GB2568968A

GB2568968A - Drainage apparatus

Info

Publication number: GB2568968A
Application number: GB1720177.3A
Authority: GB
Inventors: Varey Richard; Whitfield Paul
Original assignee: Rocket Medical PLC
Current assignee: Rocket Medical PLC
Priority date: 2017-12-04
Filing date: 2017-12-04
Publication date: 2019-06-05
Also published as: WO2019110952A1; GB201720177D0

Abstract

A drainage apparatus possibly for draining intra-pleural or peritoneal fluid from a patient with an evacuated container having preferably a single opening, a manifold 206 disposed over an opening 204 of the container and a seal 205 on the opening. The manifold comprises a twist-actuated plunger 210, which preferably has a twist grip 211, a drainage line receiving port 215 and a through-hole 208 into which the twist-actuated plunger fits. The plunger punctures the seal and connects the drainage line receiving port to the container. The plunger preferably has an O-ring 217/ soft moulding and a helical groove 213 or thread 214. The twist-grip may incorporate a vertical tube of the drain line receiving port. There may be a vacuum indicator 207 in the side wall of the manifold. A void may be formed between an inner wall of the manifold and the seal so that puncturing the seal exposes the vacuum indicator to the vacuum state inside of the container. The vacuum indicator may comprise a flexible membrane 207b drawn to an indicator disc 207c in the presence of a partial vacuum. The flexible membrane may be semi-opaque so the disc is visible when in contact with the membrane.

Description

DRAINAGE APPARATUS

Technical Field

The present invention relates to apparatus for draining fluid from patients. Certain embodiments of the invention relate to drainage apparatus for performing drainage procedures such as intrapleural drainage procedures and peritoneal drainage procedures.

Background

Drainage apparatus for draining fluid from patients are well known and widely used.

Figure 1 provides a schematic diagram of an example of a conventional drainage apparatus 101 (sometimes referred to as a “drainage bottle”) for draining fluid from a patient.

The drainage apparatus 101 includes a fluid container 102 which, during assembly, is evacuated so that a partial vacuum is present inside the fluid container. The fluid container 102 includes three openings: a drainage line port 103, an emptying port 104 and a vacuum indicator port 105. Connected to the drainage line port 103 is a flexible tube 106 which is sealed by a pinch-clamp 107. A drainage line 108 is mounted into the other end of the flexible tube 106.

Connected to the emptying port 104 is a removable plug 109 and connected to the vacuum indicator port 105 is a vacuum indicator 110. Each opening is sealed (the drainage line port 103 by the pinch clamp 107, the emptying port 104 by the removable plug 109 and the vacuum indicator port 105 by the vacuum indicator 110), thus the partial vacuum in the fluid container is maintained 102 ahead of use.

In use, an end of the drainage line 108 (not shown) is coupled, via a valve (not shown), to one end of a catheter (not shown). The other end of the catheter is inserted into a region of a patient to be drained (for example a pleural space).

On coupling of the drainage line 108 and the catheter, the pinch-clamp 107 is removed. The drainage line, and via the valve, the catheter is exposed to the partial vacuum of the fluid container. By virtue of this partial vacuum, fluid is drawn from the patient, through the catheter, via the valve into the drainage line 108, and into the fluid container. The valve typically includes a flow-control mechanism allowing the rate at which fluid is drawn from the patient to be controlled.

The vacuum indicator 110 comprises a collapsible bulb which remains in a collapsed configuration providing a partial vacuum is present in the fluid container 102. In the absence of the partial vacuum, resilient concertinaed walls of the bulb cause the bulb to expand. In this way, the presence or absence of the partial vacuum in the fluid container 102 is immediately apparent by visual inspection. The vacuum indicator is typically adapted so that when the internal pressure approaches atmospheric pressure the vacuum indicator expands.

When the draining process is completed, the pinch clamp 107 is replaced and the drainage line 108 is uncoupled from the catheter detaching the apparatus from the patient. The removeable plug 109 can then be removed and collected fluid can be poured away. Typically, the apparatus 101 is then disposed of.

