Subcutaneous port with locking member

Abstract

A 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 and into the socket. The stem includes an outer surface having an outer diameter less 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 has a plunger that is received within the socket from the distal end and has 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.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 004,142, filed Apr. 2, 2020, under 35 U.S.C. § 119(e). The disclosure of the prior application is considered part of the disclosure of this application and is hereby incorporated by reference in its entirety. Technical Field

[0003] This disclosure generally relates to subcutaneous ports. Background Art

[0004] This section provides background information related to the present disclosure, which is not necessarily prior art.

[0005] When connecting a catheter to a subcutaneous port, it may be difficult to securely connect the catheter to the subcutaneous port due to various potential problems such as anatomical interference, surgical device interference, etc. Additionally, ensuring that the catheter remains connected to the subcutaneous port is important for ensuring proper drug delivery to the patient. Thus, there may be room for improvement in the way the catheter is connected to the subcutaneous port. Summary of the Invention

[0006] This section provides a general overview of the present disclosure but not an exhaustive disclosure of its full scope or all of its features.

[0007] One aspect of the present disclosure provides a subcutaneous port assembly that 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 that defines a socket having an inner diameter. The stem extends from the base and into the socket. The stem includes an outer surface having an outer diameter that is less 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 has a plunger that is received within the socket from the distal end and has 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.

[0008] Embodiments of the present disclosure may include one or more of the following optional features. In some embodiments, the stem is surrounded by the sealing element. Optionally, the sealing element may be spaced apart from the outer diameter of the stem by a first distance in an uncompressed state. In some examples, the plunger in the second position may be configured to axially and radially compress the sealing element toward the outer diameter of the stem.

[0009] The locking member may include a cap attached to the plunger. In some examples, the cap includes a position indicator. The position indicator may be configured to communicate the rotational position of the cap. In some examples, the cap includes a gripping member and the position indicator is disposed on the gripping member. The cap may include a plurality of first threads and the connector may include a plurality of second threads that engage the first threads. The plunger may move between a first position and a second position via engagement of the first threads with the second threads.

[0010] The socket may include a first radial protrusion on the inner surface, and the plunger may include a second radial protrusion on the outer surface of the plunger, the first radial protrusion and the second radial protrusion being configured to selectively engage each other to hold at least a portion of the plunger within the socket.

[0011] The sealing element may include a tapered end facing the terminal of the plunger. The terminal 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.

[0012] Another aspect of the present disclosure provides a subcutaneous port assembly that includes a base, a connector, a rod, a collar, and a sealing element. The connector extends from a first end adjacent the base to a second end. The connector includes a neck having a first width at the first end and a shoulder having a second width closer to the second end, and a socket defined by an inner surface extending through the connector from the second end. The rod extends from the base into the socket, the rod including an outer surface spaced inwardly from the inner surface of the socket. The collar includes an inwardly biased surface having a third width that is greater than the first width of the neck and less than the second width of the shoulder. The collar may operate between a first position where the inwardly biased surface is adjacent the neck and a second position where the inwardly biased surface is adjacent the shoulder. The sealing element is disposed within the socket between the rod and the inner surface of the socket. The sealing element surrounds the rod when the collar is in the first position and presses against the rod when the collar is in the second position. This aspect may include one or more of the following optional features.

[0013] In some embodiments, the rod is surrounded by the connector. Optionally, the collar in the second position may be configured to radially compress the sealing element to secure a catheter between the sealing element and the rod.

[0014] The connector may include at least one slot extending through the shoulder from the socket. When the collar moves from the first position to the second position, the connector may deflect radially toward the seal element via 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, the engagement of the inner biasing surface and the tapered outer surface may cause the connector to deflect radially toward the seal element and the seal element to radially compress the conduit and secure the conduit to the stem. The tapered outer surface of the connector may be provided between the neck and the shoulder. The at least one slot may include a plurality of slots that define a plurality of flexible tabs of the connector. Each flexible tab of the connector may be spaced apart from an adjacent flexible tab of the connector by one of the slots.

[0015] Another aspect of the present disclosure provides a locking mechanism for a subcutaneous port assembly, the locking mechanism including a connector, a stem, a seal element, a braided conduit, 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 seal element is disposed within the socket between the stem and the connector. The braided conduit has an end coupled to the stem and surrounded by the seal element. The locking member is slidably coupled to the connector and is movable along the connector between a first position and a second position to selectively change the seal element around the conduit between a compressed state and an uncompressed state. This aspect may include one or more of the following optional features.

