阅读说明：本技术 具有视觉和触觉指示器的医疗装置 (Medical device with visual and tactile indicators ) 是由 J·迪乌巴尔迪 T·纳古 于 2018-04-05 设计创作，主要内容包括：用于医疗装置的连接器,包括作为该连接器的连接类型的指示器的视觉和触觉特征。这允许在忙碌和/或低光照情况下用于区分连接类型。(A connector for a medical device includes visual and tactile features as indicators of the type of connection of the connector. This allows for use in busy and/or low light situations to distinguish connection types.)

1. A medical device, the medical device comprising:

a device body having an end; and

a connector extending from an end of the device body, the connector in fluid communication with the end of the device body, wherein an exterior surface of the connector includes visual and tactile features that are indicators of a connection type of the connector.

2. The medical device of claim 1, wherein the connection type is defined by an interior surface of the connector.

3. The medical device of claim 1, wherein the interior surface is smooth, the visual and tactile features are one or more grooves or protrusions substantially parallel to a longitudinal axis of the syringe, and the connection type is a sliding type connection.

4. The medical device of claim 1, wherein the interior surface includes threads, the visual and tactile features are one or more grooves or protrusions that spiral at an angle greater than zero relative to an edge of the end, and the connection type is a locking type connection.

5. The medical device of claim 1, wherein the connector is engageable with one or more of a hub, a filter, and an adapter.

6. The medical device of claim 1, wherein the connector is made of an opaque material.

7. The medical device of claim 1, wherein the connector comprises a ring disposed coaxially about the elongate tip.

8. The medical device of claim 1, wherein the device body is a syringe barrel having a distal wall at the end from which the connector extends.

9. A syringe, the syringe comprising:

a syringe barrel having a distal end, a distal tip, an open proximal end, a barrel sidewall extending between the distal end to the open proximal end and defining a chamber, the distal end of the syringe barrel comprising a distal wall;

a connector extending distally from the syringe barrel at the distal wall, the connector including visual and tactile features that are indicators of a connection type of the connector.

10. The syringe of claim 9, wherein the connector comprises a ring coaxially disposed about an elongate tip in fluid communication with the distal tip, a channel being formed between the elongate tip and the ring, an outer surface of the ring comprising the visual and tactile features.

11. The syringe of claim 9, wherein the connector is made of an opaque material.

12. The syringe of claim 9, wherein the connector comprises a 5% taper.

13. The syringe of claim 9, wherein the connector conforms to ISO80369-6 (2016).

14. The syringe of claim 9, wherein the visual and tactile features are effective to indicate an insertion action for engaging the connector with one or more of a hub, a filter, and an adapter.

15. The syringe of claim 14, wherein the visual and tactile features are one or more grooves or protrusions substantially parallel to a longitudinal axis of the syringe.

16. The syringe of claim 15, wherein the connection type is a sliding type connection.

17. The syringe of claim 9, wherein the visual and tactile features are one or more grooves or protrusions spiraling at an angle greater than zero relative to an edge of the distal wall.

18. The syringe of claim 17, wherein the connector comprises one or more internal threads that spiral at an angle greater than zero relative to an edge of the distal wall.

19. The syringe of claim 18, wherein the connection type is a locking type connection.

20. The syringe of claim 9, wherein the syringe barrel is made of a glass material.

21. The syringe of claim 9, wherein the syringe barrel is made of a polymeric material.

22. A syringe, the syringe comprising:

a syringe barrel having a distal end, a distal tip, an open proximal end, a barrel sidewall extending between the distal end to the open proximal end and defining a chamber, the distal end of the syringe barrel comprising a distal wall;

a connector extending distally from the syringe barrel at the distal wall, the connector comprising a ring coaxially disposed about an elongate tip in fluid communication with the distal tip, a channel being formed between the elongate tip and the ring, the ring comprising an inner surface and an outer surface and visual and tactile features on the outer surface of the ring.

23. The syringe of claim 22, wherein the ring is made of a metallic material and further comprises a syringe ring interface; the syringe barrel is made of a glass material and further includes a distal wall extension that interfaces with the syringe ring.

24. The syringe of claim 22, wherein both the ring and the syringe barrel are made of a polymeric material, the ring being integrally formed with the syringe barrel.

25. The syringe of claim 22, wherein the ring comprises a 5% taper.

26. The syringe of claim 22, wherein the ring conforms to ISO80369-6 (2016).

27. The syringe of claim 22, wherein the visual and tactile features are effective to indicate an insertion motion for engaging the connector with one or more of a hub, a filter, and an adapter.

