) and the sparring pin (132) for the most part, but weak enough to allow rotation of the compression sleeve (124) and / or the sparring pin (132) when acted upon by an operator. The cradle (130) includes a recess (132) configured to receive the aforementioned device (10). In addition, the cradle (130) includes a magnet (134) embedded in the cradle (130) adjacent to the recess (132). In an embodiment of the instrument (10) equipped with a magnetic bushing similar to the bushing (44) described above, the magnet (134) may function to detachably connect the instrument (10) to the cradle (130).

[0074] In a typical use of the support assembly (110), the components of the support assembly (110) can be rotated around the axis shown by the dashed line in Figure 11. Specifically, the support assembly (110) can be operated so that the cradle (130) moves in an orbital motion around the longitudinal axis of the flex arm (112). Similarly, the support assembly (110) can be operated so that the cradle (130) moves in an orbital motion around the longitudinal axis of the clamp sleeve (124). Finally, the support assembly (110) can be operated so that the cradle (130) rotates around the longitudinal axis of the aligning nail (132). In addition to the malleability of the flex arm (112), the rotatability of the components of the support assembly (110) makes it possible to move the cradle (130) to various desired positions relative to the patient.

[0075] In one example use, the cradle (130) may first be moved to the desired position relative to the patient. The instrument (10) may then be placed inside the cradle (130) as shown in Figure 12. Alternatively, in another typical use, the instrument (10) may first be placed inside the cradle (130), and then the cradle (130) and the instrument (10) may be moved together. Other preferred methods of using the support assembly (110) in conjunction with the instrument (10) will be apparent to those skilled in the art in light of the teachings herein.

[0076] III. Exemplary Suture Measurement Template As will be described in more detail later, Figure 13 shows a typical suture measurement template (210) used in a method for delivering therapeutic drugs to the choroidal space. Generally, the template (210) is configured to be pressed against the patient's eye to stamp a specific pattern of pigment onto the patient's eye. The reference herein to pressing the template (210) against the patient's eye is not necessarily limited, but should be understood to include pressing the template (210) directly onto the scleral (304) surface (for example, after peeling or otherwise shifting the conjunctiva). The template (210) includes a rigid body (220) and a rigid shaft (240). As will be described in more detail later, the body (220) is generally contoured to match the curvature of the patient's eye so that the body (220) can be pressed against or positioned on at least a portion of the patient's eye. The main body (220) includes an upper guide portion (222) and a plurality of protrusions (230) extending distally from the eye-facing surface (224) of the main body (220).

[0077] The upper guide portion (222) is approximately semicircular in shape and is positioned on the upper part of the main body (220). The semicircular shape of the upper guide portion (222) has a radius corresponding to the curvature of the rim of the patient's eye. In other words, the upper guide portion (222) is curved proximal along a first radius corresponding to the radius of curvature of the patient's eyeball, and downward along a second radius corresponding to the radius of curvature of the rim of the patient's eye (towards the longitudinal axis of the shaft (240)). As will be described in more detail later, the upper guide portion (222) can be used to properly position the template (210) relative to the rim of the patient's eye. Thus, any coloring that can be deposited on the patient's eye by the template can be positioned relative to the rim of the patient's eye.

[0078] The projection (230) is positioned at a predetermined distance from the upper guide portion (222). Specifically, the projection (230) forms a pattern that can correspond to relevant marks used during the implementation of the method described below. The projection (230) in this embodiment includes four suture loop projections (230a to 230h) and two scleral incision projections (230i, 230j). The suture loop projections (230a to 320h) and the scleral incision projections (230i, 230j) extend equidistant outward from the main body (220), and these projections (230) as a whole maintain the curvature defined by the main body (220). In other words, the tips of all projections (230a to 230j) follow a curved surface defined by a radius of curvature that complements the radius of curvature of the patient's eyeball. The protrusions (230a-230j) have rounded tips and are non-traumatic, allowing them to be pressed against the eye without damaging the sclera or other parts of the patient's eye.

[0079] The shaft (240) extends proximal to the body (220). The shaft (240) is configured to allow the operator to grasp the template (210) and manipulate the body (220). In this embodiment, the shaft (240) is integral with the body (220). In other embodiments, the shaft (240) may be selectively attachable to the body by mechanical fastening means such as screw connections or mechanical snap-fits. In some variations, the operator may be presented with a kit containing the shaft (240) and multiple bodies (220). The bodies (220) may have different curvatures corresponding to different eyeballs with different radii of curvature. Thus, the operator can select the appropriate body (220) from the kit based on the anatomical structure of a particular patient before surgery. The operator can then fix the selected body (220) to the shaft (240). Although not shown in the illustration, the proximal end of the shaft (240) may additionally include a T-shaped grip, knob, or other gripping mechanism to allow the operator to more easily grasp the shaft (240).

[0080] In typical use, the suture loop projection (232) and the scleral incision projection (234) correspond to specific parts of the method described later. Specifically, before or during the method described later, the operator can coat the projection (230) with a biocompatible dye or ink by pressing it against a dye or ink pad (250), by applying the dye or ink to the projection (230) with a brush, or by applying the dye or ink to the projection (230) in another way. Once the projection (230) has received the dye or ink, the operator can mark the patient's eye by pressing the projection (230) of the template (210) against the patient's eye, as will be described in more detail later. After removing the template (210) from the patient's eye, the dye from the projection remains on the eye and can mark a specific point of interest.

[0081] IV. Exemplary methods for delivering therapeutic drugs to the suprachoroidal space Figures 14A to 17C illustrate typical procedures for delivering therapeutic agents to the choroidal space using the aforementioned instrument (10). As mere examples, the methods described herein may be employed to treat macular degeneration and / or other ocular conditions. While the procedures described herein are discussed in relation to the treatment of age-related macular degeneration, it should be understood that this is not intended or implied to be a limitation. For example, several merely illustrative alternative procedures can be used to treat retinitis pigmentosa, diabetic retinopathy, and / or other ocular conditions using the same techniques as those described herein. Furthermore, it should be understood that the procedures described herein can be used to treat either age-related dry or wet macular degeneration.

[0082] As can be seen in Figure 14A, the procedure begins with the operator immobilizing the tissues surrounding the patient's eye (301) (e.g., the eyelids) using a palpebrae retractor (312) and / or other instruments suitable for immobilization. It should be understood that although immobilization is described herein with respect to the tissues surrounding the eye (301), the eye (301) itself may remain free to move. Once the tissues surrounding the eye (301) are immobilized, an eye chandelier port (314) is inserted into the eye (301) to illuminate the inside of the eyeball when viewing the inside of the eye (301) through the pupil. In this embodiment, the eye chandelier port (314) is positioned within the inferior medial quadrant so that a superior temporal quadrant scleral incision can be made. As can be seen in Figure 15A, the eye chandelier port (314) is positioned to direct light toward the inside of the eye (314) and illuminate at least a portion of the retina (including, for example, at least a portion of the macula). Naturally, such illumination corresponds to the area of ​​the eye (301) that is targeted for delivery of the therapeutic agent. In this embodiment, only the chandelier port (314) is inserted at this stage, and the optical fiber (315) has not yet been inserted into the port (314). In some other variations, the optical fiber (315) may be inserted into the chandelier port (314) at this stage. In any case, the eye can be visually inspected using a microscope as optional to confirm the proper positioning of the eye chandelier port (314) relative to the target site. In some embodiments, the target area can be identified by the relative absence of retinal pigmentation. Figure 14A shows a specific positioning of the eye chandelier port (314), but it should be understood that the eye chandelier port (314) may be in any other position, as will be apparent to those skilled in the art in light of the teachings herein.

[0083] Once the eye chandelier port (314) is positioned, the sclera (304) can be accessed by incising the conjunctival flap and pulling the flap posteriorly. After such incision is complete, the exposed surface (305) of the sclera (304) may be blanched using a cauterizing instrument if necessary to minimize bleeding. After such conjunctival incision is complete, the exposed surface (305) of the sclera (304) may be dried using a WECK-CEL or other suitable absorbent device if necessary. Next, the eye (301) can be marked using the template (210) described above. As can be seen in Figure 14B, the template (210) is positioned to align with the edge of the eye (301). The operator can apply the dye to the eye (301) by applying light pressure to the template (210). Next, the template (210) is removed, and the dye is applied to the exposed surface (305) of the sclera (304), as can be seen in Figure 14C, providing the operator with a visual guide (320). The operator can then use the visual guide (320) to attach the suture loop assembly (330) and perform a scleral incision. The visual guide (320) includes a set of suture loop markers (321, 322, 323, 324, 325, 326, 327) and a pair of scleral incision markers (329).

[0084] Figure 14D shows the completed suture loop assembly (330). As will be described in more detail later, the suture loop assembly (330) is generally configured to guide the cannula (20) of the instrument (10) through the scleral incision into the eye (301). Figures 16A to 16E show typical procedures for attaching suture loop assemblies (330), such as the suture loop assembly (330) shown in Figure 14D. Specifically, as can be seen in Figure 16A, a curved needle (333) is used to pass the suture (332) through the eye (301) at the position of the first suture loop marker (321). The suture (332) is then guided out of the eye (301) through the second suture loop marker (322). In this way, the suture (332) is firmly fixed between the first suture loop marker (321) and the second suture loop marker (322). Next, the suture (332) is similarly firmly fixed between the third and fourth suture loop markers (323, 324), between the fifth and sixth suture loop markers (325, 326), and between the seventh and eighth suture loop markers (327, 328).

[0085] When the suture (332) is securely fixed as described above, the suture (332) forms the configuration shown in Figure 16B. As can be seen from the figure, the suture (332) is configured to form two free ends (334), two guide loops (336), and one return loop (338). As can be seen from Figure 16C, the free ends (334) may be tied so that the operator can grasp them. Similarly, as can be seen in Figures 16D and 16E, a second suture (339) may be attached using the return loop (338) so that the operator can grasp the return loop (338). It should be understood that the free ends (334) and the second suture (339) can be used to help stabilize the eye (301) throughout the procedure. Alternatively, the free end (334) and the second suture (339) may be positioned or tied away from the eye (301). As will be described in more detail later, a guide loop (336) may be used to guide the cannula (20) of the instrument (10) through the scleral incision, thereby ensuring that the cannula (20) enters at a tangential angle as it passes through the scleral incision into the suprachoroidal space, thereby reducing the risk of the cannula (20) injuring the choroid (306).

[0086] Once the suture loop assembly (330) is attached to the eye (301), a scleral incision of the eye (301) can be made. As can be seen in Figure 14E, the eye (301) is cut between the scleral incision markers (329) using a conventional surgical scalpel (313) or other suitable cutting instrument. The scleral incision markers (329) are shown as containing two separate dots, but it should be understood that in other embodiments, the markers (329) may contain any other type of mark, such as a solid line, dotted line, or dashed line. The scleral incision procedure creates a small incision (316) through the sclera (304) of the eye (301). As is best seen in Figure 15B, the scleral incision is preformed with particular care to avoid perforating the choroid (306). Thus, the scleral incision procedure provides access to the space between the sclera (304) and the choroid (306). Once an incision (316) has been formed in the eye (301), a blunt incision may be made, if necessary, to locally separate the sclera (304) from the choroid (306). As will be apparent to those skilled in the art in light of the teachings herein, such an incision can be made using a small, elongated instrument with a blunt tip.

[0087] After the scleral incision procedure is performed, the operator can insert the cannula (20) of the instrument (10) into the space between the sclera (304) and the choroid (306) through the incision (316). As can be seen in Figure 14F, the cannula (20) is guided into the incision (316) through the guide loop (336) of the suture loop assembly (330). As described above, the guide loop (336) can stabilize the cannula (20). In addition, the guide loop (336) holds the cannula (20) in an approximately tangential orientation to the incision (316). This tangential orientation reduces trauma when guiding the cannula (20) through the incision (316), stabilizes the cannula (20), and prevents damage to surrounding tissues. When inserting the cannula (20) into the incision (316) through the guide loop (336), the operator may use forceps or other instruments to further guide the cannula (20) along a non-traumatic route. Naturally, the use of forceps or other instruments is entirely optional and may be omitted in some embodiments. Although not shown in the illustration, it should be understood that in some embodiments, the cannula (20) may include one or more markers on its surface to indicate various insertion depths. While entirely optional, such markers may be desirable to help the operator identify the appropriate insertion depth as the cannula (20) is guided along a non-traumatic route. For example, the operator can visually observe the position of such markers relative to the guide loop (336) and / or incision (316) as an indicator of the depth to which the cannula (20) is inserted into the eye (301). As just one example, one such marker could correspond to an insertion depth of approximately 6 mm for the cannula (20).