[0016] In some embodiments, the locking member includes a plunger received within the socket and a cap threadedly coupled to the connector. In some examples, the cap includes a position indicator. The position indicator may be configured to convey the rotational position of the cap. In some examples, the cap includes a gripping member and the position indicator is disposed on the gripping member. The cap may be movable relative to the connector between a locked position and an unlocked position via the engagement of the threads. The connector may include a first radial protrusion on an inner surface, and the locking member may include a second radial protrusion on an outer surface. The first radial protrusion and the second radial protrusion may be configured to engage with each other to fix at least a portion of the plunger to the connector. The seal element may include a sleeve having a tapered first end, and the plunger may include 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 may engage, causing the sleeve to axially and radially compress the braided conduit and secure the braided conduit to the stem.

[0017] Details of one or more embodiments of the present disclosure will be set forth in the accompanying drawings and the following description. Other aspects, features, and advantages will be apparent from the specification, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The accompanying drawings described herein are for illustrative purposes only for selected configurations and are not intended to limit the scope of the present disclosure.

[0019] Figure 1 is a partially exploded perspective view of a subcutaneous port in accordance with the principles of the present disclosure;

[0020] Figure 2 is Figure 1 an exploded perspective view of the subcutaneous port of;

[0021] Figure 3 is a cross-sectional view of the subcutaneous port of taken along line 3-3 in an unlocked position; Figure 1 of;

[0022] Figure 4 is a cross-sectional view of the subcutaneous port of taken along line 3-3 in a locked position; Figure 1 of;

[0023] Figure 5A is a detailed cross-sectional view of the subcutaneous port of taken along line 3-3 in an unlocked position; Figure 1 of;

[0024] Figure 5B is a detailed cross-sectional view of a portion of the subcutaneous port of taken along line 3-3 in an unlocked position and having a flat engagement between a sealing element and a locking member; Figure 1 of;

[0025] Figure 6 is a perspective view of another subcutaneous port in accordance with the principles of the present disclosure;

[0026] Figure 7 is a perspective view of the subcutaneous port of in a locked position; Figure 6 of;

[0027] Figure 8 is a cross-sectional perspective view of the subcutaneous port of taken along line 8-8 in an unlocked position; Figure 6 of;

[0028] Figure 9 is a detailed cross-sectional view of the subcutaneous port of taken along line 8-8 in an unlocked position; and Figure 6 of;

[0029] Figure 10 is a detailed cross-sectional view of the subcutaneous port of taken along line 8-8 in a locked position; Figure 6 of.

[0030] Throughout the drawings, corresponding reference numerals indicate corresponding parts. Detailed Description

[0031] Exemplary configurations will now be described more fully with reference to the accompanying drawings. The exemplary configurations are provided so that this disclosure will be complete and will fully convey the scope of the disclosure to those of ordinary skill in the art. Specific details, such as examples of specific components, devices, and methods, are set forth to provide a thorough understanding of the configurations of this disclosure. It will be apparent to those of ordinary skill in the art that the exemplary configurations may be embodied in many different forms without the use of specific details, and the specific details and exemplary configurations should not be construed as limiting the scope of this disclosure.

[0032] Reference Figures 1 to 5B , generally shows a first example of a subcutaneous port assembly 100. The subcutaneous port assembly 100 includes a port 102, which includes a base 104, a cap 106, a septum 108, and a connector 110. The subcutaneous port assembly 100 can be surgically installed under the skin of a patient. As Figure 2 and Figure 3 can be seen, the base 104 can define a reservoir 112, and the cap 106 can define an access aperture 114 for receiving the septum 108, which can be a membrane formed of silicone or any other suitable material. As will be elaborated in more detail below, the connector 110 can receive the distal end 10a of the catheter 10, and the opposite end of the catheter 10 can be connected to a vein, muscle, bone, tissue, or any other suitable anatomical structure or system of the patient. The catheter 10 can be a braided catheter having any suitable elasticity, strength, and stiffness. In some embodiments, the catheter 10 has a minimal elasticity or stretch rate along its longitudinal axis.

[0033] Healthcare providers (such as doctors, nurses, etc.) can inject drugs through the patient's skin and through the septum via a syringe and needle to deliver the drugs to the reservoir 112. The drugs can then be delivered through the catheter 10 to the desired location for drug administration. The base 104, cap 106, and connector 110 can be formed of any suitable material, such as titanium, stainless steel, cobalt-chromium alloy, nitinol, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, or any combination of the foregoing.

[0034] The connector 110 extends from a first end 110a attached to the base 104 to a distal end 110b spaced apart from the base 104. The connector 110 includes an inner surface 116 that defines a socket 118. As Figure 5A indicated, the socket 118 includes a first inner diameter ID 118a and a second inner diameter ID 118a that is greater than the first inner diameter ID 118b . The first inner diameter ID 118a can be closer to the first end 110a than the second inner diameter ID 118b . The socket 118 can be on the inner surface 116 at a location having the second inner diameter ID 118bincludes a plurality of first threads 120 at a portion thereof (e.g., a portion extending from the distal end 110b).

