Device and method for obtaining a biological sample

• US 8,734,364 B1
• Filed: 11/07/2013
• Issued: 05/27/2014
• Est. Priority Date: 11/07/2013
• Status: Active Grant

• Current Assignee: Genetic Technologies Limited
• Original Assignee: Genetic Technologies Limited
• Inventors: Mantzaris, Debbie, Andrews, Nicola Charlotte, Greco, Denis, Sparling, David Jonathan
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/074,215
• Time in Patent Office: 201 Days
• Field of Search: 600564-567, 600569-572
• US Class Current: 600/572
• CPC Class Codes: A61B 10/0291 for uterus A61B10/0045 takes precedence
• CPC Class Codes: A61B 2010/0074 Vaginal or cervical secretions
• CPC Class Codes: A61B 2503/02 Foetus
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters

Abstract

Embodiments relate generally to a sampling device adapted for sampling of biological materials from a subject and methods of use or manufacture of such devices, as well as diagnostic methods employing such devices and kits including such devices. The sampling device may comprise: an outer tube; an elongate insertion member having a first end and a second end, wherein the first end is distal of the second end, the insertion member being received in and sized to be movable through the outer tube; a coupling portion disposed at the first end of the insertion member; and a sampling portion coupled to the coupling portion and configured to collect the biological materials. The coupling portion is separable from the insertion member.

Claims

1. A sampling device adapted for transcervical sampling of biological materials from a patient comprising:

an outer tube having visible reference marks at a first end of the tube, the marks indicating intervals of distance along the first end of the tube;

an elongate insertion member having a first end and a second end, wherein the first end is distal of the second end, the insertion member being received in and sized to be movable through the outer tube;

a coupling portion disposed at the first end of the insertion member;

a sampling portion coupled to the coupling portion and configured to collect the biological materials by absorption or adsorption;

a first stop disposed adjacent the reference marks on the outer tube, the position of the first stop being adjustable with respect to the reference marks on the outer tube; and

a second stop arranged to restrict the distance that the first end of the insertion member can extend past the first end of the outer tube;

wherein the first stop is sized to pass through a vagina of the patient but to be restricted from passing through an external os of a cervix of the patient, and wherein the outer tube is sized to pass through the external os; and

wherein the insertion member is formed to have a structurally weakened portion that is structurally weakened relative to immediately adjacent portions of the insertion member and is formed proximally of the coupling portion at the first end of the insertion member, wherein the structurally weakened portion facilitates separation of the coupling portion from the insertion member; and

wherein the outer tube and insertion member are movable relative to each other between at least a first position where the sampling portion is covered by the outer tube, a second position where the sampling member is uncovered by the outer tube and the coupling portion is at least partially covered by the outer tube, and a third position where the sampling portion, coupling portion and structurally weakened portion are uncovered by the outer tube to allow separation of the coupling portion from the insertion member.

2. The device of claim 1, wherein the movement of the outer tube with respect to the elongate insertion member from the first position to the third position is limited by the second stop contacting a limiting structure that restrains the outer tube in the second position until the second stop overcomes the limiting structure.

3. The device of claim 2 wherein the limiting structure is a circumferentially enlarged portion of the insertion member and the second stop is a tubular member, the tubular member being able to overcome the limiting structure by receiving the limiting structure within a portion of a central lumen, and the limiting member having an interference fit with the second stop.

4. The device of claim 1, wherein the structurally weakened portion is arranged such that when a moment is applied about the structurally weakened portion, plastic deformation or breaking of the insertion member tends to occur at the weakened portion.

5. The device of claim 1, wherein a structural weakening of the structurally weakened portion is highly localized.

6. The sampling device of claim 1, wherein the reference marks on the outer tube allow the distance between the position of the first stop and the first end of the tube to be determined.

7. The sampling device of claim 1, wherein the first stop is adjustable to a position that allows the sampling portion of the insertion member to be positioned at the internal os of the patient when the first stop is abutting the external os of the patient and the insertion member has been moved through the outer tube until the second stop has been engaged.

8. The sampling device of claim 1, wherein the coupling portion comprises a hook and the sampling portion is retained in the first end of the insertion member by being inserted into an opening of the hook.

9. The sampling device of claim 8, wherein the opening of the hook is covered by the outer tube when the outer tube is in the first and second positions, and wherein the opening of the hook is uncovered by the outer tube when the outer tube is in the third position.

10. The sampling device of claim 1, wherein the sampling portion comprises a sponge material.

11. The sampling device of claim 10, wherein the sponge material comprises a multi-filamentous array of sponge fingers.

12. The sampling device of claim 1, wherein the sponge material is polyvinyl acetal.

13. The sampling device of claim 1, wherein the sampling portion comprises a material adapted to expand upon absorption of the biological materials from a dry compressed state to a swollen state.

14. The sampling device of claim 1 wherein the insertion member is curved along a long dimension of the insertion member.

15. The sampling device of claim 1 wherein the sampling material is configured to collect any one or more of:

cell-free nucleic acids (DNA and RNA);

miRNAs;

protein;

cell free fetal nucleic acids (DNA/RNA);

fetal cells;

free fetal nuclei;

sperm;

viruses;

bacteria;

nuclear material;

cellular material; and

molecular material.

16. A sampling device adapted for transcervical sampling of biological materials from a patient comprising:

an outer tube having visible reference marks at a first end of the tube, the marks indicating intervals of distance along the first end of the tube;

an elongate insertion member having a first end and a second end, wherein the first end is distal of the second end, the insertion member being received in and sized to be movable through the outer tube;

a coupling portion disposed at the first end of the insertion member;

a sampling portion coupled to the coupling portion and configured to collect the biological materials by absorption or adsorption;

a first stop disposed adjacent the reference marks on the outer tube, the position of the first stop being adjustable with respect to the reference marks on the outer tube; and

a second stop arranged to restrict the distance that the first end of the insertion member can extend past the first end of the outer tube;

wherein the first stop is sized to pass through a vagina of the patient but to be restricted from passing through an external os of a cervix of the patient, and wherein the outer tube is sized to pass through the external os; and

wherein the insertion member is formed to have a structurally weakened portion that is structurally weakened relative to immediately adjacent portions of the insertion member and is formed proximally of the coupling portion at the first end of the insertion member, wherein the structurally weakened portion facilitates separation of the coupling portion from the insertion member.

17. A kit for transcervical sampling of biological materials from a patient comprising:

the sampling device of claim 1;

a severing member actuable to separate the coupling and sampling portions from the insertion member; and

a transport medium to transport the coupling and sampling portions after they have been severed from the insertion member.

18. A kit for transcervical sampling of biological materials from a patient comprising:

the sampling device of claim 16;

a severing member actuable to separate the coupling and sampling portions from the insertion member; and

a transport medium to transport the coupling and sampling portions after they have been severed from the insertion member.