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US-12623010-B2 - Blood oxygenator with an organic membrane

US12623010B2US 12623010 B2US12623010 B2US 12623010B2US-12623010-B2

Abstract

The device for blood oxygenation includes a gas exchange chamber with passage openings. One side the chamber is connected in a gas-tight manner with the expansion tank feeding the gas mixture containing oxygen to the chamber, having the inlet opening of gas mixture from the feeding installation. The other side of the chamber is connected in a gas-tight manner with the gas mixture discharging tank, having the outlet opening of gas mixture. The inner part of the chamber has a membrane as a capillary bundle permeable to gas mixture particles and non-permeable to blood particles, ends of which are anchored in the passage openings. The capillary bundle is tensed with a tension force and is parallel to the longitudinal axis of the chamber and to each other, or are arranged spirally. The side wall of the chamber has at least one inlet/outlet opening.

Inventors

  • Andrzej SWINAREW
  • Michal Zembala
  • Tomasz DAROCHA
  • Konrad MENDRALA
  • Katarzyna MIZIA STEC
  • Arkadiusz STANULA
  • Hubert OKLA
  • Jadwiga GABOR
  • Mateusz PRZYBLYA
  • Ewa TREJNOWSKA
  • Szymon SKOCZYNSKI
  • Grzegorz BROZEK
  • Agnieszka SKOCZYNSKA
  • Piotr KNAPIK

Assignees

  • UNIWERSYTET SLASKI
  • SLASKI UNIWERSYTET MEDYCZNY

Dates

Publication Date
20260512
Application Date
20211126
Priority Date
20201127

Claims (14)