28. The syringe of claim 22, wherein the visual and tactile features are one or more grooves or protrusions substantially parallel to a longitudinal axis of the syringe, and the connection type is a sliding type connection.

29. The syringe of claim 22, wherein the visual and tactile features are one or more grooves or protrusions spiraling at an angle greater than zero relative to the edge of the distal wall, the ring comprises one or more threads spiraling at an angle greater than zero relative to the edge of the distal wall on the interior surface, and the connection type is a locking type connection.

30. A method of manufacturing a medical device, the method comprising:

forming a connector comprising visual and tactile features that are indicators of a connection type of the connector; and

incorporating the connector into a device body of the medical device.

31. A method of distinguishing between different connection types of medical devices or syringes, the method comprising:

obtaining the medical device or syringe of claim 1; and

the visual and tactile features are inspected visually and/or tactilely.

Technical Field

The present disclosure relates to medical devices having visual and tactile indicators. In particular, the medical device, such as a syringe, may be engaged with a hub, filter, adapter, or the like, and have one or more features on an exterior surface that provide a visual and tactile indication of the type of connection, such as a sliding type connection or a locking type connection, located inside the components of the syringe.

Background

Error-proof coupling rings have been used on both slide-type and lock-type syringes to avoid misrouting medication errors. A misrouted medication error is caused by a connection between unrelated delivery systems having different intended uses (e.g., vascular, intestinal, respiratory, epidural, and intrathecal). The error-proof connection ring helps fluids (e.g., medications, enteral feeding) or gases (e.g., oxygen) to properly take the desired path into the patient. International Standard ISO 80369-l: 2016(En) relates to small bore connectors for fluids and gases in healthcare applications. It is desirable in neurological applications that a small bore connector for connection should conform to ISO 80369-6. The requirement in ISO80369-6(2016), which is incorporated herein by reference, is a 5% taper.

The technical situation is as follows: the error-proof connection rings for the slide type syringe and the lock type syringe are visually the same. Unlike many plastic syringes having a transparent ring, glass syringes have an opaque ring that makes it difficult to distinguish the connection type under busy and/or low light conditions. The plastic syringe may be transparent or may be opaque, so that it may also be difficult to distinguish the type of connection of the plastic syringe under busy and/or low light conditions.

There is a need to provide a way of how to distinguish between components that provide a sliding type connection and components that provide a locking type connection.

Disclosure of Invention

A medical device, in particular a syringe, is provided that provides differentiated visual and tactile characteristics. Methods of distinguishing between devices having a sliding-type connection and devices having a locking-type connection are also provided.

In one aspect, a medical device comprises: a device body having an end; and a connector extending from an end of the device body, the connector in fluid communication with the end of the device body, wherein an exterior surface of the connector includes a visual and tactile feature that is an indicator of a connection type of the connector.

The connection type may be defined by an interior surface of the connector. The inner surface may be smooth, the visual and tactile features being one or more grooves or protrusions substantially parallel to the longitudinal axis of the syringe, the connection type being a sliding type connection. The inner surface may include threads, the visual and tactile features being one or more grooves or protrusions spiraling at an angle greater than zero relative to the edge of the end, the connection type being a locking type connection.

The connector may be engaged with one or more of the hub, the filter and the adapter. The connector may be made of an opaque material. The connector may comprise a ring coaxially disposed about the elongate tip.

The device body may be a syringe barrel having a distal wall at an end from which the connector extends.

In another aspect, there is provided a syringe comprising: a syringe barrel having a distal end, a distal tip, an open proximal end, a barrel sidewall extending between the distal end and the open proximal end and defining a chamber, the distal end of the syringe barrel comprising a distal wall; a connector extending distally from the syringe barrel at the distal wall, the connector including a visual and tactile feature that is an indicator of a connection type of the connector.

The connector may include a ring coaxially disposed about the elongate tip, the elongate tip in fluid communication with the distal tip, a channel formed between the elongate tip and the ring, an outer surface of the ring including visual and tactile features. The connector may be made of an opaque material.

The connector may include a 5% taper. The connector may conform to ISO80369-6 (2016).

In one or more embodiments, the visual and tactile features are effective to indicate an insertion action for engaging the connector with one or more of the hub, the filter, and the adapter. The visual and tactile features may be one or more grooves or protrusions substantially parallel to the longitudinal axis of the syringe. The connection type may be a sliding type connection. The visual and tactile features may be one or more grooves or protrusions that spiral at an angle greater than zero relative to the edge of the distal wall. The connector may include one or more internal threads that spiral at an angle greater than zero relative to the edge of the distal wall. The connection type may be a lock type connection.

