Medicament application adapter comprising a gas blocking element for a hemodialysis tube set

• US 9,744,296 B2
• Filed: 11/03/2010
• Issued: 08/29/2017
• Est. Priority Date: 11/04/2009
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Inventors: Fini, Massimo, Weiss, Stefan, Terpin, Andreas, Veneroni, Alain
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US13/508,164
• Publication Number:
  US 20120226236A1
• Time in Patent Office: 2,491 Days
• Field of Search: 604122-126
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 2005/1623 Details of air intake
• CPC Class Codes: A61M 2205/7509 for virus
• CPC Class Codes: A61M 2205/7518 bacterial
• CPC Class Codes: A61M 2205/7527 liquophilic, hydrophilic
• CPC Class Codes: A61M 2205/7536 allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
• CPC Class Codes: A61M 5/1411 Drip chambers A61M5/162, A61M5/1689, A61M5/40 take precedence
• CPC Class Codes: A61M 5/155 pressurised by gas introduced into the reservoir
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/38 using hydrophilic or hydrophobic filters
• CPC Class Codes: A61M 5/385 using hydrophobic filters
• CPC Class Codes: A61M 5/40 using low-level float-valve to cut off media flow from reservoir position detection of a floating member A61M5/1685

Abstract

For the administering of medicaments, an adapter is provided for connection to a haemodialysis tube set, which makes possible the direct connection of a standard injection vial to the extracorporeal circuit, avoiding the introduction of air into the circuit. The adapter has two conduit pathways. The conduit pathway for the application of medicament contains a gas-blocking element. The second conduit pathway serves for the aeration of the injection vial.

Claims

1. A medical device for introduction of a liquid medicament stored in an injection vial into an extracorporeal blood circuit of a haemodialysis machine during operation thereof, said device comprising:

a gas reservoir for storing a gas, wherein pressure in said gas reservoir is selectable to regulate liquid medicament flow rate into the extracorporeal blood circuit and a period of time over which the liquid medicament in the injection vial is administered into the extracorporeal blood circuit, and wherein a pressure in said gas reservoir is greater than a pressure in conduit pathways of the extracorporeal blood circuit at an addition site;

a piercing structure for opening the injection vial, said piercing structure having a first conduit pathway and a second conduit pathway,

a first end of said first conduit pathway opening into an interior of the injection vial when said piercing structure has been inserted to penetrate fully into the interior of the injection vial,

a second end of said first conduit pathway being joined to the conduit pathways of the extracorporeal blood circuit of the haemodialysis machine at the addition site,

a first end of said second conduit pathway opening into the interior of the injection vial when said piercing structure has been inserted to penetrate fully into the interior of the injection vial,

a second end of said second conduit pathway being connected with said gas reservoir so that gas held in said gas reservoir is able to flow into the interior of the injection vial via the second conduit pathway,

a gas-blocking filter element being arranged in said first conduit pathway, said gas-blocking filter element configured to block passage of gases therethrough while allowing the liquid medicament from said injection vial to pass through the gas-blocking filter element and into the extracorporeal blood circuit of the haemodialysis machine at the addition site via said first conduit pathway, said gas-blocking filter element having a filter area and pore size dimensioned to create a desired flow resistance that, in cooperation with a selected pressure in said gas reservoir, is effective to regulate the liquid medicament flow rate from the injection vial to the extracorporeal blood circuit by increasing or decreasing the liquid medicament flow rate through said gas-blocking element so as to administer a greater or lesser quantity, respectively, of the liquid medicament to the extracorporeal blood circuit per unit of time during operation of the haemodialysis machine;

a venous drip chamber;

a first pressure measuring device that determines a pressure of the gas in said venous drip chamber; and

a second pressure measuring device that determines a pressure of the gas in thesaid gas reservoir,

wherein the pressure in said gas reservoir is selected based on a pressure difference determined by a comparison the pressure of the gas in said venous drip chamber with the pressure of the gas in said gas reservoir, and wherein the selected pressure is that which is required to regulate the liquid medicament flow rate into the extracorporeal blood circuit without the pressure difference exceeding a bubble pressure of said gas-blocking filter element.

2. The medical device according to claim 1, wherein the device is an integral component of a tube set or a cassette set for the construction of the extracorporeal blood circuit of a haemodialysis.

3. The medical device according to claim 1, wherein the piercing structure is an adapter for connection to a tube set or to a cassette set of the extracorporeal circuit of the haemodialysis machine.

4. The medical device according to claim 3, wherein the adapter is configured such that the connection with the extracorporeal circuit is effected in a needleless manner.

5. The medical device according to claim 1, further comprising a receiving device that is closable by a cap.

6. The medical device according to claim 1, further comprising a hydrophobic membrane which is arranged in said first conduit pathway so that said hydrophobic membrane forms a connection to ambient air such that said hydrophobic membrane does not close said first conduit pathway in a fluid-tight manner.

7. The medical device according to claim 1, further comprising a hydrophobic sterile filter arranged in said second conduit pathway.

8. The medical device according to claim 1, further comprising a flow-regulating element arranged in said first conduit pathway above and/or beneath said gas-blocking element.

9. The medical device according to claim 1, wherein said piercing device is a double-lumen spike.

10. The medical device according to claim 1, wherein said gas-blocking element is a hydrophilic membrane, wherein said hydrophilic membrane in a wet state creates said desired flow resistance to the liquid medicament and is impassable to gas.

11. The medical device according to claim 10, wherein said hydrophilic membrane has a pore size of less than 100 μ

m.

12. The medical device according to claim 10, wherein said hydrophilic membrane has a material construction of a hydrophilic polymer.

