GB2613150A

GB2613150A - Infusate bag spike

Info

Publication number: GB2613150A
Application number: GB2116872.9A
Authority: GB
Inventors: Henry Buckberry Clive; Wallace Mark; Fincham Sam
Original assignee: Quanta Dialysis Technologies Ltd
Current assignee: Quanta Dialysis Technologies Ltd
Priority date: 2021-11-23
Filing date: 2021-11-23
Publication date: 2023-05-31
Also published as: GB202116872D0; WO2023094797A1

Abstract

A double lumen fluid bag spike. In one arrangement the spike 10 comprises a shaft 12 defining a base end 14 and a tip end 16, the shaft having two lumens, a first lumen 22 with at least one first opening 23, and a second lumen 24 with a second opening 25, the openings being separated by a wall 13. The second lumen may comprise a first channel 44 at the base end, and a second channel 46 at the tip end, wherein the first and second channels are fluidly connected at a transition region 48. The second channel has a larger cross-sectional area than the first channel. The at least first opening 23 may be disposed on a sidewall of the shaft. In another arrangement, the spike (410, Fig 9a) comprises first and second lumens (422, 424, Fig 9a) together defining a shaft, and a sliding collar (450, Fig 9a) with first and second apertures (452, 454, Fig 9c), the first apertures sized to slidably retain the first lumen and the second aperture sized to slidably retain the second lumen. A method of priming a medical device using such a bag spike is also taught.

Description

INFUSATE BAG SPIKE

TECHNICAL FIELD

The present disclosure relates to a fluid bag spike, a tubing set with a fluid bag spike, a medical device with a fluid bag spike and a method of priming a medical device using a fluid bag spike. Particularly, but not exclusively, the disclosure relates to alternative and complementary implementations of a fluid bag spike.

BACKGROUND

Fluid or infusate bags, such as saline or pre-mixed dialysate bags, generally only have a single access port used to withdraw fluid. The provision of a single access port is standard across the industry where dual port infusate bags are not commonly available (and therefore expensive if available at all). A fluid bag may be a rigid walled container or a flexible walled container. The single access port is generally a perforateable seal.

Fluid is usually withdrawn from saline or pre-mixed dialysate bags using an infusate bag spike which has a single lumen (e.g. for an intravenous (IV) drip). In general use, no fluid is returned to the bag so there is no need for a second lumen on the infusate bag spike.

Infusate bag spikes are described in the international standard: BS EN ISO 8536 -Infusion equipment for medical use.

For applications such as dialysis, a feed and return line is required for priming the dialysis machine (via the feed line) and to remove air from within a pumping cartridge or a fluid path (via the return line) of the dialysis machine. The air may be returned to the bag along with any fluid. Such a return line has two benefits, it removes air bubbles in the dialysis machine, and it also recycles the fluid back into the infusate bag.

The present invention aims to provide an improved infusate bag spike that may be used with an infusate bag having a single port.

SUMMARY OF THE INVENTION

Aspects and embodiments of the invention provide a fluid bag spike, a tubing set, a medical device, a dialysis machine and a method of priming a medical device According to a first aspect of the invention a fluid bag spike is provided. The fluid bag spike comprising: a dual lumen shaft having a base end and a tip end; wherein the dual lumen shaft comprises a first lumen and a second lumen, the first lumen having at least one first opening, the second lumen having a second opening, the at least one first opening and second opening being separated by a separating wall; wherein the second lumen comprises a first channel at the base end and a second channel at the tip end, wherein the first and second channels are fluidly connected at a transition region and wherein the second channel has a larger cross-sectional area than the first channel.

The larger cross-sectional area second channel opens to the second opening. Advantageously, providing a second lumen split into two fluidly connected channels allows for greater control of the fluid flow through the channel. The benefit of the wider bore outlet is that it allows smaller air bubbles to coalesce into larger bubbles. A larger diameter bubble has a greater buoyancy force thus it accelerates away from the tip faster so there is less chance of it being dragged back into the liquid flow entering the first opening and therefore any connected component (such as a haemodialysis cartridge) downstream of the first opening. By providing such a channel for bubble coalescing removal of air from a fluid circuit of a medical device can be achieved more quickly reducing time for priming operations.

Preferably the transition region connecting the first and second channels is stepped. The stepped transition allows the second channel to exist across the entire space of the shaft in embodiments where the second channel extends above the first opening. The step reduces the volume of unused space that would otherwise be taken up by the dual lumen shaft wall material. The step also advantageously allows for an increased ability for bubble formation within the spike itself. Alternatively, the transition region may be curved or linear.

Preferably the at least one first opening is disposed on a sidewall of the dual lumen shaft. Advantageously providing the first opening on a sidewall of the dual lumen shaft provides greater separation between the inlet and outlet fluid streams and reduces the chance of them mixing. The first opening may be provided substantially perpendicular to the second opening.

Preferably, the number of first openings is at least two. Providing multiple first openings enables greater fluid flow rate to pass into the fluid bag spike per second.

Preferably there are a plurality of first openings. Providing a plurality of first openings enables greater fluid flow rate to pass into the fluid bag spike per second.

Preferably the first openings are disposed along the sidewall of the dual lumen shaft substantially linearly between the base end and tip end.

According to another complementary aspect of the invention a fluid bag spike is provided.

The fluid bag spike comprising: a dual lumen shaft having a base end and a tip end; wherein the dual lumen shaft comprises a first lumen and a second lumen, the first lumen having at least one first opening, the second lumen having a second opening, the at least one first opening and second opening being separated by a separating wall; wherein the at least one first opening is disposed on a sidewall of the dual lumen shaft.

Advantageously providing the first opening on a sidewall of the dual lumen shaft provides greater separation between the inlet and outlet fluid streams and reduces the chance of the inlet and outlet fluid streams mixing. The first opening may be provided substantially perpendicular to the second opening.

Preferably the second lumen comprises a first channel at the base end and a second channel at the tip end, wherein the first and second channels are fluidly connected and wherein the second channel has a larger cross-sectional area than the first channel.

According to any of the complementary preceding aspects, preferably, the at least one first opening and/or second opening are located along the shaft axis toward the tip end of the shaft. Locating the first and second openings toward the tip end of the shaft means that the spike need not be fully inserted into a fluid bag in order to withdraw and return fluid via the feed and return lines. The spike may be partially inserted and still fulfil the same function.

Preferably the first opening and second opening are located at different distances from the base end.

The first and second openings may be disposed at the same distance from the base end or different distances from the base end. Where the first and second openings are at different distances the arrangement aids in preventing the mixing of the fluid streams.

The separating wall advantageously separates the first lumen from the second lumen to reduce and prevent mixing of the feed and return fluid streams. The first and second openings may be disposed on opposite sides of the shaft and separating wall, such an embodiment provides the advantage of reducing mixing of the feed and return fluid streams.

In some embodiments there may be provided a plurality of first openings. Providing multiple first openings increases the flow rate into/out of the first lumen. The number may be 1-10, 15, or two, or three, or four or five or a plurality or any number.

In some embodiments there may be provided a plurality of second openings. Providing multiple second openings increases the flow rate into/out of the second lumen.

The first lumen extends along at least a portion of the length of the shaft. The second lumen extends along the length of the shaft wherein the at least one first opening and second opening are located along a shaft axis toward the tip end of the shaft.

