WO2017066847A1

WO2017066847A1 - Universal sampling cap

Info

Publication number: WO2017066847A1
Application number: PCT/AU2016/051000
Authority: WO
Inventors: Chris Whelan
Original assignee: Chris Whelan
Priority date: 2015-10-23
Filing date: 2016-10-24
Publication date: 2017-04-27

Abstract

A sampling port has an axially extending cannula with a pointed end facing an open end, whereby a sampling vial passed into the port from the open end may be impaled on the cannula and a plurality of wall members arranged about the axis with at least part of each wall member being movable radially away from the axis to increase the size of the space defined by the wall members with the or each wall member flexes, hinges, bends or otherwise deflects about at least one first hinge line spaced radially from the axis and the at least one first hinge line comprises a straight line, or a curved line having, at any point along the first hinge line, a radius of curvature greater than the distance from the axis to that point, or a curved line having, at any point along the first hinge line, a radius of curvature greater than or equal to the shortest distance from the axis to the first hinge line.

Description

Universal Sampling Cap

Field of Invention

This invention relates to medical sampling ports and more particularly providing a sampling port that can accommodate different diameter sampling bottles and/or vials. For ease of reading the term "sampling vial" alone is used in this specification and the term "sampling vial" is to be interpreted to include both sampling vial and sampling bottle.

The present invention is an improvement on the Universal Sampling Cap disclosed in PCT/AU2014/000805, the contents of which are incorporated herein.

Background

PCT/AU2014/000805 discloses a sampling port that readily accommodates vials of different diameters.

The sampling port of PCT/AU2014/000805 has a number of disadvantages and the present invention is an improvement on the sampling port disclosed in PCT/AU2014/000805.

Summary of the Invention

In one broad form the invention provides a sampling port having: a body having a space having a longitudinal direction, open at one end and adapted to receive a sampling vial; a cannula having an axis and extending longitudinally along the space with a pointed end facing the open end, whereby a sampling vial passed into the space from the open end may be impaled on the cannula; the space defined by a plurality of wall members arranged about the axis and extending generally axially from a base; at least part of each wall member being movable radially away from the axis to increase the size of the space defined by the wall members, and wherein the or each wall member flexes, hinges, bends or otherwise deflects relative to the base portion about at least one first hinge line, and wherein the at least one first hinge line is spaced radially from the axis and wherein the at least one first hinge line comprises: a straight line, or a curved line having, at any point along the first hinge line, a radius of curvature greater than the distance from the axis to that point, or a curved line having, at any point along the first hinge line, a radius of curvature greater than or equal to the shortest distance from the axis to the first hinge line.

The or each wall member may have a base end portion, a free end portion at or adjacent the open end of the space and at least one intermediate portion located between the base and free end portions.

Part of at least one of the intermediate portion may be spaced a first distance from the axis.

Part of the free end portion may be spaced a second distance from the axis. Part of the base end portion may be spaced a third distance from the axis.

Preferably the first distance is less than the second distance. Preferably first distance is less than the third distance. The second and third distances may be the same. Preferably one of the at least one intermediate portion is connected to the base portion about at least one second hinge line, and wherein the at least one second hinge line is spaced radially from the axis and wherein the at least one second hinge line comprises: a straight line, or a curved line having, at any point along the second hinge line, a radius of curvature greater than the distance from the axis to that point, or a curved line having, at any point along the second hinge line, a radius of curvature greater than or equal to the shortest distance from the axis to the second hinge line.

Preferably one of the at least one intermediate portion is connected to the free end portion about at least one third hinge line, and wherein the at least one third hinge line is spaced radially from the axis and wherein the at least one third hinge line comprises: a straight line, or a curved line having, at any point along the third hinge line, a radius of curvature greater than the distance from the axis to that point, or a curved line having, at any point along the third hinge line, a radius of curvature greater than or equal to the shortest distance from the axis to the third hinge line.

Where a (first, second or third) hinge line is a curved line, preferably at any point along the hinge line, the radius of curvature is preferably more than 70% greater than the shortest distance from the hinge to the axis. The shortest distance from the hinge to the axis is preferably the midpoint of the hinge line. The curved line may be an arc of a circle, part of an ellipse or oval or a free form curve. In a preferred form the at least one intermediate portion comprises one intermediate portion.

A connection member may connect the free end portions of at least two wall members to limit radial movement of the free ends.

In a preferred implementation the connection member is connected to at least one free end at a connection location. Where there is a plurality of wall members there may be connection members connected to all of the free ends at a respective connection location or only some of the free ends.

The connection member may be elastic. Preferably the connection member is flexible and has a length greater than the circumference of a circle centred on the axis and passing through its connection locations.

