The present invention relates to an connector or fitting adapter that is adapted to connect devices that have connector fittings that are not directly connectable to each other, and also act as an intermediary connector to devices with connector fittings.
To prevent mis-connection of a fluid line or a fluid store containing a particular medication to a needle and/or an infusion line, the prior art discloses the use of a two part connector with complementary configured opposing surfaces. Such two part connector is disclosed in U.S. Pat. No. 6,612,624 and its parent U.S. Pat. No. 6,402,207.
U.S. Pat. No. 7,497,484, assigned to the assignee of the instant application, discloses a three component connector or fitting adapter for connecting devices with different connector fittings that include a shroud, an inner shroud and a core. US application No. 11/342,620, filed Jan. 31, 2006, published as US 2007/0179454, also assigned to the assignee of the instant invention, discloses a fitting adapter that has a shroud and an adapter core fitted therein. In both the '484 patent and the '620 application, the adapter core has a through channel where fluid between the devices with different fittings flows. The respective disclosures of the '484 patent and the '620 application are incorporated by reference to the disclosure of the instant application.
Each fitting adapter of the '484 patent and the '620 application has a core through which fluid is directly conveyed between two devices each independently connected to one of the ends of the adapter. Due to possible mis-tolerance during the manufacturing of the components, friction that may result from the interaction between the components, and/or possible material dissimilarities of the mating to the components that cause the components to stick, there are instances where the rotation of one device connected to one end of the adapter may cause rotation of the other device connected to the other end of the adapter. As a result, instead of being able to remove a device from a particular end of the adapter, the device may actually be removed with the adapter attached thereto, as the adapter is disconnected at its other end from the other device.
The adaptive connector or fitting adapter (or simply connector or adapter) of the instant invention has a first member and a second member, with each of the members having a portion matable to each other. Respective coacting coupling mechanisms in each of the members ensure that the members, once matingly coupled to each other, remain non-removably connected to each other. The members have respective through passages that are aligned to be inline along a longitudinal axis, when the members are coupled together, so that the in alignment passages in combination establish a through channel wherethrough fluid may flow across the connector.
At the respective ends of the members not connected together there are provided different types of connector fittings or the same connector fitting. One of the fittings is a conventional fitting such as a female luer connector that is matable to a counterpart conventional fitting such as a male luer connector of one device. The other connector fitting is a non-conventional fitting, for example a male CorrectInject™ (CI) connector, that is matable only to a counterpart non-conventional fitting, i.e., a female CorrectInject™ (CI) connector, of another device. Both the male and female CI connectors are manufactured by the assignee of the instant application. An elastomeric seal such as a silicone O-ring is positioned at or proximate to the interface of the through passages of the two mated members to prevent fluid leakage from the adapter. An alternative embodiment of the inventive connector has both of its fittings being conventional fittings, i.e., luer fittings, so that the connector may be advantageously used as an intermediary to connect devices that have counterpart conventional connector fittings.
A ratchet mechanism is provided in the adapter to enable the members to rotate relative to each other in one direction but rotate together or in unison when either one of the members is rotated in a counter rotation, or a rotation that is opposite to the rotation that causes the members to rotate in unison. A device, such as a medical device including a syringe, a fluid line or a fluid store or bag, that has a counterpart conventional fitting is connectable to the conventional fitting of the one member. Once fully mated, the medical device is no longer removable from the adapter, as the rotation of the medical device in the direction opposite to that used to connect it to the adapter would merely cause the medical device to rotate with the one member of the adapter it is mated to, as the other member of the adapter remains stationary relative to the one member.
A second device such as a medical device including a needle or a fluid line for providing a medicament or infusate to the patient having a counterpart conventional or non-conventional fitting is matingly connectable to the conventional or non-conventional fitting at the other member of the adapter. Once fully mated, if the second medical device were turned in a counter direction, i.e., a rotation opposite to that used to connect it to the adapter, the second medical device likewise is not removable from the adapter, as the member to which it is connected would rotate together with the second medical device. The connector therefore enables the devices connected thereto to be rotated relative to each other to rotatably align to each other, if such rotational alignment is desired. However, the second medical device is removable from the adapter by a counter-rotational movement relative to the second member, if the housing of the second member, which forms the housing of the adapter, is fixedly held while the second medical device is turned.