Preferably, the second opening is a larger cross-sectional area than the at least one first opening. A larger second opening has the benefit of allowing smaller bubbles to coalesce into larger bubbles. Further, having a smaller first opening (in comparison to the second opening) reduces the likelihood of large bubbles fitting into the smaller first opening. The bubbles may have a larger diameter than the cross-sectional area of the first opening therefore reducing the ability for the bubbles to fit through the first opening.

The at least one first opening is located further towards the base end than the second opening. Locating the first opening further towards the base end than the second opening has the benefit of reducing air bubbles entering via the second opening into an infusate bag being dragged into the liquid flow entering the first opening. Preferably the at least one first opening is located adjacent the first channel and below the second channel.

In on embodiment the separating wall is continuous with the first lumen and/or second lumen. The separating wall provides structural and mechanical strength the spike assembly.

In an alternative embodiment the separating wall is contiguous with the first lumen and/or second lumen.

The first lumen and second lumen are located at approximately the same distance from the base end.

Advantageously the provision of the first opening and second opening at approximately the same point along the length of the shaft means there is a lesser chance of the inlet and outlet streams becoming mixed.

Further, providing the first and second openings at the same point along the length of the shaft means that the infusate bag spike can be set up with either a feed line attached to the first lumen and a return line attached to the second lumen, or vice versa. The benefit is that the person setting up the apparatus and infusate bag spike does not need to be mindful of which line to attach to which lumen as either first or second lumen may act as feed or return.

The nature of the device to be set up in either fashion means that it can be set up quicker and reduces the chance for operator error as there is no preferred set up.

Preferably the base further comprises a flange extending from the base. The flange helps the user to push the spike into a fluid bag in use Preferably, the base further comprises at least one gripping portion wherein the at least one gripping portion has at least one gap. The gripping portion assists the user to hold the spike and push it into the fluid bag in use. The gripping portion may be used with the flange to increase ease of use. The gap advantageously allows the user to see if a line has been inserted into the spike sufficiently.

The infusate bag spike is a dual lumen bag spike.

The tip end has a cutting blade suitable for piercing a seal in fluid bag. The cutting blade may be a spiked point, blade, or other such feature for opening the seal of a bag.

The tip may extend over the first and second openings such that it covers the first and second opening when the spike is viewed from above.

Alternatively, the tip may partially extend over the first and second openings such that it covers the first and second opening when the infusate bag spike is viewed from above.

Covering (or partially covering) the first and second openings with a portion of the tip helps to prevent part of the infusate bag seal from becoming trapped within the first or second opening when the infusate bag spike is inserted into the infusate bag.

Moreover, the extended portion of the tip may be suitably disposed to guide bubbles or gas or fluid away from the opening.

Moreover, the extended portion of the tip may be suitably disposed to guide bubbles or gas or fluid towards the opening.

The shaft may further comprise at least one protrusion located on the shaft between the first opening and the tip. The protrusion may partially or fully cover the first opening when the infusate bag spike is viewed from above in plan view. The protrusion helps to prevent a portion of the infusate bag seal from becoming trapped within the first opening when the infusate bag spike is inserted into the infusate bag.

Alternatively, the shaft may further comprise at least one protrusion located on the shaft between the second opening and the tip. The protrusion may partially or fully cover the second opening when the infusate bag spike is viewed from above in plan view. The protrusion helps to prevent a portion of the infusate bag seal from becoming trapped within the second opening when the infusate bag spike is inserted into the infusate bag.

Alternatively, the shaft may further comprise at least one protrusion located on the shaft between the second opening and the tip.

The separating wall may have a first side and a second side, wherein the first lumen is located on the first side of the separating wall and the second lumen is located on the second side. Locating the first and second lumens on different sides of the separating wall helps to prevent mixing of the feed and return fluid streams.

The first and second openings may be one of: circular, round, oblong, oval, square, rectangular, an annulus, or any other shape known within the art.

The first and second openings may be located on the end of the first and second lumens.

The first and second openings may be parallel to the base.

Alternatively, the first and second openings may be at an angle between 0-90 degrees measured substantially parallel to the base. The angle may be 20-70 degrees or 30-60 degrees or 40-50 degrees or 45 degrees. The angle may be any combination of those ranges or any subset of those ranges or any value that occurs within said ranges.

The first and second openings may be located parallel to the shaft on the first and second lumens. The first and second openings may be substantially or approximately parallel to the shaft. The first and second openings may face away from the shaft.

The shaft is uniform in cross-sectional area across at least half the length of the shaft between the first and tip end of the shaft.

Alternatively, the shaft is uniform in cross-sectional area across the whole length of the shaft between the first and tip end of the shaft.

A uniform cross-section means the infusate bag spike may easily fit within the infusate bag seal. Moreover a uniform cross-section will prevent fluid from leaking around the shaft of the infusate bag spike. A uniform cross-section provides a better seal when the infusate bag spike is inserted.

The distance may be from the base to just below the tip.

The uniform cross-section may be one of: a square, a rectangle, a circle, an oblong, an oval, a triangle, a pentagon, a hexagon, a septagon, an octagon, a nonagon or any n-sided shape.

Provision of a uniform cross-section infusate bag spike has a number of benefits, for example, such a component is easier to manufacture using extrusion or injection moulding techniques thus reducing cost for complex tooling requirements.

In alternative embodiments the cross-section may be a tapered from a maximum cross-sectional area at or near the base to a minimum cross-sectional area at or towards the tip.

In alternative embodiments the shaft may be dimensioned or substantially dimensioned as described in international standard: BS EN ISO 8536 -Infusion equipment for medical use, or as in updated versions of said standard.

Preferably the fluid bag spike further comprises a tip having a base portion and an apex portion. The cross-sectional area of the tip decreases from the base portion to the apex portion. In such an embodiment the tip may rise to form a point at the centre of the cross-section. For example, in the case of a uniform square cross-section the end of the tip will be located at the apex of a square-based pyramid. As a further example, in the case of a uniform circular cross-section the end of the tip will be located at the apex of a cone or other similar shape.

Alternatively, the uniform cross-section may be substantially S-shaped. In such an embodiment the first lumen is located within the curve at the top or bottom of the S-shape. The second lumen is located in the other of the top or bottom of the S-shape.

In such an embodiment the tip may rise to form a point from the mid-point of the S of the uniform S-shaped cross-section. Wherein the mid-point is the point from which the two arms of the S retaining the first and second lumen extend.

The base may extend radially outwards from the shaft.

The base may be sized suitably for being received in a port of an infusate bag. The base may be sized suitably for being removably retained by an interference fit within an infusate bag. Advantageously the base prevents the infusate bag spike from falling out of the infusate bag.

The base may have a first lock portion suitable for engaging with a second lock portion located on an infusate bag. Advantageously the first lock portion prevents the infusate bag spike from falling out of the infusate bag.

The lock may be a bayonet fitting. A bayonet fitting prevents the bag spike from falling out of an infusate bag.

The first lock portion may be a male connecting portion of a bayonet fitting. The second lock portion is therefore a female connecting portion of a bayonet fitting.

The first lock portion may be a female connecting portion of a bayonet fitting. The second lock portion is therefore a male connecting portion of a bayonet fitting.

The tip may be located adjacent the first orifice, or second orifice is a cutting edge suitable for piercing an infusate bag seal.

