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US-20260124620-A1 - FLIPPING STATION FOR TRANSFERRING FLUIDS

US20260124620A1US 20260124620 A1US20260124620 A1US 20260124620A1US-20260124620-A1

Abstract

A device for performing by flipping-over a quantitative liquid transfer from a crimp capped vial to another vial, container, or cassette includes: an extension tube equipped with a spike on one end; a shielded pot with a lid, intended to enclose the crimp capped vial; and a component including: a lower cylindrical part with a beveled cylindrical notch for receiving in tight insertion a crimp capped vial, the notch having an aperture on a side of the lower cylindrical part; an upper cylindrical part in communication with the lower cylindrical part and including a hollow cylindrical protrusion for guiding the extension tube equipped with a spike, a groove being provided in the upper cylindrical part for keeping the extension tube in place during the handling of the device; and a central cylindrical part, provided between the lower and the upper cylindrical parts, that includes a furrow.

Inventors

  • Julien MASSET
  • Corentin WARNIER
  • Ugur GÜLSU
  • Charles VRIAMONT
  • Frederic Baplue
  • Jean-Luc Morelle

Assignees

  • TRASIS S.A.

Dates

Publication Date
20260507
Application Date
20240130
Priority Date
20230519

Claims (9)

  1. 1 : A device for performing by flipping-over a quantitative liquid transfer from a crimp capped vial to another vial, container, or cassette, the device comprising: an extension tube equipped with a spike on one end; a shielded pot with a lid, intended to enclose the crimp capped vial; and a component comprising: a lower cylindrical part with a beveled cylindrical notch, configured to receive in tight insertion a crimp capped vial, the notch having an aperture on a side of the lower cylindrical part; an upper cylindrical part in communication with the lower cylindrical part and comprising a hollow cylindrical protrusion for guiding the extension tube equipped with a spike, a groove being provided in the upper cylindrical part for keeping the extension tube in place during the handling of the device; and a central cylindrical part, provided between the lower and the upper cylindrical parts, comprising a furrow configured to ensure a correct positioning of the extension tube during the transfer of the fluid to another vial, container, or cassette, a round rail being provided on each side of the central cylindrical part so as to allow the shielded pot and the lid to be anchored on the component, wherein the aperture is extended in the respective central and upper cylindrical parts and the spike is connected to a luer lock ring.
  2. 2 : The device of claim 1 wherein the upper cylindrical part with a beveled cylindrical notch is adaptable to a variety of sizes and shapes of small volume commercially available crimp capped vials.
  3. 3 : The device of claim 1 , wherein the spike is comprises a metal-free material.
  4. 4 : The device of claim 1 , wherein the component comprises a rigid plastic material.
  5. 5 : A method of quantitatively transferring a liquid from a crimp capped vial to another vial, container, or cassette using the device claim 1 , the method comprising, successively: inserting the spike connected to the luer lock ring in the aperture of the beveled notch of the first cylindrical part, maintaining the spike downwards so that the luer lock ring is stopped by an upper flange of the beveled notch, while the extension tube is inserted in the extended aperture in the respective central and upper cylindrical parts; removing the lid of a shielding pot enclosing the vial which contains the liquid to be transferred and placing the lid onto the upper round rail of the central cylindrical part of the element; positioning an assembly of the element and the lid on top of the shielded pot using the lower round rail, and pressing the assembly down until a septum of the vial located inside the shielded pot is pierced by the spike; connecting the extension tube on the end opposite to the spike to the other vial, container, or cassette; and flipping over the element and proceeding to the quantitative liquid transfer.
  6. 6 : The method of claim 5 , wherein the liquid to be transferred comprises a radioactive substance.
  7. 7 : The method of claim 6 , wherein the radioactive substance comprises a radiometal.
  8. 8 : The method of claim 7 , wherein the radiometal is selected from the group consisting of: 99mTc, 67Ga, 111 In, 68Ga, 89Zr, 64Cu, 67Cu, 177Lu, 90Y, 89Sr, 223Ra, 225Ac, 211At, 213Bi, 47Sc, 161Tb, and 227Th.
  9. 9 : The method of claim 5 , wherein the liquid transfer is operated until a remaining activity in the original vial is less than 3%.

