Patent Application
20210372551
The present invention is related to medical access devices, and more particularly to a disconnect system for medical tubing.
Medical access devices are used in the treatment of hospitalized patients for a variety of purposes, including intravenous catheters, feeding tubes, Foley catheters, chest tubes, and a variety of surgical drains. Many of these medical access devices transport fluids to or from the patient and use a variety of flexible tubes to give the patient a range of movement during treatment. Unfortunately, due to the freedom of movement that some patients exhibit, the tubing associated with medical access devices is often subjected to forces that cause damage to the tubing, the patient, or both. For example, the tubing typically used in the administration of intravenous fluids is often several feet long, and accordingly can become entangled on hospital beds or other medical equipment surrounding the patient. As the patient moves, the tubing can be stretched and disconnected. In extreme cases, the fluids being administered to the patient, or the patient's own body fluids can be spilled, creating a risk of contamination to the patient's treatment environment, and potentially exposing the patient to a risk of infection.
To alleviate these concerns, a number of different tubing connectors and adapters have been developed that are designed to “break away” when subjected to sufficient tensional forces. In some cases, these connectors include internal valves that prevent fluid from passing through the separated connector. Although these products are often effective at mitigating leaks from the separated adapter, these prior art connectors present a contamination risk if the patient or caregiver attempts to reconnect the tubing adapter. Once the tubing adapter has been disconnected and exposed to the non-sterile environment, reassembly of the adapter presents a significant contamination risk that may increase the probabilities for patient infection. Accordingly, there is a need for an improved tubing adapter that presents the benefits of a leak-resistant breakaway design, while also mitigating the contamination and infection risks associated with the reconnection of the separated adapter. It is to these and other deficiencies in the prior art that the present embodiments are directed.
As used in this disclosure, it will be appreciated that tubing connector system 100 is generally cylindrical and symmetrical about a longitudinal axis that extends through the middle of the central connector 102 between the first and second tubing adapters 102, 104. A reference to “longitudinal” will refer to a direction or axis that is parallel or co-linear with the central longitudinal axis extending through the tubing connector system 100. A reference to a radial direction or radial axis will be understood to be in a direction that is substantially orthogonal to the central longitudinal axis. A reference to a rotational movement or direction will be understood to be a reference to a clockwise or counterclockwise movement around the longitudinal axis (unless another axis or rotation is specified). When describing features within the tubing connector system 100, a reference to an interior feature or inward direction refers to something toward the middle of the central connector 106 (either radially or longitudinally), while an exterior feature or outward direction refers to something away from the center of the tubing connector system 100 (again either radially or longitudinally). Unless otherwise noted, the components of the tubing connector system 100 are manufactured from medical grade plastic that is easily sterilized during manufacture.
The first tubing adapter 102 is configured for connection to the first piece of the medical tubing (T1). The second tubing adapter 104 is configured for connection to the second piece of the medical tubing (T2). As depicted, the first tubing adapter 102 includes a first compression fitting 108 that retains a first tubing fitting 110 in connection with the central connector 102. Similarly, the second tubing adapter 104 includes a second compression fitting 112 that retains a second tubing fitting 114 in connection with the central connector 106. In some embodiments, the first and second tubing adapters 102, 104 are configured for use in connecting conventional “Luer” adapters that rely on a friction-fit connection with the medical tubing. It will be appreciated that the first and second tubing adapters 102, 104 can be configured to connect a variety of medical tubing fittings to the central connector 106.
The central connector 106 includes a two-part breakaway assembly 116, depicted in isolation in
Turning to
The female module 120 includes a female valve housing 144 and a female module stem 146 that extends from the female valve housing 144 to the second tubing fitting 114. As depicted in
The second fluid passageway 148 extends through the middle of the female module stem 146 from an exterior end 150 of the female module stem 146 to an interior end 152 of the female module stem 146 inside the female valve housing 144. The female module stem 146 includes one or more female module pores 154 proximate the interior end 152 of the female module stem 146. The one or more female module pores 154 are apertures in the female module stem 146 that place the second fluid passageway 148 in fluid communication with a second annular space 156 of the female valve housing 142. As depicted in
The first and second valve members 124, 126 are retained in the first and second annular spaces 150, 156, respectively. The male valve housing 128 includes an interior valve flange 160, a foot wall 162 and an outer wall 164 that cooperate to retain the first valve member 124. The first annular space 140 resides between the outer wall 164 and the male module stem 130. The female valve housing 144 similarly includes an interior valve flange 166, a foot wall 168 and an outer wall 170 that cooperate to retain the second valve member 126. The second annular space 156 resides between the outer wall 170 and the female module stem 146.
