Implantable drug delivery systems, assemblies, and methods

Abstract

An exemplary recipient-implantable drug delivery system may include a coupling assembly, a source catheter, and a microcatheter. The proximal end of the source catheter may be configured to be fluidly coupled to a fluid source configured to provide a fluid (e.g., a neurotherapeutic agent). The distal end of the source catheter may be configured to be fluidly coupled to the coupling assembly. The microcatheter may include a proximal end configured to be fluidly coupled to the coupling assembly and a distal end including an elution opening configured to elute the fluid to a target location (e.g., the brain) within the recipient. The fluid source may be configured to provide the fluid to the target location via the source catheter, the coupling assembly, and the microcatheter.

Description

Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 219,744, filed July 8, 2021, which is hereby incorporated by reference in its entirety. [Background technology]

[0002] Individuals suffering from neurological disorders and other conditions may be treated with drugs, such as neurotherapeutic drugs. Drugs are often administered intravenously to a recipient, but intravenous administration often has drawbacks. For example, the blood-brain barrier may prevent effective transport of neurotherapeutic drugs to target locations in brain tissue. In addition, intravenous administration of drugs may cause various systemic side effects to the recipient, such as in the cardiovascular and / or gastrointestinal systems. Thus, there is a need for systems and methods for delivering drugs to target locations within the body of a recipient that are more effective and have fewer side effects to the recipient.

[0003] The accompanying drawings illustrate various embodiments and form a part of this specification. The illustrated embodiments are merely examples and are not intended to limit the scope of the present disclosure. Throughout the drawings, the same or similar reference numbers refer to the same or similar elements. [Brief description of the drawings]

[0004] [Figure 1] FIG. 1 is a functional diagram of an exemplary implantable drug delivery system. [Diagram 2] 2 is a cross-sectional view of a distal end of an exemplary implementation of a microcatheter provided in the implantable drug delivery system of FIG. 1. [Diagram 3] 3 is a cross-sectional view of the distal end of the microcatheter of FIG. 2 when fluid from a fluid source is forced through the microcatheter. [Figure 4] 2 is a cross-sectional view of a distal end of another exemplary implementation of a microcatheter provided in the implantable drug delivery system of FIG. 1. [Figure 5A]2A-2C show an exemplary implementation of a source catheter in the implantable drug delivery system of FIG. 1. [Figure 5B] FIG. 5B is a cross-sectional view of the source catheter of FIG. 5A. [Figure 6A] 2 is a top view of an exemplary cranial port in which the connection assembly provided in the implantable drug delivery system of FIG. 1 may be implemented. [Figure 6B] FIG. 6B is a side view of the cranial port of FIG. 6A. [Figure 7] FIG. 6C is a top view of the cranial port of FIGS. 6A and 6B when the proximal end of the microcatheter and the distal end of the source catheter are connected via the manifold of the cranial port. [Figure 8A] FIG. 1 is a cross-sectional side view of an exemplary implementation of a microcatheter and a connector for a microcatheter in an unassembled state. [Figure 8B] FIG. 8B is a cross-sectional side view of the connector and microcatheter of FIG. 8A in an assembled state. [Figure 9A] 2 is a top view of another exemplary implementation of a cranial port that may implement the connection assembly provided in the implantable drug delivery system of FIG. 1. [Figure 9B] FIG. 9B is a top view of a cover configured to cover the cranial port of FIGS. 6A, 6B, 7, and 9A. [Figure 10A] 2 is a cross-sectional view of an exemplary implementation of a coupling that may implement the connection assembly provided in the implantable drug delivery system of FIG. 1. [Figure 10B] FIG. 10B is a cross-sectional view of the assembled coupling of FIG. 10A connected to a microcatheter and a source catheter. [Figure 11A] 2 is a top view of an exemplary implementation of an inlet that may implement a fluid source provided in the implantable drug delivery system of FIG. 1. [Figure 11B] FIG. 11B is a cross-sectional side view of the inlet of FIG. [Figure 12] FIG. 11C is a cross-sectional side view of the inlet of FIGS. 11A and 11B in an assembled state, coupled to a source catheter. [Figure 13] FIG. 2 is a functional diagram of another exemplary implantable drug delivery system including an external pump. [Figure 14] FIG. 2 is a functional diagram of another exemplary implantable drug delivery system including an implantable pump. [Figure 15] Figure 15A is a functional diagram of an example implementation of an internal alignment circuit that may be provided in a fluid source and an external alignment circuit that may be provided in an external device. Figure 15B shows an example implementation of the inlet of Figures 11A-12 with an internal alignment circuit and an internal conductive coil positioned around the chamber of the inlet. [Figure 16] 15B shows another exemplary implementation of the inlet of FIGS. 11A-12 with the internal alignment circuit of FIG. 15A and with multiple internal conductive coils positioned within the sidewall of the inlet. FIG. [Figure 17A] FIG. 2 is a side view of an exemplary implementation of a dual lumen catheter in which the microcatheter of the drug delivery system of FIG. 1 may be implemented. [Figure 17B] FIG. 17B is a cross-sectional view of the dual lumen catheter of FIG. 17A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0005] Described herein are implantable drug delivery systems, assemblies, and methods. For example, an exemplary implantable drug delivery system may include a coupling assembly, a source catheter, and a microcatheter. The proximal end of the source catheter may be configured to be fluidly coupled to a fluid source configured to provide a fluid (e.g., a neurotherapeutic agent). The distal end of the source catheter may be configured to be fluidly coupled to the coupling assembly. The microcatheter may include a proximal end configured to be fluidly coupled to the coupling assembly. The distal end of the microcatheter may include an elution aperture configured to elute the fluid to a target location (e.g., the brain) within a recipient. As described herein, the fluid source may be configured to provide the fluid to the target location via the source catheter, the microcatheter, and a coupling assembly that fluidly couples the source catheter to the microcatheter.

[0006] As used herein, a source catheter and a microcatheter may be "fluidically coupled" one to the other by being coupled such that fluid flows from the source catheter to the microcatheter. For example, an exemplary coupling assembly may include a cranial port comprising a base member configured to be attached to a recipient's skull and a manifold on the base member. The proximal end of the microcatheter and the distal end of the source catheter may be coupled to the manifold. Thus, a fluid source and a source catheter, which may be physically distinct from the microcatheter (e.g., in shape, robustness, stiffness, etc.), may be fluidly coupled to the microcatheter through the manifold of the cranial port.

[0007] Because the cranial port is tethered to the skull and the source catheter and microcatheter are fluidly coupled through the cranial port, mechanical forces that may act on the microcatheter are reduced or eliminated, thus helping to fix the position of the implanted microcatheter at the target location and preventing dislocation of the implanted distal end of the microcatheter.

[0008] Various embodiments of the implantable drug delivery systems, assemblies and methods are described in more detail below with reference to the drawings.

[0009] FIG. 1 illustrates a functional diagram of an exemplary implantable drug delivery system 100 ("system 100"). FIG. 1 illustrates system 100 in an assembled state, such as after system 100 is implanted in a recipient. However, system 100 may be in an unassembled state, such as prior to implantation in a recipient. While in an unassembled state, one or more components of system 100 may not be coupled with other components of the system.

[0010] 1, the system 100 includes a microcatheter 102, a source catheter 104, a coupling assembly 106 (e.g., a cranial port) that fluidly couples the microcatheter 102 and the source catheter 104, and a fluid source 108 (e.g., an inlet) configured to provide a fluid. The fluid may include, for example, a drug (e.g., a neurotherapeutic agent), a rinse (e.g., saline), water, or any other fluid. The system 100 may include additional or alternative components (not shown) as may be useful for a particular implementation (e.g., bone screws, pumps, syringes, non-coring needles, etc.).

[0011] The distal end of the microcatheter 102 is configured to be implanted at a target location 110 within a recipient. As used herein, a "recipient" may include a living human or animal body, a human or animal cadaver, a portion of a human or animal anatomy, tissue removed from a human or animal anatomy, a non-tissue work piece, a training model, a dummy, and the like. In some examples, the target location 110 is the brain of the recipient and the fluid includes a neurotherapeutic agent. For example, the distal end of the microcatheter 102 may be implanted in parenchymal tissue (e.g., neural tissue) of the brain to deliver the neurotherapeutic agent directly to the parenchymal tissue, thereby bypassing the blood-brain barrier and the cardiovascular system. Any one or more additional components of the system 100 may be implantable in the recipient. For example, the coupling assembly 106 may be implantable in the recipient's skull, the fluid source 108 may be implantable in the recipient's thorax, and / or the source catheter 104 may extend from the thorax to the cranium and be implantable in the recipient. The system 100 is configured to deliver fluid from a fluid source 108 through the source catheter 104, the connection assembly 106, and the microcatheter 102 to a target location 110, as indicated by arrow 112.

[0012] As used herein, "distal" means a location away from the fluid source 108 in the direction of fluid flow through the system 100 (as indicated by arrow 112) and "proximal" means a location closer to the fluid source 108. For example, as shown in Figure 1, a distal end of a microcatheter 102 is implantable at a target location 110 and a proximal end of the microcatheter 102 is coupled to a linkage assembly 106. Also, a distal end of a source catheter 104 is coupled to the linkage assembly 106 and a proximal end of the source catheter 104 is coupled to a fluid source 108.

[0013] Exemplary embodiments of the microcatheter 102, the source catheter 104, the connection assembly 106, and the fluid source 108 are described below.

[0014] The microcatheter 102 comprises a flexible hollow tube configured to be implanted at the target location 110 and deliver fluid to tissue at the target location 110. The microcatheter 102 may be formed from any suitable material, such as polyurethane, silicone, and / or any other biocompatible material. The microcatheter 102 may be soft and flexible to prevent damage to the surrounding tissue and facilitate implantation at the target location 110. In some examples, the hardness of the microcatheter 102 is about 70 Shore A durometer or less. In further examples, the hardness of the microcatheter 102 is about 20 Shore A to about 60 Shore A durometer. In still further examples, the hardness of the microcatheter 102 is about 30 Shore A to about 50 Shore A durometer. In some examples, such as when the target location 110 is in the brain, the microcatheter 102 is softer than the surrounding tissue to prevent damage to the surrounding tissue.