The tip may have a first portion and a second portion; wherein the first portion is located adjacent the first orifice; the second portion is located adjacent the second orifice; and wherein the first and second portions are cutting edges suitable for piercing an infusate bag seal.

In a further embodiment of the present invention, shaft further comprises a shaft aperture and a separating wall, wherein the separating wall fluidly separates the shaft aperture into the first lumen and the second lumen. The first and second lumens are fluidly separated from each other by the separating wall.

In the present embodiment, the aperture may be divided by the separating wall such that the first lumen opening occupies 2/3 to 5/6 of the area of the shaft aperture and the balance is made up by the second lumen opening, or wherein the second lumen opening occupies between 2/3 to 5/6 of the area of the shaft aperture and the balance is made up by the first lumen opening and the separating wall. For example where the first lumen opening occupies 2/3 of the shaft aperture the second lumen occupies 1/3 of the shaft aperture.

The infusate bag spike may have a uniform cross-section. The uniform cross-section may be one of: a square, a rectangle, a circle, an oblong, an oval, a triangle, a pentagon, a hexagon, a septagon, an octagon, a nonagon or any n-sided shape. The uniform cross-section may define the shaft aperture.

The separating wall may be uniform in shape and cross-section along the length of the shaft.

Provision of a uniform cross-section infusate bag spike and separating wall has a number of benefits, for example, such a component is easier to manufacture using extrusion or injection moulding techniques thus reducing cost for complex tooling requirements.

The first lumen opening may occupy between 2/3 to 3/4 of the area of the shaft aperture and the second lumen opening may occupy between 1/3 to 1/4 of the area of the shaft aperture, or vice versa.

The separating wall may be substantially V-shaped. For example, the V-shaped separating wall may be disposed such that the shaft aperture is separated into the first and second lumen similar to pie-chart with two areas (one area being bigger than the other) or similar to a pizza with one slice removed. The second lumen may therefore be defined within and by the V-shaped separating wall and the first lumen may therefore be defined by the space outside the V-shaped separating wall within the spike aperture, or vice versa.

In alternative embodiments, the separating wall may be an arc. The second lumen may therefore be defined within and by the arc and the first lumen may therefore be defined by the space outside the arc within the spike aperture, or vice versa.

In such an embodiment the tip is continuous with the separating wall. The separating wall rises to a tip cutting blade suitable for piercing a infusate bag seal. Advantageously providing a tip as part of the separating wall reduces the complexity of the infusate bag spike.

Alternatively, the separating wall may be an annulus contained entirely within the shaft aperture. The annulus may therefore define the second lumen within the inner area. The first lumen is therefore defined by the outer edge of the annulus and the shaft aperture.

The annulus may be connected to the inner edge of the shaft by at least one connection point. There may be a plurality of connection points between the annulus and the inner edge of the shaft.

The tip is located at a distance further from the base than the first opening and second opening.

The tip may further comprise at least one protrusion located on the tip between the first opening and the apex of the tip. The protrusion may partially or fully cover the first opening when the infusate bag spike is viewed from above in plan view. The protrusion helps to prevent a portion of the infusate bag seal from becoming trapped within the first opening when the infusate bag spike is inserted into the infusate bag.

The tip may further comprise at least one protrusion located on the tip between the second opening and the apex of the tip. The protrusion may partially or fully cover the second opening when the infusate bag spike is viewed from above in plan view. The protrusion helps to prevent a portion of the infusate bag seal from becoming trapped within the second opening when the infusate bag spike is inserted into the infusate bag.

The separating wall is continuous with the tip. The separating wall is part of the tip and the tip forms part of the separating wall. The separating wall therefore provides structural integrity and strength for the tip. The tip which may be a cutting blade may be prevented from bending by the structural reinforcement provided by the separating wall.

Alternatively, the separating wall is contiguous with the tip. The separating wall therefore provides structural integrity and strength for the tip. The tip which may be a cutting blade may be prevented from bending by the structural reinforcement provided by the separating wall.

The infusate bag spike may further comprise a third lumen fluidly connected to the first lumen or the second lumen. The third lumen may be an emergency saline line used to provide more saline in the case one of the first or second lumens or fluid lines connected to said lines become blocked or otherwise has fluid flow rate restricted through them.

In a second aspect, a further infusate bag spike is provided The infusate bag spike comprising: * a shaft with a base end, a tip end and a shaft axis; 10 * abase; * a fip; * a first lumen with a first opening; * a second lumen with a second opening; * a sliding collar with a first aperture and a second aperture; the first lumen and second lumen together define the shaft; wherein the base is located at the base end of the shaft and the tip is located at the tip end of the shaft; the first lumen extends along the length of the shaft; the second lumen extends along the length of the shaft; wherein the first opening and second opening are located along the shaft axis toward the tip end of the shaft; and wherein the first aperture is sized to slidably retain the first lumen and the second aperture is sized to slidably retain the second lumen.

The infusate bag spike having a sliding collar allows the infusate bag spike to inserted into a bag and extended into a deployed position. The deployed position is when the sliding collar is adjacent to the base of the two lumens. The advantage being that the sliding collar pushes the two lumens away from each other such that the feed and return fluid streams do not mix.

The first lumen and second lumen are joined at the base; and wherein the sliding collar is slidable between the base and the tip of the shaft such that moving the collar towards the base of the infusate bag spike moves the first opening away from the second opening.

The shaft is made up of the first and second lumens that are connected at the base and only the base such that the first and second lumen may move at the top but not at the bottom connected to the base.

The infusate bag spike has an undeployed position and a deployed position.

In the undeployed position the sliding collar is located adjacent to the tip and holds the first and second openings together.

In the deployed position the sliding collar moves down the shaft away from the tip towards the base. The sliding collar in the deployed position no longer holds the first and second openings together. The first and second openings may therefore move independently of each other.

According to a third aspect of the invention, a tubing set is provided with an infusate bag spike as described above.

The tubing set may be provided as a kit of parts including an infusate bag spike as described above.

According to a fourth aspect of the invention, a medical device is provided with an infusate bag spike as described above. Preferably, the medical device is a dialysis machine According to a fifth aspect of the invention, a method of priming a medical device is described. The method of priming a medical device comprising the steps of: providing a medical device; providing an fluid bag spike according to any of the previous aspects or embodiments; providing a tubing set; providing a fluid bag containing fluid; and fluidly connecting an inlet line of the tubing set to the medical device; fluidly connecting a return line of the tubing set to the medical device; fluidly connecting the inlet line to the first or second lumen of the fluid bag spike; fluidly connecting the return line to the other of the second or first lumen of the infusate bag spike; drawing fluid from the fluid bag via the inlet line of the tubing set; priming the medical device; and returning a gas from the medical device to the fluid bag via the return line.

The method may further comprise the step of providing a second inlet line and a fluid bag spike further comprising a third lumen fluidly connected to the first lumen or the second lumen; fluidly connecting the second inlet line of the tubing set to the medical device; fluidly connecting the second inlet line to the third lumen of the fluid bag spike, drawing fluid from the fluid bag via the second inlet line of the tubing set; and priming a second location of the medical device.