The syringe barrel may be made of a glass material. The syringe barrel may be made of a polymeric material.

Another aspect is a syringe, comprising: a syringe barrel having a distal end, a distal tip, an open proximal end, a barrel sidewall extending between the distal end to the open proximal end and defining a chamber, the distal end of the syringe barrel comprising a distal wall; a connector extending distally from the syringe barrel at the distal wall, the connector comprising a ring coaxially disposed about an elongate tip, the elongate tip in fluid communication with the distal tip, a channel formed between the elongate tip and the ring, the ring comprising an inner surface and an outer surface and visual and tactile features on the outer surface of the ring.

The ring may be made of a metallic material and further comprises a syringe ring interface; the syringe barrel is made of a glass material and further includes a distal wall extension to which the syringe ring is interfaced. Both the ring and the syringe barrel may be made of a polymeric material, and the ring is integrally formed with the syringe barrel. The ring may comprise a 5% taper. The ring may conform to ISO80369-6 (2016).

In one or more embodiments, the visual and tactile features are effective to indicate an insertion action for engaging the connector with one or more of the hub, the filter, and the adapter. The visual and tactile features may be one or more grooves or protrusions substantially parallel to the longitudinal axis of the syringe, the connection type being a sliding type connection. The visual and tactile features may be one or more grooves or protrusions spiraling at an angle greater than zero relative to the edge of the distal wall, the ring comprising one or more threads on an interior surface spiraling at an angle greater than zero relative to the edge of the distal wall, the connection type being a locking type connection.

Another aspect is a method of manufacturing a medical device, the method comprising: forming a connector including visual and tactile features that are indicators of a connection type of the connector; and incorporating the connector into a device body of a medical device.

In one aspect, a method of distinguishing between different connection types of medical devices or syringes, comprising: obtaining any of the medical devices or syringes disclosed herein; and visually and/or tactilely inspecting the visual and tactile characteristics.

Drawings

Fig. 1 and 2 provide perspective views of a connector having a lock-type connection according to an embodiment;

FIG. 3 is a perspective view of a medical device including the connector of FIGS. 1 and 2;

fig. 4 and 5 provide perspective views of a connector having a sliding-type connection according to an embodiment;

FIG. 6 is a perspective view of a medical device including the connector of FIGS. 4 and 5;

fig. 7 and 8 provide perspective views of a connector having a lock-type connection according to one embodiment;

FIG. 9 is a perspective view of a medical device including the connector of FIGS. 7 and 8;

fig. 10 and 11 provide perspective views of a connector having a sliding-type connection according to an embodiment;

FIG. 12 is a perspective view of a medical device including the connector of FIGS. 10 and 11;

FIG. 13 is a cross-sectional view of the medical device of FIG. 12;

FIG. 14 is an enlarged view of the cross-sectional view of FIG. 13; and

FIG. 15 is an exploded view of an embodiment of a medical device.

Detailed Description

Before describing several exemplary embodiments of the invention, it is to be understood that the invention is not limited to the details of construction or process steps set forth in the following description. The invention is capable of other embodiments and of being practiced or of being carried out in various ways.

Visual and tactile features are provided on the medical device to provide a way to distinguish the type of connection.

One or more embodiments provide a syringe having a mistake-proof connection ring that will enable the syringe to meet ISO80369-6(2016) mistake-proof connection requirements. According to one or more embodiments, a syringe may be used for axonal applications when the ring is coupled with a syringe barrel, which syringe will conform to ISO80369-6 (2016).

For the purposes of this application, the following terms shall have the corresponding meanings set forth below.

The recitation of "visual and tactile features" refers to those features that provide an indication by both their appearance (which can be discerned by viewing the feature) and their three-dimensional shape (which can be discerned by touch). The visual and tactile features herein provide an indication as to the type of connection inside the connector, for example, a sliding type or a locking type. The visual and tactile features of one or more embodiments indicate an insertion motion for engaging the connector with another component. For example, one or more grooves or protrusions substantially parallel to the longitudinal axis of the medical device indicate a straight pushing motion. Alternatively, one or more grooves or protrusions that spiral at an angle greater than zero relative to the edge of the medical device perpendicular to its longitudinal axis indicate a turning, twisting motion.