[0015] The stiffness and flexibility of the microcatheter 102 may depend on the wall thickness of the microcatheter 102. In some examples, the wall thickness of the microcatheter 102 is between about 0.05 mm and about 0.15 mm. In other examples, the wall thickness of the microcatheter 102 is between about 5% and about 30% of the outer diameter of the microcatheter 102. In yet further examples, the wall thickness of the microcatheter 102 is between about 7% and about 20% of the outer diameter of the microcatheter 102. In other examples, the wall thickness of the microcatheter 102 is between about 10% and about 15% of the outer diameter of the microcatheter 102.

[0016] The microcatheter 102 may have any suitable outer and / or inner diameter as may be useful for a particular implementation. In some examples, the outer diameter of the microcatheter 102 is about 1.0 millimeter (mm) or less. In further examples, the outer diameter of the microcatheter 102 is about 0.50 mm to about 1.0 mm. In some examples, the inner diameter of the microcatheter 102 is about 0.30 mm to about 0.80 mm. Typically, the length of the microcatheter 102 depends on where the distal end is implanted (e.g., implantation depth into brain tissue, thickness of the skull, etc.) and the distance from the target location 110 to the linkage assembly 106. Thus, the microcatheter 102 may be cut to a desired length during implantation.

[0017] The microcatheter 102 includes an elution aperture through which the drug elutes from the microcatheter 102. In some embodiments, the elution aperture may be at the distal tip of the microcatheter 102. To prevent the backflow of ambient fluid (e.g., cerebrospinal fluid (CSF)) into the microcatheter 102 through the elution aperture, which may cause accumulation of proteins and other particles within the microcatheter 102, the distal tip may include a one-way valve, such as a duckbill valve. However, due to the small dimensions of the microcatheter 102, it may be difficult to form a duckbill valve at the distal tip. Thus, in other embodiments, the elution aperture is provided in the sidewall of the microcatheter 102 and the one-way valve is provided over the elution aperture, as described below with reference to FIG. 2.

[0018] FIG. 2 illustrates a cross-sectional view of the distal end 202 of an exemplary implementation of the microcatheter 102. As shown in FIG. 2, a hole 204 is formed in a sidewall 206 of the distal end 202 of the microcatheter 102. The hole 204 may have any suitable size and shape. In some examples, the hole 204 has a diameter or width of about 0.25 mm to about 0.50 mm. In further examples, the hole 204 has a diameter or width of about 50% to about 90% of the inner diameter of the microcatheter 102. Although FIG. 2 illustrates a single hole 204, the microcatheter 102 may have any other number of holes 204 positioned in any suitable location.

[0019] To prevent ambient fluid from flowing back into the microcatheter 102 through the hole 204, the microcatheter 102 includes a one-way valve 208 at or upstream of the hole 204. In the example shown in FIG. 2, the one-way valve 208 includes a flexible tubular sleeve 210 positioned over the hole 204. The sleeve 210 may be formed from any suitable material (e.g., polyurethane or silicone) and may be the same or different from the material used for the microcatheter 102. In some examples, the sleeve 210 is formed from silicone and has a durometer of about 20 Shore A to about 70 Shore A.

[0020] The sleeve 210 may be formed to have a friction-fit on the microcatheter 102 to prevent the sleeve 210 from moving along the microcatheter 102 once the sleeve 210 is positioned over the hole 204. To this end, the sleeve 210 may have an inner diameter that is slightly smaller (e.g., within about 0.05 mm) than the outer diameter of the microcatheter 102 to maintain a tight fit around the microcatheter 102. For example, the inner diameter of the sleeve 210 may be about 0.02% to about 0.05% smaller than the outer diameter of the microcatheter 102, which is sufficient to prevent backflow and still allow fluid to flow out of the microcatheter 102. In some examples, the proximal end 212 (or, alternatively, the distal end 214) of the sleeve 210 may be attached to the sidewall 206 by adhesive 215, and may be a bonding area that prevents the sleeve 210 from moving away from the sidewall 206. The adhesive bond area is not limited to the proximal end 212 (or distal end 214) of the sleeve 210, and the sleeve 210 may be adhesively bonded to the side wall 206 in additional or alternative locations, provided that the sleeve 210 is capable of partially detaching from the side wall 206 and allowing fluid to flow out of the microcatheter 102.

[0021] When fluid from the fluid source 108 is not being forced through the microcatheter 102 and pressure is not being applied to the sleeve 210 through the holes 204, the sleeve 210 forms a hermetic seal over the holes 204, preventing ambient fluid from flowing back into the microcatheter 102 through the holes 204, as shown in FIG. 2. When fluid from the fluid source 108 is being forced through the microcatheter 102, the fluid exerts pressure on the inner wall of the sleeve 210 through the holes 204, as shown by arrows 302 in FIG. 3, and moves the non-bonded portion of the sleeve 210 (e.g., the distal end 214 or the proximal end 212) away from the sidewall 206, creating a small gap through which the fluid can flow out of the microcatheter 102 and into the surrounding tissue, as shown by arrows 304. When the fluid flow stops and the pressure is reduced, the sleeve 210 returns to its original shape and position to seal the holes 204, as shown in FIG. 2.

[0022] 2 and 3 show one hole 204, in other examples, the microcatheter 102 may have multiple holes 204 formed in the sidewall 206 and a single sleeve 210 may cover each of the holes 204. In alternative examples, different sleeves may be used for different holes 204.

[0023] In examples where the elution aperture comprises holes 204 in the sidewall 206, the distal tip 216 of the microcatheter 102 may be sealed with a sealant 218 to prevent fluid from exiting through the distal tip 216 and ensure that fluid exits the microcatheter 102 only through the holes 204. Any suitable sealant may be used, such as adhesive, silicone, or molten polyurethane.

[0024] In addition to or alternatively to using a sealant, the distal tip 216 may be closed and sealed by a sleeve having a closed distal tip, as shown in FIG. 4. FIG. 4 is similar to FIG. 2, except that the distal tip 216 of the microcatheter 102 is not sealed with a sealant, but the sleeve 210 has a closed distal tip 402 that covers the distal tip 216. Thus, the sleeve 210 seals both the distal tip 216 and the hole 204. In some embodiments, the sleeve 210 may be secured to the distal end 202 of the microcatheter 102 with an adhesive (e.g., distal to the hole 204). When fluid from the fluid source 108 is pumped through the microcatheter 102, the friction fit (and / or adhesive) of the sleeve 210 prevents the sleeve 210 from dislodging from the distal end 202 of the microcatheter 102. The fluid pulls the proximal end 212 of the sleeve 210 away from the sidewall 206, creating a small gap through which the fluid can pass to exit the microcatheter 102 and enter the surrounding tissue.

[0025] The sealed distal tip 216, as in the embodiment shown in Figures 2-4, also allows the microcatheter 102 to be implanted with the use of a stylet. For example, a stainless steel stylet having an outer diameter smaller than the diameter of the microcatheter 102 may be inserted into the microcatheter 102 to stiffen the microcatheter 102 and allow the microcatheter 102 to be guided to the target location. The stylet may then be removed after the microcatheter 102 is implanted at the target location. In some examples, the distal tip 216 or distal tip 402 may be atraumatic to minimize or prevent damage to tissue during implantation of the distal end of the microcatheter 102. For example, as shown in Figures 2-4, the distal tip 216 and distal tip 402 are rounded.

[0026] The microcatheter 102 may be configured to be implanted in the body under image guidance (e.g., fluoroscopy, x-ray fluoroscopy, etc.) and / or stereotactic guidance. For example, as shown in FIGS. 2 and 3, the microcatheter 102 includes markers 220 (e.g., markers 220-1 and 220-2) positioned about the sidewall 206 on either side of the hole 204. The markers 220 may be formed of a fluorescent material (e.g., indocyanine green), a radiopaque material (e.g., platinum, iridium, barium sulfate, bismuth compounds, tungsten, etc.), and / or any other material that may be imaged by alternative imaging methods (e.g., imaging methods other than visible light imaging). The markers 220 may be incorporated, painted, adhered, or otherwise provided to the microcatheter 102. In some examples, the markers 220 include separate rings or sleeves that frictionally fit around the microcatheter 102. In yet a further example, as shown in Figure 4, one or more markers 220 may be provided (e.g., incorporated, applied, adhered, etc.) on a sleeve (e.g., sleeve 210) positioned around the microcatheter 102. For example, as shown in Figure 4, marker 220-1 is provided on sleeve 210 and marker 220-2 is provided on sidewall 206. However, marker 220-2 may also be provided on the sleeve 210 opposite hole 204, provided that marker 220-2 is flexible enough to open one-way valve 208.

[0027] The marker 220 may be configured to indicate the location of the elution aperture (e.g., hole 204). For example, the marker 220 may be positioned within a predetermined distance (e.g., within about 5 mm to about 10 mm) from the hole 204 or from the open distal tip of the microcatheter 102. In a further example, the marker 220 may have a unique shape configured to indicate the elution aperture (e.g., a ring or circle surrounding the hole 204). Under image guidance, the marker 220 may be used to position the hole 204 at a target location during implantation. Although FIGS. 2-4 show the microcatheter 102 or sleeve 210 with two annular markers 220, the microcatheter 102 and sleeve 210 may have any other number (e.g., one or more) and any other configuration of markers 220 as may be useful for a particular implementation. Alternatively, the microcatheter 102 and sleeve 210 may not have markers 220.

[0028] 1, when the system 100 is implanted in a recipient, the microcatheter 102 is configured to receive a fluid (e.g., a neurotherapeutic agent) from a fluid source 108. In some embodiments, the fluid source 108 may be implanted in the recipient away from a target location 110. For example, the target location 110 may be the recipient's brain and the fluid source 108 may be implanted in the recipient's chest (e.g., a pectoral region).