The type of drainage apparatus described with reference to Figure 1 provides a convenient means of draining fluid from a patient. The arrangement is simple to manufacture, assemble and operate, particular compared to drainage apparatus that rely on powered pumps. However, in certain circumstances, particularly if the apparatus is stored for a prolonged period of time, air leaks into the fluid container degrading partial vacuum, rendering the apparatus unusable.

US2004/0116902 describes examples of drainage apparatus in which an evacuated bottle is sealed at an opening. A deformable elastomeric cap is positioned, providing a further seal, over the sealed opening. A tube passes through a sleeve of the elastomeric cap with one end positioned above the sealed opening. This end of the tube includes a seal-piercing spike. The other end of the tube leads away from the apparatus and is connectable to a drainage line. In use, the tube is connected to a drainage line which is connected to a patient. The tube, using a connected circumferential flange, is then pushed downwards and the spike pierces the seal. This exposes the tube, and thus the drainage line, to a partial vacuum within the bottle and fluid can be drained from the patient into the bottle. The tube can be pushed down in this way because the elastomeric cap is deformable. To prevent accidental piercing of the seal, a removeable clip can be provided which, until it is removed, prevents the tube with the spiked end being pushed towards the seal.

It is an object of certain embodiments of the invention to address drawbacks associated with the prior art.

Summary of the Invention

In accordance with a first aspect of the invention, there is provided a drainage apparatus for draining fluid from a patient. The apparatus comprises an evacuated container, a manifold disposed over an opening of the container with said opening covered by a seal. The manifold comprises a twist-actuated plunger, a drainage line receiving port and a through-hole into which the twist-actuated plunger is received. On twist actuation, the plunger is adapted to puncture the seal and thereby fluidly connect the drainage line receiving port to the container and expose the drainage line receiving port to a partial vacuum of the container.

Optionally, the plunger comprises a seal-piercing end adapted to puncture the seal on actuation of the plunger.

Optionally, the drainage line port is incorporated in the plunger.

Optionally, a through-hole extends through the drainage line receiving port, through a main body of the plunger and through the seal-piercing end.

Optionally, the drainage line receiving port extends as a vertical tube from a top of the main body of the plunger.

Optionally, the seal-piercing end extends as vertical tube from a base of the main body of plunger.

Optionally, the plunger includes an O-ring or soft moulding providing a seal between the through-hole and the plunger.

Optionally, an outer surface of the plunger comprises a helical groove or helical thread and a wall of the through-hole of the manifold comprises a corresponding helical thread or helical groove facilitating twist actuation of the plunger.

Optionally, the plunger includes a twist-grip.

Optionally, the twist-grip incorporates the vertical tube of the drain line receiving port extending from the top of the main body of the plunger includes the twist-grip.

Optionally, the drainage apparatus further comprises a vacuum indicator adapted to provide an indication of a vacuum state of the container.

Optionally, the vacuum indicator is adapted to provide a visual indication of a vacuum state of the container.

Optionally, the vacuum indicator is incorporated in the manifold.

Optionally, a void is formed between an inner wall of the manifold and the seal covering the opening and the vacuum indicator is exposed to the void such that, on puncturing of the seal covering the opening, the vacuum indicator is exposed to the vacuum state of the inside of the container.

Optionally, the vacuum indicator is mounted in a side wall of the manifold.

Optionally, the vacuum indicator comprises an externally-visible flexible membrane drawn to an indicator disc in the presence of a partial vacuum.

Optionally, the flexible membrane is semi-opaque such that indicator disc is visible through the flexible membrane if the membrane is substantially contacting the indicator disc.

Optionally, the drainage apparatus is an intrapleural or peritoneal drainage apparatus.

Optionally, the seal covering the opening of the container is a foil or laminate or nonpermeable seal.

Optionally, the manifold is substantially rigid.

Optionally, the container comprises a single opening.

