Subcutaneous port with locking element

Abstract

The subcutaneous port assembly includes a base, a connector, a stem, a sealing element, and a locking member. The connector extends from a first end attached to the base to a distal end and includes an inner surface defining a socket having an inner diameter. The stem extends from the base to the socket. The stem includes an outer surface having an outer diameter smaller than the inner diameter of the socket. The sealing element is disposed within the socket between the stem and the inner surface of the socket. The locking member includes a plunger received within the socket from the distal end and having an end facing the sealing element. The plunger is axially movable between a first position and a second position to selectively compress the sealing element within the socket.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 63 / 004,142, filed April 2, 2020. The disclosure of this prior application is considered part of the disclosure of this application and is hereby incorporated by reference in its entirety herein. Field

[0002] The present disclosure relates generally to subcutaneous ports. [Background technology]

[0003] This section provides background information related to the present disclosure, which is not necessarily prior art.

[0004] When connecting a catheter to a subcutaneous port, it may be difficult to securely connect the catheter to the subcutaneous port due to a variety of potential issues, such as anatomical interference(s), surgical instrument interference(s), etc. Furthermore, ensuring that the catheter remains connected to the subcutaneous port is important for proper delivery of medication to the patient. Therefore, there may be room for improvement in the method of connecting the catheter to the subcutaneous port. Summary of the Invention

[0005] This section provides a general overview of the disclosure and is not intended to be a comprehensive disclosure of its entire scope or all of its functionality.

[0006] One aspect of the disclosure provides a subcutaneous port assembly including a base, a connector, a stem, a sealing element, and a locking member. The connector extends from a first end attached to the base to a distal end and includes an inner surface defining a socket having an inner diameter. The stem extends from the base to the socket. The stem includes an outer surface having an outer diameter smaller than the inner diameter of the socket. The sealing element is disposed within the socket between the stem and the inner surface of the socket. The locking member is received within the socket from the distal end and includes a plunger having a terminus facing the sealing element. The plunger is axially movable between a first position and a second position to selectively compress the sealing element within the socket.

[0007] Implementations of the present disclosure may include one or more of the following optional features: In some implementations, the stem is surrounded by a sealing element. Optionally, the sealing element may be spaced a first distance from an outer diameter of the outer surface of the stem in an uncompressed state. In some examples, the plunger in the second position may be configured to compress the sealing element axially and radially toward the outer diameter of the outer surface of the stem.

[0008] The locking member may comprise a cap attached to the plunger. In some embodiments, the cap comprises a position indicator. The position indicator may be configured to communicate a rotational position of the cap. In some embodiments, the cap includes a gripping member, and the position indicator is disposed on the gripping member. The cap may comprise a plurality of first threads and the connector may comprise a plurality of second threads that engage the first threads. The plunger may move between the first position and the second position via the first threads that engage the second threads.

[0009] The socket may include a first radial protrusion on an inner surface and the plunger may include a second radial protrusion on an outer surface of the plunger, the first radial protrusion and the second radial protrusion configured to selectively engage with each other to retain at least a portion of the plunger in the socket.

[0010] The sealing element may include a tapered end facing a terminal end of the plunger. The terminal end of the plunger may be configured to axially and radially compress the tapered end of the sealing element when the plunger moves from the first position to the second position.

[0011] Another aspect of the disclosure provides a subcutaneous port assembly comprising a base, a connector, a stem, a collar and a sealing element. The connector extends from a first end adjacent the base to a second end. The connector comprises a neck portion having a first width at the first end, a shoulder portion having a second width proximate the second end, and a socket defined by an inner surface extending from the second end through the connector. The stem extends from the base into the socket and comprises an outer surface spaced inwardly from the inner surface of the socket. The collar comprises an inner biasing surface having a third width greater than the first width of the neck portion and less than the second width of the shoulder portion. The collar is operable between a first position in which the inner biasing surface is adjacent the neck portion and a second position in which the inner biasing surface is adjacent the shoulder portion. The sealing element is disposed within the socket between the stem and the inner surface of the socket. The sealing element surrounds the stem when the collar is in the first position and is compressed against the stem when the collar is in the second position. This aspect may include one or more of the following optional features.

[0012] In some implementations, the stem is surrounded by the connector. Optionally, the collar in the second position can be configured to radially compress the sealing element to secure the catheter between the sealing element and the stem.

[0013] The connector may include at least one slot extending from the socket through the shoulder. When the collar moves from the first position to the second position, the connector may be radially biased toward the sealing element through the at least one slot. The inner biasing surface may be tapered and the connector may include a tapered outer biasing surface. When the collar moves from the first position to the second position, engagement of the inner biasing surface with the tapered outer surface may cause the connector to radially bias toward the sealing element, which may radially compress the catheter to secure it to the stem. The tapered outer surface of the connector may be disposed between the neck portion and the shoulder portion. The at least one slot may include a plurality of slots defining a plurality of flexible tabs of the connector. Each flexible tab of the connector may be spaced one slot from an adjacent flexible tab of the connector.

[0014] Another aspect of the present disclosure provides a locking mechanism for a subcutaneous port assembly, the locking mechanism including a connector, a stem, a sealing element, a braided catheter, and a locking member. The connector has a socket and a plurality of threads at a first end of the socket. The stem is disposed within the socket. The sealing element is disposed within the socket between the stem and the connector. The braided catheter is coupled to the stem and has an end surrounded by the sealing element. The locking member is slidably coupled to the connector and movable between a first position and a second position along the connector to selectively alter the sealing element between a compressed state and an uncompressed state about the catheter. This aspect may include any one or more of the following features.

