METHODS AND SYSTEMS FOR BIOLOGICAL SAMPLE COLLECTION AND ANALYSIS

• US 20110151463A1
• Filed: 11/14/2008
• Published: 06/23/2011
• Est. Priority Date: 11/14/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Pathway Medical Technologies, Inc. (Bayer AG)
• Inventors: Wulfman, Edward I.
• Granted Patent: US 8,784,654 B2
• Time in Patent Office: Days
• US Class Current: 435/6.12
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• CPC Class Codes: A61M 5/165 Filtering accessories, e.g. blood filters, filters for infusion liquids A61M1/14 , A61M1/34, A61M1/3627, A61M1/3679, A61M1/3687 take precedence; needle sets with incorporated air inlet filters A61M5/162
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

Filtration devices for collection and filtration of biological samples are disclosed. Devices having a filtration element oriented in a generally vertical orientation are provided, as well as filtration devices that incorporate a cooling mechanism to reduce the temperature of collected solids. Tissue collection devices, such as aspiration assemblies, tissue sampling devices, and the like incorporating filtration devices are disclosed. Methods of collecting biological samples and separating biological solids from a liquid/solids mixture are also disclosed, together with analytical techniques and protocols for analyzing biological samples.

Claims

1. A cooled filtration assembly for filtering biological materials comprising a liquid/solids input port communicating with a liquid/solids input chamber, a liquid output chamber and a liquid output port communicating with the liquid output chamber, and a filtration member interposed between the liquid/solids input chamber and the liquid output chamber, wherein filtrate comprising biological materials residing in the filtration assembly during a filtration operating are cooled to a temperature at least 20°

F. cooler than the temperature of biological materials entering the liquid/solids input port.

2. The cooled filtration assembly of claim 1, wherein the filtration member is oriented in a generally vertical orientation during operation of the cooled filtration assembly.

3. The cooled filtration assembly of claim 1, wherein at least one of the input chamber, the output chamber and the filtration member is actively cooled during operation.

4. The cooled filtration assembly of claim 3, wherein at least one of the input chamber, the output chamber and the filtration member comprises a thermoelectric cooling surface.

5. The cooled filtration assembly of claim 1, additionally comprising a jacket mountable on the filtration assembly and comprising an active or passive cooling system.

6. The cooled filtration assembly of claim 1, additionally comprising an insulating jacket mountable on the filtration assembly.

7. The cooled filtration assembly of claim 1, wherein the filtration element comprises a size exclusion filtration member.

8. The cooled filtration assembly of claim 2, wherein the filtration member extends less than the full height of the liquid/solids input chamber and liquid output chamber, leaving a gap permitting material to flow between the input and output chambers.

9. The cooled filtration assembly of claim 1, wherein the cooled filtration assembly comprises an additional port in proximity to the liquid/solids input chamber for introduction of a cooled fluid during a filtration operation.

10. An aspirating system for withdrawal of biological materials from a subject comprising a distal operating head for withdrawing a biological liquid/solids mixture sample from a target interventional site in a subject, a catheter having a lumen for transporting the biological liquid/solids mixture sample in a proximal direction, and a cooled filtration assembly comprising a liquid/solids input port communicating with a liquid/solids input chamber, a liquid output chamber and a liquid output port communicating with the liquid output chamber, and a filtration member interposed between the liquid/solids input chamber and the liquid output chamber, wherein filtrate comprising biological materials residing in the filtration assembly during a filtration operating are cooled to a temperature at least 20°

F. cooler than the temperature of biological materials entering the liquid/solids input port.

11. An aspirating system of claim 10, additionally comprising a reservoir for collecting the biological liquid/solids mixture prior to passage of the biological liquid/solids mixture to the cooled filtration assembly.

12. A filtration device for filtering biological materials comprising a liquid/solids input port communicating with a liquid/solids input chamber, a liquid output chamber and a liquid output port communicating with the liquid output chamber, and a filtration member interposed between the liquid/solids input chamber and the liquid output chamber, wherein the filtration member is adapted to be oriented in a substantially vertical orientation during a filtration operation.

13. A filtration device of claim 12, wherein the filtration member extends less than the full height of the liquid/solids input chamber and liquid output chamber, leaving a gap permitting material to flow between the input and output chambers.

14. (canceled)

15. A method for processing a biological sample comprising:

(a) withdrawing a liquid/solids mixture comprising a target tissue sample from a target site in a subject;

(b) conveying the liquid/solids mixture to a filtration device for separation of at least a fraction of the solids from liquids, whereby the filtrate comprising biological materials resides in the filtration device and the liquids are withdrawn from the filtration device;

(c) cooling the solids separated from liquids and residing in the filtration device during the collection procedure; and

(d) analyzing the cooled solids.

16. A method of claim 15, wherein the target tissue sample comprises solids removed from blood vessels.

17. A method of claim 15, additionally comprising removing the separated solids from the filtration device and washing them with cold, sterile water;

pelleting and freezing the washed solids.

18. A method of claim 15, additionally comprising assaying the cooled solids for expression of at least one of the genes identified in Table 2.