The present disclosure relates generally to subcutaneous ports.
This section provides background information related to the present disclosure which is not necessarily prior art.
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 equipment interference(s), etc. Additionally, ensuring that the catheter remains connected to the subcutaneous port is important to ensure proper delivery of medication to the patient. Accordingly, there may be room for improvement in the manner in which catheters are connected to subcutaneous ports.
This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.
One aspect of the disclosure provides a subcutaneous port assembly comprising 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 inside diameter. The stem extends from the base and into the socket. The stem includes an outer surface having an outside diameter that is less than the inside 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 received within the socket from the distal end and having a terminal 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.
Implementations of the disclosure may include one or more of the following optional features. In some implementations, the stem is surrounded by the sealing element. Optionally, the sealing element may be spaced apart from the outside diameter of the outer surface 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 towards the outside diameter of the outer surface of the stem.
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 a rotational position of the cap. In some example, the cap includes a gripping member and the position indicator is provided on the gripping member. The cap may include a plurality of first threads and the connector may include a plurality of second threads engaged with the first threads. The plunger may move between the first position and the second position via the first threads engaging with the second threads.
The socket may include a first radial protrusion on the 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 one another to retain at least a portion of the plunger within the socket.
The sealing element may include a tapered end facing the 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.
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 to the base to a second end. The connector includes a neck portion having a first width at the first end and a shoulder portion 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 stem extends from the base into the socket, the stem including an outer surface spaced inwardly from the inner surface of the socket. The collar includes an inner biasing surface having a third width that is 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 where the inner biasing surface is adjacent to the neck portion and a second position where the inner biasing surface is adjacent to 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 compressed against the stem when the collar is in the second position. This aspect may include one or more of the following optional features.
In some implementations, the stem 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 stem.
The connector may include at least one slot extending from the socket through the shoulder portion. When the collar moves from the first position to the second position, the connector may radially deflect toward the sealing 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, engagement of the inner biasing surface and the tapered outer surface may cause the connector to radially deflect toward the sealing element and the sealing element to radially compress and secure a catheter 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 from an adjacent flexible tab of the connector by one of the slots.
Another aspect of the disclosure provides a locking mechanism for a subcutaneous port assembly, the locking mechanism comprising 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 between the stem and the connector within the socket. The braided catheter has an end coupled to the stem and surrounded by the sealing element. The locking member is slidably coupled to the connector and moveable between a first position and a second position along the connector to selectively change the sealing element between a compressed state and an uncompressed state around the catheter. This aspect may include one or more of the following optional features.
In some implementations, the locking member includes a plunger received within the socket and a cap coupled to the connector by threads. In some examples, the cap includes a position indicator. The position indicator may be configured to communicate a rotational position of the cap. In some example, the cap includes a gripping member and the position indicator is provided on the gripping member. The cap may be movable between a locked position and an unlocked position relative to the connector via 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 one another to secure at least a portion of the plunger to the connector. The sealing 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. The tapered first end and the tapered second end may engage when the locking member moves from the first position to the second position, causing the sleeve to axially and radially compress and secure the braided catheter to the stem.
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.
The drawings described herein are for illustrative purposes only of selected configurations and are not intended to limit the scope of the present disclosure.
Corresponding reference numerals indicate corresponding parts throughout the drawings.
Example configurations will now be described more fully with reference to the accompanying drawings. Example configurations are provided so that this disclosure will be thorough, and will fully convey the scope of the disclosure to those of ordinary skill in the art. Specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of configurations of the present disclosure. It will be apparent to those of ordinary skill in the art that specific details need not be employed, that example configurations may be embodied in many different forms, and that the specific details and the example configurations should not be construed to limit the scope of the disclosure.
Referring to
A healthcare provider, such as a physician, nurse, etc., may inject, via a syringe and needle, medication through the skin of the patient and through the septum to deliver the medication to the reservoir 112. The medication may then be delivered through the catheter 10 to the desired location for medication application. The base 104, the cap 106, and the connector 110 may be formed of any suitable material, such as titanium, stainless steel, cobalt-chrome alloy, nickel-titanium allow, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, or any combination of the foregoing.
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 defining a socket 118. As indicated in
Referring to
The port 102 includes a stem 126 extending from the base 104 and into the socket 118. The stem 126 includes an outer surface 128 having an outside diameter OD126 that is less than the first inside diameter ID118a and the second inside diameter ID118b of the socket 118. In some implementations, the outside diameter OD126 of the stem 126 may be between approximately 0.2 mm and 1.0 mm. In some implementations, the outside diameter OD126 of the stem 126 may be between approximately 0.3 mm and 0.7 mm. The stem 126 may extend along substantially an 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 past or terminate before the distal end 110b of the connector 110. The stem 126 may be formed of any suitable type of material, such as titanium, stainless steel, cobalt-chrome alloy, nickel-titanium allow, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, or any combination of the foregoing.