[0015] In some implementations, the locking member comprises a plunger received in the socket and a cap coupled to the connector by a thread. In some examples, the cap comprises a position indicator. The position indicator can be configured to communicate a rotational position of the cap. In some examples, the cap comprises a gripping member, and the position indicator is provided on the gripping member. The cap can be movable between a locked position and an unlocked position relative to the connector via threaded engagement. The connector can comprise a first radial protrusion on an inner surface, and the locking member can comprise a second radial protrusion on an outer surface. The first radial protrusion and the second radial protrusion can be configured to engage with each other to secure at least a portion of the plunger to the connector. The sealing element can comprise a sleeve having a tapered first end, and the plunger can comprise a tapered second end configured to engage the tapered first end of the sleeve. When the locking member moves from the first position to the second position, the tapered first end and the tapered second end engage and the sleeve may be compressed axially and radially to secure the braided catheter to the stem.

[0016] The details of one or more implementations of the disclosure are set forth in the accompanying drawings and the description below. Other aspects, features, and advantages will be apparent from the description and drawings, and from the claims.

[0017] The drawings described herein are only for purposes of illustrating selected configurations and are not intended to limit the scope of the present disclosure. [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 is a partially exploded perspective view of a subcutaneous port according to the principles of the present disclosure; [Diagram 2] FIG. 2 is an exploded perspective view of the subcutaneous port of FIG. 1. [Diagram 3] 3 is a cross-sectional view of the subcutaneous port of FIG. 1 in an unlocked position taken along line 3-3. [Figure 4]3 is a cross-sectional view of the subcutaneous port of FIG. 1 in a locked position taken along line 3-3. [Figure 5A] 3 is a cross-sectional detail view of a portion of the subcutaneous port of FIG. 1 in an unlocked position taken along line 3-3. [Figure 5B] FIG. 3 is a cross-sectional detail view of a portion of the subcutaneous port of FIG. 1 in an unlocked position with a flat engagement between the sealing element and the locking member along line 3-3. [Figure 6] 1 is a perspective view of another subcutaneous port according to the principles of the present disclosure; [Figure 7] FIG. 7 is a perspective view of the subcutaneous port of FIG. 6 in a locked position. [Figure 8] 8 is a cross-sectional perspective view of the subcutaneous port of FIG. 6 in an unlocked position along line 8-8. [Figure 9] 8 is a cross-sectional detail view of the subcutaneous port of FIG. 6 in an unlocked position taken along line 8-8. [Figure 10] Figure 8 is a cross-sectional detail view of the subcutaneous port of Figure 6 in a locked position taken along line 8-8.Corresponding reference numerals indicate corresponding parts throughout the drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] The exemplary configuration will now be described in more detail with reference to the accompanying drawings. The exemplary configuration is provided so that this disclosure will be complete and will fully convey the scope of the disclosure to those skilled in the art. Specific details, such as examples of specific components, devices, and methods, are described to provide a thorough understanding of the disclosed configuration. It will be apparent to those skilled in the art that specific details need not be employed, that the exemplary configuration may be embodied in many different forms, and that the specific details and exemplary configuration should not be construed as limiting the scope of the present disclosure.

[0020] 1-5B, a first example of a subcutaneous port assembly 100 is generally shown. The subcutaneous port assembly 100 includes a port 102 including a base 104, a cap 106, a septum 108, and a connector 110. The subcutaneous port assembly 100 may be surgically placed under the skin of a patient. As seen in FIGS. 2 and 3, the base 104 may define a reservoir 112, and the cap 106 may define an access opening 114 that receives the septum 108, which may be a membrane formed of silicone or other suitable material. As described in more detail below, the connector 110 may receive a distal end 10a of the catheter 10, the opposite end of which may be connected to a vein, muscle, bone, tissue, or any other suitable anatomical structure or system of the patient. The catheter 10 may be a braided catheter having any suitable elasticity, strength, and stiffness. In some implementations, the catheter 10 has minimal elasticity or stretchability along its longitudinal axis.

[0021] A healthcare provider, such as a doctor or nurse, may inject the medication through the patient's skin and septum via a syringe and needle to deliver the medication to the reservoir 112. The medication may then be delivered via the catheter 10 to a desired location for medication application. The base 104, cap 106, and connector 110 may be formed of any suitable material, such as titanium, stainless steel, cobalt chromium alloy, nickel titanium alloy, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, or any combination of the above.

[0022] The connector 110 extends from a first end 110a attached to the base 104 to a distal end 110b spaced from the base 104. The connector 110 includes an inner surface 116 that defines a socket 118. As shown in FIG. 5A, the socket 118 has a first inner diameter ID 118a and the first inner diameter ID 118a Larger Second Inner Diameter ID 118b The first inner diameter ID 118a is the second inner diameter ID 118bThe socket 118 may be disposed closer to the first end 110a than the second inner diameter ID. 118b 10, for example, at a portion extending from distal end 110b, may include a plurality of first threads 120 on inner surface 116.

[0023] 3-5B, the socket 118 has a first inner diameter ID 118a The first radial protrusion 122 may include a first radial protrusion 122 extending from the inner surface 116 at a portion having a first inner diameter ID. The first radial protrusion 122 may be barbed and may have an angled portion that slopes in a direction extending from the distal end 110b toward the first end 110a, and the first radial protrusion 122 may have a substantially flat portion adjacent the angled portion and facing the first end 110a. The flat portion of the first radial protrusion 122 may be perpendicular to the inner surface 116 or may be undercut to provide an obstacle along the inner surface 116. In some implementations, the first radial protrusion 122 is generally parallel to the first inner diameter ID. 118a In other implementations, the first radial protrusion 122 may be disposed at an end of a portion of the socket 118 having a first inner diameter ID. 118a The socket 118 may be placed in any location of the socket 118 having the base 104 or the connector 110. The socket 118 may be in fluid communication with the reservoir 112 via a conduit 124 defined by one of the base 104 or the connector 110.

[0024] The port 102 includes a stem 126 that extends from the base 104 into the socket 118. The stem 126 is aligned with a first inner diameter ID of the socket 118. 118a and the second inner diameter ID 118b Smaller outside diameter OD 126 In some implementations, the stem 126 has an outer surface 128 having an outer diameter OD 126 In some implementations, the outer diameter OD of the stem 126 may be between about 0.2 mm and 1.0 mm. 126may be between about 0.3 mm and 0.7 mm. The stem 126 may extend along substantially the entire length of the socket 118, i.e., from the base 104 to the distal end 110b of the connector 110. In some implementations, the stem 126 may extend beyond or terminate before the distal end 110b of the connector 110. The stem 126 may be formed of any suitable material, such as titanium, stainless steel, cobalt chromium alloy, nickel titanium alloy, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, or any combination of the above.

