Fluid Delivery System

Abstract

The fluid delivery devices, systems, and methods described herein include a subcutaneous port, a catheter, and a connection assembly configured to fluidly couple the port and the catheter.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 893,034, filed Aug. 28, 2019, which is incorporated by reference in its entirety.

[0002] The present disclosure relates generally to fluid delivery systems, and more particularly to port and catheter fluid delivery systems. [Background technology]

[0003] Intrathecal administration is a valuable tool to introduce therapeutic agents into the cerebrospinal fluid (CSF) allowing for distribution throughout the central nervous system. Indeed, therapeutic agents administered to the CSF are distributed to the brain and spinal cord, thereby avoiding potential delivery issues through the blood-brain barrier. Most drugs delivered to the CSF require multiple administrations, necessitating access to the intrathecal cavity at least periodically over the course of the treatment plan. Some individuals are unable to receive drug treatment via lumbar puncture due to anatomical barriers such as spinal deformity, and / or surgical interventions such as implantation of stabilizing rods and spondylosis. Bone fusions, sharp angles, and instrumentation in these individuals complicate or prevent penetration of a direct lumbar puncture into the intrathecal cavity, as there is no space between the bones to allow safe puncture of the dura. In these patients, special measures are often required to achieve intrathecal access, for example, an impact drill may be required to penetrate the bone mass, or a laminectomy may be required, which increases the risks associated with intrathecal administration. There remains a need in the art for a delivery system that allows repeated administration of substances into the intrathecal cavity. Summary of the Invention

[0004] According to a first aspect, a fluid delivery system is disclosed that includes a body defining a cavity therein, the cavity having a cylindrical configuration with a delivery opening at a proximal end and an open distal end. The cavity defines a seating surface extending radially inward into the cavity adjacent the delivery opening and a threaded portion adjacent the open distal end. The fluid delivery system further includes a catheter connection assembly disposed within the cavity and configured to couple a catheter to a body. The catheter connection assembly includes a washer configured to abut the seating surface, a gasket, an engagement tip disposed on an opposite side of the gasket from the washer, and a connector having male threads configured to engage the threaded portion of the cavity. The washer, gasket, engagement tip, and connector each define a central passage extending therethrough for receiving the catheter, and the catheter connection assembly is configured such that when the connector is threaded into the cavity, the connector causes the engagement tip and washer to compress the gasket therebetween, thereby radially compressing the gasket around the catheter to retain the catheter within the cavity.

[0005] According to some embodiments, the cavity includes an interior portion extending from the seating surface to the delivery opening, and the catheter connection assembly further includes a base portion and a stem member extending outwardly from the base portion. The stem member is configured to be disposed within the interior portion of the cavity such that the stem portion extends longitudinally within the cavity away from the delivery opening and into a catheter inserted through the washer, the gasket, the engagement tip, and the connector. In a further embodiment, the stem portion can have a length that extends through the washer and the gasket into a central passage of the engagement tip, such that the stem portion then stiffens the catheter along that portion compressed by the gasket when the connector is threaded into the cavity, and / or the interior portion of the cavity and the base portion of the stem member can have complementary contoured surfaces such that the base is seated within the interior portion of the cavity and is limited in longitudinal movement within the cavity toward the delivery opening.

[0006] According to some forms, the fluid delivery system can include one or more of the following aspects: the gasket can be a plurality of O-rings, the seating surface of the cavity can extend rearwardly along its longitudinal axis, and the inner surface of the washer can have a complementary chamfer configuration such that the washer nests within the seating surface; or the connector can include a throat portion having a reduced diameter compared to the threaded portion, and the body further includes a bore radially opening into the cavity and a retaining member configured to be inserted into the bore and extend along the throat portion rearwardly of the threaded portion, thereby retaining the connector within the cavity.

[0007] According to some forms, the compression surfaces of the engagement tip and washer engage the gasket on both sides, and at least one of the compression surfaces of the engagement tip and washer can have a contoured configuration that extends away from the gasket, thereby providing deformation space for the gasket as it is compressed. In further forms, the compression surfaces of both the engagement tip and washer can have a contoured configuration that extends away from the gasket, thereby providing deformation space for the gasket on both sides, and at least one compression surface of the engagement tip can have a bullet-shaped configuration and / or at least one compression surface of the engagement tip can have a chamfered configuration.

