WO2003018095A1

WO2003018095A1 - Flexible connector for e.g. medical applications

Info

Publication number: WO2003018095A1
Application number: PCT/US2002/012631
Authority: WO
Inventors: David M. Cise; Edward B. Madsen; L. John Teuscher
Original assignee: Kimberly-Clark Worldwide, Inc.
Priority date: 2001-08-27
Filing date: 2002-04-19
Publication date: 2003-03-06

Abstract

A flexible connector including at least one hub, each hub having an outer wall extending along at least a portion of the circumference of the hub. An inner annulus is disposed within at least a portion of the outer wall, the inner annulus including a surface. A channel extends through the hub, at least a portion of the channel being formed by the inner annulus. A flexible tube having a passageway and a flexible portion and at least one end having an interior surface that is adapted to be attached to at least a portion of the surface of the inner annulus so that, when the end of the flexible tube is attached to the surface of the inner annulus, at least a portion of the end of the flexible tube is positioned within at least a portion of the outer wall.

Description

FLEXIBLE CONNECTOR FOR E . G . MEDICAL APPLICATIONS

The present invention relates generally to flexible connectors, and more particularly to flexible connectors for use in medical applications. Flexible connectors have many applications, including applications in the medical areas such as, for example, respiratory and anesthesiology. In the respiratory and anesthesiology areas, there is frequently a limited amount of space within which to maneuver and position various medical devices to assist the patient. Respiratory therapists and anesthesiologists in particular frequently are active in and around the facial area of the patient.

Such connectors should not collapse radially when flexed to at least a 90-degree angle or twisted so that flow through the connector is unobstructed. To reduce the tendency of the connector to collapse when positioned in a sharp angle, such as, for example, a 90-degree angle, the flexible connector may include a flexible portion. Many different configurations of flexible portions may be used in the present invention, including flexible portions such as those used in bendable straws, pipes, hoses, ductwork, and the like. To further avoid radial collapse of the flexible connector, the flexible portion of the connector may be increased in length. Unfortunately, this may make the device longer than may be desired, due to the spatial constraints in the medical environment. The length of certain portions of such connectors may be governed by international standards, such as ISO 5356-1 (second edition, 1996-12-15). Flexible connectors which do not collapse radially and which occupy a limited amount of space enable the caregivers to more easily and effectively work with and around the patient.

Additionally, flexible connectors that are easy to process are also desirable. Certain molding processes, such as, for example, blow mold extrusion, may have flash from the molding process that remains on particular surfaces of the molded product. It is advantageous, in selected instances, to have a flexible connector that does not require additional or complicated processes to assemble and avoids flash that may be inherent in the molding process. Various embodiments of the present invention are disclosed herein and are directed to a flexible connector that may include at least one hub. Each hub may include an outer wall that extends along at least a portion of the circumference of the hub. An inner annulus may be provided and, in particular embodiments, may be disposed within at least a portion of the outer wall. The inner annulus may include a surface. A channel may extend through the hub, and at least a portion of the channel may be formed by the inner annulus. The flexible connector may also include, in some embodiments, a flexible tube having at least one end, a flexible portion, and a passageway extending through the end and the flexible portion. The end may include an interior surface that may be adapted to be attached to at least a portion of the surface of the inner annulus. In such embodiments, when the end of the flexible tube is attached to the surface of the inner annulus, at least a portion of the end of the flexible tube may be positioned within at least a portion of the outer wall.

Figure 1 is a perspective view of an embodiment of the flexible connector of the present invention.

Figure 2 is a perspective exploded view of an embodiment of the flexible connector of the present invention.

Figure 3 is a partial cross-sectional view of the embodiment of the flexible connector depicted in Figure 1 taken along line 3-3.

Figure 4 is a cross-sectional view of an embodiment of a hub.

Figure 5 is a cross-sectional view of an embodiment of another hub.

Figure 6 is a perspective cross-sectional view of the embodiment of the hub as shown in Figure 5.

Figure 7 is a partial cross-sectional view of an embodiment of the flexible tube of the present invention.

Figure 8 is a perspective view of an alternate embodiment of the flexible connector of the present invention.

Figure 9 is an end view of the flexible connector that is depicted in Figure 8.

Figure 10 is a cross-sectional view of the flexible connector that is depicted in Figure 8, taken along line 10-10. Figure 11 is a perspective view of an alternate embodiment of the present invention.

Figure 12 is a partial side view of an embodiment of the flexible tube of the present invention.

Figure 13 is a partial side view of a portion of the embodiment of the flexible tube that is depicted in Figure 12.

