Needleless connector
By adding chlorhexidine gluconate to the lubricant of the needleless connector, the risk of infection when reconnecting the needleless connector without sterilization is eliminated, achieving sterile connection and improving the safety of the infusion system.
Patent Information
- Application Number
- CN202423122290.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Priority Date
- 2024-01-04
- Filing Date
- 2024-12-18
- Publication Date
- 2026-02-24
- Estimated Expiration
- 2034-12-18
AI Technical Summary
Existing needleless connectors pose a risk of bloodstream infection or other infections during reconnection, especially if sterilization procedures are not performed, and the lubricant may be contaminated, affecting the safety of the infusion system.
Adding antibacterial ingredients, such as chlorhexidine gluconate, at a concentration between 4% and 6% wt/wt to the lubricant of pinless connectors kills bacteria that come into contact with the lubricated surface, ensuring that no sterilization step is required during the connection process.
By adding antibacterial components to the lubricant, the risk of infection during needleless connector reconnection is significantly reduced, improving the safety and sterility of the infusion system and avoiding potential infections caused by unsterilized connections.
Smart Images
Figure CN223930497U_ABST
Abstract
Description
Technical Field
[0001] This disclosure generally relates to pinless connectors, and in some embodiments, to pinless connectors having antibacterial properties. Background Technology
[0002] Force-activated disengagement devices (FASDs) in intravenous (IV) kits are an important safety feature designed to prevent accidental disconnection. These devices are designed and manufactured to disconnect the IV line when a certain force is applied, thus ensuring the safe delivery of fluid to the patient. This disengagement is intended to prevent damage or displacement of more critical components of the infusion system, such as catheters. They are particularly useful in clinical settings to mitigate the risk of accidental line displacement that could lead to complications or infection. FASDs in IV kits enhance patient safety by maintaining the integrity of the infusion system. Utility Model Content
[0003] FASDs have two main categories: single-use and reconnectable. Single-use devices are replaced upon disconnection. Reconnectable devices can be reconnected after component separation. Examples of needle-free connectors and reconnectable devices are designed to maintain a closed access to the infusion system when not in use and allow for reconnection of Luer devices (e.g., syringes, IV kits, etc.). Because the mating surfaces of the devices can be contaminated upon disconnection, there is a risk of bloodstream infection (CLABSI) or other infections associated with the central tubing when reconnecting a contaminated device. Clinicians must ensure that each surface is wiped with disinfectant as directed by the device manufacturer. Infection is highly likely to occur if the patient or a family member reconnects without disinfection.
[0004] Therefore, antimicrobial properties are needed to add to FASDs to allow or significantly reduce the injection risk during connection without any sterilization procedures. The valve side of a FASD typically contains a silicone lubricant between the valve and the center post to aid in the smooth sliding movement of the plug on the plug side over the valve. During connection, this lubricant is coated on the surface of the valve on the valve side and the interior of the plug on the plug side. By adding an antimicrobial compound at a specific concentration to the silicone lubricant mixture, bacteria in contact with the lubricated surfaces are killed. The lubricant is located in the core fluid path of the device and covers most of the surface after connection. Combined with the bactericidal properties of the lubricant impregnated with the antimicrobial compound, this allows the connector to operate without any sterilization steps while still ensuring a bacteria-free fluid path.
[0005] In some embodiments, the pinless connector includes: a first component comprising: a housing having a proximal end and a distal end opposite the proximal end, the housing defining an internal volume; a central post disposed in the internal volume and extending proximally within the internal volume; a valve disposed in the internal volume at the proximal end of the first component to surround at least a portion of the central post; and a lubricant disposed between the central post and the valve. In some embodiments, the lubricant contains an antibacterial component.
[0006] In some embodiments, the second component includes: a housing having a proximal end and a distal end opposite the proximal end, the housing defining a fluid path therein; and a plug disposed in the fluid path at the distal end of the second component. In some embodiments, the plug is a deformable member. In some embodiments, the plug includes a diaphragm extending therethrough. In some embodiments, the diaphragm is sized and shaped to receive a central post. In some embodiments, the diaphragm is coated with a lubricant as the central post passes through the diaphragm.
