WO2022265571A1

WO2022265571A1 - Sample collection device

Info

Publication number: WO2022265571A1
Application number: PCT/SE2022/050597
Authority: WO
Inventors: Helge Steg
Original assignee: Arta Plast AB
Current assignee: Arta Plast AB
Priority date: 2021-06-18
Filing date: 2022-06-17
Publication date: 2022-12-22
Anticipated expiration: 2023-12-18
Also published as: EP4356097A1; SE545594C2; EP4356097A4; SE2150787A1

Abstract

A sample collection device 100 comprising an elongated sleeve-shaped body 110, and a biased spring 130 arranged within the sleeve shaped body 110. An elongated piston unit 120 having a front end 121 with a sample collection member 121a, and a rear end 122 with a first shoulder 122a. The piston 120 further comprises a sealed chamber 125 arranged within the elongated piston 120 and arranged for holding a reagent. Wherein the piston unit 120 is movably arranged between three positions within the elongated sleeve shaped body 110. In use, pushing the first shoulder 122a of the piston 120 towards the sleeve-shaped body 110 biases the spring 130 and exposes the front end 121 of the piston 120, allowing collection of the test sample. Releasing the piston 120 and twisting the shoulder 121a returns the piston 120 into the sleeve-shaped body 110 and breaks the chamber 125 seal, releasing the reagent from the chamber 125 into the sleeve shaped body 110.

Description

SAMPLE COLLECTION DEVICE

Field of the invention

The present invention relates to a sample collection device for retrieval of a fluid sample.

Background of the invention

Testing for substances, viruses, bacteria or similar is a common practice in medicine today. These tests often involve collection of samples such as blood, saliva, or any mucus. The tests may help identify disease or substances in a person. Tests have been conducted in a similar manner over long time and may be standard procedure to perform for healthcare professionals. However, as a market for self-tests is rapidly increasing there may be a need to improve the collection of fluid samples. Presently, the collection of samples is primarily conducted using a swab collecting the sample which is then dissolved in a liquid located in a separate container The liquid with the dissolved sample may then be analysed.

Performing the collection of the sample may however be cumbersome. Further, after the sample is collected, the treatment of the swab may include a risk of compromising the sample. This may be especially true if a person is performing the sampling collection on themselves.

There is thus a need for facilitating sample collection.

Summary

According to a first aspect of the present invention there is provided a sample collection device. The sample collection device comprising: an elongated sleeve-shaped body extending along an axis A, having a first end and a second end. A biased spring assembly arranged within the sleeve shaped body. An elongated piston unit comprising: a front end having a sample collection member. A rear end having a first shoulder having a diameter equal to or larger than the diameter of the sleeve shaped body. A second shoulder arranged between the first end and second end and having a diameter smaller than the diameter of the sleeve shaped body. A sealed chamber arranged within the elongated piston and arranged for holding a reagent. The piston unit is movab!y arranged between three positions within the elongated sleeve shaped body. A resting position wherein the front end of the elongated piston unit is arranged within the first end of the elongated sleeve-shaped body and the rear end of the piston is extending out of the second end of the elongated sleeve shaped body, and the second shoulder is engaged with the biased spring. A sample collecting position wherein the rear end of the piston is pushed towards the second end of the sleeve-shaped body, further biasing the spring, and extending and exposing the front end of the piston from the front end of the sleeve shaped body. An analysis position wherein the first shoulder is rotated at least partly around the axis A, the chamber seal is broken, and the spring bias released such that at least a portion of the piston is arranged within the chamber.

In use, the sample collection device according to the invention is placed adjacent to where the sample is to be collected, through absorbing, swabbing or similar. This may for example be orally, nasally, vaginally or any mucosa or near any other substance to be collected. Substance to be collected may for example comprise blood, saliva, or mucus.