Preferably each connection member comprises a plurality of peaks and troughs.

Preferably the ring member comprises a plurality of curved portions.

Preferably adjacent curved portions are curved in opposite direction. Preferably adjacent curved portions are joined to each other at a point of inflection.

In cross section, each curved portion may be part of an ellipse, oval or circle. However, at least the curved portion may be a freehand spline rather than a mathematically defined line. These and other aspects of the invention will be apparent from the following non-limiting description of a preferred implementation of the invention with reference to the attached representations.

Brief Description of the Drawings

Figure 1 is a front view of a sampling port according to a first implementation of the invention.

Figure 2 is a side view of the sampling port of figure 1.

Figure 3 is an end view from below of the sampling port of figure 1.

Figure 4 is a cross sectional side view taken along line AA in figure 1.

Figure 5 is a cross sectional side view taken along line BB in figure 2. Figure 6 is a perspective view from above of the sampling port of figure 1.

Figure 7 is a perspective view from below of the sampling port of figure 1.

Figure 8 is a front view of the sampling port of figure 1 in use with a first size vial.

Figure 9 is a side view of the sampling port of figure 1 in use with a first size vial.

Figure 10 is a cross sectional side view taken along line AA in figure 8. Figure 11 is a cross sectional side view taken along line BB in figure 9.

Figure 12 is a perspective view from above the sampling port of figure 1 in use with a second size vial.

Figure 13 is a side view of the sampling port of figure 1 in use with a second size vial.

Figure 14 is a cross sectional side view taken along line AA in figure 13.

Figure 15 is a front view of the sampling port of figure 1 showing various cut lines.

Figure 16 is a cross sectional end view taken along line AA in figure 15. Figure 17 is a cross sectional end view taken along line BB in figure 15.

Figure 18 is a cross sectional end view taken along line CC in figure 15.

Figure 19 is a cross sectional end view taken along line DD in figure 15.

Figure 20 is a cross sectional end view taken along line EE in figure 15.

Figure 21 is a perspective view from above of a prior art sampling cap with a large vial partially inserted.

Figure 22 is a side view of the prior art sampling cap of figure 22 with the large vial fully inserted.

Detailed Description of Preferred and other Embodiments

Referring to figures 21 and 22 there is shown a prior art sampling port 10. The sampling port 10 has a generally tubular body 12. The body 12 has a base 16 at one end and a side wall 18 that extends away from the base 16. The side wall 18 defines an open end 120 and a space 121. Mounted on the base 16 is a needle assembly 122 having a cannula, not shown.

The wall 18 of the body 12 has six elongate flexible wall members 40 spaced about the axis of the body. Each wall member 40 extends from the base portion 16 to the open end 120 and is waisted at 60.

In the undeflecetd state the waist portion 60 of the wall members 40 will guide a small diameter vial into the sampling port. The wall members 40 may be flexed outwards to accommodate a larger diameter vial. Each wall member 40 is curved in end view and so flexing of the wall members 40 relative to the base and internally at the waist region is along generally curved hinge lines, which causes issues.

The present invention provides a sampling port that has a series of wall members that flex internally or with other parts of the sampling port hinge lines that are curved less than their distance from the axis or are generally straight.

Referring to figures 1 to 20 there is shown a sampling port 1000 according to one implementation of the invention.

The sampling port 1000 has a generally tubular body 1002. The body 1002 has a base 1006 at one end and a side wall 1008 that extends away from the base 1006. The side wall 1008 defines an open end 1020 and a space 1021. Mounted on the base 1006 is a needle assembly 1022 having a cannula 1024. The cannula 1024 is mounted generally centrally and extends along the body toward the open end 1020. The free end 1026 of the cannula 1024 is located away from the open end 1020. A rubber sheath 1025 surrounds the cannula 1024.

The interior of the cannula 1024 communicates with a connector or piercing device of needle assembly 1022 so that fluid may pass from the connector to the cannula 1024 or vice versa. In the implementation shown the connector is a male luer connector 1030 and the assembly 1022 is a screw fit into base 1006. If desired the base 1006 and assembly 1022 may be formed together with the cannula mounted in the integral base. The type of connector or piercing device is not critical and variations may be used, including a male or female luer, locking luer, multi-sample (double-ended) needle, blunt cannula, spike etc.

The wall 1008 of the body 1002 has six elongate flexible wall members 1040 spaced about the axis 1042 of the body. Each wall member 1040 extends from the base portion 1006 to the open end 1020. In this implementation each wall member is attached to adjacent wall members by connector members 1044 at or near the open end 1020. Each connector member is preferably attached to each wall member at connection points 1046. As seen in figure 3, the end portion 1047 of each wall member 1040 is curved in end view so the free ends extend generally circumferentially about the axis.