[0088] Once the cannula (20) is at least partially inserted into the eye (301), the operator can insert the optical fiber (315) into the eye chandelier port (314), which at this point does not yet have the fiber (315) inserted. With the eye chandelier port (314) in place and assembled with the optical fiber (315), the operator can activate the eye chandelier port (314) by directing light through the optical fiber (315) to illuminate the eye (301) and thereby visualize the inside of the eye (301). Further adjustments to the positioning of the cannula (20) may be made at this point as needed to ensure proper positioning relative to the geographic atrophy area of ​​the retina (308). In some cases, the operator may want to rotate the eye (301), for example by pulling the sutures (334, 339), to orient the pupil of the eye (301) toward the operator in order to optimize visualization of the inside of the eye (301) through the pupil.

[0089] Figures 14G and 15C–15D show the cannula (20) as it is guided between the sclera (304) and choroid (306) to reach the drug delivery site. In this embodiment, the delivery site corresponds to the generally posterior region of the eye (301), adjacent to the geographic atrophic area of ​​the retina (308). Specifically, the delivery site in this embodiment is in the latent space between the neurosensory retina and the retinal pigment epithelium, above the macula. Figure 14G shows the eye (301) as directly visualized by a microscope directed through the pupil of the eye (301), with illumination provided via a fiber (315) and port (314). As can be seen from the figure, the cannula (20) is at least partially visible through the retina (308) and choroid (306) of the eye (301). Therefore, the operator can track the cannula (20) as it is advanced through the eye (301) from the position shown in Figure 15C to the position shown in Figure 15D. This tracking can be enhanced in a modified configuration that uses an optical fiber (34) and emits visible light through the distal end of the cannula (20).

[0090] As shown in Figure 15D, once the cannula (20) has been advanced to the delivery site, the operator can advance the needle (30) of the instrument (10) as described above with respect to Figures 6-8. As can be seen from Figures 14H-14I, 15E, and 17A, the needle (30) is advanced relative to the cannula (20) so as to penetrate the choroid (306) without perforating the retina (308). As can be seen from Figure 14H, just before penetrating the choroid (306), the needle (30) appears to be "tenting" the surface of the choroid (306) under direct visualization. In other words, the needle (30) can push the choroid upward and deform the choroid (306), resulting in an appearance similar to that of a tent pole deforming the roof of a tent. The operator can use such visual events to determine whether the choroid (306) is about to be perforated or to determine any final perforation location. The specific amount of needle (30) advancement sufficient to initiate “tenting” and subsequently perforate the choroid (306) may be any preferred amount, which may be determined by many factors, including but not limited to, the patient’s overall anatomical structure, the patient’s partial anatomical structure, the operator’s preference, and / or other factors. As described above, merely exemplary ranges of needle (30) advancement may be about 0.25 mm to about 10 mm, or more specifically about 2 mm to about 6 mm.

[0091] In this embodiment, after the operator confirms that the needle (30) has advanced properly by visualizing the aforementioned tenting effect, the operator injects an equilibrium salt solution (BSS) or other similar solution when the needle (30) has advanced into the cannula (20). Such a BSS may form a leading bleb (340) in front of the needle (30) when the needle (30) has advanced through the choroid (306). The leading bleb (340) may be desirable for two reasons. First, as shown in Figures 14I, 15F, and 17B, the leading bleb (340) may provide the operator with further visual indication of the point in time when the needle (30) has been properly positioned at the delivery site. Second, the leading bleb (340) may provide a barrier between the needle (30) and the retina (308) once the needle (30) has penetrated the choroid (306). Such a barrier pushes the retinal wall outward (as is best seen in Figures 15F and 17B), thereby minimizing the risk of retinal perforation as the needle (30) is advanced to the delivery site. In some variations, a foot pedal may be operated to advance the leading bleb (340) from the needle (30). Alternatively, other suitable mechanisms that can be used to advance the leading bleb (340) from the needle (30) will become apparent to those skilled in the art in light of the teachings herein.

[0092] As can be seen from Figures 14I, 15F, and 17B, once the operator has visualized the preceding bleb (340), the operator may stop injecting the BSS, leaving a fluid pocket. The therapeutic agent (341) can then be injected by operating a syringe or other fluid delivery device as described above with respect to the instrument (10). The specific therapeutic agent (341) to be delivered may be any suitable therapeutic agent configured to treat ocular symptoms. Some merely exemplary suitable therapeutic agents, as will be apparent to those skilled in the art in view of the teachings herein, include, but are not limited to, drugs having small or large molecules, therapeutic cell solutions, specific gene therapy solutions, and / or any other suitable therapeutic agents. As merely an example, the therapeutic agent (341) may be provided in accordance with at least some of the teachings of U.S. Patent No. 7,413,734, issued August 19, 2008, “Treatment of Retinitis Pigmentosa with Human Umbilical Cord Cells,” whose disclosure is incorporated herein by reference.

[0093] In this embodiment, the amount of therapeutic agent (341) ultimately delivered to the delivery site is approximately 50 μL, but any other suitable amount may be delivered. In some variations, a foot pedal is operated to dispense the agent (341) from the needle (30). Alternatively, other suitable mechanisms that can be used to dispense the agent (341) from the needle (30) will become apparent to those skilled in the art in light of the teachings herein. As can be seen from Figures 14J, 15G, and 17C, the delivery of the therapeutic agent (341) can be visualized by the expansion of the fluid pocket (340, 341). As shown in the figure, once the therapeutic agent (341) is injected into the suprachoroidal lumen, it essentially mixes with the fluid of the preceding bleb (340).

[0094] Once delivery is complete, the needle (20) can be retracted by sliding the operating assembly (60) proximal to the body (40), and then the cannula (30) can be withdrawn from the eye (301). Depending on the size of the needle (20), the site where the needle (20) penetrates the choroid (306) self-seals, so it should be understood that no further steps are needed to seal the delivery site through the choroid (306). The suture loop assembly (330) and chandelier (314) can be removed, and the incision (316) in the sclera (304) can be closed using any preferred prior art.

[0095] As stated above, the above procedures may be performed to treat patients with macular degeneration. In some such cases, the therapeutic agent (341) delivered by the needle (20) may include postpartum umbilical and placental cells. As stated above, and as an example only, the therapeutic agent (341) may be provided in accordance with at least some of the teachings of U.S. Patent No. 7,413,734, issued August 19, 2008, entitled “Treatment of Retinitis Pigmentosa with Human Umbilical Cord Cells,” whose disclosure is incorporated herein by reference. Alternatively, any other suitable substance(s) may be delivered using the needle (20) in addition to or instead of those described in U.S. Patent No. 7,413,734 and / or elsewhere herein. As an example only, the therapeutic agent (341) may include, but is not limited to, various types of agents such as small molecules, large molecules, cells, and / or gene therapies. It should be understood that macular degeneration is merely one example of a disease that can be treated by the procedures described herein. Other biological conditions that can be addressed using the instruments and procedures described herein will be obvious to those skilled in the art.

[0096] V. Exemplary alternative devices and mechanisms In some embodiments, it may be desirable to modify certain components or mechanisms of the instrument described herein. For example, it may be desirable to use an instrument similar to instrument (10) having an alternative mechanism for acting the needle (30). In yet other embodiments, it may be desirable to use an instrument similar to instrument (10) equipped with a cannula (20) or needle (30) of a different geometric shape. Instruments with such variations may be desirable to engage tissue structures with various physical properties in different surgical procedures or surgical procedures similar to those described above. While specific examples of modifications are described herein, it should be understood that the instruments described herein may include any other alternative mechanisms, as will be apparent to those skilled in the art in light of the teachings herein.

[0097] A. Exemplary alternative device having a rotary operating mechanism Figures 18 to 21 show exemplary alternative instruments (410) similar to the aforementioned instrument (10). It should be understood that instrument (410) can be readily used in place of instrument (10) to perform the aforementioned medical procedures. Furthermore, it should be understood that, unless otherwise specifically stated herein, instrument (410) in this embodiment is substantially identical to instrument (10) described herein. Like instrument (10), instrument (410) includes a cannula (420), a body (440), and an operating assembly (460). Since the cannula (420) is substantially the same as the aforementioned cannula (20), no further description of the specific details of the cannula (420) will be given. The body (440) is also substantially the same as the aforementioned body (40), except that it is composed of a more compact shape factor. Therefore, no further details of the body (440) will be given herein.

[0098] The main difference between instrument (10) and instrument (410) is that the actuation assembly (460) of instrument (410) is rotatable instead of slidable. As can be seen from Figures 18 and 19, the actuation assembly (460) includes a rotatable actuation member (462), a threaded member (464), and a threaded receiving member (466). The actuation member (462) is generally cylindrical and configured to be grasped by the operator's fingers. In addition, in some embodiments, the actuation member (462) may include a rubberized surface, serrations, ridges, and / or other features configured to enhance the grip of the actuation member (462). A fluid supply tube (463) passes through a central hole (not shown) formed through the actuation member (462) and is connected to the proximal end of the needle (430). Thus, the fluid supply tube (463) can be used to supply therapeutic drugs and / or other fluids to the needle (430). Since the fluid supply pipe (463) is not fixed to the operating member (462) or the threaded member (464), when the operating member (462) and the threaded member (464) rotate, the fluid supply pipe (463) does not rotate or twist.

[0099] The threaded member (464) extends distally from the actuating member (462) and includes threads (465) on the outside of the threaded member (464). As will be described in more detail later, the threaded member (464) has a length suitable for acting the needle (430) by a predetermined length when the threaded member (464) is rotated relative to the receiving member (466) by the actuating member (462). The length of the threaded member (464) is further suitable for extending through the threaded receiving member (466) to engage with the needle body (434) at the proximal end of the needle (430). The needle body (434) is slidable on a track (412) disposed within the body (410). As will be described in more detail later, the needle body (434), together with the track (412), defines the range of motion of the needle (430). The needle body (434) is fixedly attached to the proximal end of the needle (430) and rotatably fixed to the distal end of the threaded member (464). Therefore, the needle body (434) translates relative to the body (440) together with the threaded member (464), but the needle body (434) does not rotate relative to the body (440) together with the threaded member (464).

[0100] The threaded receiving member (466) is fixedly mounted within the main body (440) and is generally configured to receive the threaded member (464). The threaded receiving member (466) is substantially cylindrical, and a threaded hole (not shown) extends through the threaded receiving member (466). The outside of the threaded receiving member (466) may include a knurled surface to maintain the position of the threaded receiving member (466) relative to the main body (440). Of course, the knurled surface is entirely optional, and in other embodiments, the threaded receiving member (466) may be fixed inside the main body (440) by a mechanical fastening mechanism, adhesive bonding, and / or other structure or technique.

[0101] The threaded hole in the threaded receiving member (466) contains threads complementary to the outer threads (465) of the threaded member (464). Thus, the threaded receiving member (466) is configured to receive the threaded member (464), and by rotating the threaded member (464) in a given direction, the threaded member (464) can advance distally or proximal. In other words, the threaded member (464) acts as a translational main screw, and the threaded receiving member (466) acts as a stationary nut.

[0102] In an exemplary operating mode, as can be seen in Figures 20 and 21, the needle (430) is generally advanced relative to the cannula (420) by the operator rotating the actuator (462). Specifically, the rotation of the actuator (462) rotates the threaded member (464) accordingly. Since the threaded receiving member (466) is fixed to the body (410), the rotation of the threaded member (464) relative to the threaded receiving member (466) causes the threaded member (464) to translate relative to the body (410). As the threaded member (464) translates, it pushes the needle body (434) distally along the track (412). The distal movement of the needle body (434) subsequently results in the distal movement of the needle (430) relative to the body (410) and the cannula (420).

