CA2390893A1 - Tissue interface device - Google Patents
Tissue interface device Download PDFInfo
- Publication number
- CA2390893A1 CA2390893A1 CA002390893A CA2390893A CA2390893A1 CA 2390893 A1 CA2390893 A1 CA 2390893A1 CA 002390893 A CA002390893 A CA 002390893A CA 2390893 A CA2390893 A CA 2390893A CA 2390893 A1 CA2390893 A1 CA 2390893A1
- Authority
- CA
- Canada
- Prior art keywords
- orifice
- sensor
- interface device
- tissue interface
- housing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000012528 membrane Substances 0.000 claims abstract 47
- 239000012530 fluid Substances 0.000 claims abstract 30
- 230000008878 coupling Effects 0.000 claims abstract 5
- 238000010168 coupling process Methods 0.000 claims abstract 5
- 238000005859 coupling reaction Methods 0.000 claims abstract 5
- 239000012790 adhesive layer Substances 0.000 claims 5
- 238000004026 adhesive bonding Methods 0.000 claims 3
- 239000010410 layer Substances 0.000 claims 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims 2
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 claims 2
- 239000013060 biological fluid Substances 0.000 claims 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims 2
- FPIPGXGPPPQFEQ-UHFFFAOYSA-N 13-cis retinol Natural products OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-UHFFFAOYSA-N 0.000 claims 1
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- FPIPGXGPPPQFEQ-BOOMUCAASA-N Vitamin A Natural products OC/C=C(/C)\C=C\C=C(\C)/C=C/C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-BOOMUCAASA-N 0.000 claims 1
- 229930003268 Vitamin C Natural products 0.000 claims 1
- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 claims 1
- 239000012491 analyte Substances 0.000 claims 1
- 235000011089 carbon dioxide Nutrition 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 235000014655 lactic acid Nutrition 0.000 claims 1
- 239000004310 lactic acid Substances 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 230000007704 transition Effects 0.000 claims 1
- 235000019155 vitamin A Nutrition 0.000 claims 1
- 239000011719 vitamin A Substances 0.000 claims 1
- 235000019154 vitamin C Nutrition 0.000 claims 1
- 239000011718 vitamin C Substances 0.000 claims 1
- 229940045997 vitamin a Drugs 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Physics & Mathematics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- Pathology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Optics & Photonics (AREA)
- Surgery (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Measuring And Recording Apparatus For Diagnosis (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Prostheses (AREA)
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 (35)
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.
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.
2. The tissue interface device of Claim 1, wherein the housing defines an orifice extending therein 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.
3. The tissue interface device of Claim 2, 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 1, wherein the sensor channel has an outlet port to discharge fluid.
6. The tissue interface device of Claim 5, wherein the outlet port is suitable for connection to a vacuum source.
7. The tissue interface device of Claim 2, wherein the sensor is positioned in the sensor channel in fluid communication with the orifice 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.
8. The tissue interface device of Claim 2, 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.
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.
9. The tissue interface device of Claim 8, 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.
10. The tissue interface device of Claim 8, wherein at least a portion of the opening of the adhesive layer overlies the distal end of the orifice.
11. The tissue interface device of Claim 1, wherein the sensor generates a signal representing the characteristic of the biological fluid.
12. The tissue interface device of Claim 1, wherein the sensor generates an electrical sensor signal representing the characteristic of the biological fluid.
13. The tissue interface device of Claim 12, 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.
14. The tissue interface device of Claim 13, wherein the electrical connector is coupled to a monitor and control unit.
15. The tissue interface device of Claim 13, 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.
16. The tissue interface device of Claim 4, wherein the orifice has a bell-shaped curve in cross-section.
17. 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.
18. The tissue interface device of Claim 17, 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.
19. The tissue interface device of Claim 1, wherein the housing is disposable.
20. 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.
21. The tissue interface device of Claim 2, further comprising a flexible membrane having 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 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, in use, at least a portion of the flexible membrane is positioned in temporarily 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 tapered orifice.
22. The tissue interface device of Claim 2, 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.
23. The tissue interface device of Claim 4, further comprising a flexible membrane having 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 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, in use, at least a portion of the flexible membrane is positioned in temporarily 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 tapered orifice.
24. The tissue interface device of Claim 4, 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.
25. The tissue interface device of Claim 1, wherein the sensor comprises a biosensor.
26. The tissue interface device of Claim 25, wherein the sensor comprises an analyte biosensor for detecting at least one of: glucose, pH, vitamin A, vitamin C, CO2, and lactic acid.
27. The tissue interface device of Claim 1, wherein the sensor comprises a colorometric sensor.
28. The tissue interface device of Claim 1, wherein the sensor is adapted for continuously assaying fluid flowing from the artificial opening.
