Cap system for medical connectors, base element used with the cap, and method for holding the cap on the base element.

Abstract

A cap for a medical connector comprising: a body having a closed proximal end and an open distal end; an interior volume within the body; an elongate member extending axially from a proximal end of the body through at least a portion of the interior volume; threads for securing the cap to the medical connector; and a radially inwardly facing sealing surface on the cap located distal to the threads to provide a fluid-tight seal between the cap and the medical connector when the cap is installed on the medical connector.

Description

Technical Field

[0001] The embodiments disclosed in this specification This invention relates to a cap system for medical connectors, a base element used with the cap, and a method for holding the cap on the base element. are included.

Background Art

[0002] Infusion devices such as catheters and on-catheter devices are commonly used in providing modern medical care to patients. For example, catheters such as hemodialysis catheters, peritoneal dialysis catheters, peripherally inserted central catheters, midline catheters, and drainage catheters are all commonly used in providing modern medical care to patients. Other infusion devices used in providing medical care include needleless connectors, intravenous (IV) administration sets, peritoneal dialysis lines, transfer sets, syringes, valves, and filters.

[0003] These infusion devices are useful for treating various medical conditions. For example, peritoneal catheters can remove waste and fluids from the bodies of patients with kidney diseases. Therefore, catheters and other infusion devices are often essential for enabling critical medical care and improving healthcare outcomes.

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, long-term use of catheters has a significant drawback in that a significant percentage of catheters become non-functional due to infection, resulting in an increased mortality rate and a significant increase in the medical costs associated with treatment. Furthermore, infections are a major cause of death in the United States, and many of those infections are caused by infusion devices. The mortality rates associated with such infections are substantial. Therefore, there is a need for solutions to reduce infections associated with the use of infusion devices. [Means for solving the problem]

[0005] Each of the systems, methods, and apparatuses in this disclosure has several innovative aspects, embodiments, or forms, and not just one of them carries the desirable attributes disclosed herein. Nothing is essential or indispensable in this specification. Any structure, material, component, method, or step described and / or shown in any embodiment of this specification may be provided independently and / or in combination with any other structure, material, component, method, or step described and / or shown in any other embodiment of this specification or known in the art. All relative sizes and dimensions of parts and components shown in the drawings are intended to form part of this disclosure, but should not be used to limit the scope of such claims unless enumerated in the claims. Any word in this specification that is generally associated with circular or circular structures, such as radius, radial, diameter, or circumference, should be understood to also apply to non-circular structures in similar ways, such as indicating cross-sectional width or cross-sectional perimeter.

[0006] Infection-causing organisms are constantly present in the environment. These organisms reside on the skin of patients and can survive and spread in the air and water. Conventional medical device connectors and caps, such as male and female connectors with tapered luers, have a threaded region along with a tapered sealing region, such as the overlapping sealing region of the tapered portion of the male connector and the tapered portion of the female connector. The overlapping sealing region seals the fluid within the medical device and keeps out air and organisms. However, our tests have shown that organisms can still move through the threaded region and enter a portion of the path leading into the sealing region. This allows organisms to be present along a portion of the wall of the device. When the male and female connectors are separated from each other, a small amount of organism may remain on the walls of the male and female connectors. When the connection is made again, some of the organisms may be pushed through the sealing surface into the fluid pathway. Once organisms enter the fluid pathway, they can multiply and spread, potentially causing infection. A peritoneal dialysis transfer set can be used to create a fluid connection between the peritoneal dialysis catheter and the patient line for injecting and removing dialysate from the peritoneal cavity.

[0007] An embodiment of a cap for a medical connector is disclosed herein, which may include a body having a closed base end and an open tip; an internal volume within the body; an elongated member containing an antimicrobial agent extending axially from the base end of the body through at least a portion of the internal volume; a thread for securing the cap to a medical connector; and a radially inward sealing surface on the cap, positioned distal to the thread, which provides a seal, such as a liquid-tight and / or airtight seal, between the cap and the medical connector when the cap is mounted on the medical connector.

[0008] Any embodiment of the caps, methods, and systems disclosed herein may, in further embodiments, include one or more of the following steps, features, components, and / or details in any combination with any other steps, features, components, and / or details of any other embodiment disclosed herein. The medical connector is part of a peritoneal dialysis transport set. A radially inward sealing surface on the cap provides a seal (e.g., airtight and / or liquidtight) between the cap and the medical connector when the cap is mounted on the medical connector by being tightened around the outer surface of the medical connector. The cap further comprises an end-facing sealing surface, which is located distal to the threads, and when the cap is mounted on the medical connector, the end-facing sealing surface provides a second liquidtight seal between the cap and the medical connector. The end-facing sealing surface is located at the tip of the cap and has a substantially flat surface that is substantially perpendicular to the longitudinal axis centerline of the cap. All sealing surfaces are located at the tip of the body of the cap. The cap is configured to overlap a portion of the outer surface of the medical connector and to form a seal with respect to the overlapping portion of the outer surface of the medical connector. The internal volume of the main body is provided with a porous element, which is dry and free of antimicrobial substances before mounting onto the medical connector. The porous element is configured to hold fluid flowing out of the medical connector when the cap is mounted onto the transfer set. The porous element surrounds at least about 75%, or less than about 75%, or about 75% to about 125%, or about 125%, or less than about 125%, or at least about 125% of the volume of liquid moved by the elongated member when the elongated member is advanced into the medical connector. The porous element is configured to be dimensioned to contact the end of the medical connector when the cap is engaged with the medical connector. The elongated member does not form a fluid seal within the lumen of the medical connector. And / or, the antimicrobial agent includes chlorhexidine acetate. Embodiments of a kit that may include a cap for a medical connector of any embodiment disclosed herein and a base element are also disclosed herein, the cap being coupled with the base element.

[0009] Embodiments of a cap for a medical connector are disclosed herein, which may include a body having a closed base end and an open tip; an internal volume within the body; an elongated member extending axially from the base end of the body through at least a portion of the internal volume, the elongated member having a dry antimicrobial agent on its surface; threads for securing the cap to a medical connector; a porous element in the internal volume within the body, which, before use, is unsaturated with or substantially free of antimicrobial agent; and a radially inward sealing surface on the cap. In some embodiments, the inward sealing surface may be positioned distal to the threads to provide a liquid-tight seal between the cap and the medical connector when the cap is mounted on the medical connector. In some embodiments, the porous element is free of at least about 95% of the antimicrobial agent before use. This may mean that the porous element may have about 5% or less of the total amount of antimicrobial agent that the porous element is allowed to retain within it. In some embodiments, the porous element is free of at least about 90% of the antimicrobial agent before use. This means that the porous element may contain no more than 10% of the total amount of antimicrobial agent that the porous element can support.

[0010] Embodiments of a method for delivering an antimicrobial agent to a medical connector are also disclosed herein, which may include advancing the cap to engage with a medical connector having a lumen with an inner wall, an outer wall with an outer surface, and a proximal end surface; advancing the elongated member of the cap into the lumen to wet a dry antimicrobial agent coated on the outer surface of the elongated member and dissolve the antimicrobial agent in the liquid inside the medical connector; and sealing the cap with a sealing surface located at the tip of the cap against the outward-facing surface of the medical connector.

