IE84795B1 - An apparatus for the collection of samples for liquid based cytology tests - Google Patents

Abstract

ABSTRACT A sample collection and shipping apparatus for use in liquid based Cytology testing comprises an outer container. One or more groups of cytology sample collection components are located within the outer container for collecting one or more cytology samples. Each group of cytology collection components comprises a cytology collection device, a corresponding vial containing a preservative liquid for receiving the cytology sample from the cytology collection device, and a corresponding requisition form and vial label for completion with the information pertaining to the sample. One or more groups of shipping components are also located within the outer container for packaging one or more collected cytology samples for shipping to one ore more laboratories for analysis. Each group of shipping components comprises a shipping carton comprising a support means for packaging a vial containing a cytology sample and a corresponding requisition form for shipping to one or more laboratories for analysis.

Description

An apparatus for the collection of samples for liquid based cytology tests Introduction This invention relates to an apparatus for the collection of samples for liquid based cytology tests and distribution thereof.

Background In one approach, cytology testing involves collecting a sample and transferring the sample to a slide at the sample collection site. The prepared slide is then sent to a laboratory for testing. Slides are relatively compact, inert and easy to pack and transport. In another approach liquid based cytology sample testing is used in place of slide based sample testing. In liquid based cytology sample testing a collected sample is transferred immediately into a vial containing a preservative liquid and the vial containing the sample is sealed. The preservative liquid is often a methanol buffered liquid and there are standards and regulations relating to the carriage and transport of such flammable liquids. The main issues relate to the volumes of flammable liquids that can be transported via public carriage systems, to the types of containers required for the liquid, the methods of transport. and the temperature at which they are stored and transported. There are also issues relating to the transport of medical samples. In addition, it is often necessary that medical samples arrive at a laboratory for testing within certain time limits. As a result of the above the cost for carriage of the test materials and the samples is often prohibitive and the provision of testing services is often limited to large centralised sites.

The invention addresses these problems.

Statement of invention According to the invention there is provided a sample collection and shipping apparatus for use in liquid based cytology testing comprising: an outer container; one or more groups of cytology sample collection components located within the outer container for collecting one or more cytology samples, each group of cytology collection components comprising a cytology collection device. a corresponding vial containing a preservative liquid for receiving the cytology sample from the cytology collection device, a corresponding requisition form and vial label for completion with information pertaining to the sample and a tray for supporting a vial in distribution and storage, and one or more groups of shipping components located within the outer container for packaging collected cytology samples for shipping to a laboratory for analysis, each group of shipping components comprising a shipping carton comprising a support means for packaging one or more vials containing cytology samples and corresponding requisition forms for shipping to a laboratory for analysis.

In one embodiment the preservative liquid comprises 21 methanol buffered liquid.

In another embodiment the cytology sample is a smear test sample.

In a further embodiment the group of shipping components comprises a shipping label.

In one embodiment the support means comprises an insert having a hollowed out portion shaped for conformity with a vial to support a vial therein.

In another embodiment the support means comprises a base liner.

In a further embodiment the insert and/or the base liner are comprised of a foam material.

In one embodiment the shipping components are of a material suitable for recycling.

In another embodiment the cytology collection device comprises a cytology collection brush or a cytology collection spatula.

In 21 further embodiment the cytology collection device and vial are sterilised for IISC.

In one embodiment the cytology collection device is contained in a sterilised container means during distribution and storage. Altematively the cytology collection device is contained in sterilised wrapping during distribution and storage.

Preferably the tray comprises a seal.

The invention also provides method for the collection and shipping of a cytology sample for analysis comprising the steps of: distributing to a sample collection site, a sample collection and shipping apparatus of the invention using a group of sample collection components to collect a cytology sample, and using a group of shipping components to package said collection samples for shipment from the sample collection site to a testing site.