[0025] 3-5B, the subcutaneous port assembly 100 includes a sleeve or sealing element 130 disposed within the socket 118 between the outer surface 128 of the stem 126 and the inner surface 116 of the socket 118. The sealing element 130 extends from a proximal end 130a to a distal end 130b. The proximal end 130a has a first inner diameter ID 118a The distal end 130b may be located at or near the end of the portion of the socket 118 having a tapered end 130b. In some implementations, the distal end 130b may be tapered toward the longitudinal center of the sealing element 130, as shown in FIG. 5A. In other implementations, the distal end 130b may be substantially flat or non-tapered, as shown in FIG. 5B. The sealing element 130 may include a central bore 132 extending completely through the sealing element 130 such that the sealing element 130 completely surrounds the stem 126. The sealing element 130 may be spaced apart from the outer surface 128 of the stem 126 when in an uncompressed state. In particular, the surface defining the central bore 132 of the sealing element 130 is spaced apart from the outer surface 128 of the stem 126 by a distance greater than the wall thickness of the catheter 10. Thus, when the sealing element 130 is in an uncompressed state, a catheter may be inserted through the space between the outer surface 128 of the stem 126 and the sealing element 130. The sealing element 130 may be formed of any suitable material, such as foam, rubber, neoprene, silicone, or the like.

[0026] The subcutaneous port assembly 100 includes a plunger 136, a cap 138 adjacent the plunger 136, and a locking member 134 having a central bore 140 extending through the plunger 136 and the cap 138. The plunger 136 is received within the socket 118 from a distal end 110b. The plunger 136 includes a terminal end 136a that faces the distal end 130b of the sealing element 130. In some implementations, the terminal end 136a tapers away from the longitudinal center of the plunger 136 to mate with a taper of the distal end 130b of the sealing element 130, as shown in FIG. 5A. In other implementations, the terminal end 136a of the plunger 136 may be substantially flat adjacent to a flat end of the distal end 130b of the sealing element 130, as shown in FIG. 5B. The plunger 136 is axially movable between a first position (FIG. 3) and a second position (FIG. 4) to selectively compress the sealing element within the socket 118. The locking member 134 may be formed of any suitable material, such as titanium, stainless steel, cobalt chromium alloy, nickel titanium alloy, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, a polymeric material, a plastic material, or any combination of the above.

[0027] The plunger 136 is fitted to a first inner diameter ID of the socket 118. 118a The outer surface 142 includes an outer radial surface 142 extending into the first inner diameter ID of the socket 118. The outer surface 142 includes a second radial protrusion 144 extending therefrom. The second radial protrusion 144 may have an inclined portion that increases in a direction extending from the terminus 136a toward the cap 138, and the second radial protrusion 144 may have a substantially flat portion adjacent the inclined portion and facing the cap 138. The first radial protrusion 122 of the socket 118 and the second radial protrusion 144 of the plunger 136 are configured to selectively engage one another to retain at least a portion of the plunger 136 within the socket 118, as can be seen in FIGS. 5A and 5B. The inclined portions of the first and second radial protrusions 122, 144 are configured to selectively engage one another to retain at least a portion of the plunger 136 within the socket 118, as can be seen in FIGS. 5A and 5B. 118aAfter the second radial protrusion 144 passes the first radial protrusion 122, the flat portions of the first and second radial protrusions 122, 144 allow the plunger 136 to enter the first inner diameter ID of the socket 118. 118a Such a configuration ensures that locking member 134 will not become dislodged from port 102 after proper installation. Although first radial protrusion 122 and second radial protrusion 144 are shown and described as having a shape resembling a right triangle, it should be understood that any suitable shape is contemplated.

[0028] The cap 138 includes an exterior surface 146 having a plurality of second threads 148 and a plurality of gripping members 150. The plurality of second threads 148 are adapted to engage a second inner diameter ID of the socket 118. 118b and configured to engage the plurality of first threads 120. The plunger 136 moves between a first position (FIG. 3) and a second position (FIG. 4) via the first threads 120 engaging the second threads 148. The second threads 148 are configured such that a single rotation of the locking member 134 moves the plunger 136 between the first position (FIG. 3) and the second position (FIG. 4) to selectively compress the sealing element 130 within the socket 118 to secure the catheter. More specifically, when the plunger is in the second position (i.e., fully retracted) shown in FIG. 3, a single clockwise rotation of the locking member 134 moves the plunger 136 to the first position shown in FIG. 4 to compress the sealing element 130 to provide a locking force to the catheter 10 in accordance with ISO 10555. Conversely, a full counterclockwise rotation returns the plunger 136 from the first fully locked position to the second fully unlocked position shown in FIG. 3, thereby allowing the catheter 10 to be easily removed from the stem 126.

[0029] The gripping member 150 may be a series of recesses, protrusions, or areas with a higher coefficient of friction, for example, to facilitate gripping and twisting of the cap 138 by a healthcare provider. The cap 138 may include a position indicator 151a configured to communicate the position of the locking member 134 to a user. Specifically, as described above, the first and second threads 120, 148 are configured such that a single rotation of the locking member 134 moves the locking member 134 between a fully unlocked first position (FIG. 3) and a fully locked second position (FIG. 4). Thus, the position indicator 151a communicates the rotational position of the cap 138 to a user so that the user can determine whether the locking member 134 is in the first position, the second position, or an intermediate position between the first and second positions. The position indicator 151a further cooperates with the first and second radial protrusions 122, 144 to prevent the locking member 134 from being inadvertently removed from the connector 110. For example, position indicator 151a provides visual feedback to the user that locking member 134 is adjacent or in the first position (i.e., fully retracted), while first and second radial protrusions 122, 144 provide physical or tactile feedback to the user when second radial protrusion 144 of plunger 136 abuts first radial protrusion 122 of socket 118 in the first position. The redundant feedback (i.e., visual and tactile) advantageously minimizes the chance of locking member 134 becoming dislodged from socket 118, which is particularly advantageous when implemented with a catheter that is inserted into a patient.