[0029] Due to the soft and flexible configuration of the microcatheter 102, the microcatheter 102 may not be physically and mechanically suitable for implantation to directly couple the fluid source 108 from the head to the thorax. For example, reeling in the microcatheter 102, such as by stretching, tearing, and / or shrinking the microcatheter 102, may damage the microcatheter 102. Furthermore, a single microcatheter 102 extending from the head to the thorax may be damaged after implantation due to the length of the microcatheter 102 and the various twists, bends, and movements the microcatheter 102 undergoes during normal activities by the recipient. Also, a single microcatheter 102 extending from the head to the thorax may be too long to be implanted with a stylet.

[0030] To prevent these problems, the proximal end of the microcatheter 102 may be fluidly coupled to the distal end of the more physically and mechanically robust source catheter 104 via the coupling assembly 106. Thus, a shorter, softer, more flexible microcatheter 102 may be easily implanted with a stylet and receive fluid from the fluid source 108 via the source catheter 104 and coupling assembly 106 when fluidly coupled to the source catheter 104 via the coupling assembly 106.

[0031] 5A and 5B show example implementations of the source catheter 104. FIG. 5A shows a side view of the source catheter 104, and FIG. 5B shows a cross-sectional view of the source catheter 104 along the dashed line labeled VB-VB. The source catheter 104 comprises a hollow tube 502 and may be formed from any suitable material, such as polyurethane, silicone, and / or other biocompatible materials. The source catheter 104 may be physically and mechanically stronger than the microcatheter 102. In some examples, the source catheter 104 has a hardness greater than the hardness of the microcatheter 102. In some examples, the hardness of the source catheter 104 is about 70 Shore A durometer or less. In further examples, the hardness of the source catheter 104 is about 20 Shore A to about 60 Shore A durometer. In still further examples, the hardness of the source catheter 104 is about 30 Shore A to about 50 Shore A durometer.

[0032] In some examples, as shown in Figures 5A and 5B, the source catheter 104 includes an inner braid 504 (e.g., a stainless steel braid) designed to resist kinking or excessive bending of the source catheter 104. The braid 504 may have any suitable number of braid strands and stiffness. In some examples, as shown in Figure 5A, the distal and / or proximal ends of the source catheter 104 do not include a braid 504. For example, the distal and proximal ends 506 and 508 of the source catheter 104 may each include a molded tip 510 to prevent fraying of the ends of the braid 504. Although Figures 5A and 5B show the source catheter 104 including an inner braid 504, in other examples, the source catheter 104 does not include an inner braid 504.

[0033] The source catheter 104 may have any suitable wall thickness. In some examples, the wall thickness of the source catheter 104 is between about 0.25 mm and about 0.50 mm. In other examples, the wall thickness of the source catheter 104 is between about 10% and about 40% of the outer diameter of the source catheter 104. In still further examples, the wall thickness of the source catheter 104 is between about 15% and about 35% of the outer diameter of the source catheter 104. In other examples, the wall thickness of the source catheter 104 is between about 20% and about 30% of the outer diameter of the source catheter 104. In further examples, the wall thickness of the source catheter 104 is greater than the wall thickness of the microcatheter 102.

[0034] The source catheter 104 may have any suitable outer and / or inner diameter as may be useful for a particular implementation. In some examples, the outer diameter of the source catheter 104 is about 1.5 mm or less. In further examples, the outer diameter of the source catheter 104 is between about 1.0 mm and about 1.5 mm. In some examples, the inner diameter of the source catheter 104 is between about 0.5 mm and about 1.0 mm.

[0035] Due to the configuration of the source catheter 104, the source catheter 104 may be physically different in various ways from the microcatheter 102, such as in material, hardness, braiding, and / or one or more size measurements (e.g., outer diameter, inner diameter, and / or wall thickness). Thus, the source catheter 104 may be configured to be tunneled subcutaneously by pulling (e.g., with a tunneling tool) without damaging the source catheter 104.

[0036] 1, the coupling assembly 106 is configured to fluidly couple a proximal end of the microcatheter 102 to a distal end of a source catheter 104 that is larger and / or physically and mechanically robust than the microcatheter 102. Thus, the microcatheter 102 may be easily implanted and, when fluidly coupled to the source catheter 104 via the coupling assembly 106 (e.g., a cranial port), the microcatheter 102 may receive fluid from a fluid source 108 via the source catheter 104. In some examples, the coupling assembly 106 may be configured to be tethered to the body, such as bone (e.g., the skull) and / or tissue. Thus, the coupling assembly 106 may reduce or eliminate stresses or mechanical forces on the microcatheter 102, such as stresses or forces transmitted from the source catheter 104.

[0037] In some examples, the connection assembly is implemented by a cranial port that may be secured to the recipient's skull. FIGS. 6A-9B show an exemplary embodiment of a cranial port 600 in which the connection assembly 106 may be implemented. FIG. 6A shows a top view of the cranial port 600, and FIG. 6B shows a side view of the cranial port 600. FIGS. 6A and 6B show the cranial port 600 not coupled to the microcatheter 102 and the source catheter 104. As shown in FIGS. 6A and 6B, the cranial port 600 comprises a base member 602 and a manifold 604. Through the manifold 604, the proximal end of the microcatheter 102 may be fluidly coupled to the distal end of the source catheter 104. FIG. 7 shows a top view of the cranial port 600 when the proximal end of the microcatheter 102 and the distal end of the source catheter 104 are coupled to the manifold 604.

[0038] The base member 602 may be formed from any suitable rigid or semi-rigid material, such as metal (e.g., stainless steel), rigid plastic (e.g., polyethylene or polyetheretherketone (PEEK)), or rigid polymer (e.g., polyurethane). As shown, the base member 602 is formed from a top plate 602-1 and a bottom plate 602-2 joined and held together by adhesive, screws, snap fits, clips, or other suitable fasteners. Alternatively, the base member 602 may be a unitary piece.

[0039] The base member 602 may be configured to be anchored to a recipient. For example, the base member 602 includes two holes 606 formed in anchor tabs 608 protruding from a main portion 610 configured to provide structural support for the microcatheter 102 and the manifold 604. The anchor tabs 608 may be formed in the top plate 602-1 and / or the bottom plate 602-2. The holes 606 may be used to attach the base member 602 to a body (e.g., skull or tissue), such as by bone screws 702 (see FIG. 7), sutures, staples, and / or other fasteners. In some examples, the anchor tabs 608 are formed in both the top plate 602-1 and the bottom plate 602-2, and bone screws (or other fasteners) passing through the holes 606 may fasten the top plate 602-1 and the bottom plate 602-2 together. 6A and 6B show two holes 606, the base member 602 may have any other suitable number (e.g., one or more) of holes 606 as may be useful in a particular implementation. In addition to or in the alternative to the holes 606, the base member 602 may be attached to the body with an adhesive (e.g., bone adhesive, tissue glue, etc.).

[0040] 6A and 6B show the base member 602 to be generally circular, the base member 602 may have any other suitable shape (e.g., circular, rectangular, oval, freeform, etc.). The base member 602 may have any suitable size. In some examples, the base member 602 (e.g., main portion 610) has a diameter or width of about 10 mm to about 25 mm. The base member 602 (e.g., main portion 610) may have a thickness of about 3 mm to about 5 mm. Thus, the cranial port 600 has a low profile and little appearance when implanted in a recipient.

[0041] The manifold 604 comprises a hollow chamber 612 having a first opening 614-1 for connection to the microcatheter 102 and a second opening 614-2 for connection to the source catheter 104 (collectively referred to as "openings 614"). As shown, the manifold 604 may be integrally formed with the base member 602. The manifold 604 and openings 614 may be formed by forming wells or cavities in the top plate 602-1 and / or bottom plate 602-2 and subsequently bonding the top plate 602-1 and bottom plate 602-2 together. An adhesive and / or sealer, such as an O-ring (not shown), may be positioned between the top plate 602-1 and bottom plate 602-2 and around the wells or cavities to prevent fluid leakage between the top plate 602-1 and bottom plate 602-2 when the cranial port 600 is implanted in a recipient. In alternative embodiments, base member 602 may be formed as a unitary piece by additive manufacturing or by removing material through openings 614. In yet a further example, manifold 604 may be formed separately and attached to base member 602, such as by mechanical fasteners or adhesives.

[0042] 7, the microcatheter 102 may be fluidly coupled to the manifold 604 through a first opening 614-1 via a first connector 704-1, and the source catheter 104 may be fluidly coupled to the manifold 604 through a second opening 614-2 via a second connector 704-2 (collectively referred to as "connectors 704"). The connectors 704 may have a similar configuration, but may differ in size in some embodiments based on the size of the microcatheter 102 and the source catheter 104. Because the microcatheter 102 and the source catheter 104 are each fluidly coupled to the manifold 604, the microcatheter 102 and the source catheter 104 are fluidly coupled to each other through the manifold 604.

[0043] 8A and 8B show an example implementation of the connector 704-1 for the microcatheter 102. FIG. 8A shows a cross-sectional side view of the connector 704-1 and the microcatheter 102 in an unassembled state, and FIG. 8B shows a cross-sectional side view of the connector 704-1 in an assembled state with the microcatheter 102. It will be understood that the connector 704-2 for the source catheter 104 may have a similar configuration, although the descriptors "distal" and "proximal" are interchangeable where appropriate. Thus, a description of the connector 704-2 will be omitted. As shown in FIG. 8A and 8B, the connector 704-1 includes an outer member 802, a sealing member 804, and a press member 806.