Detailed Description of the Invention The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only with reference to the accompanying drawings in which:— Fig. 1 is an exploded perspective view ofa sample collection apparatus of the invention; Fig. 2 is a plan view from above of the apparatus of Fig. l assembled; Figs. 3(a) and 3(b) are perspective views of the sample collection components of the apparatus of Figs. 1 and 2; Figs. 4(a) and 4(b) are detailed perspective views of the packaging means of the apparatus of Figs. 1 and 2; Figs. 5(a) and 5(b) are detailed perspective views of the packaging means being prepared for shipping; Figs. 6(a), 6(b) and 6(c) are perspective views of an alternative packaging means of the invention; Fig. 7 is a perspective view of covering material; Fig. 8 is an illustration of the step of applying covering material to a shipping carton in preparation for reuse; and Fig. 9 is a diagram illustrating the steps of the system of distribution of the apparatus of the invention. _ 5 _ Referring to Figs. 1 and 2 a composite sample collection and shipping apparatus 1 comprises an outer distribution container 2 packed with one or more groups of sample collection components and one or more groups of shipping components.

The groups of sample collection components facilitate collection of samples at a sample collection site. The groups of shipping components facilitate packaging of collected samples for shipping from the sample collection site to one or more laboratories for testing.

Each group of sample collection components comprises a vial 3 containing a preservative liquid. a cytology brush 4, a cytology analysis request form 7, and a cytology analysis vial label 8. The vial labels 8 are in place on the vials 3. The apparatus 1 also includes instruction literature and a vial support stand 6. Each group of shipping components comprises a shipping carton 9, support means 13 and 14, and a shipping label 10.

The apparatus 1 includes a plurality of groups sample collection components and shipping components. The apparatus 1 ensures that the medical user at the sample collection site is equipped to collect samples over time and has sufficient shipping components to enable packaging and shipping of the samples as they are collected.

The components of the apparatus 1 may be stored in the outer container 2 until required for use. The outer container 2 is designed to enable secure carriage of the sample collection apparatus 1 to a testing site. As shown in Fig. 2, when the outer container 2 is packed the components fit securely therein and are prevented from being displaced and damaged during carriage. Additional packaging may be provided if required.

The composite apparatus 1 meets the regulations for the carriage of buffered methanol liquids. The vials 3 are supported in trays ll for distribution and storage purposes. The vials and trays are sealed. The vial 3 comprises a plastic container with a lid 12. - 6 _ The sample collection devices and vials are sterilised and retained in sterilised packaging 5 and 11 until required for use.

While in the embodiment illustrated the cytology collection device comprises a cytology brush it will be appreciated that any suitable cytology collection device may be used.

Referring to Figs. 3(a) and 3(b) some of the steps of collecting a sample and packaging a sample for shipping are shown. A single vial 3 is removed from the tray 11 and a single brush 4 is removed from the multiple brush pack 5. The sample. in this case a smear test sample. is collected by medical personnel using the cytology brush 4 and is transferred into the vial 3 which is then sealed. The vial label 8 is completed. The medical user completes a corresponding laboratory test request form 7 which is packaged with the labelled vial.

Referring to Figs. 4(a) and 4(b) the labelled vial 3 is then packaged into a shipping carton 9 for shipping. The shipping carton 9 is designed to receive and support a number of sample containing vials 3. The insert 13 is comprised of foam hollowed out to provide substantially cylindrical reccsscs for accommodating and supporting vials 3. The base layer 14 acts as protective padding. The base layer 14 and vial support 13 are of dimensions which together combine to fill the carton 9 so that vials contained therein are prevented from moving during carriage. The cytology analysis request forms 7 corresponding to the sample containing vials are also accommodated in the carton 9.

The carton 9 comprises a lid 15 and side—flaps 16 and 17 to enable it to be closed quickly and securely. lnstructions or labelling may be printed on the carton.

Referring to Figs. 5(a) and 5(b) the shipping label 10 complete with shipping address information 18 is applied to the carton 9. Also the carton 9 is sealed with a scaling strip 19. The outer container 2 and shipping cartons 9 may be manufactured of cardboard.