BRIEF DESCRIPTION OF THE DRAWINGS

One or more embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which: Figure la is an infusate bag spike; Figure 1b is a cut away side view of the infusate bag spike of Figure la; Figure 2 is a cross-section of a tubing set incorporating the infusate bag spike of Figures la and lb; Figure 3a is a further embodiment of the infusate bag spike; Figure 3b is a profile view of the infusate bag spike of Figure 3a; Figure 3c is a plan view of the infusate bag spike of Figure 3a; Figure 4a is a further embodiment of the infusate bag spike of Figure 3a with protrusion partially covering the first and second lumen openings; Figure 4b is a profile view of the infusate bag spike of Figure 4a; Figure 4c is a plan view of the infusate bag spike of Figure 4a; Figure 5a is a further embodiment of the infusate bag spike; Figure 5b is a section view of the infusate bag spike of Figure 5a along plane A; Figure 5c is a further section view of the infusate bag spike of Figure 5a along plane B; Figure 6a is a further embodiment of the infusate bag spike; Figure 6b is a profile view of the infusate bag spike of Figure 6a; Figure 6c is a plan view of the infusate bag spike of Figure 6a; Figure 7a is a further embodiment of the infusate bag spike; Figure 7b is a close up view of the infusate bag spike of Figure 7a; Figure 7c is a plan view of the infusate bag spike of Figure 7a; Figure 8a is an alternative separating wall construction of the infusate bag spike of Figure 7a; Figure 8b is an alternative separating wall construction of the infusate bag spike of Figure 7a; Figure Sc is an alternative separating wall construction of the infusate bag spike of Figure 7a; Figure 8d is an alternative separating wall construction of the infusate bag spike of Figure 7a; Figure 9a is a further embodiment of the infusate bag spike in an undeployed position; Figure 9b is the infusate bag spike of Figure 7a in a deployed position; Figure 9c is a sliding collar used with the infusate bag spike of Figure 9a; Figure 10a is a further embodiment of an infusate bag spike; Figure 10b is a sectional view of the infusate bag spike of Figure 10a; Figure lla is a further embodiment of an infusate bag spike; Figure 11 b is a sectional view of the infusate bag spike of Figure 11a; Figure 12 is a cross-section of a tubing set incorporating the infusate bag spike of Figures lla and 11b; Figure 13 is a sectional view of a further embodiment of an infusate bag spike with a third lumen port; Figure 14 is a sectional view of a further embodiment of an infusate bag spike with a further lumen port; Figure 15 is a medical device connected to a fluid bag during a priming operation; Figure 16 is a base of the infusate bag spike of any of the preceding embodiments; Figure 17 is a sectional view of the base of Figure 16 connected to a return line and a feed line.

DETAILED DESCRIPTION

The invention will be described with reference to the Figures la-17.

According to the first aspect of the invention, a number of different implementations of an infusate bag spike 10, 50, 110, 210, 310, 410 are disclosed. Each of which will be described below with the aid of the drawings. Various features of each implementation may be used in combination or combined together without departing from the teaching of the present disclosure. The terms infusate bag spike, fluid bag spike and spike are used interchangeably.

Whilst specific examples are given the title of first, second, third, etc..., implementation these are illustrative examples and various modifications and combinations can be made to each of these examples without departing from the scope of the disclosure.

In Figure la, lb and 2 an infusate bag spike 10 is shown. The infusate bag spike 10 is used to transfer fluid 8 inside of an infusate bag to fluid lines 4 and components downstream, such as a medical device 1100. Figure 15 shows a medical device 1100, in this case a dialysis machine, connected to a fluid bag 1 by a fluid bag spike 10. The infusate bag spike 10 may be used with other medical devices 1100 that require the infusion of fluids from a fluid bag, for example, but not limited to, infusion pumps, supplying of intravenous (IV) medications, haemodialysis machines, and/or peristaltic dialysis machines.

The infusate bag spike 10 comprises: a shaft 12 with a base end 14, a tip end 16 and a shaft axis C; a base 18; a tip 20; a separating wall 13; a first lumen 22 with at least one first opening 23; a second lumen 24 with at least one second opening 25; and a first port 21 and a second port 28.

The base 18 is located at the base end 14 of the shaft 12.

The spike 10 may have one or more support portions 47 as shown in Figure la. The support portion is a region of material with an increased wall thickness that provides structural support to the spike 10. The support portion 47 may be used to grip the spike 10 in use and assist the user to push the spike 10 into a fluid bag port 2.

As shown in Figure la and lb the first and second lumens 22 and 24 extend along the length of the shaft 12 between the base end 14 of the shaft 12 and the tip end 16 of the shaft 12. The first and second lumen 22 and 24 extend along the shaft axis C. The second lumen 24 comprises a first channel 44 and a second channel 46. The first channel 44 is fluidly connected to the second channel 46 to permit fluid flow along the second lumen 24 between the second opening 25 and a second port 28. The first fluid channel 44 is located at the base end 14 of the shaft 12 as shown in Figure 1 b. The second fluid channel 46 is located between the first channel 44 and the second opening 25.

The first channel 44 may be sized to have the same internal cross-sectional area as the first lumen 22. This is shown graphically in Figure 1 b. Alternatively the first channel 44 may be greater in internal cross-sectional area than the first channel 44 or smaller in internal cross-sectional area than the first lumen 22.

The transition region 48 connecting the first and second channels 44, 46 is preferably a stepped transition. In alternative embodiments the transition may be curved or linear.

The second channel 46 has an internal cross-sectional area that is approximately the width of the shaft 12 minus the two times the shaft wall thickness.

The first lumen 22 has at least one first opening 23 located towards the tip end 16 and a first port 21 at the base 18. The first port 21 may extend through the base 18 and is preferably sized to retain a fluid line 4 as shown in Figure 2, for example via an interference fit. Preferably, the location of the at least one first opening 23 is below the junction of the first channel 44 and second channel 46. Preferably the number of first openings 23 is greater than one (a plurality of first openings 23). The number of first openings 23 may be two or three or four or five or between 1 and 5 or between 1 and 10 or any sub range therein. Alternatively, more than 10 first openings may be provided.

In the embodiment shown in Figures la, lb and 2 the three first openings 23 are shown in a line parallel to the shaft axis C. In alternative embodiments the plurality of first openings 23 may be orientated differently, e.g. in an arc around the portion of the first lumen 22 encapsulated by the shaft 12. Or, an array or grid of first openings 23 may be provided along the shaft 12.

The second lumen 24 has the second opening 25 located at the tip end 16 and a second port 28 at the base end 14. The second port 28 may extend through the base 18 and is preferably sized to retain a fluid line 4 as shown in Figure 2, for example, via an interference fit.

The first and second lumens 22 and 24 are preferably circular in cross-section. However, the first and second lumens 22, 24 may be oval in cross-section.

In alternative embodiments, the first and second lumens 22 and 24 define lumens of the same diameter such that the infusate bag spike 10 can be coupled to return and feed lines 6, 5 of a medical device 1100 in either orientation. That is, the first lumen 22 connected to the return line and the second lumen 24 connected to the feed line 5 or vice versa.

The tip 20 is located at the tip end 16 of the shaft 12. The tip 20 terminates in a cutting blade 30. The cutting blade 30 may be a point or a sharp part of the tip 20 suitable for piercing the seal of an infusate bag 1. Preferably the cutting blade 30 is continuous with the tip 20.

The first lumen 22 and the second lumen 24 are fluidly separated by the separating wall 13.

