Capillary filtration and collection device for long-term monitoring of blood constituents

• US 4,854,322 A
• Filed: 09/18/1987
• Issued: 08/08/1989
• Est. Priority Date: 02/25/1987
• Status: Expired due to Fees

• Current Assignee: Ash Access Technology, Inc.
• Original Assignee: ASH Medical Systems Incorporated
• Inventors: Janle-Swain, Elsa M., Ash, Stephen R.
• Primary Examiner(s): Hindenburg, Max
• Application Number:
  US07/098,400
• Time in Patent Office: 690 Days
• Field of Search: 128/632, 128/635, 128/768, 128/769, 604/4, 604/29, 604/50, 604/66, 604/27, 604/35, 604/48, 604/51, 604/93, 604/118, 604/119, 604/186
• US Class Current: 600/347
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/14528 invasively
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: B01D 2313/06 External membrane module supporting or fixing means
• CPC Class Codes: B01D 61/18 Apparatus therefor
• CPC Class Codes: B01D 63/024 with a single potted end
• CPC Class Codes: B01D 63/0241 being U-shaped

Abstract

A method and device for long term monitoring of the blood level of various blood constituents. The monitoring is accomplished by capillary filtration and collection of an ultrafiltrate of blood. Filtration of the ultrafiltrate occurs through a filter composed of hollow fibers which are implanted within an interstitial body space in fluid communication with blood capillaries. The ultrafiltrate is drawn through the filter and into an ultrafiltrate collector which extends externally of the body. The collector provides a vacuum for withdrawing the ultrafiltrate and holds discrete liquid samples of the ultrafiltrate. The method and device is particularly suited for long term monitoring of blood glucose levels in diabetic patients or other blood chemical constituents in other patients.

Claims

1. A capillary filtration and collection system for monitoring a physiological constituent of blood, comprising:

a filtration means for filtering a plasma ultrafiltrate from blood capillaries in an interstitial space inside a body, said filtration means including a porous filter made of a material compatible for long-term patency inside the body, said filter adapted to be implanted inside the body in fluid communication with blood capillaries in the interstitial space and having pores sized not greater than approximately 300,000 daltons;

an ultrafiltrate collector including an elongate tube connected to said filter in fluid communication therewith and adapted to extend externally of the body with said filter implanted inside the body; and

a negative pressure generating means for generating a negative pressure relative to atmospheric for withdrawing the plasma ultrafiltrate through said filter and into said ultrafiltrate collector.

2. The system of claim 1 wherein said filter includes one or more polymeric hollow fibers.

3. The system of claim 2 wherein said filter includes at least two fibers but not greater than seven fibers.

4. The system of claim 2 wherein said filter includes only two fibers, said fibers folded to form loops extending from said ultrafiltrate collector.

5. The system of claim 2 wherein the one or more fibers are made of either a polysulfone or polyacrylonitrile material.

6. The system of claim 5 wherein the fibers are made of a polyacrylonitrile material.

7. The system of claim 1 wherein said filter includes a plurality of polymeric sheet membranes.

9. The system of claim 1 wherein said filtration means is further for filtering a plasma ultrafiltrate and gas from blood capillaries in an interstitial space inside a body.

10. The system of claim 9 wherein said filtration means and said negative pressure generating means are for filtering the plasma ultrafiltrate and gas through said filter and withdrawing the plasma ultrafiltrate and gas through said filter and into said ultrafiltrate collector at a volume ratio of gas to ultrafiltrate of about ten to one.

11. The system of claim 10 wherein said filter has pore sizes not greater than 50,000 daltons and not less than 1,000 daltons.

12. The system of claim 11 wherein said filter has pore sizes not greater than 50,000 daltons and not less than 30,000 daltons.

13. The system of claim 10 wherein said elongate tube having an inner diameter sized to permit movement of the plasma ultrafiltrate therethrough in discrete liquid boluses separated by said gas.

14. The system of claim 13 wherein said elongate tube having an inner diameter of less than 0.115".

15. The system of claim 1 and further comprising:

a means for securing the position of said filter inside the body, said securing means including a porous or textured cuff extending around the tubing and compatible with adjacent body tissues to promote fibrous tissue ingrowth when sutured thereto.

16. The system of claim 1 wherein said negative pressure generating means is a roller pump.

8. The system of claim1 wherein said filter has a porous outer surface having pore sizes not greater than 100,000 daltons.'"'"'

17. A capillary filtration and collection system, comprising:

a filter including at least one hollow fiber compatible for long-term patency within an interstitial space of a body in fluid communication with blood capillaries and having a porous outer surface having pore sizes less than approximately 300,000 daltons;

an ultrafiltrate collector including a tube connected to said filter in fluid communication therewith and adapted to extend externally of the body with said filter implanted within an interstitial body space; and

a negative pressure generating means for generating a negative pressure for withdrawing an ultrafiltrate of blood through said filter and into said ultrafiltrate collector at a desired flow rate in a range from about 20 to 500 microliters per hour.

18. A capillary filtration and collection system for monitoring a physiological constituent of blood, comprising:

a filtration means for filtering a plasma ultrafiltrate from blood capillaries in an interstitial space inside a body, said filtration means including an unsupported porous filter made of a material compatible for long-term patency inside the body, said filter adapted to be implanted inside the body in fluid communication with blood capillaries in the interstitial space and having pores sized not greater than approximately 300,000 daltons;

an ultrafiltrate collector including an elongate tube connected to said filter in fluid communication therewith and adapted to extend externally of the body with said filter implanted inside the body; and

a negative pressure generating means for generating a negative pressure relative to atmospheric for withdrawing the plasma ultrafiltrate through said filter and into said ultrafiltrate collector.