[0011] Embodiments of a cap or set of caps (collectively referred to herein as "caps") for a medical connector for peritoneal dialysis are disclosed herein, which may include a partially enclosed internal space (also referred to herein as the internal space), an elongated member at least partially positioned within the partially enclosed internal space, an antimicrobial agent on or within the elongated member, threads on the cap for securing the cap to a medical connector, and a sealing surface on the cap. In some embodiments, the sealing surface may be positioned distal to the threads to provide a liquid-tight seal between the cap and the medical connector when the cap is mounted on the medical connector.

[0012] Disclosed herein are embodiments of a cap for a medical connector for peritoneal dialysis, which may include a partially enclosed internal space, an elongated member at least partially positioned within the partially enclosed internal space, an antimicrobial agent on or within the elongated member, threads on the cap for securing the cap to a medical connector, and a sealing surface on the cap. In some embodiments, the sealing surface may be positioned distal to the threads and may provide a first sealing capacity when mounted on the medical connector. The first sealing capacity may be more than 50 percent of the total sealing capacity between the cap and the medical connector when the cap is mounted on the medical connector.

[0013] Embodiments of a cap for a medical connector for peritoneal dialysis are disclosed herein, which may include a partially enclosed internal space, an elongated member at least partially positioned within the partially enclosed internal space, an antimicrobial agent on or within the elongated member, threads on the cap for securing the cap to a medical connector, and a sealing surface on the cap. In some embodiments, the sealing surface may have an inner diameter larger than the inner diameter of the threads on the cap.

[0014] This specification discloses an embodiment of a cap for a medical connector for peritoneal dialysis, which may include an elongated member, an antimicrobial agent on or within the elongated member, a screw thread on the cap for fixing the cap to a medical connector, the screw thread on the cap having an inner diameter, and a sealing surface on the cap having an inner diameter larger than the inner diameter of the screw thread on the cap.

[0015] Disclosed herein are embodiments of a cap for a medical connector for peritoneal dialysis, which may include a partially enclosed internal space, an elongated member at least partially positioned within the partially enclosed internal space, an antimicrobial agent on or within the elongated member, threads on the cap for securing the cap to a medical connector, and a sealing surface on the cap. In some embodiments, the sealing surface may be positioned distal to the threads and may be configured to provide a seal between the cap and the medical connector. In some embodiments, the cap may be configured not to form an additional seal with the medical connector when mounted on it.

[0016] This specification discloses an embodiment of a cap for delivering an antimicrobial agent to a medical connector, which may include an elongated member, an antimicrobial agent on or within the elongated member, a screw thread having an inner diameter, and a sealing surface. The screw thread may be configured to secure the cap to the medical connector, and the sealing surface may have an inner diameter larger than the inner diameter of the screw thread.

[0017] Disclosed herein is an embodiment of a cap for delivering an antimicrobial agent to a medical connector, which may include an elongated member, an antimicrobial agent on or within the elongated member, a screw thread configured to secure the cap to a medical connector, and a sealing surface, wherein the elongated member is positioned at least partially at the base end of the sealing surface.

[0018] Disclosed herein is an embodiment of a cap for a medical connector, which may include a partially enclosed internal space, an elongated member at least partially within the partially enclosed internal space, an antimicrobial agent on or within the elongated member, and a compressible porous element (also referred to herein as a porous material) positioned near the proximal end of the elongated member, which is substantially free of the antimicrobial agent before use.

[0019] An embodiment of a cap for a medical connector is disclosed herein, which may include a base end and a tip end having an opening on the tip end leading to the inside of the cap, a tread disposed in a partially enclosed internal space of the cap, an elongated member at least partially within the partially enclosed internal space of the cap, a dry antimicrobial agent on the elongated member, and a sealing surface disposed over the entire tip of the threads on the cap.

[0020] An embodiment of a cap for a medical connector is disclosed herein, which may include an elongated member configured to be inserted into the lumen of the medical connector, an antimicrobial agent on or within the elongated member, and a sealing surface positioned at least a portion of the tip of the elongated member to form a fluid-tight seal.

[0021] An embodiment of a cap for a medical connector is disclosed herein, which may include an elongated member configured to be inserted into the lumen of the medical connector, an antimicrobial agent on or within the elongated member, and a sealing surface configured to form a fluid-tight seal on the outer surface of the medical connector.

[0022] An embodiment of a cap for a medical connector is disclosed herein, which may include an elongated member configured to be inserted into the lumen of the medical connector, an antimicrobial agent on or within the elongated member, and a sealing surface having an inner diameter larger than the outer diameter of the threads of the medical connector.

[0023] An embodiment of a cap for a medical connector is disclosed herein, which may include a base portion and a tip portion having an opening on the tip, an elongated member at least partially inside the cap, a dried antimicrobial agent on the elongated member, and a sealing surface on the tip of the cap, wherein the sealing surface is configured to prevent air from venting after the cap is attached.

[0024] An embodiment of a cap for a medical connector is disclosed herein, which may include a base end and a tip end having an opening on the tip, a longitudinal member at least partially inside the cap, a dry antimicrobial agent on the longitudinal member, and a porous element positioned at the base end of the longitudinal member, wherein, after the cap is attached to the medical connector, the dry antimicrobial agent may be configured to move within the lumen region between the porous element and the clamp of the medical device.

[0025] This specification discloses embodiments of a method for in-situ formation of an antimicrobial porous element, comprising providing a cap having a base end and a tip end, an opening on the tip end, an elongated member at least partially inside the cap, a dried antimicrobial agent on the elongated member, and a compressible porous element substantially free of the antimicrobial agent; providing a medical device having a lumen; and inserting the elongated member into a liquid contained within the lumen of the medical device such that the dried antimicrobial agent dissolves in the liquid to produce an antimicrobial liquid and wets the porous element with the antimicrobial liquid.

[0026] A base end portion and a tip end portion, an opening on the tip end portion, a long member that is at least partially within the interior of a cap—a long member having a volume, a dry antibacterial agent on the long member, and a cap having a compressible porous element that partially surrounds a portion of the long member; and inserting the long member into a liquid such that a portion of the volume of the long member passes through the compressible porous element to move a portion of the liquid, at least a portion of the dry antibacterial agent dissolves in the liquid to form an antibacterial liquid, and at least a portion of the antibacterial liquid contacts the porous element. Embodiments of a method for in situ formation of an antibacterial porous element are disclosed herein. In some embodiments, the compressible porous element can substantially exclude the antibacterial agent and can at least partially contain air.

[0027] A base end portion and a tip end portion having an opening on the tip end portion, a long member that is at least partially within the interior of a cap, a dry antibacterial agent on the long member, and a cap having a compressible porous element that partially surrounds a portion of the long member; and attaching the cap onto a transfer set. Embodiments of a method for cleaning a base end portion of a dialysis transfer set are disclosed herein. In some embodiments, the compressible porous element can be compressed during attachment by a strong pushing movement on the base end portion of the transfer set.

[0028] A base end portion and a tip end portion, an opening on the tip end portion, a long member that is at least partially within the interior of a cap, a dry antibacterial agent on the long member, a cap having a dried compressible porous element that partially surrounds a portion of the long member; and attaching the cap onto a medical connector. Embodiments of a method for attaching a cap to a medical connector are disclosed herein. In some embodiments, the compressible porous element can substantially exclude the antibacterial agent. In some embodiments, when inserted into a lumen, the long member can move liquid within the lumen of the transfer set such that air moves through the porous element and liquid is retained by the compressible porous element.