[0044] The outer member 802 is a rigid or semi-rigid hollow tube having an inner channel 808, a proximal end wall 810, and an open distal end 812. The outer member 802 is configured to fit the opening 614-1 of the manifold 604. Thus, the outer member 802 may be formed and shaped to substantially match the size and shape of the opening 614-1. For example, if the opening 614-1 is cylindrical, the outer shape of the outer member 802 may also be cylindrical. The outer member 802 may be secured to the sidewalls of the opening 614-1 with an adhesive to seal the gap between the outer member 802 and the sidewalls of the opening 614-1. Alternatively, the outer member 802 may be integrally formed with the base member 602. The inner channel 808 includes a proximal inner portion 808-1 and a distal inner portion 808-2 within which the sealing member 804 and / or the press member 806 may be positioned. The proximal end wall 810 has an opening 814 through which the proximal end 816 of the microcatheter 102 may be inserted when the microcatheter 102 is coupled to the connector 704-1. In some examples, the size of the opening 814 is approximately equal to the outer diameter of the microcatheter 102. The open distal end 812 is open to allow the sealing member 804 and / or the pressing member 806 to be inserted into the inner channel 808. In some examples, the outer member 802 has a length of about 4 mm to about 8 mm. In further examples, the inner channel 808 has a diameter or width of about 0.5 mm to about 1 mm.

[0045] The sealing member 804 is formed from a resilient material (e.g., silicone) and has an inner channel 818 through which the proximal end 816 of the microcatheter 102 may be inserted when the microcatheter 102 is coupled to the connector 704-1. In some examples, the sealing member 804 has a hardness of about 20 Shore A durometer to about 50 Shore A durometer. The sealing member 804 is configured to be positioned within the proximal inner portion 808-1 with minimal gap or space between the sealing member 804 and the outer member 802. In some examples, the sealing member 804 may be formed and shaped to substantially match the size and shape of the inner channel 808 (e.g., the proximal inner portion 808-1). For example, if the inner channel 808 is cylindrical, the sealing member 804 may also be cylindrical.

[0046] The press member 806 is configured to press the sealing member 804 to compress the sealing member 804 between the press member 806 and the proximal end wall 810. The pressure on the sealing member 804 creates a watertight seal that prevents leakage of fluid through the opening 814 by forcing the sealing member 804 against the outer member 802 around the proximal end 816 of the microcatheter 102. The sealing member 804 also holds the microcatheter 102 securely and prevents separation of the microcatheter 102 from the connector 704-1, but does so without limiting the patency of the microcatheter 102. The press member 806 may be formed from any suitable material that is harder than the sealing member 804. For example, the press member 806 may be formed from a hard plastic (e.g., PEEK), a hard polymer (e.g., polyurethane), or a metal (e.g., stainless steel).

[0047] The press member 806 may have any suitable configuration and may operate in any suitable manner. In some examples, as shown in Figures 8A and 8B, the press member 806 includes a threaded latch screw configured to be positioned within the distal inner portion 808-2, which is also threaded to match the latch screw. The latch screw includes an inner channel 820 through which the proximal end 816 of the microcatheter 102 may be inserted.

[0048] The distal end surface 822 of the latch screw includes an engagement member that can be used to tighten the latch screw when the proximal end 816 of the microcatheter 102 is positioned through the inner channel 818 and the inner channel 820. As shown, the engagement member includes a socket 824 on the distal end surface 822 of the latch screw. The latch screw can be tightened by inserting a tool into the socket 824 and using the tool to leverage from within the socket 824 to rotate the latch screw within the distal inner portion 808-2 of the outer member 802 of the connector 704-1. For example, such a tool can be configured to be placed around the outer member 802, the tool including a mounting rod that can be positioned within the socket 824, such that the outer member 802 and the tool body are used simultaneously to leverage and rotate the latch screw. In an alternative embodiment, the engagement member may be a ridge or protrusion that is higher than the distal end face 822 of the latch screw and can be grasped and pulled or pushed by a tool to rotate the latch screw. In other embodiments, the engagement member may include one or more holes extending from the radially outer face of the press member 806 into the inner channel 820, such that a tool having extensions can be inserted into the one or more holes to provide an accessible surface that can be grasped with the extensions to rotate the latch screw.

[0049] The press member 806 may have configurations other than a latch screw. For example, the press member 806 may comprise a lid (having an opening through which the microcatheter 102 passes) that attaches to the outer member 802 (e.g., by a snap fit or threaded fit) and presses directly against the sealing member 804. In other examples, the press member 806 may be an unthreaded hollow rigid or semi-rigid body that is positioned within the distal inner portion 808-2 and held in place, such as by a snap fit or a lid (having an opening through which the microcatheter 102 passes) that covers the distal end 812 of the outer member 802.

[0050] As described above, the outer member 802 may be secured within the opening 614-1 with an adhesive. The microcatheter 102 may be coupled to the manifold 604 by inserting the sealing member 804 and the press member 806 into the inner channel 808 of the outer member 802 with the opening 814, the inner channel 818, and the inner channel 820 axially aligned. The proximal end 816 of the microcatheter 102 may be inserted through the press member 806, the sealing member 804, and then the opening 814. Alternatively, the microcatheter 102 may first be inserted through the press member 806 and the sealing member 804, and then the assembly may be inserted into the inner channel 808 of the outer member 802. The press member 806 is engaged (e.g., the latch screw is tightened) to press the sealing member 804, which in turn presses the sealing member 804 against the microcatheter 102, the proximal end wall 810 of the outer member 802, and the inner wall of the inner chamber 808 of the outer member 802, holding the microcatheter 102 in place and also sealing the fluid passing around the microcatheter 102 within the outer member 802.

[0051] The distal end of the source catheter 104 may be coupled to the manifold 604 in a manner similar to the way the proximal end of the microcatheter 102 is coupled to the manifold 604. When the microcatheter 102 and the source catheter 104 are coupled to the manifold 604, as shown in FIG. 7, the manifold 604 of the cranial port 600 acts as a fluid interface through which the microcatheter 102 is fluidly coupled to the source catheter 104 and allows fluid to flow from the source catheter 104 into the chamber 612 and then through the microcatheter 102, as indicated by arrows 706. By indirectly coupling the microcatheter 102 to the source catheter 104 via the manifold 604, forces (e.g., pulling, twisting, shaking, etc.) from the source catheter 104 are minimized or prevented from being transmitted to the microcatheter 102.

[0052] To prevent the proximal end 708 of the microcatheter 102 and the distal end 710 of the source catheter 104 from being pushed too far into the chamber 612, the manifold 604 may include a stopper 616 formed in the chamber 612 near the opening 614. The stopper may be a protrusion integrally formed with the top plate 602-1 and / or the bottom plate 602-2, or may be formed separately and attached to the top plate 602-1 and / or the bottom plate 602-2. In addition to or as an alternative to the stopper 616, the opening 614 may be angled relative to the chamber 612 to allow the proximal end 708 of the microcatheter 102 and the distal end 710 of the source catheter 104 to be pushed into the chamber 612 without hitting the chamber walls. In another example, a sleeve having an outer diameter larger than the diameter of the inner channel 820 of the press member 806 (or the inner channel 818 of the sealing member 804) may be placed over the outside of the proximal end of the microcatheter 102 to prevent the proximal end 708 of the microcatheter 102 from being pushed in too far; that is, the sleeve is too large to fit into the connector 704-1 in some places, so the connector 704-1 itself acts as a stop. A similar sleeve may be used over the outside of the distal end of the source catheter 104 to prevent the distal end 710 of the source catheter 104 from being pushed in too far.

[0053] 6A, 6B, and 7, the base member 602 may be configured to minimize or reduce stress and forces that may be applied to the microcatheter 102. For example, as shown in FIGS. 6A and 6B, the base member 602 includes an access hole 618 and a guide channel 620. The access hole 618 is a hole through the base member 602 through which the distal end of the microcatheter 102 may be inserted for implantation at a target location. For example, the access hole 618 may provide access to a burr hole 712 in the skull, as shown in FIG. 7. The access hole 618 may be of any size and shape as may be useful for a particular implementation.

[0054] The guide channel 620 extends from the access hole 618 to an outer edge 622 of the base member 602. As shown in FIGS. 6A and 7, the guide channel 620 is an open channel (e.g., a groove) formed in the surface of the base member 602, although the guide channel 620 may alternatively be a closed channel (e.g., a tube). The guide channel 620 is configured to hold the microcatheter 102 in place, limiting movement of the microcatheter 102 near the access hole 618 and preventing dislocation of the implanted distal end of the microcatheter 102. For example, the guide channel 620 may have a width approximately equal to the outer diameter of the microcatheter 102. To hold the microcatheter 102 in place, the guide channel 620 may be configured such that the microcatheter 102 "snaps" into place within the guide channel 620 and does not move away from the guide channel 620. In an alternative embodiment, the cranial port 600 may include a cover (see FIG. 9B ) that may be placed over the base member 602 to further limit movement of the microcatheter 102 and protect various components of the cranial port 600.

[0055] The proximal end of the guide channel 620 may be positioned at any position relative to the opening 614-1 of the cranial port 600. In some examples, the proximal end of the guide channel 620 is positioned directly opposite (e.g., 180°) the opening 614-1 of the cranial port 600 to maximize the distance that the microcatheter 102 is wrapped around the base member 602. In other examples, the proximal end of the guide channel 620 may be positioned less than or more than 180° (e.g., 210°, 135°, 90°, 45°, etc.) from the opening 614-1 of the cranial port 600.

[0056] 7, the microcatheter 102 may be loosely wrapped around (e.g., not in contact with) the base member 602. In other examples, the microcatheter 102 may be tightly wrapped around or on the outer edge 622 of the base member 602.