When the sample collection device is arranged in its intended position the user pushes the first shoulder of the piston towards the second end of the sleeve-shaped body. This moves the piston through the sleeve shaped body, biasing the spring and exposing the sample collection member, arranged on the front end of the piston, through the first end of the sleeve shaped body. The sample is at this stage collected by the sample collection member arranged on the front end of the piston. The first shoulder is released, wherein the biased spring returns the piston to its initial position with the front end of the piston inside the first end of the sleeve-shaped body. The first shoulder is then twisted, breaking the seal of the chamber, allowing the reagent to flow from the chamber towards the front end of the piston. The chamber seal may comprise a plastic portion being thinner and/or more fragile than the other parts of the piston body. Hence, upon twisting of the first shoulder the chamber seal will be cracked open and the contents of the chamber may be released.

It will be appreciated that the device of the present invention offers a user-friendly sample collection device with improved handling which facilitates the collection of test samples.

According to an embodiment of the present invention, the sample collection device further comprises a cap arranged for essentially hermetically sealing the front end of the sleeve-shaped body. The present embodiment will be beneficial as the reagent may be stored within the sleeve-shaped body. Thus, the handling of a collected sample may be improved, for example in transportation and storage after the sample is connected until the sample test is analysed.

According to an embodiment of the present invention, the sample collection device is arranged with the spring applying pressure on the second shoulder such that at least a portion of the piston penetrates the chamber if the chamber seal is broken. This embodiment will further facilitate the reagent to flow toward the first end of the sleeve-shaped body and the efficiency and usability of the sample collection may be increased.

According to an embodiment of the present invention, the sample collection device comprises a sample collection member which comprises a fluid absorbing material. The present embodiment may facilitate the collection of a test sample and may thus further increase the usability of the device.

According to an embodiment of the present invention, the sample collection device is arranged such that, as the piston is in the analysis position, at least a portion of the piston and the second end of the sleeve- shaped body forms an essentially hermetical seal. The present embodiment may thus be beneficial as the reagent may be kept within the sleeve-shaped body without a risk of leakage.

According to an embodiment of the present invention, the spring is a helical spring. This embodiment may further facilitate the production and usage of the device.

According to the present invention, a method comprising a sample collection device according to claim 1, comprises the steps of: a. arranging the sample collection device adjacent the sample to be collected. b. pushing the first shoulder of the piston towards the second end of the sleeve-shaped body, biasing the spring and exposing the front end of the piston through the first end of the sleeve-shaped body. c. releasing the first shoulder, wherein the biased spring returns the piston to its initial position with the front end of the piston inside the first end of the sleeve-shaped body. d. twisting the first shoulder, breaking the seal of the chamber, allowing the spring to move at least a portion of the piston into the chamber, and allowing the reagent to flow from the chamber into the sleeve-shaped body towards the front end of the piston.

The present invention is beneficial as the an efficient, secure and easy-to-use method for test sample collection is provided.

According to an embodiment of the present invention, the method further comprises, in step c, covering the first end of the sleeve-shaped body, after releasing the first shoulder. Thus, the embodiment further enhances the sample collection process and analysis as the sample collection device may be sent to a laboratory without leakage.

Brief description of the drawings

The above, as well as additional objects, features, and advantages of the present invention, will be better understood through the following illustrative and non-limiting detailed description of embodiments of the present invention. Reference will be made to the appended drawings, on which: figure 1 is a schematic view of the sample collection device according to some embodiments of the present invention. figure 2 is a schematic view of the sample collection device according to some embodiments of the present invention. figures 3 is a schematic view of the sample collection device according to some embodiments of the present invention. figure 4 is a schematic view of the sample collection device according to some embodiments of the present invention.