However, it will be appreciated that any suitable material such as corrugated cardboard or plastics may also be used. The materials used are non-toxic.

Containers 2 and cartons 9 are sufficiently robust that they securely contain the various components and furthermore withstand the wear and tear of use and .

A sample collection and shipping apparatus 1 may be assembled using shipping cartons 9 of different sizes selected based on test site requirements. The outer container 2 may be packed with cartons 9 of the same size or of different sizes to provide for handling different and changing numbers of samples collected at a sample collection site. In the embodiment illustrated in Figs. 1 and 2, five cartons 9 are included in outer distribution container 2. Referring to Figs. 6(a), 6(b) and 6(c) an alternative shipping carton with capacity for ten vials is shown.

Smaller cartons with a capacity for two or four vials may also be used.

The system of the invention provides means for the distribution, shipment, collection and recycling of the components 9, 13 and 14 of the apparatus 1.

Referring to Figs. 7 and 8 a roll 20 of adhesive covering material is illustrated.

The covering comprises stickers 21 for placing over markings on an exterior face of a used carton 9 to enable reuse of the carton. Stickers 21 of appropriate size and layout are provided. The stickers are manufactured of any suitable material such as plastics or paper material. The stickers may be opaque to provide increased confidentiality.

Referring to Fig. 9 the main steps of the system of the invention are described.

The sample collection and shipping apparatus 1 is assembled at a distribution centre for supply to a sample collection site. If, in general the sample collection sites handles only a few samples per day then a small sized sample collection and shipping apparatus I packed with small sized return shipment cartons 9 may be most appropriate. The sample collection site selects and orders a sample collection and shipping apparatus as required.

The steps involved in the distribution of the sample collection apparatus, shipment of samples, collection and recycling of the components are as follows: III.

Sample collection apparatus 1 is distributed to a sample collection site.

Cytology samples are collected at a sample collection site. A cytology sample collection device from the apparatus 1 is used to collect a sample which is transferred to a corresponding vial 3 containing cytology preservative liquid. A corresponding request form 7 is completed and the vial label 8 completed.

In the embodiment shown, the vials 3 are supplied with the labels 8 in place. However, it will be appreciated that the labels may be provided separately or integrally with the request fonn. If the label is provided separately then the completed label is attached to the vial.

The items to be transported to a laboratory for processing namely, the vial containing the sample and the corresponding request form are packaged into a shipment carton 9 for shipment to one or more laboratories for processing. The sample containing vials are supported in the insert and the requisition or request form is placed in the carton which is then sealed.

The carton is then transported to a laboratory by any suitable means.

At the laboratory, sample containing vials are removed from the carton for processing. The shipping components ie. the cartons 9 and associated support means 13 and 14 are retained for collection. to U1 _ 9 _ VI. The used components are collected from the laboratories and returned to a distribution centre. The cartons 9 and associated support means , 14 are recycled.

The recycling process involves the steps of inspecting the components and replacing any damaged foam or cartons. Stickers 21 are applied to the carton 9 to cover previous carriage marks. Additional blank stickers may be used to cover any further marks on the carton.

VII. Sample collection apparatus 1 is assembled for distribution to a test site.

A distribution centre handles the supply to sample collection sites of the sample collection apparatus. The sample collection sites and processing laboratories are independent entities and the samples are typically shipped between them by independent means. The apparatus 1 conforms to the requirements for shipping medical fluids, and so do samples shipped using the shipping components supplied with the sample collection and distribution apparatus.

The invention overcomes the problems of the prior art by providing means for the secure distribution of sample collection and shipping apparatus and shipment of collected liquid cytology samples from sample collection sites for processing.

The system is flexible and takes account of the reality that different test sites handle different numbers of liquid cytology samples and therefore have different requirements.

The apparatus of the invention and the system for the distribution of the apparatus and shipment of collected samples answers the requirements of different sized GP (General Practitioner) surgeries where the number of liquid cytology samples collected may vary from day to day and where the overall number of samples collected may be limited.

