Drug delivery system for implantable medical devices

Abstract

Various example embodiments and methods of use of a drug delivery system for an implantable medical device are disclosed herein. The system provides for simultaneous treatment of two different medical conditions with two different therapies-a first therapy provided by the implant device and a second drug therapy provided by an agent housed in a product well of the drug delivery module. The clinical provider selects the implantable medical device and the drug delivery module separately, and mechanically couples together in the operating room or operating room during the implantation procedure, depending on the condition and need of the individual patient. A module insert assembly and method of use are also provided.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 523,639, filed on June 27, 2023, entitled “Drug Delivery System and Methods for an Implantable Medical Device,” the annexes of which are incorporated herein by reference in their entirety. background Technical Field

[0003] The disclosure herein relates to a drug delivery system for an implantable medical device. Specifically, the disclosed invention relates to components of a drug eluting device system configured to couple with an implantable medical device, and methods of use for attaching a drug eluting device to an implantable medical device immediately prior to surgical implantation. Background Art

[0004] Traditionally, drug delivery for the treatment of eye diseases is by administering small molecule therapeutic agents via eye drops. Recently, intraocular injections have been used to deliver macromolecular compositions "back of the eye" to the vitreous, suprachoroidal space, and subretinal space. These methods deliver a single dose of the drug, and repeated interval administration is generally necessary for successful treatment. However, multiple doses need to be given at predetermined time intervals, which requires patient compliance. Missed administration and incomplete therapy produce suboptimal results. Patients forget to use their eye drops, or feel that it is inconvenient and disruptive to apply eye drops at the prescribed time. In addition, intraocular injections cannot be performed by patients and are uncomfortable. Worse, the experience of inserting a needle into a person's eye is terrifying for almost everyone, can be painful, and carries the risk of serious complications, including bleeding, retinal detachment, and infectious eye inflammation, among others.

[0005] In order to improve treatment outcomes by reducing patient compliance requirements, intraocular drug eluting implants have been developed in recent years. However, such intraocular drug eluting implants are only used to deliver therapeutic agents. Drug eluting implants currently known in the art do not solve other clinical problems and have no other therapeutic purpose other than to deliver the drug close to the target tissue, such as the interior of the eye.

[0006] Cataracts are considered a normal consequence of aging. In addition, cataracts can be caused by or are often associated with other eye diseases, such as glaucoma, diabetes, a history of previous eye surgery, or injury. According to the National Eye Institute, most people have cataracts or have had cataract surgery by the age of 80. Cataracts are treated with surgery. This involves removing the cataract-clouded lens and inserting an intraocular lens ("IOL") replacement.

[0007] Many different pharmacological therapies are often prescribed to treat a variety of primary eye diseases and secondary eye conditions caused by systemic diseases such as diabetes in patients who also need cataract surgery. Because cataract patients generally have other conditions that are suitable for treatment with intraocular medications, and because patients who require intraocular injections or daily eye drops generally suffer from cataracts, IOLs with drug eluting capabilities are desirable. However, the IOLs used in cataract surgery are not "one size fits all". As with external corrective lenses (i.e., glasses and contact lenses), eye surgeons select an IOL with a refractive index, focal length, and diameter suitable for a given individual patient from the many sizes and types of IOLs currently available.

[0008] It is impractical to provide the necessary variety of specific IOL types, each configured to deliver each of a wide variety of different agents for treating each different eye disease.

[0009] For at least the foregoing reasons, there is a need for a drug delivery system having an implantable medical device that can be coupled to a separate drug eluting module, creating a practical solution to improve patient compliance for long-term treatment of chronic conditions that overcomes the above-mentioned deficiencies herein. An example of such a drug delivery system is a replacement IOL with an interchangeable drug eluting mechanism, where any number of therapeutic drugs may be coupled to the IOL immediately prior to implantation. Summary of the invention

[0010] Embodiments of a drug delivery implantable medical device system are disclosed herein. Example embodiments of a drug eluting intraocular implant coupled to a drug delivery module will be discussed in detail, however this is not meant to be limiting. Other implantable medical devices configured to be coupled to a drug delivery module when implanted for implantation in non-ocular locations throughout the body are contemplated from the following disclosure, and alternative examples will be apparent to those skilled in the art of implantable medical devices in general.

[0011] The key feature of the example embodiments disclosed herein is the ability to treat two separate, different clinical conditions - a first condition treated with an implantable medical device and a second different and possibly unrelated condition treated with a timed release drug eluting composition, wherein the timed release drug eluting composition contains a medicament loaded into a product well of a drug delivery module connected to an implantable medical device during an implantation procedure. The ability to deliver therapeutic drugs directly to target tissues minimizes the amount of drugs entering the patient, reduces the total amount of drugs required, and in many cases, is more effective than oral, topical, topical drops, inhaled aerosols, or other more common delivery methods that do not concentrate the concentrated, continuous, timed release of therapeutic agents near the tissue target of the therapeutic drug. Because the drug delivery module preloaded with therapeutic agents can be selected separately from the implantable medical device, two different conditions can be effectively treated, so that there may be dozens or even hundreds of possible combinations between implantable medical devices of different types, sizes, and configurations for individual patients' bodies and treatment needs and drug delivery modules for pharmacological therapies selected by the health care providers of the patients who carry the patients for the treatment of the second condition.