[0035] Reference Figures 3 to 5B , the socket 118 may include a first radial protrusion 122 extending from the inner surface 116 at a portion having a first inner diameter ID 118a . The first radial protrusion 122 may be a barb and have an angled portion that is inclined in a direction extending from the distal end 110b toward the first end 110a, and the first radial protrusion 122 may have a generally flat portion adjacent to 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 obstruction along the inner surface 116. In some embodiments, 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 . In other embodiments, the first radial protrusion 122 may be disposed at any position of the socket 118 having a first inner diameter ID 118a . 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.

[0036] The port 102 includes a rod 126 that extends from the base 104 and into the socket 118. The rod 126 includes an outer surface 128 having an outer diameter OD 118a that is less than the first inner diameter ID 118b and a second inner diameter ID 126 of the socket 118. In some embodiments, the outer diameter OD 126 of the rod 126 may be between about 0.2 mm and 1.0 mm. In some embodiments, the outer diameter OD 126 of the rod 126 may be between about 0.3 mm and 0.7 mm. The rod 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 embodiments, the rod 126 may extend beyond the distal end 110b of the connector 110 or terminate before the distal end of the connector. The rod 126 may be formed of any suitable type of material, such as titanium, stainless steel, cobalt-chromium alloy, nitinol, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, or any combination of the foregoing.

[0037] Continuing to refer to 3 to Figure 5B , the subcutaneous port assembly 100 includes a sleeve or seal element 130 that is disposed within the socket 118 between the outer surface 128 of the rod 126 and the inner surface 116 of the socket 118. The seal element 130 extends from a proximal end 130a to a distal end 130b. The proximal end 130a may be disposed at a portion of the socket 118 having a first inner diameter ID 118aat or near an end of a portion thereof. In some embodiments, the distal end 130b may taper towards the longitudinal center of the sealing element 130, as Figure 5A shown. In other embodiments, the distal end 130b may be substantially flat or non-tapered, as Figure 5B shown. The sealing element 130 may include a central bore 132 that extends completely through the sealing element 130 such that the sealing element 130 completely surrounds the shaft 126. When in an uncompressed state, the sealing element 130 may be spaced apart from the outer surface 128 of the shaft 126. Specifically, the surface defining the central bore 132 of the sealing element 130 is spaced apart from the outer surface 128 of the shaft 126 by a distance greater than the wall thickness of the catheter 10. Thus, when the sealing element 130 is in an uncompressed state, the catheter may be inserted through the space between the outer surface 128 of the shaft 126 and the sealing element 130. The sealing element 130 may be formed of any suitable material, such as foam, rubber, neoprene, silicone, etc.

[0038] The subcutaneous port assembly 100 includes a locking member 134 having a plunger 136, a cap 138 adjacent to the plunger 136, and a central bore 140 extending through the plunger 136 and the cap 138. The plunger 136 is received within the socket 118 from the distal end 110b. The plunger 136 includes a terminus 136a facing the distal end 130b of the sealing element 130. In some embodiments, the terminus 136a may taper away from the longitudinal center of the plunger 136 to mate with the taper of the distal end 130b of the sealing element 130, as Figure 5A shown. In other embodiments, the terminus 136a of the plunger 136 may be substantially flat to abut the flat end of the distal end 130b of the sealing element 130, as Figure 5B shown. The plunger 136 may be axially movable between a first position ( Figure 3 ) and a second position ( Figure 4 ) to selectively compress the sealing element 130 within the socket 118. The locking member 134 may be formed of any suitable material, such as titanium, stainless steel, cobalt-chromium alloy, nitinol, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, polymeric material, plastic material, or any combination of the foregoing.

[0039] The plunger 136 includes an outer surface 142 that extends into a first inner diameter ID of the socket 118 118aInside. The outer surface 142 includes a second radial protrusion 144 extending from the outer surface 142. The second radial protrusion 144 may have an angled portion that is inclined in a direction extending from the terminal 136a towards the cap 138, and the second radial protrusion 144 may have a substantially flat portion adjacent to the angled 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 with each other to hold at least a portion of the plunger 136 within the socket 118, as Figure 5A and Figure 5B visible in. The angled portions of the first radial protrusion 122 and the second radial protrusion 144 allow the plunger 136 to enter the first inner diameter ID of the socket 118 118a , but after the second radial protrusion 144 passes the first radial protrusion 122, the flat portions of the first radial protrusion 122 and the second radial protrusion 144 restrict the plunger 136 from exiting the first inner diameter ID of the socket 118 118a . Such a configuration ensures that after proper installation, the locking member 134 will not disconnect from the port 102. Although the first radial protrusion 122 and the second radial protrusion 144 are shown and described as having a shape similar to a right triangle, it should be understood that any suitable shape can be envisioned.