[0029] Embodiments of a capping system for a medical connector are disclosed herein, which may include a base element having a finger rest on the tip of the base element, a cap having a partially enclosed internal space, a proximal end and a tip, and a heat-shrinkable band at the tip of the cap and the proximal end of the base element, providing a barrier to the inside of the cap. Embodiments of a cap system for a medical connector are disclosed herein, which may include a base element having a finger rest on the tip of the cap system, and a cap having a partially enclosed internal space, a proximal end and a tip. Embodiments of a cap system for a medical connector are also disclosed herein, which may include a base element having a finger rest on the tip of the cap system, a cap, and a heat-shrinkable band at the tip of the cap providing a barrier to the partially enclosed internal space of the cap.

[0030] Embodiments of a method for holding a cap on a base so that the cap cannot be reattached to the base are disclosed herein. This method may include providing a cap system including a cap, and removing the cap from the base such that a heat shrink band is held on the base but shrinks to prevent reattachment to the base. The cap may include a partially enclosed internal space, a base end, and a tip. The cap system may further include a base element including a finger restraint on the base end of the cap, and a heat shrink band at the tip of the cap that provides a barrier to the partially enclosed internal space of the cap. The cap may be secured to the base element by the heat shrink band, for example, at or adjacent to the tip of the cap.

[0031] Embodiments of a method for delivering an antimicrobial agent to a medical connector are disclosed herein, which may include providing a medical connector having a lumen, an inner wall, and a proximal end face; providing a cap having a proximal end and a tip having an opening on the tip, an elongated member at least partially inside the cap, a dry antimicrobial agent on the elongated member, and a dry, compressible, porous element substantially free of the antimicrobial agent; and inserting the elongated member into a liquid contained within the lumen so as to dissolve the dry antimicrobial agent in the liquid to generate an antimicrobial liquid within the lumen and the porous element. In some embodiments, the antimicrobial liquid in the lumen may be in contact with the inner wall, and the antimicrobial agent in the porous element may be in contact with the proximal end face.

[0032] Embodiments of caps for medical connectors substantially described herein or shown in the accompanying drawings are disclosed herein. Embodiments of methods for using caps for medical connectors substantially described herein or shown in the accompanying drawings are also disclosed herein.

[0033] Any embodiment of the caps, methods, and systems disclosed herein may, in further embodiments, include one or more of the following steps, features, components, and / or details in any combination with any other steps, features, components, and / or details of any other embodiment disclosed herein: The medical connector is part of a peritoneal dialysis transport set. The sealing surface is positioned outward from the threads. The cap further includes a proximal cavity in a partially enclosed internal space. The proximal cavity includes a portion of the interior that is the proximal end of the proximal end of the transport set when the cap is mounted on the transport set. A porous element is contained within the proximal cavity. The porous element is dry before mounting on the transport set. The porous element is free from disinfectants, antimicrobial agents, or other substances before mounting. The porous element is configured to hold fluids exiting the medical connector when the cap is mounted on the medical connector. The proximal cavity surrounds a volume larger than the volume of the elongated member transport volume. The porous elements of the base cavity surround a volume of 75–125 percent of the elongated member's moving volume. The porous elements of the base cavity surround a volume of 50–150 percent of the elongated member's moving volume. The base cavity includes one or more dividers to form a secondary cavity. The base cavity provides a fluid channel for fluids exiting the lumen of the medical connector during cap installation. The elongated member is completely contained within a partially enclosed internal space of the cap. The elongated member extends from the tip of the partially enclosed internal space. The sealing surface is oriented radially inward and positioned outward from the threads. The cap further includes a tip-planar sealing surface oriented towards the tip and positioned outward from the threads. The cap further includes a tip-planar sealing surface and a tip-radial sealing surface, the sealing surfaces oriented outward from the threads. The cap further includes a tip-inclined sealing surface oriented outward from the threads. The medical connector has a base end, and the elongated member has a movable volume defined as the volume of the elongated member that is the tip end of the base end of the medical connector when the cap is fully attached to the medical connector.The medical connector has a base end, and the base end cavity may include the volume of the partially enclosed internal space of the base end of the medical connector when the cap is mounted on the medical connector, and / or the medical connector has a base end, and the partially enclosed internal space may include the volume of the partially enclosed internal space radially outward from the tip end of the medical connector, the base end of the seal between the cap and the medical connector, and the outer wall of the transfer set when the cap is mounted on the medical connector.

[0034] Any embodiment of the caps, methods, and systems disclosed herein may, in further embodiments, include one or more of the following steps, features, components, and / or details in any combination with any other steps, features, components, and / or details of any other embodiment disclosed herein: The elongated member does not form a fluid seal within the lumen of the medical connector. The cap does not constitute a seal within the lumen of the medical connector. The cap further includes a cap retaining flange for securing the cap to a base. The cap for the medical connector has a partially enclosed internal space, an elongated member at least partially positioned within the partially enclosed internal space, an antimicrobial agent on or within the elongated member, threads on the cap for securing the cap to the medical connector, and a sealing surface on the cap, the sealing surface being located toward the tip of the threads and providing a primary seal between the cap and the medical connector when the cap is mounted on the medical connector. The sealing surface is located outward from the threads. The cap further includes a base cavity in the partially enclosed internal space. The cap may include a porous element within the base cavity. The elongated member is completely contained within the partially enclosed internal space of the cap. When the cap is mounted on a medical connector, the first sealing capacity is greater than 75 percent of the total sealing capacity between the cap and the medical connector. When the cap is mounted on a medical connector, the first sealing capacity is greater than 90 percent of the total sealing capacity between the cap and the medical connector. When the cap is mounted on a medical connector, the first sealing capacity is greater than 95 percent of the total sealing capacity between the cap and the medical connector. And / or, the cap does not constitute a seal within the lumen of the medical connector.

[0035] Any embodiment of the caps, methods, and systems disclosed herein may, in further embodiments, include one or more of the following steps, features, components, and / or details in any combination with any other steps, features, components, and / or details of any other embodiment disclosed herein: The sealing surface is a primary sealing surface. The cap does not constitute a seal within the lumen of the medical connector. The sealing surface is located on the tip side of the threads and provides a first sealing capacity when mounted on the medical connector, and when the cap is mounted on the medical connector, the first sealing capacity is greater than 50 percent of the total sealing capacity between the cap and the medical connector. The sealing surface is located on the tip side of the threads and provides a first sealing capacity when mounted on the medical connector, and when the cap is mounted on the medical connector, the first sealing capacity is greater than 75 percent of the total sealing capacity between the cap and the medical connector. The sealing surface is located outward from the threads. The cap further includes a base cavity. Furthermore, a porous element may be included within the base cavity. The elongated member is completely contained within a partially enclosed internal space of the cap. The cap further includes a base cavity within the partially enclosed internal space. Furthermore, a porous element may be included within the base cavity. The porous element surrounds 75–125 percent of the elongated member's moving volume. The porous element surrounds 50–150 percent of the elongated member's moving volume. Furthermore, a silver-based antibacterial agent may be included. The silver-based antibacterial agent is coated onto a portion of the cap. The silver-based antibacterial agent is integrally formed on at least a portion of the cap. The silver-based antibacterial agent contains a silver salt. The silver-based antibacterial agent contains a silver complex. The silver-based antibacterial agent contains silver ions. The silver-based antibacterial agent contains silver nanoparticles. The silver-based antibacterial agent contains a silver nanolayer. The silver-based antibacterial agent includes silver pentaoxiodate, silver sulfadiazine, silver trifluoroacetate, silver nitrate, silver stearate, and combinations thereof. The antibacterial agent contains chlorhexidine acetate. The cap contains chlorhexidine acetate and a silver-based antibacterial agent. [Brief explanation of the drawing]