[0012] A drug delivery system for an implantable medical device is disclosed, comprising: an implantable medical device selected to deliver a first treatment for a first condition to an individual patient; and a drug delivery module comprising an agent selected to deliver a second treatment for a second condition to the individual patient, wherein the drug delivery module becomes coupled to the implantable medical device immediately prior to implantation in the patient.

[0013] In some embodiments, the implantable medical device comprises an intraocular lens. In some embodiments, the pharmaceutical agent is combined with a carrier composition. In some embodiments, the carrier composition is a biopolymer.

[0014] In some embodiments, the first condition is a condition of the eye. In some embodiments, the first condition is cataracts. In some embodiments, the second condition is a condition different from the first condition. In some embodiments, the second condition is a condition of the eye. In some embodiments, the second condition is glaucoma.

[0015] In some embodiments, an implantable medical device includes: an artificial lens and a haptic arm connected to the artificial lens at a flexible connection; a first connection feature disposed on the implantable medical device, close to the flexible connection; and a second connection feature disposed on the drug delivery module, configured to cooperate with the first connection feature, wherein the connection between the drug delivery module and the implantable medical device is established and maintained by the interaction between the first connection feature and the second connection feature.

[0016] In some embodiments, the drug delivery module includes a rotation lock. In some embodiments, the coupling of the drug delivery module to the implantable medical device is reversible. In some embodiments, the coupling of the drug delivery module to the implantable medical device is irreversible.

[0017] A drug delivery system is disclosed, including an implantable medical device selected to deliver a first treatment for a first condition to an individual patient; a drug delivery module having at least one sidewall defining a product well; and a module insert assembly having: a top body carrying a first alignment feature; an intermediate body having a module recess configured to receive the drug delivery module and carrying a second alignment feature, and a base body having an implant recess configured to receive the implantable medical device and carrying a third alignment feature, wherein the intermediate body is configured to be reversibly coupled between the base body and the top body by coaxial interaction between the first alignment feature, the second alignment feature, and the third alignment feature, and wherein the intermediate body is compressed between the base body and the top body by a force applied to the top body under the condition that the first alignment feature, the second alignment feature, and the third alignment feature are coaxial, wherein the intermediate body is loaded with the drug delivery module located in the module recess, and the base body is loaded with the implantable medical device loaded in the implant recess, so that the drug delivery module is coupled to the implantable medical device.

[0018] In some embodiments, the implantable medical device is an intraocular implant. In some embodiments, the modular insertion assembly is disposable.

[0019] A kit is disclosed, comprising: an implantable medical device; and a module insert assembly configured to receive the implantable medical device, wherein the module insert assembly comprises a top body, a middle body, and a base body, and wherein the module insert assembly is configured to connect a drug delivery module to the implantable medical device.

[0020] In some embodiments, the implantable medical device is an intraocular medical device. In some embodiments, the intraocular medical device comprises an intraocular lens. In some embodiments, the modular insertion assembly is disposable.

[0021]

[0013] The features and advantages of the present invention will be apparent to those skilled in the art from the following more particular and detailed description of selected example embodiments of the disclosed systems and methods and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 is a top view of a drug eluting intraocular implant system;

[0023] Figure 2 is a side view of a drug eluting intraocular implant system;

[0024] Figure 3 is a perspective view of a drug eluting intraocular implant system;

[0025] Figure 4 is an enlarged perspective view of a drug delivery module of a drug eluting intraocular implant system;

[0026] Figure 5 is an enlarged bottom view of a drug delivery module of a drug eluting intraocular implant system;

[0027] Figure 6 is a top view of a drug delivery module of a drug eluting intraocular implant system;

[0028] Figure 7 is a side view of a drug delivery module of a drug eluting intraocular implant system;

[0029] Figure 8 is an enlarged perspective view of a drug delivery module of a drug eluting intraocular implant system;

[0030] Fig. 9 is an end view of a drug delivery module of a drug eluting intraocular implant system;

[0031] Fig.10 is a side view of a drug delivery module of a drug eluting intraocular implant system;

[0032] Fig.11 is a second end view of the drug delivery system assembly;

[0033] Fig.12 is a cross-sectional view of a drug delivery module of a drug eluting intraocular implant system;

[0034] Fig.13 is an enlarged side view of the haptic arm of the drug eluting intraocular implant system;

[0035] Fig.14 is an exploded perspective view of a modular insertion assembly of a drug eluting intraocular implant system;

[0036] Fig.15 is an exploded side view of a modular insertion assembly of a drug eluting intraocular implant system; and

[0037] Fig.16 This is a diagram of how to use a drug-eluting intraocular implant system. DETAILED DESCRIPTION

[0038] Various example embodiments of a drug eluting implantable medical device system are discussed herein. The system includes an intraocular replacement lens ("IOL") equipped with a feature connected to a drug delivery module. The IOL prosthesis and the drug delivery module are selected separately for an individual patient based on (1) the desired IOL and (2) the planned drug therapy. For example, various IOL substitutes are available. Examples of differences between IOLs include the diameter of the lens, the focal length, whether the lens is monofocal or toric, etc. The IOL is selected by the ophthalmic surgeon in consultation with the patient to provide the best IOL design and desired specifications.