[0103] The operator can continue rotating the actuator (462) until the needle (430) advances a desired distance relative to the cannula (420). Alternatively, if the operator continues rotating the actuator (462) indefinitely, further rotation will be prevented when the needle body (434) reaches the distal end of the track (412). The operator can then deliver the fluid and / or therapeutic agent through the needle (430). The operator may then wish to retract the needle (430). At this point, the operator simply needs to reverse the rotation of the actuator (462). By reversing the rotation of the actuator (462), the threaded member (464) is translated proximally relative to the body (410). Subsequently, the needle body (434) retracts proximally relative to the body (410), and the needle (430) retracts proximally relative to the cannula (420). In some variations, the instrument (410) includes an elastic member that biases the needle (430) proximal, thereby further assisting the retraction of the needle (430) relative to the cannula (420).

[0104] B. Illustrative alternative cannulas Figures 22 and 23 show an exemplary alternative cannula (520) for use with the aforementioned instruments (10, 410). Cannula (520) is substantially the same as cannula (20) described above. For example, like cannula (20), cannula (520) has sufficient flexibility to conform to the specific structure and contour of the patient's eye, but cannula (520) also has sufficient rigidity to allow it to be advanced without buckling. As can be seen from Figure 22, cannula (520), like cannula (20), has three lumens (522, 524), these lumens extending longitudinally through cannula (520) and terminating at an inclined distal end (526). Since the lumens (522, 524) and the inclined distal end (526) are substantially the same as the lumens (22, 24) and the inclined distal end (26) described above, specific details of these elements will not be described herein.

[0105] The cannula (520) of this embodiment includes a needle (530) and an optical fiber (534). Since the optical fiber (534) is substantially the same as the optical fiber (34) described above, specific details of the optical fiber (534) will not be repeated here. The needle (530) of this embodiment is similar to the needle (30) described above, except that the needle (530) includes a mechanism for increasing the flexibility of the needle (530). Specifically, as is best seen in Figure 23, the needle (530) includes an inner liner (531), a sharp distal end (532), and a series of alternating slits (533) on the outer surface of the needle (530). The inner liner (531) includes polyimide or other similar material. The inner liner (531) is generally operable to seal the needle (530) to the slits (533).

[0106] The sharp distal end (532) is similar to the sharp distal end (32) described above, except that the sharp distal end (532) includes a single bevel structure. Specifically, the sharp distal end (532) is shown having a single bevel at 45° with respect to the longitudinal axis of the needle (530). Similar to the sharp distal end (32), the sharp distal end (532) may be formed by grinding or laser cutting. While a 45° bevel is shown, it should be understood that any other suitable bevel angle may be used. For example, in some embodiments, the bevel angle may be in the range of 25° to 50° with respect to the longitudinal axis of the needle.

[0107] The slits (533) are arranged in an alternating pattern along the top and bottom of the needle (530). Specifically, the slits (533) are created by laser cutting each slit laterally along the entire needle (530) from either the top or bottom to approximately the middle. Each slit (533) is spaced apart from the subsequent slit (533). While specific spacings are shown, it should be understood that any suitable spacing may be used. For example, the slits (533) in this embodiment are configured to increase the flexibility of the needle (530), allowing it to be bent away from its straight longitudinal axis. Thus, in other embodiments, the needle (530) may have more slits (533) oriented closer together to each other to increase the bendability of the needle (530). In yet another embodiment, the needle (530) may include a further number of oriented slits (533) to increase the rigidity or decrease the bendability of the needle (530). Naturally, as will be apparent to those skilled in the art in view of the teachings herein, any other preferred configuration of slits (533) may be used. In this embodiment, the guide member (36) is omitted, but it should be understood that a guide member (36) may be included if desired.

[0108] Figures 24 and 25 show yet another alternative cannula (620) for use with the aforementioned instruments (10, 410). Cannula (620) is substantially the same as cannula (20) described above. For example, like cannula (20), cannula (620) has sufficient flexibility to conform to the specific structure and contour of the patient's eye, but cannula (620) also has sufficient rigidity to allow it to advance without buckling. As can be seen from Figure 22, cannula (620), like cannula (20), has three lumens (622, 624), these lumens extending longitudinally through cannula (620) and terminating at an inclined distal end (626). The lumens (622, 624) and the inclined distal end (626) are substantially the same as the lumens (22, 24) and the inclined distal end (26) described above, so the specific details of these elements will not be repeated here.

[0109] The cannula (620) of this embodiment includes a needle (630) and an optical fiber (634). Since the optical fiber (634) is substantially the same as the optical fiber (34) described above, specific details of the optical fiber (634) will not be repeated here. The needle (630) of this embodiment is similar to the needle (30) described above, except that it includes a needle cannula (631) and an inner core wire (633). Specifically, as is best seen in Figure 25, the inner core wire (633) is arranged longitudinally within the needle cannula (631). The needle cannula (631) of this embodiment is an elongated hollow tube made of plastic such as polycarbonate, polypropylene, and / or any other suitable material. The inner diameter of the needle cannula (631) is configured to provide space for the inner core wire (633) and to provide further clearance for fluid flow. Therefore, it should be understood that the needle cannula (631) is configured to deliver the fluid to the aforementioned delivery site.

[0110] The inner core wire (633) includes a wire made of stainless steel, nitinol, or the like. The inner core wire (633) in this embodiment has an outer diameter of approximately 1.3 μm, but any other suitable diameter may be used. The inner core wire (633) includes a sharp distal tip (632). Unlike the sharp distal tips (32, 532) described above, the shape of the sharp distal tip (632) in this embodiment is conical, and therefore the sharp distal tip (632) tapers toward a point located on the longitudinal central axis of the inner core wire (633). As will be apparent to those skilled in the art in view of the teachings herein, the sharp distal tip (632) may taper toward any suitable slope.

[0111] In typical use, the needle cannula (631) and the internal core wire (633) are advanced simultaneously to perforate the tissue. Specifically, the internal core wire (633) advances ahead of the needle cannula (631), and as both the needle cannula (631) and the internal core wire (633) advance relative to the cannula (620), the tip (632) is positioned distal to the distal end of the needle cannula (631). Since the internal core wire (633) advances ahead of the needle cannula (631), the internal core wire (633) is the first to make contact with the tissue and can begin to penetrate it with its sharp distal tip (632). As both the needle cannula (631) and the internal core wire (633) advance further, the needle cannula (631) begins to penetrate the tissue through the opening created by its sharp distal tip (632). Next, the needle cannula (631) can deliver fluid through the tissue as described above.

[0112] Although the needle cannula (631) and the inner core wire (633) are described herein as advancing simultaneously, it should be understood that in other embodiments, the needle cannula (631) and the inner core wire (633) may advance separately. For example, in one exemplary mode of operation, the inner core wire (633) may advance first and penetrate the tissue. Then, the needle cannula (631) may follow the inner core wire (633) after it has penetrated the tissue to deliver fluid. In yet another embodiment, the needle cannula (631) may advance first and make contact with the tissue. Then, the inner core wire (633) may advance and penetrate the tissue. Finally, the needle cannula (631) may advance again and penetrate the tissue through the opening formed by the inner core wire (633). Naturally, as will be apparent to those skilled in the art in view of the teachings herein, the outer cannula (621) and the inner core wire (633) may be used in any other preferred order. In this embodiment, the guide member (36) is omitted, but it should be understood that the guide member (36) may be included if desired.

[0113] Figures 26 and 27 show yet another alternative cannula (730) that can be used with the aforementioned instruments (10, 410). Cannula (720) is similar to cannula (20) described herein. For example, like cannula (20), cannula (720) has sufficient flexibility to conform to the specific structure and contour of the patient's eye, but cannula (720) also has sufficient rigidity to allow it to be advanced without buckling. However, unlike cannula (20), cannula (720) in this embodiment includes a blunt distal end (726) with a central lumen (724) opening. The blunt distal end (726) may be preferable to the other distal ends (26, 526, 626) described herein to reduce trauma when advancing cannula (720) into the tissue structure of the patient's eye. Specifically, the blunt distal end (726) is rounded so as not to contain any sharp edges that could catch on the tissue as the cannula (720) advances through the tissue of the patient's eye. Although the blunt distal end (726) is shown to have a specific radius of curvature (i.e., along the vertical and horizontal dimensions), it should be understood that the blunt distal end (726) may be rounded to any preferred radius, as will be apparent to those skilled in the art in light of the teachings herein.

[0114] As can be seen from Figure 27, the blunt distal end (726) contains only a central lumen (724) that opens through the distal end, while the cannula (720) still contains three lumens (722, 724), similar to the cannula (20) mentioned above. Specifically, the two lateral lumens (722) extend longitudinally through the cannula (720), much like the lateral lumen (22) mentioned above. However, unlike the lateral lumen (22), the lateral lumens (722) are closed at each of their distal ends by the blunt distal end (726). The central lumen (724) also extends longitudinally through the cannula (720), but as mentioned above, the central lumen (724) also penetrates the blunt distal end (726). The central lumen (724), like the aforementioned central lumen (24), is configured to slidably receive a suitable needle, similar to the needles (30, 530, 630) described herein.

[0115] Figures 28 and 29 show an exemplary alternative cannula (820) for use with the aforementioned instruments (10, 410). Cannula (820) is substantially the same as cannula (20) described above. For example, like cannula (20), cannula (820) has sufficient flexibility to conform to the specific structure and contour of the patient's eye, but cannula (820) also has sufficient rigidity to allow it to be advanced without buckling. As can be seen from Figure 28, cannula (820), like cannula (20), has two lateral lumens (822) and one central lumen (824), these lumens extending longitudinally through cannula (820) and terminating at an inclined distal end (826). The lumen (822, 824) and the inclined distal end (826) are substantially the same as the aforementioned lumen (22, 24) and inclined distal end (26), so specific details of these elements will not be described herein. To maintain the non-traumatic nature of the inclined distal end (826), a needle guide (880) may be positioned within the lumen, with the distal surface (882) of the needle guide (880) either directly overlapping the inclined distal end (826) or slightly proximal to the inclined distal end (826).

[0116] Unlike the cannula (20), the cannula (820) includes a needle guide (880) disposed within a central lumen (824), but does not include an optical fiber. The needle guide (880) is generally configured to guide the needle (830) upward at a predetermined angle with respect to the longitudinal axis of the cannula (820). In this embodiment, the needle guide (880) is made of stainless steel, but it should be understood that any other suitable biocompatible material may be used. The shape of the needle guide (880) is configured for insertion into the central lumen (824). In this embodiment, the needle guide (880) is fixed within the central lumen (824) by press-fit or interference fit, but in other embodiments, the needle guide (880) may be fixed using adhesive, mechanical locking mechanisms, and / or other structures or techniques.

[0117] As best seen in Figure 29, the needle guide (880) defines an internal lumen (882) configured to slidably receive the needle (830). Specifically, the internal lumen (882) includes a nearly straight proximal portion (886) and a curved distal portion (888). The straight proximal portion (886) coincides with the longitudinal axis of the cannula (820), while the curved distal portion (888) curves upward away from the longitudinal axis (LA) of the cannula (820). In this embodiment, the curved distal portion (888) is curved to guide the needle (830) along a path extending distally from the cannula (820) along an exit axis (EA) that is at an angle of approximately 7° to approximately 9° with respect to the longitudinal axis (LA) of the cannula (820). It should be understood that such angles may be desirable to deflect the needle (830) in a direction that ensures the needle penetrates the choroid (306) and minimizes the possibility that the needle (830) will pass through the suprachoroidal space and remain below the choroid (306) (rather than penetrating the choroid (306)). It should be further understood that such angles may be desirable to deflect the needle (830) in a direction that minimizes the risk of the needle (830) perforating the retina after it has entered the suprachoroidal space. For example, in some embodiments, if such an angle is too steep, the needle (830) may tend to perforate the retina (308). If the angle is too shallow, the needle (830) may fail to penetrate the choroid (306). As merely a further example, the curved distal portion (888) may bias the needle (830) to exit the cannula (820) along an exit axis (EA) oriented at an angle in the range of approximately 5° to approximately 30° with respect to the longitudinal axis (LA) of the cannula (820), or more specifically, at an angle in the range of approximately 5° to approximately 20° with respect to the longitudinal axis (LA) of the cannula (820), or more specifically, at an angle in the range of approximately 5° to approximately 10° with respect to the longitudinal axis (LA) of the cannula (820).

