AU754811B2 - Medical connector - Google Patents

Description

4 AUSTR4.LIA PATENTS ACT 1990 DIVISIONAL APPLICATION NAME OF APPLICANT(S): ICU Medical, Inc.

ADDRESS FOR SERVICE: DAVIES COLLISON CAVE Patent Attorneys 1 Little Collins Street Melbourne, 3000.

INVENTION TITLE: "Medical connector" The following statement is a full description of this invention, including the best method of performing it known to us: 4 4.

*4 Q:\OPER\DH\Arch 2000\june\62716-96div.180.doc 28/6/00 -1A- MEDICAL CONNECTOR Background of the Invention Field of the Invention This invention relates to the field of medical devices using a valve for transferring medication intravenously from one location to another. More specifically, this invention is directed to an improvement in medical valves to ensure that the patient receives the entire dosage of medication, while also providing a means for withdrawing blood from the patient.

Background Discussion The manipulation of fluids for parenteral administration in hospital and medical settings routinely involves the use of connectors for facilitating the movement of fluids between two points. Oftentimes it is desirable to have the patient receive medication from a number of different sources using the same IV. Such a system may be accomplished, for example, by using a Y-connector, a piggy-back connector, a T-connector, or a manifold. Such devices have at least one secondary conduit connected with the primary conduit to add one or more secondary fluids, such as drugs, for example, to the primary fluid being infused into a patient through the primary conduit.

Many connectors or valves, especially those employing several mechanical components, have a relatively high volume of fluid space within them. A serious problem in the medical field has been the S'existence of this "dead space" at the intersection between the arm and the main bore in medical connectors which prevents the patient from receiving the full dosage of medication, since some of the medicine remains 20 in the dead space of the connector. For example, in several prior art manifolds the operator inserts a syringe into the secondary conduit to introduce a secondary fluid into the primary fluid stream. However, because of the dead space that exists between the end of the syringe and the primary conduit passage, some of the secondary fluid will remain in the junction between the secondary conduit and the primary conduit Previous valving devices have focused on removing the undesirable dead space in such devices.

A one-way valving apparatus formed in a manner such that creation of undesirable volumetric dead space is substantially precluded is shown in U.S. Patent No. 4,666,429 to Stone and U.S. Patent No.

3,416,567 to Von Dardel et aL In the several embodiments described, a movable element is positioned adjacent to the inner wall of the primary conduit at the junction between the secondary and primary conduits so that the movable element forms a one-way valve. The design of the secondary conduit allows the tip of a syringe nozzle to be substantially adjacent to the movable element. The movable element is partially displaced due to fluid pressure from the flow of secondary fluid through the secondary conduit toward the primary conduit thereby allowing the secondary fluid to pass by the movable element and enter the primary conduit stream. Once the secondary fluid passes through the junction, the movable element returns to its original position, blocking the junction between the primary and secondary conduits.

In the intravenous environment, it is often desirable to utilize a device having the capability of both introducing fluid medication or withdrawing blood from a patient. However, the movable element of the '429 and '567 patents provide only one-way fluid flow, since the movable element is not displaced due to fluid flow in the primary passageway, and therefore, fluid from the patient cannot be drawn into the secondary conduit. Two-way valves are advantageous for drawing a patient's blood back to determine if the IV system is properly inserted into a patient's vein to provide medication. Further, two-way valves have the additional advantage of having the capacity to withdraw blood samples from the patient.

An example of a two-way valve is shown in U.S. Patent No. 5,269,771 to Thomas, et aL A hollow plunger means is extended through the valve means within a housing to provide free fluid communication between the inlet and the outlet of the device through the central passageway of the plunger means. A syringe coupled to the inlet may then introduce fluid to the patient or, in the alternative, withdraw fluid from the patient.

A serious drawback to this prior art device is the large amount of volumetric dead space that exists not only within the central passageway of the plunger means, but also within the passageways of the housing. Thus, a large amount of the medication to be transferred to the patient remains in the dead space, thereby preventing the delivery of an exact amount of medication. The delivery of an exact amount of medication may be critical in some situations when chemotherapeutic agents are being administered or small children are being treated. An inexpensive medical connector for transferring medication from a number of different sources using the same IV wherein dead space is minimized and fluid in the secondary conduit is bidirectional would be of great benefit to the medical community.