[0039] Similarly, the range of agents used to treat eye diseases is wide and growing. Therefore, a drug delivery module with a specific agent, concentration, and elution mechanism can be created to provide a timed intraocular release of the drug. The manufacture of a drug delivery module for delivering a specific agent selected from any number of pharmaceutical compounds can be coupled to an IOL selected separately from the agent for a patient's prescription.

[0040] Embodiments of the intraocular drug delivery system incorporate a secure coupling mechanism between the IOL and the drug delivery module, whereby a surgeon or other practitioner can easily, quickly, and reliably couple the delivery module to the IOL. Such a simple and reliable mechanism for coupling a drug eluting accessory to an implanted medical device is particularly important for intraocular implants, which are small compared to the surgeon's hands and whose intraocular separation can be more severe and more difficult to correct than separation of a drug eluting accessory from a medical device implanted elsewhere.

[0041] In some embodiments, the drug eluting attachment is configured to couple to a replacement intraocular lens ("IOL"), such as that frequently used during cataract surgery. Cataract surgery is an extremely common surgical procedure worldwide, with a global prevalence estimated at 20 million in 2021. Many patients who receive an IOL during cataract removal suffer from co-occurring eye conditions, including glaucoma, age-related maculopathy, and diabetic retinopathy. In addition, postoperative medications are used to prevent infection, uveitis, posterior capsule opacification, and other sequelae of IOL replacement during cataract surgery. It will be appreciated that many eye conditions can be treated with a drug eluting attachment of an IOL replacement device.

[0042] definition :

[0043] As used herein, "implantable medical device" means any therapeutic medical device designed for implantation within a target tissue of a patient. As used herein, "intraocular implant" means any therapeutic medical device designed for implantation within tissue contained within the eye of a patient.

[0044] As used herein, "implantation" means surgical implantation, i.e., forming an incision through tissue and passing an implantable medical device, such as an intraocular implant, through the incision into a target tissue, such as eye tissue, and then closing the incision with sutures or other suitable means. Implantation includes traditional "open" surgery, minimally invasive surgery, laparoscopic surgery, endoscopic or endoscopic surgery, and other surgical methods known in the art for placing an implantable medical device in a patient's target tissue, but is not limited thereto.

[0045] As used herein, "immediately prior to implantation" means a period of time shortly before the surgical implantation of an implantable medical device. "Immediately prior to" does not have a specific time value, but refers to a period of time during the surgical procedure, i.e., in the operating room, operating room, or hospital room where the surgical procedure is performed, rather than at a remote location separate from the operating room or at a time separate from the surgical procedure, such as hours, days, or longer before the surgery.

[0046] As used herein, "treatment" means medical care given to a patient for a disease or injury. Examples of treatment include procedures such as surgery and medication.

[0047] As used herein, "ocular" means pertaining to or relating to the eye.

[0048] As used herein, "agent" means any composition, compound, drug, or other substance used in the treatment of a disease or condition. A medicament may include an active drug and a carrier substance or composition, such as a buffer, a thickener, a composition configured to dissolve in a target tissue to release the active drug from the composition over an extended period of time ("timed release"), etc.

[0049] As used herein, "drug elution" means the release of the drug from a carrier composition or material over time by the action of a solvent such as water, interstitial tissue fluid, blood, or any other fluid in the body.

[0050] As used herein, "distal end" refers to the direction away from the more central part. In addition, any directional references used in this article, such as right, left, up, down, top, bottom, etc., are intended to facilitate description and are not intended to limit the disclosed structure to any specific position or spatial orientation.

[0051] As used herein, "anterior" means toward the front of the anatomy, such as the front of the face, in front of the eyes, or the front of the body.

[0052] As used herein, "posterior" means toward the rear of an anatomical structure, such as the back of the head, the back of the eyes, or the back of the body. Posterior refers to the side, aspect, or direction away from or opposite to the front. Similarly, anterior refers to the side, aspect, or direction away from or opposite to the rear. Anterior and posterior refer to the position or location of an anatomical structure.

[0053] As used herein, "radial" or "lateral" refers to a direction orthogonal to a central longitudinal axis of a structure.

[0054] As used herein, "circumferential" or "circumferentially" refers to a curved path around the body of a structure or substructure in a plane orthogonal to the central longitudinal axis.

[0055] As used herein, "another additional embodiment," "another additional embodiment," "yet another additional embodiment," "a different additional embodiment," and similar terms refer to different examples of embodiments of drug delivery systems and methods and components thereof that are within the scope of the teachings of the disclosure and discoveries herein.

[0056] As used herein, "line of sight" or "collimation axis" means coaxial with a line that passes from front to back through the center of the pupil, the center of the lens, and to the retina of the eye.

[0057] Details of a drug eluting attachment for an implantable medical device will now be discussed with reference to several of the accompanying drawings. While many embodiments for implantation into the eye are described herein, it should be considered within the scope of these disclosures to provide a similar concept of a drug eluting drug delivery module that can be selected separately from the implantable medical device and coupled to the medical device in the operating room using simple and reliable coupling features immediately prior to implantation. One skilled in the art will immediately appreciate that such a system as disclosed herein is useful not only for IOL implants, but also for other implantable medical devices.