The term "connector" as used herein is understood to include any structure that is part of an axle cable arrangement to which an auxiliary axle cable arrangement can be connected. Non-limiting examples of connectors according to the present invention include syringe tips, needleless connectors, male luer connectors, female luer connectors, side port valves, y-port valves, and other similar structures.

"connection type" refers to a mechanism by which a connector is connected to another medical component. Connection types include, but are not limited to, sliding type connections and locking type connections. Sliding type connections are those that use a nominally linear motion to secure the medical device to the connector. Locking type connections are those that primarily use a twisting or turning motion to secure the medical device to the connector. Other medical components connected to the connector include, but are not limited to, spinal needle assemblies, epidural needle assemblies, spinal and epidural Combination (CSE) needle assemblies, fluid filters, tube adapters.

In fig. 1 and 2, a connector 100 having an exterior surface 102 and an interior surface 104 includes a loop 106 and an elongated tip 108. On the exterior surface 102, there are visual and tactile features 110 corresponding to the type of connection defined by the interior surface 104. The interior surface 104 of this embodiment shows threads 112 that are angled greater than zero relative to an edge 114 of the ring 106. The threads 112 define the connection type as a lock type connection. The threads 112 can engage with corresponding structure on another medical component, such as a lug of a seat of an epidural needle assembly or the like. The movement of the connection to the thread 112 is a twist. The visual and tactile features 110 include grooves that spiral at an angle greater than zero relative to the edge 114. Visually, the groove follows a curved, twisted shape, and tactilely, the touch of a finger will follow the curvature of the groove as an indication that twisting motion will be required to assemble the connector 100 with another component in a locking type connection. Although a groove is illustrated in the present embodiment, a protrusion may alternatively be used. The visual and tactile features do not structurally affect the engagement of the connector with another medical component. In this embodiment, the connector 100 is opaque such that the threads 112 are not visually detectable when viewing the exterior surface 102.

Fig. 3 provides a medical device 120 and connector 100 having visual and tactile features 110 according to fig. 1 and 2. The device has a device body 122 and an end 124 from which the connector 100 extends. The medical device in this embodiment is a syringe that includes a syringe barrel 126, a distal wall 128, and a plunger 130. In one or more embodiments, the medical device is made of a polymeric material or plastic and the connector is integrally formed with the device body 122. Although the embodiments of fig. 1-3 illustrate an opaque connector 100, it is to be understood that non-opaque connectors, such as transparent or translucent connectors, would also benefit from the present disclosure, for example, when a low-light environment is present.

In fig. 4 and 5, connector 150 has an outer surface 152 and an inner surface 154, and includes a loop 156 and an elongated tip 158. On the exterior surface 152, there are visual and tactile features 160 corresponding to the type of connection defined by the interior surface 154. The interior surface 154 of this embodiment is smooth, which defines the connection type as a sliding type connection. The inner surface is engageable with another medical component, such as a seat of an epidural needle assembly or the like, that fits snugly into the channel formed between the ring 156 and the elongate tip 158. The movement of the connection to the connector is a sliding movement. The visual and tactile features 160 comprise grooves that are substantially parallel to the longitudinal axis of the syringe. Visually, the groove follows a straight shape, and tactilely, the touch of a finger will follow the curvature of the groove as an indication that a pushing motion will be required to assemble the connector 150 with another component in a sliding type connection. Although a groove is illustrated in the present embodiment, a protrusion may alternatively be used. The visual and tactile features do not structurally affect the engagement of the connector with another medical component. In this embodiment, the connector 150 is opaque such that the interior surface 154 is not visually detectable when the exterior surface 152 is viewed.

Fig. 6 provides a medical device 170 and connector 150 having visual and tactile features 160 according to fig. 4 and 5. The device has a device body 172 and an end 174 from which the connector 150 extends. The medical device in this embodiment is a syringe that includes a syringe barrel 176, a distal wall 178, and a plunger 180. In one or more embodiments, the medical device is made of a polymeric material or plastic and the connector is integrally formed with the device body 172. While the embodiments of fig. 4-6 show an opaque connector 150, it is to be understood that non-opaque connectors, such as transparent or translucent connectors, would also benefit from the present disclosure, for example, when a low-light environment is present.