There are a variety of flexible connectors that have been used in the medical arena. Some devices utilize an arrangement of segments, which form a flexible portion of the flexible connector, that may collapse at least partially into each other along a longitudinal direction. One very familiar example of such an arrangement of segments is used in a flexible drinking straw. The segments utilized in such an arrangement may take many various shapes.

For example, such a flexible portion may be formed of circumferential saucer-shaped sections or saw tooth-shaped sections which are integrally formed into the wall of the tubing or other elongated hollow member by a process such as blow mold extrusion and the like. When collapsed, a portion of each saw tooth section may abut against and fit slightly within another portion of that saw tooth section. The saw tooth sections of the flexible portion permit the flexible connector to collapse longitudinally along the length of the flexible portion. In an expanded position, the flexible portion may be bent so that an angle is formed along the longitudinal axis of the flexible portion. Once positioned in such a manner, the flexible portion may retain its bent position when released. Figures 1 and 2 depict an embodiment of the flexible connector 10 according to the present invention. The flexible connector 10 may include a first hub 12, a flexible tube 14 and a second hub 16. Each hub 12 and 16 has a length, L and L' respectively, as shown in Figures 4 and 5. The lengths L and L' extend in a direction parallel to the longitudinal axis of the flexible connector 10. The first hub 12 may be attached to an end 18 of the flexible tube 14 and the second hub 16 may be attached to an end 22 of the flexible tube

14. Disposed between the ends 18 and 22 of the flexible tube 14 is a flexible section 20. A passageway 26 extends through flexible tube 14, permitting gasses, instruments, and the like to pass through the flexible connector 10.

The flexible section 20 may, in selected embodiments, permit the flexible tube 14 to be bent to a particular position without collapsing the flexible tube radially inwardly. In some embodiments, the flexible section 20 may be formed so that the flexible tube 14 is retained in a bent position once it has been so positioned by a user. A variety of means for flexing the tube 14 may be used in the present invention, and many of these different configurations are well-known as forming such and similar types of flexible sections.

In some embodiments and as shown in Figures 1-3 and- 7, 8, and 10-13, the flexible section 20 may include a plurality of saw-tooth segments 24. Many different configurations of such saw tooth segments are available and may be suitable for use in various embodiments of the present invention. For example, the saw tooth segments used in the present invention may be similar to that shown and described in U.S. Patent Application having serial no. 09/401 ,397, filed on September 22, 1999 and which is hereby incorporated by reference in its entirety. Some additional configurations of flexible sections which may be used in the present invention are disclosed in the following U.S. patents, each of which are hereby incorporated by reference in its entirety: U.S. Patent No. 4,921 ,147 issued to Poirier; U.S. Patent No. 4,516,573 issued to Gedeon; U.S. Patent No. 4,340,089 issued to Freiherr von Arnim et al.; U.S. Patent No. 3,929,165 issued to Diebolt et al.; U.S. Patent No. 3,409,224 issued to H.J. Harp et al.; and U.S. Patent No. 3,388,705 issued to Grosshandler.

A partial view of an embodiment of the flexible section 20 of the present invention is depicted in Figures 12 and 13. In such an embodiment, the flexible section 20 includes a plurality of sections 121-129 that have a configuration that permits the flexible section 20 to bend and, in some embodiments, retain its bent orientation when released. Each section 121-129 includes a pair of oppositely facing frustoconical members 130 and 132, such as those depicted with respect to the section 122. While the largest and the smallest diameters of each frustoconical member 130 and 132 are the same, the longitudinal lengths of the frustoconical members 130 and 132 are different. In the embodiment depicted in Figures 12 and 13, the frustoconical member 132 has a greater longitudinal length than the longitudinal length of the frustoconical member 130. When the end 104 is forced toward the end 106 along the longitudinal axis of the flexible section 20, the frustoconical member 132 substantially maintains its shape, while the frustoconical member 130 inverts to fit within the frustoconical member 132. Thus, the flexible section 20 will collapse at least partially upon itself to shorten its length. A similar condition occurs when the flexible section 20 is bent in a direction relative to its longitudinal axis. As the flexible section 20 is bent, the sides of the frustoconical members 130 and 132 on the side of the flexible section 20 that are in the direction of bend will fold upon themselves to shorten the length of the flexible section 20 along that side. Referring now to Figure 13, the sections 123 and 124 are defined by frustoconical members 134, 135, 136, and 137, respectively. The frustoconical members 134 and 136 face in opposite directions to and alternate with the frustoconical members 135 and 137, respectively. The frustoconical members 134 and 135 define an apex 139. The frustoconical members 136 and 137 define an apex 141. The apexes 139 and 141 define an outer diameter of the flexible section 20 which may be approximately equal to the 5 diameter of the ends 18 and 22 of the flexible section 20.