The separating wall 13 forms part of the shaft 12 as shown in Figure lb. The separating wall 13 is continuous with the tip 20. In some embodiments the separating wall 13 may extend to a point forming at least a portion of the tip 20 and cutting blade 30.

The base 18 is located at the base end 14 of the shaft 12. The base is preferably cylindrical, however the base 18 may be substantially cylindrical or oval in cross-section. The base 18 extends from the shaft 12 away from the base end 18. The base 18 is preferably larger in diameter than the shaft 12. The base 18 defines the first and second ports 21, 28 which are orifices suitable for receiving fluid lines 4.

The base 18 may optionally have ridges 19 (not shown). The ridges 19 are raised portions that extend around the periphery of the base 18. In the embodiment shown in Figure la and lb the base 18 has two ridges 19. Alternative embodiments may have alternative number of ridges 19, for example, 1-5 ridges or one or three ridges 19. The ridges 19 provide a gripping surface for assisting the user when they push the infusate bag spike 10 into the seal of an infusate bag 1.

Preferably the ridges 19 are continuous with the base 18 and are made of the same material as the rest of the infusate bag spike 10. In alternative embodiments the ridges 19 may be made of a different material, for example a material such as a rubber or other polymer that provides greater grip. In alternative embodiments, alternative portions may be provided to enhance grip.

The first opening 23 and second opening 25 are disposed at different heights along the shaft 12. In the implementation shown in Figure lb the first opening 23 is located further towards the base end 14 of shaft 12 than the second opening 25 which is located further towards the tip end 16 of the shaft 12. In use the second opening 25 and the second lumen 24 may be connected to the return line 6 of a tubing set 1000 (as shown in Figure 2). The return line 6 may be used to transport air (or other fluid 8) from internal lines within a medical device 1100 connected to said tubing set 1000 as shown in Figure 15. For example, when purging a dialysis machine prior to its first use air bubbles 7 may be passed to the infusate bag 1 via the second opening 25. Such a priming operation is shown schematically in Figure 15.

Having the second opening 25 spaced apart from the first opening reduces the likelihood of air bubbles 7 entering the first opening 23.

The at least one first opening 23 is at an angle 0 to the shaft axis 12. Preferably the angle is 90 degrees. The angle may be 0-90 degrees, or the angle may be 20-70 degrees or 30-60 degrees or 40-50 degrees or 45 degrees. The angle may be any combination of those ranges or any subset of those ranges or any value that occurs within said ranges.

The second opening 25 is at an angle (.1) to the shaft axis 12. The angle may be 0-90 degrees, or the angle may be 20-70 degrees or 30-60 degrees or 40-50 degrees or 45 degrees. The angle may be any combination of those ranges or any subset of those ranges or any value that occurs within said ranges.

The at least one first opening 23 may be partially enveloped in a shroud. The shroud partially covers the first opening reducing the likelihood of material from the infusate bag 1 seal entering the infusate bag spike 10 and becoming trapped within the first lumen 22. The shroud may overhang the first opening 23 such that from an end on view it partially covers the first opening 23. The shroud is continuous with the shaft 12.

The shroud may further comprise a protrusion 36 (not shown in Figures la or lb for reasons of clarity). The protrusion 36 is above the first opening 23. Above in this case meaingin that the protrusion 36 is located between the tip 20 and the first opening 23. The protrusion 36 helps to prevent any material from the infusate bag 1 seal from entering the infusate bag spike 1. The protrusion is continuous with the shroud. Where a plurality of first openings 23 are provided a single protrusion 36 may be provided, or conversely, a single protrusion 36 may be provided for each of the first openings 23.

The second opening 25 may be partially enveloped in a shroud. The shroud partially covers the second opening reducing the likelihood of material from the infusate bag 1 seal entering the infusate bag spike 10 and becoming trapped within the second lumen 24. The shroud may overhang the second opening 25 such that from an end on view it partially covers the second opening 25. The shroud is continuous with the shaft 12.

The shroud may further comprise a protrusion 38. The protrusion 38 is above the second opening 25. The protrusion 38 is located between the tip 20 and the second opening 23. The protrusion 36 helps to prevent any material from the infusate bag 1 seal from entering the infusate bag spike 1.

The infusate bag spike 10 may be made as a single component. For example, the infusate bag spike 10 may be manufactured from a medical grade polymer using injection moulding. The polymer may be a biocompatible polymer. For example, the polymer may be polyurethane, acrylonitrile butadiene styrene, a latex free polymer.

The infusate bag spike 10 may optionally have a third lumen 26 with a third port 29 fluidly connected to the third lumen 26. The third lumen 26 and third port 29 are optional features. The third lumen 26 is fluidly connected to the first lumen 22 shown in Figure 1 b.

Alternatively, the third lumen 26 may be connected to the second lumen 28.

The third lumen 26 may be used to draw extra fluid 8 from the infusate bag 1 when required by the medical device. For example, the third lumen 26 and third port 29 may be used to provide emergency saline to the medical device to account for variations in patient blood pressure. Alternatively, the third lumen 26 and third port 29 may be used to provide saline to other fluid circuits of the medical device.

An alternative embodiment of the first implementation is shown in Figure 10a and 10b. Many of the features of the embodiment of Figure 10a are similar to those of the infusate bag spike 10. The features of the infusate bag spike 10a which are similar to infusate bag spike 10 are prefixed by the letter "a".

The embodiment of Figure 10a shows an infusate bag spike 10b that has a plurality of first openings 23a disposed along a sidewall of the shaft 12a on a first tip side 32a. The number of first openings 23a in the Figure 10a, 10b is five. Alternatively, any number of first openings 23a may be provided. The number of first openings 23a may be two or three or four or five or six or seven or eight or nine or ten or between 1 and 5 or between 1 and 10 or any sub range therein.

In such an embodiment the shaft 12a may taper between the base end 14a and the tip end 16b. In other words, the cross-sectional area of the shaft 12a may decrease from a maximum diameter closest to the base end 14a and a minimum shaft diameter closest to the tip end 16a. In such an implementation the area of each first opening 23a may decrease from a maximum diameter (of the first opening 23a disposed closest to the base end 14a in relation to the other first openings 23a) and a minimum diameter (of the first opening 23a disposed closest to the tip end 16a in relation to the other first openings 23a).

The change in diameter between maximum diameter and minimum diameter may be a constant value in mm such that there is a linear decrease in first opening 23a diameter. Alternatively, the change in diameter may not be linear and the value may not be constant. Advantageously changing the size of the openings along the length of the shaft 12a increases structural integrity of the spike 10a where the cross-sectional area of the shaft 12a decreases.

The diameter of the first openings 23a are preferably sized such that they permit fluid 8 to enter the infusate bag spike 10a without the need for a high vacuum or high pump speed within the medical device 1100 downstream of the spike 10a for pulling fluid through the spike 10a.

The infusate bag spike 10a has the second fluid channel 46a located between the first channel 44a and the second opening 25a as shown in Figure 10b. In the embodiment shown in Figure 10b the first lumen 22a may have a changing cross-section along the length of the shaft 12a. So too may the second lumen 24a along the first fluid channel 44a. In such a case the second channel 46a has a greater diameter than the maximum diameter of the changing cross-section first channel 44a as shown in Figure 10b.