[0058] Implantable medical device with drug delivery module

[0059] Figure 1 is a top view of a drug eluting intraocular implant system. Figure 1An example drug delivery system 100 with an implantable medical device 101 is shown. In this example, the implantable medical device 101 is constructed as a replacement intraocular lens ("IOL")-related device typically used in cataract surgery. The device 101 includes an intraocular lens (IOL) 102 and a pair of haptic arms 103. In the example implantable medical device 101 constructed for IOL replacement surgery, the haptic arms 103 interact with intraocular tissue to maintain and center the system 100 in an appropriate position within the eye relative to the line of sight. In some embodiments, the device 101 is centrally positioned below the pupil in the posterior chamber, however this is not meant to be limiting. Anterior chamber placement and device designs for scleral fixation can also be used. The haptic arms 103 have a friction grid 105 on the distal section of each arm 103 to help fix the system 100 to the surrounding ocular tissue depending on the type of IOL used and the placement position within the eye. The haptic arms 103 are each coupled to the lens 102 at a flexible link 107. Links 107 allow the haptic arms 103 to be placed under slight compressive tension, like a compressed spring, to create a resilient connection that keeps the lens 102 centered beneath the pupil or relative to the cornea and retina of the eye.

[0060] Figure 1 Also shown is a first coupling feature 104 disposed on an outer surface of the device 101 at the location of each flexible link 107. In some embodiments, the outer surface is a top surface, such as Figure 1 In some embodiments, the outer surface is a bottom surface or a side surface. The first coupling feature 104 is configured to be coupled to a corresponding second coupling feature 113 (in Figure 4-5 , Figure 7-12 and Fig.15 107). In some embodiments, the first coupling feature 104 is a hole that passes through the entire thickness of the flexible link 107. However, this is not meant to be limiting. In some embodiments, the first coupling feature 104 is a partial thickness hole that may be perpendicular to the outer surface of the link 107, or may be angled relative to the outer surface of the link 107. Alternatively, the feature 104 may be a protrusion or other feature that protrudes from the outer surface of the link 107 and extends a certain distance. In any particular embodiment, the specific shape and configuration of the feature 104 must match the corresponding complementary feature on the drug delivery module, as will be discussed.

[0061] Figure 2 is a side view of a drug eluting intraocular implant system. Figure 2 A drug delivery module 110 is shown coupled to each of the two haptic arms 103 proximate to the flexible link 107. Figure 2As shown, delivery module 110 is positioned at the top of the junction between IOL 102 and haptic arm 103. The location of delivery module 110 is determined by the following Figure 3 Shown in more detail.

[0062] Figure 3 is a perspective view of a drug eluting intraocular implant system. Figure 3 A drug delivery module 110 is shown coupled to each haptic arm 103 at each flexible link 107. Note that the delivery module 110 is shaped so as not to cover any light-transmissive portion of the lens 102. This is important to prevent the module 110 from interfering with the field of view. This design, shape, and overall configuration of the system 100 described herein is for a medical device 101 configured as an implantable IOL. Alternative shapes and configurations will be used in embodiments of the system 100 utilizing other alternative implantable medical devices 101.

[0063] Drug delivery module 110 includes product well 112. Product well 112 is configured to hold a pharmaceutical agent for delivery to tissue surrounding an implantation site of medical device 101. In some embodiments, product well 112 is open, such as in Figure 3 and throughout the example embodiments shown in several figures. In some embodiments, the product well 112 is windowed. In some embodiments, the product well 112 includes a permeable membrane that constrains the agent so that the agent diffuses through the permeable membrane at a predetermined rate, and the predetermined rate is consistent with the chemical composition of the agent and the conditions at the implanted anatomical site, such as pH or osmotic pressure. In some embodiments, the agent is distributed throughout the carrier. In some embodiments, the carrier is a biopolymer. Examples of biopolymers and related drug delivery systems include hydrogels, cellulose-based compositions, other protein-based compositions, etc., which are provided by Fazel, T. et al. in "Recent developments in natural biopolymer-based drug delivery systems" in Royal Society of Chemistry Advances (Royal Society of Chemistry), Vol. 13, pp. 23087-121 (2023), which is incorporated herein by reference in its entirety. Various other controlled or time-release mechanisms for the agents packaged in the product well 112 are conceivable and fall within the scope of these disclosures.

[0064] Although implantable medical device 101 and drug delivery module 110 can have many different configurations, the key element of drug delivery system 100 is to allow practitioners to select the specific configuration of medical device 101 separately from the medicament, and match device 101 with drug delivery module 110 carrying a specific drug delivery composition containing a specific medicament. Medical device 101 is selected according to the patient's implantation site, size, and other anatomical or physical characteristics specific to the patient, regardless of the disease condition being treated. Drug delivery module 110 is selected according to the disease condition being treated, without relying on the physical characteristics of the individual patient. The required medicament is packaged in the drug delivery composition contained in product well 112. Moreover, medical device 101 and drug delivery module 110 are packaged separately. They can have separate expiration dates. If necessary, device 101 and module 110 can be manufactured separately at separate locations by different manufacturers at different times. These features also allow surgeons or other practitioners to select and connect medical device 101 and drug delivery module 110 immediately before implantation, such as in an operating room. In some cases, the surgeon cannot determine the size or specific model of implantable medical device 101 to be implanted until the implant site is surgically exposed and examined by the surgeon in the operating room. Thus, the features listed herein add tremendous versatility and other advantages to device and drug manufacturing processes, facility inventory, procedure planning, and other treatment aspects for individual patients.