In accordance with certain aspects of the invention, there is provided a drainage apparatus which comprises an evacuated fluid container for drawing in and collecting fluid from a patient. A manifold is disposed over a sealed opening of the container and a plunger is positioned within a through-hole of the manifold which can be moved within the through-hole to puncture the seal. Advantageously, and in contrast with prior art apparatus, the plunger is twist-actuated. That is, in order to operate the plunger to pierce the seal exposing the drainage line to the vacuum and fluidly connect the container with the drainage line, a user rotationally twists the plunger. This rotational movement is translated into movement of the plunger towards the seal to puncture the seal. By actuating the plunger by rotational movement rather than, for example, a simple linear pushing action as used in certain prior art apparatus, apparatus in accordance with this aspect of the invention are less likely to be actuated accidently, for example in storage. Moreover, there is no requirement for removeable clips to prevent actuation as is required in certain prior art apparatus.

Advantageously, in certain embodiments rather than providing a separate port in the fluid container for a vacuum indicator, advantageously, a manifold is provided over the sealed opening which itself incorporates the vacuum indicator which is only activated when the sealed opening is punctured for use.

Advantageously, in certain embodiments the drainage line receiving port extends through the plunger and therefore there is no need to provide an additional though hole in the manifold for receiving a drainage line.

Advantageously, in certain embodiments, by providing a vacuum indicator with a flexible membrane which is semi-opaque such that the indicator disc is visible through the flexible membrane if the membrane is substantially contacting the indicator disc, the risk of an ambiguous vacuum state indication (e.g. where it is unclear to a user if the partial vacuum is present or not) is reduced.

In accordance with a second aspect of the invention, there is provided a kit for performing a drainage procedure on a patient comprising a drainage apparatus according to the first aspect.

Various further features and aspects of the invention are defined in the claims.

Brief Description of the Drawings

Embodiments of the present invention will now be described by way of example only with reference to the accompanying drawings where like parts are provided with corresponding reference numerals and in which:

Figure 1 provides a schematic diagram of a conventional drainage apparatus;

Figure 2 provides a simplified schematic diagram providing an exploded view of a drainage apparatus in accordance with certain embodiments of the invention;

Figure 3 provides a schematic diagram providing a cross-sectional view of part of a drainage apparatus in accordance with certain embodiments of the invention;

Figure 4 provides a schematic diagram depicting use of a drainage apparatus in accordance with certain embodiments of the invention;

Figures 5 provides a schematic diagram depicting drainage apparatus in accordance with certain embodiments of the invention in which a vacuum indicator is provided on a control valve, and

Figures 6 provides a schematic diagram depicting drainage apparatus in accordance with certain embodiments of the invention in which a vacuum indicator is incorporated within a wall of a fluid container.

Detailed Description

Drainage apparatus in accordance with embodiments of the invention are suited for drainage procedures such as intrapleural drainage and peritoneal drainage procedures. Figure 2 provides a simplified schematic diagram showing an exploded view depicting component parts of a drainage apparatus 201 in accordance with certain embodiments of the invention.

The apparatus comprises a fluid container 202 with a port 203 comprising an aperture 204 providing an opening into the fluid container 202. The apparatus 201 includes a seal 205, typically a foil seal which seals the aperture 204 with an air-tight seal. The seal can be made from any non-permeable seal material, for example any suitable non-permeable laminate material.

During assembly, the fluid container is evacuated to a pressure of typically around 700 to 760mmHg providing a partial vacuum within the fluid container 202. After evacuation, the aperture 204 is sealed by the seal 205 thereby maintaining the partial vacuum within the fluid container.

The fluid container 202 is typically blow moulded from a rigid thermoplastic or thermosetting plastic. However, other suitably rigid materials can be used, for example glass. Typically, the fluid container is transparent or semi-transparent so that, in use, an amount of fluid in container is visible.

The drainage apparatus 201 further comprises a manifold 206 also typically made from a rigid thermoplastic or thermosetting plastic. During assembly, the manifold 206 is ultrasonically welded or bonded onto the fluid container 202 and in particular over the aperture 204 forming an air-tight seal between the manifold 206 and the fluid container 202. As can be seen from Figure 2, in contrast to the conventional arrangement shown in Figure 1, the fluid container only comprises a single sealed aperture reducing the rate at which the partial vacuum within the container degrades.