An embodiment comprising a third lumen 26 of infusate bag spike 10a is shown in Figure 13.

An alternative embodiment of the first implementation is shown in Figure 11a and 11b. Many of the features of the embodiment of Figure lla are similar to those of the infusate bag spike 10. The features of the infusate bag spike 10b which are similar to infusate bag spike 10 are prefixed by the letter "b".

The embodiment of Figure lla is very similar to the embodiment of Figure 10a however, the embodiment of spike 10b does not have a second lumen 22a split into a first channel 44a and second channel 46a. The second lumen 22b is a single channel.

In such an embodiment where the second lumen 22b is a single channel an additional first opening 23b may be provided towards the tip end 16b. As shown in Figure 11 b there are six first openings 23b.

An embodiment comprising a third lumen 26 of infusate bag spike 10b is shown in Figure 14.

A base 18 is shown in Figure 16 and 17. The base 18 of Figure 17 and 18 may be implemented on any of the herein described spike designs. The spikes 10a, 10b have a base 18a, 18b similar to the one shown in Figures 16 and 17.

The base 18 has a flange 90 which extends outwards from the base 18 as shown in Figure 16. The flange 90 provides an area to assist the user to push the spike 10 into a fluid bag 1. The flange 90 is preferably circular or oval in shape. In the embodiment shown in Figure 16 the flange is oval. Any suitable flange shape may be used without departing from the scope of the invention.

The first port 21 and second port 28 are at least partially surrounded by a first gripping portion 92 and a second gripping portion 94 as shown in Figure 16. The first and second gripping portions 92, 94 extend from the flange 90 away from the spike 10. The gripping portions 92, 94 are preferably sized so that the user may grip the spike 10 comfortably in their hand. Preferably the user grips the spike 10 at the first and second gripping portions 92, 94 by their thumb and at least their index finger or multiple fingers. The side of the user's fingers or thumb may then push up against the flange 90 to push the spike 10 into a fluid bag 1 in use.

The gripping portions 92, 94 at least partially surround the openings of the first port 21 and second port 28 as shown in Figure 16.

The gripping portions 92, 94 are complementary to the shape of a line 4 on the edge of the portions 92, 94 which surrounds the first and second ports 21, 28.

The gripping portions 92, 94 have at least one opening 96 such that a line 4 may be inserted into the first port 21 through the opening 96 as shown in Figure 17. The opening 96 is preferably sized to be complementary to a line 4 to permit easy insertion of a line 4. In use the line 4 is held in the first port 21 by an interference fit. In the embodiment shown in Figure 16 the opening 96 is substantially figure-of-eight shaped with the "top" circle of the figure-of-eight made up of the opening of the first port 21 and the "bottom" circle of the figure-of-eight made up of the second port 28. In the embodiment shown in Figure 16 there is no middle wall connecting the first and second gripping portions 92, 94 extending from the portion of material that lies between the first and second ports 21, 28. In use this is advantageous as it enables easier insertion of a line 4 into base 18 of spike 10. In alternative embodiments the portion of material that lies between the firs and second ports 21, 28 may by continuous with the first and second gripping portions 92, 94.

The first and second gripping portions 92, 94 have two gaps 98 separating the gripping portions 92, 94 from each other. The gaps 98 may be sized to permit a line to be inserted through the gap 98. Advantageously the gap may be used by the user as a visual indicator as to whether a line 4 has been fully inserted into the first or second port 21, 28 as in Figure 17. If a line 4 has not been correctly inserted the user may see an end of the line 4 through the gap 98. The gap 98 provides a quick and convenient check for the user.

SECOND IMPLEMENTATION

A second implementation of the infusate bag spike 50 will now be described with the reference of Figures 3a-3c. Many of the features of the infusate bag spike 50 are similar to the features found in the infusate bag spike 10.

The infusate bag spike 50 comprises: a shaft 52 with a base end 54, a tip end 56 and a shaft axis C; a base 58; a tip 60; a separating wall 53; a first lumen 62 with a first opening 63; a second lumen 64 with a second opening 65.

As shown in Figure 3a-3c the first and second lumens 62 and 64 extend along the length of the shaft 52 between the base end 54 of the shaft 52 and the tip end 56 of the shaft 52. The first and second lumen 62 and 64 extend along the shaft axis C. The base 58 is located at the base end 54 of the shaft 52.

The first lumen 62 has the first opening 63 located at the tip end 56 and a first port 61 at the base end 54. The first port 61 may extend through the base 58 and is preferably sized to retain a fluid line 4. The second lumen 64 has the second opening 65 located at the tip end 56 and a second port 68 at the base end 54. The second port 68 may extend through the base 58 and is preferably sized to retain a fluid line 4.

The first and second lumens 62 and 64 are preferably circular in cross-section. However, the first and second lumens 62, 64 may be oval in cross-section.

Preferably the first and second lumens 62 and 64 define lumens of the same diameter such that the infusate bag spike 50 can be coupled to return and feed lines of a medical device in either orientation. That is, the first lumen 62 connected to the return line and the second lumen 64 connected to the feed line or vice versa.

The tip 60 is located at the tip end 56 of the shaft 52. The tip 60 terminates in a cutting blade 70. The cutting blade 70 may be a point or a sharp part of the tip 60 suitable for piercing the seal of an infusate bag 1. Preferably the cutting blade 70 is continuous with the tip 60.

The first lumen 62 and the second lumen 64 are fluidly separated by the separating wall 53. The separating wall 53 forms part of the shaft 52 as shown in Figure 3a and 3b. The separating wall 53 is continuous with the tip 60. In the embodiment shown in Figure 3c the separating wall 53 extends to a point forming the tip 60 and cutting blade 70. The separating wall 53 rises from a tip base portion 80 to a tip apex portion 82 which may form part of the cutting blade 70. The cutting blade 70 and separating wall 53 defines a first tip side 72 with the first lumen 62 located on that side and a second tip side 74 with the second lumen 64 located on that side.

The infusate bag spike 50 may further comprise protrusions 76, 78 as shown in Figures 4a- 4c. The first protrusion 76 is located above the first orifice 63. The second protrusion 78 is located above the second orifice 65.

The infusate bag spike 50 may have a third lumen 66 with a third port 69 fluidly connected to the third lumen 66. The third lumen 66 and third port 69 are optional features. The third lumen 66 is fluidly connected to the first lumen 62. Alternatively, the third lumen 66 may be connected to the second lumen 68.

The third lumen 66 may be used to draw extra fluid 8 from the infusate bag 1 when required by the medical device. For example, the third lumen 66 and third port 69 may be used to provide emergency saline to the medical device to account for variations in patient blood pressure. Alternatively, the third lumen 66 and third port 69 may be used to provide saline to other fluid circuits of the medical device.

THIRD IMPLEMENTATION

A further implementation of the infusate bag spike 110 will be described with reference to Figures 5a-5c. Features of infusate bag spike 110 which are similar to features found in infusate bag spike 10 are prefixed by 100.

Figure 5a shows an infusate bag spike 110 with a constant cross-section along the shaft 112. The constant cross-section may be any shape in cross-section, in the design shown in Figure 5a the cross-section is substantially square. Alternatively, the shape in cross-section may be square, rectangular, triangular, circular, oval, hexagonal or any alternative regular or irregular shape.