[0036] [Figure 1]This is a schematic diagram showing a peritoneal catheter extending into the peritoneal cavity of a patient undergoing peritoneal dialysis. Dialysis fluid is injected into the peritoneal cavity, and then the catheter is removed. [Figure 2] This is a perspective view of a peritoneal dialysis transfer set. [Figure 3] Figure 2 is a cross-sectional view of the peritoneal dialysis transport set along its longitudinal centerline. [Figure 4] This is a perspective view of an embodiment of a cap combination set including a peritoneal dialysis cap and base elements. [Figure 5] Figure 4 is a front view of an embodiment of the cap combination set shown. [Figure 6] This is a cross-sectional view of an embodiment of the cap combination set shown in Figure 4, taken along line LL shown in Figure 5. [Figure 7] Figure 4 is a side view of an embodiment of the cap combination set shown. [Figure 8] This is a cross-sectional view of an embodiment of the cap combination set shown in Figure 4, taken along line KK shown in Figure 7. [Figure 9] A side view of an embodiment of a peritoneal dialysis cap. [Figure 10] This is a cross-sectional view of an embodiment of the peritoneal dialysis cap set shown in Figure 9, taken along line JJ shown in Figure 9. [Figure 11] This is a side view of an embodiment of a peritoneal dialysis cap base. [Figure 12] This is a cross-sectional view of an embodiment of the peritoneal dialysis cap base element shown in Figure 11, taken along line DD shown in Figure 11. [Figure 13] This is a side view of an embodiment of a peritoneal dialysis cap attached to the hub or end portion of a transfer set. [Figure 14] This is a cross-sectional view of a peritoneal dialysis cap attached to the hub or end portion of the transfer set shown in Figure 13, taken along line HH shown in Figure 13. [Figure 15] This is a side view of an embodiment of a peritoneal dialysis cap mounted on the hub or end portion of a transfer set. [Figure 16] This is a cross-sectional view of an embodiment of a peritoneal dialysis cap mounted on the hub or end portion of the transfer set shown in Figure 15, taken along line II shown in Figure 15. [Figure 17] This is a cross-sectional view of an embodiment of a peritoneal dialysis cap mounted on a hub or end portion of a transfer set, according to various embodiments of this specification, showing the proximal / tip orientation and the internal / external orientation. [Figure 18] This is a perspective view of an embodiment of a peritoneal dialysis cap base element. [Figure 19] This is a cross-sectional view of an embodiment of a peritoneal dialysis cap and base element. [Figure 20] A perspective view of another embodiment of the peritoneal dialysis cap base element. [Figure 21] A perspective view of another embodiment of the peritoneal dialysis cap base element. [Figure 22] A perspective view of another embodiment of the peritoneal dialysis cap base element. [Figure 23] This is a perspective view of another embodiment of a peritoneal dialysis cap base element, which is made according to various embodiments described herein. [Modes for carrying out the invention]

[0037] Referring to the drawings, Figure 1 is a schematic diagram of a patient undergoing peritoneal dialysis, showing a peritoneal catheter 110 extending into the patient's peritoneal cavity 112 (surrounded by the peritoneum 113), through which dialysate from the source bag 115 flows to the patient and into the peritoneal cavity 112. The dialysate can then be drained into a drain bag 116. The peritoneal catheter 110 can be fluidly connected to bags 116 and 115 by a transfer set 114 and an infusion set 119. Connectors 117 and 118 can be located at either end of the transfer set 114. In some examples, the transfer set 114 may be a peritoneal dialysis transfer set 119, as described.

[0038] Figure 2 is a perspective view of the peritoneal dialysis transport set 114, and Figure 3 is a cross-sectional view of the peritoneal dialysis transport set 114. The peritoneal dialysis transport set 114 may include a tube 213 extending from the proximal end 208 to the distal end 210 of the transport set 114. The proximal end 208 of the transport set 114 may be a threaded male connector 214 having a first male thread 216 and a second male thread 218. The threaded male connector 214 is the proximal end portion of the peritoneal dialysis transport set 114.

[0039] During the exchange process, the waste dialysate can flow from the peritoneal cavity 112 to the connector 117 and transfer set 114, then through the connector 118, and finally through the lower part of the infusion set 119 to the drain bag 116. After the exchange process is complete, the infusion set 119 can be separated from the transfer set 114 at the connector 118, and the female connector of the transfer set 114 can be covered (not shown) until the next dialysate exchange is started. Thus, in a typical peritoneal dialysis, the exchange process can be started by removing the cap from the tip 210 of the transfer set 114, and then connecting it to the infusion set 119 to form the connector 118. This process can be reversed at the end of the exchange process by removing the infusion set 116 at the connector 118 and attaching a new cap.

[0040] Figure 4 is a perspective view of an embodiment of a cap combination set 410 comprising a peritoneal dialysis cap 420 and a base element 430. Some embodiments of the peritoneal dialysis cap 420 may have a proximal end 422 and a tip end 424. The base element 430 may include a ring 432 dimensioned to receive a user's finger, with a hole 434 passing through the ring 432. Furthermore, in the shown embodiments, the base element 430 may include a pair of lateral extensions 436 that can restrict the rotation of the base element 430 when the base element 430 is positioned in the user's hand. For example, but not limited to, in some embodiments, the user may press one or both of the lateral extensions 436 to increase the torque force applied to the base element 430. In some embodiments, the lateral extensions 436 may have pointed or triangular, rounded shapes, or any other desired shape as shown.

[0041] In any embodiment disclosed herein, the cap 420 may have one or more gripping portions 510 on the outer surface of the body 421 of the cap 420. In some embodiments, the gripping portions 510 may be located at or adjacent to the base end 422 of the cap 420 and may extend axially along the length of the outer surface of the cap. As shown, some embodiments of the cap 420 may have two gripping portions 510 formed on the body 421 of the cap 420, facing each other. Referring to Figure 5, in some embodiments, the gripping portions 510 may have channels, ridges, roughened textures, or other features configured to improve the grip of the user's fingers on the cap 420 during use.

[0042] Figure 5 is a side view of an embodiment of the cap combination set 410 shown in Figure 4, which may include a peritoneal dialysis cap 420 and a base element 430. The peritoneal dialysis cap 420 may have a proximal end 422 and a proximal end 424. The base element 430 may include a ring 432 sized to receive a user's finger, with a hole 434 passing through the ring 432. Furthermore, in the embodiment shown, the base element 430 may include a pair of lateral extensions 436 as described above.

