A CORD BLOOD COLLECTION DEVICE

Abstract

A cord blood collection device (1), the device (1) comprising a chamber (2) in fluid communication with a tapered nozzle (4); and in which the tapered nozzle further comprises at least one step (20) along its length.

Claims

1. A cord blood collection device (1), the device (1) comprising a chamber (2) in fluid communication with a tapered nozzle (4); and in which the tapered nozzle (4) further comprises at least one step (20) along its length.

2. A device (1) according to claim 1, wherein the tapered nozzle (4) comprises a distal end (10), an aperture (12) and an internal channel (14).

3. A device (1) according to claim 1, wherein the tapered nozzle (4) comprises a distal end (10), an aperture (12) and an internal channel (14) and wherein the tapered nozzle (4) comprises a series of steps (20) along its length, the series of step (20) configured to engage with a series of collection containers (100) having different diameters.

4. A device (1) according to claim 1 wherein the tapered nozzle (4) comprises a distal end (10), an aperture (12) and an internal channel (14), wherein the tapered nozzle (4) comprises a series of steps (20) along its length, the series of step (20) configured to engage with a series of collection containers (100) having different diameters, and wherein the step (20) is configured to engage with an open end (106) of the collection container (100).

5. A device (1) according to claim 1, wherein the nozzle (4) further comprises a luer lock (50) at a distal end (10) thereof.

6. A device (1) according to claim 1, wherein the nozzle (4) further comprises a luer lock (50) at a distal end (10) thereof; and wherein the luer lock (50) is integrated with and permanently connected to the distal end (10) of the nozzle (4); or wherein the luer lock (50) is configured to secure the nozzle (4) by means of a male fitting on the luer lock (50) which screws into threads in the distal end (10) of the nozzle (4); or wherein the luer lock (50) is configured to secure to the nozzle (4) by means of a female fitting on the luer lock (50) which screw onto a male fitting on the distal end (10) of the nozzle (4).

7. (canceled)

8. (canceled)

9. A device according claim 1, wherein the chamber (2) comprises a wall (8) enclosing a space (7) and an open end (6a) adapted to receive a distal end of an umbilical cord and an open end (6b) in fluid communication with the nozzle (4).

10. A device (1) according to claim 1, wherein the chamber (2) further comprises a stepped portion (16) adapted to receive and engage with the open end (106) of the collection container (100).

11. A device (1) according to claim 1, wherein the wall (8) of the chamber (2) further comprises a textured internal surface.

12. A device (1) according to claim 1, wherein the device is constructed from a durable yet rigid material selected from polypropylene, polyethylene (PE), polyethylene terephthalate (PET), polyethylene terephthalate copolymer (PETG), amorphous polyethylene terephthalate (APET), Acrylonitrile-Butadiene-Styrene (ABS), Styrene Acrylonitrile (SAN), high impact polystyrene (HIPS), polycarbonate (PC), (thin-walled) surgical stainless steel.

13. (canceled)

14. A device (1) according to claim 1, wherein the device is pre-sterilised.

15. A device (1) according to claim 1, wherein the device (1) is suitable for multiple uses.

16. A device (1) according to claim 1, wherein the device (1) is suitable for multiple uses and which the device is suitable for multiple sterilisation cycles in, for example, a central sterile services department (CSSD) in a medical facility.

17. A device (1) according to claim 1, wherein the device is needleless.

18. A stand (400) for use with a cord blood collection device (1), the device (1) comprising a chamber (2) in fluid communication with a tapered nozzle (4); and in which the tapered nozzle (4) further comprises at least one step (20) along its length, and the stand (400) comprising a base (402) and a vessel (404).

19. A stand (400) according to claim 15, further comprising an enclosure (406,506) configured to secure and contain a cap of a container (100).

20. A kit for collecting umbilical cord blood, the kit comprising a cord blood collection device (1), the device (1) comprising a chamber (2) in fluid communication with a tapered nozzle (4); and in which the tapered nozzle (4) further comprises at least one step (20) along its length.

