US20130079608A1 - Implantable sensor method and system - Google Patents
Implantable sensor method and system Download PDFInfo
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- US20130079608A1 US20130079608A1 US13/622,927 US201213622927A US2013079608A1 US 20130079608 A1 US20130079608 A1 US 20130079608A1 US 201213622927 A US201213622927 A US 201213622927A US 2013079608 A1 US2013079608 A1 US 2013079608A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0031—Implanted circuitry
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- A61B5/04—
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- 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
-
- 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
- A61B5/14503—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 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
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- 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
- A61B5/14532—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 for measuring glucose, e.g. by tissue impedance measurement
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- 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
- A61B5/1455—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 optical sensors, e.g. spectral photometrical oximeters
- A61B5/14551—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 optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
- A61B5/14552—Details of sensors specially adapted therefor
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- 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
- A61B5/14865—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 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
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- A—HUMAN NECESSITIES
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- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6879—Means for maintaining contact with the body
- A61B5/6882—Anchoring means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1698—Blood oxygenators with or without heat-exchangers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2230/00—Measuring parameters of the user
- A61M2230/20—Blood composition characteristics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2230/00—Measuring parameters of the user
- A61M2230/20—Blood composition characteristics
- A61M2230/201—Glucose concentration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
Definitions
- a silicone plug may be used to plug the receptacle so that it remains open during the period of time the foreign body capsule is forming around the implant unit. If a silicone plug has been inserted into the receptacle 16 , it may also be removed at this time.
- FIG. 3C shows a process for making a non-vascular placement of the sensor 12 into subcutaneous tissue according to an embodiment of the present invention.
- a large incision may be made in the body at a desired or convenient location for the implant unit 10 .
- a pocket may be made in the subcutaneous tissue above the cavity to be used that is large enough to support the implant unit 10 .
- the heterogeneous nature of a physiological parameter in that area may result in varying amounts of the physiological parameter.
- the amount of a physiological parameter sensed may vary depending on the location of the sensing element within that particular area of the body.
- the particular area of the body is the peritoneum and the physiological parameter is oxygen
- the capillaries of the peritoneum are the sources of the oxygen.
- the topology of capillaries within the peritoneum may vary in different areas of the peritoneum.
- the oxygen levels may also vary in different areas of the peritoneum.
Abstract
Systems and methods for non-vascular sensor implantation and for measuring physiological parameters in areas of a body where the physiological parameters are heterogeneous. An implant unit is implanted in an area of a body and a foreign body capsule is allowed to form around the implant unit area. A sensor may be directed into a body cavity such as, for example, the peritoneal space, subcutaneous tissues, the foreign body capsule, or other area. A subcutaneous area of the body may be tunneled for sensor placement. Spatially separated sensing elements may be used for detecting individual amounts of the physiological parameter. An overall amount of the physiological parameter may be determined by calculating a statistical measurement of the individual sensed amounts in the area. Another embodiment of the invention, a multi-analyte measuring device, may include a substrate having an electrode array on one side and an integrated circuit on another side.
Description
- Embodiments of the present invention relate to U.S. application Ser. No. 10/034,627, filed Dec. 27, 2001 and U.S. Provisional Application Ser. No. 60/335,627, filed Oct. 23, 2001, each entitled “Method and System for Non-Vascular Sensor Implantation,” each of which is incorporated by reference herein, and from a U.S. Provisional Application Ser. No. 60/414,290, filed Sep. 27, 2002, entitled “Implantable Sensor Method and System,” which is also incorporated by reference herein and is a basis for a claim of priority.
- 1. Field of the Invention
- The present invention relates to the field of in vivo sensors and, in particular, to in vivo sensors that are implanted in non-vascular areas of the body. The present invention also relates to a system and method for accurately measuring a physiological parameter in areas of a body (or external to the body) where amounts of the physiological parameter are heterogeneous in nature.
- 2. Description of Related Art
- Traditional methods of physiological parameter sensing typically rely on vascular placement of a physiological parameter sensor. Such placement permits a sensing element such as, for example, a biomolecule, to make direct contact with the blood, providing sensing capabilities of blood components. Such sensing capabilities have greatly facilitated analysis, diagnosis and treatment of many debilitating diseases and medical conditions.