[0043] Figure 6 is a cross-sectional view of an embodiment of a cap combination set 410 including a peritoneal dialysis cap 420 and a base element 430. The base element 430 may include a ring 432 sized to receive a user's finger, with a hole 434 passing through the ring 432. Some embodiments of the peritoneal dialysis cap 420 may include an internal volume 610 into which an elongated member 620 can extend, the elongated member having a tip portion 622. Some embodiments of the cap 420 may have a porous element 630 which may include a sponge material, an open-cell foam, or other suitable dry foam or dry porous material. In some embodiments, the porous element 630 may have an opening therein configured to receive an elongated member 622. The porous element 630 may be positioned to abut against the base end wall and the inner side wall of the cap. The porous element 630 may be expandable and compressible, and in some embodiments, the porous element may have an outer diameter larger than the inner diameter of the cap so that it expands relative to the inner wall of the cap when bonded to the cap or assembled separately from the cap. The porous element 630 may be bonded to the cap so that it is positioned in contact with the inner surface of the base end of the cap.

[0044] In some embodiments, the porous element 630 can be positioned at the base of the elongated member 620, at the base portion of the internal volume 610, and / or at any location within the internal volume 610. For example, in some embodiments, though not limited to those embodiments, the porous element 630 can be positioned at the base of the elongated member 620 and may have an opening therein that can be dimensioned and configured to avoid the elongated member 620, so that when the porous element 630 is positioned in a usable location (e.g., the base portion of the internal volume 610), the elongated member 622 can pass through the opening in the porous element 630.

[0045] In some embodiments, the space occupied by the porous element 630, or the volume of the porous element 630, can be a sub-part of the internal volume 610. In other words, in some embodiments, the porous element 630 can occupy less than the total volume of the internal volume 610. In some embodiments, the porous element 630 can occupy 25% or about 25% of the internal volume 610 of the cap, or in some embodiments, it can occupy 20% or about 20% or less than 20% of the internal volume 610 of the cap, or 50% or about 50% or more than 50% of the internal volume 610 of the cap, or in some embodiments, it can occupy 30% or about 30% of the internal volume 610 of the cap, or 40% or about 40% of any value within the aforementioned range, or from any value within the aforementioned range, and the volume of the internal volume 610 of the cap is determined before the individual connectors advance into the internal volume 610 (i.e., before the individual connectors are connected to the catheter). In some embodiments, the volume in the internal volume 610 is greater than the volume of liquid in the hub or connector configured to be moved by the elongated member 620 when the elongated member 620 advances into the hub or connector.

[0046] In any embodiment disclosed herein, the porous element 630 may be configured to absorb and retain any liquid it comes into contact with until the porous element 630 is saturated with liquid. In some embodiments, the porous element 630 may have spongy properties. In this configuration, the porous element 630 can absorb and retain any liquid discharged from the catheter or transfer set hub when the cap is engaged with the hub, thereby reducing the possibility of liquid leaking from the cap when the cap is engaged with the catheter hub. Furthermore, since the antimicrobial agent can dissolve in the liquid when the cap is engaged with the hub, the liquid that can be absorbed by the porous element 630 may contain an antimicrobial agent so as to provide further disinfection capability to the porous element 630 and other surfaces when any liquid is discharged from the porous element, if any.

[0047] Figure 7 is a side view of an embodiment of a cap combination set 410 including a peritoneal dialysis cap 420 and a base element 430, including one or more gripping portions 510 and a sealing band 730. As shown, any embodiment disclosed herein may include a sealing band 730 that secures the peritoneal dialysis cap 420 to the cap base element 430. The sealing band can hold the peritoneal dialysis cap 420 to the base element 430 before use, or prevent the cap 420 from separating from the base element 430 before use, and / or prevent the reattachment of the peritoneal dialysis cap 420 to the base element 430 after the cap 420 has separated from the base element 430, in order to prevent or prevent the reuse of the cap 420 (which may be unhygienic). The peritoneal dialysis cap 420 may include a proximal portion 422 and a tip portion 424. The base element 430 may include a ring 432 sized to receive a user's finger, and the ring 432 has an opening 434 sized and configured to receive a user's finger through the ring 432. Furthermore, in the shown embodiments, the base element 430 may include a pair of lateral extensions 436 as described above. In some embodiments, the lateral extensions 436 may allow the user to apply a greater level of torque to the base element 430 when the base element 430 is positioned in the user's hand.

[0048] Figure 8 is a cross-sectional view of an embodiment of a cap combination set 410 including the peritoneal dialysis cap 420 and base element 430 shown in Figure 5, taken along line KK in Figure 7. Figure 9 is a side view of the peritoneal dialysis cap 420 according to various embodiments of this specification, including showing the grip portion 510. Figure 10 is a side cross-sectional view of the peritoneal dialysis cap of Figure 9, taken along line JJ shown in Figure 9. As shown in Figure 10, in some embodiments, the diameter or horizontal cross-sectional width of the elongated member 620 may be greater than the horizontal cross-sectional width of the side wall(s) of the cap 420 and / or the vertical width of the base portion 422 of the cap 420. For example, as shown, along the elongated member, or along at least a large portion of the vertical length of the elongated member 620, and / or at at least one point along the entire vertical length of the elongated member 620, the diameter or horizontal cross-sectional width of the elongated member 620 may be greater than the horizontal cross-sectional width of several and / or all points along the vertical length of the side wall(s) of the cap 420, and / or several and / or all points along the vertical width of the base end 422 of the cap 420. As shown, the outer surface of the cap 420 may be tapered outward at the leading edge of the cap 420.

[0049] As shown in many figures, in some embodiments, the elongated member 620 can be solid (not hollow) and / or can be integrally formed with the sidewall(s) and / or base end 422 of the cap 420 without assembling separately formed components. As shown, the elongated member 620 can be long enough to extend to about the tip of the cap 420 and / or can be slightly shorter than the total vertical length of the sidewall of the cap 420. By making the elongated member 620 shorter than the sidewall of the cap 420, the elongated member 620 is less likely to be contaminated if the user places the cap 420 on a surface (improperly) before use. Furthermore, in some embodiments, when the elongated member 620 is shorter than the side wall of the cap 420, the cap 420 may be provided with a removable, adhesive lid or seal (not shown) that extends across the entire tip opening of the side wall of the cap 420 to prevent contamination of the inside of the cap 420 before use. As shown, the tip of the threaded inner portion of the cap 420 may be in the direction of the base end of the tip of the side wall of the cap 420, and the portion of the side wall that is in the direction of the tip from the tip of the threaded inner portion of the cap 420 may have a horizontal cross-sectional width thinner than the horizontal cross-section of the portion of the side wall that is in the direction of the base from the threaded inner portion of the cap 420. This thinner portion may provide some flexibility that allows for slight movement or temporary radial expansion of the tip of the cap 420 when it is attached to the hub 212 in order to help form a seal between the cap 420 and the hub 212.

[0050] In some embodiments, as shown, the porous element 630 can surround the base of the elongated member 620 along at least a large portion of the internal region between the base of the elongated member 620 and the base end of the threaded region inside the cap 420. As shown, the vertical height or thickness of the porous element 630 can be at least the same as the distance between the base end and the tip of the threaded region of the cap 420. In some embodiments, as shown, the fluid absorption volume of the porous element 630 can be at least the same as the volume of the elongated member 420, allowing the porous element 630 to absorb any fluid that moves by inserting the elongated member 420 into the hub 212 which is already filled with fluid.

[0051] Some embodiments of the peritoneal dialysis cap 420 may include an internal volume 610 through which a lengthwise member 620 can pass. The internal volume 610 may extend from the base end 422 of the body 421 of the cap 420 to the tip end 424 of the body 421 of the cap 420. As described above, the lengthwise member 620 may extend through the longitudinal axis centerline of the body 421 of the cap 420 and the internal volume 610 of the cap 420.