[0118] In some embodiments, the desired effect of changing the angle of the needle (830) relative to the cannula (820) can be achieved without a needle guide (880). For example, in some embodiments, the needle (830) may be pre-bent so that it is elastically deflected to a desired angle (e.g., 20°). In such embodiments, the needle (830) may be constrained to follow a substantially straight path inside the cannula (820) and then advance distally relative to the cannula (820) at a position that is at an angle to the cannula (820). Furthermore, in other embodiments, the cannula (820) itself may be configured to guide the needle (830) at a predetermined angle using a curved lumen similar to the curved distal portion (888) of the needle guide (880). Furthermore, in other embodiments, as will be apparent to those skilled in the art in view of the teachings herein, the angle of the needle (830) may be changed by any other suitable means.

[0119] Figures 30 and 31A show an exemplary alternative cannula (2620) for use with the aforementioned instruments (10, 410). Cannula (2620) is substantially the same as cannula (20) described above. For example, like cannula (20), cannula (2620) has sufficient flexibility to conform to the specific structure and contour of the patient's eye, but cannula (2620) also has sufficient rigidity to allow it to be advanced without buckling. As can be seen from Figure 30, cannula (2620), like cannula (20), has two lateral lumens (2622) and one central lumen (2624), these lumens extending longitudinally through cannula (2620) and terminating at an inclined distal end (2626). The lumens (2622, 2624) and the inclined distal end (2626) are substantially the same as the lumens (22, 24) and the inclined distal end (26) described above, so specific details of these elements will not be described herein. The needle guide (2680) is positioned within the lumen (2624) such that the needle guide (2680) abuts against a separate inclined opening (2682) within the cannula (2620), which is oriented laterally on the upper surface of the cannula (2620) proximal to the inclined distal end (2626).

[0120] Unlike the cannula (20), the cannula (2620) includes a needle guide (2680) disposed within a central lumen (2624). The needle guide (2680) is generally configured to guide the needle (2630) upward through an inclined opening (2682) of the cannula (2620) along an exit axis (EA) oriented obliquely to the longitudinal axis (LA) of the cannula (2620). The needle guide (2680) may be formed of plastic, stainless steel, and / or any other suitable biocompatible material. The shape of the needle guide (2680) is configured for insertion into the central lumen (2624). In this embodiment, the needle guide (2680) is fixed within the central lumen (2624) by press-fit or interference fit, but in other embodiments, the needle guide (2680) may be fixed using adhesive and / or a mechanical locking mechanism.

[0121] As best seen in Figure 31A, the needle guide (2680) defines an internal lumen (2684) configured to slidably receive the needle (2630). Specifically, the internal lumen (2684) includes a nearly straight proximal portion (2686) and a curved distal portion (2688). The straight proximal portion (2686) coincides with the longitudinal axis of the cannula (2620), while the curved distal portion (2688) curves upward away from the longitudinal axis of the cannula (2620). In this embodiment, the curved distal portion (2688) curves at an angle of approximately 7° to 9° with respect to the longitudinal axis (LA) of the cannula (2620) to guide the needle (2630) along the exit axis (EA) extending distally from the cannula (2620). It should be understood that such angles may be desirable to ensure that the needle penetrates the choroid (306) and to deflect the needle (2630) in a direction that minimizes the possibility of the needle (2630) passing through the suprachoroidal space and remaining below the choroid (306) (rather than penetrating the choroid (306)), and the possibility of retinal perforation. As merely a further example, the curved distal portion (2688) may be biased to cause the needle (2630) to exit the cannula (2620) along an exit axis (EA) oriented at an angle in the range of approximately 5° to approximately 30° with respect to the longitudinal axis (LA) of the cannula (2620), or more specifically, at an angle in the range of approximately 5° to approximately 20° with respect to the longitudinal axis (LA) of the cannula (2620), or more specifically, at an angle in the range of approximately 5° to approximately 10° with respect to the longitudinal axis (LA) of the cannula (2620).

[0122] The needle (2630) in this embodiment is substantially the same as the needle (30) described above with respect to Figures 5A and 5B. Specifically, the needle (2630) has a sharp distal end (2632). Although not shown, similar to the distal end (32) described above, the distal end (2632) in this embodiment has a tri-slanted shape with three separate slanted surfaces (not shown) that converge to form the distal end (2632). Similarly, since the needle (2630) is a subcutaneous injection needle, the slanted surfaces intersect with the opening (2637) at the distal end of the needle (2630). Although the needle (2630) is described herein as having three slanted surfaces, in other embodiments the distal end (32) may include any other suitable number of slanted surfaces having any suitable angle of inclination, as similarly described above with respect to the distal end (2632).

[0123] Figures 31B to 31D show various alternative cannulas (3420, 3520, 3620) that can be used as a substitute for cannula (2620). Unless otherwise specified herein, cannulas (3420, 3520, 3620) are substantially the same as cannula (2620) described above. Specifically, like cannula (2620), each cannula (3420, 3520, 3620) has a central lumen (3424, 3524, 3624), these lumens extending longitudinally through each corresponding cannula (3420, 3520, 3620) and terminating at the corresponding distal end (3426, 3526, 3626). The needle guide (2680) is positioned within each lumen (3424, 3524, 3624) such that the needle guides (3480, 3580, 3680) contact separate inclined openings (3482, 3582, 3682) within each corresponding cannula (3420, 3520, 3620), and these inclined openings are oriented laterally on the upper surface of each cannula (3420, 3520, 3620) proximal to each inclined distal end (3426, 3526, 3626).

[0124] Each needle guide (3480, 3580, 3680) is generally configured to guide each needle (3430, 3530, 3630) upward through each corresponding inclined opening (3482, 3582, 3682) along its respective exit axis (EA), which is oriented obliquely to the longitudinal axis (LA) of each cannula (3420, 3520, 3620). Each needle guide (3480, 3580, 3680) defines an internal lumen (3484, 3584, 3684) configured to slidably receive each corresponding needle (3430, 3530, 3630). Specifically, each internal lumen (3484, 3584, 3684) includes a nearly straight proximal portion (3486, 3586, 3686) and a curved distal portion (3488, 3588, 3688), all of which are similar to the aforementioned proximal portion (2686) and distal portion (2688).

[0125] The general difference between cannulas (3420, 3520, 3620) and cannula (2620) is that each cannula (3420, 3520, 3620) includes an alternative distal tip (3426, 3526, 3626). For example, as can be seen in Figure 31B, cannula (3420) generally includes a rounded distal tip (3426). Similarly, as can be seen in Figure 31C, cannula (3520) includes a spherical distal tip (3526). It should be understood that the spherical distal tip (3526) may be spherical along the transverse plane (entering and exiting the page showing Figure 31C) and / or along the vertical plane (along the page showing Figure 31C). For example, in some variant forms, the distal tip (3526) is spherical only along the transverse plane (entering and exiting the page showing Figure 31C), and along the vertical plane (along the page showing Figure 31C), it appears simply as a rounded distal tip (3526). Finally, as can be seen from Figure 31D, the cannula (3620) includes a partially rounded distal tip (3626). It should be understood that each distal tip (3426, 3526, 3626) described herein may provide different penetration characteristics when each cannula (3420, 3520, 3520) is inserted into the patient's eye. For example, round or spherical distal tips (3426, 3526) can offer relatively more non-traumatic properties, while a partially rounded distal tip (3626) can offer intermediate properties, possessing similar penetration capabilities to the distal tip (2626) and similar non-traumatic properties to the round and spherical distal tips (3426, 3526). While specific distal tips (2626, 3426, 3526, 3626) are shown and described herein, it should be understood that many other suitable distal tips can be used, as will be apparent to those skilled in the art in light of the teachings herein.

[0126] C. Exemplary alternative suture measurement template Figure 32 shows an exemplary alternative suture measurement template (910) which is substantially the same as the template (210) described above, unless otherwise specified herein. For example, the template (910) includes a body (920) similar to the body (220) described above. However, unlike the template (210), the template (910) of this embodiment does not have a shaft. As will be described in more detail later, the body (920) is generally configured to be grasped by forceps instead of a shaft. The body (920) includes an upper guide section (922), similar to the body (220). Unlike the body (220), the body (920) of this embodiment includes a number of openings (930), so that the body (920) can be used like a stencil for marking the patient's eye, instead of using the projection (230) to mark the eye as described above.

[0127] The upper guide portion (922) is approximately semicircular in shape and is positioned on the upper part of the main body (920). The semicircular shape of the upper guide portion (922) has a radius corresponding to the radius of curvature of the rim of the patient's eye. As will be described in more detail later, the upper guide portion (922) can be used to position the template (910) relative to the rim of the patient's eye. Thus, any coloring that can be deposited on the patient's eye using the template (910) can be positioned relative to the rim of the patient's eye. The opening (930) is similar to the aforementioned projection (230) in that it can be used to mark a specific location of interest on the patient's eye. The opening (930) in this embodiment includes four suture loop openings (932) and one scleral incision opening (934).

[0128] Unlike the main body (220), the main body (920) of this embodiment includes two gripping members (960). The gripping members (960) extend proximal to the main body (920) and are generally configured to be grasped by forceps or other instruments. Thus, the operator can grasp the gripping members (960) using forceps or other surgical instruments and manipulate the main body (920). Although the gripping members (960) are shown as elongated rectangles, it should be understood that any other suitable shape may be used in other embodiments.

[0129] In a typical use, the suture loop opening (932) and the scleral incision opening (934) correspond to specific parts of the method described above. Specifically, during the execution of the method described above, the operator can grasp one or more gripping members (960) with forceps or other instruments to position the main body (920) relative to the patient's eye. Once the main body (920) is positioned, the operator can obtain a dye pen or other dye application device and use this pen to apply dye into the opening (930). After the dye has been applied, the operator may remove the template (910). As described above, after the template (910) is removed from the patient's eye, the dye applied through the opening (930) remains in the eye and can be used to mark specific points of interest.

[0130] Figure 33 shows an exemplary alternative suture measurement template (1010) which is substantially the same as the template (210) described above, unless otherwise specified herein. For example, template (1010) includes a body (1020) similar to the body (220) described above. However, unlike template (210), template (1010) of this embodiment does not have a shaft. As will be described in more detail later, the body (1020) is generally configured to be grasped by forceps instead of a shaft. Like body (220), body (1020) includes an upper guide section (1022). Unlike body (220), body (1020) of this embodiment includes a number of openings (1030), so that body (1020) can be used like a stencil for marking the patient's eye instead of using the projection (230) to mark the eye as described above.

[0131] The upper guide portion (1022) is approximately semicircular in shape and is positioned on the upper part of the main body (1020). The semicircular shape of the upper guide portion (1022) has a radius corresponding to the radius of curvature of the rim of the patient's eye. As will be described in more detail later, the upper guide portion (1022) can be used to position the template (1010) relative to the rim of the patient's eye. Thus, any coloring that can be deposited on the patient's eye using the template (1010) can be positioned relative to the rim of the patient's eye. The opening (1030) is similar to the aforementioned projection (230) in that it can be used to mark a specific location of interest on the patient's eye. The opening (1030) in this embodiment includes four suture loop openings (1032) and one scleral incision opening (1034). In contrast to the aforementioned opening (930), the opening (1030) in this embodiment is larger than the opening (930), allowing for easier marking of the patient's eye through the opening (1030).

[0132] Unlike the main body (220), the main body (1020) of this embodiment includes two gripping openings (1060). The gripping openings (1060) are generally configured to be grasped by forceps or other instruments. Thus, the operator can grasp the gripping openings (1060) using forceps or other surgical instruments and manipulate the main body (1020). The gripping openings (1060) are shown as hexagonal openings, but it should be understood that any other suitable shape may be used in other embodiments.

[0133] In typical use, the suture loop opening (1032) and the scleral incision opening (1034) correspond to specific parts of the method described above. Specifically, during the execution of the method described above, the operator can grasp one or more grasping openings (1060) with forceps or other instruments to position the main body (1020) relative to the patient's eye. Once the main body (1020) is positioned, the operator can obtain a dye pen or other dye application device and use this pen to apply dye into the opening (1030). After applying the dye, the operator may remove the template (1010). As described above, after the template (1010) is removed from the patient's eye, the dye applied through the opening (1030) remains on the eye and can be used to mark specific points of interest.

