Tissue interface device

• US 7,041,057 B1
• Filed: 11/17/2000
• Issued: 05/09/2006
• Est. Priority Date: 11/19/1999
• Status: Expired due to Fees

• Current Assignee: MidCap Funding III, LLC, Nitto Denko Corporation
• Original Assignee: Spectro Incorporated (Spectro Scientific, Inc.)
• Inventors: Smith, Alan, Kumar, Krishna, Faupel, Mark L., Vreeke, Mark, Hatch, Michael, Farquhar, J. David, Woods, Teresa
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US10/130,686
• Time in Patent Office: 1,999 Days
• Field of Search: 600/309, 600345-347, 600/348, 600352-354, 600361-366, 600/387, 600/391, 600/573, 600/578, 600/580, 600/583
• US Class Current: 600/365
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase

Abstract

A tissue interface device (10) suitable for positioning on or about one or more artificial openings in a biological membrane of an organism and for coupling to a monitor and control unit and a vacuum source. The tissue interface device (10) comprises a housing (100), a sensor channel (130), and a sensor (150). The housing (100) defines an orifice (120), the orifice (120) having an open inlet port (122) on the bottom end (102) of the housing (100) and a distal end (124) that is in fluid communication with the sensor channel (130). The orifice (120) is in fluid communication with fluid that flows from the artificial opening formed in the biological membranes. The sensor channel (130) is for coupling to, and fluid communication therewith, the vacuum source. The sensor (150) is positioned in the sensor channel (130) in a flow path of the fluid for sensing a characteristic of the fluid as it flows out from the artificial opening. The sensor generates a sensor signal representative thereof.

Claims

1. A tissue interface device for positioning about an artificial opening in a biological membrane to measure tissue characteristics, comprising:

a. a housing having a bottom end,

b. at least one sensor, and

c. a sensor channel, wherein, within the housing, the sensor channel couples the bottom end with the sensor

d. wherein the housing defines an orifice extending into the housing, the orifice having an open inlet port on the bottom end of the housing to receive liquid and a distal end that is in fluid communication with the sensor channel and wherein a portion of the bottom end of the orifice is radiused.

2. The tissue interface device of claim 1, wherein the sensor is positioned in the sensor channel that is in fluid communication with the sensor channel for sensing a characteristic of fluid flowing from the artificial opening in the biological membrane, and whereby, in use, the orifice is in fluid communication with the artificial opening in the biological membrane.

3. The tissue interface device of claim 1, wherein the inlet port has a first diameter and the distal end has a second diameter.

4. The tissue interface device of claim 3, wherein the orifice is tapered and wherein the second diameter is less than the first diameter.

5. The tissue interface device of claim 4, wherein the orifice has a bell-shaped curve in cross-section.

6. The tissue interface device of claim 4, wherein the orifice has a shaped orifice surface that extends from the inlet port to the distal end of the orifice, and wherein at least a portion of the orifice surface is curved in cross-section.

7. The tissue interface device of claim 1, wherein the sensor channel has an outlet port to discharge fluid.

8. The tissue interface device of claim 7, wherein the outlet port is suitable for connection to a vacuum source.

9. The tissue interface device of claim 1, wherein the sensor generates a signal representing a characteristic of the biological fluid.

10. The tissue interface device of claim 1, wherein the sensor generates an electrical sensor signal representing a characteristic of the biological fluid.

11. The tissue interface device of claim 10, further comprising an electrical connector and an electrical lead line in operative communication with the sensor, the electrical lead line coupling the electrical sensor signal to the electrical connector.

12. The tissue interface device of claim 11, wherein the electrical connector is coupled to a monitor and control unit.

13. The tissue interface device of claim 1, wherein the housing is disposable.

14. The tissue interface device of claim 1, wherein, in use, at least a portion of the bottom end of the housing is positioned in sealed contact with the biological membrane around the artificial opening.

15. The tissue interface device of claim 1 wherein the housing has a notch extending therein, wherein the housing further comprises a flexible insert having a base surface, the flexible insert shaped to be complementarily received within the notch so that the base surface forms a portion of the bottom end of the housing, and wherein the flexible insert includes at least a portion of the orifice.

16. The tissue interface device of claim 1, wherein the sensor is adapted for continuously assaying fluid flowing from the artificial opening.

17. The tissue interface device of claim 1, wherein the sensor is positioned proximate the distal end of the orifice.

18. A tissue interface device for positioning about an artificial opening in a biological membrane to measure tissue characteristics, comprising:

a. a housing having a bottom end,

b. at least one sensor, and

a sensor channel, wherein, within the housing, the sensor channel couples the bottom end with the sensor and wherein the housing defines an orifice extending into the housing, the orifice having an open inlet port on the bottom end of the housing to receive liquid and a distal end that is in fluid communication with the sensor channel and wherein the housing comprises;

a) a body having a passage and a body surface having a groove therein, the passage forming a first portion of the sensor channel which includes an outlet port, wherein the passage is connected to a proximal end of the groove, and wherein the distal end of the orifice is defined on the body surface of the body,

b) a well-forming adhesive layer having a top surface and an opposing bottom surface and defining an opening extending therethrough, wherein at least a portion of the bottom surface of the well-forming adhesive layer is connected to the body surface and overlies the groove of the body surface, wherein a portion of the opening of the well-forming adhesive layer overlies a portion of the body surface to form a well, the well connected to a distal end of the groove of the body surface and in fluid communication with the distal end of the orifice, and

c) a sensor member having a lower surface, wherein the sensor is mounted to the lower surface of the sensor member, and wherein a portion of the lower surface of the sensor member is connected to the top surface of the well-forming adhesive layer so that at least a portion of the sensor overlies the well, wherein the groove and the well are enclosed to form a second portion of the sensor channel that is in fluid communication with the first portion of the sensor channel and the distal end of the orifice.