[0008] According to some aspects, the engagement tip and connector can be a single piece component. According to other aspects, the engagement tip and connector can be separate components. In a further aspect, so configured, the engagement tip and connector can have a stepped connection therebetween, where one of the engagement tip or connector includes a counterbore and the other of the engagement tip or connector includes a collar configured to be received within the counterbore.

[0009] According to some forms, the connector can include a tool engagement end having a diameter larger than the cavity, such that the tool engagement end defines a stop surface configured to engage the body when the connector is fully threaded into the cavity. In a further form, a central passage extending through the tool engagement end of the connector can have a grooved configuration and / or an exterior radial surface of the tool engagement end can include a rib, and the system can include a wrench having a mouth configured to extend around the tool engagement end, an inner surface of the mouth including an indentation configured to engage the rib of the tool engagement end, such that the wrench is configured to tighten the connector into the cavity. Optionally, the rib and the indentation can be configured to slide out of engagement with one another upon application of a rotational force to the wrench greater than a threshold force.

[0010] According to some forms, the body can be a port implantable in a subcutaneous location, the port defining a chamber having an open top and a delivery opening, and a septum extending across the open top of the chamber. In a further form, the system can include a catheter extending through the washer, the gasket, the engagement tip, and the connector, the gasket compressed around a proximal end of the catheter to retain the catheter within the cavity and fluidly couple the catheter to the chamber of the port.

[0011] According to a second aspect, a method of assembling any of the above fluid delivery systems is described herein. [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is a perspective view of an exemplary fluid delivery system including a port, a catheter, and a connection assembly, according to various embodiments. [Diagram 2] 2 is a cross-sectional view of the fluid delivery system of FIG. 1 taken along line 2-2. [Diagram 3] 3 is a cross-sectional view of the fluid delivery system of FIG. 1 taken along line 3-3. [Figure 4]FIG. 4 is a cross-sectional view of the port, catheter, and connection assembly of FIG. 3. [Diagram 5] FIG. 4 is a top view of a first alternative O-ring for the connection assembly of FIG. 3. [Figure 6] FIG. 4 is a top view of a second alternative O-ring for the connection assembly of FIG. 3. [Figure 7] FIG. 4 is a perspective view of a first alternative washer for the connection assembly of FIG. 3; [Figure 8] FIG. 4 is a perspective view of a second alternative washer for the connection assembly of FIG. 3 . [Figure 9] FIG. 4 is a perspective view of a third alternative washer for the connection assembly of FIG. 3 . [Figure 10] FIG. 4 is a perspective view of a first alternative engagement tip for the connection assembly of FIG. 3. [Figure 11] FIG. 4 is a perspective view of a second alternative engagement tip for the connection assembly of FIG. 3. [Figure 12] FIG. 2 is a perspective view of a tool for the connection assembly of FIG. 1; [Figure 13] 6 is a cross-sectional view of the tool of FIG. 5 engaging a connector of the connection assembly of FIG. 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The fluid delivery devices, systems, and methods described herein include sterile, implantable intrathecal catheters and subcutaneous ports. The fluid delivery devices are designed to facilitate intrathecal access in patients with normal spines and in patients with spinal deformities and / or instruments in which intrathecal access, and associated fluid administration and sampling via lumbar puncture (LP), is difficult or not possible. Utilizing the provided devices, systems, and methods, the need for repeated anesthesia and surgery can be avoided each time intrathecal access is required for these patients.

[0014] The fluid delivery system can be used to administer fluids (optionally containing one or more therapeutic agents) to a patient by manual bolus injection, a standard syringe pump, or Pulsar's auto-injector pump. Therapeutic agents approved for bolus intrathecal administration are injected into a patient through the subcutaneous port by palpating the port to identify the septum and accessing the septum with a needle such as a standard non-coring Huber needle.