With continued reference to
The subcutaneous port assembly 100 includes a locking member 134 having a plunger 136, a cap 138 adjacent 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 terminal end 136a facing the distal end 130b of the sealing element 130. In some implementations, the terminal end 136a may taper away from a longitudinal center of the plunger 136 to mate with the taper of the distal end 130b of the sealing element 130, as shown in
The plunger 136 includes an outer surface 142 that extends into the first inside diameter ID118a of the socket 118. 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 ramps up in a direction extending from the terminal end 136a toward the cap 138, and the second radial protrusion 144 may have a generally flat portion adjacent 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 one another to retain at least a portion of the plunger 136 within the socket 118, as can be seen in
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 inside diameter ID118b of the socket 118 and are configured to engage with the plurality of first threads 120. The plunger 136 moves between the first position (
The gripping members 150 may be a series of recesses, protrusions, or areas having a higher coefficient of friction to facilitate grasping and twisting of the cap 138 by, for example, a healthcare provider. The cap 138 may include a position indicator 151a configured to communicate a position of the locking member 134 to the user. Specifically, as discussed 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 the fully-unlocked first position (
In the illustrated example, the position indicator 151a is provided as a colored portion of the outer surface 146 corresponding to one of the protrusions of the gripping members 150. Optionally, a reference indicator 151b may be formed on the connector 110 to indicate a relative position of the locking member 134 relative 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., anodizing) may be used to form each of the indicators 151a, 151b. Additionally or alternatively, each of the indicators 151a, 151b may include tactile features formed in the outer surface 146, such as knurling or alignment slots.
The cap 138 includes a parabolic recess 152 extending toward the central bore 140. Upon installation of 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 may slide along the surface of the parabolic recess 152 toward the central bore 140.
In operation, the locking member 134 starts in the first position (
Referring to
The connector 210 extends from a first end 210a adjacent to the base 204 to a distal second end 210b spaced from the base 204. The connector 210 includes an inner surface 216 defining a socket 218. The socket 218 includes an inside diameter ID218. The socket 218 includes 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 include 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 connector 210.
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 includes a first width W234 at the first end 210a of the connector, e.g., at the portion connecting to the base 204, and the shoulder portion 236 includes a second width W236 greater than the first width W234 closer to the second end 210b of the connector 210. The socket 118 extends through the head portion 222, through the shoulder portion 236, and at least partially into the neck portion 234. The shoulder portion 236 includes a lip or first catch 244 on an outer surface of the shoulder portion 236. The first catch 244 may face toward the second end 210b of the connector 210, e.g., the first catch 244 may face toward the head portion 222.
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 extending toward the socket 218. Upon installation of the catheter 10, the tapered recess 240 is configured to direct 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.
Referring to
Referring to
The port 202 includes a stem 226 extending from the base 204 and into the socket 218. The stem 226 includes an outer surface 228 having an outside diameter OD226 that is spaced inwardly from the inner surface 216 of the socket 218 and that is less than the inside diameter ID218 of the socket 218. In some implementations, the outside diameter OD226 of the stem 226 may be between approximately 0.2 mm and 1.0 mm. In some implementations, the outside diameter OD226 of the stem 226 may be between approximately 0.3 mm and 0.7 mm. The stem 226 may be surrounded by the connector 210 and may extend along substantially an 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 past or terminate before the second end 210b of the connector 210, e.g., the stem 226 may terminate at or near the start of the head portion 222. The stem 226 may be formed of any suitable type of material, such as titanium, stainless steel, cobalt-chrome alloy, nickel-titanium allow, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, or any combination of the foregoing.
Referring to
The subcutaneous port assembly 200 includes a collar 250 that is slidable relative to the connector 210 between a first, unlocked position (
The collar 250 includes an outer surface 258 including a plurality of gripping members 260. The gripping members 260 may be a series of recesses, protrusions, or areas having a higher coefficient of friction to facilitate grasping and sliding of the collar 250 by, for example, a healthcare provider. Additionally or alternatively, the inner surfaces 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 the unlocked position to the locked position. The collar 250 may be formed of any suitable material, such as titanium, stainless steel, cobalt-chrome alloy, nickel-titanium allow, gold, platinum, silver, iridium, tantalum, tungsten, polycarbonate, a polymeric material, a plastic material, or any combination of the foregoing.
In operation, the collar 250 starts in the unlocked position (
With the collar 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, sliding 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 adequately secured to the stem 226. The collar 250 is slid from the unlocked position toward the locked position, e.g., 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 back toward the base 204. As the collar 250 slides toward the locked position, the connector 210 radially deflects toward the sealing element 230 via 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 radially deflecting toward the sealing element 230 causes the radial protrusions 220 to radially compress the sealing element 230, which compresses the catheter 10 and secures the catheter 10 to the stem 226.