The shaft 112 rises to a tip apex portion 142 from a tip base portion 140 proximate to the top of shaft 112. The tip 120 and tip apex portion 142 form a cutting blade 130.

In the embodiment shown in Figure 5a-5c the first and second openings 123, 125 are perpendicular to the shaft axis C such that the fluid flow enters/exits the first and second openings 123, 125 perpendicular to the shaft axis C. This is shown in Figure 5b which is a view taken along plane A of Figure 5a.

The first and second lumens 122, 124 are contained within the shaft and are separated by the separating wall 113. This is shown in Figure 5c which is a view taken along plane B of Figure 5a.

The infusate bag spike 110 may have a third lumen 126 with a third port 129 fluidly connected to the third lumen 126. The third lumen 126 and third port 129 are optional features. The third lumen 126 is fluidly connected to the first lumen 122. Alternatively, the third lumen 126 may be connected to the second lumen 128.

The third lumen 126 may be used to draw extra fluid 8 from the infusate bag 1 when required by the medical device. For example, the third lumen 126 and third port 129 may be used to provide emergency saline to the medical device to account for variations in patient blood pressure. Alternatively the third lumen 126 and third port 129 may be used to provide saline to other fluid circuits of the medical device.

FOURTH IMPLEMENTATION

A further implementation of the infusate bag spike 220 is shown in Figures 6a-6c. Features of infusate bag spike 210 which are similar to features found in infusate bag spike 10 are prefixed by 200.

The infusate bag spike 210 is substantially S-shaped in cross-section. The first lumen 222 and first lumen 223 are located in top/bottom of the curve of S (when viewed in plan) and the second lumen 224 and second lumen 225 are located in the other of the bottom/top curve of the S (when viewed in plan).

The S shape forms the separating wall 213 between the first and second lumens 222 and 224. The central portion of the S shaped separating wall 213 rises to form the tip 220 and the cutting blade 230.

The infusate bag spike 210 may have a third lumen 226 with a third port 229 fluidly connected to the third lumen 226. The third lumen 226 and third port 229 are optional features. The third lumen 226 is fluidly connected to the first lumen 222. Alternatively, the third lumen 226 may be connected to the second lumen 228.

The third lumen 226 may be used to draw extra fluid 8 from the infusate bag 1 when required by the medical device. For example, the third lumen 226 and third port 229 may be used to provide emergency saline to the medical device to account for variations in patient blood pressure. Alternatively, the third lumen 226 and third port 229 may be used to provide saline to other fluid circuits of the medical device.

FIFTH IMPLEMENTATION

A further implementation of the infusate bag spike 310 is shown in Figures 7a-7c. Features of the infusate bag spike 310 that are similar to features found in infusate bag spike 10 are prefixed by 300.

The infusate bag spike 310 is made up of a shaft 312 with a shaft aperture 550 and a separating wall 313 disposed within the shaft 312. The separating wall 313 as shown in Figure 7c separates the internal volume of the shaft aperture 350 in two forming a first lumen 322 on one side of the separating wall 313 and a second lumen 324 on the other side of the separating wall 313.

The first lumen 322 terminates in a first opening 323 located at the tip end 316 of the shaft 312. The second lumen 324 terminates in a second opening 325 located at the tip end 316 of the dual lumen shaft 312.

In alternative embodiments the shaft 312 may be a hollow cylinder, cuboid, oval in cross-section, annulus or other shape.

The separating wall 313 rises to form a tip 320 and cutting blade 330. The separating wall 313 aids in reducing recirculation of fluid from the first lumen 323 and second lumen 325 by separating the fluid streams.

In the embodiment shown in Figure 7c the separating wall 313 is substantially V-shaped 352. In alternative embodiments, shown in Figures 8a-8d the separating wall 313 may be (in cross-section) an arc 353, a concentric annulus 354, a line 355, an off axis annulus 356.

The infusate bag spike 310 may have a third lumen 326 with a third port 329 fluidly connected to the third lumen 326. The third lumen 326 and third port 329 are optional features. The third lumen 326 is fluidly connected to the first lumen 322. Alternatively, the third lumen 326 may be connected to the second lumen 328.

The third lumen 326 may be used to draw extra fluid 8 from the infusate bag 1 when required by the medical device. For example, the third lumen 326 and third port 329 may be used to provide emergency saline to the medical device to account for variations in patient blood pressure. Alternatively the third lumen 326 and third port 329 may be used to provide saline to other fluid circuits of the medical device.

SIXTH IMPLEMENTATION

A further implementation of the infusate bag spike 410 is shown in Figures 9a-9c. Features of the infusate bag spike 410 that are similar to features found in infusate bag spike 10 are prefixed by 400.

The infusate bag spike 410 differs from the earlier infusate bag spikes in that it has an unactuated (Figure 9a) and actuated (Figure 9b) position.

The infusate bag spike 410 has a shaft 412 made up of a first lumen 422 and a second lumen 424. The first and second lumens 422, 424 are connected at the base end 414 of the infusate bag spike 410. The first and second lumens 422, 424 are not connected at the tip end 416 other than by a sliding collar 450 shown in Figure 9a.

The sliding collar 450 has a first aperture 452 that slidably receives the first lumen 422 and a second aperture 454 that receives the second lumen 424. The sliding collar 450 is shown in cross-section in Figure 9c. The sliding collar 450 is able to slide along the shaft 412 between the tip end 414 (Figure 9a) and the base end 414 (Figure 9b).

The sliding collar 450 is adapted to force the ends of the first and second lumen 422, 424 located at the tip end 416 away from each other as the collar 450 is pushed downwards towards the base end 416. For example, by having the first and second apertures 452, 454 at an angle. The result being that the first and second openings 423, 425 are also forced away from each other reducing the likelihood of the return fluid (which may contain bubbles or air) being immediately fed into the feed line. The collar 450 may be pushed downwards, for example, when the infusate bag spike 410 is pushed into an infusate bag port 2.

The infusate bag spike 410 may have a third lumen 426 with a third port 429 fluidly connected to the third lumen 426. The third lumen 426 and third port 429 are optional features. The third lumen 426 is fluidly connected to the first lumen 422. Alternatively, the third lumen 426 may be connected to the second lumen 428.

The third lumen 426 may be used to draw extra fluid 8 from the infusate bag 1 when required by the medical device. For example, the third lumen 426 and third port 429 may be used to provide emergency saline to the medical device to account for variations in patient blood pressure. Alternatively, the third lumen 426 and third port 429 may be used to provide saline to other fluid circuits of the medical device.

METHOD OF PRIMING A MEDICAL DEVICE

A method of priming a medical device 1100 will now be described with the aid of Figure 15.

Figure 15 shows a medical device 1100 fluidly connected to a tubing set 1000 comprising a bag spike 10 (or alternatively any of the hereinbefore described bag spikes 10, 10a, 10b, 50, 110, 210, 310, 410), two fluid lines 4 (a feed line 5 and a return line 6) and a fluid bag 1 containing a fluid 8.

The method comprising the steps of: providing a medical device 1100; providing a fluid bag spike 10 (or an alternative fluid bag spike as described above, or alternatively providing a generic fluid bag spike); providing a tubing set 1000; providing a fluid bag 1 containing fluid 8; and fluidly connecting an inlet line of the tubing set to the medical device 1100; fluidly connecting a return line of the tubing set to the medical device 1100; fluidly connecting the inlet line to the first or second lumen of the fluid bag spike; fluidly connecting the return line to the other of the second or first lumen of the infusate bag spike; drawing fluid from the fluid bag via the inlet line of the tubing set 1000; priming the medical device 1100; and returning a gas from the medical device to the fluid bag via the return line.