[0030] In the illustrated embodiment, the position indicator 151a is provided as a colored portion of the exterior surface 146 that corresponds to one of the protrusions of the gripping member 150. Optionally, a reference indicator 151b may be formed on the connector 110 to indicate the relative position of the locking member 134 with respect to the connector 110. Each of the indicators 151a, 151b may be applied using a tampography process (i.e., pad printing). However, other coating processes (e.g., anodization) may be used to form each of the indicators 151a, 151b. Additionally or alternatively, each of the indicators 151a, 151b may include a tactile feature formed in the exterior surface 146, such as a knurling or alignment slot.

[0031] The cap 138 includes a parabolic recess 152 that extends toward the central bore 140. Upon installation of the catheter 10, the parabolic recess 152 is configured to orient the catheter 10 toward the central bore 140. For example, the distal end 10a of the catheter 10 may slide along the surface of the parabolic recess 152 toward the central bore 140.

[0032] In operation, the locking member 134 begins in a first position (FIG. 3) and the distal end 10a of the catheter 10 is inserted into the central bore 140 of the locking member 134. The distal end 10a of the catheter 10 slides along the central bore 140 of the socket 118, over the outer surface 128 of the stem 126, and through the central bore 132 of the sealing element 130 until the distal end 10a of the catheter 10 terminates at the end of the socket 118. At this point, the catheter 10 surrounds the stem 126, but the catheter 10 may not be properly secured to the stem 126. The locking member 134 rotates through interaction with the cap 138, which moves the plunger 136 closer to the sealing element 130 as the first threads 120 engage the second threads 148. The plunger 136 moves further into the socket 118 until the terminal end 136a of the plunger 136 engages the distal end 130b of the sealing element 130. The locking member 134 continues to rotate and move toward the second position (FIG. 4) such that the terminal end 136a of the plunger 136 engages the distal end 130b of the sealing element 130 with respect to the outer diameter OD 136b of the outer surface 128 of the stem 126. 126 axially and radially toward the catheter 10, thus securing the catheter 10 to the stem 126. In other words, as the locking member 134 moves from the first position to the second position, the sealing element 130 moves from an uncompressed state (i.e., away from the catheter) to a compressed state (i.e., in contact with the catheter) to secure the catheter 10 to the stem 126.

[0033] 6-10, there is generally shown a second embodiment of a subcutaneous port assembly 200. Subcutaneous port assembly 200 comprises a port 202 having a base 204, a cap 206, a septum 208, and a connector 210. The base 204, which defines a reservoir 212, the cap 206, which defines an access opening 214, and the septum 208 are substantially similar in structure and function to the base 104, cap 106, and septum 108 of the subcutaneous port assembly 100 described above, and therefore these components will not be described in detail.

[0034] The connector 210 extends from a first end 210a adjacent the base 204 to a distal second end 210b away from the base 204. The connector 210 includes an inner surface 216 that defines a socket 218. The socket 218 has an inner diameter ID 218 The socket 218 comprises at least one radial protrusion 220 extending from the inner surface 216 toward a center of the socket 218. In some implementations, the at least one radial protrusion 220 may comprise two radial protrusions 220, or any other suitable number of radial protrusions. The radial protrusions 220 may have a generally triangular shape, such as an equilateral triangle, or any other suitable shape. The socket 218 may be in fluid communication with the reservoir 212 via a conduit 224 defined by one of the base 204 or the connectors 210.

[0035] The connector 210 includes a head portion 222, a neck portion 234, and a shoulder portion 236 between the head portion 222 and the neck portion 234. The neck portion 234 has a first width W at a first end 210a of the connector, e.g., the portion that connects to the base 204. 234 2, and shoulder portion 236 has a width W 234 The larger second width W 236 Socket 118 extends through head portion 222, through shoulder portion 236, and at least partially into neck portion 234. Shoulder portion 236 includes a lip or first catch 244 on an exterior surface of shoulder portion 236. First catch 244 may face toward second end 210b of connector 210, for example, first catch 244 may face toward head portion 222.

[0036] The head portion 222 may include a tapered outer surface 238 that extends to the second end 210b of the connector 210. The head portion 222 includes a tapered recess 240 that extends toward the socket 218. Upon placement of the catheter 10, the tapered recess 240 is configured to orient the catheter 10 toward the socket 218. For example, the distal end 10a of the catheter 10 may slide along the surface of the tapered recess 240 toward the socket 218.

[0037] 8-10, the connector 210 includes an exterior biasing surface 242 that extends from an exterior surface of the neck portion 234 to an exterior surface of the shoulder portion 236. The exterior biasing surface 242 may be tapered relative to the neck portion 234 and the shoulder portion 236. For example, the first width W of the neck portion 234 may be tapered relative to the first width W of the shoulder portion 236. 234 is the second width W of the shoulder portion 236 236 4. Since outer biasing surface 242 increases in width from neck portion 234 to shoulder portion 236 , outer biasing surface 242 increases in width from neck portion 234 to shoulder portion 236 .

[0038] 6 and 7, the connector 210 includes at least one slot 246 extending from the socket 218 through at least a portion of the head portion 222, the shoulder portion 236, and the neck portion 234. The at least one slot 246 may include four slots, or any other suitable number of slots. The slots 246 may cooperate to define at least one flexible tab 248 of the connector 210. For example, in an implementation where there are four slots 246, there may be four flexible tabs 248 defined by the four slots 246. Each tab 248 may be spaced from an adjacent tab 248 by one of the slots 246.