[0015] A fluid delivery system 10 including a port 100, a catheter 200, and a connection assembly 300 configured to fluidly couple the port 100 and the catheter 200 is shown in FIGS. 1-11. The exemplary configuration of the port 100 shown in FIG. 1 is suitable for subcutaneous implantation. The port 100 includes a body 102, a cap 104 coupled to the body 102, and a septum 106 providing needle access to a chamber 108 defined in the body 102. The chamber 108 includes a delivery opening 110 through a sidewall 109 of the chamber 108 for dispensing fluid to a desired area as described in more detail below. The port 100 can be secured to a desired location within a patient, such as a bone structure, as selected by a clinician. For example, the body 102 can include one or more openings 112 extending therethrough to receive fasteners and attach the port 100 to the bone structure. As shown, the body 102 and the cap 104 can each have a tapered profile with a smooth exterior surface. This configuration advantageously mitigates skin erosion when port 100 is implanted in a desired subcutaneous location.

[0016] As shown in FIG. 1 , the body 102 includes a lower portion 113 having a teardrop-shaped footprint with a chamber 108 generally centrally formed within the circular end of the teardrop-shaped footprint. An exterior surface 114 of the lower portion 113 extends between an upper surface 116 of the body 102 and a bottom wall portion 118. The body 102 further includes an upper portion 119 including a wall extending upwardly from the upper surface 116 of the lower portion 113. The body 102 defines an internal cavity 120 having an opening 122 opposite the bottom wall portion 118. In the illustrated form, the body 102 extends around the internal cavity 120 in an annular configuration. The internal cavity 120 includes a lower portion defining the chamber 108 and an upper bulkhead that receives the portion 124. The chamber 108 can have a smaller cross-sectional dimension than the top portion 124 such that a shoulder 126 extends between the top portion 124 and the chamber 108 of the internal cavity 120. In the illustrated form, the top portion 124 and the chamber 108 are cylindrical, and the chamber 108 has a smaller diameter than the top portion 124.

[0017] The top portion 124 is sized to receive the septum 106 therein. For example, the septum 106 can have a disc-shaped configuration and the diameter of the top portion 124 can be approximately equal to, e.g., within 2 mm, the diameter of the septum 106 such that the septum 106 is securely received within the top portion 124. Additionally, as shown in FIG. 2, the shoulder 126 can include an upwardly projecting lip 128 extending around an inner edge thereof and configured to engage the septum 106.

[0018] To secure the septum 106 within the port 100, the cap 104 is configured to mate to the upper portion 119 of the body 102 to trap the septum 106 between the cap 104 and the body 102. The cap 104 defines an interior opening 130 extending therethrough to provide needle access to the septum 106. In the illustrated form, the cap 104 has an annular configuration, with an upper portion 131 having a generally triangular cross-section in the longitudinal direction, and a lower skirt-like portion 133 projecting downwardly from the upper portion 131. So configured, the cap 104 includes an inner surface 132 that extends around the opening 130 and tapers downwardly toward the opening 130, an outer surface 134 that tapers downwardly toward the body 102, and an upper edge 135. As shown, the radially inward portion of cap 104 extends over the top surface of septum 106, and cap 104 deforms septum 106 causing the top surface of septum 106 to protrude through opening 130. This configuration allows inner surface 132 to advantageously redirect needles that escape septum 106 into opening 130 and the top surface of septum 106.

[0019] As shown, the outer surface 136 of the body upper portion 119 can have a threaded configuration and the inner surface 138 of the cap skirt portion 133 can include a corresponding threaded configuration such that the cap 104 can be threadably coupled to the body 102 to trap the septum 106 therebetween.

[0020] When the cap 104 is secured to the body 102, the cap 104 has an annular portion 142 that extends across the cavity opening 122 and, in some versions, includes a downwardly projecting lip 144 extending therearound. So configured, the outer portion 146 of the septum 106 is trapped between the annular portion 142 of the cap 104 and the shoulder 126 of the body 102, while the central portion 148 of the septum 106 provides a clear path to the chamber 108. The lips 128, 144 project toward each other on opposite sides of the septum 106 to sandwich the septum 106 between them, securing the septum 106 and ensuring a fluid-tight seal. In some versions, the thickness and diameter of the septum 106 can be optimized to provide a low profile port 100 while providing a sufficiently large diameter for the central portion 148 so that the septum 106 can be easily located and identified through tissue.