The instant invention is therefore directed to a connector for connecting devices having conventional and/or non-conventional fittings to effect a fluid path between the fittings. The connector has a first member having a first through passage, a first coupling mechanism, a first distal portion with a distal end and a first proximal portion with a first proximal end including a first fitting matable with a counterpart first fitting of a first device. The connector further has a second member having a second distal portion with a second distal end and a second proximal portion connectable to the first distal portion. The second proximal portion has an inner diameter larger than the outer diameter of the first distal portion so that the first distal portion is inserted into or matable with the second proximal portion. A second through passage extends along the second distal portion and a second coupling mechanism is formed internally in the second proximal portion. A second distal end of the second member includes a conventional or non-conventional second fitting that is matable with a counterpart conventional or non-conventional fitting. When the first distal portion is matingly coupled to the second proximal portion, the first and second coupling mechanisms are non-removably engaged to each other with the first and second through passages in alignment to establish a fluid through channel across the first and second members. An O-ring is positioned in intimate contact with the first distal portion and the second proximal portion to effect a fluid tight seal for the connector. A ratchet mechanism in the adapter enables the selective rotation of the members of the connector.
Thus, the connector of the instant invention provides a through passage established by two members that are non-removably connected to each other but rotatable independent of each other when rotated in a given direction relative to each other, so as to enable the rotational alignment of the devices.
The present invention is also directed to a connector adapted to connect devices with conventional and/or non-conventional connector fittings that are not matable to each other. The connector has a first member having a first through passage, a first coupling mechanism and a first fitting at a first proximal end for mating with a counterpart first connector fitting of a first device. The connector further has a second member having a second through passage, a second coupling mechanism and a second fitting at a second distal end for mating with a counterpart second connector fitting of a second device. The first and second through passages are positioned in alignment along a longitudinal axis when the first and second members are connected to each other with the first and second coupling mechanisms engaged, so that the in-alignment first and second through passages effect a through channel across the first and second members to enable the exchange of fluid between the first and second devices when the first and second devices are mated to the first and second members, respectively. A seal may be provided in the connector to prevent fluid leak. A ratchet mechanism may be provided in the connector to enable the first and second members to rotate in unison when either of the members is rotated in one direction relative to the other, and each rotate independently of the other when either of the members is rotated in an opposite direction relative to the other. The one and other directions may also be referred to as the clockwise and counterclockwise rotation or direction.
The connector of the instant invention is also adapted to connect one device with a conventional connector fitting and an other device with a non-conventional connector fitting so that the one and other devices that otherwise are not connectable to each other may nonetheless be connected via the connector so that a fluid path may be established between the one and other devices. Conversely, the inventive connector prevents the inadvertent connection of a device, for example a medical syringe, to another device, for example a medical needle, that were not meant to be connected together, to thereby prevent mis-connection of the devices.
The invention is further directed to a method of making a connector for connecting two devices each with a connector fitting to enable the exchange of fluid between the devices that includes the steps of:
The inventive method also includes the steps of providing a seal to prevent fluid leakage from the connector, and providing a ratchet mechanism in the connector to selectively enable the members of the connector to rotate in unison in one direction but rotate independently of each other when either of the members is rotated in an opposite direction relative to the other.
In an alternative embodiment, the connector may have conventional connector fittings at the respective ends of the members that are not coupled to each other so that the connector may act as a bridge for devices with conventional fittings where it may be advantageous to have one of the devices non-removably connected to the connector and the other of the devices removably connectable to the one device. This obviates the need to have the two devices connected directly to each other, as the connector of the instant invention provides a robust connector bridge for the devices in the event that it may not be a good idea to repeatedly connect/disconnect the conventional connector fitting of one of the devices to the conventional connector fitting of the other device.