[0040] The cap 138 includes an outer surface 146 having a plurality of second threads 148 and a plurality of gripping members 150. The plurality of second threads 148 extend into the second inner diameter ID of the socket 118 118b and are configured to engage with the plurality of first threads 120. The plunger 136 is engaged with the second threads 148 via the first threads 120 to move between a first position ( Figure 3 ) and a second position ( Figure 4 ). The second threads 148 are configured such that a single rotation of the locking member 134 moves the plunger 136 between the first position ( Figure 3 ) and the second position ( Figure 4 ) to selectively compress the sealing element 130 within the socket 118 and secure the conduit. More specifically, when the plunger is in the Figure 3 shown second position (i.e., fully retracted), a single clockwise rotation of the locking member 134 moves the plunger 136 to the Figure 4 shown first position to compress the sealing element 130 to provide a locking force on the conduit 10 in accordance with ISO 10555. Conversely, a full counterclockwise rotation returns the plunger 136 from the fully locked first position to the Figure 3 shown fully unlocked second position to allow the conduit 10 to be easily disconnected from the rod 126.

[0041] The gripping member 150 can be a series of recesses, protrusions, or regions with a high coefficient of friction to facilitate, for example, a healthcare provider in gripping and twisting the cap 138. The cap 138 can include a position indicator 151a configured to communicate the position of the locking member 134 to the user. Specifically, as described above, the first thread 120 and the second thread 148 are configured such that a single rotation of the locking member 134 moves the locking member 134 between a first fully unlocked position ( Figure 3 ) and a second fully locked position ( Figure 4 ). Accordingly, the position indicator 151a communicates the rotational position of the cap 138 to the user such 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 also cooperates with the first radial protrusion 122 and the second radial protrusion 144 to prevent the inadvertent removal of the locking member 134 from the connector 110. For example, when the second radial protrusion 144 of the plunger 136 abuts the first radial protrusion 122 of the socket 118 in the first position, the position indicator 151a provides visual feedback to the user that the locking member 134 is adjacent to or in the first position (i.e., fully retracted), while the first radial protrusion 122 and the second radial protrusion 144 provide physical or tactile feedback to the user. The redundant feedback (i.e., visual and tactile) advantageously minimizes the likelihood of the locking member 134 being removed from the socket 118, which is particularly advantageous when implementing a catheter inserted into a patient.

[0042] In the illustrated example, the position indicator 151a is provided as a colored portion of the outer surface 146 that corresponds to one of the protrusions of the gripping member 150. Optionally, a reference indicator 151b can be formed on the connector 110 to indicate the relative position of the locking member 134 relative to the connector 110. Each of the indicators 151a, 151b can be applied using a pad printing process (i.e., pad printing). However, other coating processes (e.g., anodizing) can be used to form each of the indicators 151a, 151b. Additionally or alternatively, each of the indicators 151a, 151b can include tactile features formed in the outer surface 146, such as knurling or alignment slots.

[0043] The cap 138 includes a parabolic recess 152 that extends toward the central bore 140. When installing the catheter 10, the parabolic recess 152 is configured to direct the catheter 10 toward the central bore 140. For example, the distal end 10a of the catheter 10 can slide along the surface of the parabolic recess 152 toward the central bore 140.

[0044] In operation, the locking member 134 starts in the first position ( Figure 3) And the distal end 10a of the catheter 10 is inserted into the central hole 140 of the locking member 134. The distal end 10a of the catheter 10 continues along the central hole 140 in the socket 118, slides on the outer surface 128 of the rod 126, and passes through the central hole 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 time, the catheter 10 surrounds the rod 126, but the catheter 10 may not be sufficiently fixed to the rod 126. The locking member 134 rotates via interaction with the cap 138, which causes the plunger 136 to move closer to the sealing element 130 as the first thread 120 engages the second thread 148. The plunger 136 further moves into the socket 118 until the 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 towards the second position ( Figure 4 ) moving, causing the end 136a of the plunger 136 to axially and radially compress the distal end 130b of the sealing element 130 towards the outer diameter OD of the outer surface 128 of the rod 126 126 Thereby fixing the catheter 10 to the rod 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., spaced apart from the catheter) to a compressed state (i.e., contacting the catheter) to fix the catheter 10 to the rod 126.

[0045] Reference Figures 6 to 10 , generally shows a second example of a subcutaneous port assembly 200. The subcutaneous port assembly 200 includes a port 202 having a base 204, a cap 206, a septum 208, and a connector 210. The base 204 defining the reservoir 212, the cap 206 defining the access orifice 214, and the septum 208 are substantially similar in structure and function to the base 104, the cap 106, and the septum 108 of the subcutaneous port assembly 100 described above, and therefore, these components will not be described in detail again.