[0065] Figure 4 is an enlarged perspective view of a drug delivery module of a drug eluting intraocular implant system. Figure 4 A drug delivery module 110 is shown having a body 111 defining a product well 112. In this and some other embodiments, a second coupling feature 113 is shown protruding from a surface of the body 111 opposite the product well 112.

[0066] Figure 5 is an enlarged bottom view of the drug delivery module of the drug eluting intraocular implant system. Figure 5A second coupling feature 113 is shown generally centered on the bottom surface of the body 111. The second coupling feature 113 of the drug delivery module 110 is configured to interact with the first coupling feature 104 of the implantable medical device 101 to couple the module 110 to the device 101. In the examples and some embodiments shown in several figures, the second coupling feature 113 is a mushroom-shaped protruding "button" that allows the second coupling feature 113 to be pushed through a corresponding aperture provided by the first coupling feature 104, thereby locking the drug delivery module 110 to the implantable medical device 111. In some embodiments of the system 100 that employs this configuration of the first coupling feature 104 and the second coupling feature 113, the second coupling feature 113 is partially or completely formed of a deformable elastic material so that the mushroom-shaped protrusion can be sufficiently deformed to be pushed through the aperture forming the first coupling feature 104. In some embodiments, the mating of the first coupling feature 104 with the second coupling feature 113 is reversible. This is desirable and beneficial for embodiments of the system 100 in which, after implantation of the medical device 101, the drug delivery module 110 must be replaced one or more times when the therapeutic agent residing in the product well 112 is exhausted and must be replaced. In some embodiments, the engagement of the first coupling feature 104 with the second coupling feature 113 is irreversible, such that the drug delivery module 110 and the implantable medical device 101 are permanently inseparable once coupled together. This is desirable and beneficial for embodiments of the system 100 in which replacement of the delivery module 110 involves unacceptably high risks or complications, or is impractical because of the anatomical location in which the implantable medical device 101 is located.

[0067] The "button in a hole" interaction between the second coupling feature 113 and the first coupling feature 104 shown in several figures is provided by way of example only. In some embodiments, other coupling mechanisms are possible. Some non-limiting example alternative designs of other coupling mechanisms include: interacting tabs, clips, snaps, etc. presented by the first coupling feature 104 and the second coupling feature 113.

[0068] Figure 4-Figure 5Also shown is an example embodiment of a body 111 including a fixed frame 114. In some embodiments, the fixed frame 114 resists the rotation of the delivery module 110 on the implantable device 101. In some embodiments, the frame 114 interacts with a corresponding feature such as a lip, an edge, or a complementary frame (not shown in the drawings) presented by the implantable device 101. In some embodiments of the system 100 where the delivery module 110 is not rotationally symmetrical, the technician will recognize the importance of preventing the rotation of the module 110 around the axis 120 defined by the first coupling feature and the second coupling feature from causing undesirable interference to the physiological function at the implant site. For example, when the implantable medical device 101 is an IOL device, this rotational stability is particularly important because with any rotation of the crescent-shaped delivery module 110 above the lens 102, the module 110 will cross into the line of sight and enter the optical path, interfering with the visual field of the recipient patient.

[0069] Figure 6 is a top view of a drug delivery module of a drug eluting intraocular implant system. Figure 7 is a side view of a drug delivery module of a drug eluting intraocular implant system. Figure 8 is an enlarged perspective view of a drug delivery module of a drug eluting intraocular implant system. Fig. 9 is an end view of a drug delivery module of a drug eluting intraocular implant system. Figure 6-Figure 9 Several views are shown depicting features of the drug delivery module 110, including the second coupling feature 113, the mount 114, and the product well 112. The embodiments of the drug delivery module 110 shown in the figures are directed to the drug delivery system 100 in conjunction with an IOL implantable medical device 101, however other configurations of the drug delivery module 110 are contemplated to be configured to couple to other implantable medical devices 101 within the system 100.

[0070] Fig.10 is a side view of a drug delivery module for an intraocular drug eluting intraocular implant system. Fig.10 A drug delivery module 110 is shown having a body 111 with two rotation locks 114 and a second coupling feature 113. Fig.10 As shown, the second coupling feature 113 protrudes from the module 110. Fig.10In some embodiments, including the example shown in , the second coupling feature includes a head 113a and a protrusion 113b. In some embodiments, the head 113a has a generally truncated cone shape and is formed of an elastic material to pass through the first coupling feature 104 to lock the implantable medical device 101 to the drug delivery module 110. In some embodiments, the head 113a is formed of a substantially rigid material, and the first coupling feature 104 is formed of a substantially deformable elastic material layer, or is lined with a substantially deformable elastic material layer to allow the head 113a to pass through the first coupling feature 104. In some embodiments, the protrusion 113b offsets the head 113a from the body 111 to allow the head 113a to pass completely through the first coupling feature 104. Other configurations of the first coupling feature 104 and the second coupling feature 113 and the form of interaction between the first feature 104 and the second feature 113 are contemplated according to the disclosure herein. Fig.10 Also shown is an axis of rotation 120 that passes through the central long axis of the second coupling feature 113 .