[0021] The catheter 200 is coupled to the port 100 and can be fluidly coupled with the delivery opening 110 of the chamber 108 to dispense fluid to a desired area. The catheter 200 can be utilized to provide homogenous delivery of a composition (optionally including one or more therapeutic agents) to the patient's spinal cavity. As such, the catheter 200 can be configured to extend along substantially the entire length of the patient's spinal column, or along any portion thereof. As shown, the catheter 200 includes an elongated tubular body 202 having a central passageway 204. A proximal end 206 of the catheter 200 is configured to couple to the port 100. As will be appreciated, the catheter 200 can include any number or configuration of radial and / or distal ports to provide a desired fluid delivery pattern and / or targeted fluid delivery.

[0022] The catheter 200 can be configured for long term implantation in a patient and therefore can be constructed from materials that make the catheter soft, flexible and kink resistant. Additionally, in some versions, the catheter 200 can be configured for patients with complex spines such as scoliosis, where the materials can provide column strength, crush resistance and stiffness so that the catheter 200 can be threaded during insertion. In accordance with this, the catheter 200 can include a reinforcement layer or reinforced sidewall at least at the proximal end 206 to increase the hoop strength of the catheter 200, i.e., the strength of the catheter to resist crush damage due to compressive forces. This can be advantageously utilized to provide a strong connection and seal with the port 100. In some examples, the catheter size can range from 0.5 mm to 5 mm.

[0023] Details of a connection assembly 300 configured to fluidly couple the port 100 and the catheter 200 are shown in Figures 2-11. The components of the assembly 300 and its dimensions can be configured to allow for assembly without significant pre-compression of the assembly 300. Additionally, the described configurations can target optimal compression during assembly and catheter connection. For example, the assembly 300 described herein can generate axial compression in the range of about 0.08 inches to about 0.09 inches, and more specifically, about 0.84 inches.

[0024] The port 100 defines a cylindrical cavity 302 sized to receive the components of the assembly 300 therein. The cavity 302 extends radially through the body 102 with a delivery opening 110 at an inner end 304 and an outer end 306. As shown, the cavity 302 can include portions sized and shaped to receive various components of the assembly 300 therein, as described below. In the illustrated example, the cavity 302 includes an innermost portion 308 having a delivery opening 110 at one end thereof, a middle portion 310, and an outer portion 312. As previously discussed, the port body 102 can have a teardrop-shaped configuration with a protruding portion 314 extending radially outward from a generally circular central portion that defines the chamber 108. So configured, the cavity 302 can be disposed within the protruding portion 314.

[0025] The assembly 300 further includes a stem member 316, a washer 318, a gasket 320, which in the illustrated form is a plurality of O-rings, an engagement tip 322, and a connector 324 that interact to fluidly couple the catheter 200 to the port 100. The stem member 316 includes a base portion 326 and an elongated stem portion 328 extending outwardly from the base 326. A passageway 330 extends longitudinally through the base 326 and the stem 328 such that fluid may flow longitudinally through the stem member 316. The passageway 330 may include a mouth 332 that extends around the delivery opening 110 and narrows to a portion within the stem 328. In the illustrated form, the mouth 332 has a conical shape that narrows toward the passageway 330 within the stem 328.

[0026] As shown, the innermost portion 308 of the cavity 302 is sized to receive the base 326 of the stem member 316 therein, with the stem 328 extending radially within the cavity 302 away from the chamber 108. To limit movement of the stem member 316 relative to the port 100, the base 326 and the innermost portion 308 of the cavity can have complementary surfaces such that the base 326 can be seated within the cavity portion 308. For example, the base 326 can have a frustoconical configuration with an inwardly tapered outer surface 334, and the innermost portion 308 of the cavity can have a complementary inwardly tapered surface 336 such that the base portion 326 can be inserted radially into the innermost portion 308 of the cavity 108 until further radial movement is limited by the interengaging surfaces 334, 336. In this configuration, the catheter 200 can be inserted into the cavity 302 over the stem 328, with the stem 328 extending into the central passage 204 of the catheter 202 and the proximal end 206 abutting the base 326. The dimensions of the stem 328 can have a small clearance relative to the inner diameter of the catheter 200, providing easy assembly while providing a secure connection therewith when the catheter 200 is compressed onto the stem 328. In one form, the outer surface of the stem 328 can have a textured configuration that grips the inner surface of the catheter 202 when the stem 328 is inserted into the catheter 202 and the O-ring 320 is compressed therearound. For example, the stem 328 can have a sand / grit blasted or equivalent outer surface, a distribution of small notches or protrusions, etc. In an additional or alternative form, the inner surface of the O-ring 320 can have a textured configuration.