21. A kit according to claim 17, further comprising a stand (400) that comprises a base (402) and a vessel (404).

22. A kit according to claim 17, further comprising one or more collection containers (100).

23. A kit according to claim 17, further comprising a catheter, a connecting tube, a cord clamp, a diathermy/instrument pouch, a drape, a baby blanket, a hand towel, a mayo cover, a sharps box, a swab, a yankauer, a gown, a trolley cover, a wrap, a crepe, a bag and a breather.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The invention will be more clearly understood from the following description of an embodiment thereof, given by way of example only, with reference to the accompanying drawings, in which:

[0044] FIG. 1A illustrates a side view of one embodiment of the cord blood collection device of the present invention; while FIG. 1B illustrates a bottom view, FIG. 1C a perspective view, and FIG. 10 the side view of FIG. 1 A with a collection container attached thereto.

[0045] FIG. 2A illustrates a longitudinal view of one embodiment of the device;

[0046] FIG. 2B illustrates a bottom view of the embodiment of the device; and FIG. 2C illustrates a perspective view of the embodiment of the device of the present invention.

[0047] FIGS. 3A to 3C illustrate longitudinal sectional views of the cord blood collection device of FIG. 2 engaged with collection tubes of varying diameters.

[0048] FIG. 4A illustrates an array of tubes used for cord blood analysis (Vacuette 9 ml K3EDTA, Sarstedt Monovette 7.5 ml EDTA KE, Vacuette 2.5 ml K3EDTA, Sarstedt Monovette 2.7 ml EDTA KE and Sarstedt Monovette 2 ml blood gas containers, BD Vacutainer K2E (EDTA) 6.0 ml, BD Vacutainer K2E 4.0 ml.

[0049] FIG. 5 illustrates a side view of one embodiment of the cord blood collection device connected to a sample tube used for cord blood collection and with an umbilical cord in situ within the housing of the device.

[0050] FIG. 6 illustrates a side view of one embodiment of the cord blood collection device of FIG. 1 or FIG. 2 showing a luer lock connector at the opening of the tapered nozzle.

[0051] FIGS. 7A and 7B illustrate perspective views of a stand for the device of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

Materials and Methods

[0052] When the device described herein is utilised, umbilical cord blood can be safely and effectively collected from the cut end of the cord. The required materials include: cut end of delivered umbilical cord (where the cord is either (a) attached to placenta and cut or (b) cut from placenta and clamped at either or both cut ends), blood collection tube and the device described herein. Personal Protective Clothing and Equipment (PPCE) such as gloves, gowns, face masks etc. would also be worn by the person collecting the cord blood, as per the safe work procedures of the institute collecting the blood. The blood collection tube is uncapped and the nozzle of the device described herein is inserted into the tube. A secure connection between the nozzle of the device described herein and the collection tube is achieved via the tapered, stepped design of the nozzle. One hand is used to insert the distal end of the cut cord into the chamber of the device described herein while the other hand holds the device described herein with the collection tube securely attached to it. The distal end of the cord is stabilised in place in the chamber with the thumb of the same hand holding the device and the attached tube. The other hand is then used to milk the cord blood into the device. The blood is directly funnelled into the collection tube. When a sufficient volume of clot-free blood has been collected, the device described herein is released from the blood collection tube and set aside. The blood-filled collection tube can then be placed in a collection tube holder while gloves are changed. The tube is then capped with clean gloves. When using the device described herein as a single-use item, the device can be discarded along with the cord/placenta. Where the device is a re-usable item, the device can be set aside for cleaning and sterilisation and the cord/placenta discarded.

[0053] The collected blood can then be sent for blood typing, stem cell collection, genetic testing and a range of diagnostic and screening tests.