[0052] The elongated member 620 may have a base end 621 adjacent to the base end 422 of the cap 420 and may extend to a tip end 623 along the longitudinal axis centerline of the internal volume 610. In some embodiments, the elongated member 620 may have a circular cross-sectional shape as shown, or any other desirable cross-sectional shape such as a star, hexagon, octagon, or other polygonal shape. The elongated member 620 may be uniform along its length, or it may be tapered along its entire length or in part such that the diameter or cross-sectional size of the elongated member 620 at its tip end 623 is smaller than the diameter or cross-sectional size of the elongated member 620 at its base end 621. In some embodiments, the elongated member 620 may extend to a length shorter than the length of the cap 420 at its tip end 424, or to a point or plane, such that the tip end 623 of the elongated member 620 does not extend beyond the tip end 424 of the cap 420.

[0053] In some embodiments, the elongated member 620 can be formed integrally (i.e., monolithically) with the body 421 of the cap 420. In some embodiments, the elongated member 620 can be formed separately and coupled with the body 421 of the cap 420.

[0054] In some embodiments, the porous element 630 can be positioned at the proximal end of the internal volume 610 of the peritoneal dialysis cap 420. Furthermore, at the tip of the peritoneal dialysis cap, 420 is an overlapping region 640 having a flange that engages with the base element 430. In the shown configuration, the base element 430 may include a recess 634 to which the proximal end 622 of the elongated member can extend.

[0055] Figure 11 is a side view of an embodiment of the peritoneal dialysis base element 430. Figure 12 is a side cross-sectional view of the peritoneal dialysis base element 430 of Figure 11, taken along line DD shown in Figure 11. The base element 430 may include a ring 432 sized to receive a user's finger, with a hole 434 passing through the ring 432. The base element 430 may further include a recess 634 into which the tip 623 of an elongated member 620 (not shown) can extend when the cap 420 is coupled to the base element 430. In some embodiments, the base element 430 may include an upper flange surface 1210 and a lower flange surface 1220, along with an outer flange surface 1230.

[0056] Figure 13 is a side view of an embodiment of a peritoneal dialysis cap 420 mounted on the proximal hub 212 of a transfer set. Figure 14 is a cross-sectional view of the embodiment of the peritoneal dialysis cap 420 shown in Figure 13, mounted on the proximal hub 212 of a transfer set, taken along line HH shown in Figure 13. As the cap 420 is advanced to engage with the hub 212, the cap 420 can be rotated so that the threads 632 of the cap 420 engage with the threads 216 of the proximal hub 212 of the transfer set. As the cap 420 is advanced to engage with the hub 212, the elongated member 620 can extend into the passage 217 of the proximal hub 212 of the transfer set. As the body 421 of the cap 420 moves to a position over the threads 216 on the proximal hub 212 of the transfer set, the elongated member can protrude into the interior of the proximal hub 212 of the transfer set or into the passage 217.

[0057] Figure 15 is a side view of an embodiment of a peritoneal dialysis cap 420 mounted on an exemplary proximal hub 212 of a transfer set. Figure 16 is a cross-sectional view of an embodiment of a peritoneal dialysis cap 420 mounted on the proximal hub 212 of a transfer set, taken along line II shown in Figure 15. Figure 17 shows a cross-sectional view, proximal / tip orientation and internal / external orientation of an embodiment of a peritoneal dialysis cap 420 mounted on a transfer set according to various embodiments of this specification. An elongated member 620 on the peritoneal dialysis cap 420 may extend into the lumen of the transfer set, and the threads 632 of the peritoneal dialysis cap 420 may engage with the corresponding threads 216 of the transfer set.

[0058] In any embodiment disclosed herein, the cap may have one or more sealing surfaces configured to provide a liquid-tight seal between the cap and the medical connector with which the cap engages when the cap is engaged with the medical connector. In some embodiments, one or more sealing surfaces may be configured to seal against the outer surface (e.g., outer diameter) of the hub of the catheter or transfer set. In some embodiments, one, two or more sealing surfaces may be located distal to the threads to provide a liquid-tight seal between the cap and the medical connector when the cap is mounted on the medical connector.

[0059] In some embodiments, the cap 420 may have an overlapping region 640 at the tip of the cap 420 that can overlap one or more parts or surfaces of the hub of the catheter or transfer set. In some embodiments, the overlapping region 640 may have a sealing flange 440 that engages with the base element 430 and / or one or more surfaces of the hub of the catheter or transfer set. In some embodiments of the cap 420, the tip 424 of the body 421 of the cap 420 may have one or more sealing surfaces.

[0060] For example, but not limited to, with reference to Figures 13-16, some embodiments of the cap 420 may have a sealing flange 440 at the tip 424 of the body 421 of the cap 420. In some embodiments, the sealing flange 440 may have a first or tip sealing surface 442 configured to engage with the first surface 219 of the base hub 212 of the transfer set and to seal against the first surface 219. In some embodiments, the first or tip sealing surface 442 may be configured to axially abut against the first surface 219 when the cap 420 is screwed onto the base hub 212 to form a seal against the first surface 219 of the base hub 212 of the transfer set. In some embodiments, the first sealing surface 442 may have a planar end surface that is substantially perpendicular to the longitudinal axial centerline of the cap 420 and configured to abut against the first surface 219 of the base hub 212 of the transfer set.

[0061] In some embodiments, the sealing flange 440 may have a second or radial sealing surface 444 configured to engage with the second surface 221 of the base hub 212 of the transfer set and seal against the second surface 221. In some embodiments, the second or radial sealing surface 444 may be configured to be tightened or pressurized radially inward with respect to the second surface 221 of the base hub 212 of the transfer set in order to form a seal against the second surface 221. For example, in some embodiments, though not limited to these, the sealing flange 440 may be configured to form an interlocking fit with respect to the second surface 221 of the base hub 212, and having an inner diameter smaller than the outer diameter of the second surface 221 of the base hub 212. In some embodiments, but not limited to them, the sealing flange 440 may be configured to form an interlocking fit with the second face 221 of the base hub 212, and having an inner diameter that is 5% or about 5% smaller than the outer diameter of the second face 221 of the base hub 212, or 10%, about 10%, or more than 10%, or 2%, about 2% to 15%, or about 15% smaller.

[0062] As shown in Figure 16, in some embodiments, the cap 420 and / or at least the threaded area inside the cap 420 may be substantially rigid and not generally elastomer, elastic, and / or flexible, thereby the threaded area does not change shape and / or expand during or after mounting to the hub 212. When the cap 420 is mounted to the hub 212, the cap 420 can form a seal to the hub 212 by making tight, snug, forced, fixed, and / or frictional contact with the hub 212 in the radial and / or longitudinal directions, as shown. For example, in some embodiments, the cap 420 may be configured to block the normal fluid or air pressure within the hub 212, for example, at the mean blood pressure of a patient, which is within the expected pressure range of a peritoneal dialysis or hemodialysis catheter in normal use. In some embodiments, the pressure resistance of the cap 420 when mounted on the hub 212 can be substantially higher, for example, at least about 68.9 kPa (10 psi) or at least about 137.9 kPa (20 psi), to improve protection against leakage during mounting.