  1. 1 . A device for blood oxygenation, with a membrane made of an organic material of blowing properties, comprising: a gas exchange chamber of longitudinal shape in a form of a straight cylinder or a elliptic cylinder, with passage openings made at its bases, provided that on one side the chamber is connected in a gas-tight manner with the expansion tank feeding the gas mixture containing oxygen to the chamber, having the inlet opening of gas mixture from the feeding installation, and on the other side the chamber is connected in a gas-tight manner with the gas mixture discharging tank transporting it from the chamber, having the outlet opening of gas mixture, and the inner part of the chamber has the membrane in the form of capillary bundle, uniformly distributed inside the chamber, wherein capillaries are comprised of a semi-permeable material, that is permeable to gas mixture particles and non-permeable to blood particles, ends of which are anchored in the passage openings in the chamber bases on both sides, the capillaries are tensed with a tension force of a value from 1 to 100 N, and are parallel to the longitudinal axis of the chamber and to each other, or are arranged spirally, that is twisted along the longitudinal axis of the chamber by the same angle falling within the range from 15 to 720 degrees, in addition the side wall of the chamber near each chamber base has at least one inlet/outlet opening of blood stream, provided that the capillaries forming the membrane have the form of tubes of external diameter from 30 to 600 μm, wherein the capillaries forming the membrane are comprised of an organic material of blowing properties, anti-inflammatory properties and antithrombotic properties, the organic material consisting of: base in the form of polypropylene (PP) or polyurethane (PU) or polyethylene terephthalate (PET) or polycarbonate (PC) polyoxymethylene (POM) or polysulphone (PSU) or fluoric silicone or polytetrafluoroethylene (PTFE) or polyvinylidene fluoride (PVDF) or copolymer of hexafluoropropylene and tetrafluoroethylene (FEP), admixture of 4-(diphenylamino)benzaldehyde in the base-admixture ratio from 50÷1 to 5000÷1, and admixture of 1,3-indandione in the base-admixture ratio from 50÷1 to 5000÷1.
  2. 2 . The device for blood oxygenation, according to claim 1 , wherein the capillaries forming the membrane are comprised of the material comprising additionally the admixture of: albumin embedded in the micro-structure of a base material, in the base-admixture ratio from 80÷1 to 1200÷1, provided that the membrane comprises of pores, of which from 40 to 60% are open pores, while the remaining are closed pores, that is filled with active substance in the form of albumin or admixture of argatroban embedded in the microstructure of a base material, in the base admixture ratio from 80÷1 to 1200÷1, provided that the membrane comprises of pores, of which from 40 to 60% are open pores, while the remaining are closed pores, that is filled with active substance in the form of argatroban or admixture of bivalirudin embedded in the microstructure of a base material, in the base admixture ratio from 80÷1 to 1200÷1, provided that the membrane comprises of pores, of which from 40 to 60% are open pores, while the remaining are closed pores, that is filled with active substance in the form of bivalirudin or admixture of fondaparinux dembedded in the microstructure of a base material, in the base admixture ratio from 80÷1 to 1200÷1, provided that the membrane comprises of pores, of which from 40 to 60% are open pores, while the remaining are closed pores, that is filled with active substance in the form of fondaparinux or admixture of heparin embedded in the microstructure of a base material, in the base admixture ratio from 80÷1 to 1200÷1, provided that the membrane comprises of pores, of which from 40 to 60% are open pores, while the remaining are closed pores, that is filled with active substance in the form of heparin.
  3. 3 . The device for blood oxygenation, according to claim 1 , wherein the inlet opening of blood stream to the gas exchange chamber is connected with the blood stream cooler of parameters enabling its cooling down by 0.5-3.5° C., while in a more preferable variant, the outlet opening of blood stream from the gas exchange chamber is connected with a blood stream heating module of parameters enabling its heating to the physiological blood temperature.
  4. 4 . The device for blood oxygenation, according to claim 1 , wherein the Peltier cells are used as a blood stream cooler or blood stream heating module.
  5. 5 . The device for blood oxygenation, according to claim 1 , wherein the opening placed near the base of chamber from the side of gas mixture discharging tank constitutes the blood stream inlet, while the opening placed near the base of chamber from the side of the expansion tank feeding the gas mixture constitutes the blood stream outlet.
  6. 6 . The device for blood oxygenation, according to claim 1 , wherein the openings in the bases of chamber are arranged in equal distances from each other and symmetrically to each other, and at the same time the capillaries in anchored in these openings are also arranged in equal distances from each other and symmetrically to each other.
  7. 7 . The device for blood oxygenation, according to claim 1 , wherein a high efficiency particulate air (HEPA) filter is assembled at the outlet from the gas mixture discharging tank.
  8. 8 . The device for blood oxygenation, according to claim 1 , wherein outlet opening of blood stream and outlet opening of blood stream are made in a distance not exceeding 5 mm from a given chamber base.
  9. 9 . The device for blood oxygenation, according to claim 1 , wherein inlet opening of blood stream is made at the opposite side compared to the outlet opening of blood stream, symmetrically to the chamber's centre of symmetry.
  10. 10 . The device for blood oxygenation, according to claim 1 , wherein, on the surface of the inner chamber at its entire length at least to blood stream regulators are assembled symmetrically to the axis of symmetry of the chamber, having the form of longitudinal notches provided that in the variant with straight capillaries that is arranged in parallel to the longitudinal axis of the chamber, the regulators are also parallel to the longitudinal axis of the chamber, while in the variant with spiral capillaries the regulators are also arranged spirally, i.e. rotated along the longitudinal axis of the chamber by the same angle falling within the range from 15 to 720 degrees.
