Device and method for obtaining a biological sample
First Claim
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.
3 Assignments
0 Petitions
Accused Products
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.
40 Citations
18 Claims
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1. A sampling device adapted for transcervical sampling of biological materials from a patient comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17)
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16. A sampling device adapted for transcervical sampling of biological materials from a patient comprising:
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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. - View Dependent Claims (18)
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Specification