[0063] Any embodiment of the cap disclosed herein can be configured such that, even when the cap is fully engaged with the hub or connector, no seal or blockage is made with respect to the inner surface (e.g., the inner passage) of the hub or connector with which the cap engages. Any embodiment of the cap can be configured such that, even when the cap is fully engaged with the hub or connector, the cap seals only with respect to the outer surface or outward-facing surface of the hub or connector with which the cap engages. In some embodiments, the cap can be configured such that there are no sealing surfaces at or adjacent to the base portion of the elongated member. In some embodiments, the cap can be configured such that all sealing surfaces or seals are located at or adjacent to the tip portion of the cap, adjacent to the opening at the tip of the cap.

[0064] Figure 18 is a perspective view of an embodiment of a peritoneal dialysis base element 430 having a ring 432, a lateral extension 436, and a recess 634. Figure 19 is a cross-sectional view of an embodiment of a peritoneal dialysis cap 420 and an embodiment of the base element 430 shown in Figure 18, passing through the longitudinal axis centerline of the base element 430. In any embodiment of a base element disclosed herein (including, but not limited to, the base element 430 shown in any of Figures 11-12 and 18-20), the base element may have, in place of, or in combination with, any other embodiment of a base element disclosed herein (including, but not limited to, the base element 430), any other embodiment of the base element. In some embodiments, the tip of the cap 420 and / or the elongated member 620 may extend into the recess 634 of the base element 430.

[0065] Figure 20 is a perspective view of another embodiment of the peritoneal dialysis base element 430, showing a ring 432 having a divided region 690 of the ring 432. In some embodiments, the divided region 690 of the ring 432 can allow the ring to be enlarged (e.g., increased) and contracted (e.g., decreased) to accommodate fingers of different sizes of the user.

[0066] Figure 21 is a perspective view of another embodiment of the peritoneal dialysis base element 700. In any embodiment of the base element disclosed herein (including, but not limited to, the embodiment of the base element 700 shown in Figure 21), the base element may have, in place of, or in combination with, any of the features, components, materials, or other details of any other embodiment of the base element disclosed herein (including, but not limited to, the base element 700) of the base element. Referring to Figure 21, some embodiments of the base element 700 may have a shaft 702 and a plurality of prong-holding areas 704 that can be grasped by a user. The base element 700 may have an annular flange or shelf 706 sized and configured to receive the tip portion of a cap, and a recess 708 formed at the end of the base element 700 from which the tip portion of the elongated member of the cap can extend.

[0067] Figure 22 is a perspective view of another embodiment of the peritoneal dialysis base element 720. In any embodiment of the base elements disclosed herein (including, but not limited to, the embodiment of the base element 720 shown in Figure 22), the base element may have, in place of, or in combination with, any of the features, components, materials, or other details of any other embodiment of the base element disclosed herein (including, but not limited to, the base element 720). Referring to Figure 22, some embodiments of the base element 720 may have a shaft 722 and a circular or disc-shaped holding area 724 that can be grasped by a user. The base element 720 may have an annular flange or shelf 726 sized and configured to receive the tip portion of a cap, and a recess 728 formed at the end of the base element 720 from which the tip portion of the elongated member of the cap can extend.

[0068] Figure 23 is a perspective view of another embodiment of the peritoneal dialysis base element 740. In any embodiment of the base element disclosed herein (including, but not limited to, the embodiment of the base element 740 shown in Figure 23), the base element may have, in place of, or in combination with, any of the features, components, materials, or other details of any other embodiment of the base element disclosed herein (including, but not limited to, the base element 740) of the base element. Referring to Figure 23, some embodiments of the base element 740 may have a shaft 742 and a circular or disc-shaped holding area 744 that can be grasped by a user. The shaft 742 may have a substantially rectangular cross-section. The base element 740 may have an annular flange or shelf 746 sized and configured to receive the tip portion of a cap, and a recess 748 formed at the end of the base element 740 from which the tip portion of the elongated member of the cap can extend.

[0069] In any embodiment disclosed herein, the cap may contain an antimicrobial agent, for example, chlorhexidine acetate, for example, but not limited to these. Other antimicrobial agents that can be used in any embodiment disclosed herein may include chlorhexidine base, chlorhexidine acetate, chlorhexidine gluconate, EDTA, silver sulfadiazine, or tauroridine, or combinations thereof. Other suitable antimicrobial agents can be used with any cap embodiment disclosed herein. As used herein, the term “antimicrobial agent” may include any substance that kills or inhibits the growth of organisms such as bacteria, fungi, protozoa, viruses, etc. It should also be noted that this may refer to one or more antimicrobial agents used in some embodiments disclosed herein. Therefore, throughout this document, it should be understood that the term “antimicrobial agent” or “antimicrobial agent” may refer to one or more antimicrobial agents.

[0070] In any embodiment disclosed herein, the antimicrobial agent can be coated onto the elongated member and / or onto other surfaces of the cap, such as the inner surface of the cap body and / or the proximal end wall of the cap. Thus, the antimicrobial agent can be delivered as a coating that elutes from the coated elongated member, which is coated or impregnated onto the elongated member (for example, 250 μg or about 250 μg of chlorhexidine acetate in a layer 2 μm or about 2 μm thick along the length of the elongated member, or 50 μg or about 50 μg of chlorhexidine acetate in a layer 0.4 μm or about 0.4 μm thick). The antimicrobial agent from the cap can dissolve in the fluid being transported, thereby disinfecting the proximal end of the catheter. In this configuration, the antimicrobial agent can be transferred from the cap into the solution in the catheter. The antimicrobial substance or antimicrobial agent from the cap can dissolve in the fluid in the catheter, thereby disinfecting at least the proximal end of the catheter. Furthermore, in some embodiments, when the catheter fluid dries, it may leave a deposit or coating of chlorhexidine acetate or other suitable antimicrobial agent on the cap and / or catheter hub.

[0071] In some embodiments, as the elongated member advances to the hub of the catheter, it can be configured to move a volume of fluid from within the catheter. In some embodiments, the volume of fluid that can be moved can be equal to or approximately equal to the volume of the coated or uncoated elongated member. In some embodiments, the volume of fluid that can be moved can be equal to or approximately equal to the volume of the coated or uncoated elongated member extending in the tip direction beyond the porous element, or the volume of the coated or uncoated elongated member minus the actual or moved volume of the porous element.

[0072] While several embodiments of the present invention have been described, these embodiments are provided for illustrative purposes only and are not intended to limit the scope of this disclosure. In fact, the novel methods and systems described herein may be embodied in various other forms. Furthermore, various omissions, substitutions, and modifications in the systems and methods described herein may be made without departing from the spirit of this disclosure. The appended claims and their equivalents are intended to include such forms or modifications that fall within the scope and spirit of this disclosure.

[0073] Features, materials, properties, or groups described in conjunction with specific embodiments, models, or examples are applicable to any other embodiments, models, or examples described in this section or elsewhere in this Spec. All features disclosed herein (including any appended claims, abstracts, and drawings), and / or all steps of any method or process so as to be disclosed, may be combined in any combination, except for any combination in which at least some of such features and / or steps are mutually exclusive. The protection is not limited to the details of any of the aforementioned embodiments. The protection extends to any novel features or any novel combination of features disclosed herein (including any appended claims, abstracts, and drawings), or any novel steps or any novel combination of any method or process so as to be disclosed.