[0134] D. Exemplary alternative device having an alternative rotary operating mechanism Figures 34–46D show an exemplary alternative instrument (2010) similar to the instruments (10, 410) described above. Like instruments (10, 410), instrument (2010) can generally be used to deliver therapeutic fluid onto the choroid of the patient's eye in the aforementioned procedure. It should be understood that instrument (410) can therefore be readily used in place of instrument (10) to perform the aforementioned medical procedure. Similar to instrument (10), instrument (2010) in this embodiment includes a cannula (2020), a body (2040), and an operating assembly (2100). The cannula (2020) includes a nitinol needle (2030) extending through the cannula and is substantially the same as the cannula (20) described above. Although the cannula (2020) is shown to be substantially the same as the cannula (20) described herein, it should be understood that any other cannula described herein can be easily incorporated into the instrument (2010). As will be described in more detail below, the body (2040) is also the same as the body (40) described herein, except that the body (2040) includes a valve operating recess (2043).

[0135] The main difference between instrument (10) and instrument (2010) is that the operating assembly (2100) of instrument (2010) is rotatable instead of slidable. In addition, instrument (2010) includes a valve assembly (2200) that is operable to change the fluid state of the needle (2030). As will be described in more detail later, the operating assembly (2100) is generally operable to translate the valve assembly (2200) longitudinally by rotating the knob member (2110), thereby translating the needle (2030) longitudinally relative to the cannula (2020).

[0136] As can be seen from Figures 35-36 and 38, the actuation assembly (2060) includes a knob member (2110), a translation assembly (2130), and a clutch assembly (2160). As is best seen in Figure 39, the knob member (2110) includes an actuation part (2116) and an elongated drive part (2118). In addition, the knob member (2110) has openings (2111, 2112) at both ends, which define a lumen (2114) that extends longitudinally through both the actuation part (2116) and the drive part (2118). The actuation part (2116) is located outside the main body (2040) and is generally configured to be grasped and rotated by the operator's hand to actuate the actuation assembly (2060).

[0137] As will be described in more detail later, the drive unit (2118) of the knob member (2110) extends distally within the body (2040) and is generally operable to drive various components of the actuation assembly (2100). As is best seen in Figure 39, the drive unit (2118) includes an annular flange (2120) and two elongated grooves (2122). The annular flange (2120) extends radially outward from the outer surface of the drive unit (2118). Generally, the annular flange (2120) is configured to engage with the translation assembly (2130), as will be described in more detail later. Each groove (2122) of the drive unit (2118) is recessed into the outer surface of the drive unit (2118). Each groove (2122) has substantially the same shape and includes a first portion (2124) and an assembly portion (2126). The first portion (2124) extends longitudinally along the length of the drive unit (2118) and terminates proximal to the distal end of the drive unit (2118) and distal to the annular flange (2120). As will be described in more detail later, the first portion (2124) is configured to slidably engage with the clutch assembly (2160). The assembly portion (2126) is L-shaped and intersects at least a portion of the first portion (2124) and the distal end of the drive unit (2118). Naturally, the assembly portion (2126) is included only for assembly purposes and generally serves no additional function after the device (2010) is assembled. Therefore, it should be understood that the assembly portion (2126) is entirely optional and may be omitted in other embodiments.

[0138] As is best seen in Figure 40, the translational assembly (2130) includes a threaded insert (2132) and a translational member (2140). The threaded insert (2132) is nearly circular, with a hole (2134) passing through it. The exterior of the threaded insert (2132) includes a pair of outwardly extending tabs (2136). As is best seen in Figure 36, the tabs (2136) engage with a pair of corresponding recesses (2042) formed within the body (2040) to secure the threaded insert (2132) within the body (2040) both translationally and rotationally. The recesses (2042) are also shown in Figure 37. Referring back to Figure 40, the interior of the threaded insert (2132) includes a pair of threaded members (2138) extending radially inward into the hole (2134). As will be described in more detail later, the threaded member (2138) screw-type engages with the corresponding thread (2148) on the outside of the translational member (2140), thereby causing the threaded insert (2132) to function as a nut. Naturally, the threaded insert (2132) is generally operable to cause the translational member (2140) to translate relative to the body (2040) when the translational member (2140) is rotated relative to the threaded insert (2132).

[0139] The translational member (2140) includes a mounting portion (2142), a threaded portion (2146), and a pair of longitudinally extending arms (2150). The mounting portion (2142) is rounded overall and includes a distal opening (2143) and a mounting groove (2144) in the form of an annular recess. The distal opening (2143) is substantially circular and defines a lumen (2145) extending through the translational member (2140). The threaded portion (2146) includes threads (2148) configured to engage with the threaded member (2138) described above, so that the translational member (2140) can be translated relative to the body (2040) by rotating the translational member (2140) relative to the threaded insert (2132). In other words, the translational member (2140) acts as a rotating main screw, and the threaded insert (2132) acts as a fixing nut.

[0140] The arms (2150) have a nearly semicircular contour and extend proximal to the threaded portion (2146). Each arm (2150) is separated from the other and defines two substantially similar elongated grooves (2152) between each arm (2150). Each arm (2150) includes an annular groove (2154) located near the proximal end of each arm (2150). Each annular groove (2154) corresponds to the other, and as a result, the annular grooves (2154) together are configured to receive the annular flange (2120) of the knob member (2110). It should be understood that the arms (2150) are relatively rigid so that the annular flange (2120) is fixed in translation within the groove when the annular flange (2120) of the knob member (2110) is inserted into the annular groove (2154). Therefore, when the knob member (2110) is connected to the translation member (2140) via the arm (2150), the knob member (2110) and the translation member (2140) can translate integrally with each other. However, because the shape of the annular groove (2154) is annular, the knob member (2110) and the translation member (2140) can maintain a state in which they can rotate freely independently of each other.

[0141] As is best seen in Figure 41, the clutch assembly (2160) includes a first drive gear (2162), a second drive gear (2168), a first clutch gear (2172), a second clutch gear (2178), and a spring (2186) positioned between each clutch gear (2172, 2178). Each drive gear (2162, 2168) is approximately circular in shape, through which holes (2163, 2169) extend. Each drive gear (2162, 2168) further includes a pair of drive protrusions (2164, 2170) and a plurality of gear teeth (2166, 2172). The drive projections (2164, 2170) are oriented radially outward and are configured to penetrate elongated grooves (cannels) (2152) defined by the arms (2150) of the translational member (2140). The drive projections (2164, 2170) are further configured to be received by corresponding grooves (2044, 2046) of the main body (2040) (see Figures 35 and 37), thereby allowing the drive projections (2164, 2170) to maintain the longitudinal position of the drive gears (2162, 2168) and to allow the drive gears (2162, 2168) to rotate freely relative to the main body (2040) (as seen in Figure 35). Naturally, since the drive projections (2164, 2170) act on the arm (2150) of the translational member (2140), rotating the drive gears (2162, 2168) can cause the translational member (2140) to rotate accordingly. It should be understood that the translational member rotates together with the drive gears (2162, 2168) and also translates relative to the drive gears (2162, 2168).

[0142] The gear teeth (2166) of the first drive gear (2162) are oriented to protrude proximally from the first drive gear (2162). In contrast, the gear teeth (2172) of the second drive gear (2168) are oriented to protrude distally from the second drive gear (2168). Both sets of gear teeth (2166, 2172) are generally serrated and extend circumferentially around the outer circumference of each face of the corresponding drive gears (2162, 2168). As will be described in more detail later, each set of gear teeth (2166, 2172) is configured to mesh with the corresponding set of gear teeth (2178, 2184) of the corresponding clutch gears (2174, 2180).

[0143] Each clutch gear (2174, 2180) is approximately circular in shape, through which holes (2175, 2181) extend. Each clutch gear (2174, 2180) further includes a pair of projections (2176, 2182) and a plurality of gear teeth (2178, 2184). The projections (2176, 2182) protrude inward into their respective corresponding holes (2175, 2181). It should be understood that the projections (2176, 2182) are configured to slidably engage with the grooves (2122) of the knob member (2110). As will be described in more detail later, the protrusions (2176, 2182) are configured to rotate and fix each clutch gear (2174, 2180) relative to the knob member (2110) while allowing each clutch gear (2174, 2180) to translate along the length of the groove (2127). In other words, the clutch gears (2174, 2180) rotate together with the knob member (2110) and also translate relative to the knob member (2110).

[0144] The gear teeth (2178) of the first clutch gear (2174) are oriented to protrude distally from the first clutch gear (2174). In contrast, the gear teeth (2184) of the second clutch gear (2180) are oriented to protrude proximally from the second clutch gear (2180). The gear teeth (2178, 2184) of both sets are generally serrated and extend circumferentially around the outer circumference of each face of the corresponding clutch gears (2174, 2180). As described above, the gear teeth (2178, 2184) of each set are configured to mesh with the corresponding gear teeth (2166, 2172) of the drive gears (2162, 2168).

[0145] When the gear teeth (2178, 2184) of each pair mesh with the gear teeth (2166, 2172) of the corresponding pair, the gear teeth (2178, 2184) are configured to drive or slide against the gear teeth (2166, 2172) in proportion to the angular rotation of each clutch gear (2174, 2180) in a given direction. For example, depending on the orientation of the gear teeth (2178) of the first clutch gear (2174) relative to the orientation of the gear teeth (2166) of the first drive gear (2162), a counterclockwise rotation of the first clutch gear (2174) (for example, when viewed from the proximal end to the distal end of the instrument 2010) drives the rotation of the first drive gear (2168). In contrast, the clockwise rotation of the first clutch gear (2174) causes the first clutch gear (2174) to slip relative to the first drive gear (2168). Similarly, due to the orientation of the gear teeth (2184) of the second clutch gear (2180) relative to the orientation of the gear teeth (2172) of the second drive gear (2168), the second drive gear (2168) is driven when the second clutch gear (2180) rotates counterclockwise, and slip occurs when the second clutch gear (2180) rotates clockwise. Therefore, and as will be described in more detail later, the first clutch gear (2174) is operable to drive the first drive gear (2162) when the first clutch gear (2174) rotates clockwise, and the second clutch gear (2180) is operable to drive the second drive gear (2168) when the second clutch gear (2180) rotates clockwise.

[0146] As is best seen in Figures 42 to 44B, the valve assembly (2200) includes a valve body (2210), a valve actuator (2230), and a needle coupler (2240). Specifically, the valve body (2210) includes a valve housing (2212), a cylindrical mounting member (2218) extending proximal to the valve housing (2212), and a coupler insert (2220). The valve housing (2212) is approximately cylindrical in shape. As is best seen in Figure 43, the valve housing (2212) defines a chamber (2214), which is configured to receive a pair of supply pipes (2090, 2091) and a valve actuator (2230), which will be described in more detail later. The valve housing (2212) includes a pair of actuator openings (2216) on both sides, which are configured to rotatably receive a valve actuator (2230) into the chamber (2214) via the valve housing (2212). In this embodiment, a first supply pipe (2090) is configured to connect to a source of breb fluid (340) (e.g., BSS), and a second supply pipe (2091) is configured to connect to a source of therapeutic agent (341). It should be understood that each fluid supply pipe (2090, 2091) may include a conventional Luer mechanism and / or other structure that allows the fluid supply pipe (2090, 2091) to connect to its respective fluid source.

[0147] The proximal end of the valve housing (2212) defines a pipe opening (2215) that extends into the chamber (2214). As shown in the figure, the pipe opening (2215) is configured to receive a pipe (2092) that houses the supply pipes (2090, 2091). As will be described in more detail later, the pipe (2092) surrounds the supply pipes (2090, 2091) to prevent accidental rotation of the supply pipes (2090, 2091) by the operating assembly (2100). In this embodiment, the pipe opening (2215) is sized such that the pipe (2092) is secured to the valve housing (2212) by compression or interference fit. In other embodiments, the pipe (2092) may be secured within the pipe opening (2215) by other means, such as adhesive bonding, welding, mechanical fasteners, and / or any other suitable structure or technique.