[0027] Each of the washer 318, the one or more O-rings 320, the engagement tip 322, and the connector 324 includes a central opening 338 extending therethrough to allow the catheter 200 to extend through each of the components within the cavity 302. To facilitate placement, the diameter of the central opening 338 may be larger than the outer diameter of the catheter 200. Further, as shown, when the catheter 200 is inserted into the central opening 338 and through the components of the assembly 300, the catheter 200 is aligned with the delivery opening 110 and approximately centered within the cavity 302.

[0028] As shown, the innermost portion 308 of the cavity 302 can have a smaller diameter than the intermediate portion 310 such that a shoulder surface 340 is defined in the cavity 302 extending therebetween. So configured, when the washer 318 is inserted into the cavity 302, the washer 318 abuts the shoulder surface 340 to limit further movement of the components of the assembly 300. Additionally, the outer portion 312 of the cavity 302 can have a threaded configuration and the connector 324 can include a corresponding threaded portion 342 such that the connector 324 can be threaded into the cavity 302. In this configuration, to secure the catheter 200 to the port 100 and create a fluid-tight seal, the connector 324 can engage the threads of the cavity outer portion 312 and be rotated to compress the O-ring 320 between the washer 318 and the engagement tip 322. This causes the O-rings 320 to compress and expand radially into firm engagement with the surfaces of the cavity 302 and the catheter 200, which compresses the catheter 200 around the stem 328. In this manner, the catheter 200 is held within the cavity 302 by components that firm engage both the interior of the central passageway 204 and the exterior of the body 202. In the illustrated form, the assembly 300 includes three O-rings 320, although other numbers, such as one, two, four, five, or more, may be utilized. It has been found that utilizing multiple O-rings 320 provides multiple points of contact with the catheter 200, which deforms uniformly to achieve a targeted and uniform compression.

[0029] Alternative configurations of the O-ring 320 are shown in Figures 5 and 6. Rather than an O-ring 320 with a flat side configured as shown in Figure 4, the assembly 300 may alternatively be provided with an O-ring 320 having a chamfered edge 343. In two exemplary configurations, the chamfered edge 343 may extend along a 15 degree angle as shown in Figure 5, or along a 25 degree angle as shown in Figure 6. Other angles are also suitable. While the edges 343 in both the embodiments shown in Figures 5 and 6 are chamfered, it will be understood that one side may be flat, if desired. Additionally, the edges may alternatively have a rounded configuration.

[0030] If desired, as shown in FIG. 4, the shoulder surface 340 and seating surface 344 of the washer 318 facing the chamber 108 can have complementary surface configurations (curved surfaces, etc.), such as an inwardly tapered chamfered surface as shown, so that the washer 318 can seat within the shoulder surface 340 at the end of the intermediate portion 310.

[0031] In some versions, one or both compression surfaces 346, 348 of the washer 318 and the engagement tip 322 facing the O-ring 320 can have a contoured configuration that provides one or more axial deformations or buffer spaces 350 to the O-ring 320 when the assembly 300 is tightened. This allows the O-ring 320 to deform to engage the cavity 302 and the catheter 200, as well as to axially deform a predetermined desired configuration into the buffer space 350. For example, one or both compression surfaces 346, 348 can have a tapered and / or curved configuration. In the illustrated form, the washer compression surface 346 has a chamfered configuration that engages the adjacent O-ring 320 around a central opening 338 therethrough and tapers away from the O-ring 320, and the engagement tip compression surface 348 has a curved configuration that engages the adjacent O-ring 320 around a central opening 338 therethrough. The curved configuration can be convex, like a bullet, as shown, or concave if desired. Of course, it will be understood that the configuration of the compression surfaces 346, 348 can be switched or can be the same.