[0039] The port 202 includes a stem 226 that extends from the base 204 into the socket 218. The stem 226 is spaced inwardly from the inner surface 216 of the socket 218 and is spaced inwardly from the inner diameter ID of the socket 218. 218 Smaller outside diameter OD 226 In some implementations, the stem 226 has an outer surface 228 having an outer diameter OD 226In some implementations, the outer diameter OD of the stem 226 may be between about 0.2 mm and 1.0 mm. 226 may be between about 0.3 mm and 0.7 mm. The stem 226 may be surrounded by the connector 210 and may extend along substantially the entire length of the socket 218, i.e., from the base 204 to the second end 210b of the connector 210. In some implementations, the stem 226 may extend beyond or terminate before the second end 210b of the connector 210, for example, the stem 226 may terminate at or near the beginning of the head portion 222. The stem 226 may be formed of any suitable material, such as titanium, stainless steel, cobalt chromium alloy, nickel titanium alloy, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, or any combination of the above.

[0040] 8-10, the subcutaneous port assembly 200 includes a sleeve or sealing element 230 disposed within the socket 218 between the stem 226 and the inner surface 216 of the socket 218. The sealing element 230 extends from a proximal end 230a to a distal end 230b. The proximal end 230a may be disposed at or near the end of the portion of the socket 218 closer to the base 204. The sealing element 230 may include a central bore 232 extending completely through the sealing element 230 such that the sealing element 230 completely surrounds the stem 226. The sealing element 230 may be spaced apart from the outer surface 228 of the stem 226 when in an uncompressed state. In particular, the surface defining the central bore 232 of the sealing element 230 is spaced apart from the outer surface 228 of the stem 226 by a distance greater than the wall thickness of the catheter 10. Thus, when the sealing element 230 is in an uncompressed state, the catheter 10 may be inserted through the space between the outer surface 228 of the stem 226 and the sealing element 230. The sealing element 230 may be formed of any suitable material, such as foam, rubber, neoprene, silicone, or the like.

[0041] Subcutaneous port assembly 200 includes a collar 250 that is slidable relative to connector 210 between a first unlocked position (FIGS. 6 and 9) and a second locked position (FIGS. 7 and 10). Collar 250 is configured to extend beyond a first width W of neck portion 234 of connector 210. 234 A third width W that is greater than 252 2. The collar 250 includes a first inner surface 252 having a lip or second catch 254 extending therefrom. The second catch 254 is configured to engage the first catch 244 extending from the shoulder portion 236. The catches 244, 254 are oriented to allow movement of the collar 250 away from the base 204, but after the second catch 254 passes the first catch 244, the first catch 244 engages the second catch 254 to limit movement of the collar 250 towards the base 204. The collar 250 has a fourth width W that increases in a direction away from the base 204. 256 That is, a portion of the second inner surface 256 is inclined to cooperate with the flared outer biasing surface 242 of the connector 210. 256 is the first width W of the neck portion 234 234 and a second width W of the shoulder portion 236 is greater than 236 In the unlocked position, the second inner surface 256 of the collar 250 is adjacent the neck portion 234. In the locked position, the second inner surface 256 of the collar 250 is adjacent the shoulder portion 236. The second catch 254 is disposed between the first inner surface 252 and the second inner surface 256.

[0042] The collar 250 includes an outer surface 258 that includes a plurality of gripping members 260. The gripping members 260 may be a series of recesses, protrusions, or areas with a higher coefficient of friction, for example, to facilitate gripping and twisting of the collar 250 by a healthcare provider. Additionally or alternatively, the inner surface 252, 256 of the collar 250 may include a plurality of first threads and the outer surface of the connector 210 may include a plurality of corresponding second threads configured to engage the first threads such that the collar 250 may rotate about the connector 210 to move from an unlocked position to a locked position. The collar 250 may be formed of any suitable material, such as titanium, stainless steel, cobalt chromium alloy, nickel titanium alloy, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, a polymeric material, a plastic material, or any combination of the above.

[0043] In operation, the collar 250 begins in an unlocked position (FIG. 6). As described above, in the unlocked position, the collar 250 is positioned such that the second inner surface 256 is aligned with the neck portion 234 of the connector 210. Thus, the shoulder portion 236, and more specifically, the tab 248 of the shoulder portion 236, is not compressed by the collar 250. As shown in FIG. 9, in the uncompressed state, the radial protrusion 220 formed on the inner surface 216 of the socket 218 is spaced radially outward from the sealing element 230 such that the inner bore of the sealing element 230 is spaced from the stem 226.

[0044] With the collar 250 unlocked, the distal end 10a of the catheter 10 is inserted into the socket 218. The distal end 10a of the catheter 10 slides along the socket 218, over the outer surface 228 of the stem 226, and through the central bore 232 of the sealing element 230 until the distal end 10a of the catheter 10 terminates at the end of the socket 218. At this point, the catheter 10 surrounds and is coupled to the stem 226, but the catheter 10 may not be properly secured to the stem 226. The collar 250 is slid from the unlocked position toward the locked position, for example, until the second catch 254 passes the first catch 244. At this point, the engagement of the catches 244, 254 restricts the collar 250 from sliding rearward toward the base 204. As the collar 250 slides toward the locked position, the connector 210 is biased radially toward the sealing element 230 through the slots 246 by the second inner surface 256 of the collar 250 sliding along the outer biasing surface 242 of the connector 210. The connector 210 biasing radially toward the sealing element 230 causes the radial protrusions 220 to radially compress the sealing element 230, which in turn compresses the catheter 10 and secures the catheter 10 to the stem 226.

[0045] It should be understood that other implementations and / or embodiments are possible in addition to the foregoing description. Furthermore, any implementations or embodiments, including any features of each implementation, may be combined or interchanged as appropriate.

[0046] In some implementations, the catheter may be at least partially secured to the stem via a sleeve or insert that wraps around the catheter and is secured in any suitable manner, including by threads, ridges, ribs, protrusions, radial compression, etc.