In fig. 7 and 8, the connector 200 has an outer surface 202 and an inner surface 204, and includes a ring 206, an elongated tip 208, and a hub 216. On the exterior surface 202, there are visual and tactile features 210 corresponding to the type of connection defined by the interior surface 204. The interior surface 204 of this embodiment shows threads 212 that are angled greater than zero relative to an edge 214 of the ring 206. The threads 212 define the connection type as a lock type connection. The threads 212 can engage with corresponding structure on another medical component, such as a lug of a seat of an epidural needle assembly or the like. The movement of the connection to the thread 212 is a twist. The visual and tactile features 210 include grooves that spiral at an angle greater than zero relative to the edge 214. Visually, the groove follows a curved, twisted shape, and tactilely, the touch of a finger will follow the curvature of the groove as an indication that twisting motion will be required to assemble the connector 200 with another component in a locking type connection. Although a groove is illustrated in the present embodiment, a protrusion may alternatively be used. The visual and tactile features do not structurally affect the engagement of the connector with another medical component. In this embodiment, the connector 200 is opaque, such as metal, so that the threads 112 are not visually detectable when viewing the exterior surface 102.

Fig. 9 provides a medical device 220 and connector 200 having visual and tactile features 210 according to fig. 7 and 8. The device has a device body 222 and an end 224 from which a distal wall extension 232 and connector 200 extend. The medical device in this embodiment is a syringe that includes a syringe barrel 226, a distal wall 228, and a plunger 230. In one or more embodiments, the medical device is made of glass and the connector 200 is made of metal that form fits at the syringe ring interface 216 and the distal wall extension 232. While the embodiments of fig. 7-9 show an opaque connector 200, it is to be understood that non-opaque connectors, such as transparent or translucent connectors, would also benefit from the present disclosure, for example, when a low-light environment is present.

In fig. 10 and 11, connector 250 has an outer surface 252 and an inner surface 254 including a ring 256, an elongated tip 258, and a hub 266. On the exterior surface 252, there are visual and tactile features 260 corresponding to the type of connection defined by the interior surface 254. The interior surface 254 of this embodiment is smooth, which defines the connection type as a sliding type connection. The interior surface can be engaged with another medical component, such as a seat of an epidural needle assembly or the like, that fits snugly into the channel formed between the ring 256 and the elongate tip 258. The movement of the connection to the connector is a sliding movement. The visual and tactile features 260 include grooves that are substantially parallel to the longitudinal axis of the syringe. Visually, the groove follows a straight shape and tactilely, the touch of a finger will follow the curvature of the groove as an indication that a pushing motion will be required to assemble the connector 250 with another component in a sliding type connection. Although a groove is illustrated in the present embodiment, a protrusion may alternatively be used. The visual and tactile features do not structurally affect the engagement of the connector with another medical component. In the present embodiment, connector 250 is opaque, such as metal, so that interior surface 254 is not visually detectable when exterior surface 252 is viewed.

Fig. 12 provides a medical device 270 and connector 250 having visual and tactile features 260 according to fig. 10 and 11. The device has a device body 272 and an end 274 from which the connector 250 extends. The medical device in this embodiment is a syringe that includes a syringe barrel 276, a distal wall 278, and a plunger 280. In one or more embodiments, the medical device is made of glass and the connector 250 is made of metal that form fits at the syringe ring interface 266 and the distal wall extension 282. While the embodiments of fig. 10-12 show an opaque connector 250, it is to be understood that non-opaque connectors, such as transparent or translucent connectors, would also benefit from the present disclosure, for example, when a low-light environment is present.

Fig. 13 is a cross-sectional view of the medical device of fig. 12, and fig. 14 is an enlarged view of the connector end 284 of fig. 13. Longitudinal axis "a" is shown relative to medical device 270. The connector 250 according to fig. 10 and 11 has a visual and tactile feature 260 which is a groove substantially parallel to the longitudinal axis a, indicating a straight pushing movement. Connector 250 is form-fit at its syringe ring interface 266 at a distal wall extension 282 extending from a distal wall 278 of syringe barrel 276. A plunger 280 is located in the body of the syringe barrel 276.

Fig. 15 is an exploded view of an embodiment of a medical device in the form of a syringe 320 that includes a connector 300, which may be the connector in any embodiment of the present disclosure. When syringe 320 is assembled, gasket 301 is positioned between connector 300 and a portion of syringe barrel 326. In this embodiment, there is a distal wall 328 from which extends a distal wall extension 332 to which the syringe ring interface 316 of the connector 300 is mated. When the device is assembled, the plunger 330 is positioned in the syringe barrel 326.

Various examples are listed below. It is to be understood that the embodiments listed below may be combined with all aspects and other embodiments according to the scope of the invention.