[0071] Fig.11 is a second end view of the drug delivery system assembly, and Fig.12 is a cross-sectional view of a drug delivery module of a drug eluting intraocular implant system. Figure 11-Figure 12 Additional details of some embodiments of drug delivery module 110 are shown. In some embodiments, product well 112 and second coupling feature 113 are formed integrally with body 111. In some embodiments, second coupling feature 113 is formed separately from body 111 and subsequently bonded to body 111 using adhesive, heat welding, or other suitable techniques.

[0072] Fig.13 This is an enlarged view of the junction between the haptic arm of the drug-eluting intraocular implant system and the intraocular lens. Fig.13 An example of an implantable medical device consistent with system 100 including an IOL is shown. Haptic arm 103 is coupled to body 111 at flexible link 107. As discussed herein, flexible link 107 facilitates fixation and centering of implantable medical device 101 configured as an intraocular implant within the eye. Fig.13 104 and 105. In embodiments of the system 100 where the drug delivery module 110 is not rotationally symmetric or is not allowed to rotate relative to the implantable medical device 101, the corresponding feature 115 interacts with the mount 114 of the drug delivery module 110 to resist rotation of the drug delivery module 110 about an axis 120 passing through the first coupling feature 104 and the second coupling feature 113.

[0073] Module Insertion Assembly

[0074] In some embodiments, the drug eluting intraocular implant system 100 includes a module insertion assembly that is configured to achieve or assist the connection of an implantable medical device 101 with a drug delivery module 110. In some embodiments of the system 100, the use of the module insertion assembly is desirable, such as for use with an implantable medical device configured to be used with a drug delivery module having a maximum size less than about 10 mm. This size and smaller drug delivery modules may be difficult to manipulate with fingers, resulting in a long time spent connecting the drug delivery module to the implantable device. For many reasons known to those skilled in the art of surgical implantable medical devices, saving time in the operating room is critical. Connecting the implantable medical device to the drug delivery module requires controlled application of force to approach the first coupling feature to the second coupling feature along a fully aligned axis. The misalignment between the first coupling feature and the second coupling feature increases the risk of breakage of fragile parts, such as those parts that form an implantable drug eluting intraocular device. In addition, manipulating small objects increases the risk of device parts falling on the floor of the operating room, resulting in the need to discard contaminated or damaged drug delivery modules or implantable medical devices.

[0075] Thus, disclosure of modular insert assemblies is provided to at least (1) reduce the operating room time required to assemble a drug delivery system; (2) reduce the risk of damage to system components during assembly; and (3) minimize the risk of destroying potentially expensive components with limited availability through contamination or breakage.

[0076] Fig.14 is an exploded perspective view of a modular insert assembly for a drug delivery system. Fig.15 is an exploded side view of a modular insertion assembly of a drug eluting intraocular implant system. Figure 14-15 2 shows a modular insert assembly 200 of a drug eluting intraocular implant system 100. In some embodiments, the modular insert assembly 200 is formed of aligned stacked components including a base body 206, an intermediate body 203, and a top body 201. Figure 14-15 As shown, the base 206, the intermediate body 203, and the top body 201 are aligned and assembled together, and are reversibly assembled and disassembled by coaxial alignment of one or more series of complementary alignment features. In some embodiments, the first alignment feature 202 is disposed on the top body 201, the second alignment feature 204 is disposed on the intermediate body 203, and the third alignment feature 208 is disposed on the base 206. In some embodiments, either the first alignment feature 202 or the third alignment feature 208 is formed as a protrusion that is configured to reversibly couple with a corresponding feature, such as an aperture sized to receive the protrusion, forming the other of the first alignment feature 202 or the third alignment feature 208.

[0077] Base body 206 includes an implantable medical device receiver 210. Medical device receiver 210 is essentially an "opening" that is large enough in size and shape to easily receive an implantable medical device, such as device 101, but not large enough to allow movement of a first coupling feature carried by the medical device and a second coupling feature of a drug delivery module, such as delivery module 110. In use with an IOL implantable device and as shown in FIG. Fig.10 In some embodiments shown, the device receiver 210 is sized to receive and constrain an IOL coupled to a haptic arm. This is not meant to be limiting. In some other embodiments, the size of the received medical device can be designed to receive and constrain other implantable medical devices for coupling to a drug delivery module to form the system 100, but is not limited thereto.

[0078] In some embodiments, the intermediate body 203 includes one or more module recesses 205. The intermediate body 203 includes a first surface 214 and a second surface 216 opposite the first surface 214. When the top body 201, the intermediate body 203, and the base 206 are assembled, the first surface 214 faces the top body 201 and the second surface 216 faces the base 206. The intermediate body 203 also includes a second alignment feature 204. Figure 14 to Figure 15 In some embodiments of the illustrated example, intermediate alignment feature 204 is an aperture configured to receive a protrusion forming either first alignment feature 202 or third alignment feature 208. Alignment features 202, 204, and 208 are used to align corresponding portions of top body 201, intermediate body 203, and base body 206 to maintain alignment of first coupling feature 103 of implantable medical device 101 and second coupling feature 113 of drug delivery module 110 along axis 120.

[0079] Fig.14 Also shown is a pair of module recesses 205 on the intermediate body 203. The module recesses 205 are configured to receive and constrain a drug delivery module 210 for coupling with the implantable medical device 101, as will be discussed briefly. Figure 14-15 As shown, the intermediate body 203 is configured to be sandwiched between the base body 206 and the top body 201 .