- However, vascular placement of a physiological parameter sensor may suffer from several disadvantages. A physiological parameter sensor is not inserted into a vein without great difficulty and painstaking effort by an attending physician. Moreover, a physiological parameter sensor is not adjusted within or extracted from a vein without similar difficulty and effort.
- Furthermore, vascular placement of a physiological parameter sensor subjects the sensor to a constant fluid environment. Such an environment may have several detrimental effects on the sensor. Due to constant fluidic contact, the sensor may suffer from decreased sensitivity, stability and effective life. Should a characteristic of the sensor be diminished to an extent rendering the sensor ineffective, the sensor must be removed and replaced, introducing the difficulties for both patient and physician associated with such removal and replacement. To complicate matters, every time a physiological parameter sensor is removed and replaced, it must be disconnected and reconnected to an implant unit utilizing the sensor output.
- In an effort to assuage some of the disadvantages associated with vascular implantation of physiological parameter sensors, integrated sensor/implant unit systems have been developed. Such systems may be placed in or near a body cavity and may provide non-vascular sensing of physiological parameters. However, the incision required for such sensor/implant unit systems is relatively large and the trauma in the area of implantation can be significant. Such trauma generally prevents sensing of physiological parameters. Because such trauma may not subside for several weeks or a month or even longer, pre-implantation analysis methods used by the patient must continue. Without continuation of preimplantation analysis methods, a patient may go undiagnosed and untreated for many weeks, possibly even a month or longer. Such delay in treatment and diagnosis could be harmful or even fatal for patients who need daily diagnosis and treatment.
- In addition, vascular implantation of physiological parameter sensors allow the sensing elements to sense a relatively homogenous amount of oxygen or other physiological parameter as it flows past the sensing elements. In contrast, when placing the sensor in a non-vascular area of the body, the physiological parameter may have a more heterogeneous nature, i.e., the amount of the physiological parameter may vary significantly at different locations within the non-vascular area. In such a case, the sensing element may sense the physiological parameter through diffusion from, for example, fluid around the sensing element. Thus, depending on the location of the sensing element within the non-vascular area, the amount of the physiological parameter sensed by the sensing element may more or less accurately represent the “overall amount” of the physiological parameter within the non-vascular area, i.e., an amount that accurately represents, for example, an average amount or other suitable statistical measure of the physiological parameter in the particular area of the body. In addition, another problem results from the fact that the heterogeneous nature of the physiological parameter being sensed by the sensing element may induce noise in the signal obtained from the sensing element.
- Embodiments of the present invention relate to systems and methods for non-vascular sensor implantation and to a system and method for accurately measuring a physiological parameter in areas of a body (or external to the body) where amounts of the physiological parameter are heterogeneous in nature.
- A method for non-vascular implant of a sensor may include implanting an implant unit in an area of a body; allowing a foreign body capsule to form around the area of the implant unit; and directing the sensor into the foreign body capsule.
- Implanting an implant unit may include incising an area of the body large enough for the implant unit. Allowing a foreign body capsule to form may comprise inserting materials around the implant unit to promote growth characteristics. A material may be placed around the implant unit for promoting growth characteristics. The implant unit may include electronics and/or a pump. The electronics may be sensor electronic or other electronics. The electronics may be integrated with the pump or may be mutually exclusive from the pump.
- The sensor may be attached to the implant unit. The sensor may be attached to the implant unit prior to formation of the foreign body capsule or may be attached to the implant unit subsequent to formation of the foreign body capsule.
- The method may further include incising an area of the body large enough for the sensor. The incised area of the body large enough for the sensor is smaller than an incised area of the body large enough for the implant unit.
- A method for non-vascular implant of a sensor may also include incising an area of a body large enough for inserting an implant unit; incising an area remote from a sensor location for inserting a sensor; directing the sensor into a body cavity; connecting the sensor to the implant unit; and inserting the implant unit into the body. The method may further include fixing the sensor in place using suture. The implant unit may be inserted into a pocket formed when incising an area of the body large enough for inserting the implant unit.