Incorporated into the manifold 206 is a vacuum indicator 207. The vacuum indicator comprises an indicator cover 207a including a pinhole, a flexible indicator membrane 207b and an indicator moulding and indicator disc 207c. The manifold 206 includes a vacuum indicator aperture 207d which, when the drainage apparatus is assembled, provides a through-hole into a void formed between an inner wall of the manifold 206 and the outer part 216 of the fluid container 202 covered by the manifold 206. The vacuum indicator is arranged to provide a visual indication of the vacuum state of the fluid container, that is the presence, or absence, of a partial vacuum. Operation of the vacuum indicator 207 is explained in further detail below.

The manifold 206 comprises a through-hole 208 into which is received a plunger 209. The plunger 209 comprises a main body 210, a user twist-grip 211 and a seal-piercing end 212 which has a point for puncturing the seal 205.

The main body 210 of the plunger 209 includes an O-ring 217 and a helical groove 213 and an inner-facing wall of the through-hole 208 for receiving the plunger 209 comprises a corresponding protruding helical thread 214. In certain embodiments, this configuration may be reversed, e.g. the main body of the plunger includes a protruding helical thread and the inner-facing wall of the through-hole comprises a corresponding helical groove. The O-ring 217 provides an air-tight seal between the through-hole and the plunger 209 allowing the plunger to be rotated and moved down within the throughhole of the manifold 206 during twist-actuation.

In certain embodiments, rather than using an O-ring, a soft-moulding technique is used in which the outer surface of the main body of the plunger is made from a partially compressible plastic or rubber which forms an air-tight seal in contact with the inner facing wall of the through-hole. This material is such that the main body of the plunger can be moved within the through-hole (e.g. on twist-activation of the plunger) whilst maintaining an air-tight seal. In some embodiments, the whole of the main body of the plunger is made from such a material. In other embodiments, only an outer region of the main body of the plunger is made from such a material.

The protruding helical thread 213 and the corresponding helical groove 214 are such that when the plunger 209 is received into the through-hole 208, when the plunger is twisted by a user rotating the twist-grip 211 in the requisite direction, the plunger is driven towards the aperture 204 and the seal 205. Thus, the plunger 209 is twistactuated. Typically, the helical thread 213 and helical groove 214 are configured so that the seal-piercing end 212 fully punctures the seal 205 when the plunger is rotated substantially 180 degrees of rotation.

The plunger 209 has incorporated therein a drainage line receiving port 215. The drainage line receiving port extends as a vertical tube from a top of the main body 210 of the plunger 209 and is incorporated in the twist-grip 211. A through-hole extends through the drainage line receiving port 215, through the main body 210 and through the seal-piercing end 212 of the plunger 209. The seal-piercing end 212 extends as vertical tube from the main body 210 of the plunger 209.

When the seal-piercing end 212 of the plunger 209 punctures the seal 205, this through-hole fluidly connects the drainage line receiving port 215 to the fluid container thereby providing fluid communication between a drainage line inserted into the drainage line receiving port 215 and the inside of the fluid container 202. On puncturing of the seal 205, the drainage line port is exposed to the partial vacuum within the fluid container 202.

Figure 3 provides a schematic diagram showing a cross-sectional view of part of the drainage apparatus when assembled.

As can be seen in Figure 3, the side wall of the manifold 206 comprises an inner wall 302a and an outer wall 302b. The vacuum indicator assembly 207 is mounted in an aperture in the outer wall 302b of the manifold side wall. During assembly, a void 301 is formed in a space 301 between the port 203 of the fluid container 202 and an inner wall 302a of the manifold 206.

The void 301 is substantially at atmospheric pressure until the seal-piercing end 212 of the plunger 209 punctures the seal 205, exposing the void to the partial vacuum in the fluid container 202. By virtue of the vacuum indicator aperture 207d and a corresponding aperture in the vacuum indicator disc 207e, the pressure differential between the air in the void 301 and the air at atmospheric pressure outside the drainage apparatus 201 gives rise to an inward force (indicated in Figure 3 by an arrow) on the flexible indicator membrane 207b which causes it to touch the indicator disc 207c. The indicator membrane is typically semi-opaque such that the indicator is visible from outside the apparatus only when the membrane is touching the indicator disk.