Each of the frustoconical members 135 and 137 that resist inversion when the flexible section 20 is longitudinally collapsed may be provided with circumscribing reinforcing ribs 140 and 142 that may be integrally formed therewith. With reference to the apex 139, the rib 140 may be configured to have a width that is similar to its height 0 and may be positioned adjacent to or near the apex 139. The second rib 142 may have a smaller diameter, depending upon its location, and may be spaced apart from the first rib 140. The ribs 140 and 142 may provide structural support for the frustoconical member 135 so that the flexible section 20 will more rigidly hold its position when bent to a position that causes one or more frustoconical members, such as frustoconical member 134, to 5 invert. Thus, the ribs 140 and 142 may be configured to stop compression of the frustoconical portion 135 in a direction perpendicular to the longitudinal axis of the flexible section 20.

In the embodiment depicted in Figure 3, the saw tooth segments 24 are positioned between two ends 18 and 22, each end having an interior surface 19 and 23, respectively. 0 A passageway 26 extends through the flexible tube 14. In some embodiments, the interior diameter of the end 18 may be the same as the interior diameter of the end 22. Such a configuration may permit simpler and more expedient processing of the flexible connector 10.

The first hub 12 may, in particular embodiments, include an outer wall 30. As 5 shown in Figure 1 , the outer wall 30 may be generally cylindrical in shape and have an outer circumference.

A gripping ring 32 may also be provided that assists a user to properly grip and position the hub 12. The gripping ring 32 may be formed of an annular member 35 that may extend outwardly from the outer wall 30 or other portion of the hub 12. The gripping o ring 32, in selected embodiments, may also include a step 36 that extends downwardly from the annular member 35 and extends toward the flexible tube 14.

In some embodiments, the gripping ring 32 may include additional grip-enhancing features such as, for example, the detents 34 that are best seen in Figures 1 and 6.

As shown in Figures 3, 4 and 10, an inner annulus 40 may be positioned within the 5 outer wall 30 and may be joined to the outer wall 30. In some embodiments, the inner annulus 40 may be joined to the outer wall 30 proximate to one end of the hub 12. In other embodiments, the inner annulus 40 may be joined to the outer wall 30 somewhere along their lengths. At least a portion of the inner annulus may form a channel 42. The channel 42 may extend through the length L of hub 12, having an outer portion 44 and an inner portion 46, the inner portion 46 being disposed proximate to the end 18 of the flexible tube 14. A transition portion 48 may also be included in the channel 42, the transition portion 48 extending between the outer portion 44 and the inner portion 46. The transition portion 48 may have a variety of configurations and, in particular embodiments, selected areas of the transition portion 48 may be sloped (as shown in Figure 5) or curved (as shown in Figure 4). The inner annulus 40 includes a surface 52 which, as seen in the embodiment shown in Figures 3 and 4, may be spaced apart from the interior surface 31 of the outer wall 30 along at least a portion of the length L of the outer wall^' 30. As shown in Figure 4, the inner annulus 40 may extend beyond the gripping ring 32.

The hub 12 may be attached to the end 18 of the flexible tube 14 by fitting the end 18 over the surface 52 of the inner annulus 40. In some embodiments, at least a portion of the end 18 of the flexible tube 14 may be positioned within at least a portion of the outer wall 30. Many attachment schemes may be used to secure the hub 12 to the flexible tube 14 and minimize air leakage between the surface 52 of the inner annulus 40 and the interior surface 19 of the end 18. For example, the end 18 may be force-fit onto the surface 52 of the inner annulus 40. Alternately, the flexible tube 14 may, after placement over the surface 52, be shrunk to fit more securely to the hub 12.

As shown in Figures 3, 5, 6 and 10, the second hub 16 may, in particular embodiments, include an outer wall 60, which may be generally cylindrical in shape and have an outer circumference. Other configurations of the outer wall 60, such as, for example, the configuration shown in Figures 8-10 having an elliptical cross-section, may also be used. The configuration of the outer wall 60 may be altered to enhance grippability, if desired for a particular application in any one or more of the manners noted above.