- Systems for non-vascular implant may include an implant unit for delivering drug to a human body and a sensor for detecting a physiological parameter. The sensor may be separate from and connectable to the implant unit and the sensor is placed in a non-vascular area of the human body.
- The implant unit may include a pump and/or electronics. The drug delivered by the implant unit may be insulin. The sensor may include a biomolecule, a lead and a sensing element. The sensing element may be a biomolecule and the biomolecule may be a glucose oxidase enzyme. The physiological parameter sensed may be oxygen or glucose. The non-vascular area of the human body where the sensor is placed may be the peritoneum or subcutaneous tissue.
- A plurality of spatially separated sensing elements may be used for detecting the physiological parameter. The sensing elements may be connectable to the implant unit. The sensing elements may be implanted in a non-vascular area of the body such that each of the sensing elements sense an individual amount of the physiological parameter within the area. The sensing elements may substantially simultaneously sense individual amounts of the physiological parameter or may sense the individual amounts in succession within a given time period. An overall amount of the physiological parameter in the area may then be determined by employing a combination of the individual sensed amounts in a statistical analysis, such as in an algorithm or combined calculation.
- The plurality of spatially separated sensing elements may be a one, two, or three-dimensional array of spatially separated sensing elements. Two or more sensing elements may be spatially separated in a sensor lead by a pre-determined distance. The sensor lead may include a first sensing element located at a proximal end of the sensor lead and a second sensing element located at a distal end of the sensor lead. The sensing elements may be connected to the implant unit in a daisy chain fashion.
- Each of the plurality of spatially separated sensing elements may generate a signal representing an individual sensed amount of the physiological parameter. The overall amount of the physiological parameter may be determined by calculating a statistical measurement of the individual sensed amounts represented by the generated signals. The statistical measurement may be, but is not limited to, a maximum amount for the individual sensed amounts, an average amount of the individual sensed amounts, a median of the individual sensed amounts, an arithmetic mean of the individual sensed amounts, a weighted arithmetic mean of the individual sensed amounts, or the like. In this manner, a more accurate overall measurement of the physiological parameter is possible. In addition, noise induced in the signals produced by the sensing elements may be reduced by averaging the amounts of each of the plurality of spatially separated sensing elements.
- Embodiments of the present invention may also include a method for non-vascular implant of a sensor including incising an area of a body large enough for inserting an implant unit; creating a tunnel in subcutaneous tissue; directing the sensor through the tunnel; connecting the sensor to the implant unit; and inserting the implant unit into the body. The tunnel may be created using a blunt instrument such as, for example, a trocar, or other blunt instrument which minimizes trauma to the subcutaneous tissue.
- Embodiments of the present invention may also include a structure for defining an in vivo implant site, the structure including a cylinder having a hollow area in an interior portion thereof, wherein a portion of the cylinder is covered with a coating. The coating may be silicone rubber and the cylinder may be a right circular cylinder. The hollow area may be sufficiently large to accept a sensor. In addition, the cylinder may have at least one hole in an outer surface thereof.
- Embodiments of the present invention may also include a multi-analyte measuring device having a substrate, an electrode array on a first side of the substrate, and an integrated circuit on a second side of the substrate. The electrode array and the integrated circuit may be electrically connected. The integrated circuit processes signals or monitors signals. The electrode array may include an agent, such as, for example, an enzyme. The substrate may include channels. The multi-analyte measuring device may also include a connector for providing access to the integrated circuit. The connector may connect to a display device or a monitoring device. The multi-analyte measuring device may also include a power supply, such as, for example, a battery or a capacitor.
- These and other objects, features, and advantages of embodiments of the invention will be apparent to those skilled in the art from the following detailed description of embodiments of the invention when read with the drawings and appended claims.