[0047] In some implementations, the port assembly includes a connector extending from a base to a distal end. The connector includes an internal cavity extending from the distal end of the connector, the inner diameter of the cavity tapering along a direction away from the distal end. Similar to the above example, a stem extends from the base through the cavity toward the distal end of the connector. The port assembly further includes a locking member having a tube configured to be axially inserted into the cavity of the connector. The shaft may be configured as a hollow shaft or tube having a passageway formed axially therethrough. A plurality of slots or notches are formed through the distal end of the shaft to provide a plurality of flexible tabs on the distal shaft. When the distal end of the shaft is inserted into the cavity of the connector, the fingers engage the tapered inner diameter of the cavity and are urged radially inward toward the stem. In use, a catheter is threaded through the stem before the locking member engages the tapered portion of the cavity. The locking member is then moved toward the locking position so that the distal end of the shaft engages the tapered portion of the cavity. The fingers are now urged radially inward, compressing the catheter against the stem. In some cases, the cavity may include a slot or detent formed therein, and the locking member may include a corresponding rib or protrusion. When the locking member is fully engaged with the cavity, the rib of the screw cap may create a snap-fit ​​connection to the connector to secure the catheter to the connector and indicate that the locking member is properly seated.

[0048] In some implementations, the port assembly includes a catheter lock having a plurality of rigid, angled tabs extending radially around a flexible segment that may have a cylindrical shape. The catheter lock may wrap around an outer surface of the catheter and secure the catheter lock to the catheter, for example, by threading a pin of the catheter lock through a screw. Similar to the above example, the port base may define a cavity, and the stem may extend from the base through the cavity. The port base may include a plurality of slots extending from the cavity and configured to receive the plurality of tabs. The catheter lock may be inserted into the cavity at an angle of the tabs that causes the tabs to compress the flexible segment such that the tabs bend toward the center of the flexible segment. The catheter lock continues to move further into the cavity until the slots receive the tabs and the engagement of the tabs and slots resists the catheter lock from moving away from the port base. In such implementations, the catheter lock may resemble a Bayonet Neill-Concelman (BNC) connector, with the base of the port functioning as a BNC male and the catheter lock functioning as a BNC female.

[0049] In some implementations, the port assembly includes a port base that may extend from a proximal end to a distal end. The distal end may be bent radially, for example, via at least one slot extending through the port base, the port base being formed of a flexible material, or the like. The port base may define a cavity having a stem extending through the cavity. The catheter lock may be wrapped around the catheter and temporarily secured to the catheter, for example, by friction. The catheter lock may have a cylindrical shape and a longitudinal split extending along the catheter lock such that the catheter lock may be opened along the longitudinal split to remove the catheter lock from attachment to the catheter. The catheter lock, including the catheter, extends into the cavity of the port base and bends the distal end radially outward to allow the catheter to wrap around the outer surface of the stem. The catheter lock may be removed from the cavity and the distal end may bend radially inward, pressing the catheter against the stem. The catheter lock may then be opened via the longitudinal split and detached from the catheter.

[0050] In some implementations, the port assembly may define a cavity and a stem extending through the cavity. The port assembly may include a collet wrapped around a catheter, and the catheter may include a cover with a snap feature. The catheter may be threaded through the collet and onto the stem, and the cover with a snap feature may secure the catheter to the collet. That is, the cover may encase the collet, the collet may encase the catheter, and the catheter may encase the stem, creating an interference fit between these components to secure the catheter to the stem. The collet may have barbs or flares that engage with a portion of the cover, such as slots, indentations, etc.

[0051] In some implementations, the catheter may be connected to a locking cap having a generally cylindrical shape and extending from the proximal end to the distal end, including a silicone gasket attached to the distal end. The locking cap may include a keyed slot having a first portion extending along the length of the cylindrical locking cap, a second portion extending perpendicular to the first direction around the circumference of the locking cap, and a third portion extending parallel to the first portion, e.g., the keyed slot may resemble a "J" shape. The catheter may be threaded onto a stem that extends through a cavity in the port base. The port base may include a pin extending from an outer surface of the stem. The locking cap slides over the stem and rotates the locking cap to receive the pin into the keyed slot, i.e., the third portion of the keyed slot, thereby securing the locking cap to the port base. In the locked position, the silicone gasket may be adjacent to the port base and compressed to maintain the catheter in the locked position.

[0052] The terms used herein are for the purpose of describing particular cases only and are not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms unless the context clearly indicates otherwise. The terms "comprises", "comprising", "including" and "having" are inclusive and thus specify the presence of features, steps, operations, elements and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components and / or groups thereof. The steps, processes and operations of the methods described herein should not be construed as necessarily having to be performed in the particular order described or illustrated, unless specifically identified as an order of performance. Additional or alternative steps may be used.

[0053] When an element or layer is referred to as being "on," "coupled," "connected," "attached," or "coupled" to another element or layer, it may be directly engaged, connected, attached, or coupled to the other element or layer, or there may be intervening elements or layers present. In contrast, when an element is referred to as being "directly," "directly engaged," "directly connected," "directly attached," or "directly coupled" to another element or layer, there may not be intervening elements or layers present. Other words used to describe relationships between elements should be interpreted in a similar manner (e.g., between and directly between, adjacent and directly adjacent, etc.). As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0054] In this specification, terms such as first, second, third, etc. may be used to describe various elements, components, regions, layers, and / or sections. These elements, components, regions, layers, and / or sections should not be limited by these terms. These terms may only be used to distinguish one element, component, region, layer, or section from another region, layer, or section. Terms such as "first", "second", and other numerical terms do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer, or section discussed in this specification may be referred to as a second element, component, region, layer, or section without departing from the teachings of the configuration example.