[0054] A number of Dublin maternity hospitals were using a 20 ml syringe (with the plunger removed) as a way of funnelling cord blood straight into appropriate laboratory containers but, on testing by clinical staff in the Rotunda Hospital, this method was found to be unsafe and unwieldy.

[0055] The present invention provides a cord blood collection device that is safe, practical, efficient and simple to use. The cord blood collection device described herein addresses the safety and sample quality issues associated with a commonly employed method of cord blood collection. The current problems include: jeopardized sample viability due to lack of appropriate preservative agents in universal collection tube, sub-sampling error, risk of blood splash and leakage, risk of needle stick injury and overall encumbrance of the process.

[0056] Referring now to the figures, where FIG. 1 illustrates a general embodiment of an umbilical cord blood collection device of the present invention, and is generally referred to by reference numeral 1. The umbilical cord blood collection device 1 comprises a chamber 2 in fluid communication with a tapered nozzle 4. The chamber 2 comprises a wall 8 enclosing a space 7, the wall 8 having an inner diameter 3 and outer diameter 5. The chamber 2 further comprises an open end 6a, adapted to receive and accommodate a distal end of an umbilical cord, and an open end 6b which is in fluid communication with the nozzle 4. The open end 6b is configured to transfer fluid received from the umbilical cord accommodated within the space 7 of the chamber 2 to the nozzle 4. While the chamber 2 can be any desired shape (for example, circular or multi-sided (for example, triangle, square, rectangle, oval, 4-sided, 5-sided, 6-sided or more)), the chamber 2 is generally substantially circular. The chamber 2 has a length of approximately 4 cm, which allows for a sufficient section of cord to be inserted therein, and preventing the cord from slipping out of the device 1. In one embodiment, the wall 8 enclosing space 7 has a textured internal surface, which provides purchase on the distal end of the umbilical cord when accommodated within the device 1. During cord blood collection, the cord is further stabilised within the chamber 2 with the thumb of the hand used to hold the device 1 and an attached collection container 100.

[0057] The nozzle 4 comprises a distal end 10 in fluid communication with the open end 6b of the chamber 2 via the channel 14. The distal end 10 has an aperture 12, which is in fluid communication with the open end 6b. The nozzle 4 is tapered, with a larger diameter at the open end 6b when compared to the distal end 10.

[0058] The chamber 2 further comprises a stepped portion 16, which is in fluid communication with, and in between, the open end 6b and nozzle 4. The stepped portion 16 is adapted to receive and (reversibly) engage with the mouth of the collection container 100 having a suitable diameter (see FIG. 4). In certain scenarios, the diameter of the collection container 100 will be of a particular size that the mouth of the container 100 will not engage with the stepped portion 16 but with the surface of the tapered nozzle 4 itself (see FIG. 10). Typically, the collection container 100 comprises a housing 102 having an open end (mouth) 106 and a rim or lip 108 surrounding the open end 106. The engagement between the device 1 and the collection container 100 provides a secure fit. The secure fit is reversible and is achieved by the gradual taper on the nozzle 4 which provides interference fit with the container 100 but would not be so tight so as to hinder the removal of the container 100 that would be filled with cord blood from the device 1. This reversibly secure fit will reduce any risk of blood leakage that would otherwise result in contamination of the exposure of the collection container 100.

[0059] Referring to FIG. 2, there is illustrated an embodiment of an umbilical cord blood collection device 1 of the present invention, in which parts described with reference to the previous embodiment are assigned the same numerals. In the embodiment, the nozzle 4 comprises a series of steps 20 that run from the stepped portion 16 to the aperture 12 of the distal end 10. This is more clearly seen in FIGS. 2A and 2C where the circumference of the steps 20 start off widest at the stepped portion 16 and progressively narrows towards the aperture 12 of the distal end 10 of the nozzle 4.