Detailed description

Figure 1 shows an embodiment of the present invention. Depicted is a sample collection device 100 for facilitating the collection of fluid samples. The sample collection device 100 comprises an elongated sleeve-shaped body 110. The sleeve-shaped body 110 depicted has a first end 111 and a second end 112. The body is of a tapered configuration towards the first end 111. Further, in the depicted embodiment the sleeve-shaped body 110 has protrusions 113 for easier handling. The sleeve-shaped body 110 in the present embodiment comprises a plastic material, however other embodiments may utilize alternative materials. As seen figure 1 , the sample collection device comprises a piston unit 120 having a front end 121 and a rear end 122. The rear end has a first shoulder 122a which is of a diameter greater than the diameter of the sleeve shaped body 110, thus preventing the rear end from penetrating the body. Further, on the front end 121 of the piston a sample collection member 121a is disclosed. The sample collection member 121a in the present embodiment is of a cotton material, arranged for absorbing a fluid and thus facilitating the collection of a sample. Other embodiments may utilize a sample collection member 121a of any other suitable material. The absorption of the sample may for example be accomplished with capillary force. This may for example be especially suitable for collecting blood-samples. The sample collection member 121a may further be arranged in different geometrical shapes than depicted in the figure. Further, the sample collection member may be arranged with various surface structures such as ribs or cavities which may be arranged for collecting a specific amount of a sample, this may be especially suitable for sample collection anally or vaginally. As seen in the depicted figure, the piston 120 comprises a second shoulder 123, which is arranged against a spring 130. The spring 130 is biased and thus applies a force against the second shoulder 123. Further, protrusions 126 on the piston are arranged for preventing the piston from sliding out of the sleeve-shaped body 110 from the force of the biased spring 130. The depicted embodiment shows the piston in the intended resting position.

The piston further comprises a sealed chamber 125, accommodating a reagent, in other words, a substance for the sample analysis. As depicted, the reagent is a liquid reagent, or a buffer solution. The reagent may for example comprise a saline solution. The reagent may for example be arranged to preserve the collected sample, alternatively, the reagent may be chosen to affect the sample. The reagent may for example be an active buffer for the purpose of preparing the sample for further handling and analysis. The reagent may be chosen with respect to the sample to be collected and to the analysis to be made, for example a reagent may be a marker changing colour or affecting another substances to change colour when in contact with the reagent. The chamber 125 is sealed such that the reagent may be arranged therein, without leakage. The chamber 125 is sealed by the piston, whereas the chamber seal 125a in the end of the chamber 125 closest to the front end 121 of the piston is thinner and/or more fragile than the other enclosing parts of the piston. The first shoulder 122a may be arranged with a sealing foil 122b and/or a sealing plastic for ensuring that the chamber does not leak.

The sample collection device 100 is configured for removably arranging a cap on the first end 111 of the sleeve-shaped body 110. The cap may beneficially be liquid sealing or hermetically sealing. However, other alternatives maty be possible. The cap is in the present embodiment arranged on the sleeve-shaped body before the sample collection device is set to be used. The cap may thus protect the sample collection member 121a before the sample is to be retrieved. This secures that the sample collection member 121a does not absorb any other substance or is otherwise contaminated. Before use of the sample collection device 100, the cap is removed. As the sample collection process is complete, the same, or a different cap may be placed on the first end 111 of the sleeve-shaped body 110. This facilitates handling and secures the sample within the sleeve shaped body 110 until the sample is to be analysed.

The process of collecting a sample may be initiated as the cap has been removed from the sleeve-shaped body 110, the sample collection device 100 is arranged with the piston 120 in the resting position and the sample collection device 100 is ready for use and. The sample collection device 100 is then placed with the first end 111 adjacent to the sample to be collected, for example a mucosa. The user of the sample collection device 100 then presses the first shoulder 122a located on the rear end 122 of the piston 120. This brings the piston 120 to the sample collection position, depicted in figure 2.

In figure 2, the sample collection position, the piston is pushed by a person so that the first shoulder 122a is adjacent to the second end 112 of the sleeve-shaped body. This will further bias the spring 130 and allow the front end 121 of the piston 120 to exit through the first end 111 of the sleeve shaped body 110. This will leave the sample collection member 121a exposed for as long as the first shoulder 122a is pressed towards the sleeve- shaped body 110. The sample collection member 121a may then absorb the sample, in this example mucus, but may also comprise blood, saliva or similar. As the sample collection member 121a has made contact and absorbed a sample, the first shoulder 122a may be released. This will release the bias of the spring 130 which may push the piston 120 back to its return position. At this stage, the sample collection member 121a is returned in the sleeve shaped body 110 with the absorbed sample. The piston is thus returned to the resting position, as shown in figure 1.