[0032] Alternative configurations of the washer 318 are shown in Figures 7-9. Rather than the washer 318 having generally symmetrical frusto-conical surfaces 344, 346 configured as shown in Figure 4, the washer 318 can alternatively have offset frusto-conical surfaces 344, 346 in which one of the surfaces 344, 346 extends along a more acute angle relative to the other of the surfaces 344, 346, as shown in Figures 7 and 8. In another example shown in Figure 9, the washer 318 can have a stepped configuration with a reduced diameter portion 347 such that the compression surface 346 has a smaller diameter relative to the cavity 302 that provides the annular buffer space 350. Additionally, the frusto-conical surfaces can alternatively have a rounded configuration.

[0033] An alternative configuration of the engagement tip 322 is shown in Figures 10 and 11. Instead of the engagement tip 322 having a curved compression surface 348 configured as shown in Figure 4, the engagement tip 322 can alternatively have a frusto-conical compression surface 348.

[0034] In the illustrated form, the connector 324 and the engagement tip 322 are separate components. This allows rotation of the connector 324 to not extend to the engagement tip 322 or to extend minimally to the engagement tip 322 as the connector 324 is threaded into the cavity 302, for example, due to friction. In this manner, rotational engagement between the engagement tip 322 and the adjacent O-ring 320 and resulting friction and / or locking is minimized, thereby controlling deformation of the O-ring 320 to a desired shape and area. If desired, the engagement tip 322 and the connector 324 can have cooperating structure to maintain alignment of the engagement tip 322 within the cavity 302. For example, the engagement tip 322 and the connector 324 can have a stepped configuration therebetween. As illustrated, the engagement tip 322 can include a rearwardly extending collar 349 and the connector 324 can include an axial counterbore 351 in the threaded portion 342 sized to receive the collar 349. Of course, it will be appreciated that in some versions, the connector 324 and the engagement tip 322 may be an integral part of a single piece component.

[0035] Additional details of the connector 324 and optional tool 352 are shown in Figures 4, 12, and 13. In the illustrated form, in addition to the threaded portion 342 at the proximal end 354, the connector 324 can include a tool interface 356 at the distal end 358 and a neck portion 360 extending between the threaded portion 342 and the tool interface 356. Optionally, the central opening 338 through the tool interface 356 can have a grooved exit configuration 361, which provides a curved surface as the catheter 200 exits the assembly 300. The curved surface, compared to an edge, reduces stress and strain that may be applied to the catheter 200 as it is moved relative to the port 100.

[0036] The neck portion 360 reduces the radius of the connector 324 relative to the threaded portion 342 and creates an annular radial space 362 within the cavity 302 when the connector 324 is threaded into the cavity 302. Advantageously, this radial space 362 may be utilized to hold the assembly 300 in place in an assembled configuration with all components received within the cavity 302. Accordingly, one or more bores 364 may extend through the body 102 into the cavity 302 in a direction transverse to the longitudinal axis of the cavity 302, such as generally perpendicular as shown. One or more retaining members 366 are then inserted into the bores 364 after the connector 324 is partially threaded into the cavity 302 such that the retaining members 366 can extend into the radial space 362 adjacent the neck portion 360. In the illustrated form, the port 100 includes two aligned bores 364 such that two retaining members 366 can be inserted into the cavity 302 on opposite sides of the connector neck portion 360.

[0037] The retaining member 366 may be configured to be permanently attached within the bore 364, such as by friction fit, deformation, e.g., mushrooming, ultrasonic welding, etc., such that the connector 324, and thus the remaining components of the assembly 300, are permanently retained within the cavity 302. In other words, if the connector 324 is inadvertently dislodged from the cavity 302, the retaining member 366 will abut a stop surface 368 of the threaded portion 342 transitioning into the neck portion 360. This prevents components from falling out of the cavity 302 when the port 100 is being handled or when small components of the assembly 300 must be manipulated and inserted in situ or in other difficult situations. Rather, a user may assemble the components of the assembly 300, insert the components into the cavity 302, and then insert one or more retaining members 366 into the bore 364 to ensure that the assembly 300 is ready for subsequent installation. In the configuration shown in FIG. 4, the assembly 300 is in an uncompressed state, it being understood that the configuration of the bore 364 and the retaining member 366 may correspond to a partially compressed state, or a fully compressed state, if desired.