13. The medical device according to claim 10, wherein said hydrophilic membrane is gas-tight, with a bubble pressure which corresponds to the pressure difference between said gas reservoir and the extracorporeal circuit.

14. The medical device according to claim 1, wherein said gas-blocking element is a hydrophilic membrane, wherein said hydrophilic membrane in a wet state creates said desired flow resistance to the liquid medicament and is impassable to gas, and said hydrophilic membrane has a pore size of less than 15 μ

m.

15. The medical device according to claim 1, wherein said gas-blocking element is a hydrophilic membrane, wherein said hydrophilic membrane in a wet state creates said desired flow resistance to the liquid medicament and is impassable to gas, and said hydrophilic membrane has a pore size of less than 0.3 μ

m.

16. The medical device according to claim 1, wherein said selected pressure is applied to said gas reservoir by a pump.

17. A medical device for introducing a liquid medicament contained in an injection vial into an extracorporeal blood circuit of a haemodialysis machine during operation thereof, said device comprising

a gas reservoir for storing a gas, wherein said gas reservoir is acted upon by pressure that enables a particular pressure in said gas reservoir to be set to control a liquid medicament flow rate from the injection vial into the extracorporeal blood circuit during operation of the haemodialysis machine, and wherein pressure in said gas reservoir is greater than a pressure in conduit pathways of the extracorporeal blood circuit at an addition site;

a piercing structure for opening the injection vial, said piercing structure having a first conduit pathway and a second conduit pathway,

a first end of said first conduit pathway and a first end of the second conduit pathway opening into an interior of the injection vial when said piercing structure has been inserted to penetrate fully into the interior of the injection vial,

a second end of said first conduit pathway being joined to the conduit pathways of the extracorporeal blood circuit of the haemodialysis machine at the addition site,

a second end of said second conduit pathway being in fluid communication with said gas reservoir so that gas held in the gas reservoir is able to flow into the interior of the injection vial via the second conduit pathway,

a gas-blocking element configured to block passage of gases therethrough while, at the same time, allowing the liquid medicament flowing through said first conduit pathway from said injection vial to pass through said gas-blocking element and into the extracorporeal blood circuit of the haemodialysis machine under the pressure of the gas that flows from said gas reservoir into the interior of the injection vial via said second conduit pathway, wherein said gas-blocking element forms a flow resistance that, in cooperation with the particular pressure set in the gas reservoir, is effective to administer a particular quantity of the liquid medicament from the injection vial into the extracorporeal blood circuit per unit of time during operation of the haemodialysis machine;

a venous drip chamber;

a first pressure measuring device that determines a pressure of the gas in the venous drip chamber; and

a second pressure measuring device that determines a pressure of the gas in the gas reservoir,

wherein the pressure in the gas reservoir is selected based on a pressure difference determined by a comparison of the pressure of the gas in said venous drip chamber with the pressure of the gas in said gas reservoir so as to regulate the liquid medicament flow rate into the extracorporeal blood circuit without the pressure difference exceeding a bubble pressure of the gas-blocking filter element while taking into account a pore size and filter area of said gas-blocking element so as to effect different liquid medicament flow rates through said gas-blocking element and into the extracorporeal blood circuit and to regulate a corresponding period of time over which the liquid medicament in the injection vial is administered into the extracorporeal blood circuit for each of said different liquid medicament flow rates through said gas-blocking element.

18. The medical device according to claim 17, wherein said selected pressure is applied to said gas reservoir by a pump.

19. The medical device according to claim 17, wherein an increase in said gas reservoir pressure increases the liquid medicament flow rate through said gas-blocking element and reduces the corresponding period of time of liquid medicament administration.

20. The medical device according to claim 17, wherein a decrease in said gas reservoir pressure decreases the liquid medicament flow rate through said gas-blocking element and increases the corresponding period of time of liquid medicament administration.

21. A device for regulated introduction of a liquid medicament, said device comprising:

an injection vial containing the liquid medicament;

a venous drip chamber, the venous drip chamber having a first pressure measuring device that determines a pressure of a gas therein;

a gas reservoir containing the gas, the gas reservoir having a second pressure measuring device that determines a pressure of the gas therein;

a piercing structure for opening said injection vial; and

a gas-blocking filter element;

a pressure of the gas in the gas reservoir being selectable to regulate a liquid medicament flow rate,

said piercing structure having a first conduit pathway and a second conduit pathway, a first end of said first conduit pathway opening into an interior of the injection vial, a second end of said first conduit pathway being joined to conduit pathways at a liquid medicament introduction site for haemodialysis, a first end of the second conduit pathway opening into said interior of said injection vial, and a second end of said second conduit pathway being connected with said gas reservoir,

said gas-blocking filter element being arranged in said first conduit pathway and being configured to block passage of the gas therethrough while allowing passage of the liquid medicament therethrough,

said gas-blocking filter element having a filter area and pore size dimensioned to provide a desired flow resistance that, in cooperation with said selected pressure of the gas in the gas reservoir, is effective to regulate the liquid medicament flow rate from said injection vial to the introduction site,

wherein, the pressure of the gas reservoir is selected based on a pressure difference determined by comparison of the pressure of the gas in the venous drip chamber with the pressure of the gas in the gas reservoir so as to determine the pressure of the gas in the gas reservoir that is required to regulate the liquid medicament flow rate without the pressure difference exceeding a bubble pressure of the gas-blocking filter element.

22. The device according to claim 21 wherein an increase or a decrease in the liquid medicament flow rate through said gas-blocking element administers, respectively, a greater or a lesser quantity of the liquid medicament per unit of time.