[0060] The steps 20 are adapted to securely fit to, and reversibly release from, the open end 106 of the collection container 100 having a particular diameter housing 102 (see FIG. 3A-C), as described above for FIG. 1. The series of steps 20 are configured to accommodate collection containers 100 of varying diameters, such as a Vacuette 9 ml K3EDTA, a Sarstedt Monovette 7.5 ml EDTA KE, a Vacuette 2.5 ml K3EDTA, a Sarstedt Monovette 2.7 ml EDTA KE, a Sarstedt Monovette 2 ml blood gas containers, a BD Vacutainer K2E (EDTA)6.0 ml, a BD Vacutainer K2E 4.0 ml. (see FIG. 4). This versatility in being able to connect to and fit a wide variety of collection containers 100 is one advantage of the device 1 of the invention.

[0061] In use, as illustrated in FIG. 5, the open end 106 of the collection container 100 is placed over the nozzle 4 of the device 1. The aperture 12 is positioned within the housing 102 of the collection container 100 and the rim 108 of the open end 106 of the collection container 100 engages with either one of the steps 20 or the stepped portion 16. The diameter of the open end 106 of the container 100 will determine where along the nozzle 4, such as which step 20 or the stepped portion 16, the container 100 engages. The collection container 100 generally finds a position on the nozzle 4 or stepped portion 16 so that the container 100 fits to the device 1 but not so tight as to make it difficult to remove when the cord blood has been collected. A distal end of an umbilical cord 200 is placed through the open end 6a of the chamber 2 and into the space 7 such that it is enclosed by the wall 8. Any blood or fluid removed from the umbilical cord 200 either by physical manipulation or gravity will flow from the open end 6b of the chamber 2 and into the nozzle 4. The fluid or blood will be directed via the internal channel 14 of the nozzle 4, through the aperture 12 and into the collection container 100.

[0062] The device 1 is designed to accept the distal end of an umbilical cord and securely connect with a range of collection containers (100), enabling the safe and efficient collection of cord blood. It is used on delivered umbilical cords/placentas. Sterile devices can be used in the immediate patient care area. This would allow the device to be incorporated, for example, in sterile/surgical packs used in operating theatres. A caesarean section pack for example, would typically include the device 1 of the present invention, a catheter, a connecting tube, a cord clamp, a diathermy/instrument pouch, a drape, a baby blanket, a hand towel, a mayo cover, a sharps box, a swab, a yankauer, a gown, a trolley cover, a wrap, a crepe, a bag and a breather.

[0063] Referring to FIG. 6, there is illustrated an embodiment of an umbilical cord blood collection device 1 of the present invention, in which parts described with reference to the previous embodiment are assigned the same numerals. In the embodiment, the nozzle 4 comprises the series of steps 20 that run from the stepped portion 16 to the aperture 12 of the distal end 10. The circumference of the steps 20 start off widest at the stepped portion 16 and progressively narrows towards the aperture 12 of the distal end 10 of the nozzle 4. The nozzle 4 further comprises a luer lock 50 in fluid communication with the aperture 12 of the distal end 10 via a channel within the lock 50 which ends with an aperture 12a distal the aperture 12. The luer lock 50 further comprises threads 52 which are configured to engage with a tabbed hub on a female fitting which screws onto the threads 52 on the lock 50. The channel within the luer lock 50 can also have an internal taper (wider towards aperture 12a and tapering towards the distal end 10) to engage with a male fitting, such as a needless syringe. The luer lock 50 incorporated into device 1 allows for the collection of cord blood when engaged with the current collection tubes 100 of varying diameters. The luer lock 50 connection expands the possible range/number of devices/collection systems that may be used now and in the future for example; collection tubes to bags, syringes, interconnectors etc.