Description

CROSS-REFERENCE TO PRIOR APPLICATIONS This application is a U.S. National Phase application under 35 U.S.C. § 371 of International Application No. PCT/EP2024/052260, filed on Jan. 30, 2024, and claims benefit to European Patent Application No. EP 23174204.0, filed on May 19, 2023. The International Application was published in English on Nov. 28, 2024 as WO/2024/240370 under PCT Article 21(2). FIELD The present invention relates to a device for transferring fluids between a container containing a liquid, for example a radioactive substance solution, and a dedicated apparatus for its preparation. The invention relates more particularly to a piercing needle holding device. BACKGROUND Nuclear Medicine Cancer is considered one of the biggest health problems in the world today. According to recent reports, more than 10,000 hospitals worldwide use radionuclides for in vivo diagnosis or therapy, and about 35 million patients receive cancer therapy with radionuclides each year (European Commission: supply of medical radioisotopes. Available online: https://euratom-supply.ec.europa.eu/activities/supply-medical-radioisotopes_en, accessed on Mar. 24, 2023). In addition to cancer therapy, radionuclides are used in nuclear medicine for the diagnosis and treatment of various diseases, such as cardiovascular and brain diseases. Different radionuclides are used in different areas of nuclear medicine. Taking into account the half-life and decay emission of the respective radionuclides, they are used for imaging by positron emission tomography (PET) or single-photon emission computed tomography (SPECT) and for therapy by means of a, b−, conversion and/or Auger electron emission. Beta particles, alpha particles and Auger electrons can irradiate tissue volumes with multicellular, cellular and subcellular dimensions thanks to the different linear energy transfer (LET), defined as the amount of energy transferred from a travelling particle per unit length to the surrounding material (A. Ku et al., Auger electrons for cancer therapy-a review. EJNMMI Radiopharma. Chem. 2019, 4, 1-36). Radiometals Radiochemistry Radiometals have been extensively used in clinical diagnostics over the last three decades, particularly, 99mTc, 67Ga and 111In for SPECT and, more recently, 68Ga, 89Zr and 64Cu for PET. On the other hand, therapeutic radiometals in clinical use are nowadays mainly limited to 177Lu, 90Y, 89Sr, 223Ra, 225Ac, 211At, 213Bi, 47Sc, 161Tb and 227Th (See: H. Ahmadzadehfar et al., Therapeutic response and side effects of repeated radioligand therapy with 177Lu-PSMA-DKFZ-617 of castrate-resistant metastatic prostate cancer. Oncotarget 2016, 7, 12477-12488; A. K. Pfeifer et al., Peptide Receptor Radionuclide Therapy with Y-DOTATOC and 177Lu-DOTATOC in Advanced Neuroendocrine Tumors: Results from a Danish Cohort Treated in Switzerland. Neuroendocrinology 2011, 93, 189-196; K. Yamada et al., Concurrent use of Sr-89 chloride with zoledronic acid is safe and effective for breast cancer patients with painful bone metastases. Exp. Ther. Med. 2012, 3, 226-230; R. B. Den et al., Ra-223 treatment for bone metastases in castrate-resistant prostate cancer: Practical management issues for patient selection. Am. J. Clin. Oncol. Cancer Clin. Trials 2019, 42, 399-406; B. Nelson et al., Targeted Alpha Therapy: Progress in Radionuclide Production, Radiochemistry, and Applications. Pharmaceutics 2021, 13, 49-75; E. Hindie et al., Dose Deposits from 90Y, 177Lu, 111In, and 161Tb in Micrometastases of Various Sizes: Implications for Radiopharmaceutical Therapy. J Nucl. Med. 2016, 57, 759-764; K. A. Domnanich et al. 47Sc as useful b-emitter for the radiotheragnostic paradigm: A comparative study offeasible production routes. EJNMMI Radiopharm. Chem. 2017, 2, 1-17). 223Ra is the only approved radionuclide by health authorities for targeted alpha therapy to extend survival. Radiometals are mainly produced by cyclotron or nuclears reactors (P. Daya, Increasing Radiopharmaceutical Production with Cyclotrons. News from the International Atomic energy Agency (mai 2011). Accessible online: https://www.idea.org/newscenter/news/increasing-radiopharmaceutical-production-with-cyclotrons, accessed on Mar. 24, 2023), shipped and supplied as a liquid acidic solution (pH 1-2). Automation of the Labeling Procedure Towards GMP Production Once produced, a radiometal need to be labelled to a vector molecule to form a radiopharmaceutical that would eventually target the disease. Radiopharmaceutical products for clinical applications must follow the universal requirements for the drug products. Drug products must for the sake of patient safety be of good quality. The European Pharmacopoeia (EP) and likewise the United States Pharmacopoeia (USP) and the Japanese Pharmacopoeia (JP) set the minimum quality standards for drug products in general and also for radiopharmaceuticals. Recently the European Directorate for the Quality of Medicines & HealthCare (EDQM) published the “Gui