[0074] Furthermore, several features described in the context of separate embodiments in this disclosure may be combined and implemented in a single embodiment. In contrast, various features described in the context of a single embodiment may be implemented separately in multiple embodiments or in any suitable subcombination. Furthermore, features may be described as functioning in several combinations, but one or more features in a claimed combination may be excluded from that combination in some examples, and this combination may be claimed as a subcombination or a variation of a subcombination.

[0075] Furthermore, while operations may be shown in the drawings and described herein in a specific order, such operations do not need to be performed in a specific illustrated or sequential order to achieve the desired result, or all of them may be performed. Other operations not shown or described may be incorporated into the methods and processes of these examples. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Furthermore, these operations may be rearranged or reordered in other embodiments. As will be apparent to those skilled in the art, in some embodiments, the actual steps performed in the illustrated and / or disclosed processes may differ from those shown in the drawings. Depending on the embodiment, some of the steps described above may be omitted, and others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of this disclosure. Also, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and systems may generally be integrated as a single product or packaged into multiple products.

[0076] For the purposes of this disclosure, several aspects, advantages, and novel features are described herein. Not all such advantages are necessarily realized by any particular embodiment. Therefore, it will be understood by those skilled in the art that, for example, this disclosure may be embodied or implemented in a manner that realizes one advantage or set of advantages as taught herein without necessarily realizing other advantages that may be taught or suggested herein.

[0077] Conditional words such as “can,” “could / might,” or “may” are generally intended to mean that other embodiments do not include certain features, elements, and / or steps, but some embodiments do, unless otherwise specifically stated or understood otherwise in the context in which they are used. Therefore, such conditional words are generally not intended to suggest that features, elements, and / or steps are necessarily required for one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without user input or instruction, whether these features, elements, and / or steps are included in or performed in any particular embodiment.

[0078] Conjunctions such as “at least one of X, Y, and Z” are generally understood in context to indicate that an item, item, etc., may be any of X, Y, or Z, unless otherwise specifically indicated. Therefore, such conjunctions are not generally intended to suggest that some embodiments require the presence of at least one X, at least one Y, and at least one Z.

[0079] Terms used herein to indicate degree, such as “approximately,” “about,” “generally,” and “substantially,” represent values, quantities, or characteristics close to the listed values, quantities, or characteristics that still perform the desired function or still achieve the desired result. The scopes disclosed herein include any and all of the overlaps, partial scopes, and combinations thereof, as well as any specific values ​​within those scopes. Terms such as “up to,” “at least,” “greater than,” “less than,” and “between” include the listed numbers. Numbers and values ​​following terms such as “about” or “approximately” used herein include the listed numbers. For example, “approximately 7mm” includes “7mm,” and any number and range following terms such as “about” or “approximately” should be interpreted as disclosing a number and range, regardless of whether such terms precede the number or value. This application supports asserting any number, value, and range disclosed in the specification and / or claims, regardless of whether such numbers, values, or ranges are preceded by terms such as “about” or “approximately,” for example, “about 2 to about 5 times” also includes a disclosure of a range of “2 to 5 times.” The scope of this disclosure is not intended to be limited by specific disclosures of preferred embodiments in this chapter or elsewhere in this specification, and may be defined by claims as shown or hereafter shown in this chapter or elsewhere in this specification. The terms used in the claims should be interpreted broadly based on the terms adopted in the claims and are not limited to the examples described herein or in the proceedings of this application. These examples should be interpreted non-limitingly.

Claims

1. A cap system for medical connectors, It is a base element, A finger-holding portion on the tip of the base element, which includes a hole that penetrates the finger-holding portion, A recess formed at the base end of the base element, The base element includes an annular upper flange surface formed at the base end, The recess extends from the upper flange surface toward the tip, and the base element It's a cap, A body having a closed base end and an open tip, The internal volume inside the main body, An elongated member extending axially from the closed base end of the main body through at least a portion of the internal volume, the elongated member containing an antibacterial agent, The cap has screw threads for securing it to the medical connector, A sealing surface positioned distal to the screw threads and facing radially inward, Including the cap and Equipped with, A cap system in which the base element is fixed together with a sealing band to a sealing surface of the cap that faces radially inward, thereby preventing the base element from separating from the cap and preventing the cap from being reattached to the base element after it has been separated from the cap.

2. In the cap system according to claim 1, A cap system in which the recess is configured to receive the tip of the elongated member of the cap.

3. In the cap system according to claim 1 or 2, The sealing band is a cap system comprising a heat-shrinkable band at the tip of the cap that provides a barrier to the internal volume.

4. A method for holding a cap on a base element for a medical connector, To obtain a base element including a finger-holding portion on the tip of the base element, a hole penetrating the finger-holding portion, an annular upper flange surface at the base end of the base element, a recess extending from the upper flange surface toward the tip, and a lower flange surrounding the recess, The lower flange of the base element is attached to the sealing flange at the tip of the cap, wherein the cap includes a partially enclosed internal space and a base end. The sealing flange of the cap is fixed to the base element together with the sealing band, so as not to separate from the cap and so as not to reattach the cap to the base element after it has been separated from the cap. A method that includes [a certain feature].

5. The method according to claim 4 further, The cap is removed from the base element so that the sealing band is held on the base element. A method that includes [a certain feature].

6. In the method according to claim 5, A method wherein the sealing band is configured to prevent reattachment onto the base element.

7. A base element for use with a cap for a medical connector, The aforementioned base element is A ring configured and sized to accommodate the user's finger, The hole that penetrates the aforementioned ring, A recess formed at the base end of the base element and extending from the base end of the base element, An annular upper flange surface formed at the base end of the base element, wherein the recess extends from the upper flange surface toward the tip, The annular lower flange surface surrounding the recess and Equipped with, The base element is configured to be coupled to the cap, The base element is configured such that its lower flange surface is fixed to the sealing flange of the cap.

8. The base element described in claim 7 further comprises: The base element comprises one or more lateral extensions configured to restrict rotation, The base element wherein one or more of the aforementioned lateral extensions are rounded or triangular in shape.

9. The base element according to claim 7 or 8 further, One or more lateral extensions configured to increase the torque force applied to the base element when a user presses one or more of the lateral extensions. A base element that includes the following features.

10. In the base element described in any one of claims 7 to 9, The base element is configured to engage with the sealing flange of the cap.

11. In the base element described in any one of claims 7 to 10, The recess is configured such that when the cap is coupled to the base element, the tip of the elongated member of the cap extends into the base element.

12. In the base element according to any one of claims 7 to 11, The base element includes a lower flange surface and an outer flange surface, which are sized and configured to receive the cap.

13. The base element described in any one of claims 7 to 12 is further: A sealing band configured to secure the cap to the base element. A base element that includes the following features.

14. In the base element according to claim 13, The sealing band is configured to hold the cap and prevent the cap from separating from the base element before use.

15. In the base element according to claim 13 or 14, The sealing band is configured to prevent the cap from being reattached to the base element in order to prevent the cap from being reused.

16. In the base element described in any one of claims 13 to 15, The sealing band is configured to contract to prevent the cap from being reattached to the base element, the base element.

17. In the cap system according to any one of claims 1 to 3, The base element includes an annular lower flange surface surrounding the recess, A cap system in which the radially inward-facing sealing surface is configured to engage with the annular lower flange surface of the base element.

18. The base element described in any one of claims 7 to 16 is further: The recessed portion of the base element extends from the upper flange surface beyond the lower flange surface toward the tip.

Images