[0007] In some embodiments, in the disconnected configuration, the proximal end of the first component and the distal end of the second component are separated. In some embodiments, in the connected configuration, the proximal end of the first component and the distal end of the second component are removably connected. In some embodiments, in the connected configuration, the first component and the second component are in fluid communication. In some embodiments, in the connected configuration, the valve is longitudinally deformed in the distal direction to expose the central column.
[0008] In some embodiments, the central column is a rigid member. In some embodiments, the antibacterial component comprises chlorhexidine gluconate. In some embodiments, the concentration of the antibacterial component is between 4% and 6% wt / wt of the lubricant.
[0009] In some embodiments, a method for reducing the presence of bacteria in a needleless connector includes: providing a first component including a valve and a central post; providing a second component including a plug; providing a lubricant to a region between the central post and the valve; connecting the first and second components such that the plug displaces the valve and surrounds the central post, wherein the lubricant is transferred to the plug when the first component is connected to the second component, and wherein the lubricant contains an antibacterial component.
[0010] In some embodiments, the first component further includes: a housing having a proximal end and a distal end opposite to the proximal end, the housing defining an internal volume; a central post disposed in the internal volume and extending proximally within the internal volume; and a valve disposed in the internal volume at the proximal end of the first component to surround at least a portion of the central post.
[0011] In some embodiments, the second component further includes: a housing having a proximal end and a distal end opposite to the proximal end, wherein the housing defines a fluid path therein; and a plug disposed in the fluid path at the distal end of the second component.
[0012] In some embodiments, the stopper includes a diaphragm extending therethrough. In some embodiments, the diaphragm is sized and shaped to be part of a receiving central post. In some embodiments, the diaphragm is coated with a lubricant as the central post passes through the diaphragm. In some embodiments, the antimicrobial component comprises chlorhexidine gluconate. In some embodiments, the concentration of the antimicrobial component is between 4% and 6% wt / wt of the lubricant. Attached Figure Description
[0013] The foregoing overview and the following detailed description of embodiments of the components will be better understood when read in conjunction with the accompanying drawings of exemplary embodiments. However, it should be understood that the present invention is not limited to the precise arrangement and tools shown.
[0014] In the attached diagram:
[0015] Figure 1 This is a schematic diagram of an IV kit connected to a patient according to an exemplary embodiment of the present disclosure;
[0016] Figure 2 This is a top perspective view of a pinless connector assembly according to an exemplary embodiment of the present disclosure;
[0017] Figure 3 This is a side cross-sectional view of a pinless connector in a disconnected configuration according to an exemplary embodiment of the present disclosure;
[0018] Figure 4 This is a side cross-sectional view of a pinless connector in a connection configuration according to exemplary embodiments of the present disclosure; and
[0019] Figure 5 This is a side cross-sectional view of the valve side of a pinless connector according to an exemplary embodiment of the present disclosure. Detailed Implementation
[0020] The detailed description set forth below is intended as a description of various constructions of the present technology and is not intended to represent the only constructions in which the present technology can be practiced. The detailed description includes specific details intended to provide a thorough understanding of the present technology. However, it will be clear to those skilled in the art that the subject matter can be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid confusion with the concepts of the subject matter. For ease of understanding, similar components are labeled with the same element number. Reference numerals may be appended with letter suffixes to indicate individual instances of common elements, while common elements are generally referred to by the same number without a suffix.
[0021] While the following description is intended to reduce the presence of bacteria by utilizing the disclosed pinless connector with antimicrobial properties, it should be understood that this description is merely an example of use and does not limit the scope of the claims. Various aspects of the disclosed pinless connector can be used in any application where it is desirable to reduce the presence of bacteria in the pinless connector.
[0022] Now refer to the attached diagram, Figure 1 An IV kit 1, connected to a patient 10 according to aspects of this disclosure, is shown. The IV kit 1 includes a medication bag 12, an infusion chamber 14, and a fitting 22. The fitting 22 extends between the infusion chamber 14 and the fluid connector assembly 100 of the IV kit 1. To prevent the fitting 16 or catheter 18 from unintentionally shifting or breaking off from the patient, tape 26 is placed over the fitting 16 and catheter 18, such that the tape 26 engages the fitting 16, catheter 18, and patient 10.