[0055] The description of the embodiments is presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular configuration are generally not limited to that particular configuration, but may be interchangeable where applicable and may be used in a selected configuration even if not specifically shown or described. The same may also be modified in various ways. Such modifications are not considered to depart from the disclosure, and all such modifications are intended to be included within the scope of the disclosure. (Additional Note) (Appendix 1) 1. A subcutaneous port assembly comprising: Base and; a connector extending from a first end attached to the base to a distal end and including an inner surface defining a socket having an inner diameter; a stem extending from the base into the socket, the stem having an outer surface having an outer diameter smaller than the inner diameter of the socket; a sealing element disposed within the socket between the stem and an inner surface of the socket; a locking member having a plunger received within the socket from the distal end and having a terminus facing the sealing element, the plunger being axially movable between a first position and a second position to selectively compress the sealing element within the socket; 13. The subcutaneous port assembly comprising: (Appendix 2) 2. The subcutaneous port assembly of claim 1, wherein the stem is surrounded by the sealing element. (Appendix 3) 3. The subcutaneous port assembly of any one of claims 1 or 2, wherein the sealing element is spaced from the outer diameter of the outer surface of the stem by a first distance in an uncompressed state. (Appendix 4) 4. The subcutaneous port assembly of claim 1, wherein the plunger in the second position is configured to axially and radially compress the sealing element toward the outer diameter of the outer surface of the stem. (Appendix 5) 5. The subcutaneous port assembly of claim 1, wherein the locking member further comprises a cap attached to the plunger, the cap comprising a plurality of first threads, and the connector comprising a plurality of second threads that engage with the first threads. (Appendix 6) 6. The subcutaneous port of claim 5, wherein the cap comprises a position indicator. (Appendix 7) 7. The subcutaneous port of claim 6, wherein the position indicator is configured to communicate a rotational position of the cap. (Appendix 8) 8. The subcutaneous port of claim 6 or 7, wherein the cap comprises a gripping member, and the position indicator is provided on the gripping member. (Appendix 9) 9. The subcutaneous port assembly of claim 5, wherein the plunger moves between the first position and the second position via the first thread engaging the second thread. (Appendix 10) 10. The subcutaneous port assembly of any one of claims 1-9, wherein the socket comprises a first radial protrusion on the inner surface and the plunger comprises a second radial protrusion on an outer surface of the plunger, the first radial protrusion and the second radial protrusion configured to selectively engage one another to retain at least a portion of the plunger in the socket. (Appendix 11) 11. The subcutaneous port assembly of any one of claims 1-10, wherein the sealing element comprises a tapered end facing a terminal end of the plunger, the terminal end of the plunger configured to axially and radially compress the tapered end of the sealing element when the plunger moves from the first position to the second position. (Appendix 12) 1. A subcutaneous port assembly comprising: Base and; a connector extending from a first end adjacent the base to a second end, the connector comprising: a neck portion having a first width at the first end, a shoulder portion having a second width proximate the second end, and a socket defined by an inner surface extending through the connector from the second end; a stem extending from the base into the socket and having an outer surface spaced inwardly from the inner surface of the socket; a collar including an inner biasing surface having a third width greater than the first width of the neck portion and less than the second width of the shoulder portion, the collar being movable between a first position in which the inner biasing surface is adjacent to the neck portion and a second position in which the inner biasing surface is adjacent to the shoulder portion; a sealing element disposed within the socket between the stem and an inner surface of the socket, the sealing element surrounding the stem when the collar is in the first position and compressed against the stem when the collar is in the second position; 13. The subcutaneous port assembly comprising: (Appendix 13) 13. The subcutaneous port assembly of claim 12, wherein the stem is surrounded by the connector. (Appendix 14) 14. The subcutaneous port assembly of claim 12 or 13, wherein the collar in the second position is configured to radially compress the sealing element to secure the catheter between the sealing element and the stem. (Appendix 15) 15. The subcutaneous port assembly of any one of claims 12 to 14, wherein the connector includes at least one slot extending from the socket through the shoulder portion. (Appendix 16) 16. The subcutaneous port assembly of claim 15, wherein the connector is radially deflected toward the sealing element through at least one slot when the collar moves from the first position to the second position. (Appendix 17) 17. The subcutaneous port assembly of claim 15 or 16, wherein the inner biasing surface is tapered and the connector includes a tapered outer biasing surface, and when the collar moves from the first position to the second position, engagement of the inner biasing surface with the tapered outer surface biases the connector radially toward the sealing element, which radially compresses the catheter to secure it to the stem. (Appendix 18) 18. The subcutaneous port assembly of claim 17, wherein the tapered outer surface of the connector is disposed between the neck portion and the shoulder portion. (Appendix 19) 19. The subcutaneous port assembly of any one of claims 15 to 18, wherein the at least one slot comprises a plurality of slots defining a plurality of plastic tabs of the connector, each plastic tab of the connector being spaced from an adjacent plastic tab of the connector by one of the slots. (Appendix 20) 1. A locking mechanism for a subcutaneous port assembly, the locking mechanism comprising: a connector having a socket and a plurality of threads on a first end of the socket; a stem disposed within the socket; a sealing element disposed within the socket between the stem and the connector; a braided catheter coupled to the stem and having an end surrounded by the sealing element; a locking member slidably coupled to the connector and movable along the connector between a first position and a second position to selectively vary the sealing element between a compressed state and an uncompressed state about the catheter. (Appendix 21) 21. The locking mechanism of claim 20, wherein the locking member comprises a plunger received within the socket and a cap coupled to the connector by threads, the cap being movable between a locked position and an unlocked position relative to the connector via engagement of the threads. (Appendix 22) 22. The subcutaneous port of claim 21, wherein the cap comprises a position indicator. (Appendix 23) 23. The subcutaneous port of claim 22, wherein the position indicator is configured to communicate a rotational position of the cap. (Appendix 24) 23. The subcutaneous port of claim 21 or 22, wherein the cap comprises a gripping member, and the position indicator is provided on the gripping member. (Appendix 25) 25. The locking mechanism of any one of claims 21 to 24, wherein the connector has a first radial protrusion on an inner surface and the locking member has a second radial protrusion on an outer surface, the first radial protrusion and the second radial protrusion being configured to engage with each other to secure at least a portion of the plunger to the connector. (Appendix 26) 26. The locking mechanism of any one of appendices 21 to 25, wherein the sealing element comprises a sleeve having a tapered first end, and the plunger comprises a tapered second end configured to engage with the tapered first end of the sleeve, and when the locking member moves from the first position to the second position, the tapered first end and the tapered second end engage to axially and radially compress the sleeve to secure the braided catheter to the stem.