*ge *o P:\OPER\Df'2310098 sr'I.doc-02109/02 -3- Summary of the Invention In accordance with the invention, there is provided a medical connector for use in transferring fluids to and from a patient, comprising: a primary conduit, said primary conduit having an upstream branch to be put in fluid communication with a primary source of fluid and a downstream branch to be put in fluid communication with a patient; a secondary conduit in fluid communication with said primary conduit between said upstream and downstream branches of said primary conduit; and a hollow, generally tubular resilient valve having a first end and a second end, said first end positioned in said upstream branch of said primary conduit and said second end positioned in said downstream branch of said primary conduit, said valve permitting a primary fluid to flow through said valve when said valve is in a decompressed state, said valve having a tab extending into said secondary conduit such that a luer inserted in said secondary conduit compresses said tab collapsing said valve, thereby preventing flow of a fluid through said primary conduit of said connector while permitting both flow of fluid to said patient from said luer and flow of fluid from said patient to said luer.

o* o P:IOPE\DHF2310098 sr..p do-02/09102 -4- Brief Description of the Drawings The preferred embodiments of this invention, illustrating its features, will now be discussed in detail. These embodiments depict the novel and nonobvious medical connectoror of this invention shown in the accompanying drawings, which are for illustrative purposes only. These drawings include the following figures, with like numerals indicating like parts: Figure 1 is a partial cross-sectional view of a valve in a closed position within a medical connector.

Figure 2 is a partial cross-sectional view of the valve in the open position within a medical connector for injecting fluid into a patient.

Figure 3 is a partial cross-sectional view of the valve in an open position within a medical connector for withdrawing fluid from the patient.

Figure 4 is a partial cross-sectional view of an alternate medical connector wherein the valve is in a closed position.

Figure 5 is a partial cross-sectional view of the connector shown in Figure 4 wherein the valve is in an open position for withdrawing fluid from the patient.

Figure 6a is a perspective view of an alternate valve in a closed position.

Figure 6b is a partial cross-sectional perspective view of valve shown in Figure 6a.

Figures 7a and 7b are cross-sectional views of the valve shown in Figures 6a and 6b where the valve is shown in a closed position and an open position, respectively.

•Figures 8a and 8b are cross-sectional views of a further alternative, showing the valve in a closed position and an open position, respectively.

Figures 9a and 9b are cross-sectional views showing an alternate valve in a closed position and an open position, respectively.

S*

5555t P:\OPER\DH\2310098 spal.dc-02/09102 Figures 10a and 10b are cross-sectional views showing an alternate valve in a closed position and an open position, respectively.

Figures 11 a and 11b are cross-sectional views showing the valve in a closed position and an open position, respectively.

Figures 12a and 12b are cross-sectional views showing an alternate valve in a closed position and an open position, respectively.

Figures 13a and 13b are cross-sectional views showing an alternate valve in a closed position and an open position, respectively.

Figures 14a and 14b are cross-sectional views showing an alternate valve in a closed position and an open position, respectively.

Detailed Description of the Drawings Figure 1 illustrates a medical connector 10 of the present invention where the valve 20 is in the closed position. Medical connector 10 comprises a primary conduit 11 in fluid communication with a secondary conduit 12 at junction 16. The primary conduit 11 has an inlet 13 at its upstream end and an outlet 14 at its downstream end. The primary conduit 11 has an upstream portion 26 defined by the portion between the upstream end (inlet 13) and the junction 16 with the secondary conduit 12, as well as a downstream portion 27 defined by the portion between the downstream end (outlet 14) and the junction 16. Valve 20 is preferably located at junction 16. The longitudinal axis of valve 20 is in alignment with the longitudinal axis of primary conduit 11. Positioned at junction 16 of medical connector 20 10, valve 20 in its uncompressed state prevents any fluid flow between secondary conduit 12 and primary conduit 11. Valve 20 comprises a hollow, resilient tube 24 and tab 21, where the tube 24 is further defined by upstream wall section 23 and downstream wal section 22. Tab 21 of valve 20 extends from the side wall of valve 20 into secondary conduit 12. Valve downstream wall section 22 extends a short distance downstream in primary conduit 11 beyond junction 16, and valve upstream wall section 23 may extend comparatively a longer distance upstream past junction 16. Along the inner walls of secondary conduit 12 is annular ring 15 positioned slightly above tab 21 of valve 20. Preferably, the cavity of secondary conduit *o 12 tapers inwardly so that secondary conduit 12 may be adapted to fit snug with an ANSI (American National Standards Institute, Washington, standard end of a medical implement. Typically, the implement is a syringe, luer, or any one of a wide variety of conduits used in medical applications. A luer 30 is defined as any tube for fluid communication and may also be commonly used with a medical implement.