As shown in
The first valve member 124 includes a first valve bore 182 that axially extends through the interior of the first valve member 124. During installation, the first valve member 124 is placed into the male module 118 such that the interior end 136 of the male module stem 130 is located inside the first valve bore 182. As noted in
The second valve member 126 includes a second valve foot 186, a second valve bellows 188 and a second valve head 190. The second valve head 190 has a larger outside diameter than the outside diameter of the second valve bellows 188. The second valve head 190 includes a second valve shoulder 192 and a receiver 194 that is configured accept in close tolerance the first valve projection 180 from the first valve head 176.
The second valve member 126 includes a second valve bore 196 that axially extends through the interior of the second valve member 126. During installation, the first valve member 124 is placed into the female module 120 such that the interior end 152 of the female module stem 146 is located inside the second valve bore 196. As noted in
During assembly of the tubing connector system 100, the male module 118 and female module 120 are connected (as depicted in
As the male module stem 130 and female module stem 146 are approximated closer together during assembly, the first valve head 176 and second valve head 190 remain stationary. This forces the interior end 136 of the male module stem 130 to move beyond the first valve seal 184 of the first valve member 124, thereby exposing the male module pores 138. At the same time, the interior end 152 of the female module stem 146 is pressed beyond the second valve seal 198 of the second valve member 126, thereby exposing the female module pores 154. In this retracted position, the first valve bellows 174 and second valve bellows 188 are compressed and apply a spring force to maintain a sealed connection between the first valve head 176 and the second valve head 190. This ensures that fluid passing between the male module pores 138 and the female module pores 154 through the inter-valve flow path 200 is contained within the connected first and second valve members 124, 126 (as illustrated in
Importantly, the first and second valve members 124, 126 are configured such that the first valve head 176 and second valve head 190 have a gimbaled connection to the first valve bellows 174 and second valve bellows 188, respectively. As depicted in
Turning to
The male module 118 includes a plurality of stabilizers 202 that project longitudinally inward toward the female module 120. Each stabilizer 202 is generally configured as a finger or tab with a radial curvature that matches the cylindrical form of the male module 118. In exemplary embodiments, the stabilizers 202 are equally distributed around the circumference of the male module 118. The male module 118 also includes a plurality of alignment tabs 204 that extend radially outward from an abutment ring 206 that circumferentially extends around the outside of the male module 118. The male module 118 further includes a locking ring 208 that circumferentially extends around the male module 118 on the interior side of the abutment ring 206. As best depicted in
The female module 120 includes a locking collar 210 that circumferentially extends around the interior end of the female module 120. The locking collar 210 is attached to the outside of the female module 120 by a plurality of collar mounts 212. The locking collar 210 includes a plurality of locking tabs 214 that extend inward toward the male module 118. Each locking tab 214 is generally configured as a U-shaped member in which two proximal ends are affixed to adjacent collar mounts 212 to support a cross member 216 in a cantilevered manner. In this way, each locking tab 214 presents a stabilizer recess 218 between the adjacent collar mounts 212 to which the locking tab 214 is attached.
As best illustrated in
The cross member 216 of each locking tab 214 includes a plurality of teeth 220 that project radially inward from the cross member 216. As depicted, each cross member 216 includes a pair of teeth 220 disposed in a spaced apart relationship on the outside ends of the cross member 216. The teeth 220 are spaced back from the distal end of the cross member 216. The cross member 216 also includes an alignment tab recess 222 on the inward side of the middle of the cross member 216. Each alignment tab recess 222 is configured to accommodate a corresponding one of five alignment tabs 204 extending radially outward from the abutment ring 206 of the male module 118. The locking tabs 214 and teeth 220 are cylindrically contoured to match the circular shape of the corresponding locking features of the male module 118.