[0080] The top body 201 includes one or more implant pressing members 209. Fig.15As shown and in some embodiments, each implant depressor 209 is formed as a raised portion having a profile similar to the profile presented by the drug delivery module 210. When the module insert assembly 200 is fitted with an implantable medical device and a drug delivery module and is fully assembled or "stacked" and pressed together, each implant depressor 209 transfers the force F applied by the user to the loaded and fully assembled module insert assembly to each corresponding drug delivery module 110, pushing each corresponding first coupling feature 104 and second coupling feature 113 together.

[0081] Fig.15 An intermediate body 203 is shown on top of a substrate 206. Fig.15 As can be seen in FIG. 2 , the intermediate body 203 and the base body 206 are substantially aligned through the interaction of the corresponding plurality of alignment features 202 , 204 , and 208 . Fig.11 Also shown is a pair of implant depressors 209 disposed on the lower surface of the top body 201. Each implant depressor 209 is formed as a raised feature having a shape similar to the cross-section of the drug delivery module 110 and slightly smaller dimensions. The implantable device 101 is received in a recess in the base 206, forming a device receiver 207. Fig.11 As shown in the partially assembled assembly device 100, each module recess 205 of the intermediate body 203 is positioned so that the recess 205 covers the coupling feature 104 of the implantable device 101, wherein the device 101 rests within the device receiver 207. In this manner, the delivery module 110 can be placed within the module recess 205 so that the second coupling feature 113 contacts the first coupling feature 104. The top body 201 is then positioned on top of the assembly and aligned by the interaction of the first alignment feature 202 with the locked third alignment feature 208, wherein the locking member 209 is pushed to contact the corresponding plurality of drug delivery modules 110. With all parts of the assembly device 200 aligned and loaded with the devices 101 and modules 110, a force "F" (at Fig.15 ) to push the top body 201 and the base body 206 toward each other to the middle body 203, thereby forcing the first coupling feature 104 and the second coupling feature 113 to lock together and "mate", while constraining the drug delivery module 110 to align with the implantable medical device 101. Figure 14-15 In some embodiments, including the illustrated example embodiment, the strategy locks the drug delivery module 110 to the flexible link of the implantable intraocular medical device 101 near the haptic arm-body interface at the mating first and second coupling features 104, 113, respectively.

[0082] Fig.14The third alignment feature 208 is shown to be configured as a protrusion in some embodiments and as a recess in some embodiments. Fig.14 In some embodiments, including the illustrated example embodiment, the base body 206 includes a plurality of third alignment features 208, one or more of the third alignment features 208 being formed as protrusions, and one or more of the features 208 being formed as recesses. Similarly, in some embodiments, the top body 201 includes one or more first alignment features 202 having a corresponding number of configurations corresponding to the number of third alignment features 208, wherein the recessed features 202 receive the protruding features 208, and the recessed features 208 receive the protruding features 202. It is contemplated and within the scope of these disclosures that in some embodiments (not shown in several of the figures), the second alignment feature(s) 204 presented by the intermediate body 203 are formed as protrusions extending from the first surface 214 of the intermediate body 203 and / or the second surface 216 of the intermediate body 203, and are received by corresponding recesses forming the first alignment features 202 and the third alignment features 208, respectively.

[0083] Fig.16 is a diagram of a method of assembling a drug delivery system. Fig.16 A method 300 of forming a drug delivery system for an implantable medical device is shown, including a positioning step 210 , a first placement step 320 , a second placement step 330 , a third placement step 340 , a coupling step 350 , and a disassembly step 360 .

[0084] In some embodiments, the positioning step 310 includes positioning the implantable medical device within a base device receiver. In some embodiments, the implantable medical device is an IOL. In some embodiments, the IOL has a haptic arm.

[0085] In some embodiments, the first placement step 320 includes placing the intermediate on the substrate. In some embodiments, the first placement step 320 includes threading one or more second alignment features of the intermediate onto corresponding one or more locking alignment features of the substrate so that the intermediate is very tightly aligned in place on top of the substrate. "Aligned in place" means that when the intermediate is coupled to the substrate, one or more module recesses of the intermediate are maintained in place directly above corresponding locations of the substrate device receiving member through interaction between the (multiple) second alignment features and the (multiple) third alignment features so that each first coupling feature of the implantable medical device is aligned above each corresponding second coupling feature of the drug delivery module loaded into each module recess of the intermediate.

[0086] In some embodiments, the second placement step 330 includes placing one or more drug delivery modules in a corresponding number of module recesses in the intermediate body after the intermediate body has been positioned on top of and aligned with the base body. The drug delivery modules are placed so that the second coupling features of the drug delivery modules resting in the module recesses contact the corresponding first coupling features of the implantable medical device constrained in the device receiving member of the base body and held in place by the intermediate body.

[0087] In some embodiments, the third placement step 340 includes placing the top body on the intermediate body and the base body. The third placement step 240 includes positioning the first alignment feature of the top body onto the locking alignment feature of the base body so that the top body is very closely aligned on top of the intermediate body, with one or more push locks positioned to contact a corresponding number of drug delivery modules.