The present invention will become apparent and the invention itself will be best understood with reference to the following description of the present invention taken in conjunction with the accompanying drawings, wherein:
With reference to
Further with reference to
Further per shown in
There is further provided at the distal portion 4f of the first member 4 a circumferential shoulder 4i that has a diameter smaller than either of flanges 4g and 4e. An extension 4j extends from shoulder 4i to the distal end 4k at the distal portion 4f of the first member 4. It is at extension 4j that an elastomeric seal such as the silicone O-ring shown in
The second member or the housing 6 of the fitting adapter of the instant invention is shown in greater detail in
Second member 6 has at its proximal portion 6a an enlarged base or ring 6h that has a number of apertures or windows 6i which, for the embodiment shown in
Each of projections 6j has a surface 6j1 that slopes downwards at an incline toward the interior of second member 6 from its inner wall 6k. The thus chamferred protrusions 6j enable disklike flange 4g, with counter chamferred surface 4g1 at its outer edge, to readily move past the protrusions 6j, when the first distal portion 4f is inserted into the second proximal portion 6a along the direction indicated by directional arrow 10. The back surfaces 6j2 of the respective protrusions, since they are flat, along with the flat back surface 4g2 of flange 4g, prevent first member 4 and second member 6 from separating once flange 4g moves past protrusions 6j and the respective back surfaces 4g2 of flange 4g and 6j2 of protrusions 6j are non-fixedly engaged to each other, per shown in
Base 6h of second member 6 also has an internal shoulder 6I whose inner wall is formed to have a plurality of ramp stops 6m. As best shown in the end view of
As best illustrated with
As shown from the distal end view of member 6 in
With reference to
Although the distal end 4k of member 4 is in close proximity to the internal opening of passage 16 at distal portion 6b of member 6, to prevent leakage of fluid that passes through passages 8 and 16, an elastomeric seal such as a silicone O-ring 17 is placed in the space defined by the well 6o of member 6, so as to be in intimate contact with the outer wall of distal portion 4f of member 4 and the inner wall of well 6o, i.e., the inner wall of the proximal portion 6a of member 6. With O-ring 17 in place, a fluid tight seal is established between members 4 and 6 as fluid passes along the through channel formed by the inline passages 8 and 16. The internal thread 6s of the non-conventional CI fitting at distal portion 6b of member 6 is shown in the cross-sectional view of
When fitting adapter 2 is matingly connected to the counterpart conventional fitting 20 by its conventional fitting at proximal end 4b, and matingly connected to the counterpart non-conventional fitting 22 by its non-conventional fitting at distal portion 6b, the medicament stored in device 18 is conveyable to a patient by means of device 24 via the through channel established by through passages 8 and 16 in fitting adapter 2. Device 18 has a passage 18a at its conventional male luer fitting 20 that is mated to the conventional female luer fitting at proximal end 4b of fitting adapter 2. Device 24 has a passage 24a at its counterpart non-conventional fitting 22 (female CI fitting) that is mated to the non-conventional fitting (male CI fitting) at distal end 16g of fitting adapter 2.
Device 18 is connectable to member 4 by rotating device 18, relative to member 4, in one direction, for example the clockwise direction designated by positional arrow 12, to mate the male luer fitting of device 18 to the female luer fitting of member 4. Once fully connected, additional rotation of device 18 in the same clockwise direction, relative to member 4 and member 6 being held fixedly, would cause members 4 and 6 to rotate in unison, as end 4h2 of at least one of the pawls 4h comes into contact with end stop 6m2 of at least one of the ramp stops 6m, as shown in
The counterpart non-conventional fitting of device 24 is connectable to the non-conventional fitting of member 6 of the adapter by rotating device 24 in the clockwise direction while member 6 is fixedly held, for example by the user's fingers holding elongate extension 6c. Once the non-conventional CI fittings are fully mated, additional rotation of device 24, relative to adapter 2, in the clockwise direction without fixedly holding in place member 6 would cause members 6 and 4 to rotate together in unison, as once again the end 4h2 of one of the pawls 4h comes into contact with one of the stops 6m2 of the plurality of ramp stops 6m to force the tandem rotation of members 4 and 6. This occurs when for example the user is holding device 18 (or device 24) while rotating device 24 (or device 18) in the clockwise direction.
When device 24 is rotated in the counterclockwise direction while device 18 is being fixedly held, device 24 is not removable from the distal portion 6b of member 6, as member 6 is rotated along with device 24, due to the plurality of pawls 4h and ramp stops 6m passing over each other by means of their respective curved surfaces 4h1 and ramped surfaces 6m1. However, device 24 is removable from fitting adapter 2 when extension 6c is fixedly held while device 24 is rotated in the counterclockwise direction.
Advantageously, given that the two members 4 and 6 have respective passages 8 and 16 that are separate from each other, the fluid passages are therefore independent from each other. As a result, the possibility that the rotational movement of one device attached to one end of the fitting adapter may cause an unintended rotation of the other device attached to the other end of the fitting adapter due to a single core having a single through passage is eliminated for the fitting adapter of the instant invention. Thus, subject to the interaction of the pawls with the ramp stops, the devices attached to the fitting adapter of the instant invention would rotate in unison in one direction and are freely rotatable relative to each other in the opposite direction, i.e., an other direction. Yet if the housing of the adapter were fixedly held, and the device with the counterpart non-conventional fitting is rotated in the counterclockwise direction relative to the adapter, the counterpart non-conventional fitting is removable from the non-conventional fitting of the adapter.