29. The tissue interface device of Claim 2, wherein the sensor is positioned proximate the distal end of the orifice.
30. 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 channel, 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, an 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.
a) a housing having a bottom end, a sensor channel, a vacuum channel, 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, an 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.
31. The tissue interface device of Claim 30, wherein the flexible membrane is a gas permeable membrane.
32. The tissue interface device of Claim 30, 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.
33. The tissue interface device of Claim 30, wherein the sensor is positioned proximate the distal end of the orifice.
34. 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, and a sensor, wherein the housing defines a tapered orifice extending therein the housing, the tapered orifice having an open inlet port on the bottom end of the housing to receive fluid and a distal end that is in fluid communication with the sensor channel, wherein the inlet port has a first diameter and the distal end has a second diameter that is less than the first diameter, wherein the sensor channel has a outlet port to discharge fluid, the outlet port suitable for connection to the vacuum source, wherein the sensor is positioned in the sensor channel in fluid communication with the orifice for sensing a characteristic of fluid flowing from the artificial opening in the biological membrane, and b. a flexible membrane having 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 the flexible membrane is connected to the bottom end of the housing so that the opening of the flexible membrane is proximate the inlet port of the orifice, wherein, in use, the opening 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 surrounds and is in fluid communication with the artificial opening in the biological membrane and the open inlet port of the orifice is in fluid communication with the opening of the flexible membrane.
a. a housing having a bottom end, a sensor channel, and a sensor, wherein the housing defines a tapered orifice extending therein the housing, the tapered orifice having an open inlet port on the bottom end of the housing to receive fluid and a distal end that is in fluid communication with the sensor channel, wherein the inlet port has a first diameter and the distal end has a second diameter that is less than the first diameter, wherein the sensor channel has a outlet port to discharge fluid, the outlet port suitable for connection to the vacuum source, wherein the sensor is positioned in the sensor channel in fluid communication with the orifice for sensing a characteristic of fluid flowing from the artificial opening in the biological membrane, and b. a flexible membrane having 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 the flexible membrane is connected to the bottom end of the housing so that the opening of the flexible membrane is proximate the inlet port of the orifice, wherein, in use, the opening 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 surrounds and is in fluid communication with the artificial opening in the biological membrane and the open inlet port of the orifice is in fluid communication with the opening of the flexible membrane.
35. The tissue interface device of Claim 34, wherein the sensor is positioned proximate the distal end of the orifice.
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US16648199P | 1999-11-19 | 1999-11-19 | |
| US60/166,481 | 1999-11-19 | ||
| US17814800P | 2000-01-26 | 2000-01-26 | |
| US60/178,148 | 2000-01-26 | ||
| US24456800P | 2000-10-31 | 2000-10-31 | |
| US60/244,568 | 2000-10-31 | ||
| PCT/US2000/031765 WO2001035820A1 (en) | 1999-11-19 | 2000-11-17 | Tissue interface device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2390893A1 true CA2390893A1 (en) | 2001-05-25 |
| CA2390893C CA2390893C (en) | 2010-10-05 |
Family
ID=27389276
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2390893A Expired - Fee Related CA2390893C (en) | 1999-11-19 | 2000-11-17 | Tissue interface device |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US7041057B1 (en) |
| EP (1) | EP1229825B1 (en) |
| JP (1) | JP2003514244A (en) |
| AU (1) | AU1778601A (en) |
| BR (1) | BR0015716A (en) |
| CA (1) | CA2390893C (en) |
| MX (1) | MXPA02005068A (en) |
| WO (1) | WO2001035820A1 (en) |
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-
2000
- 2000-11-17 JP JP2001537619A patent/JP2003514244A/en active Pending
- 2000-11-17 CA CA2390893A patent/CA2390893C/en not_active Expired - Fee Related
- 2000-11-17 BR BR0015716-3A patent/BR0015716A/en not_active Application Discontinuation
- 2000-11-17 EP EP00980533A patent/EP1229825B1/en not_active Expired - Lifetime
- 2000-11-17 AU AU17786/01A patent/AU1778601A/en not_active Abandoned
- 2000-11-17 WO PCT/US2000/031765 patent/WO2001035820A1/en active Application Filing
- 2000-11-17 US US10/130,686 patent/US7041057B1/en not_active Expired - Fee Related
- 2000-11-17 MX MXPA02005068A patent/MXPA02005068A/en unknown
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| CA2390893C (en) | 2010-10-05 |
| BR0015716A (en) | 2003-05-06 |
| WO2001035820A1 (en) | 2001-05-25 |
| AU1778601A (en) | 2001-05-30 |
| WO2001035820A9 (en) | 2002-05-16 |
| EP1229825B1 (en) | 2012-06-20 |
| MXPA02005068A (en) | 2002-11-07 |
| US7041057B1 (en) | 2006-05-09 |
| EP1229825A1 (en) | 2002-08-14 |
| JP2003514244A (en) | 2003-04-15 |
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