A cap, as previously discussed, may then be placed on the first end 111 of the sleeve-shaped body 110.

The following step in the sample collection process involves twisting the first shoulder 122a, bringing the piston to the analysis position as shown in figure 3.

In figure 3 the piston is arranged in the analysis position. The analysis position is accomplished by twisting, and in some embodiments twisting and pushing simultaneously, the first shoulder 122a in either direction. This twisting will break the piston 120 in such a manner that the sealed chamber 125 is opened.

This is accomplished as the piston is not rotatable in the sleeve- shaped body the twisting of the rear end of the piston will cause the piston to break apart at its most fragile location. The most fragile location of the piston being the chamber seal 125a. The twisting of the first shoulder thus cracks the chamber seal 125a in such a manner that the sealed chamber 125 is opened. Thus, regardless of direction of rotation the piston will break at the location of the chamber seal 125a, preferably, in the end of the chamber closest to the front end of the piston. The chamber seal may for example comprise the same material as the piston body 110, arranged in a thinner configuration. Other embodiments may utilize a chamber seal 125a material more fragile than the material of the piston body.

As shown in figure 3, the fluid, or reagent, contained in the sealed chamber 125 is, upon breakage of the chamber seal 125a, free to flow out of the chamber 125 into the interior of the sleeve-shaped body 110. The fluid may flow as depicted by the arrows in figure 3. This may be accomplished partly by gravity. However, as the chamber seal 125a breaks, the spring 130 applying a force onto the second shoulder 123 will force at least a portion 124 of the piston 120 into the chamber 125 where the reagent has been held. This will further encourage the reagent to leave the chamber 125, regardless of how the sample collection device 100 is positioned.

The reagent may then, as it in this stage is held in the sleeve-shaped body 110, reach the sample collection member 121a, The reagent may thus at least partly dissolve the sample gathered in the sample collection member 121a. This will further facilitate test analysis of the sample. The reagent may then be analysed for drawing conclusions regarding the collected sample. The analysis may be performed in a plurality of ways, for example by the person conducting the sample collection, or may be sent to a laboratory for evaluation, depending for example on the sample and reason for sample collection.

In the present embodiment, the collected sample is to be sent via mail to a laboratory for evaluation. As the piston 120 is in the analysis position, the protrusion 126 of the piston is arranged fitted against the second end 112 of the sleeve-shaped body 110. Other embodiments may accomplish this with other parts of the piston. This arrangement is beneficially liquid sealing or hermetically sealing such that no reagent may exit the sleeve shaped body through its second end 112. Further, a cap is placed to seal the first end 111, such that the fluid with the dissolved sample is held secured inside the sleeve-shaped body 110. The sample collection device 100 may then for example be sent to a laboratory via mail for analysis, as no fluid may enter or exit the sleeve-shaped body 110. It may also be beneficial to shake or stir the sample collection device 100 in order to facilitate the dissolving of the sample in the reagent.

In another example, the collected samples may be analysed immediately. In such an instance, a person may collect a sample from themselves using the sample collection device and analyse the sample on a sample card. The sample card may preferably be a paper card adapted for reacting with the sample. This may for example mean that the card assumes a colour or other visual reference such as a geometrical figure in response to the sample contents. In such a testing there may not be a need for utilizing the cap. Instead the reagent may exit the front end 111 of the sleeve-shaped body 110 essentially immediately upon twisting of the first shoulder 122a. As the twisting breaks the chamber seal 125a and releases the fluid from the chamber 125. Thus, the fluid may exit the sleeve-shaped body 110 through its first end 111, collecting or dissolving part of the sample from the sample collection member 121a. The dissolved or collected sample may then be poured with the reagent onto a sample card for analysis. The flow path of the present example is depicted with arrows in figure 3.