The expanded length of each connector member 1044 between adjacent connection points 1046 is greater than the circumferential distance between them. In this implementation each connector member 1044 is formed with a series of generally curved portions 1048 in alternating directions.

In this implementation there are two peaks 1050 and one trough 1052 between each connection point 1046. If desired there could be a single peak and no trough between connection points. As the number of peaks between adjacent connection points increases the radial extent of the relaxed connection member reduces for the same length between adjacent connection points. The connector, wall members and base are preferably all formed as a single moulding but may be formed of separate components.

The wall members 1040 are flexible and may be flexed, hinged, bent or otherwise deflected radially outwards so that the free ends of the wall members are further away from the axis and the effective circumference of the open end 1020 is increased.

The tubal body 1002 is waisted, in that it has a reduced diameter portion 1060 between the base portion 1006 and the open end 1020. The internal diameter of the open end 1020 may be the same diameter as that of the base portion 1006.

The body 1002 thus has an open end with diameter D1 and a minimum diameter at waist 1060 of D2.

This waisting is achieved by having each wall member 1040 extend inwards toward the axis. Each wall member 1040 is connected to the base portion 1016 about a first hinge line 1070. This first hinge line 1070 has a radius of curvature about the centre line 1075 substantially more than its distance from the axis of the body 1071 and/or the diameter of the socket 1082 of the base portion. In the embodiment shown the radius of the circular socket 1082 is 10.5 mm whilst the radius of the first hinge line is about 18.5 mm. If desired the hinge line 1070 may be substantially straight, i.e. have an infinite radius of curvature.

Each wall member 1040 thus rotates relative to the base portion 1016 about a line that is relatively straight.

A first portion 1072 of the wall member 1040, extending from the hinge line 1070, has a similar radius of curvature about the centre line 1075. A second portion 1074 of the wall member 1040 is connected to the first portion 1072 about second hinge line 1076. If the first portion 1072 has a radius of curvature, as opposed to being planar, its radius of curvature may change along its length in the axial direction. As best seen in figures 4 and 5, the hinge line 1076 is formed of a relatively large area of reduced thickness of the wall member 1040. The second wall portion 1074 preferably has a similar radius of curvature about the centre line to that of the first wall portion 1072.

A third wall portion 1078 is connected to the second wall portion about hinge line 1080. At the hinge line the third wall portion has a radius of curvature about the centre line similar to that of the third wall portion 1074 but it transitions to have a smaller radius of curvature at the open end 1020.

Preferably the free end of each wall member has a radius of curvature equal to its distance from the centre line 1075. In the implementation shown the waist region 1060 of the body 1002 is between the open end 1020 and the free end 1026 of the cannula. The waist region 1060 thus serves to centralise a vial having a diameter approximately D2 when partially inserted but not yet impaled on the cannula.

In use, a vial having a maximum diameter less than D2 may be inserted into the body 1002. Ideally the device is used with vials having a maximum diameter the same or greater than D2 but this is not essential.

The base portion 1016 of the sampling pot is provided with a first socket portion 1082 sized to receive an object, such as the end of a sampling vial, that fits within a circle having a diameter the same or similar, preferably larger if not the same, as D2. This first socket portion 1082 is intended to receive small size vials. Preferably the wall(s) 1084 of the first socket portion are generally parallel to the axis but may diverge toward the open end 1020 to aid insertion of a vial into the first socket portion. A vial may be inserted into the socket, with inwards movement limited by one or both of the needle assembly 1022 or the walls 1084 of the first socket portion 1082 A second socket portion 1086 is provided adjacent the open-end of the first socket portion and so there is an annular flange 1088 formed between the two socket portions. The junction of the flange 1088 with the wall of the second socket portion 1086 is preferably circular

The second socket portion 1086 is generally circular adjacent the flange 1088. In end view, the hinge line 1070 preferably does not fall within the circle of the flange 1088. Thus the centre 1071 of hinge 1070 on its inner surface is preferably no closer to the axis than that circle or further away from the axis than that circle. However, because the hinge line 1070 has a larger radius of curvature than the flange 1088, the ends 1073 are further away from the axis than the centre 1071. Accordingly, the wall 1087 of socket 1086 preferably diverges toward the hinge 1070 and does so differently at different

circumferential positions. This is best seen in figure 17.

Doing so provides a smooth transition from the wall member 1040 to the second socket portion without any steps. It will be appreciated that the second socket portion 1088 could have a constant, circular cross section.