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FIG. 1 shows a general position of an implant unit and a sensor in the human body according to an embodiment of the present invention. -
FIG. 2 shows a generalized implant unit and a sensor according to an embodiment of the present invention. -
FIG. 3A shows a process for making a non-vascular placement of a sensor into a foreign body capsule according to an embodiment of the present invention -
FIG. 3B shows a process for making a non-vascular placement of a sensor into a body cavity such as, for example, the peritoneal space, according to an embodiment of the present invention. -
FIG. 3C shows a process for making a non-vascular placement of a sensor into subcutaneous tissue according to an embodiment of the present invention. -
FIG. 4 shows a biopsy trocar used according to an embodiment of the present invention. -
FIG. 5A shows glucose data over a period of several days for a sensor implanted into a foreign body capsule according to an embodiment of the present invention. -
FIG. 5B shows glucose data over a period of several days for a sensor implanted into subcutaneous tissue according to an embodiment of the present invention. -
FIG. 5C shows glucose data over a period of several days for a sensor implanted into a body cavity such as a peritoneal space according to an embodiment of the present invention. -
FIG. 6 shows a blood oxygenator in which a sensing element may be placed, according to an embodiment of the present invention. -
FIG. 7 shows a sensor lead including two sensing elements according to an embodiment of the present invention. -
FIG. 8 shows a graphical representation of glucose data over a period of several days for each of two sensing elements of a sensor lead implanted into the peritoneum according to an embodiment of the present invention. -
FIG. 9 shows a graphical representation of the average of the glucose data for the two sensing elements ofFIG. 7 over the same period according to an embodiment of the present invention. -
FIG. 10 shows a graphical representation of unfiltered glucose data over a period of several days for a sensing element of a sensor lead implanted into the peritoneum according to an embodiment of the present invention. -
FIG. 11 shows a graphical representation of filtered glucose data for the sensing element ofFIG. 10 over the same period according to an embodiment of the present invention. -
FIG. 12 shows a graphical representation of the unfiltered average of the glucose data for the two sensing elements ofFIG. 7 over a period of several days according to an embodiment of the present invention. -
FIG. 13 shows a graphical representation of the filtered average of the glucose data for the two sensing elements ofFIG. 7 over the same period according to an embodiment of the present invention. -
FIG. 14 shows a perspective view of a placement site structure according to an embodiment of the present invention. -
FIG. 15 shows a side cutaway view of a multi-analyte sensing device according to an embodiment of the present invention. -
FIG. 16 shows a top view of a multi-analyte sensing device according to an embodiment of the present invention. -
FIG. 17 shows a multi-analyte sensing device and an electronic monitoring/display device according to an embodiment of the present invention. - In the following description of preferred embodiments, reference is made to the accompanying drawings which form a part hereof, and in which are shown by way of illustration specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the preferred embodiments of the present invention.
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FIG. 1 shows a general placement of animplant unit 10 and asensor 12 in the human body according to an embodiment of the present invention. Theimplant unit 10 may be placed into a human body in a variety of locations such as, for example, adjacent to theabdominal cavity 14, or in other locations such as, for example, the spinal cavity or chest cavity. Asensor 12 connecting to theimplant unit 10 may be located in theperitoneum 13, the membrane lining the abdominal cavity and connecting and supporting internal organs; insubcutaneous tissue 13, i.e., tissue beneath the skin; in a foreign body capsule; or in another area of the body. For example, thesensor 12 may be implanted into the shoulder area. - The
implant unit 10 may contain electronics for data acquisition, data storage, data processing or other functions as may be required for physiological parameter sensing. In addition, theimplant unit 10 may also contain, for example, a drug delivery system including a drug reservoir and a pumping mechanism to move a drug from the reservoir to a patient through, for example, a delivery catheter. Thesensor 12 may sense a variety of physiological parameters. For example, thesensor 12 may sense glucose and oxygen and may be used in connection with theimplant unit 10 to pump insulin for diabetics. -