[0046] The connector 210 extends from a first end 210a adjacent to the base 204 to a distal second end 210b spaced apart from the base 204. The connector 210 includes an inner surface 216 defining a socket 218. The socket 218 includes an inner diameter ID 218 . The socket 218 includes at least one radial protrusion 220 extending from the inner surface 216 towards the center of the socket 218. In some embodiments, the at least one radial protrusion 220 may include two radial protrusions 220, or any other suitable number of radial protrusions. The radial protrusion 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 catheter 224 defined by either the base 204 or the connector 210.

[0047] The connector 210 includes a head 222, a neck 234, and a shoulder 236 between the head 222 and the neck 234. The neck 234 includes a first width W at a first end 210a of the connector (e.g., at a portion connected to the base 204). 234 and the shoulder 236 includes a second width W that is greater than the first width W and is closer to the second end 210b of the connector 210 234 of the second width W 236 . The socket 118 extends through the head 222, through the shoulder 236, and at least partially into the neck 234. The shoulder 236 includes a lip or a first snap 244 on the outer surface of the shoulder 236. The first snap 244 can face the second end 210b of the connector 210. For example, the first snap 244 can face the head 222.

[0048] The head 222 may include a tapered outer surface 238 that extends to the second end 210b of the connector 210. The head 222 includes a tapered recess 240 that extends toward the socket 218. When installing the conduit 10, the tapered recess 240 is configured to guide the conduit 10 toward the socket 218. For example, the distal end 10a of the conduit 10 can slide along the surface of the tapered recess 240 toward the socket 218.

[0049] Reference Figures 8 to 10 , the connector 210 includes an outer offset surface 242 that extends from the outer surface of the neck 234 to the outer surface of the shoulder 236. The outer offset surface 242 can be tapered relative to the neck 234 and the shoulder 236. For example, since the first width W of the neck 234 234 is less than the second width W of the shoulder 236 236 , the width of the outer offset surface 242 increases from the neck 234 to the shoulder 236.

[0050] Reference Figure 6 and Figure 7 , the connector 210 includes at least one slot 246 that extends from the socket 218 through the head 222, the shoulder 236, and at least a portion of the neck 234. The at least one slot 246 can include four slots, or any other suitable number of slots. The slots 246 can cooperate to define at least one flexible tab 248 of the connector 210. For example, in an embodiment with four slots 246, there may be four flexible tabs 248 defined by the four slots 246. Each tab 248 can be spaced apart from an adjacent tab 248 by one of the slots 246.

[0051] The port 202 includes a rod 226 that extends from the base 204 and into the socket 218. The rod 226 includes an outer surface 228 having an outer diameter OD 226 that is inwardly spaced from the inner surface 216 of the socket 218 and is less than the inner diameter ID of the socket 218218 。In some embodiments, the outer diameter OD of the stem 226 226 can be between about 0.2 mm and 1.0 mm. In some embodiments, the outer diameter OD of the stem 226 226 can be between about 0.3 mm and 0.7 mm. The stem 226 can be surrounded by the connector 210 and can 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 embodiments, the stem 226 can extend beyond the second end 210b of the connector 210 or terminate before the second end of the connector. For example, the stem 226 can terminate at or near the starting point of the head 222. The stem 226 can be formed of any suitable type of material, such as titanium, stainless steel, cobalt-chromium alloy, nitinol, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, or any combination of the foregoing.

[0052] Referring Figures 8 to 10 , the subcutaneous port assembly 200 includes a sleeve or seal element 230 disposed between the stem 226 and the inner surface 216 of the socket 218 within the socket 218. The seal element 230 extends from a proximal end 230a to a distal end 230b. The proximal end 230a can be disposed at or near the end of a portion of the socket 218 closer to the base 204. The seal element 230 can include a central bore 232 that extends completely through the seal element 230 such that the seal element 230 completely surrounds the stem 226. When in an uncompressed state, the seal element 230 can be spaced apart from the outer surface 228 of the stem 226. Specifically, the surface defining the central bore 232 of the seal 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 seal element 230 is in an uncompressed state, the catheter 10 can be inserted through the space between the outer surface 228 of the stem 226 and the seal element 230. The seal element 230 can be formed of any suitable material, such as foam, rubber, neoprene, silicone, etc.