19. The tissue interface device of claim 18, wherein the sensor member has a upper surface, and wherein the housing further comprises an adhesive bonding layer and a support member, wherein the adhesive bonding layer is connected to the upper surface of the sensor member, and wherein the support member is fixedly connected to adhesive bonding layer.

20. The tissue interface device of claim 18, wherein at least a portion of the opening of the adhesive layer overlies the distal end of the orifice.

21. A tissue interface device for positioning about an artificial opening in a biological membrane to measure tissue characteristics, comprising:

a. a housing having a bottom end,

b. at least one sensor, and

c. a sensor channel, wherein, within the housing, the sensor channel couples the bottom end with the sensor

d. an electrical connector and an electrical lead line in operative communication with the sensor, the electrical lead line coupling the electrical sensor signal to the electrical connector and wherein the sensor generates an electrical sensor signal representing the characteristic of the biological fluid

and wherein the housing has a thermo-well extending therein, the thermo-well having a base that is proximate the distal end of the orifice, and further comprising a thermistor positioned in the thermo-well proximate the base of the thermo-well, wherein the thermistor is connected to the electrical connector.

22. A tissue interface device for positioning about an artificial opening in a biological membrane to measure tissue characteristics, comprising:

a. a housing having a bottom end,

b. at least one sensor, and

a sensor channel, wherein, within the housing, the sensor channel couples the bottom end with the sensor

and wherein the housing defines an orifice extending into the housing, the orifice having an open inlet port on the bottom end of the housing to receive liquid and a distal end that is in fluid communication with the sensor channel and

wherein the inlet port has a first diameter and the distal end has a second diameter and wherein the orifice is tapered and wherein the second diameter is less than the first diameter and wherein the orifice has a shaped orifice surface that extends from the inlet port to the distal end of the orifice, and wherein at least a portion of the orifice surface is curved in cross-section and

wherein a portion of the shaped orifice surface of the orifice proximate the bottom end of the housing is curved so that the transition from the bottom end of the housing to the inlet port of the orifice is radiused.

23. A tissue interface device for positioning about an artificial opening in a biological membrane of an organism and for coupling to a monitor and control unit and a vacuum source, comprising:

a) a housing having a bottom end, a sensor channel, a vacuum channels, and a sensor, wherein the housing defines an orifice extending therein the housing, the orifice having an open inlet port on the bottom end of the housing and a distal end that is in fluid communication with the vacuum channel, and wherein the sensor channel and the vacuum channel are for fluid communication with the vacuum source,

b) a flexible membrane having a top surface, a bottom surface, and an opening extending therethrough, wherein the opening in the flexible membrane has a diameter less than the first diameter of the inlet port of the orifice, wherein at least a portion of the top surface of the flexible membrane is connected to the bottom end of the housing so that the opening of the flexible membrane is positioned near the inlet port of the orifice, wherein at least a portion of the top surface of the flexible membrane is in fluid communication with the vacuum source, and wherein, in use, at least a portion of the bottom surface of the flexible membrane is positioned in sealed contact with the biological membrane around the artificial opening so that the opening of the flexible membrane is in fluid communication with the artificial opening in the biological membrane and with the inlet port of the orifice, and

c) a flexible conduit connected to, and in fluid communication therewith, the sensor channel and the opening in the flexible membrane, wherein the sensor is positioned in the sensor channel in fluid communication with the flexible conduit for sensing a characteristic of fluid flowing from the artificial opening in the biological membrane, and wherein the flexible membrane is a gas permeable membrane.

24. The tissue interface device of claim 23, wherein the orifice is tapered, and wherein the inlet port has a first diameter and the distal end has a second diameter that is less than the first diameter.

25. The tissue interface device of claim 23, wherein the sensor is positioned proximate the distal end of the orifice.

26. A tissue interface device for positioning about an artificial opening in a biological membrane to measure tissue characteristics, comprising:

a. a housing having a bottom end,

b. an orifice in the housing, the orifice having an open inlet port on the bottom end of the housing to receive liquid from the tissue and a distal end

c. a sampling channel within the housing the channel being in fluid communication with the distal end; and

d. a fluid permeable flexible membrane is connected to the bottom end of the housing so that the opening of the flexible membrane is positioned near the inlet port of the orifice, wherein, in use, at least a portion of the flexible membrane is positioned in temporarily sealed contact with the biological membrane and around the biological membrane.