FIG. 2 shows ageneralized implant unit 10 and asensor 12 according to an embodiment of the present invention. Theimplant unit 10 and thesensor 12 are not integrated. They are discreet devices and may or may not be used independently of one another. Theimplant unit 10 and thesensor 12 may be used in conjunction with one another and may be inserted into a patient at separate times. The ability to insert theimplant unit 10 and thesensor 12 into a patient at different times gives physicians and patients enhanced flexibility when implanting the devices. - As can be seen in
FIG. 2 , thesensor 12, according to an embodiment of the present invention, includes aconnector 18, asensor lead 20 connected to the connector at one end, and asensing element 22 connected to thesensor lead 20 at another end. Thus, thesensing element 22 of thesensor 12 may be located away from theimplant unit 10 which, as will be seen shortly, offers enhanced functionality in sensing physiological parameters. - As shown in
FIG. 2 , according to an embodiment of the present invention theimplant unit 10 may include areceptacle 16 for accepting theconnector 18 portion of thesensor 12. Also, thesensor lead 20 is not limited to any particular length. For example, thesensor lead 20 may be approximately nine inches long, permitting thesensing element 22 to be approximately nine inches from theimplant unit 10. However, thesensor lead 20 may be longer or shorter than nine inches depending on the application and the particular placement of thesensing element 22 desired. - Also, the
implant unit 10 may include its own lead that connects to thesensor lead 20. Thus, rather than connecting thesensor lead 20 to thereceptacle 16, thesensor lead 20 may connect to an implant unit lead. -
FIG. 3A shows a process for making a non-vascular placement of thesensor 12 into a foreign body capsule according to an embodiment of the present invention. Atstep 30, a large incision may be made in the body at a desired or convenient location for theimplant unit 10. While making the incision ofstep 30, a pocket may be made in the subcutaneous tissue that is large enough to support theimplant unit 10. Atstep 32, theimplant unit 10 may be inserted into the subcutaneous tissue pocket. The pocket may then be closed. - Once the
implant unit 10 has been inserted into the subcutaneous tissue pocket and the pocket has been closed, theimplant unit 10 may be left in the body for a period of time long enough that a foreign body capsule forms around theimplant unit 10. Theimplant unit 10 may need to be left undisturbed in its position in the body for up to several weeks, a month, or longer in order to allow the foreign body capsule to form. The foreign body capsule is made up of scar tissue, primarily collagen and fibrin. - During the period when the foreign body capsule is forming, a
sensor 12 may or may not be attached to theimplant unit 10. If asensor 12 is not attached to theimplant unit 10, it may still be possible to use theimplant unit 10 in an open-loop configuration. For example, if theimplant unit 10 contains telemetry circuitry, it may be possible to communicate with theimplant unit 10 from a remote location. For example, if theimplant unit 10 is an insulin pump, and nosensor 12 is attached to theimplant unit 10 during the period in which the foreign body capsule is forming around theimplant unit 10, the patient may still analyze his or her insulin levels by traditional methods, such as, for example, using a home analysis system to take a blood sample and analyze the levels of insulin in the blood. If it is determined that the patient needs a dosage of insulin, and if the insulin pump which has been placed into the patient's body is equipped with telemetry electronics, the patient may communicate with the insulin pump telemetrically using a portable transmitting unit and command the pump to deliver a dosage of insulin. Thus, the patient may begin to immediately use the insulin pump, without having asensor 12 attached to the pump, in an open-loop configuration. Thus, using embodiments of the present invention, there is no need to wait for the foreign body capsule to form around theimplant unit 10 before making use of theimplant unit 10. - An oxygen sensor may be used in the vicinity of the foreign body capsule to determine if the foreign body capsule has formed and the area has healed. Generally, no oxygen will be detected during formation of the foreign body capsule.