[0148] The mounting member (2218) is configured to connect to the distal end of the translational member (2140). Specifically, the mounting member (2218) includes a cylindrical inward projection (2219) configured to engage with a mounting groove (2144) of the translational member (2140). In this embodiment, the mounting member (2218) simply connects the valve assembly (2200) to the translational member (2140) in a translational manner, but it should be understood that the translational member (2140) maintains the ability to rotate freely relative to the valve assembly (2200). In other words, the valve assembly (2200) translates with the translational member (2140), but the valve assembly (2200) does not rotate with the translational member (2140).

[0149] The coupler insert (2220) extends distally from the valve housing (2212) and is generally configured to be inserted into the proximal end of the needle coupler (2240), as will be described in more detail later. The coupler insert (2220) is substantially cylindrical in shape and includes an annular recess (2222) and a distal tip (2224). The annular recess (2222) receives a rubber O-ring (2223) or other sealing device. The distal tip (2224) includes a pair of fluid openings (2226) and a conical projection (2228). The fluid openings (2226) open to a pair of tube lumens (2227), which extend through the coupler insert (2220). As will be described in more detail later, the lumen of the tube (2227) is generally configured to receive the supply tubes (2090, 2091), so that the fluid can be delivered to the needle connector (2240) through the fluid opening (2226). As will be described in even more detail later, the conical projection (2228) is configured to be received by the needle connector (2240) to guide the fluid from the fluid opening (2226) into the needle (2030).

[0150] The valve actuator (2230) includes a pair of actuating arms (2232), a connector shaft (2234), and a pinch valve member (2236). As described below, the actuator arms (2232) are generally configured to apply a rotational force to the connector shaft (2234), thereby rotating the pinch valve member (2236) about the longitudinal axis of the connector shaft (2234). In this embodiment, the shape of the actuating arms (2232) is substantially rectangular. In other embodiments, the actuating arms (223) may be any other preferred shape, as will be apparent to those skilled in the art in view of the teachings herein. The connector shaft (2234) is a substantially cylindrical shaft connecting each actuating arm (2232) to the other. In this embodiment, the connector shaft (2234) is shown as being integrated with the actuating arms (2232). In other embodiments, the connector shaft (2234) may be a separate component of the valve actuator (2230) and can be fixed to the actuating arm (2232) by any suitable connection means such as compression fitting, adhesive bonding, welding, or mechanical fastening.

[0151] The pinch valve member (2236) is substantially elliptical in shape and includes an annular recess (2238) extending around the outer circumference of the valve member (2236). The valve member (2236) is shown as being integrally constructed with the connector shaft (2234). In other embodiments, the valve member (2236) may be a separate part and can be attached to the connector shaft (2234) by overmolding, adhesive bonding, welding, etc. The annular recess (2238) has an internal radius of curvature corresponding to the outer diameter of the supply pipes (2090, 2091) so that each supply pipe (2090, 2091) is at least partially positioned within the annular recess (2238). The valve member (2236) is eccentrically positioned on the connector shaft (2234). As will be described in more detail later, the valve member (2236) is approximately elliptical in shape, and the valve member (2236) is mounted eccentrically. As a result, when the valve member (2236) is rotated by the connector shaft (2234) via the operating arm (2232), the valve member (2236) can grip the supply pipes (2090, 2091), thereby sealing the supply pipes (2090, 2091).

[0152] The needle coupler (2240) includes a valve body receiving portion (2242) and an elongated needle receiving portion (2250). The valve body receiving portion (2242) is substantially cylindrical in shape and defines a corresponding cylindrical chamber (2244). The cylindrical chamber (2244) is sized to receive the coupler insert (2220) through the proximal end of the valve body receiving portion (2242). At the distal end of the chamber (2244), the valve body receiving portion (2242) defines a conical recess (2246) corresponding to a conical projection (2228) of the valve body (2210). The distal end of the conical recess (2246) includes a fluid opening (2248). As will be described in more detail later, the fluid opening (2248) communicates with the needle lumen (2254) and allows fluid to flow to the needle (2030). The conical recess (2246) corresponds to the conical projection (2228) of the valve body (2210), but it should be understood that the conical recess (2246) is sized such that a fluid cavity (2249) exists between the conical recess (2246) and the conical projection (2228). Therefore, as will be described in more detail later, the fluid enters the fluid cavity (2249) from the supply pipe (2090, 2091) through the fluid opening of the valve body (2210), passes through the fluid opening (2248) of the conical recess (2246), and reaches the needle lumen (2254).

[0153] The needle receiving portion (2250) is substantially cylindrical in shape and extends distally from the valve body receiving portion (2242). The distal end of the needle receiving portion (2250) includes a conical opening (2252) configured to receive the needle (2030) through which it passes. Specifically, the conical opening (2252) communicates with the needle lumen (2254), which extends longitudinally through the needle receiving portion (2250). The needle lumen (2254) includes a distal portion (2256) and a proximal portion (2258). The distal portion (2256) of the needle lumen (2254) has a larger diameter than the outer diameter of the needle (2030) so that the needle (2030) is positioned freely within the distal portion (2256). The proximal portion (2258) of the needle lumen (2254) extends proximally from the distal portion (2256) and intersects with the fluid opening (2248) of the conical recess (2246). Therefore, the needle (2030) extends through the proximal portion (2258), resulting in fluid communication between the needle (2030) and the fluid chamber (2249). The proximal portion (2258) is relatively smaller than the distal portion (2256). Specifically, the diameter of the distal portion (2256) is close to the outer diameter of the needle (2030) so that the needle (2030) is supported by the distal portion (2256). However, it should be understood that the diameter of the proximal portion (2258) is large enough for the needle (2030) to be inserted into the proximal portion (2258).

[0154] The proximal portion (2258) further intersects with a lateral notch (2260) within the needle receiving portion (2250). The lateral notch (2260) provides access to the proximal portion (2258) from outside the needle receiving portion (2250). Although not illustrated, it should be understood that in some embodiments, the lateral notch (2260) may be filled with an adhesive such as epoxy or a similar liquid curing agent to fix, mount, and seal the needle (2030) within the proximal portion of the needle lumen (2254).

[0155] Typical use of the valve assembly (2200) can be seen in Figures 44A to 44C. As is best seen in Figure 44A, the actuating arm (2232) first begins in a first position where the actuating arm (2232) is facing backward along a plane parallel to the longitudinal axis of the valve assembly (2200). The valve member (2236) is positioned in the chamber (2214) of the valve housing (2212) such that the supply pipes (2090, 2091) are at least partially positioned within the annular recess (2238) of the valve member (2236). In the first position, the first supply pipes (2090) are loosened relative to the valve member (2236) so that the valve member (2236) does not pinch the first supply pipes (2090), or if present, does not apply any significant force to the first supply pipes (2090). Therefore, the leading bleb fluid (340) can be freely communicated to the needle (2030) via the first supply pipe (2090). However, as can be seen from Figure 44A, the valve member (2236) is configured and positioned at this point such that the second supply pipe (2091) is sandwiched or otherwise compressed by the valve member (2236). Therefore, with the valve assembly (2200) in the first position, the first supply pipe (2090) is open so that the fluid can pass freely, while the second supply pipe (2091) is closed so that the fluid cannot flow through the second supply pipe (2091).

[0156] To actuate the valve assembly (2200) to a second state, the operator can grasp one or both of the actuating arms (2232) and rotate the actuating arms (2232) around the axis of the connector shaft (2234). Due to the shape of the valve actuating recess (2043) of the body (2040), the actuating arms (2232) are rotatable distally and upward relative to the body (2040). Naturally, in other embodiments, the body (2040) may be configured differently to allow rotation in the opposite direction. When the actuating arms (2232) are rotated, the valve member (2236) is also rotated by the connector shaft (2234). As shown in Figure 44B, when the valve member (2236) reaches an angular position of approximately 90° with respect to the position shown in Figure 44A, the position and configuration of the valve member (2236) relative to the supply pipes (2090, 2091) allows the fluid to flow through both supply pipes (2090, 2091). In this way, by rotating the actuating arm (2232) by approximately 90°, the valve assembly (2200) is operated to a fully open position, at which point the actuating arm (2232) is oriented along a plane perpendicular to the longitudinal axis of the valve assembly (2200). It should be understood that in some alternative configurations, when the actuating arm (2232) is oriented along a plane parallel to the longitudinal axis of the valve assembly (2200), the valve assembly (2200) is fully open, and when the actuating arm (2232) is oriented along a plane perpendicular to the longitudinal axis of the valve assembly (2200), the valve assembly (2200) is partially open. Other preferred orientations and relationships will be apparent to those skilled in the art in light of the teachings herein. Furthermore, it should be understood that the device (2010) may be packaged and shipped in the configuration shown in Figure 44B so that the supply pipes (2090, 2091) are not subjected to stress from being continuously pinched before the device (2010) is put into use.

[0157] After being actuated to the second state, the actuating arm (2232) may be actuated to the third state shown in Figure 44C. As can be seen from the figure, when the actuating arm (2232) is in the third state, the actuating arm (2232) is oriented forward along a plane parallel to the longitudinal axis of the valve assembly (2200). In the third state, the second supply pipe (2091) is loosened relative to the valve member (2236) so that the valve member (2236) does not pinch the second supply pipe (2091), or if it is present, does not apply any significant force to the second supply pipe (2091). Thus, the therapeutic agent (341) can be freely communicated to the needle (2030) via the second supply pipe (2091). However, as can be seen from Figure 44C, the valve member (2236) is configured and positioned at this point so that the first supply pipe (2090) is clamped or otherwise compressed by the valve member (2236). Regardless of which particular supply pipe (2090) is loosened or clamped, it should be understood that the configuration of the third position is such that the particular supply pipes (2090, 2091) that were loosened in the first state are clamped in the third state. Similarly, the particular supply pipes (2090, 2091) that were clamped in the first state are loosened in the third state. Therefore, in the valve assembly (2200) in the third state, the supply pipes (2090, 2091) are in the opposite state to that of the first state.

[0158] When used, the first, second, and third states can be configured to suit different parts of the procedure. For example, as shown in Figures 14I, 15F, and 17B, and as described above, the valve assembly (2200) may initially be in the first state and maintained in the first state until the operator has finished dispensing the preceding fluid bleb (340) to the target site. The operator may then operate the valve assembly (2200) through the second state to the third state. Once the third state is reached, as shown in Figures 14J, 15G, and 17C, and as described above, the operator can begin dispensing the therapeutic agent (341) to the target site. It should be understood that the operator does not necessarily need to be dispensing fluid while the valve assembly (2200) is in the second state, while transitioning to the second state, or while transitioning from the second state. Other preferred methods of using the valve assembly (2200) will become apparent to those skilled in the art in light of the teachings herein.

[0159] Figures 45A–45D and 46A–46D show a typical use of the actuation assembly (2100) to drive the valve assembly (2200) longitudinally, thereby driving the needle (2030) longitudinally. When the instrument (2010) is used in the medical procedure described above, it should be understood that this actuation of the actuation assembly (2100) may begin at the stage shown in Figures 14G and 15D and proceed to the state shown in Figures 14H, 15E, and 17A. As can be seen from Figures 45A and 46A, the actuation assembly (2100), valve assembly (2100), and needle (2030) are initially in a fully proximal position. In this position, the translational member (2140) is positioned proximal to the threaded insert (2132), and therefore the threaded member (2138) engages with the threads (2148) of the translational member (2140) near the distal end of the translational member (2140). Since the knob member (2110) is fixed translationally to the translational member (2140), the knob member (2110) is also positioned proximal to the threaded insert (2132). As can be seen best from Figure 46A, the groove (2122) is oriented relative to the clutch gears (2174, 2180) such that the first clutch gear (2174) is pushed proximal by the groove (2122), while the second clutch gear (2180) is pushed proximal by the spring (2186) and engages with the second drive gear (2168).

[0160] When the operating assembly (2100) is in the proximal position, the operator can rotate the knob member (2110) in either a counterclockwise or clockwise direction. When the knob member (2110) is rotated counterclockwise, the rotating member (2110) simply rotates freely. This occurs for two reasons. First, the first clutch gear (2174) is moved proximal to the first drive gear (2162) by the groove (2122) of the knob member (2110). Second, due to the structure of the gear teeth (2184) of the second clutch gear (2180), when the second clutch gear (2180) is rotated counterclockwise by the knob member (2110) via the groove (2122) of the knob member (2110), the second clutch gear (2180) simply slips against the second drive gear (2168).