[0057] By using the cranial port 600 fixed to the skull to hold the microcatheter 102 securely in place within the guide channel 620 and connecting the microcatheter 102 and the source catheter 104 into the manifold 604 through the respective connectors 704-1 and 704-2 without a direct physical connection between the microcatheter 102 and the source catheter 104, the microcatheter 102 may be partially or substantially mechanically isolated from external forces. For example, movement of the portion of the microcatheter 102 extending between the access hole 618 and the first opening 614-1 may be isolated from the obstruction of the portion of the microcatheter 102 extending within the skull by the microcatheter 102 being held in place within the guide channel 620 and by the cranial port 600 being fixed to the skull. In another example, movement of the source catheter 104 may be isolated from obstruction of the portion of the microcatheter 102 extending intracranially by the source catheter 104 being positioned within the second connector 704-2, by the source catheter 104 being physically distanced from the microcatheter 102 by a fluid coupling through the manifold 604, by the microcatheter 102 being held in position within the guide channel 620, and by the cranial port 600 being secured to the skull. Typically, the portion of the microcatheter 102 extending intracranially may be protected in a number of ways from intracranial movement that may result from the application of external forces in the absence of the cranial port 600.

[0058] FIG. 9A shows a top view of another example implementation of a cranial port 600. FIG. 9A is similar to FIG. 6A, except that in FIG. 9A, the cranial port 600 includes an outer guide channel 902 to which the microcatheter 102 can be secured to an outer edge 622 of the base member 602. The outer guide channel 902 may be configured similarly to the guide channel 620. The outer guide channel 902 may communicate with the opening 614-1. In some examples, the outer guide channel 902 is deep enough so that the microcatheter 102 does not protrude beyond the outer edge 622 of the base member 602 or beyond the top surface of the base member 602.

[0059] FIG. 9B illustrates a top view of an optional cover 904 covering the cranial port 600 shown in FIGS. 6A, 6B, 7, and 9A. The cover 904 is configured to cover the top surface and outer edge 622 of the base member 602. The cover 904 may be attached to the base member 602 in any suitable manner, such as by fasteners, a snap fit, a thread fit, and / or an adhesive. When placed on the base member 602 of FIG. 9A, the cover 904 may cover the outer guide channel 902 to protect the microcatheter 102 and prevent the microcatheter 102 from separating from the outer guide channel 902. Thus, the cover 904 may completely cover the microcatheter 102 such that the entire microcatheter 102 is not exposed outside the cover 904. The cover 904 may include an opening (not shown in FIG. 9B) corresponding to the opening 614-2 to allow the source catheter 104 to be coupled to the manifold 604 through the cover 904.

[0060] In the example described above, the coupling assembly 106 (see FIG. 1 ) is implemented by a cranial port 600. In an alternative example, the coupling assembly 106 may be implemented by a coupling that directly couples the proximal end of the microcatheter 102 with the distal end of the source catheter 104. For example, FIGS. 10A and 10B show another exemplary implementation of the coupling assembly 106. As shown, the coupling assembly 106 is implemented by a coupling 1000. FIG. 10A shows the coupling 1000 in an unassembled state, and FIG. 10B shows the coupling 1000 in an assembled state coupled to the microcatheter 102 and the source catheter 104.

[0061] The coupling 1000 comprises a microcatheter connector 1002 and a source catheter connector 1004 joined end to end. The connectors 1002 and 1004 are similar to the connectors 704-1 and 704-2 and will not be described in detail. In some examples, the outer members of the connectors 1002 and 1004 are formed as a unitary body, as shown in FIGS. 10A and 10B. Alternatively, the outer members of the connectors 1002 and 1004 are formed separately and joined together, such as by adhesive, snap fit, fasteners, thread fit, or other suitable attachment. In some examples, as shown in FIGS. 10A and 10B, the coupling 1000 may comprise anchor tabs 1006 to allow the coupling 1000 to be attached to the body (e.g., bone).

[0062] In an alternative embodiment, such as when the microcatheter 102 and the source catheter 104 have similar sizes, the microcatheter 102 and the source catheter 104 may be directly coupled, such as by adhesive, between the proximal tip of the microcatheter 102 and the distal tip of the source catheter 104. However, a direct coupling may not be appropriate when the microcatheter 102 and the source catheter 104 are physically different and / or when the source catheter 104 may apply stress or force to the microcatheter 102.

[0063] 1, the proximal end of the source catheter 104 is coupled to a fluid source 108. The fluid source 108 may be implanted in the body, such as within the pectoral fascia between the skin and muscle.

[0064] In some examples, the fluid source 108 may be implemented by an inlet. Figures 11A and 11B show an example implementation of an inlet 1100 in which the fluid source 108 may be implemented. Figure 11A shows a top view of the inlet 1100, and Figure 11B shows a cross-sectional side view of the inlet 1100 along the dashed line labeled XIB-XIB.

[0065] 11A and 11B, the inlet 1100 includes a body 1102, a septum 1104, and a chamber 1106. The body 1102 is formed of a rigid material, such as a rigid plastic (e.g., PEEK) or metal. The body 1102 includes a cavity 1108 formed therein, defined by a sidewall 1110 and an opening 1112 on the top surface of the body 1102. The opening 1112 provides access to the cavity 1108. As shown in FIG. 11B, the inner surface of the sidewall 1110 is inwardly angled or curved such that the size of the opening 1112 is smaller than the size of the cavity 1108. Alternatively, the sidewall 1110 may have any other suitable configuration (e.g., straight or outwardly angled or curved) as may be useful in a particular implementation. The body 1102 may be atraumatic, such as having rounded edges and smooth curves. The body 1102 may further include an anchor portion 1114 having holes 1116 for attaching the body 1102 to the body, such as by bone screws, sutures, and / or staples. The body 1102, the cavity 1108, and the opening 1112 may each have any suitable shape and size. For example, FIG. 11A shows that the body 1102, the cavity 1108, and the opening 1112 have a generally circular or rounded shape when viewed from the top. In some examples, the outer diameter of the body 1102 is about 18 mm to about 25 mm. In some examples, the diameter of the cavity 1108 may be about 5 mm to about 20 mm. In some examples, the thickness of the body 1102 may be about 8 mm to about 10 mm.

[0066] The septum 1104 comprises a sac 1118 and a soft gel 1120 within the sac 1118. The sac 1118 may be formed, for example, from a soft elastomer (e.g., silicone), and the gel 1120 may be any suitable soft gel (e.g., silicone gel). The septum 1104 is positioned within and seals the opening 1112. The septum 1104 may be attached to the sidewall 1110 with an adhesive. The bottom surface 1122 of the septum 1104, the sidewall 1110 of the cavity 1108, and the bottom surface 1124 of the cavity 1108 define the interior walls of the chamber 1106. The chamber 1106 is a fluid chamber for receiving and / or holding a fluid (e.g., a neurotherapeutic agent) to be delivered to a target location via the source catheter 104 and the microcatheter 102.

[0067] The body 1102 includes an opening 1126 in the sidewall 1110 that fluidly couples the source catheter 104 to the chamber 1106. The source catheter 104 may be fluidly coupled to the chamber 1106 via a connector, as shown in FIG. 12. FIG. 12 is similar to FIG. 11B, except that the source catheter 104 is coupled to the inlet 1100 via a connector 1202. The connector 1202 may have any suitable configuration. As shown in FIG. 12, the connector 1202 includes an elastomeric sleeve 1204 positioned over the proximal end of the source catheter 104. The sleeve 1204 may be formed to have a snug frictional fit over the source catheter 104 and within the opening 1126. For example, the sleeve 1204 may have an inner diameter slightly smaller than the outer diameter of the source catheter 104 and an outer diameter slightly larger than the inner diameter of the opening 1126. The outer surface of the sleeve 1204 may include a protruding seal 1206 around the circumference of the sleeve 1204. The seal 1206 is configured to engage a correspondingly shaped channel in the opening 1126 to secure the sleeve 1204 within the opening 1126 and prevent the sleeve 1204 and source catheter 104 from being disconnected from the inlet 1100. In an alternative example, the connector 1202 may be implemented with a connector similar to the connector 704-2 used to couple the source catheter 104 to the cranial port 600. In some examples, the connector 1202 and correspondingly shaped opening 1126 may be used in the cranial port 600 in place of the connectors 704-1 and / or 704-2 and openings 614-1 and / or 614-2.

[0068] The chamber 1106 may be filled with a fluid (e.g., a neurotherapeutic agent) by inserting a non-coring needle into the chamber 1106 through the upper surface 1128 of the septum 1104. As the fluid is forced under pressure into the chamber 1106, the pressure forces the fluid through the source catheter 104, the connection assembly 106 (e.g., the manifold 604 of the cranial port 600), and the microcatheter 102, where it elutes to the target location. After the non-coring needle is removed from the inlet 1100, the gel 1120 returns to its crosslinking orientation, allowing the septum 1104 to recover from the puncture.

[0069] Fluid may be pushed through system 100 in any suitable manner. For example, in some implementations, fluid may be pushed through system 100 by a syringe coupled to a non-coring needle.

[0070] FIG. 13 illustrates another implementation for pushing fluid through the system 100 using an external pump 1302. FIG. 13 is similar to FIG. 1, except that in FIG. 13, an external pump 1302 (e.g., external to the recipient) is coupled to the source catheter 104 and pushes fluid through the system 100. The external pump 1302 may be coupled to the source catheter 104 in any suitable manner, such as by a percutaneous access port or cannula. The external pump 1302 may be fluidly coupled to an external fluid source (not shown) and provide fluid from the fluid source to the microcatheter 102 via the source catheter 104 and the coupling assembly 106.

[0071] FIG. 14 illustrates yet another implementation for pushing fluid through the system 100 using an implantable pump 1402. FIG. 14 is similar to FIG. 1, except that in FIG. 14, an implantable pump 1402 is implanted in the recipient and is coupled between the source catheter 104 and the fluid source 108 (e.g., chamber 1106 of inlet 1100) to push fluid through the system 100. Alternatively, the implantable pump 1402 may be fluidly coupled to the source catheter 104, with the fluid source 108 located between the source catheter 104 and the implantable pump 1402. In still further embodiments, the implantable pump 1402 and the fluid source 108 may be integrated as a single device. The fluid source 108 may be implantable in the recipient or may be external to the recipient.