- Once the foreign body capsule has formed around the
implant unit 10, at step 34 a small incision may be made in the vicinity of theimplant unit 10 pocket allowing access to thereceptacle 16 of theimplant unit 10. If a sensor has been previously connected to theimplant unit 10, it may be disconnected at this time. After the small incision has been made and any previously connected sensors have been disconnected from the implant unit, atstep 36 thesensor 12 may be directed into the foreign body capsule. Thesensing element 22 may be introduced into the foreign body capsule surrounding the implant unit through the small incision made atstep 34. Thesensing element 22 may be placed within the foreign body capsule. Theconnector 18 may reside in the subcutaneous pocket created for theimplant unit 10 by the body. - In addition, a silicone plug may be used to plug the receptacle so that it remains open during the period of time the foreign body capsule is forming around the implant unit. If a silicone plug has been inserted into the
receptacle 16, it may also be removed at this time. - At
step 38, thesensor 12 may be connected to theimplant unit 10 at thereceptacle 16 on theimplant unit 10 designed for connecting to thesensor 12 by connecting theconnector 18 to thereceptacle 16. Once thesensor 12 has been connected to theimplant unit 10, the small incision may be closed atstep 40. At this point, theimplant unit 10 and thesensor 12 may be used in a closed-loop configuration. For example, if theimplant unit 10 is an insulin pump and thesensing element 22 of thesensor 12 contains a glucose oxidase enzyme for sensing glucose and oxygen in order to determine insulin levels in the patient, the glucose and oxygen levels and, consequently, the insulin levels in the patient may be determined by thesensing element 22 in the foreign body capsule. Vascular placement of thesensor 12 is not required. -
FIG. 3B shows a process for making a non-vascular placement of thesensor 12 into a body cavity such as, for example, the peritoneal space, according to an embodiment of the present invention. Atstep 50, a large incision may be made in the body at a desired or convenient location for theimplant unit 10. While making the incision ofstep 50, a pocket may be made in the subcutaneous tissue above the cavity to be used that is large enough to support theimplant unit 10. - After the large incision has been made for the
implant unit 10 atstep 50, at step 52 a small incision may be made in a muscle wall of the cavity such as, for example, the peritoneal space, for allowing implantation of thesensor 12. The small incision may be far or remote from final placement of thesensor 12. After the small incision has been made, atstep 54 thesensor 12 may be directed into the cavity. Thesensing element 22 may be introduced into the cavity through the small incision made atstep 52. Theconnector 18 may reside in the subcutaneous pocket created for theimplant unit 10 by the body. - At
step 56, thesensor 12 may be connected to theimplant unit 10 at thereceptacle 16 on theimplant unit 10 designed for connecting to thesensor 12 by connecting theconnector 18 to thereceptacle 16. Once thesensor 12 has been connected to theimplant unit 10, atstep 58 theimplant unit 10 may be inserted into the subcutaneous tissue pocket created atstep 50. After theimplant unit 10 has been inserted into the subcutaneous tissue pocket, the pocket may be closed atstep 60. As before, at this point theimplant unit 10 and thesensor 12 may be used in a closed-loop configuration. -
FIG. 3C shows a process for making a non-vascular placement of thesensor 12 into subcutaneous tissue according to an embodiment of the present invention. At step 70, a large incision may be made in the body at a desired or convenient location for theimplant unit 10. While making the incision of step 70, a pocket may be made in the subcutaneous tissue above the cavity to be used that is large enough to support theimplant unit 10. - After the large incision has been made for the
implant unit 10 at step 70, at step 72 a small tunnel may be made for the sensor at the edge of pocket created for theimplant unit 10. An incision for the tunnel may be made far or remote from final placement of thesensor 12. The tunnel may be made using a blunt, minimally traumatic tissue implant. Thesensor 12 may be tunneled through the subcutaneous tissue by starting at an edge of theimplant unit 10 pocket and tunneling into the subcutaneous tissue parallel to the skin. It may be desirable to stay within the subcutaneous tissue while tunneling. If the blunt, minimally traumatic tissue implant device used includes an introducer, the introducer may be left in the subcutaneous tissue while the remaining portion of the blunt, minimally traumatic tissue implant device may be removed. - After the tunnel has been made, at step 74 the
sensing element 22 ofsensor 12 may be directed into the introducer of the blunt, minimally traumatic tissue implant device. Theconnector 18 may reside in the subcutaneous pocket created for theimplant unit 10 by the body. If it is desired that the sensor be fixed in its location, suture tabs such as, for example, those used on pacing leads or long term catheters may be used. - At step 76, the
