Umbilical cord sampling system and method

• US 20050197596A1
• Filed: 09/10/2004
• Published: 09/08/2005
• Est. Priority Date: 09/10/2003
• Status: Abandoned Application

• Current Assignee: Mitchell J. Bellucci, Richard Smith
• Original Assignee: Mitchell J. Bellucci, Richard Smith
• Inventors: Smith, Richard A., Bellucci, Mitchell J.
• Application Number:
  US10/938,745
• Publication Number:
  US 20050197596A1
• Time in Patent Office: Days
• US Class Current: 600/573
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150038 for blood from umbilical cord
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

The system and method of the present invention includes an umbilical cord sampling device comprising a needle assembly, a base and at least one sampling needle operatively linked to at least one sampling reservoir. A removable cassette can be used to transfer a fluid to an analyzer to provide for the measurement of fluid characteristics.

Claims

1. An umbilical cord fluid sampling device comprising:

at least one moveable sampling needle;

a needle housing constructed and arranged to support the at least one moveable sampling needle;

a base housing constructed and arranged to support a portion of the umbilical cord of a patient, at least one of the base housing and the needle housing being moveable between a closed position and an open position in order to insert the umbilical cord therein;

an interior chamber disposed between the needle housing and the base housing;

at least one sampling reservoir supported within a portion of the chamber and in fluid communication with the at least one moveable sampling needle; and

an opening disposed through at least one of the base and needle housing and in fluid communication with the sampling reservoir, the opening being configured and dimensioned to receive the removable cassette such that a fluid sample may be removed from the sampling reservoir while the base and needle housing remain in the closed position.

2. The umbilical cord sampling device of claim 1 wherein the opening is a slot in fluid communication with the sampling reservoir, the slot being dimensioned to receive a portion of a removable cassette.

3. The umbilical cord sampling device of claim 2, wherein the cassette includes a deposition well and the slot is disposed within the sampling device such that the deposition well is positioned in fluid communication with the reservoir upon insertion of the cassette so that a sample of the fluid is transported from the at least one sampling reservoir to the deposition well upon insertion of the cassette.

4. The umbilical cord sampling device of claim 3, wherein the reservoir further includes a valve constructed and arranged to restrict flow of the fluid from the reservoir, the valve being aligned with the slot such that the valve is activated when the cassette is inserted and engages the valve.

5. The umbilical cord sampling device of claim 4, wherein the valve is a ball valve disposed within a conduit that provides fluid communication between the reservoir and slot, the ball valve being biased into a closed position by a spring so as to restrict the flow of fluid through the conduit in the closed position.

6. The umbilical cord sampling device of claim 1 wherein the opening is a port that is configured and dimensioned to receive a syringe therein.

7. The umbilical cord sampling device of claim 1 further comprising a roller.

8. The umbilical cord sampling device of claim 1 wherein at least one sampling needle is positionable relative to an umbilical cord segment within the device.

9. The umbilical cord sampling device of claim 8 further comprising at least one knob operatively connected to the at least one sampling needle so as to move the needle in a transverse direction with respect to a longitudinal axis of the cord.

10. The umbilical cord sampling device of claim 8 further comprising a plunger constructed and arranged to move the at least one sampling needle into the umbilical cord.

11. The umbilical cord sampling device of claim 1 in combination with an analyzer unit constructed and arranged to receive the removable cassette so as to perform fluid analysis on the sample removed from the at least one reservoir.

12. The device of claim 1 wherein the at least one sampling needle comprises two sampling needles and a pair of knobs for moving the sampling needles in a transverse direction with respect to a longitudinal axis of the cord and a plunger for inserting the needles into the cord.

13. The device of claim 1 further comprising a window positioned so as to view the sampling needles during use.

18. The method of claim 13 further comprising measuring a blood analyte.

14. A method for determining the values of physiologically relevant parameters of a biological fluid, comprising the steps of:

providing an umbilical cord sampling device having at least one moveable sampling needle operatively connected to at least one sampling reservoir;

placing an umbilical cord segment in the umbilical cord sampling device;

penetrating a fluid-containing lumen of the umbilical cord segment with a moveable sampling needle;

collecting the fluid in a sampling reservoir; and

removing the collected fluid from the sampling reservoir for analysis.

15. The method of claim 14 further comprising the step of providing a valve to restrict fluid flow from the reservoir and an opening in the sampling device in fluid communication with the reservoir, the opening being configured and dimensioned to receive one of a syringe or cassette.

16. The method of claim 14 further comprising the step of inserting the cassette into the opening and into engagement with the valve so as to allow fluid to flow from the reservoir to the cassette.

17. The method of claim 16 further comprising the step of removing the cassette from the opening and inserting it into an analyzer.

19. An umbilical cord fluid sampling device comprising:

at least one moveable sampling needle;

a needle housing constructed and arranged to support the at least one moveable sampling needle;

a base housing constructed and arranged to support a portion of the umbilical cord of a patient, at least one of the base housing and the needle housing being moveable between a closed position and an open position in order to insert the umbilical cord therein;

.

an interior chamber disposed between the needle housing and the base housing;

at least one sampling reservoir supported within a portion of the chamber and in fluid communication with the at least one moveable sampling needle;

a removable cassette including a base, a cover, a deposition well constructed and arranged to receive fluid therein and a calibrant solution supported within the cassette;

an opening disposed through at least one of the base and needle housing and in fluid communication with the sampling reservoir, the opening being configured and dimensioned to receive the removable cassette such that a fluid sample may be removed from the sampling reservoir while the base and needle housing remain in the closed position.

20. The umbilical cord sampling device of claim 19, wherein the calibrant solution is disposed within a pouch and the cassette further includes a barb for releasing the solution from within the pouch upon insertion within an analyzer.