It should be understood that in addition to the foregoing description, other implementations and/or embodiments are also contemplated. Additionally, any of the implementations or embodiments, including any features of each implementation, may be combined or interchanged as suitable.
In some implementations, the catheter may be at least partially secured to a stem 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.
In some implementations, a port assembly includes a connector extending from a base to a distal end. The connector includes an inner cavity extending from the distal end of the connector, where an inside diameter of the cavity tapers along a direction away from the distal end. Similar to the examples above, a stem extends from the base and through the cavity, towards 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 passage formed axially therethrough. A plurality of slots or notches are formed through a distal end of the shaft to provide the distal end shaft with a plurality of flexible tabs. When the distal end of the shaft is inserted into the cavity of the connector, the fingers engage the tapered inside diameter of the cavity and are biased radially inwardly towards the stem. In use, the catheter is threaded over the stem prior to the locking member being engaged with the tapered portion of the cavity. The locking member is then moved towards the locking position so that the distal end of the shaft engages the tapered portion of the cavity. Here, the fingers are biased radially inwards to compress the catheter against the stem. In some instances, the cavity may include slots or detents formed therein, and the locking member may include corresponding ribs or protrusions. When the locking member is fully engaged with the cavity, the ribs on the screw cap may create a snap-fit connection to the connector to secure the catheter to the connector and to indicate that the locking member is properly seated.
In some implementations, a 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, securing the catheter lock to the catheter, e.g., by being threaded through a screw and a over a pin of the catheter lock. Similar to the examples above, the port base may define a cavity and a 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 with the angle of the tabs causing the tabs to compress the flexible segment such that the tabs flex toward a center of the flexible segment. The catheter lock continues further into the cavity until the slots receive the tabs and resist movement of the catheter lock away from the port base via engagement of the tabs and the slots. In such implementations, the catheter lock may be similar to a Bayonet Neill-Concelman (BNC) connector with the port base acting as the BNC male and the catheter lock acting as the BNC female.
In some implementations, a port assembly includes a port base that may extend from a proximal end to a distal end. The distal end may radially flex, e.g., via at least one slot extending through the port base, the port base being formed of a flexible material, etc. The port base may define a cavity with a stem extending through the cavity. A catheter lock may be wrapped around the catheter and temporarily secured to the catheter, e.g., via friction. The catheter lock may have a cylindrical shape and a longitudinal divide extending along the catheter lock, such that the catheter lock may be opened along the longitudinal divide to remove the catheter lock from attachment to the catheter. The catheter lock, including the catheter, may extend into the cavity of the port base, causing the distal end to flex radially outwardly to allow the catheter to wrap around an outer surface of the stem. The catheter lock may be removed from the cavity, causing the distal end to flex radially inwardly to compress the catheter to the stem. The catheter lock may then be opened via the longitudinal divide and disconnected from the catheter.
In some implementations, a port assembly may define a cavity and a stem extending through the cavity. The port assembly may include a collet wrapped around the catheter, and the catheter may include a cover with a snap feature. The catheter may be threaded over the stem, through the collet, and the cover with the snap feature may secure the catheter to the collet. That is, the cover may wrap around the collet, which may wrap around the catheter, which may wrap around the stem, creating an interference fit between these components to secure the catheter to the stem. The collet may have barbs or flares to engage with portions of the cover, such as a slots, recesses, etc.
In some implementations, the catheter may be connected to a locking cap having a generally cylindrical shape and extending from a proximal end to a distal end including a silicone gasket attached to the distal end. The locking cap may include a keyed slot having a first portion that extends along a longitudinal direction of the cylindrical locking cap, a second portion extending perpendicular to the first direction around an outer periphery 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 over a stem extending through a cavity of the port base. The port base may include a pin extending from an outer surface of the stem. The locking cap may slide over the stem and the locking cap may be rotated to receive the pin within the keyed slot, i.e., the third portion of the keyed slot, thus securing the locking cap to the port base. In the locked position, the silicone gasket may abut the port base and be compressed to maintain the catheter in the locked position.
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 articles “a,” “an,” and “the” may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having,” are inclusive and therefore 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 method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. Additional or alternative steps may be employed.
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 may be directly on, engaged, connected, attached, 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, there may be no intervening elements or layers 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.
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 only 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 herein could be termed a second element, component, region, layer or section without departing from the teachings of the example configurations
The foregoing description has been provided 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, where applicable, are interchangeable and can be used in a selected configuration, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.
This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application 63/004,142 filed on Apr. 2, 2020. The disclosures of this prior application is considered part of the disclosure of this application and is hereby incorporated by reference in its entireties.
Filing Document | Filing Date | Country | Kind |
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PCT/JP2021/014310 | 4/2/2021 | WO |
Number | Date | Country | |
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63004142 | Apr 2020 | US |