[0053] The subcutaneous port assembly 200 includes a collar 250 that is slidable relative to the connector 210 between a first unlocked position ( Figure 6 and Figure 9 ) and a second locked position ( Figure 7 and Figure 10 ). The collar 250 includes a first inner surface 252 having a third width W 252 that is greater than a first width W of the neck 234 of the connector 210 234。The first inner surface 252 includes a lip or a second latch 254 extending from the first inner surface 252. The second latch 254 is configured to engage with a first latch 244 extending from the shoulder 236. The latches 244, 254 are oriented to allow the collar 250 to move away from the base 204, but after the second latch 254 passes the first latch 244, the first latch 244 engages with the second latch 254 to restrict the movement of the collar 250 toward the base 204. The collar 250 includes a second inner surface 256 having a fourth width W that increases in the direction of movement away from the base 204 256 。That is, a portion of the second inner surface 256 is beveled to mate with the outwardly biased surface 242 of the connector 210 that is flared. The fourth width W of the second inner surface 256 256 is greater than the first width W of the neck 234 234 and less than the second width W of the shoulder 236 236 。In the unlocked position, the second inner surface 256 of the collar 250 is adjacent to the neck 234. In the locked position, the second inner surface 256 of the collar 250 is adjacent to the shoulder 236. The second latch 254 is disposed between the first inner surface 252 and the second inner surface 256

[0054] The collar 250 includes an outer surface 258 that includes a plurality of gripping members 260. The gripping members 260 can be a series of recesses, protrusions, or regions having a relatively high coefficient of friction to facilitate, for example, a healthcare provider in gripping and sliding the collar 250. Additionally or alternatively, the inner surfaces 252, 256 of the collar 250 can include a plurality of first threads, and the outer surface of the connector 210 can include a plurality of corresponding second threads configured to engage the first threads such that the collar 250 can be rotated around the connector 210 to move from the unlocked position to the locked position. The collar 250 can be formed of any suitable material, such as titanium, stainless steel, cobalt-chromium alloy, nitinol, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, polymeric material, plastic material, or any combination of the foregoing

[0055] In operation, the collar 250 begins in the unlocked position ( Figure 6 ). As described above, in the unlocked position, the collar 250 is arranged such that the second inner surface 256 is aligned with the neck 234 of the connector 210. Thus, the shoulder 236, and more specifically, the tab 248 of the shoulder 236, is not compressed by the collar 250. As Figure 9 shown, in the uncompressed state, the radial protrusion 220 formed on the inner surface 216 of the socket 218 is radially spaced apart from the sealing element 230 such that the inner bore of the sealing element 230 is spaced apart from the rod 226

[0056] With the ferrule 250 in the unlocked state, the distal end 10a of the catheter 10 is inserted into the socket 218. The distal end 10a of the catheter 10 continues along the socket 218, slides on the outer surface 228 of the rod 226, and passes 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 time, the catheter 10 surrounds and is coupled to the rod 226, but the catheter 10 may not be fully secured to the rod 226. The ferrule 250 slides from the unlocked position toward the locked position, for example, until the second latch 254 passes the first latch 244. At this time, the engagement of the latches 244, 254 restricts the ferrule 250 from sliding back toward the base 204. As the ferrule 250 slides toward the locked position, the connector 210 deflects radially toward the sealing element 230 via the slot 246 by sliding along the outer biasing surface 242 of the connector 210 through the second inner surface 256 of the ferrule 250. The radial deflection of the connector 210 toward the sealing element 230 causes the radial protrusion 220 to radially compress the sealing element 230, which compresses the catheter 10 and secures the catheter 10 to the rod 226.

[0057] It should be understood that other embodiments and / or implementations are contemplated in addition to the above description. Moreover, any embodiment or implementation (including any features of each embodiment) can be appropriately combined or interchanged.

[0058] In some embodiments, the catheter can be secured to the rod at least in part via a sleeve or insert that wraps around the catheter and is tightened in any suitable manner (including via threads, ridges, ribs, protrusions, radial compression, etc.).

[0059] In some embodiments, the port assembly includes a connector extending from a base to a distal end. The connector includes a lumen extending from the distal end of the connector, wherein the inner diameter of the lumen tapers gradually in a direction away from the distal end. Similar to the above example, the rod extends from the base toward the distal end of the connector and passes through the lumen. The port assembly further includes a locking member having a tube configured to be axially inserted into the lumen of the connector. The shaft can be configured as a hollow shaft or tube having a channel axially formed therethrough. A plurality of slots or notches are formed through the distal end of the shaft to provide a distal shaft having a plurality of flexible tabs. When the distal end of the shaft is inserted into the lumen of the connector, the fingers engage the tapered inner diameter of the lumen and are radially biased inwardly toward the rod. In use, the catheter passes through the rod before the locking member engages the tapered portion of the lumen. Then the locking member is moved toward the locked position such that the distal end of the shaft engages the tapered portion of the lumen. Here, the fingers are radially biased inwardly to press the catheter against the rod. In some cases, the lumen can include slots or detents formed therein, and the locking member can include corresponding ribs or protrusions. When the locking member is fully engaged with the lumen, the ribs on the screw cap can form a snap connection with the connector to secure the catheter to the connector and indicate that the locking member is properly in place.