[0161] To initiate the forward movement of the actuation assembly (2100), the valve assembly (2200), and the needle (2030), the operator can rotate the knob member (2110) clockwise. As described above, the gear teeth (2184) of the second clutch gear (2180) are configured to drive the second drive gear (2168) when the second clutch gear (2180) is rotated clockwise. When the second drive gear (2170) is driven by the second clutch gear (2180), the drive projection (2170) of the second drive gear (2170) acts on the translation member (2140) to initiate the clockwise rotation of the translation member (2140) as described above. As the translation member (2140) rotates clockwise, the threads (2148) of the translation member (2140) act on the threaded member (2138) of the threaded insert (2132). Since the threaded insert (2132) is fixed to the main body (2040), when the translation member (2140) rotates clockwise, the threaded insert (2132) acts to translate the translation member (2140) distally. Since the translation member (2140) is fixed to the knob member (2110) in a translational manner, when the translation member (2140) translates distally, the translation member (2140) acts to translate the knob member (2110) distally. Similarly, since the valve assembly (2200) is fixed to the translation member (2140) in a translational manner, when the translation member (2140) translates, the translation member (2140) also acts to translate the valve assembly (2200) distally.

[0162] The operator can continue rotating the knob member (2110) clockwise to advance the needle (2030) out of the distal end of the cannula (2020). Figures 45C and 46C show the actuation assembly (2100), the valve assembly (2200), and the needle (2030) in the position immediately in front of the actuation assembly (2100) and the valve assembly (2200), with the needle (2030) moved to its full distal position. In this position, both the first clutch gear (2174) and the second clutch gear (2180) are engaged with the first drive gear (2164) and the second drive gear (2170), respectively. Therefore, in the positions shown in Figures 45C and 46C, the actuation assembly (2100) can be driven distally or proximal, respectively, by rotating the knob member (2110) clockwise or counterclockwise. However, as can be seen best from Figure 46C, at this position, the rotating member (2110) moves distally to a position where, as will be described in more detail later, the groove (2122) of the rotating member (2110) begins to drive the second clutch gear (2180) so that it disengages from the second drive gear (2170).

[0163] As can be seen in Figures 45D and 46D, the rotating member (2110) is rotated clockwise, translating the actuation assembly slightly distal to the position shown in Figures 45C and 46D. At this position, the actuation assembly (2100), valve assembly (2200), and needle (2030) are at their most distal position relative to the body (2040). As can be seen in the figures, this position corresponds to the needle (2030) being advanced to its most distal position relative to the distal end of the cannula (2020). At this most distal position, the translation member (2140) is translated distally such that the threaded member (2138) of the threaded insert (2132) engages with the thread (2148) of the translation member (2140) just distal to the proximal end of the thread (2148). Since the knob member (2110) is fixed in translation relative to the translation member (2140), the translation member (2140) translates the knob member (2110) to its most distal position relative to the main body (2040). When the knob member (2110) is at its most distal position, the groove (2122) of the knob member (2110) is positioned to drive the second clutch gear (2180) so that the groove (2122) disengages from the second drive gear (2168). It should be understood that since the first clutch gear (2174) only slips when rotated clockwise, and the second clutch gear (2180) is disengaged from the second drive gear (2168) at this stage, further clockwise rotation of the knob member (2110) will only result in free rotation of the knob member (2110).

[0164] With the needle (2030) in this distal position, the operator can then actuate the valve assembly (2200) to the open configuration shown in Figure 44A, enabling the delivery of the therapeutic agent through the tubes (2090, 2091) and the needle (2030). In other words, at this stage, the instrument (2010) can be used to perform the steps of the medical procedure shown in Figures 14I-14J, 15F-15G, and 17B-17C. The operator may then wish to retract the needle (2030).

[0165] It should be understood that when the knob member (2110) is in the distal position, the groove (2122) of the knob member (2110) drives the second clutch gear (2180) to disengage from the second drive gear (2168), while the first clutch gear (2180) maintains engagement with the first drive gear (2162). Therefore, further clockwise rotation of the knob member (2110) causes the first clutch gear (2180) to slip relative to the first drive gear (2162), while counterclockwise rotation of the knob member (2110) causes the first clutch gear (2180) to drive the first drive gear (2162) in a counterclockwise direction. The counterclockwise rotation of the first drive gear (2162) causes the translation member (2140) to rotate counterclockwise via the drive projection (2164) of the first drive gear (2162). When the translation member (2140) rotates counterclockwise, the threads (2148) engage with the threaded insert (2132), causing the translation member (2140) to translate proximally. Thus, by rotating the distal rotating member (2110) counterclockwise, the translation member (2140) is translated proximally, thereby causing the operating assembly (2100), the valve assembly (2200), and the needle (2030) to retract relative to the body (2040).

[0166] To return the actuation assembly (2100), valve assembly (2200), and needle (2030) to the proximal position shown in Figures 45A and 46A, the operator may continue to rotate the rotating member (2110) counterclockwise until the groove (2122) of the rotating member (2110) pushes the first clutch gear (2174) so ​​that it disengages from the first drive gear (2162). The actuation assembly (2100) is described herein as being typically used to translate the valve assembly (2200) and needle (2030) between the proximal and distal positions, but it should be understood that this is not intended to be such a limitation. For example, the operator may use the actuation assembly (2100) to translate the valve assembly (2200) and needle (2030) to any desired position. In one illustrative use, the needle (2030) may be partially advanced distal to the cannula (2020). In another typical use, the operator may partially advance the needle (2030) until it has just emerged from the distal end of the cannula (2020). The operator may then wish to discontinue the procedure or to retract the needle (2030) from the cannula (2020) by another means without advancing the needle (2030) outside the cannula (2020). Naturally, as will be apparent to those skilled in the art in light of the teachings herein, any other suitable amount of advancement or retraction may be used.

[0167] It should be understood that when the actuating assembly (2100) is rotated to actuate the valve assembly (2200) and needle (2030), the valve assembly (2200) and needle (2030) remain substantially stationary relative to the actuating assembly (2100) in rotation. As described above, such functionality is facilitated by the coupling between the translational member (2140) of the actuating assembly (2100) and the valve body (2210) of the valve assembly (2200). Furthermore, it should be understood that the tube (2092) extends through the lumens (2114, 2145) of the rotational member (2110) and translational member (2140) to prevent the rotational member (2110) and translational member (2140) from applying torque to the supply tube (2090, 2091) that would normally cause the valve assembly (2200) to rotate. In this embodiment, it may be desirable to prevent the rotation of the valve assembly (2200) so that the needle (2030) translates but does not rotate. This is due to the geometric shape of the needle (2030) and the possibility of interaction between its geometric shape and the structure. Naturally, in other embodiments, the needle (2030) may be configured to rotate as desirable. In such embodiments, the mechanism for preventing the rotation of the valve assembly (2200) may be omitted or modified, as will be apparent to those skilled in the art in view of the teachings herein.

[0168] E. Exemplary alternative support assembly Figures 47–49 show an exemplary alternative support assembly (2510) similar to the support assembly (110) described above. However, unlike support assembly (110), support assembly (2510) includes a relatively rigid structure and is configured to support the instrument (2010) described above. Support assembly (2510) includes a vertical support arm (2520), a clamp assembly (2540), and a horizontal support arm (2560). The vertical support arm (2520) is relatively rigid and generally allows support assembly (2510) to be attached to a conventional ophthalmic surgical wrist rest or other fixation device. The vertical support arm (2520) extends upward and has a substantially rectangular cross-section. An integrated cradle member (2522) is included near the upper end of the support arm (2520). The cradle member (2522) is generally molded as a partially cylindrical recess, thereby configuring the cradle member (2522) to receive a tubular structure which may be part of a wrist rest or other fastener. The upper end of the support arm (2520) further includes a distally extending projection (2524) configured to support the clamp assembly (2540), as will be described in more detail later. The vertical support arm (2520) may include a hole (not shown) for mounting the clamp assembly (2540), also as will be described in more detail later.

[0169] The clamp assembly (2540) includes an operating knob (2542) and a clamp bracket (2546). The operating knob (2542) is configured to be rotated by the operator's hand. A screw shaft (2544) extends distally from the operating knob (2542). As will be described in more detail later, the operating knob (2542) is generally configured to rotate and engage with the clamp bracket and vertical support arm (2520) via the screw shaft (2544). The clamp bracket (2546) includes a proximal portion (2548), a distal portion (2552), and a pair of arms (2556) extending between the proximal portion (2548) and the distal portion (2552). The proximal portion (2548) includes an opening (2550) centered on the proximal portion (2548). The opening (2550) is configured to receive the screw shaft (2544) of the operating knob (2542) so that the screw shaft (2542) can pass through it to the vertical support arm (2520). The shape of the distal portion (2552) is substantially curved to define a substantially partially cylindrical recess (2554) and is complementary to the cradle member (2522) of the vertical support arm (2520). As will be described in more detail later, the cradle member (2522) and the distal portion (2552) together are operable to clamp a tubular structure which may be part of a wrist rest or other fastener.

[0170] The arm (2556) extends between a proximal portion (2548) and a distal portion (2552). Specifically, the arm (2556) is generally curved upward as it extends between the proximal portion (2548) and the distal portion (2552). Such curvature is configured to enable the clamping operation of the clamp assembly (2540), as will be described in more detail later. Each arm (2556) includes a hole (2558) oriented near the distal portion (2552). The hole (2558) allows the arm (2556) to be pivotably attached to a projection (2524) of the vertical support arm (2520) via screws or other fasteners.

[0171] The horizontal support arm (2560) includes an adjustable collar (2562), a sliding shaft (2568), and a mounting bracket (2572). The adjustable collar (2562) is approximately L-shaped and configured to selectively allow the sliding shaft (2568) to slide relative to the vertical support arm (2520). Specifically, the lower end of the adjustable collar (2562) includes a mounting shaft (2564), a distal opening (not shown), a proximal opening (2565), and an adjustment button (2566). The mounting shaft (2564) extends downward from the adjustable collar (2562) and enters the vertical support arm (2520). As will be described in more detail later, the mounting shaft (2564) attaches an adjustable collar (2562) to the vertical support arm (2520), thereby allowing the adjustable collar (2562) to selectively rotate and translate relative to the vertical support arm (2520).

[0172] The distal and proximal openings (2565) of the adjustable collar (2562) define a lumen (not shown) extending through the adjustable collar (2562). The opening (2565) is configured to receive a sliding shaft (2568) so that the sliding shaft (2568) can extend longitudinally through the adjustable collar (2562). As will be described in more detail later, the adjustable collar (2562) is configured to selectively lock and unlock the sliding shaft (2568) so that the sliding shaft (2568) can selectively translate within the adjustable collar (2562) relative to the vertical support arm (2520).

[0173] The sliding shaft (2568) is substantially elliptical in shape and includes a central groove (2570) that extends longitudinally through the sliding shaft (2568). In some embodiments, the central groove (2570) can receive a pin or other mechanism disposed within the lumen of an adjustable collar (2562) to maintain the horizontal position of the sliding shaft (2568). Of course, such a mechanism is entirely optional and may be omitted in some embodiments.

[0174] The mounting bracket (2572) is configured to receive at least a portion of the aforementioned fixture (2010). Specifically, the mounting bracket (2572) includes an indexing pin (2574) and a quick-release handle (2576). The indexing pin (2574) engages with the corresponding geometric shape of the fixture (2010) to determine the position of the fixture (2010) relative to the mounting bracket (2572). The quick-release handle (2576) communicates with a mechanism inside the mounting bracket, thereby facilitating the release of the fixture (2010) from the mounting bracket (2572) or the release of the mounting bracket (2572) from the support assembly (2510). It should be understood that in some embodiments, the mounting bracket (2572) may include, in addition to or instead of including a quick-release handle (2576), a magnet that can engage with a corresponding magnet in the fixture (2010) to enable quick attachment and detachment of the fixture (2010) from the support assembly (2510).