A gripping ring 62 may also be provided that assists a user to properly grip and position the hub 16. The gripping ring 62 may include an annular member 65 that may extend outwardly from the outer wall 60 or other portion of the hub 16. The gripping ring 62, in selected embodiments, may also include a step 66 that extends toward the flexible tube 14 from the annular member 65. In some embodiments, the gripping ring 62 may include additional grip-enhancing features such as, for example, any one or more of the grip-enhancing features noted above. In particular, one or more detents such as detents 64 that are shown in Figures 1 and 6 may be utilized. As shown in Figures 3, 5, 6, and 10, an inner annulus 70 may be positioned within the outer wall 60 and may be joined to the outer wall 60. In some embodiments, the inner annulus 70 may be joined to the outer wall 60 proximate to the end 22 of the hub 16. In other embodiments, the inner annulus 70 may be joined to the outer wall 60 at some other point along their lengths. At least a portion of the inner annulus 70 may form a channel 72. The channel 72 may extend through the length U of hub 16, having an outer portion 74 and an inner portion 76, the inner portion 76 being disposed proximate to the end 22 of the flexible tube 14. A transition portion 78 may also be included in the channel 72, the transition portion 78 extending between the outer portion 74 and the inner portion 76. The transition portion 78 may have a variety of configurations and, in particular embodiments, selected areas of the transition portion 78 may be sloped or curved.

The inner annulus 70 may include a surface 82 which, as seen in the embodiments shown in Figures 3, 5, and 6, may be spaced apart from the interior surface 61 of the outer wall 60 along at least a portion of the length L' of the outer wall 60. As shown in Figures 5 and 6, the inner annulus 70 may extend beyond the gripping ring 62.

The hub 16 may be attached to the end 22 of the flexible tube 14 by fitting the end 22 over the surface 82 of the inner annulus 70. In particular embodiments, at least a portion of the end 22 of the flexible tube 14 may be positioned within at least a portion of the outer wall 60. Many attachment schemes may be used to secure the hub 16 to the flexible tube 14 and minimize air leakage between the surface 82 of the inner annulus 70 and the interior surface 23 of the end 22, including, for example, those discussed previously with regard to the hub 12 and the end 18 of the flexible tube 14.

Additional retention mechanisms may be used which may help to retain the ends 18 and 22 of the flexible tube 14 onto the surfaces 52 and 82 of the inner annulus 40 and 70 of the hubs 12 and 16, respectively. Such means for retaining may be used which may help to retain the end of the flexible tube onto the surfaces of the inner annulus of the hubs. For example, adhesive may be used to secure the hub to the flexible tube. Spin welding or sonic welding may also be used in the present invention.

Referring now to Figures 2, 3, 6 and 7, a groove-and-boss configuration may also be used, where a groove, such as the groove 28 formed in the ends 18 and 22 of the flexible tube 14, engages a boss, such as the boss 54 that is disposed on the surface 52 of the inner annulus 40 of the hub 12 or the boss 84 that is disposed on the surface 82 of the inner annulus 70 of the hub 16. Although the bosses 54 or 84 may be variously positioned on the outer wall, they may be positioned near the lower portion of the inner annulus 40. The groove-and-boss configuration may utilize any of a variety of groove and/or boss configurations. Such a groove-and-boss configuration, either alone or in conjunction with other mechanisms, may be useful in securing the hubs to the ends of the flexible tube.

The hubs 12 and 16 may be manufactured from a wide variety of materials, including, for example, polypropylene or styrene block copolymers such as K-Resin™ that is available from Phillips Petroleum. Other materials may also be used to manufacture the hubs 12 and 16 such as, for example, acrylic, polycarbonate, and ABS.

The hubs 12 and 16 may also be formed into various sizes so that they are suitable for connection to various respiratory devices. For example, the hub 12 may be formed so that it functions as both a 15 mm female connector and a 22 mm male connector. The hub 16 may also be formed so that it functions as a 15mm male connector. In some embodiments, the same hub configuration may be utilized on both ends 18 and 22 of the flexible tube 14. In other embodiments, only one hub may be attached to the flexible tube 14. The hubs 12 and 16 and the flexible tube 14 may be manufactured so that they are translucent, opaque or specially colored for particular applications.

The hubs 12, 16 and the flexible tube 14 may be formed from materials that are sterilizable by a variety of sterilization processes including, for example, gamma irradiation and ethylene oxide.

The flexible tube 14 may also be formed from a variety of materials, such as, for example, a polypropylene copolymer or ethylvinylacetate.

The invention may be embodied in other specific forms without departing from the scope and spirit of the inventive characteristics thereof. The present embodiments therefore are to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

It is emphasized that the Abstract is provided to comply with the rules requiring an abstract that will allow a searcher or other reader to quickly ascertain the subject matter of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. 37 CFR 1.72(b).