Luers may vary in shape and can be conical, cylindrical, or any other shape known to those of skill in the art. The secondary conduit 12 is defined by a proximal end 18 and a distal end which is at junction 16.

Advantageously, the proximal end 18 of secondary conduit 12 can be equipped with a locking mechanism to facilitate locking of secondary conduit 12 to a variety of medical implements or connector devices. For S example, referring to Figure 1, locking ears 17 near the proximal opening 18 of secondary conduit 12 are -6.

preferably provided, such that the secondary conduit 12 can be locked into any compatible luer-lock device known to those of skill in the art.

As configured, during operation fluid from a primary fluid source (not shown) enters inlet 13 of primary conduit 11 and flows through tube 24 of valve 20 and out outlet 14 of primary conduit 11 for transmission to the patient. The outer diameter of tube 24 is preferably slightly larger than the inner diameter of primary conduit 11. Therefore, a fluid-tight fit is ensured between the valve 20 and the inner wall 29 of the primary conduit 11 to prevent any primary fluid flowing in between the walls of tube 24 and primary conduit 11 and into secondary conduit 12. With the valve 20 in this configuration, no fluid is allowed to flow between secondary conduit 12 and primary conduit 11.

Upon injection of fluid from a medical implement 30 into secondary conduit 12, one-way valving is provided for fluid flow from the medical implement 30 into primary conduit 11 and to the patient. To inject fluid from the secondary conduit 12 to the patient, the medical implement 30 is inserted into a first position in secondary conduit 12 and fluid from a medical implement 30 is introduced into secondary conduit 12.

As shown in Figure 2. the proximal end 31 of medical implement 30 is inserted into secondary conduit 12 until proximal end 31 contacts annular ring 15. Because annular ring 15 is positioned to be a very short distance from junction 16, dead space between proximal end 31 of medical implement 30 and junction 16 is minimized. With the edges of proximal end 31 resting on annular ring 15, medical implement is in a first position whereupon by injecting fluid through medical implement 30, the resulting fluid 20 pressure partially deflects resilient tube 24 to allow the secondary fluid from medical implement 30 to pass beyond valve 20 and into primary conduit 11 and into the patient. After the secondary fluid from medical implement 30 has passed through junction 16, resilient tube 24 decompresses and returns to its original shape. The ability of tube 24 of valve 20 to compress under fluid pressure and to return to its original too. shape is determined by the resiliency of the material used to manufacture the valve 20. By immediately returning to its original shape upon termination of fluid pressure from the medical implement 30, valve prevents any back flow of fluid from outlet 14 to secondary conduit 12. Moreover, because upstream wall section 23 is longer than downstream wall section 22, the fluid pressure introduced by medical implement is not great enough to push the upstream end 28 of tube 24 to overcome its fluid-tight seal with the walls of primary conduit 11. Thus, during this procedure, primary fluid flow from inlet 13 into secondary 30 conduit 12 is prevented. Alternatively, the valve 20 may be manufactured from a material that does not require the upstream portion 23 of the tube 24 to be longer than the downstream portion 22 of the tube 24 while still achieving the advantages of the present invention.

Figure 3 illustrates the two-way valving feature. As shown in Figure 3, proximal end 31 of medical implement 30 biases tab 21 downward, thereby compressing and maintaining tube 24 in an open, fluid communication position. In order to withdraw a sample of fluid from the patient, proximal end 31 of medical implement 30 is pushed over annular ring 15, thereby providing an auditory "click" sound as the medical implement 30 is set in the second position. This "click" sound is an audible signal which a user may rely upon to indicate that medical implement 30 is locked into the second position within secondary conduit 12. Alternatively, the user may be able to determine the position of the medical implement 30 in the secondary conduit 12 by touch and sight, and a audible click would be unnecessary.

The edge of proximal end 31 of medical implement 30 biases tab 21 downward into the passageway of primary conduit 11. Tab 21 of valve 20 is specifically designed to be positioned off-center within junction 16 to allow the edge of proximal end 31 to contact tab 21 when medical implement 30 is in the second position. Tab 21 can be positioned off-center towards any side of secondary conduit 12.