[0175] Typical uses of the support assembly (2510) are shown in Figures 48 and 49. As can be seen from the figures, the support assembly (2510) is movable over three distinct ranges of motion (for example, as indicated by arrows (2580, 2582, and 2584)). Specifically, as can be seen from Figure 48, the support assembly (2510) can first be actuated vertically, as indicated by arrow (2580). To enable the vertical actuation of the support assembly (2510), the operator may press a button (2566), which activates an internal mechanism within the vertical support arm (2520), thereby allowing adjustment over all three ranges of motion. With the mounting shaft (2564) rotatable, the operator can grasp the horizontal support arm (2560) and move the horizontal support arm (2560) to the desired height.

[0176] The sliding shaft (2568) is also laterally translatable relative to the vertical support arm (2520), as indicated by the arrow (2582). To translate the sliding shaft (2568), the operator can press button (2566) to release the lock on the translation of the sliding shaft (2568). Although not shown in the figures, it should be understood that button (2566) may be in communication with a spring-loaded locking mechanism or other similar device that can be disengaged when button (2566) is pressed. While button (2566) is pressed, the operator can grasp the horizontal support arm (2560) and move the horizontal support arm (2560) to a desired lateral position.

[0177] As can be seen in Figure 49, the horizontal support arm (2560) can also be rotated relative to the vertical support arm (2520) as indicated by the arrow (2584). Such rotation is also initiated by pressing the button (2566) as described above. Specifically, pressing the button (2566) activates a mechanism inside the vertical support arm (2520), allowing the mounting shaft (2564) within the vertical support arm (2520) to rotate and translate. With the mounting shaft (2564) rotatable, the operator can grasp the horizontal support arm (2560) and rotate it to a desired angular position. Other preferred methods of using the support assembly (2510) will be apparent to those skilled in the art in view of the teachings herein. Similarly, other preferred methods of supporting the device (2010) will be apparent to those skilled in the art in view of the teachings herein.

[0178] VI. Others The procedures and devices described herein are discussed in relation to the treatment of age-related macular degeneration, but it should be understood that this is not intended or implied to be a limitation. The procedures and devices described herein can be used to treat a variety of other types of medical conditions. For example, the procedures and devices described herein (and their variations) can be used to treat retinitis pigmentosa, diabetic retinopathy, wet age-related macular degeneration, and / or other medical conditions. A variety of suitable medical situations in which the procedures and devices described herein can be used will be apparent to those skilled in the art.

[0179] It should be understood that any variation of the apparatus described herein may include a variety of other mechanisms in addition to, or instead of, those described herein. For example, any apparatus described herein may include one or more of the various mechanisms disclosed in any of the various references incorporated herein by reference.

[0180] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered separately from one another. In view of the teachings herein, various preferred ways in which the teachings herein can be combined will be readily apparent to those skilled in the art. Such modifications and variations are included within the claims.

[0181] Any patents, publications, or other disclosures referred to as incorporated by reference herein should be recognized as being incorporated herein only to the extent that the incorporated content, in whole or in part, does not contradict the current definitions, views, or other disclosures contained herein. Thus, and to the extent necessary, disclosures expressly contained herein shall supersede any contradictory content incorporated herein by reference. Any content, or any part thereof, that is referred to herein but contradicts existing definitions, views, or other disclosures contained herein shall be incorporated only to the extent that it does not contradict the existing disclosures.

[0182] The modifications described above may be designed to be discarded after a single use or to be designed for multiple uses. In either or both cases, each modification may be readjusted for reuse after at least one use. Such readjustment may include any combination of disassembly of the device, subsequent cleaning or replacement of specific parts, and subsequent reassembly. In particular, certain modifications of the device may be disassembled, and any number of specific components or parts of the device may be selectively replaced or removed in any combination. During cleaning and / or replacement of specific parts, some modifications of the device may be reassembled for subsequent use in a readjustment facility or by an operator immediately before the procedure. Those skilled in the art will recognize that various techniques for disassembly, cleaning / replacement, and reassembly can be used in readjusting the device. The use of such techniques and the resulting readjusted devices are all within the scope of this application.

[0183] For example, the configurations described herein may be sterilized before and / or after surgery. In one sterilization method, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device can then be placed in a radiation field that penetrates the container, such as gamma rays, X-rays, or high-energy electron beams. The radiation can kill bacteria on the device and inside the container. The sterilized device can then be stored in a sterile container for later use. The device may also be sterilized using any other technique known in the art, such as beta rays or gamma rays, ethylene oxide, or steam, but is not limited to these.

[0184] Although various embodiments of the present invention have been illustrated and described above, further adaptations of the methods and systems described herein can be achieved by appropriate modifications by those skilled in the art without departing from the scope of the invention. Some of such possible modifications have been described, but other modifications will also be obvious to those skilled in the art. For example, the examples, embodiments, geometry, materials, dimensions, proportions, processes, etc. discussed above are illustrative and not essential. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of the structure and operation illustrated and described herein and in the drawings.

[0185] [Implementation Method] (1) A device for delivering therapeutic drugs to the eye, (a) The main body and (b) A cannula extending distally from the main body, which is sized and constructed to be insertable between the choroid and sclera of the patient's eye, and which defines a longitudinal axis, (c) A hollow needle which is slidable relative to the cannula, (d) An actuation assembly that acts on the needle relative to the cannula, thereby driving the distal portion of the needle along an exit axis oriented obliquely to the longitudinal axis of the cannula, A device including a device. (2) The apparatus according to Embodiment 1, wherein the actuation assembly includes an actuation member that is movable relative to the body in order to actuate the needle. (3) The apparatus according to Embodiment 2, wherein the operating member is translatable relative to the main body in order to actuate the needle. (4) The apparatus according to Embodiment 2, wherein the operating member is rotatable relative to the main body in order to actuate the needle. (5) The device according to embodiment 4, wherein the actuating assembly includes a threaded member associated with the actuating member, and the threaded member is configured to engage a threaded hole in the body to actuate the needle when the actuating member rotates relative to the body.

[0186] (6) The device according to embodiment 1, wherein the needle includes a sharp distal tip. (7) The device according to embodiment 6, wherein the sharp distal tip of the needle includes a first inclined surface, a second inclined surface, and a third inclined surface, and the first inclined surface, the second inclined surface, and the third inclined surface are each obliquely oriented with respect to each other. (8) The device according to embodiment 1, wherein the exit axis is oriented at an angle of about 5° to about 30° with respect to the longitudinal axis of the cannula. (9) The device according to embodiment 1, wherein the exit axis is oriented at an angle of about 7° to about 9° with respect to the longitudinal axis of the cannula. (10) The device according to embodiment 1, wherein the cannula includes a blunt distal tip.

[0187] (11) The device according to embodiment 1, wherein the cannula includes an inclined distal end, the inclined distal end has an inclination angle, and the inclination angle is about 10° to about 30°. (12) The device according to embodiment 1, wherein the cannula defines a plurality of lumens extending longitudinally over the length of the cannula, and at least one of the plurality of lumens is configured to slidably receive the needle. (13) The device according to embodiment 1, wherein the cannula has a bending stiffness of 0.7×10 -6 Nm 2 ~ 11.1×10 -6 Nm 2 (14) The device according to embodiment 1, wherein the cannula has a bending stiffness of 2.0×10 -6 Nm 2 ~ 6.0×10 -6 Nm 2 (15) The apparatus according to Embodiment 1, further comprising a valve assembly, the valve assembly being operable to provide a fluid connection between a fluid source and the needle, and the valve assembly being configured to translate with the needle relative to the body.

[0188] (16) A method of using a surgical instrument, wherein the surgical instrument includes a cannula and a hollow needle movable relative to the cannula, and the method is (a) A step of performing a scleral incision by forming an incision in the eye of a patient, wherein the incision extends through the scleral layer of the eye to provide access to the suprachoroidal space of the eye, (b) The step of inserting the cannula through the scleral incision, (c) The step of advancing the cannula between the choroid and the sclera, so that the distal end of the cannula is positioned in the posterior region of the choroidal space, (d) The step of advancing the needle toward the cannula without perforating the retina, passing through the choroid and reaching the subretinal space, (e) The step of delivering the therapeutic agent into the subretinal space via the advanced needle, Instructions for using surgical instruments, including [specific examples]. (17) The method according to embodiment 16, further comprising delivering a leading bleb of fluid through the advanced needle before delivering the therapeutic agent through the advanced needle. (18) The method according to Embodiment 16, further comprising the step of attaching a suture loop to the patient's eye, wherein the act of attaching the suture loop comprises passing the suture through the patient's eye to form at least one loop defined by the suture, and the act of inserting the cannula comprises passing the cannula through the suture loop. (19) A method of administering a therapeutic solution onto the choroid in the eye of a patient, (a) The steps of passing a suture through the patient's eye to form at least one loop defined by the suture, (b) the step of making an incision in at least a portion of the eye to provide access to the choroid of the eye, (c) The step of passing the cannula through the at least one loop defined by the suture and guiding it into the incision formed by cutting at least a portion of the eye, (d) The step of advancing the needle through the cannula to penetrate the choroid and administer the therapeutic solution, Methods that include... (20) The method according to embodiment 19, further comprising the step of guiding the cannula to the injection site by directly visualizing it through the pupil of the patient's eye.

Claims

1. It is a device, (a) The main body and (b) A cannula extending distally from the main body, wherein the cannula is flexible, is sized to advance between the sclera and choroid of the patient's eye, includes a rounded distal end that does not contain any corners that could catch on tissue as it advances through the tissue, and includes a lumen, (c) A needle slidably disposed within the lumen, the needle is (i) The needle includes a sharp distal tip, and the needle is configured to translate between a proximal and distal position relative to the cannula, wherein the distal tip is positioned inside the cannula when the needle is in the proximal position, and the distal tip is positioned outside the cannula when the needle is in the distal position. (ii) A needle including a curved portion, the needle being elastically biased to extend along the curve through the curved portion, A device including a device.

2. The apparatus according to claim 1, wherein the cannula includes an opening.

3. The apparatus according to claim 2, wherein the opening is located at the distal end.

4. The apparatus according to claim 1, wherein the needle is configured to advance along an exit axis oriented obliquely to the longitudinal axis of the cannula.

5. The apparatus according to claim 4, wherein the ejection shaft is oriented at an angle in the range of 5 to 30 degrees with respect to the longitudinal axis of the cannula.

6. The apparatus according to claim 1, wherein the needle further includes a linear distal portion extending along the ejection axis, the linear distal portion extending between the curved portion and the sharp distal tip, and the needle is elastically biased to extend along a linear path along the linear distal portion.

7. The apparatus according to claim 6, wherein the needle further includes a linear proximal portion, and the curved portion is located longitudinally between the linear proximal portion and the linear distal portion.

8. The apparatus according to claim 1, wherein the cannula has sufficient flexibility to conform to the structure and contour of the patient's eye, and has sufficient columnar strength to advance the cannula without buckling between the sclera and choroid of the patient's eye.

9. The apparatus according to claim 4, wherein the ejection shaft extends distally from the cannula at an ejection angle that is oblique to the longitudinal axis of the cannula.

10. The apparatus according to claim 9, wherein the ejection angle is in the range of 5 to 30 degrees with respect to the longitudinal axis of the cannula.

11. The apparatus according to claim 10, wherein the ejection angle is in the range of 5 to 20 degrees with respect to the longitudinal axis of the cannula.

12. The apparatus according to claim 11, wherein the ejection angle is in the range of 5 to 10 degrees with respect to the longitudinal axis of the cannula.

13. The apparatus according to claim 12, wherein the ejection angle is in the range of 7 to 9 degrees with respect to the longitudinal axis of the cannula.

14. The apparatus according to claim 11, wherein the cannula has a generally rectangular cross-sectional shape configured to prevent the cannula from rotating when it is inserted into the eye of a patient, and the generally rectangular cross-sectional shape of the cannula is configured to ensure that the needle exits the opening of the cannula in a predictable direction.

15. The apparatus according to claim 11, wherein the cannula includes a needle guide coupled to the inner surface of the cannula, the needle is configured to extend through the lumen of the needle guide, the distal tip is configured to extend beyond the opening of the cannula when the needle is in the distal position, and the curved portion is configured to give an oblique exit angle to the portion of the needle that extends beyond the opening when the needle is in the distal position.

16. The apparatus according to claim 15, wherein the needle guide includes a straight portion and a curved distal portion.

17. The apparatus according to claim 1, wherein the needle is selected from the group consisting of needles ranging from 27 gauge to 45 gauge.

Images