Claims

I claim:

1. A flexible connector comprising: at least one hub comprising an outer wall extending along at least a portion of the circumference of the hub, an inner annulus disposed within at least a portion of the outer wall, the inner annulus comprising a surface, and a channel extending through the hub, at least a portion of the channel being formed by the inner annulus; a flexible tube comprising a passageway extending through the flexible tube, a flexible portion, and at least one end that is adapted to be attached to at least a portion of the surface of the inner annulus so that, when the end of the flexible tube is attached to the surface of the inner annulus, at least a portion of the end of the flexible tube is positioned within at least a portion of the outer wall.

2. The flexible connector as claimed in claim 1 , the end comprising an interior surface that is adapted to be attached to at least a portion of the surface of the inner annulus.

3. The flexible connector as claimed in claim 1 , the hub attached to the flexible tube so that the channel is substantially aligned with the passageway.

4. The flexible connector as claimed in claim 1, the flexible tube being longitudinally collapsible.

5. The flexible connector as claimed in claim 1 , the flexible portion comprising a plurality of saw tooth segments.

6. The flexible connector as claimed in claim 1 further comprising a retention mechanism that assists in retaining the end of the flexible tube on the surface of the inner annulus.

7. The flexible connector as claimed in claim 6, the retention mechanism comprising a groove-and-boss configuration.

8. The flexible connector as claimed in claim 1 , the end of the flexible tube being force fit onto the surface of the inner annulus.

9. The flexible connector as claimed in claim 1, the flexible tube being formed of polypropylene.

10. The flexible connector as claimed in claim 1 , the flexible tube being formed of ethyl vinyl acetate.

11. The flexible connector as claimed in claim 1 , the hub being formed of a styrene- butadiene-styrene block copolymer.

12. A flexible connector for use in medical applications comprising: two hubs, each hub comprising an outer wall extending along at least a portion of the circumference of the hub, an inner annulus disposed within at least a portion of the outer wall, the inner annulus comprising a surface and a boss extending from the surface, a channel extending through the hub, at least a portion of the channel being formed by the inner annulus a flexible tube comprising a passageway extending through the tube a flexible portion two ends, at least one end comprising a groove adapted to engage the boss disposed on the hub, and an interior surface that is adapted to be attached to at least a portion of the surface of the inner annulus of one hub so that, when one of the ends of the flexible tube is attached to the surface of the inner annulus of one of the hubs, at least a portion of the end of the flexible tube is positioned within at least a portion of the outer wall.

13. The flexible connector as claimed in claim 12, the hub attached to the flexible tube so that the channel is substantially aligned with the passageway.

14. The flexible connector as claimed in claim 12, the flexible portion comprising a plurality of collapsible saw tooth segments

15. The flexible connector as claimed in claim 12 further including a grip ring disposed about at least a portion of the outer wall.

16. The flexible connector as claimed in claim 15, the grip ring comprising at least one detent formed therein.

17. The flexible connector as claimed in claim 15 further including a step disposed proximate to an outer portion of the grip ring.

18. The flexible connector as claimed in claim 12 further comprising means for retaining at least one end of the flexible tube to the hub.

19. The flexible connector as claimed in claim 18 wherein the means for retaining comprises a clip.

20. The flexible connector as claimed in claim 18 wherein the means for retaining comprises adhesive.

21. A flexible connector for use in medical applications comprising: two hubs, each hub comprising an outer wall extending along at least a portion of the circumference of the hub, an inner annulus disposed within at least a portion of the outer wall, the inner annulus comprising a surface, a channel extending through the hub, at least a portion of the channel being formed by the inner annulus a flexible tube comprising a passageway extending through the tube means for flexing the tube two ends, each end comprising an interior surface that is adapted to be attached to at least a portion of the surface of the inner annulus of one hub so that, when one of the ends of the flexible tube is attached to the surface of the inner annulus of one of the hubs, at least a portion of the end of the flexible tube is positioned within at least a portion of the outer wall.

22. The flexible connector as claimed in claim 21 , the means for flexing the tube comprising a plurality of saw tooth segments.

23. The flexible connector as claimed in claim 21 further including a grip ring disposed about at least a portion of the outer wall.

24. The flexible connector as claimed in claim 23, the grip ring comprising at least one detent formed therein.

25. The flexible connector as claimed in claim 21 further comprising means for retaining at least one end of the flexible tube to the hub.

26. The flexible connector as claimed in claim 25 wherein the means for retaining comprises adhesive.

27. The flexible connector as claimed in claim 21 , each end of the flexible tube being force fit onto the surface of the inner annulus of one hub.

28. The flexible connector as claimed in claim 21 , the flexible tube being formed of a polypropylene copolymer.

29. The flexible connector as claimed in claim 21 , the flexible tube being formed of an ethylvinylacetate.

30. The flexible connector as claimed in claim 21 , the hub being formed of a styrene copolymer.