Claims

1. 1. A subcutaneous port assembly comprising: Base and; a connector including an inner surface extending from a first end attached to the base to a distal end and defining a socket having an inner diameter; a stem extending from the base into the socket, the stem having an outer surface having an outer diameter smaller than the inner diameter of the socket; a sealing element disposed within the socket between the stem and an inner surface of the socket; a locking member having a plunger received within the socket from the distal end and having a terminus facing the sealing element, the plunger being axially movable between a first position and a second position to selectively compress the sealing element within the socket; Equipped with the subcutaneous port assembly, wherein the socket comprises a first radial protrusion on the inner surface and the plunger comprises a second radial protrusion on an outer surface of the plunger, the first radial protrusion and the second radial protrusion configured to selectively engage one another to retain at least a portion of the plunger within the socket.

2. The subcutaneous port assembly of claim 1 , wherein the stem is surrounded by the sealing element.

3. 3. The subcutaneous port assembly of claim 1, wherein the sealing element is spaced from the outer diameter of the outer surface of the stem a first distance in an uncompressed state.

4. The subcutaneous port assembly of any one of claims 1 to 3, wherein the plunger in the second position is configured to axially and radially compress the sealing element toward the outer diameter of the outer surface of the stem.

5. 5. The subcutaneous port assembly of claim 1, wherein the locking member further comprises a cap attached to the plunger, the cap comprising a plurality of first threads, and the connector including a plurality of second threads that engage with the first threads.

6. The subcutaneous port assembly of claim 5 , wherein the cap includes a position indicator.

7. The subcutaneous port assembly of claim 6 , wherein the position indicator is configured to communicate a rotational position of the cap.

8. 8. The subcutaneous port assembly of claim 6 or 7, wherein the cap includes a gripping member, and the position indicator is provided on the gripping member.

9. 9. The subcutaneous port assembly of claim 5, wherein the plunger moves between the first position and the second position via the first thread engaging the second thread.

10. 10. The subcutaneous port assembly of claim 1, wherein the sealing element includes a tapered end facing a terminal end of the plunger, the terminal end of the plunger configured to axially and radially compress the tapered end of the sealing element when the plunger moves from the first position to the second position.

11. 1. A subcutaneous port assembly comprising: Base and; a connector extending from a first end adjacent the base to a second end, the connector comprising: a neck portion having a first width at the first end, a shoulder portion having a second width proximate the second end, and a socket defined by an interior surface extending through the connector from the second end; a stem extending from the base into the socket and having an outer surface spaced inwardly from the inner surface of the socket; a collar including an inner biasing surface having a third width greater than the first width of the neck portion and less than the second width of the shoulder portion, the collar being movable between a first position in which the inner biasing surface is adjacent to the neck portion and a second position in which the inner biasing surface is adjacent to the shoulder portion; a sealing element disposed within the socket between the stem and an inner surface of the socket, the sealing element surrounding the stem when the collar is in the first position and compressed against the stem when the collar is in the second position; 13. The subcutaneous port assembly comprising:

12. The subcutaneous port assembly of claim 11 , wherein the stem is surrounded by the connector.

13. 13. The subcutaneous port assembly of claim 11 or 12, wherein the collar in the second position is configured to radially compress the sealing element to secure the catheter between the sealing element and the stem.

14. The subcutaneous port assembly of any one of claims 11 to 13, wherein the connector includes at least one slot extending from the socket through the shoulder portion.

15. The subcutaneous port assembly of claim 14, wherein the connector is radially deflected toward the sealing element through at least one slot when the collar moves from the first position to the second position.

16. 16. The subcutaneous port assembly of claim 14 or 15, wherein the inner biasing surface is tapered and the connector includes a tapered outer biasing surface, and when the collar moves from the first position to the second position, engagement of the inner biasing surface with the tapered outer surface biases the connector radially toward the sealing element, which radially compresses the catheter to secure it to the stem.

17. The subcutaneous port assembly of claim 16, wherein the tapered outer surface of the connector is disposed between the neck portion and the shoulder portion.

18. 18. The subcutaneous port assembly of claim 14, wherein the at least one slot comprises a plurality of slots defining a plurality of flexible tabs of the connector, each flexible tab of the connector being spaced from an adjacent flexible tab of the connector by one of the slots.

19. 1. A locking mechanism for a subcutaneous port assembly, the locking mechanism comprising: a connector having a socket and a plurality of threads on a first end of the socket; A stem disposed within the socket; a sealing element disposed within the socket between the stem and the connector; a braided catheter coupled to the stem and having an end surrounded by the sealing element; a locking member slidably coupled to the connector and movable along the connector between a first position and a second position to selectively vary the sealing element between a compressed state and an uncompressed state about the catheter; the locking member comprises a plunger received within the socket and a cap coupled to the connector by threads, the cap being movable between a locked position and an unlocked position relative to the connector via engagement of the threads; the locking mechanism, wherein the connector comprises a first radial protrusion on an inner surface and the locking member comprises a second radial protrusion on an outer surface, the first radial protrusion and the second radial protrusion configured to engage with each other to secure at least a portion of the plunger to the connector.

20. The locking mechanism of claim 19 , wherein the cap comprises a position indicator.

21. The locking mechanism of claim 20 , wherein the position indicator is configured to communicate a rotational position of the cap.

22. 21. A locking mechanism according to claim 19 or 20, wherein the cap comprises a gripping member, the position indicator being provided on the gripping member.

23. 23. The locking mechanism of claim 19, wherein the sealing element comprises a sleeve having a tapered first end, the plunger comprises a tapered second end configured to engage the tapered first end of the sleeve, and when the locking member moves from the first position to the second position, the tapered first end and the tapered second end engage, compressing the sleeve axially and radially to secure the braided catheter to the stem.

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