[0060] In some embodiments, the port assembly includes a catheter lock having a plurality of rigid angled tabs that radially extend around a flexible segment that may have a cylindrical shape. The catheter lock can be wrapped around the outer surface of the catheter, such as by passing a screw and a pin of the catheter lock through the catheter to secure the catheter lock to the catheter. Similar to the above example, the port base can define a cavity and a stem can extend from the base through the cavity. The port base can include a plurality of slots extending from the cavity and configured to receive the plurality of tabs. The catheter lock can be inserted into the cavity, where the angle of the tabs 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 further enter the cavity until the slots receive the tabs and prevent movement of the catheter lock away from the port base via the engagement of the tabs and the slots. In such an embodiment, the catheter lock can be similar to a Bayonet Neill-Concelman (BNC) connector, where the port base serves as the BNC male and the catheter lock serves as the BNC female.

[0061] In some embodiments, the port assembly includes a port base that can extend from a proximal end to a distal end. The distal end can be radially curved, e.g., via at least one slot extending through the port base, and the port base is formed of a flexible material, etc. The port base can define a cavity through which a stem extends. The catheter lock can be wrapped around the catheter and temporarily secured to the catheter, e.g., via friction. The catheter lock can have a cylindrical shape and a longitudinal partition extending along the catheter lock such that the catheter lock can be opened along the longitudinal partition to remove the catheter lock from its attachment to the catheter. The catheter lock including the catheter can extend into the cavity of the port base, causing the distal end to bend radially outward to allow the catheter to be wrapped around the outer surface of the stem. The catheter lock can be removed from the cavity, causing the distal end to bend radially inward to compress the catheter against the stem. The catheter lock can then be opened via the longitudinal partition and disconnected from the catheter.

[0062] In some embodiments, the port assembly can define a cavity and a stem extending through the cavity. The port assembly can include a chuck wrapped around the catheter, and the catheter can include a cap having a snap feature. The catheter can pass through the stem, through the chuck, and the cap having the snap feature can secure the catheter to the chuck. That is, the cap can be wrapped around the chuck, the chuck can be wrapped around the catheter, and the catheter can be wrapped around the stem, thereby forming an interference fit between these components to secure the catheter to the stem. The chuck can have barbs or flaring to engage portions of the cap, such as slots, recesses, etc.

[0063] In some embodiments, a catheter can be connected to a locking cap that has a generally cylindrical shape and extends from a proximal end to a distal end, the distal end including a silicone gasket attached to the distal end. The locking cap can include a keyway having a first portion that extends along a longitudinal direction of the cylindrical locking cap, a second portion that extends around an outer perimeter of the locking cap perpendicular to the first direction, and a third portion that extends parallel to the first portion. For example, the keyway can be shaped like a "J". The catheter can be threadedly secured to a rod that extends through a cavity of a port base. The port base can include a pin that extends from an outer surface of the rod. The locking cap can slide onto the rod and the locking cap can be rotated to receive the pin within the keyway, i.e., the third portion of the keyway, thereby securing the locking cap to the port base. In the locked position, the silicone gasket can abut the port base and be compressed to hold the catheter in the locked position.

[0064] The terminology used herein is for the purpose of describing particular exemplary configurations only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprising", "including" and "having" are inclusive and thus specify the presence of stated 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 combinations thereof. The method steps, processes and operations described herein should not be construed as necessarily requiring them to be performed in the particular order discussed or illustrated, unless specifically identified as an order of performance. Additional or alternative steps may be employed.

[0065] When an element or layer is referred to as being "on", "engaged to", "connected to", "attached to" or "coupled to" another element or layer, it can be directly on, engaged to, connected to, attached to or coupled to the other element or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being "directly on", "directly engaged to", "directly connected to", "directly attached to" or "directly coupled to" another element or layer, intervening elements or layers may not be present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., "between" versus "directly between", "adjacent" versus "directly adjacent", etc.). As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0066] The terms first, second, third, etc. may be used herein 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 be used only to distinguish one element, component, region, layer, or section from another. Unless the context clearly indicates otherwise, terms such as "first", "second", and other numerical terms do not imply an order or sequence. Thus, a first element, component, region, layer, or section discussed herein may be termed a second element, component, region, layer, or section without departing from the teachings of the exemplary configuration.

[0067] The foregoing description has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. The individual elements or features of a particular configuration are generally not limited to that particular configuration but, where appropriate, are interchangeable and can be used in a selected configuration even if not specifically shown or described. There can also be many variations in many respects. Such variations should not be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.