[0088] In some embodiments, the coupling step 350 includes coupling the top body, the intermediate body, and the base. In some embodiments, this is accomplished by simply pushing the top body and the base together; that is, by applying a downward force to the top body or by pressing the top body, the intermediate body, and the base together, so that the one or more drug delivery modules loaded into the intermediate body are locked to the implantable medical device loaded into the base through the cooperation of the corresponding first coupling features of the implantable medical device and the second coupling features of the (multiple) drug delivery modules.

[0089] In some embodiments, the disassembly step 260 includes disassembling the top body and the intermediate body from the base body and removing the assembled drug delivery system.

[0090] In some embodiments, the modular insert assembly 200 is packaged with one or more drug delivery modules as part of a kit. In some embodiments, the modular insert assembly is provided prepackaged in a sterile package. In some embodiments, the modular insert assembly 200 is cleanly packaged and subsequently sterilized by the end user. In some embodiments, the modular insert assembly 200 is disposable. In some embodiments, the modular insert assembly 200 is reusable.

[0091] Several embodiments of the drug delivery system for implantable medical devices have been described. The drug delivery system produces versatility by selecting a drug delivery module comprising a specific medicament for being connected to an implantable medical device of a specific size and structure, for use in places where many device sizes and structures are needed and many therapeutic drug compositions can be used to improve therapeutic efficacy by eliminating the problem of patient self-administration and being associated with compliance. This is especially beneficial in the eye, where the drug delivery module can be selected immediately before implantation and easily and securely connected to IOL in the operating room. Other combinations of implantable medical devices equipped with the connection feature parts for being securely connected to the drug delivery module can be envisioned by this system. In some embodiments, the drug delivery system for implantable medical devices includes a module insertion assembly, to reduce operating room time, reduce breakage and pollution, and is convenient to assembling and use of the implantable medical device connected to the drug delivery module.

[0092] In order to best explain the present invention and its practical application, the embodiments and examples set forth herein are proposed, and thus enable those of ordinary skill in the art to make and use the present invention. However, those of ordinary skill in the art will recognize that the preceding description and examples given are for the purpose of illustration and example. The description as shown above is not intended to be exhaustive or to limit the present invention to the disclosed precise form. According to the teachings above, many modifications and variations are possible.

Claims

1. A drug delivery system for an implantable medical device, include: an implantable medical device selected to deliver a first treatment for a first condition to an individual patient; as well as a drug delivery module comprising a medicament selected to deliver a second treatment for a second condition to the individual patient, Wherein the drug delivery module becomes coupled to the implantable medical device immediately prior to implantation in the patient.

2. The drug delivery system according to claim 1, in, The implantable medical device includes an intraocular lens.

3. The drug delivery system according to claim 1, in, The agent is combined with a carrier composition.

4. The drug delivery system according to claim 3, in, The carrier composition is a biopolymer.

5. The drug delivery system according to claim 1, in, The first condition is a condition of the eye.

6. The drug delivery system according to claim 3, in, The first condition is cataracts.

7. The drug delivery system according to claim 1, in, The second condition is a different condition from the first condition.

8. The drug delivery system according to claim 5, in, The second condition is a condition of the eye.

9. The drug delivery system according to claim 6, in, The second condition is glaucoma.

10. The drug delivery system according to claim 2, in, The implantable medical device comprises: a haptic arm coupled to the intraocular lens at a flexible connection; a first coupling feature disposed on the implantable medical device proximate the flexible link; and a second coupling feature disposed on the drug delivery module and configured to mate with the first coupling feature, The connection between the drug delivery module and the implantable medical device is established and maintained through the interaction between the first connection feature and the second connection feature.

11. The drug delivery system according to claim 2, in, The drug delivery module includes a rotation lock.

12. The drug delivery system according to claim 1, in, The coupling of the drug delivery module to the implantable medical device is reversible.

13. The drug delivery system according to claim 1, in, The coupling of the drug delivery module to the implantable medical device is irreversible.

14. A drug delivery system, include: an implantable medical device selected to deliver a first treatment for a first condition to an individual patient; a drug delivery module having at least one sidewall defining a product well; as well as A module plug-in assembly having: a top body carrying a first alignment feature; an intermediate body having a module recess configured to receive the drug delivery module and carrying a second alignment feature, and a base having an implantation recess configured to receive the implantable medical device and to carry a third alignment feature, wherein the intermediate body is configured to be reversibly coupled between the base body and the top body through coaxial interaction between the first alignment feature, the second alignment feature, and the third alignment feature, and Wherein, under the condition that the first alignment feature, the second alignment feature and the third alignment feature are coaxial, the intermediate body is compressed between the base body and the top body by applying force to the top body, wherein the intermediate body is loaded with the drug delivery module located in the module recess, and the base body is loaded with the implantable medical device loaded in the implant recess, so that the drug delivery module is connected to the implantable medical device.

15. The drug delivery system according to claim 14, in, The implantable medical device is an intraocular implant.

16. The drug delivery system according to claim 14, in, The module insert assembly is disposable.

17. A kit comprising: Implantable medical devices; and a modular insert assembly configured to receive the implantable medical device, in, The modular insert assembly includes a top body, a middle body and a base body, and Wherein, the module insertion assembly is configured to couple a drug delivery module to the implantable medical device.

18. The kit according to claim 17, in, The implantable medical device is an intraocular medical device.

19. The kit according to claim 18, in, The intraocular medical device includes an intraocular lens.

20. The kit according to claim 17, in, The module insert assembly is disposable.

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