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

Patent metadata

Field	Value
Publication number	US-9744296-B2
Application number	US-201013508164-A
Country	US
Kind code	B2
Filing date	Nov 3, 2010
Priority date	Nov 4, 2009
Publication date	Aug 29, 2017
Grant date	Aug 29, 2017

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.

First claim

The invention claimed is:

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 μm.

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 μm.

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 μm.

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

Assignees

• Fini Massimo
• Weiss Stefan
• Terpin Andreas
• Veneroni Alain
• Fresenius Medical Care Deutschland Gmbh

Inventors

• Fini Massimo
• Weiss Stefan
• Terpin Andreas
• Veneroni Alain

Classifications

• A61M5/162 Primary

  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 title

• A61M2205/7536

  allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes · CPC title

• A61M2205/7518

  bacterial · CPC title

• A61M1/3621

  Extra-corporeal blood circuits (single-needle circuits A61M1/30) · CPC title

• A61M1/14

  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 title