The indicator membrane 207b is mounted within the vacuum indicator 207 such that the indicator membrane 207b will only contact the indicator disc 207c in the presence of the inward force brought about by the void being exposed to the partial vacuum. That is, the indicator membrane is resiliently biased such that in the absence of a partial vacuum (i.e. the void 301 being substantially at atmospheric pressure), and thus the absence of the inward force, the indicator membrane 207b does not contact the indicator disc 207c and therefore the indicator disc is not visible from outside the drainage apparatus 201. In order to enable the indicator membrane to readily return to its original position once the partial vacuum has been expended, the indicator cover 207a includes a pinhole.

Figure 4 provides a schematic diagram depicting use of the drainage apparatus in accordance with certain embodiments of the invention.

A drainage apparatus 401 as described above is provided. A drainage line 402 is inserted into the drainage line receiving port of the manifold of the drainage apparatus 401. The drainage line is connected to a control valve 403 which is connected to one end of a catheter 404. The control valve 403 is initially closed. The other end of the catheter 404 is placed in a patient 405, specifically in a region to be drained, for example a pleural space or peritoneum. The user grip 406 of the plunger is twisted which punctures the seal over the opening into the fluid container and thus activates the apparatus. The vacuum indicator 407 incorporated into the side wall of the manifold is exposed to the partial vacuum in the fluid container and, the indicator disc becomes visible. In the event that there is a reduced vacuum or no vacuum in the fluid container (for example because the seal is damaged) then there is insufficient force applied to the flexible membrane 207b and the indicator does not become visible and a user, for example a nurse, can tell that the apparatus should be discarded, and another apparatus used.

Assuming the indicator disc is visible indicating that a sufficient partial vacuum is present in the fluid container for the apparatus to operate, the control valve 403 is gradually opened exposing the catheter 404 and region within the patient to be drained, to the partial vacuum. As a result, fluid is drawn from the patient 405, through the valve 403, through the drainage line 402 and into the fluid container.

When the draining procedure is complete, the valve 403 is closed and the drainage line 402 is removed from the valve 403. The plunger can then be removed from the manifold and the drained fluid emptied from the fluid container. The drainage apparatus 401 can then be disposed of.

In certain embodiments, the manifold is not fitted with a vacuum indicator. Figure 5 provides a schematic diagram depicting a drainage apparatus in accordance with certain embodiments of the invention which includes a container 501 and a manifold 502 as described above, except the manifold 502 does not include a vacuum indicator. In such embodiments, a vacuum indicator 503 may be provided on an external component, for example the control valve 504 of the drainage line 505. In such embodiments, part of the vacuum indicator is open to an inner chamber of the valve which is exposed to the partial vacuum of the container 501 on puncturing of the seal by the plunger 506 as described above.

In certain embodiments, the vacuum indicator may be disposed in alternative locations within the drainage apparatus. Figure 6 provides a schematic diagram of an embodiment in which a vacuum indicator 601 is positioned within a wall of the container 603. In such embodiments, part of the vacuum indicator is exposed to the vacuum state of the inside of the container 501. As will be understood, in this way the vacuum indicator provides a visual indication of the vacuum state of the container, irrespective of whether the seal has been punctured.

The vacuum indicator in the embodiments shown in Figures 5 and 6 may typically correspond with the vacuum indicator described in more detail above, i.e. comprise a indicator cover 207a, a flexible indicator membrane 207b and an indicator moulding and indicator disc 207c and provide a visual indication of the vacuum state in a corresponding manner, i.e. by the flexible indicator membrane being forced against the indicator disc due to a pressure differential between the air outside the container and the partial vacuum provided by the evacuated container.