However, in certain embodiments, it is desirable to position tab 21 closer to the downstream end of primary conduit 11.

In response to the displacement of tab 21, tube 24 collapses, as shown in Figure 3, to close off any primary fluid flow in primary conduit 11 from inlet 13. Additionally, upstream wall section 23 also is displaced into the passageway of primary conduit 11, but because upstream wall section 23 is comparatively longer than downstream wall section 22 or alternatively, the strength of the material of the tube 24 does not cause separation of the upstream wal section 23 from the inner walls 29 of primary conduit 11 upstream of the junction 16, the force from medical implement 30 is not great enough to displace the upstream end 28 of upstream wall section 23 from its fluid-tight fit against the inner walls 29 of primary conduit 11. Thus, primary fluid flowing into inlet 13 is completely blocked from entering secondary conduit 20 12. With an open passageway maintained between outlet 14 and secondary conduit 12 through primary conduit 11, an operator may draw a fluid sample from the patient into medical implement 30. Alternatively, the two-way valving feature allows an operator to draw back a small amount of fluid from the patient into medical implement 30 to determine whether the IV system is inserted into the patient's vein so that H: medication may be safely and properly transmitted to the patient.

Advantageously, a clamp is not required to pinch off primary fluid flow in primary conduit 11 when withdrawing fluid from the patient, since valve 20 collapses down to effectively seal off conduit 11 when medical implement 30 is in the secondary position in secondary conduit 12. Thus, when luer 30 is placed in the first position, valve 20 acts as a pressure-activated one-way valve for injecting fluid into a patient; and when luer 30 is placed in the second position, valve 20 acts as a two.way valve for introducing or withdrawing fluid from the patient. Due to the limited number of components, the medical connector of the present invention is inexpensive and easy to manufacture.

An alternative two-way valving apparatus with minimal dead space is illustrated in Figure 4. In the alternate embodiment, valve 20 is a hollow, resilient tube residing within primary conduit 11 at junction 16. As in the preferred embodiment illustrated in Figures 1-3, valve 20 comprises a tube 24 having a upstream wall section 23 and a downstream wall section 22. Instead of having a tab connected to tube 44, a tab 25 is attached to the inner wall of conduit 12 adjacent junction 16 and beneath annular ring 15. Tab 25 serves primarily the same function as tab 21 of Figures 1.3 to maintain downstream wall section 42 of valve 40 in a deformed position so as to provide fluid communication between secondary conduit 12 and primary conduit outlet 14 when medical implement 30 is in the second position. Figure illustrates medical implement 30 in the second position within secondary conduit 12. Upon riding proximal end 31 of medical implement 30 over annular ring 15 and into the second position, the edge of proximal end 31 biases tab 25 downward into the passageway of primary conduit 11 to displace valve 40 from blocking junction 16, and collapsing downstream wall section 42 to close off upstream primary fluid flow from primary conduit inlet 13. Upon withdrawal of medical implement 30 from the second position within secondary conduit 12, tab 25 returns to its natural position within secondary conduit 12, allowing resilient tube 44 of valve 40 to return to its original shape.

Alternatively, annular ring 15 may be substituted for a tab, a protrusion, a ramp, or any other structure known to those of skill in the art. Preferably, annular ring 15 is made of the same material as medical connector 10, that being a plastic or any other medically inert material Figures 6a and 6b show an alternate valve 20 that may be used in medical connector 10. Valve 20 in Figures 6a and 6b have tab 21 and tube 24 with inner blocks 61 and 62 which seal off upstream primary fluid flow when tab 21 is pressed down by medical implement in the second position. Figures 7a and 7b further illustrate the functioning of the alternate valve 20 shown in Figures 6a and 6b. Figure 7 shows the valve 20 in the closed position, while 20 Figure 7b shows the valve 20 in the open position.

Figures 8a and 8b show another alternate valve 20 that may be used in medical connector 10. Valve 20 in Figures 8a and Ob have tab 21 end tube 24 with inner 0"0 :blocks 81 and 82 which seal off upstream primary fluid flow when tab 21 is pressed down by medical implement 30 when medical implement 30 is in the second position. (Figure 8b).