The method may further comprises the following optional steps when a fluid spike 10 with a third lumen 26 is provided. The step including providing a second inlet line and a fluid bag spike 10 further comprising a third lumen 26 fluidly connected to the first lumen 22 or the second lumen 24; fluidly connecting the second inlet line of the tubing set to the medical device (1100); fluidly connecting the second inlet line to the third lumen of the fluid bag spike, drawing fluid from the fluid bag via the second inlet line of the tubing set; and priming a second location of the medical device 1100.

Claims

CLAIMS1. A fluid bag spike (10, 50, 110, 210, 310, 410) comprising: a dual lumen shaft (12) haying a base end (14) and a tip end (16); wherein the dual lumen shaft (12) comprises a first lumen (22) and a second lumen (24), the first lumen (22) haying at least one first opening (23), the second lumen (24) haying a second opening (25), the at least one first opening (23) and second opening (25) being separated by a separating wall (13); and wherein the second lumen (24) comprises a first channel (44) at the base end (14) and a second channel (46) at the tip end (16), wherein the first and second channels (44, 46) are fluidly connected at a transition region and wherein the second channel (46) has a larger cross-sectional area than the first channel (44).
2. The fluid bag spike of claim 1, wherein the at least one first opening (23) is disposed on a sidewall of the dual lumen shaft (12).
3. A fluid bag spike (10, 50, 110, 210, 310, 410) comprising: a dual lumen shaft (12) haying a base end (14) and a tip end (16); wherein the dual lumen shaft (12) comprises a first lumen (22) and a second lumen (24), the first lumen (22) haying at least one first opening (23), the second lumen (24) haying a second opening (25), the at least one first opening (23) and second opening (25) being separated by a separating wall (13); and wherein the at least one first opening (23) is disposed on a sidewall of the dual lumen shaft (12).
4. The fluid bag spike of claim 3 wherein the second lumen (24) comprises a first channel (44) at the base end (14) and a second channel (46) at the tip end (16), wherein the first and second channels (44, 46) are fluidly connected and wherein the second channel (46) has a larger cross-sectional area than the first channel (44).
5. The fluid bag spike of claim 1 or 2 or 4, wherein the transition region connecting the first and second channels (44, 46) is stepped.
6. The fluid bag spike of any of claims 1-5, wherein the number of first openings (23) is at least two.
7. The fluid bag spike of any of claims 1-6, wherein there are a plurality of first openings (23).
8. The fluid bag spike any of claims 6 or 7, wherein the first openings (23) are disposed along a sidewall of the dual lumen shaft substantially linearly between the base end (14) and tip end (16).
9. The fluid bag spike (10) of any preceding claim, wherein the first lumen (22) extends along at least a portion of a length of the dual lumen shaft (12); the second lumen (24) extends along the length of the dual lumen shaft (12); and wherein the at least one first opening (23) and second opening (25) are located along a shaft axis (C) toward the tip end (16) of the dual lumen shaft (12).
10. The fluid bag spike (50, 110, 210, 310, 410) of any preceding claim, wherein the first opening (23) and second opening (25) are located at different distances from the base end (14).
11. The fluid bag spike (10) of one of claims 1 to 10, wherein the at least one first opening (23) is located further towards the base end (14) than the second opening (25).
12. The fluid bag spike (10, 50, 110, 210, 310, 410) of any preceding claim, wherein the tip end (16) has a cutting blade (30) suitable for piercing a seal on a fluid bag.
13. The fluid bag spike (10, 50, 110, 210, 310, 410) of any preceding claim, wherein the separating wall (13) has a first side (32) and a second side (34), wherein the first lumen (22) is located on the first side (32) of the separating wall (13) and the second lumen (24) is located on the second side (34).
14. The fluid bag spike (10, 50, 110, 210, 310, 410) of any preceding claim, wherein the fluid bag spike (10, 50, 110, 210, 310, 410) further comprises a tip (20) having a base portion (40) and an apex portion (42); and the cross-sectional area of the tip decreases from the base portion (40) to the apex portion (42).
15. The fluid bag spike (10, 50, 110, 210, 310, 410) of any preceding claim, wherein the fluid bag spike (10, 50, 110, 210, 310, 410) further comprises a tip (20) and the separating wall (13) is continuous with the tip (20) or contiguous with the tip (20).
16. The fluid bag spike (10) of any preceding claim wherein the fluid bag spike (10) further comprises a third lumen (26) fluidly connected to the first lumen (22) or the second lumen (24).
17. The fluid bag spike (10) of any preceding claim wherein the base (18) further comprises a flange (90) extending from the base (18).
18. The fluid bag spike (10) of any preceding claim wherein the base (18) further comprises at least one gripping portion (92, 94) wherein the at least one gripping portion (92, 94) has at least one gap (98).
19. A fluid bag spike (410) comprising: * a shaft (412) with a base end (414), a tip end (416) and a shaft axis (C); * a base (418); * a tip (420); * a first lumen (422) with a first opening (423); * a second lumen (424) with a second opening (425); * a sliding collar (450) with a first aperture (452) and a second aperture (454); the first lumen (422) and second lumen (424) together define the shaft (412); wherein the base (418) is located at the base end (414) of the shaft (412) and the tip (420) is located at the tip end (416) of the shaft (412); the first lumen (422) extends along a length of the shaft (412); the second lumen (424) extends along the length of the shaft (412); wherein the first opening (423) and second opening (425) are located along the shaft axis (C) toward the tip end (416) of the shaft (412); and wherein the first aperture (452) is sized to slidably retain the first lumen (422) and the second aperture (452) is sized to slidably retain the second lumen (424).
20. A tubing set (1000) with a fluid bag spike according to any preceding claim. 30
21. A medical device (1100) with a fluid bag spike according to any of claims 1 to 19,
22. The medical device (1100) according to claim 21 wherein the medical device (1100) is a dialysis machine. 35
23. A method of priming a medical device (1100), the method comprising the steps of: providing a medical device (1100); providing a fluid bag spike according to any of claims 1 to 19; providing a tubing set (1000); providing a fluid bag containing fluid; and fluidly connecting an inlet line of the tubing set to the medical device 1100; fluidly connecting a return line of the tubing set to the medical device 1100; fluidly connecting the inlet line to the first or second lumen of the fluid bag spike; fluidly connecting the return line to the other of the second or first lumen of the infusate bag spike; drawing fluid from the fluid bag via the inlet line of the tubing set (1000); priming the medical device (1100); and returning a gas from the medical device to the fluid bag via the return line.
24. The method of priming a medical device (1100) according to claim 23, wherein the method further comprises the step of providing a second inlet line and a fluid bag spike (10) further comprising a third lumen (26) fluidly connected to the first lumen (22) or the second lumen (24); (1100); fluidly connecting the second inlet line of the tubing set to the medical device spike; fluidly connecting the second inlet line to the third lumen of the fluid bag drawing fluid from the fluid bag via the second inlet line of the tubing set; and priming a second location of the medical device (1100).