As illustrated, the female module 120 includes five locking tabs 214 extending from the locking collar 210, which produces five stabilizer recesses 218 to accommodate five stabilizers 202 from the male module 118. It will be appreciated that these locking features can be equally spaced and distributed around the circumference of the male and female modules 118, 120. Although five locking tabs 214, five stabilizers 202 and five alignment tabs 204 are depicted in illustrated embodiments, it will be appreciated that greater or fewer numbers of these features are contemplated as within the scope of these embodiments. For example it may be desirable to include 3, 4, 5, 6, 7, 8, 9, 10 or 11 of each of the locking tabs 214, stabilizers 202 and alignment tabs 204. For some applications, an odd number of each of these locking features is preferred over an even number of locking features.
As best illustrated in the close-up views in
Each tooth 220 includes a sloped face 234 with an angle that is substantially congruent to the angle of the locking face 226 (as illustrated in
When the male module 118 and female module 120 are connected, each stabilizer 202 is captured within a corresponding one of the stabilizer recesses 218. Each alignment tab 204 is captured within a corresponding one of the alignment tab recesses 222. Each tooth 220 is engaged in a locked position in which the sloped face 234 is engaged in contact with the sloped locking face 226 of the locking ring 208 (as depicted in
Attempts to separate the male and female modules 118, 120 by pulling them in opposite directions along the central longitudinal axis causes the locking collar 210 to flex radially outward as the teeth 220 are pulled up the locking face 226 of the locking ring 208. The rigidity of the locking collar 210 resists this deformation until the tension between the male and female modules 118, 120 causes the tooth apex 236 to reach the peak 232 of the locking ring 208 between the locking face 226 and the release face 228. The peak 232 and tooth apex 236 are designed so that the relative movement between the male module 118 and female module 120 does not stall when the peak 232 is in contact with the tooth apex 236. When the tooth apex 234 is pulled into contact with the peak 232, the inward pressure exerted by the locking collar 210 to the teeth 220 on the inward slope of the release face 228 causes the male and female modules 118, 120 to rapidly spring apart. This ensures that once the male and female 118, 120 modules have been pulled apart by a “threshold longitudinal separation distance” in response to a “threshold separation force,” which would potentially compromise the seal provided by the valve assembly 122, the male and female modules 118, 120 quickly separate and the first and second valve members 124, 126 return to the deployed state to prevent leakage or contamination through the male and female module pores 138, 154. Thus, in exemplary embodiments, the longitudinal distance of travel for the first valve seal 184 and second valve seal 198 (the “valve travel distance”) is less than the threshold longitudinal separation distance to ensure that the valve assembly 122 deploys to the closed position before the male and female modules 118, 120 separate.
Importantly, the threshold longitudinal separation distance is optimally the same distance as the longitudinal length of the alignment tabs 204 and alignment tab recesses 222. This prevents the male and female modules 118, 120 from rotating with respect to one another until the two components have been unlocked and disengaged. The threshold separation force required to separate the male and female modules 118, 120 can be adjusted by altering the geometry of the mating components of the locking ring 208 and teeth 220. Increasing the slope of the locking face 226 and sloped face 234 will increase the amount of tensile force required to separate the male and female modules 118, 120. Similarly, the threshold longitudinal separation distance can be adjusted by increasing or decreasing the longitudinal distance of one or both of the locking face 226 and the sloped face 234.
Once the male and female modules 118, 120 have been separated (as depicted in
During assembly, the male module 118 is engaged with the female module 120 using an assembly tool 240, depicted in
It is clear that the present invention is well adapted to carry out its objectives and attain the ends and advantages mentioned above as well as those inherent therein. While presently preferred embodiments of the invention have been described in varying detail for purposes of disclosure, it will be understood that numerous changes may be made which will readily suggest themselves to those skilled in the art and which are encompassed within the spirit of the invention disclosed herein.
The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 63/032,609 filed May 30, 2020 entitled, “Tubing System with Reassembly Prevention Mechanism,” the disclosure of which is herein incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63032609 | May 2020 | US |