In figure 4, an alternative embodiment of a sample collection device 100 is depicted. The sample collection device 100 is depicted in the sample collection position. The sample collection device 100 comprises a sleeve shaped body 110 and a piston 120. The piston having a front end 121 with a sample collection member 121a arranged thereon, and a rear end 122, having a first shoulder 122a. Here, the first shoulder 122a is pushed toward the second end 112 of the sleeve shaped body 110, also biasing the spring 130. This position of the piston 120 exposes the sample collection member

121a from the first end 111 of the sleeve-shaped body 110. In the present embodiment, the sample collection member 121a is ribbed and arranged for collecting a sample using capillary force. The present embodiment may be especially suitable for collecting blood samples.

Claims

1. Sample collection device (100) comprising: an elongated sleeve-shaped body (110) extending along an axis A, having a first end (111) and a second end (112); a biased spring assembly (130) arranged within the sleeve shaped body; an elongated piston unit (120) comprising: a front end (121) having a sample collection member (121a), a rear end (122) having a first shoulder (122a) having a diameter equal to or larger than the diameter of the sleeve shaped body (110), a second shoulder (123) arranged between the first end (111) and second end (112) and having a diameter smaller than the diameter of the sleeve shaped body (110), a sealed chamber (125) arranged within the elongated piston (120) and arranged for holding a reagent; wherein the piston unit (120) is movably arranged between three positions within the elongated sleeve shaped body (110): a resting position wherein the front end (121) of the elongated piston unit is arranged within the first end (111) of the elongated sleeve-shaped body and the rear end (122) of the piston is extending out of the second end (112) of the elongated sleeve shaped body, and the second shoulder (123) is engaged with the biased spring (130), a sample collecting position wherein the rear end (122) of the piston is pushed towards the second end (112) of the sleeve-shaped body, further biasing the spring, and extending and exposing the front end (111) of the piston from the front end (112) of the sleeve shaped body (110); an analysis position wherein the first shoulder (122a) is rotated at least partly around the axis A, the chamber seal (125a) is broken, wherein the chamber (125) is in fluid connection with the interior of the sleeve-shaped body(110).

2, Sample collection device (100) according to claim 1 or 2, further comprising a cap arranged for essentially hermetically sealing the front end (111) of the sleeve-shaped body (110).

3, Sample collection device (100) according to any previous claim, wherein the spring (130) is arranged to apply pressure on the second shoulder (123) such that at least a portion (124) of the piston (120) penetrates the chamber (125) if the chamber seal (125a) is broken.

4, Sample collection device (100) according to any previous claim, wherein the sample collection member (111a) comprises a fluid absorbing material.

5, Sample collection device (100) according to any previous claim, wherein the piston (120) is in the analysis position, at least a portion (124) of the piston (120) and the second end (112) of the sleeve-shaped body (110) forms an essentially hermetical seal.

6, Sample collection device (100) according to any previous claim, wherein the spring (130) is a helical spring.

7, Method comprising a sample collection device (100) according to claim 1 , comprising the steps of: a. arranging the sample collection device (100) adjacent the sample to be collected; b. pushing the first shoulder (122a) of the piston (120) towards the second end (112) of the sleeve-shaped body (110), biasing the spring (130) and exposing the front end (121) of the piston (120) through the first end (111 ) of the sleeve-shaped body (110); c. releasing the first shoulder (122a), wherein the biased spring (130) returns the piston (120) to its initial position, the front end (121) of the piston (120) arranged inside the first end (111) of the sleeve-shaped body (110); d. twisting the first shoulder (122a), breaking the seal of the chamber (125), allowing the spring (130) to move at least a portion (124) of the piston (120) into the chamber (125), and allowing the reagent to flow from the chamber (125) into the sleeve-shaped body (110) towards the front end (121) of the piston (120). 8. Method according to claim 8, wherein step c further comprises covering the first end (111) of the sleeve-shaped body (110), after releasing the first shoulder (122a).