Claims

1. A subcutaneous port assembly, comprising: A base; 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 and into the socket, the stem including an outer surface having an outer diameter less than the inner diameter of the socket; A sealing element disposed within the socket between the stem and the inner surface of the socket; And A locking member having a plunger received within the socket from the distal end and having a terminal 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, Wherein the socket includes a first radial protrusion on the inner surface, and the plunger includes a second radial protrusion on an outer surface of the plunger, the first radial protrusion and the second radial protrusion being configured to selectively engage each other to retain at least a portion of the plunger within the socket.

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

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

4. The subcutaneous port assembly according to 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.

5. The subcutaneous port assembly according to claim 1, wherein the locking member further includes a cap attached to the plunger, the cap including a plurality of first threads and the connector including a plurality of second threads engaging the first threads.

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

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

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

9. The subcutaneous port assembly according to any one of claims 5-7, wherein the plunger moves between the first position and the second position by engagement of the first threads with the second threads.

10. The subcutaneous port assembly according to any one of claims 1-7, wherein the sealing element includes a tapered end facing the terminal of the plunger, and the terminal of the plunger is 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. A subcutaneous port assembly, comprising: A base; A connector extending from a first end adjacent to the base to a second end, the connector including a neck having a first width at the first end and a shoulder having a second width closer to the second end, and a socket defined by an inner surface extending through the connector from the second end; A rod that extends from the base into the socket, the rod including an outer surface that is inwardly spaced from the inner surface of the socket; A collar that includes an inwardly offset surface having a third width that is greater than the first width of the neck and less than the second width of the shoulder, the collar being operable between a first position where the inwardly offset surface is adjacent the neck and a second position where the inwardly offset surface is adjacent the shoulder; And A seal element that is disposed within the socket between the rod and the inner surface of the socket, the seal element surrounding the rod when the collar is in the first position and pressing against the rod when the collar is in the second position.

12. The subcutaneous port assembly according to claim 11, wherein the rod is surrounded by the connector.

13. The subcutaneous port assembly according to claim 11, wherein the collar in the second position is configured to radially compress the seal element to secure a catheter between the seal element and the rod.

14. The subcutaneous port assembly according to claim 11, wherein the connector includes at least one slot that extends through the shoulder from the socket.

15. The subcutaneous port assembly according to claim 14, wherein when the collar moves from the first position to the second position, the connector deflects radially toward the seal element via the at least one slot.

16. The subcutaneous port assembly according to any one of claims 14 or 15, wherein the inwardly offset surface is tapered and the connector includes a tapered outwardly offset surface, and wherein when the collar moves from the first position to the second position, the engagement of the inwardly offset surface with the tapered outwardly offset surface causes the connector to deflect radially toward the seal element and the seal element to radially compress the catheter and secure the catheter to the rod.

17. The subcutaneous port assembly according to claim 16, wherein the tapered outwardly offset surface of the connector is disposed between the neck and the shoulder.

18. The subcutaneous port assembly according to any one of claims 14 or 15, wherein the at least one slot includes a plurality of slots that define 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. A locking mechanism for a subcutaneous port assembly, the locking mechanism comprising: A connector having a socket and a plurality of threads at a first end of the socket; A rod disposed within the socket; A seal element disposed within the socket between the rod and the connector; A braided catheter having an end coupled to the rod and surrounded by the seal element; And A locking member slidably coupled to the connector and capable of moving along the connector between a first position and a second position to selectively change the seal element between a compressed state and an uncompressed state around the catheter, wherein the locking member includes a plunger received within the socket; and Wherein the connector includes a first radial protrusion on an inner surface, and the locking member includes a second radial protrusion on an outer surface, and the first radial protrusion and the second radial protrusion are configured to engage with each other to fix at least a portion of the plunger to the connector.

20. The locking mechanism according to claim 19, wherein the locking member includes a cap threadedly coupled to the connector, and the cap is movable relative to the connector between a locked position and an unlocked position via engagement of the threads.

21. The locking mechanism according to claim 20, wherein the cap includes a position indicator.

22. The locking mechanism according to claim 21, wherein the position indicator is configured to convey the rotational position of the cap.

23. The locking mechanism according to claim 21, wherein the cap includes a gripping member, and the position indicator is provided on the gripping member.

24. The locking mechanism according to any one of claims 21-23, wherein the sealing element includes a sleeve having a tapered first end, and the plunger includes a tapered second end configured to engage the tapered first end of the sleeve, and wherein when the locking member moves from the first position to the second position, the tapered first end and the tapered second end engage, causing the sleeve to axially and radially compress the braided catheter and fix the braided catheter to the rod.

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