The apparatus is also designed to cater for multiple laboratories. Each sample collection and shipping apparatus includes multiple shipping components and samples may be shipped from a sample collection site to multiple laboratories.

The apparatus and the components are acceptable for use across a wide range of sample collection sites and laboratories.

The system provides excellent flexibility.

The medical user of GP is provided with all of the components required for collecting a liquid cytology sample and returning the sample in the apparatus.

The components required for taking samples are sterilised and are retained in sterilised packaging until required for use. The kit is supplied complete with shipping components which conform with requirements and regulations for the shipment of medical samples and are appropriate for use by third party delivery lirms. A sample collection site need not be concerned with the task of independently procuring packaging for shipping the liquid cytology samples.

Depending on requirements of the test site, it is possible to select the components to be included in a sample collection and shipping apparatus, with flexibility. For example, if only a limited number of liquid cytology samples are typically taken at a particular site then that site may be supplied with an apparatus having a greater number of small sized shipment cartons.

The composite apparatus of the invention has the additional advantages that it is easy to store and that all required elements are stored together as supplied in sterilised packaging. The apparatus is self contained and all the components required for taking samples and sending them to the laboratory are conveniently at hand for the medical user or GP.

The shipment cartons are sufficiently robust to enable recycling. Also the use of robust cartons better serves the requirements for secure support and handling of the liquid cytology sample containing vials. _ 11 _ The recycling process makes distribution highly economical. The system provides for ease in repackaging and facilitates multi-party distribution.

The invention is not limited to the embodiments described but may be varied in construction and detail.

Claims (16)

1.CLAIMS

2. A sample collection and shipping apparatus for use in liquid based cytology testing comprising: an outer container, one or more groups of cytology sample collection components located within the outer container for collecting one or more cytology sample, each group of cytology collection components comprising a cytology collection device, a corresponding vial containing a preservative liquid for receiving the cytology sample from the cytology collection device, a corresponding requisition form and vial label for completion with information pertaining to the sample and a tray for supporting a vial in distribution and storage, and one or more groups of shipping components located within the outer container for packaging collected cytology samples for shipping to a laboratory for analysis, each group of shipping components comprising a shipping carton comprising a support means for packaging one or more vials containing cytology samples and corresponding requisition forms for shipping to a laboratory for analysis.

3. An apparatus as claimed in claim l, wherein the preservative liquid comprises a methanol buffered liquid.

4. An apparatus as claimed in claim 1 or 2, wherein the cytology sample is a smear test sample.

5. An apparatus as claimed in any preceding claim wherein the group of shipping components comprises a shipping label.

6. An apparatus as claimed in any preceding claim wherein the support means comprises an insert having a hollowed out portion shaped for conformity with a vial to support a vial therein.

7. An apparatus as claimed in any preceding claim wherein the support means comprises a base liner.

8. An apparatus as claimed in claims 5 or 6 wherein the insert and/or the base liner are comprised of a foam material.

9. An apparatus as claimed in any preceding claim wherein the shipping components are of a material suitable for recycling.

10. An apparatus as claimed in any preceding claim, wherein the cytology collection device comprises a cytology collection brush.

11. An apparatus as claimed in any preceding claim. wherein the cytology collection device comprising a cytology collection spatula.

12. An apparatus as claimed in any preceding claim wherein the cytology collection device and vial are sterilised for use.

13. An apparatus as claimed in any preceding claim wherein cytology collection device is contained in a sterilised container means during distribution and storage.

14. An apparatus as claimed in any preceding claim wherein the cytology collection device is contained in sterilised wrapping during distribution and storage‘

15. An apparatus as claimed in any preceding claim wherein the tray comprises a seal.

16. An apparatus as hereinbefore described with reference to the drawings. A method for the collection and shipping of a cytology sample for analysis comprising the steps of: distributing to a sample collection site, a sample collection and shipping apparatus as claimed in claim 1 using a group of sample collection components to collect a cytology sample. and using a group of shipping components to package said collected sam le for shi ment from the sam le collection site to a testing