Drainage apparatus in accordance with certain embodiments can be supplied as a kit for performing a procedure such as an intrapleural procedure on a patient who already has a catheter inserted which is terminated at a distal end by a control valve. Such a kit includes a drainage apparatus, drainage line with valve cap for fitting to the control valve and a dressing pack including, for example, gloves, alcohol swabs and dressings.

Each feature disclosed in this specification (including any accompanying claims, abstract and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

It will be appreciated that features from one embodiment may be appropriately incorporated into another embodiment unless technically unfeasible to do so.

It will be appreciated that various embodiments of the present disclosure have been described herein for purposes of illustration, and that various modifications may be made. Accordingly, the various embodiments disclosed herein are not intended to be limiting, with the scope being indicated by the following claims.

Claims

1. A drainage apparatus for draining fluid from a patient, the apparatus comprising an evacuated container, a manifold disposed over an opening of the container, said opening covered by a seal, wherein the manifold comprises a twist-actuated plunger, a drainage line receiving port and a through-hole into which the twist-actuated plunger is received, and, on twist actuation, the plunger is adapted to puncture the seal thereby fluidly connecting the drainage line receiving port to the container and exposing the drainage line receiving port to a partial vacuum of the container.

2. A drainage apparatus according to claim 1, wherein the plunger comprises a seal-piercing end adapted to puncture the seal on actuation of the plunger.

3. A drainage apparatus according to claim 1 or 2, wherein the drainage line port is incorporated in the plunger.

4. A drainage apparatus according to claim 3, wherein a through-hole extends through the drainage line receiving port, through a main body of the plunger and through the seal-piercing end.

5. A drainage apparatus according to claim 4, wherein the drainage line receiving port extends as a vertical tube from a top of the main body of the plunger.

6. A drainage apparatus according to any of claims 3 to 5, wherein the sealpiercing end extends as vertical tube from the main body of plunger.

7. A drainage apparatus according to any previous claim, wherein the plunger includes an O-ring or soft moulding providing a seal between the through-hole and the plunger.

8. A drainage apparatus according to any previous claim, wherein an outer surface of the plunger comprises a helical groove or helical thread and a wall of the through-hole of the manifold comprises a corresponding helical thread or helical groove facilitating twist actuation of the plunger.

9. A drainage apparatus according to any previous claim, wherein the plunger includes a twist-grip.

10. A drainage apparatus according to claim 9, wherein the twist-grip incorporates the vertical tube of the drain line receiving port extending from the top of the main body of the plunger includes the twist-grip.

11. A drainage apparatus according to any previous claim, further comprising a vacuum indicator adapted to provide an indication of a vacuum state of the container.

12. A drainage apparatus according to claim 11, wherein the vacuum indicator is adapted to provide a visual indication of a vacuum state of the container.

13. A drainage apparatus according to claim 11 or 12, wherein the vacuum indicator is incorporated in the manifold.

14. A drainage apparatus according to claim 13, wherein a void is formed between an inner wall of the manifold and the seal covering the opening and the vacuum indicator is exposed to the void such that, on puncturing of the seal covering the opening, the vacuum indicator is exposed to the vacuum state of the inside of the container.

15. A drainage apparatus according to claim 14, wherein the vacuum indicator is mounted in a side wall of the manifold.

16. A drainage apparatus according to any of claims 12 to 15, wherein the vacuum indicator comprises an externally-visible flexible membrane drawn to an indicator disc in the presence of a partial vacuum.

17. A drainage apparatus according to claim 16, wherein the flexible membrane is semi-opaque such that indicator disc is visible through the flexible membrane if the membrane is substantially contacting the indicator disc.

18. A drainage apparatus according to any previous claim, wherein the drainage apparatus is an intrapleural or peritoneal drainage apparatus.

19. A drainage apparatus according to any previous claim, wherein the seal

5 covering the opening of the container is a foil or laminate or non-permeable seal.

20. A drainage apparatus according to any previous claim, wherein the manifold is substantially rigid.

10

21. A drainage apparatus according to any previous claim, wherein the container comprises a single opening.

22. A kit for performing a drainage procedure on a patient comprising a drainage apparatus according to any of claims 1 to 21.