[0038] Details of the tool 352 and the tool interface 356 are shown in FIGS. 12 and 13. As discussed above, the tool 352 can be optionally provided in the system 10 to assist the user in tightening the connector 324 in the cavity 302, thereby compressing the O-ring 320 and retaining the catheter 200 within the assembly 300. Accordingly, the tool 352 and the tool interface 356 can have complementary structures 370, 372 that engage with one another and allow the tool 352 to rotate the connector 324. For example, the tool interface 356 can be generally cylindrical and the tool 352 can be a wrench having a mouth configured to extend around the circumference of the tool interface 352. Additionally, the wrench 352 can be provided with the structure 370 on its inner surface and the structure 372 of the tool interface 356 can be provided on its outer surface. Additionally, in some versions, the structures 370, 372 can be configured to provide a torque limiting function. Specifically, structures 370, 372 can be sized and shaped to slip or otherwise fail when a force exceeding a predetermined force threshold is applied to a tool. The predetermined force threshold can correspond to a maximum compressive force applied to O-ring 320. Advantageously, this configuration can ensure that a user does not over-compress O-ring 320 by over-tightening connector 324 within cavity 302, thereby causing engagement between connector 324 and tool 352 with a force greater than the desired compression.

[0039] In the illustrated form, the structure 370 of the tool 352 can have a scalloped configuration with spaced apart rounded protrusions, and the structure 372 of the tool interface 356 can be recesses sized and spaced to receive therein the scalloped protrusions of the tool 352. Of course, it will be understood that the scalloped configurations and recesses can be provided on the opposing structures. Additionally, other engagement structures can be utilized.

[0040] In a further or alternative configuration for limiting over-compression, the axial thickness of the washer 318, O-ring 320, and engagement tip 322, the axial depth of the cavity 302, and the length of the connector 324 through the threaded portion 342 and neck portion 360 may be configured to limit the depth to which the connector 324 may be threaded into the cavity 302. For example, the tool interface 356 may have a diameter greater than the inner diameter of the cavity 302 such that a stop surface 376 of the connector 324 defined by the tool interface 356 may engage an outer surface 374 of the port body 102 about the cavity opening 306. Advantageously, the assembly 300 may be configured such that optimal compression is applied to the assembly 300 when the connector 324 is threaded into the cavity 302 until the stop surface 376 abuts the outer surface 374.

[0041] In some examples, the O-ring 320 can be made from a suitable plastic / polymer material, the stem member 316 can be made from titanium, stainless steel, other suitable metals, or suitable plastics, the port body 102 can be made from titanium, stainless steel, polyetheretherketone (PEEK), or other suitable plastics, and the connector 324, washer 318, and engagement tip 322 can be made from PEEK, titanium, stainless steel, other suitable metals or plastics, or combinations thereof.

[0042] It will be understood that elements in the figures are illustrated for simplicity and clarity and are not necessarily drawn to scale. For example, the dimensions and / or relative positioning of some elements in the figures may be exaggerated relative to other elements to help improve understanding of the various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in commercially viable embodiments are often not shown to avoid obscuring the view of these various embodiments. The same reference numbers may be used to describe similar or similar parts. Furthermore, although several examples have been disclosed herein, any feature of any example may be combined with or substituted by other features from other examples. Furthermore, although several examples have been disclosed herein, changes may be made to the disclosed examples without departing from the scope of the claims.

[0043] Those skilled in the art will recognize that numerous modifications, changes and combinations can be made to the above-described embodiments without departing from the scope of the present invention, and such modifications, changes and combinations should be considered within the scope of the inventive concept.

Claims

1. 1. A fluid delivery system comprising: a body defining a cavity therein, the cavity having a cylindrical configuration with a delivery opening at a proximal end and an open distal end, the cavity defining a seating surface extending radially inward into the cavity adjacent the delivery opening and a threaded portion adjacent the open distal end; a catheter connection assembly disposed within the cavity and configured to couple a catheter to the body, the catheter connection assembly comprising: a washer configured to abut the seat surface; A gasket and an engagement tip located on an opposite side of the gasket from the washer; a connector having an externally threaded portion configured to engage the threaded portion of the cavity and a tool engaging end having an exterior radial surface; a wrench having a mouth configured to extend around the tool engaging end of the connector, wherein an inner surface of the mouth and the outer radial surface of the tool engaging end include complementary structure such that the wrench is configured to tighten the connector within the cavity, and wherein the complementary structure is configured to slide out of engagement with one another upon application of a rotational force to the wrench greater than a threshold force; A fluid delivery system, wherein the washer, gasket, engagement tip, and connector each define a central passage extending therethrough for receiving a catheter, and the catheter connection assembly is configured such that when the connector is threaded into the cavity, the connector causes the engagement tip and washer to compress the gasket therebetween, thereby radially compressing the gasket around the catheter to retain the catheter within the cavity.