[0072] 13 and 14, the source catheter 104 may be fluidly coupled to the external pump 1302 or the implantable pump 1402 in any suitable manner, including any of the methods described herein. In some examples, the proximal end of the source catheter 104 is configured to couple to the implantable pump 1402. The pumps 1302 and 1402 may be implemented with any suitable pump, such as a low pressure pump or a peristaltic pump.

[0073] In embodiments in which an external device (e.g., a syringe and non-coring needle, an external pump 1302, etc.) is used to push fluid through the system 100, the fluid source 108 may include an alignment unit configured to facilitate proper alignment of the external device with the upper surface 1128 of the septum 1104. In some examples, the alignment unit includes a metal body (e.g., a rod, a bead, a plate, a screw, etc.) that can be detected by an external device (e.g., a metal detector, a magnetic detector, etc.). The metal body may be provided (e.g., integrated, attached, etc.) to the fluid source 108 (e.g., in or on the body 1102). In some examples, the metal body includes a bone screw or staple that is used to secure the fluid source 108 to the body through the hole 1116. In further examples, one or more components of the fluid source 108 may be formed from metal (e.g., the body 1102).

[0074] In another example, the alignment unit includes an internal alignment circuit within the fluid source 108 that inductively couples to an external alignment circuit provided in an external device (e.g., an external pump, syringe, alignment device, etc.). For example, FIG. 15A shows a functional diagram of an example implementation of an internal alignment circuit 1502 within the fluid source 108 and an external alignment circuit 1504 within an external device 1506. As shown, the internal alignment circuit 1502 includes a conductive coil 1508 electrically connected to a load 1510 (e.g., a resistor). The internal alignment circuit 1502 may include any additional or alternative components as may be useful for a particular implementation (e.g., a capacitor). The external alignment circuit 1504 includes a conductive coil 1512 electrically connected to a current source 1514 and a measurement circuit 1516. The external alignment circuit 1504 may include any additional or alternative components as may be useful for a particular implementation.

[0075] The current source 1514 is configured to generate a current through the conductive coil 1512, which is inductively coupled onto the conductive coil 1508 when the external device 1506 is positioned near the fluid source 108. The inductively coupled energy is then dissipated in the load 1510. The measurement circuit 1516 is configured to measure the current drain or power transfer caused by the internal alignment circuit 1502. The measurement circuit 1516 may have any suitable configuration. The measured current drain or power transfer increases as the conductive coil 1512 and the axis 1518 of the conductive coil 1508 are aligned. The maximum current drain or power transfer occurs when the conductive coil 1512 is aligned along the same axis 1518 of the conductive coil 1508. Thus, the external device 1506 can be properly aligned with the fluid source 108 based on the current drain measured by the measurement circuit 1516 in the external device 1506. That is, the external device 1506 senses the alignment by identifying the physical position where maximum power transfer occurs.

[0076] The conductive coil 1508 of the internal alignment circuit 1502 may be in any suitable location within the fluid source 108. For example, FIG. 15B shows an example implementation of the internal alignment circuit 1502 within the inlet 1100. As shown, the conductive coil 1508 is positioned within the sidewall 1110 around the chamber 1106. The axis 1518 of the conductive coil 1508 may be positioned at any suitable location, such as at the center of the chamber 1106. However, the conductive coil 1508 may be positioned at any suitable location within the sidewall 1110 and / or body 1102. In the configuration shown in FIG. 15B, an external device (e.g., a needle and / or pump) may be in suitable alignment with the inlet 1100 such that the needle pierces the septum 1104 and pushes the fluid into the chamber 1106 and through the system 100.

[0077] Although FIG. 15B shows one conductive coil 1508, the inlet 1100 may include any other number (e.g., one or three or more) of conductive coils and internal alignment circuitry 1502 as may be useful in a particular implementation. For example, FIG. 16 shows another example implementation of an internal alignment circuitry 1502 in the inlet 1100. As shown in FIG. 16, a first internal conductive coil 1602-1 and a second internal conductive coil 1602-2 are positioned in the sidewall 1110. The axes 1604-1 and 1604-2 of the conductive coils 1602-1 and 1602-2 may be positioned in any suitable orientation. Although FIG. 16 shows two conductive coils 1602, the inlet 1100 may include any other number (e.g., one or three or more) of conductive coils and internal alignment circuitry as may be useful in a particular implementation. Conductive coils 1602-1 and 1602-2 may be coupled to the same load or to different loads.

[0078] According to the systems, assemblies, and methods described herein, various diseases and conditions may be treated more efficiently and with fewer side effects to the recipient. For example, the system 100 may be used to treat cancer (e.g., glioblastoma, tumors, etc.), Parkinson's disease, epilepsy (e.g., status epilepticus), Alzheimer's disease, Huntington's disease, multiple sclerosis, and psychiatric indications (e.g., depression, anxiety, etc.). The system 100 may also be used to treat other non-brain diseases or conditions (e.g., cancer). By delivering drugs directly to the target location instead of via intravenous administration, the system 100 may avoid various systemic side effects and complications of conventional therapies.

[0079] In the examples described herein, the various components and tools used to implement the system 100 may be provided as a kit. For example, the kit may include any one or more of the microcatheter 102, the sleeve 210, an adhesive and applicator for attaching the sleeve 210 to the microcatheter 102, a stylet for embedding the distal end of the microcatheter 102, a measuring tool (e.g., a ruler) for measuring the exact length of the microcatheter 102, and a knife or scissors for cutting the microcatheter 102. Additionally, the kit may include any one or more of the cranial port 600 or coupling 1000, the connector 704 (e.g., the outer member 802, the sealing member 804, the press member 806, and / or the sleeve stopper), an adhesive and / or sealer (e.g., an O-ring), fasteners (e.g., a bone screw and a screwdriver), a hex wrench or other tool (e.g., a lever) for tightening the press member 806 (the latch screw), and a cover 904 for the cranial port 600. Additionally, the kit may include any one or more of the source catheter 104, a tunneling tool (for implanting the source catheter 104), a fluid source 108 (e.g., inlet 1100), a connector 1202 (e.g., sleeve 1204), a needle (e.g., a non-coring needle), a syringe, a pump (e.g., external pump 1302, implantable pump 1402), an external device 1506, and a knife or scissors for cutting the source catheter 104. Additionally, the kit may include a sterilization kit for sterilizing the implantation site and / or the fluid injection site in the body.

[0080] Various modifications may be made to the system 100 and / or any of its components. For example, FIGS. 17A and 17B show another exemplary implementation of the microcatheter 102. As shown, the microcatheter 102 is implemented by a dual lumen catheter 1700. FIG. 17A shows a side view of the dual lumen catheter 1700, and FIG. 17B shows a cross-sectional view of the dual lumen catheter along dashed line labeled XVIIB-XVIIB. As shown, the dual lumen catheter 1700 comprises a stylet lumen 1702 and a fluid delivery lumen 1704 side by side. The proximal end of the stylet lumen 1702 is open, while the distal end of the stylet lumen 1702 is closed, allowing a stylet to be inserted into the stylet lumen 1702 and used to implant the distal end of the dual lumen catheter at a target location. The proximal end of the fluid delivery lumen 1704 is configured to be fluidly coupled to the distal end of the source catheter 104, such as by any of the methods described herein. Thus, as shown in FIG. 17A, the proximal end of the fluid delivery lumen 1704 is longer than the proximal end of the stylet lumen 1702. The distal end of the fluid delivery lumen 1704 is configured to be implanted at a target location and to elute fluid to the target location through an elution aperture (not shown). The elution aperture may be configured in any manner described herein.

[0081] In another modification, the fluid source 108 may be provided within the cranial port 600, eliminating the need for a source catheter 104. For example, the manifold 604 may implement the inlet (e.g., the chamber 612 of the manifold 604 may implement the chamber 1106 of the inlet 1100). Thus, the cranial port 600 may include a septum to allow the chamber 612 to be filled with fluid by an external device.

[0082] As described above, the sleeve 210 may be used as a one-way valve in the system 100 to prevent fluid from flowing back into the microcatheter 102 through the elution openings 204. It will be appreciated that this one-way sleeve valve may be used in applications other than microcatheters and / or for systems other than the system 100. For example, the sleeve 210 may be used as a one-way valve in any other catheter (e.g., a central venous catheter). Additionally, the sleeve 210 may be used in other medical and non-medical applications.

[0083] The systems, assemblies, and methods described herein provide numerous benefits and advantages over conventional systems, assemblies, and methods. For example, the systems, assemblies, and methods described herein may allow neurotherapeutic agents to be delivered directly to a target location within a recipient with minimal systemic side effects. Additionally, the efficiency of drug delivery may be improved by positioning the distal end of the microcatheter at or near the target location.

[0084] Furthermore, the microcatheter and the source catheter may each be configured to accommodate the different functions each catheter serves without sacrificing the performance of the catheter or the overall system. For example, the microcatheter may be small, soft, and flexible so that it can be implanted in or near delicate tissue, such as brain tissue, without damaging the tissue. The microcatheter may be implanted at the target location under stereotactic guidance and / or image guidance (e.g., fluoroscopy or fluoroscopy guidance). On the other hand, the source catheter may be more physically and mechanically robust, preventing kinking or collapsing and allowing for more physically demanding implantation techniques, such as tunneling and extraction. Thus, the fluid source may be implanted at a location away from the target location. For example, even if the target location is the brain, the fluid source may be implanted in the chest, which has more space than the head and less hair to carry pathogens. In this way, the fluid source does not protrude from the head and is less likely to receive pathogens that hair typically carries. This configuration is also less painful for the recipient and is more cosmetically pleasing.

[0085] Additionally, the systems, assemblies, and methods described herein may allow for more frequent or on-demand delivery of drugs to a target location. For example, drugs may be administered to a target location as needed, such as when a seizure occurs. Drugs may also be delivered to a target location more frequently and more easily. For example, drugs may be delivered to a target location (e.g., the brain) by simple injection into a fluid source through the recipient's skin. Drugs may also be replenished or even changed as needed without surgery.