[0023] Figure 2 A perspective view of a fluid connector assembly 100 for use with an IV kit, according to aspects of this disclosure, is shown. The fluid connector assembly 100 is designed for medical applications, such as IV kit 1 (e.g., Figure 1 (as shown), and other medical fluid delivery applications using catheters, as non-limiting examples, including peripheral intravenous catheters (“PIVC”).
[0024] like Figures 2-5 As shown, the fluid connector assembly 100 may include a first component 102 and a second component 104. The first component 102 may be coupled to fitting 22 or fitting 16. In some embodiments, the first component 102 is closer to the drug pouch 12 than the second component 104. In some embodiments, the second component 104 is closer to the drug pouch 12 than the first component 102.
[0025] like Figure 3 As shown, the first component may include a housing 106 having a proximal end and a distal end opposite the proximal end. Figure 3As shown, the proximal end may be located to the right of the distal end. It should be understood that in some embodiments, the proximal end may be located to the left of the distal end. The housing 106 may define an internal volume 108. The internal volume 108 may be generally cylindrical and may include components disposed therein. The internal volume 108 may extend from the proximal end toward the distal end and may include a wall 110 located on the distal portion. The housing 106 may have a collar 122 at its proximal end. The collar 122 may extend radially outward about the circumference of the proximal end.
[0026] like Figures 3-5 As shown, the internal volume 108 may include a central column 112 disposed therein. The central column 112 may be a rigid member and may extend proximally within the internal volume 108. The central column 112 may be coupled to the housing 106 and may extend through the wall 110. In some embodiments, the central column 112 is integrally formed with the wall 110. In some embodiments, the housing 106, the central column 112, and the wall 110 may be integrally formed. The central column 112 may be a generally conical member. The proximal end of the central column 112 may have a smaller circumference than the distal end of the central column 112. In some embodiments, the central column 112 may be cylindrical. The central column 112 includes a fluid inlet 114 extending therethrough to receive a fluid drug, as described in more detail below. In some embodiments, the central column 112 includes a plurality of fluid inlets 114. The fluid inlets 114 may allow a fluid drug to travel from the proximal end of the first component 102 to the distal end and into the tube 16. In some embodiments, the fluid inlet 114 may allow the fluid drug to travel from the distal end of the first component 102 to the proximal end and into the second component 104.
[0027] like Figures 3-5 As shown, the internal volume 108 may include a valve 116 disposed therein. The valve 116 may be located at the proximal end of the first component 102 and may extend distally to surround at least a portion of the central post 112. The valve 116 may be a flexible member. The valve 116 may be made of rubber, silicone, or other deformable materials. The valve 116 may have a generally cylindrical base 118. Figure 5As shown, the base 118 may include a slit 120 extending therethrough. The slit 120 may be shaped and sized to expose the fluid inlet 114 of the central column 112 in response to a force that deforms the valve 116 distally. The valve 116 may have a flare 124 at its distal end. The flare 124 may engage the wall 110 to prevent the distal end of the valve 116 from moving distally in response to a force that deforms the valve 116 distally. The valve 116 may have a body 126 extending between the base 118 and the flare 124. The body 126 may contact the central column 112. The body 126 may be ribbed to facilitate self-folding in response to a force that deforms the valve 116 distally.
[0028] The first component 102 may include a lubricant 136 disposed between the central column 112 and the valve 116. The lubricant 136 may include an antibacterial component. The antibacterial component may be chlorhexidine gluconate. The antibacterial component may have a concentration between 4% and 6% wt / wt of the lubricant 136. In some embodiments, the antibacterial component may be at least 1%, at least 1.5%, at least 2%, at least 2.5%, at least 3%, at least 3.5%, at least 4%, at least 4.5%, at least 5%, at least 5.5%, at least 6%, at least 6.5%, at least 7%, at least 7.5%, or at least 8% of the lubricant 136. In some embodiments, the antibacterial component may have a concentration of lubricant 136 between 1% and 8% wt / wt, between 1.5% and 7.5% wt / wt, between 2% and 7% wt / wt, between 2.5% and 6.5% wt / wt, between 3% and 6% wt / wt, between 3.5% and 5.5% wt / wt, or between 4% and 5% wt / wt.