2. 2. The fluid delivery system of claim 1, wherein the cavity comprises an interior portion extending from the seating surface to the delivery opening, and the catheter connection assembly further comprises a stem member having a base portion and a stem portion extending outwardly from the base portion, the stem member configured to be disposed within the interior portion of the cavity such that the stem portion extends longitudinally within the cavity, away from the delivery opening, and into a catheter that has been inserted through the washer, gasket, engagement tip, and connector.

3. 3. The fluid delivery system of claim 2, wherein the stem portion has a length that extends through the washer and gasket and into the central passage of the engagement tip such that when the connector is threaded into the cavity, the stem portion reinforces the catheter along that portion that is compressed by the gasket.

4. 4. The fluid delivery system of claim 2 or 3, wherein an inner surface of the inner portion of the cavity and an outer surface of the base portion of the stem member have complementary shapes such that the base portion seats within the inner portion of the cavity and is restricted from longitudinal movement within the cavity toward the delivery opening.

5. The fluid delivery system of any one of claims 1 to 4, wherein the gasket comprises a plurality of O-rings.

6. 6. The fluid delivery system of claim 1, wherein the seating surface of the cavity tapers towards the delivery opening and the inner surface of the washer has a complementary shape such that the washer fits along the seating surface.

7. 7. The fluid delivery system of claim 1, wherein the engagement tip and compression surfaces of the washer engage the gasket on either side thereof, and at least one of the engagement tip and compression surfaces of the washer extends away from the gasket, thereby providing deformation space for the gasket when the gasket is compressed.

8. The fluid delivery system of claim 7 , wherein the compression surfaces of both the engagement tip and the washer extend away from the gasket, thereby providing deformation space for the gasket on either side thereof.

9. The fluid delivery system of claim 7 or 8, wherein the compression surface of at least one of the engagement tip and washer is convex.

10. The fluid delivery system of any one of claims 7 to 9, wherein the compression surface of at least one of the engagement tip and washer is tapered.

11. The fluid delivery system of any one of claims 1 to 10, wherein the engagement tip and the connector are integral.

12. The fluid delivery system of any one of claims 1 to 10, wherein the engagement tip and connector are separate components.

13. 13. The fluid delivery system of claim 12, wherein the engagement tip and connector have a stepped connection therebetween, one of the engagement tip or the connector comprising a countersink and the other of the engagement tip or the connector comprising a collar configured to be received within the countersink.

14. 14. The fluid delivery system of claim 1, wherein the connector further comprises a throat portion having a reduced diameter compared to the threaded portion, the cavity extending along a longitudinal axis, the body further defining a bore therethrough that opens into the cavity from a direction transverse to the longitudinal axis, and further comprising a retaining member configured to be inserted into the bore and extend along the throat portion rearward of the threaded portion, thereby retaining the connector within the cavity.

15. 15. The fluid delivery system of claim 1, wherein the tool engaging end of the connector has a larger diameter than the cavity such that the tool engaging end defines a stop surface configured to engage the body when the connector is fully threaded into the cavity.

16. The fluid delivery system of claim 15 , wherein a central passage extending through the tool-engaging end of the connector comprises a grooved configuration.

17. The fluid delivery system of claim 15 or 16, wherein the complementary structures comprise ribs and indentations.

18. 18. The fluid delivery system of claim 1, wherein the body comprises a port implantable in a subcutaneous location, the port defining a chamber having an open top and the delivery opening, and a septum extending across the open top of the chamber.

19. 20. The fluid delivery system of claim 18, further comprising a catheter extending through the washer, gasket, engagement tip, and connector, the gasket compressed around a proximal end of the catheter to retain the catheter within the cavity and fluidly couple the catheter to the chamber of the port.

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