[0086] The advantages and features of the present disclosure may be further explained by the following statements.

[0087] 1. A coupling assembly; 1. A source catheter, a proximal end configured to be fluidly coupled to a fluid source configured to provide a fluid; a distal end configured to be fluidly coupled to a coupling assembly; and a source catheter comprising: A microcatheter comprising: a proximal end configured to be fluidly coupled to a coupling assembly; a distal end having an elution opening configured to elute a fluid to a target location within a recipient; and A microcatheter comprising: A drug delivery system implantable in a recipient, comprising:

[0088] 2. The drug delivery system of statement 1, wherein the target location comprises the recipient brain.

[0089] 3. The drug delivery system described in statement 2, wherein the distal end of the microcatheter is implantable in brain parenchymal tissue.

[0090] 4. The drug delivery system of statement 2 or 3, wherein the fluid comprises a neurotherapeutic agent.

[0091] 5. The connection assembly is a cranial port, a base member configured to be attached to a recipient's skull; Base member manifold and a cranial port comprising: A drug delivery system described in any of statements 2 to 4, wherein the proximal end of the microcatheter is configured to be fluidly connected to the distal end of the source catheter via the manifold.

[0092] 6. The drug delivery system of statement 5, wherein the manifold is integrally formed with the base member.

[0093] 7. The drug delivery system of statement 5 or 6, wherein the base member comprises an access hole for accessing a burr hole in the skull, the burr hole providing access to the brain.

[0094] 8. The base member further comprises a guide channel extending from the access hole to an outer edge of the base member; 8. The drug delivery system of statement 7, wherein the guide channel is configured to secure the microcatheter when a distal end of the microcatheter is implanted in the brain.

[0095] 9. A first connector for connecting a microcatheter to a manifold, comprising: a hollow first outer member having a first inner portion, a proximal end wall, and an opening in the proximal end wall; a first sealing member having a first inner channel configured to receive a proximal end of a microcatheter, the first sealing member being configured to be positioned within a first inner portion of the first outer member; a first pressing member configured to press the first sealing member and compress the first sealing member around the proximal end of the microcatheter when the proximal end of the microcatheter is positioned through the first inner channel of the first sealing member; A drug delivery system described in any of statements 5 to 8, further comprising a first connector comprising:

[0096] 10. The drug delivery system described in statement 9, wherein the first sealing member is configured to seal the first inner portion of the first outer member when pressed by the first press member.

[0097] 11. The drug delivery system of statement 9 or 10, wherein an inner diameter of the first inner channel of the first sealing member is approximately equal to or less than an outer diameter of the microcatheter.

[0098] 12. The first medial portion of the first outer member comprises a distal medial portion and a proximal medial portion; the first sealing member is configured to be positioned within the proximal inner portion of the first outer member; A drug delivery system described in any of statements 9 to 11, wherein the first pressing member is configured to be positioned within a distal inner portion of the first outer member.

[0099] 13. The distal inner portion of the first outer member is threaded; The drug delivery system of statement 12, wherein the first press member comprises a latch screw.

[0100] 14. A second connector for connecting a source catheter to the manifold, comprising: a hollow second outer member having a second inner portion, a distal end wall, and an opening in the distal end wall; a second sealing member having a second inner channel configured to receive a distal end of the source catheter, the second sealing member configured to be positioned within the second inner portion of the second outer member; a second pressing member configured to press the second sealing member and compress the second sealing member around the distal end of the source catheter when the distal end of the source catheter is positioned through the second inner channel of the second sealing member; A drug delivery system described in any of statements 9 to 13, further comprising a second connector comprising:

[0101] 15. The manifold has a first opening for connecting the microcatheter and a second opening for connecting the source catheter; A drug delivery system described in any of statements 9 to 14, wherein the first outer member is fixed to the first opening.

[0102] 16. A drug delivery system described in any of statements 1 to 15, wherein the hardness of the microcatheter is less than the hardness of the source catheter.

[0103] 17. A drug delivery system described in any of statements 1 to 16, wherein the hardness of the microcatheter is from about 20 Shore A durometer to about 50 Shore A durometer.

[0104] 18. A drug delivery system described in any of statements 1 to 17, wherein the source catheter comprises an inner braid.

[0105] 19. The inner diameter of the microcatheter is smaller than the inner diameter of the source catheter, or The outer diameter of the microcatheter is smaller than the outer diameter of the source catheter. 19. A drug delivery system according to any one of statements 1 to 18, wherein the drug delivery system is at least one of the above.

[0106] 20. The drug delivery system of statement 19, wherein the outer diameter of the microcatheter is about 0.5 mm to about 1.0 mm.

[0107] 21. The drug delivery system of statement 19 or 20, wherein the outer diameter of the source catheter is about 1.0 mm to about 1.5 mm.

[0108] 22. A drug delivery system described in any of statements 19 to 21, wherein the inner diameter of the microcatheter is about 0.30 mm to about 0.80 mm.

[0109] 23. A drug delivery system described in any of statements 19 to 22, wherein the inner diameter of the source catheter is about 0.5 mm to about 1.0 mm.

[0110] 24. A drug delivery system described in any of statements 1 to 23, wherein the wall thickness of the microcatheter is about 0.05 mm to about 0.15 mm.

[0111] 25. A drug delivery system described in any of statements 1 to 24, wherein the diameter of the elution opening is about 0.25 mm to about 0.5 mm.

[0112] 26. A drug delivery system described in any of statements 1 to 25, wherein the microcatheter is configured to be implanted into the recipient under at least one of image guidance or stereotactic guidance.

[0113] 27. A drug delivery system described in any of statements 1 to 26, wherein the microcatheter further comprises one or more imaging markers.

[0114] 28. A drug delivery system described in any of statements 1 to 27, wherein the microcatheter is configured to be implanted into the recipient together with the stylet.

[0115] 29. The distal tip of the microcatheter is sealed and the elution aperture is in a sidewall of the distal end of the microcatheter; 29. The drug delivery system of any of statements 1 to 28, wherein the microcatheter further comprises a one-way valve at the elution opening.

[0116] 30. The drug delivery system of statement 29, wherein the one-way valve comprises a flexible sleeve on the microcatheter that covers the elution opening.

[0117] 31. The drug delivery system according to statement 30, wherein the distal end of the sleeve or the proximal end of the sleeve is adhered to the side wall of the distal end of the microcatheter.

[0118] 32. The sleeve has a closed distal tip; 32. The drug delivery system of statement 30 or 31, wherein the distal tip of the microcatheter is sealed by a closed distal tip of the sleeve.

[0119] 33. A drug delivery system according to any one of statements 1 to 32, wherein the connection assembly comprises a coupling.

[0120] 34. A fluid source is: a body member having a cavity and an opening to the cavity in a surface of the body member; a septum positioned at the opening and having a gel within the sac; A drug delivery system as described in any of statements 1 to 33, comprising a chamber defined by a cavity in a body member and a septum.

[0121] 35. A drug delivery system described in any of statements 1 to 34, further comprising an implantable pump configured to pump fluid from the fluid source to the target location via the source catheter and the microcatheter.

[0122] 36. A drug delivery system described in any of statements 1 to 35, further comprising an external device configured to push fluid from the fluid source to the target location via the source catheter and microcatheter.

[0123] 37. The drug delivery system of statement 36, wherein the external device comprises a syringe or an external pump.

[0124] 38. The drug delivery system of statement 36 or 37, wherein the fluid source comprises an alignment unit configured to facilitate alignment of the fluid source with the external device.

[0125] 39. The drug delivery system of statement 38, wherein the alignment unit comprises one or more metal bodies configured to be detected by a metal detector of the external device.

[0126] 40. The alignment unit includes an alignment circuit including a first conductive coil electrically connected to the load; 40. The drug delivery system of any one of statements 38 to 39, wherein the first conductive coil is configured to inductively couple with a second conductive coil provided on the external device when the external device is aligned with the fluid source.

[0127] 41. Implanting a distal end of a microcatheter at a target location within a recipient, the distal end of the microcatheter comprising an elution opening for eluting a fluid to the target location; fluidly coupling a proximal end of the microcatheter to a distal end of the source catheter via a coupling assembly; fluidly coupling a proximal end of the source catheter to a fluid source configured to provide fluid to the microcatheter; The method includes:

[0128] 42. The method of statement 41, wherein the target location comprises the recipient brain.

[0129] 43. The method of statement 42, wherein the target location comprises brain parenchymal tissue.

[0130] 44. The method of statement 42 or 43, wherein the fluid comprises a neurotherapeutic agent.

[0131] 45. Implanting the distal end of a microcatheter is forming a burr hole in the recipient's skull; Inserting the distal end of a microcatheter into the burr hole; A method according to any one of statements 42 to 44, comprising:

[0132] 46. ​​The connection assembly is a cranial port, A base member; Base member manifold and a cranial port comprising: The method further includes attaching a cranial port to the skull; Fluidly coupling a proximal end of the microcatheter to a distal end of the source catheter via a coupling assembly includes: coupling a proximal end of a microcatheter to a manifold; connecting a distal end of a source catheter to the manifold; The method according to statement 45, comprising:

[0133] 47. The base member includes an access hole for accessing the burr hole and a guide channel extending from the access hole to an outer edge of the base member; The method of statement 46, wherein the method further includes positioning a microcatheter within the guide channel.

[0134] 48. Coupling the proximal end of the microcatheter to the manifold comprises: positioning a first closure member within a first interior portion of a hollow first outer member, the first outer member having a proximal end wall and an opening in the proximal end wall; inserting a proximal end of a microcatheter into the first inner channel of the first sealing member and into the opening in the proximal end wall; pressing the first sealing member with a first pressing member to compress the first sealing member around the proximal end of the microcatheter; The method according to any one of statements 46 to 47,

[0135] 49. The first medial portion of the first outer member comprises a distal medial portion and a proximal medial portion; a first sealing member positioned within a proximal inner portion of the first outer member; 49. The method of claim 48, wherein pressing the first sealing member with a first press member includes positioning the first press member within a distal inner portion of the first outer member.