[0064] Referring to FIG. 7A there is illustrated a stand 400 for use with the device 1 described herein. The stand 400 comprises a base 402 upon which is a vessel 404 and an enclosure 406. The vessel 404 is generally a cylinder having an outer wall 408 defining a lumen 410, an open end 412 and a closed end distal the open end where the outer wall 408 contacts the base 402. The vessel 404 is configured to accept and support the collection container 100, while the enclosure 406 is configured to hold and secure a cap of the container 100 when the container 100 is engaged with the device

[0065] Referring to FIG. 7B, there is illustrated a stand 400 for use with the device 1 described herein in which parts or steps described with reference to the FIG. 7A are assigned the same numerals. In FIG. 7B, the enclosure 406 of FIG. 7A is replaced with an enclosure 506. The enclosure 506 forms a barrier around the outer edge of the base 402 and creates a moat-like structure surrounding the vessel 404. The enclosure 506 permits the user to place the cap of the container 100 when the container 100 is engaged with the device 1. In some instances, the enclosures 406,506 could be combined on the same base 402, with the enclosure 406 within the confines of the enclosure 506.

[0066] In use, the container 100 is placed in the vessel 404 and the cap is removed from the container 100 and placed in the enclosure 406,506. The nozzle 4 of the device 1 is placed within the open end 106 of the collection container 100 and the cord blood is collected as described for FIG. 5 above. The advantage of using the stand 400 is that there is a greatly reduced likelihood of contaminating collection container 100 and its label as the operators gloved hands can exclusively now hold device 1 when collecting cord blood. Stand 400 eliminates the need for a variety of collection container holders (determined by the specific collection container used), as stand 400 fits all current commonly used collection containers.

[0067] Some of the advantages of the device 1 of the present invention are that: [0068] (a) It allows for a universal and precise fit applicable to the most commonly used laboratory blood or fluid collection containers, such as, Vacuette 9 ml K3EDTA, BD Vacutainer K2E (EDTA) 6.0 ml, BD Vacutainer K2E 4.0 ml, Sarstedt Monovette 7.5 ml EDTA KE, Vacuette 2.5 ml K3EDTA, Sarstedt Monovette 2.7 ml EDTA KE and Sarstedt Monovette 2 ml blood gas containers. As such, blood is collected directly into the collection tube containing the appropriate preservative agent. This helps minimize jeopardized sample viability (e.g. due to clotting). [0069] (b) Precision fit with the appropriate blood tubes reduces the risk of blood leakage and spillage during the milking process. This in turn reduces the occupational risk of blood exposure. [0070] (c) Direct funnelling into the appropriate blood tube eliminates the need for additional sub-sampling during laboratory analysis. This avoids sub-sampling errors. [0071] (d) The device 1 does not require a needle for blood collection or transfer. The blood is sampled directly from the umbilical cord into the appropriate collection container. This avoids any needle stick injuries. [0072] (e) The chamber 2 which houses the distal end of the umbilical cord, is designed so that the cord can be easily inserted and held in the device 1. This is achieved by simply inserting the cord into the chamber 2 while stabilizing the cord against the wall 8 of the chamber 2 with the one's thumb. The chamber length of approximately 4 cm allows for a sufficient section of cord to be inserted, preventing the cord from slipping out. Furthermore, the chamber's inner surface is textured, providing purchase on the distal end of the umbilical cord. The texture would also allow clearance for blood flow between the surface of the cut cord and the chambers inner surface. [0073] (f) The use of the nozzle 4 allows for the blood to be directly transferred into the collection container without pooling during transfer. This helps minimize jeopardized sample viability due to clotting. [0074] (g) While other methods of cord blood collection can be cumbersome and may require two sets of hands, the device 1 described herein can be easily used by one individual using both hands. Furthermore, the use of stand 400 means any current/common collection container 100 and cap will be securely accommodated.

[0075] In the specification the terms comprise, comprises, comprised and comprising or any variation thereof and the terms include, includes, included and including or any variation thereof are considered to be totally interchangeable and they should all be afforded the widest possible interpretation and vice versa.

[0076] The invention is not limited to the embodiments hereinbefore described but may be varied in both construction and detail.