The fitting adapter may be manufactured cost effectively, in that members 4 and 6 each are molded from a medical plastics material such as polybutylene terephthalate. Moreover, the silicone O-ring 17 is an inexpensive component that may be an off shelf item. If appropriate, other elastomeric or rubber seals or rings may be used in place of the silicone O-ring.
To enable the user to readily determine that the fitting adapter of the instant invention is to be used to connect a medical device with a conventional fitting to another medical device with a non-conventional fitting, both members 4 and 6 may be color coded to have a specific color, for example yellow, to distinguish the adapter from other medical devices or components that may be in the vicinity of the fitting adapter, for example in the same tray or container as the fitting adapter. Alternatively, members 4 and 6 may have different colors to better distinguish the connector members, for example different colors for the conventional and non-conventional connector members.
Although discussed above as having a conventional fitting at distal end 4b and a non-conventional fitting at distal end 6g, it should be appreciated that the placement of those fittings may be reversed, for example the conventional luer fitting may be formed at the distal end 6g while the non-conventional CI fitting may be formed at the distal end 4b of the fitting adapter. Also, instead of the adapter having a female luer fitting and a male CI fitting, a yet further embodiment of the fitting adapter may have a conventional male luer fitting and a non-conventional female CI fitting. Furthermore, as discussed above, the dimension of base 6h, relative to the rest of member 6, may well be different from that shown. For example, base 6h may in actuality be reduced in dimension relative to the rest of member 6. With a reduction in the diameter of base 6h, flanges 4e and 4g likewise would have a smaller diameter, so that a portion of member 4 nonetheless is insertable into a corresponding portion of member 6 and non-removably attached thereto, as discussed above. It should moreover be noted that device 18 may be bonded to member 4, for example by gluing, so that the connector of the instant invention becomes a part of the medication dispensing device.
A variant of the connector of the instant invention is illustrated in
The adaptive connector 2′ shown in
In the case where connector 2′ has securely attached at its two ends the connector fittings of different devices, the fact that members 4 and 6 are rotatable relative to each other means that the devices connected to connector 2′ may be rotated about the longitudinal axis 9 of the connector to enable rotational alignment of the devices. Such rotational alignment attribute of the inventive connector advantageously also allows a device that is not meant to be repetitively connected and disconnected to be connected to one fitting of the inventive connector, so that the other fitting of the inventive connector may act as an intermediary connector to enable the device to be repeatedly connected to and disconnected from other devices. So, too, by being able to relatively rotate the devices that are coupled to the connector, the user may readily rotate or realign each of the respective connected devices, relative to the connector, without compromising the integrity of the fluid path established between the two devices, as the fluid passage along the inventive connector is a combination of two separate but in alignment through channels. One such exemplar use is the rotational repositioning or realignment of a manometer relative to a spinal needle that has been inserted into a patient to measure the pressure in the spinal fluid. To elaborate: the inventive connector may have connected to its one end a spinal needle (either 2 or 2′ depending on whether the coupling of the spinal needle to the connector is mating between conventional or non-conventional fittings), and it is desired to connect a manometer to the spinal needle to gauge the pressure in the spinal column. For this example, the manometer may comprise a 3-way stopcock with a long hollow plastic or glass cylinder or tubing inserted into the center port and its output port connected to the fitting at member 4 and its input port presumably connectable to a syringe or fluid line. To ensure that the spinal pressure is measured correctly, the tubing has to be at a vertical position relative to the needle. That the members of the inventive connector are rotatable relative to each other means that while the spinal needle is held stationary, the tubing may be rotated to its vertical orientation without compromising the security of the fluid path to thereby determine the fluid level in the vertical tubing, and hence the pressure in the spinal column.
Even though the rotational alignment of devices connected to the connector is discussed above with reference to conventional fittings and the connector shown in
It should be appreciated that even though the embodiment of the inventive connector shown in
The present invention is subject to many variations, modifications and changes in detail. Accordingly, it is intended that the instant invention be limited only by the spirit and scope of the hereto appended claims.
Number | Date | Country | |
---|---|---|---|
61783009 | Mar 2013 | US |