Figures 9a and 9b show another alternate valve 20 that may be used in medical connector 10. Valve 20 in Figures 9a and 9b have tab 21 and tube 24 with inner S blocks 81 and 82 which seal off upstream primary fluid flow when tab 21 is pressed down by medical implement 30 when medical implement 30 is in the second position. Further, tube 24 also collapses when the tab 21 is compressed. (Figure 9b).

Figures 10a and 10b show another arrangement. Two inner blocks 81 and 82 close off primary fluid flow when the medical implement 30 is in the second position with tab 21 compressed as shown in Figure lOb.

Figures 11 a and 11 b show another valve 20 which seals off primary fluid flow upstream when tab 21 is compressed by medical implement 30 as shown in Figure 1A517N lib.

Figures 12a and 12b show another valve 20 which seals off primary fluid flow upstream when medical implement 30 compresses the tab 21 as shown in Figure 12b.

Valve 20 comprises a tab 21 and a gate 90 where gate 90 seals off primary fluid flow upstream in primary conduit 11 when medical implement 30 is pushed into the second position, thereby biasing tab 21 downward and forcing gate 90 to close.

Figures 13a and 13b show another valve 20 which seals off primary fluid flow upstream when medical implement 30 compresses the tab 21a or tab 21b as shown in Figure 13b.

Figures 14a and 14b show another valve 20 which seals off primary fluid flow upstream when medical implement 30 compresses tab 21 as shown in Figure 14b.

Scope of the Invention The above presents a description of the best mode contemplated for carrying out the present invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skiled in the art to which it pertains to make and use this invention. This invention is, however, susceptible to modifications and aternate constructions from that discussed above which are fully equivalent Consequently, it is not the intention to kmit this invention to the particular embodiments disclosed. On the contrary, the intention is to cover al modifications and alternate constructions coming within the spirit and scope of the invention as generaly expressed by the folowing claims, which particularly point out and distinctly claim the subject matter of the invention.

Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in Australia.

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Claims (11)

1. A medical connector for use in transferring fluids to and from a patient, comprising: a primary conduit, said primary conduit having an upstream branch to be put in fluid communication with a primary source of fluid and a downstream branch to be put in fluid communication with a patient; a secondary conduit in fluid communication with said primary conduit between said upstream and downstream branches of said primary conduit; and a hollow, generally tubular resilient valve having a first end and a second end, said first end positioned in said upstream branch of said primary conduit and said second end positioned in said downstream branch of said primary conduit, said valve permitting a primary fluid to flow through said valve when said valve is in a decompressed state, said valve having a tab extending into said secondary conduit such that a luer inserted in said secondary conduit compresses said tab collapsing said valve, thereby preventing flow of a fluid through said primary conduit of said connector while permitting both flow of fluid to said patient from said luer and flow of fluid from said patient to said luer. 0

2. The medical connector of Claim 1, further comprising a protrusion positioned along an inner wall of said secondary conduit. 20

3. The medical connector of Claim 2, wherein said protrusion comprises an annular ring.

4. The medical connector of Claim 2, wherein said protrusion comprises a pair of tabs positioned along an inner wall of said secondary conduit.

5. The medical connector of Claim 1, wherein at least that portion of said valve ooo 25 positioned in said upstream branch of said primary conduit is in fluid tight engagement with an inner wall of said primary conduit when said valve is in a decompressed state.

S6. The medical connector of Claim 5, wherein said valve is adapted to deform when a secondary fluid is expelled from said luer into said secondary conduit, permitting said secondary fluid to enter said primary conduit and travel to the patient.

7. The medical connector of Claim 6, wherein said valve is configured to decompress to its original position after said secondary fluid has passed from said secondary conduit to said primary conduit. P:\OPFR\DI2310098 ,l.adoc-02/09/02 -11

8. The medical connector of Claim 1, having a first and a second position for insertion of a luer within said secondary conduit, and wherein in said second position said luer biases said tab of said valve, collapsing said valve such that a primary fluid is prevented from travelling past said valve, while fluid communication is maintained between said luer and the patient.

9. The medical connector of Claim 2, wherein the connector generates an audible sound upon transversing said protrusion, by a luer.

The medical connector of Claim 1, wherein said secondary conduit further comprises a locking mechanism for engaging a locking structure on a luer for locking said secondary conduit to said luer.

11. A medical connector, substantially as hereinbefore described with reference to the drawings. DATED this 30th day of September, 2002 15 ICU Medical, Inc. By DAVIES COLLISON CAVE Patent Attorneys for the applicant o *o *oooo oo