[0029] The second component 104 may include a housing 128 having a proximal end and a distal end opposite the proximal end. The housing 128 may define a fluid path 130 therein. The fluid path 130 may be generally cylindrical in shape. The second component 104 may include a plug 132 disposed at its distal end. The plug 132 may be a generally cylindrical member and may be fixed relative to the housing 128. The plug 132 may be disposed in the fluid path 130. The plug 132 may be a deformable member made of rubber, silicone, or other deformable material. The plug 132 may include a diaphragm 134 (not shown) extending therethrough. The diaphragm 134 may be sized and shaped to receive a portion of a central post 112. The housing may further include an engaging arm 138 having a notch 140 extending therefrom. The engaging arm 138 may extend circumferentially around the housing 128 and may be spaced apart from the housing 128. The notch 140 may extend radially toward the housing 128. The engaging arm 138 and the notch 140 can be sized and shaped to receive the collar 122 of the first component 102.
[0030] like Figure 2 and Figure 3 As shown, in the disconnected configuration, the first component 102 and the second component 104 can be separated. Figure 4 As shown, in the connection configuration, the first component 102 and the second component 104 can be removably coupled. In the connection configuration, the collar 122 of the first component 102 can pass through a notch 140 in the engagement arm 138 of the second arm. The notch 140 prevents the first component 102 from disconnecting from the second component 104 until a threshold force is reached. As described above, the notch 140 allows the first component 102 to disconnect from the second component 104 to prevent unintentional removal of the catheter from the patient.
[0031] In the connection configuration, the first component 102 and the second component 104 can be in fluid communication. In the connection configuration, the valve 116 can be longitudinally deformed in the distal direction to expose the central column 112. The distal end of the second component 104 can engage the base 118 to deform the valve 116. The central column 112 can be coated with a lubricant 136. The diaphragm 134 can be coated with lubricant as the central column 112 passes through the diaphragm. A fluid drug can travel through the fluid path 130, enter the fluid inlet 114, and pass through the central column 112. In some embodiments, the fluid drug can travel through the central column 112, exit the fluid inlet 114, and pass through the fluid path 130.
[0032] This document discloses a method for reducing the presence of bacteria in a needle-free connector. The method may include: providing a first component 102 comprising a valve 116 and a central post 112; providing a second component 104 comprising a plug 132; and providing a lubricant 136 to the region between the central post 112 and the valve 116. The method may further include: connecting the first component 102 and the second component 104 such that the plug 132 displaces the valve 116 around the central post 112, wherein the lubricant 136 is transferred to the plug 132 when the first component 102 is connected to the second component 104, and wherein the lubricant 136 contains an antibacterial component.
[0033] The antibacterial component may contain chlorhexidine gluconate. The concentration of the antibacterial component may be between 4% and 6% wt / wt of the lubricant. In some embodiments, the antibacterial component may be at least 1%, at least 1.5%, at least 2%, at least 2.5%, at least 3%, at least 3.5%, at least 4%, at least 4.5%, at least 5%, at least 5.5%, at least 6%, at least 6.5%, at least 7%, at least 7.5%, or at least 8% of the lubricant 136. In some embodiments, the antibacterial component may have a concentration between 1% and 8% wt / wt, between 1.5% and 7.5% wt / wt, between 2% and 7% wt / wt, between 2.5% and 6.5% wt / wt, between 3% and 6% wt / wt, between 3.5% and 5.5% wt / wt, or between 4% and 5% wt / wt of the lubricant 136.
[0034] The first component 102 may further include a housing 106 having a proximal end and a distal end opposite the proximal end. The housing 106 may define an internal volume 108. A central post 112 may be disposed in the internal volume 108 and extend proximally within the internal volume 108. A valve 116 may be disposed in the internal volume 108 at the proximal end of the first component 102 to surround at least a portion of the central post 112.