However, that would result in a radial step between the ends 1073 of the hinge and the second socket portion 1088 upon which the end of a vial could catch.

Referring to figures 8 to 11 , a vial 1170 comprising tube 1172 and closure 1174 has been inserted and impaled on the cannula 1024. In this case the closure comprises a pierceable bung 1176 retained by cap 1178 that extends over part of the tube 1172. Both the tube 1172 and cap 1178 have a diameter less than D1. Ideally their diameters are the same or greater than D2. In use the vial 1170 is inserted until cap 1178 contacts sloping portions 1079 of wall members 1040. The vial 1170 will be centred by the wall members 1040 as the vial is inserted. As the vial is inserted the cap, if of diameter greater than D2 of waist 1060, causes the waisted portion of wall members to move outwards, expanding the diameter of waist 1060 and allowing the cap and tube to pass. In the example shown, the diameter of the tube 1170 is less than that of cap 1178 and after the cap has passed waist 1060, the wall members move radially inwards and bear against the tube 1172, thus holding and maintaining the vial 1170 centred. Withdrawal of the vial causes the wall members 1040 to move outwards to allow the cap 1178 to pass the waist.

The sampling port may also be used with containers with parts having a diameter greater than D1 of the opening and in particular sampling bottles, as shown in figures 12 to 14. In these examples the sampling bottle 1200 has a bottle body 1202 with a diameter greater than D1 with a neck 1204 opening at mouth 1205 closed by closure 1206. The closure comprises a pierceable bung 1208 and cap 1210.

The diameter of cap 1210 is less than D1 but greater than D2.

As the sampling bottle 1200 is inserted into the port the cap engages the sloped third portions 1079 of the wall members 1040 and is centred over the cannula 1024. Insertion continues until the third portions 1079 of wall members 1040 engage sloping end portion 1212 of bottle body 1202. Continued insertion causes the wall members 1140 to move relative to base portion 1016 about hinge line 1070 and also the wall portions 1072, 1074 and 1078 to move relative to each other about hinge lines 1076 and 1080 so as to increase the diameter of opening 1020, with the segments 1050, 1052 of each connector member 1044 becoming less curved and each connector member 1044 as a whole becoming less "rippled" as the distance between adjacent connection points 1046 increases.

The sampling bottle may thus be fully inserted and impaled on the cannula 1024, with the wall members 1044 extending over the bottle 1202. The flange 1088 limits insertion of the sampling bottle 1202 into the port.

The hinge 1076 is preferably sized and positioned so that it is located at the transition area 1214 between the cylindrical wall portion 1216 and conical wall portion 1218 of the bottle. The first wall portion 1072 thus extends substantially undistorted between hinge lines 1070 and 1076, with these hinges accommodating the expansion. Similarly the second wall portion 1074 extends alongside the cylindrical wall portion 1216 substantially undistorted.

The third wall portion 1078 extends from the second wall portion and their fee ends engage the cylindrical wall portion, with the connection members in tension and so urging the free ends radially inwards against the cylindrical wall portion.

The wall members 1 140 as a whole and in particular the second wall portion 1072 are not distorted to any significant extent, except at the hinges. Because the hinges have a relatively large radius of curvature or are straight, they may flex under relatively little force. Accordingly, relatively little radially directed force is required to expand the wall members 1040 to the expanded state. This in turn reduces any forces which act to expel a large bottle from the sampling port and so, once impaled on a large bottle the sampling port will tend to stay engaged.

Second socket portion 1086 may include small bumps 1300 (see figure 18) with an inner radius less than the radius of the wall of second socket portion 1086 and less than the outer radius of the cap of the large diameter sampling bottle. The bumps 1300 are small enough that they may be forced over the cap of the bottle with relatively little force, but will engage under the edge of the cap and reduce the tendency for the wall member 1040 to expel the large bottle from the sampling port. Because relatively little force is required to engage the bumps, relatively little manual force is required to disengage the bumps when removing the sampling cap from the large diameter bottle.

Each connector member 1044 serves a number of functions. The main function is to limit the flexing of the wall members 1040 relative to base 1006.

Maximum flexing of the wall members 1040 is limited by the connector members. In the absence of the connector members 1044 the wall members may flex excessively about hinge 1070, so presenting a flower petal

arrangement. Such hinging may result in non-elastic flexing, so that the wall members will not return to the initial configuration when the bottle is removed and leaving the cannula with no protection. A secondary aspect is that each connector member provides additional "closing" force to return the wall members to the original position when the bottle is removed.