[0136] 50. The distal inner portion of the first outer member is threaded; the first press member includes a latch screw; 49. The method of claim 49, wherein pressing the first closure member with the first press member further includes tightening the latch screw.

[0137] 51. Coupling a distal end of a source catheter to a manifold includes: positioning a second closure member within a second interior portion of a hollow second outer member, the second outer member having a distal end wall and an opening in the distal end wall; inserting a distal end of a source catheter into the second inner channel of the second sealing member and into the opening in the distal end wall; pressing the second sealing member with a press member to compress the second sealing member around the distal end of the source catheter; A method according to any one of statements 48 to 50, comprising:

[0138] 52. Implanting the distal end of a microcatheter is Inserting a stylet at the distal end of the microcatheter; positioning a distal end of the microcatheter at a target location using a stylet; removing the stylet from the microcatheter after the distal end of the microcatheter is positioned at the target location; A method according to any one of statements 41 to 51, comprising:

[0139] 53. The method of any of statements 41-52, wherein the microcatheter is implanted into the recipient under at least one of image guidance or stereotactic guidance.

[0140] 54. The method of statement 53, wherein the microcatheter comprises one or more imaging markers.

[0141] 55. Implanting a fluid source in the recipient; Implanting a source catheter into the recipient The method of any one of statements 41 to 54, further comprising:

[0142] 56. The method of statement 55, wherein implanting the source catheter includes tunneling the source catheter from the fluid source to the proximal end of the microcatheter through the recipient.

[0143] 57. The method of statement 55 or 56, wherein the fluid source is implanted in the recipient's chest.

[0144] 58. Providing a fluid to a fluid source; Forcing fluid from a fluid source to a target location via a source catheter and a microcatheter; The method according to any one of statements 41 to 57, further comprising:

[0145] 59. The method according to claim 1, further comprising implanting an implantable pump; 59. The method of statement 58, wherein pushing fluid from the fluid source to the target location is performed by an implantable pump.

[0146] 60. The method further includes aligning the fluid source with an external device via an alignment unit provided on the fluid source; 60. The method of statement 58 or 59, wherein at least one of providing fluid to the fluid source or pushing fluid from the fluid source to the target location is performed by an external device.

[0147] 61. A base member configured to be attached to a recipient's skull; a manifold on the base member configured to couple a proximal end of the microcatheter to a distal end of the source catheter; A coupling assembly for an implantable drug delivery system comprising:

[0148] 62. The connection assembly of statement 61, wherein the manifold is integrally formed with the base member.

[0149] 63. A coupling assembly according to statement 61 or 62, wherein the base member includes an access hole for accessing a burr hole in the skull, the burr hole providing access to the recipient's brain.

[0150] 64. The base member further comprises a first guide channel extending from the access hole to an outer edge of the base member; 64. The coupling assembly of statement 63, wherein the first guide channel is configured to secure the microcatheter when a distal end of the microcatheter is implanted in the recipient brain.

[0151] 65. The base member further comprises a second guide channel extending along an outer edge of the base member from the first guide channel to an opening to the manifold; 65. The coupling assembly of statement 64, wherein the second guide channel is configured to secure the microcatheter when a distal end of the microcatheter is implanted in the recipient brain.

[0152] 66. A first connector for connecting a microcatheter to a manifold, comprising: a hollow first outer member having a first inner portion, a proximal end wall, and an opening in the proximal end wall; a first sealing member having a first inner channel configured to receive a proximal end of a microcatheter, the first sealing member being configured to be positioned within a first inner portion of the first outer member; a first pressing member configured to press the first sealing member and compress the first sealing member around the proximal end of the microcatheter when the proximal end of the microcatheter is positioned through the first inner channel of the first sealing member; 66. The connection assembly of any of statements 61 to 65, further comprising a first connector comprising:

[0153] 67. The coupling assembly of statement 66, wherein the first sealing member is configured to seal the first inner portion of the first outer member when pressed by the first press member.

[0154] 68. The connection assembly of statement 66 or 67, wherein an inner diameter of the first inner channel of the first sealing member is approximately equal to or less than an outer diameter of the microcatheter.

[0155] 69. The first medial portion of the first outer member comprises a distal medial portion and a proximal medial portion; the first sealing member is configured to be positioned within the proximal inner portion of the first outer member; 69. The coupling assembly of any of statements 66-68, wherein the first press member is configured to be positioned within a distal inner portion of the first outer member.

[0156] 70. The distal inner portion of the first outer member is threaded; 70. The coupling assembly of claim 69, wherein the first press member comprises a latch screw.

[0157] 71. The manifold has a first opening for connecting a microcatheter; The connection assembly of any of statements 66-70, wherein the first outer member is secured to the first opening.

[0158] 72. A second connector for connecting a source catheter to the manifold, comprising: a hollow second outer member having a second inner portion, a distal end wall, and an opening in the distal end wall; a second sealing member having a second inner channel configured to receive a distal end of the source catheter, the second sealing member configured to be positioned within the second inner portion of the second outer member; a second pressing member configured to press the second sealing member and compress the second sealing member around the distal end of the source catheter when the distal end of the source catheter is positioned through the second inner channel of the second sealing member; The connection assembly of any of statements 66 to 71, further comprising a second connector comprising:

[0159] 73. The manifold includes a second opening for connecting a source catheter; The coupling assembly of statement 72, wherein the second outer member is secured to the second opening.

[0160] 74. A connection assembly as described in any of statements 61 to 74, further comprising a cover configured to cover the base member and the manifold.

[0161] In the preceding description, various exemplary embodiments have been described with reference to the accompanying drawings. However, it is apparent that various modifications and changes may be made to those embodiments and additional embodiments may be implemented without departing from the scope of the invention as set forth in the following claims. For example, a feature of one embodiment described herein may be combined with or substituted for a feature of another embodiment described herein. Thus, the description and drawings should be regarded in an illustrative and not a limiting sense.

Claims

1. A base member configured to be attached to the skull of a recipient, a manifold of the base member, the manifold being configured to couple a proximal end of a microcatheter to a distal end of a source catheter, and a first guide channel provided on a surface of the base member, the first guide channel being configured to secure the microcatheter on the base member, the first guide channel A connecting assembly for an implantable drug delivery system comprising.

2. The connecting assembly according to claim 1, wherein the manifold is integrally formed with the base member.

3. The base member includes an access hole for accessing the burr hole of the skull, the burr hole providing access to the brain of the recipient, The connecting assembly according to claim 1, wherein the first guide channel extends from the access hole to an outer edge of the base member.

4. The connecting assembly according to claim 3, further comprising a second guide channel provided on a surface of the base member, The second guide channel being configured to secure the microcatheter on the base member.

5. A first connector for connecting the microcatheter to the manifold, a hollow first outer member having a first inner portion, a proximal end wall, and an opening in the proximal end wall, a first sealing member having a first inner channel configured to receive the proximal end of the microcatheter, the first sealing member being configured to be positioned within the first inner portion of the first outer member, a first pressing member configured to press the first sealing member and pressurize the first sealing member around the proximal end of the microcatheter when the proximal end of the microcatheter is positioned through the first inner channel of the first sealing member The connecting assembly according to claim 1, further comprising a first connector comprising.

6. The connecting assembly according to claim 5, wherein the first sealing member is configured to seal the first inner portion of the first outer member when pressed by the first pressing member.

7. The connecting assembly according to claim 5, wherein an inner diameter of the first inner channel of the first sealing member is approximately equal to or less than an outer diameter of the micro catheter.

8. The first inner portion of the first outer member includes a distal inner portion and a proximal inner portion. The first sealing member is configured to be positioned within the proximal inner portion of the first outer member. The connecting assembly according to claim 5, wherein the first pressing member is configured to be positioned within the distal inner portion of the first outer member.

9. The distal inner portion of the first outer member is threaded. The connecting assembly according to claim 8, wherein the first pressing member includes a locking screw.

10. The manifold includes a first opening for connecting the micro catheter. The connecting assembly according to claim 5, wherein the first outer member is fixed to the first opening.

11. A second connector for connecting the source catheter to the manifold, a hollow second outer member having a second inner portion, a distal end wall, and an opening in the distal end wall, a second sealing member having a second inner channel configured to receive the distal end of the source catheter, the second sealing member being configured to be positioned within the second inner portion of the second outer member, and a second pressing member configured to press the second sealing member and pressurize the second sealing member around the distal end of the source catheter when the distal end of the source catheter is positioned through the second inner channel of the second sealing member. The connecting assembly according to claim 5, further comprising a second connector including the above components.

12. The manifold includes a second opening for connecting the source catheter. The connecting assembly according to claim 11, wherein the second outer member is fixed to the second opening.

13. The connecting assembly according to claim 1, further comprising a cover configured to cover the base member and the manifold.

14. A connecting assembly, a base member configured to be attached to a recipient's skull, a manifold of the base member, and a first guide channel provided on a surface of the base member. The connecting assembly comprising the above components. A source catheter, a proximal end configured to be fluidly coupled to a fluid source configured to provide fluid, and a distal end configured to be fluidly coupled to the connection assembly, the source catheter comprising; a microcatheter, a proximal end configured to be fluidly coupled to the connection assembly, and a distal end comprising an elution opening configured to elute the fluid at a target location within the recipient, the microcatheter comprising; comprising, the manifold being configured to fluidly couple the proximal end of the microcatheter to the distal end of the source catheter, a drug delivery system implantable in a recipient, wherein the first guide channel is configured to secure the microcatheter on the base member.

15. The base member further comprises an access hole for accessing the perforation hole of the skull, The drug delivery system according to claim 14, wherein the first guide channel extends from the access hole to the outer edge of the base member.

16. The connection assembly further comprises a second guide channel provided on the surface of the base member, The drug delivery system according to claim 15, wherein the second guide channel is configured to secure the microcatheter on the base member.

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