[0035] The second component 104 may further include a housing 128 having a proximal end and a distal end opposite the proximal end. The housing 128 may define a fluid path 130 therein. A plug 132 may be disposed in the fluid path 130 at the distal end of the second component 104. The plug may include a diaphragm 134 extending therethrough. The diaphragm 134 may be sized and shaped to be part of a receiving central post 112. The diaphragm 134 may be coated with a lubricant 136 as the central post 112 passes through the diaphragm.
[0036] The terms “approximately” or “approximately” are used herein to provide textual support for exact figures preceding them and for figures that are close to or approximate to those preceding the term. In determining whether a number is close to or approximates a specifically listed number, the unlisted number that is close to or approximates can be a number that is substantially equivalent to the specifically listed number provided in the context in which it appears. It should be understood that all numerical values and ranges disclosed herein are approximate values and ranges, whether or not “approximately” is used with them. It should also be understood that the term “approximately” as used herein, together with the number, refers to a value that can be ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive), ±2% (inclusive), ±3% (inclusive), ±5% (inclusive), ±10% (inclusive), or ±15% (inclusive). It should be further understood that when a numerical range is disclosed herein, any numerical value falling within that range is also specifically disclosed.
[0037] Those skilled in the art will understand that changes can be made to the exemplary embodiments shown and described above without departing from the broad inventive concept of this invention. It should be understood that the embodiments and claims disclosed herein are not limited in their application to the details of the construction and arrangement of the components set forth in the specification and shown in the drawings. Rather, the specification and drawings provide examples of contemplated embodiments. The embodiments and claims disclosed herein are further capable of being practiced and implemented in various ways through other embodiments.
[0038] Specific features of exemplary embodiments may or may not be part of the claimed utility model, and various features of the disclosed embodiments may be combined. Unless otherwise stated herein, the terms “a,” “an,” and “the” are not limited to a single element, but should be understood to mean “at least one.” Finally, unless otherwise stated herein, the disclosed or claimed methods should not be limited to performing their steps in the order they are written, and those skilled in the art will readily understand that these steps can be performed in any actual order.
Claims
1. A pinless connector, characterized in that, The pinless connector includes: The first component includes: A housing having a proximal end and a distal end opposite to the proximal end, the housing defining an internal volume; A central column, which is disposed in the internal volume and extends proximally within the internal volume; A valve, the valve being disposed in an internal volume at the proximal end of the first component to surround at least a portion of the central post; and A lubricant disposed between the central column and the valve; The second component includes: A housing having a proximal end and a distal end opposite to the proximal end, wherein the housing defines a fluid path; and A plug, the plug being disposed in the fluid path at the distal end of the second component; The lubricant contains antibacterial components.
2. The pinless connector according to claim 1, characterized in that, The plug is a deformable component.
3. The pinless connector according to claim 1, characterized in that, The plug includes a diaphragm extending through it.
4. The pinless connector according to claim 3, characterized in that, The diaphragm is sized and shaped to receive a portion of the central column.
5. The pinless connector according to claim 4, characterized in that, The diaphragm is coated with the lubricant as the central column passes through it.
6. The pinless connector according to claim 1, characterized in that, In the disconnected configuration, the proximal end of the first component and the distal end of the second component are separated.
7. The pinless connector according to claim 1, characterized in that, In the connection configuration, the proximal end of the first component and the distal end of the second component are removably connected.
8. The pinless connector according to claim 7, characterized in that, In the connection configuration, the first component and the second component are in fluid communication.
9. The pinless connector according to claim 7, characterized in that, In the connection configuration, the valve is longitudinally deformed in the distal direction to expose the central column.
10. The pinless connector according to claim 1, characterized in that, The central column is a rigid component.
11. The pinless connector according to claim 1, characterized in that, The antibacterial ingredient includes chlorhexidine gluconate.
12. The pinless connector according to claim 11, characterized in that, The concentration of the antibacterial component is between 4% and 6% wt / wt in the lubricant.