It will be appreciated that each connector member 1044 does not need to be connected to every wall member 1040, although this is preferred. A connector member 1044 that is attached to two wall members with one or more intermediate wall members not connected will still ensure that the outward movement of the unconnected wall members is still controlled. Radially outward movement of the wall members will result in the free end contacting and/or urging each connector member radially outward even if there is no actual connection between each connector member and the respective wall member.

Unless the context clearly requires otherwise, throughout the description and any claims the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to".

The features of the invention described or mentioned in this document may be combined in any combination of features where features are not mutually exclusive.

It will be apparent to those skilled in the art that many obvious modifications and variations may be made to the embodiments described herein without departing from the spirit or scope of the invention.

Claims

A sampling port having: a body having a space having a longitudinal direction, open at one end and adapted to receive a sampling vial; a cannula having an axis and extending longitudinally along the space with a pointed end facing the open end, whereby a sampling vial passed into the space from the open end may be impaled on the cannula; the space defined by a plurality of wall members arranged about the axis and extending generally axially from a base; at least part of each wall member being movable radially away from the axis to increase the size of the space defined by the wall members, and wherein the or each wall member flexes, hinges, bends or otherwise deflects relative to the base portion about at least one first hinge line, and wherein the at least one first hinge line is spaced radially from the axis and wherein the at least one first hinge line comprises: a straight line, or a curved line having, at any point along the first hinge line, a radius of curvature greater than the distance from the axis to that point, or a curved line having, at any point along the first hinge line, a radius of curvature greater than or equal to the shortest distance from the axis to the first hinge line.

2. A sampling port as claimed in any one of the previous claims wherein the or each wall member includes a base end portion, a free end portion at or adjacent the open end of the space and at least one intermediate portion located between the base and free end portions.

3. A sampling port as claimed in claim 2 wherein one of the at least one intermediate portion is connected to the base portion about at least one second hinge line, and wherein the at least one second hinge line is spaced radially from the axis and wherein the at least one second hinge line comprises: a straight line, or a curved line having, at any point along the second hinge line, a radius of curvature greater than the distance from the axis to that point, or a curved line having, at any point along the second hinge line, a radius of curvature greater than or equal to the shortest distance from the axis to the second hinge line.

4. A sampling port as claimed in claim 2 or claim 3 wherein one of the at least one intermediate portion is connected to the free end portion about at least one third hinge line, and wherein the at least one third hinge line is spaced radially from the axis and wherein the at least one third hinge line comprises: a straight line, or a curved line having, at any point along the third hinge line, a radius of curvature greater than the distance from the axis to that point, or a curved line having, at any point along the third hinge line, a radius of curvature greater than or equal to the shortest distance from the axis to the third hinge line.

5. A sampling port as claimed in any one of claims 2 to 4 wherein part of at least one of the intermediate portion is spaced a first distance from the axis and a part of the free end portion is spaced a second distance from the axis and wherein the first distance is less than the second distance.

6. A sampling port as claimed in claim 5 wherein part of the base end portion is spaced a third distance from the axis.

7. A sampling port as claimed in claim 6 wherein first distance is less than the third distance.

8. A sampling port as claimed in claim 6 or claim 7 wherein the second and third distances are the same.

9. A sampling port as claimed in any one of the previous claims wherein the first hinge line is a curved line and at any point along the first hinge line the radius of curvature is more than 70% greater than the shortest distance from the first hinge line to the axis.

10. A sampling port as claimed in any one of the previous claims when dependent on claim 3 wherein the second hinge line is a curved line and at any point along the second hinge line the radius of curvature is more than 70% greater than the shortest distance from the second hinge line to the axis.

1 1 . A sampling port as claimed in any one of the previous claims when dependent on claim 4 wherein the third hinge line is a curved line and at any point along the third hinge line the radius of curvature is more than 70% greater than the shortest distance from the third hinge line to the axis.

12. A sampling port as claimed in any one of the previous claims wherein the shortest distance from a hinge to the axis is the midpoint of the hinge line.

13. A sampling port as claimed in any one of the previous claims wherein the curved line is an arc of a circle, part of an ellipse or oval or a free form curve.

14. A sampling port as claimed in any one of the previous claims wherein the at least one intermediate portion comprises one intermediate portion.

15. A sampling port as claimed in any one of the previous claims including at least one connection member connects the free end portions of at least two wall members to limit radial movement of the free ends.

16. A sampling port as claimed in claim 15 wherein the at least one connection member is connected to at least one free end at at least one connection location and wherein the at least one connection member extends at least radially from at least one connection location.

17. A sampling port as claimed in claim 15 or claim 16 comprising a plurality of connection members and wherein each connection member is attached to two free ends.

18. A sampling port as claimed in any one of claim 15 to 17 comprising wherein at least one free end has two connection locations.