  11. 11 . The device for blood oxygenation, according to claim 1 , wherein the blood outlet opening is assembled with densely woven fibre mesh, or the material identical as the capillary material in a way that the mesh holes have the side from 15 to 100 μm, transverse to the capillaries.
  12. 12 . The device for blood oxygenation, according to claim 1 , wherein the blood inlet opening is assembled with densely woven fibre mesh, or the material identical as the capillary material in a way that the mesh holes have the side from 15 to 100 μm, transverse to the capillaries.
  13. 13 . The device for blood oxygenation, according to claim 1 , wherein the outlet channel from the blood outlet opening from the gas exchange chamber is assembled with at least one thrombus filter module with a by-pass bypass for smooth switching that is directing the blood stream to one or the other thrombus filter module interchangeably, provided that in this variant with the thrombus filter module the heating module of blood stream is assembled downstream of thrombus filter module.
  14. 14 . The device for blood oxygenation, according to claim 1 , wherein upstream of the blood stream cooler which is then fed via the blood inlet opening into the gas exchange chamber, there is at least one thrombus filter module, with a by-pass for smooth switching that is directing the blood stream to one or the other thrombus filter module interchangeably.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS See also Application Data Sheet. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable. THE NAMES OF PARTIES TO A JOINT RESEARCH AGREEMENT Not applicable. INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC OR AS A TEXT FILE VIA THE OFFICE ELECTRONIC FILING SYSTEM (EFS-WEB) Not applicable. STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR Not applicable. BACKGROUND OF THE INVENTION 1. Field of the Invention The object of the invention is the extracorporeal blood oxygen saturation device (oxygenator for blood oxygenation) and elimination of carbon dioxide from blood, preferably with organic membrane of blowing properties. Extracorporeal blood oxygenation is applied in the conditions of potentially reversible deep lung function disorders to the extent preventing the effective gas exchange using the mechanical ventilation. 2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 37 CFR 1.98. The oxygenator functions as lungs and forms the integral component of cardiopulmonary bypass. Similarly. as in the physiological conditions in lungs, the gas exchange process takes place, in which oxygen supplied to the oxygenator chamber replaces blood carbon dioxide. The oxygenator is a device constructed of plenty of thin tubes with blood flowing between them. The tube walls are made of semi-permeable membrane penetrable by gases—oxygen and carbon dioxide, however non-penetrable by blood particles. The space inside the tubes (so called capillaries) is filled with gas mixture, concentration of which is adjustable if needed. Blood flowing between the capillaries releases carbon dioxide and absorbs oxygen particles—this process normally takes place in lungs. Blood oxygenators and oxygenator materials are well known in the art. For example, two oxygenators with blood stream flow perpendicular to gas mixture flow are described in the comparative analysis by Wang et al. (2016), according to which the Quadrox-i Adult oxygenator demonstrates low resistance and high biocompatibility with lower pressure drop and lower consumption of hemodynamic energy, while the Capiox RX25 oxygenator demonstrated lower risk of gaseous microemboli (GME) in clinical conditions. This demonstrates that structural optimisation in order to improve treatment safety is necessary. The circulatory system receives thousands of GME during the ECMO (ExtraCorporeal Membrane Oxygenation) therapy despite the use of membrane oxygenator and arterial filtration. GME result in tissue ischaemia, damage of cerebral and other end organ vascular endothelium, leading to vessel expansion, increased permeability, thrombocyte activation, coagulation cascade and activation of complement and cellular inflammatory mediators. The existing technologies remove GME only partially. It is desirable to develop the systems, which will eliminate the GME production and at the same time maintain good gas exchange parameters [Wang S, Kunselman A R, (Jndar A. Evaluation of Capiox RX25 and Quadrox-i Adult Hollow Fiber Membrane Oxygenators in a Simulated Cardiopulmonary Bypass Circuit. Artif Organs. 2016; 40(5):E69-E78. doi: 10.1111/aor.12633]. According to the experience of Formica et al. (2008), the Quadrox D oxygenator demonstrated the optimum efficiency without plasma leakage and the need to replace ECMO for more than four days in adult patients with cardiogenic shock. The ECMO consisting in the membrane oxygenator with blood stream flow perpendicular to gas mixture flow and with polymethylpentene-modified material and magnetic centrifugal pump was used in the study. The preliminary observations demonstrate that such device with a modified membrane could operate properly for even two weeks. Further modifications of membranes in the oxygenators could lead to improved life span of these devices [Formica F, Avalli L, Martino A, et al. Extracorporeal membrane oxygenation with a poly-methylpentene oxygenator (Quadrox D). The experience of a single Italian centre in adult patients with refractory cardiogenic shock. ASAIO J. 2008; 54(1): 89-94. doi: 10.1097/MAT.0b013e31815ff27e]. Clingan et al. (2016) performed the studies initiated by Gipson et al. (2014). They applied hypobaric oxygenations to achieve a slight hypoxic state in the Terumo® FX15 oxygenators. Hypobaric oxygenation may decrease the risk related to GME production during the pulsatile flow perfusion, vacuum assisted venous drainage and rapid temperature changes. Similar observations were made by Ginther et al. (2013) during the clinical use of Maquet Quadrox-i neonatal oxygenator. The benefits resulting from low drop of transmembrane pressure were demonstrated [Clingan S, Schuldes M, Francis S, Hoerr H Jr, Riley J. In vitro elimination of gaseous microemboli utilizing hypobaric oxygenation in the Terumo® FX15 oxygenator. Perfusion. 2016; 31(7):552-559. doi:10.1177/0267659116638148; Gipson K E, Rosinski