sensor 12 may be connected to theimplant unit 10 at thereceptacle 16 on theimplant unit 10 designed for connecting to thesensor 12 by connecting theconnector 18 to thereceptacle 16. Once thesensor 12 has been connected to theimplant unit 10, at step 78 theimplant unit 10 may be inserted into the subcutaneous tissue pocket created at step 70. After theimplant unit 10 has been inserted into the subcutaneous tissue pocket, the pocket may be closed at step 80. As before, at this point theimplant unit 10 and thesensor 12 may be used in a closed-loop configuration. - The blunt, minimally traumatic tissue implant device used to tunnel the
sensor 12 into a subcutaneous region may be abiopsy trocar 90 shown generally inFIG. 4 . As shown inFIG. 4 , thebiopsy trocar 90 includes anintroducer 92 into which themain body 94 of thetrocar 90, having asharp end 100, and asecondary body 96 of thetrocar 90, having ablunt end 98, may be inserted. Theintroducer 92 may be made of plastic while themain body 94 and thesecondary body 96 may be made of metal. Thesecondary body 96 having theblunt end 98 may be inserted into themain body 94 having thesharp end 100, and both thesecondary body 96 and themain body 94 may be inserted into theintroducer 92. All three portions of thetrocar 90 may then be tunneled into the subcutaneous tissue. Thesharp end 100 of themain body 94 of thetrocar 90 may make an initial incision, while theblunt end 98 of thesecondary body 96 may tunnel through the subcutaneous tissue. By tunneling through the subcutaneous tissue with theblunt end 98 of thesecondary body 96, less damage occurs to the subcutaneous tissue than would occur if the subcutaneous tissue were tunneled with thesharp end 100 of themain body 94, resulting in less bleeding and less trauma to the tissue and the patient. Once the end of thetrocar 90 has reached the desired location for thesensing element 22 of thesensor 12, themain body 94 and thesecondary body 96 are removed from theintroducer 92. Thesensor 12 is then guided through theintroducer 92 so that thesensing element 22 eventually arrives at its desired location. Theintroducer 92 may then be removed from the body and theconnector 18 may then be connected to theimplant unit 10. Because thesensing element 22 of thesensor 12 is not located in the vicinity of the main incision that was made to insert theimplant unit 10, the difficulties associated with obtaining a signal from thesensing element 22 due to the trauma of the area are avoided. Because thesensing element 22 is located away from theimplant unit 10 incision, there is nothing to prevent obtaining a signal from thesensing element 22 in a very short period of time. For example, after thesensor 12 has been tunneled into the subcutaneous tissue and connected to theimplant unit 10, it may possible to obtain a signal from thesensing element 22 within 24 hours ofsensor 12 placement. Thus, for example, if theimplant unit 10 is an insulin pump and thesensing element 22 of thesensor 12 is a glucose oxidase enzyme for sensing insulin levels in diabetics, automated insulin analysis and insulin delivery in a diabetic patient may be feasible within 24 hours of in vivo implantation of theimplant unit 10 and thesensor 12. - If so desired, a variety of materials may be placed around the
implant unit 10 orsensor 12 to promote different characteristics of the foreign body capsule or sensor area. For example, if it is desired to grow more blood vessels in the area of the foreign body capsule orsensor 12, theimplant unit 10 orsensor 12 may be covered with GORE-TEX or PTFE. Other materials may also be used to cover theimplant unit 10 orsensor 12 depending on the nature of the characteristics of the foreign body capsule or area around thesensor 12 desired. In addition, various chemicals may be pumped into the area of the foreign body capsule in order to promote different characteristics of the foreign body capsule, such as, for example, blood vessel growth. - The
implant unit 10 and thesensor 12 are modular units and may connect to each other via a mechanical interface. Because of the modularity of theimplant unit 10 and thesensor 12, thesensor 12 may be removed or replaced without removing theimplant unit 10. Thus, due to the small size of thesensor 12, only a small incision is required and trauma to the patient is minimized. No large incision is necessary to remove theimplant unit 10 unless theimplant unit 10 itself needs to be removed or replaced. - Data for sensors used in glucose sensing applications may be seen in
FIGS. 5A , 5B and 5C. InFIG. 5A , glucose data over a period of several days for a sensor implanted into a foreign body capsule may be seen. InFIG. 5B , glucose data over a period of several days for a sensor implanted into subcutaneous tissue may be seen. InFIG. 5C , glucose data over a period of several days for a sensor implanted into a body cavity such as a peritoneal space may be seen. - According to another embodiment of the present invention, a physiological parameter sensing element may be placed in any medical article or device that has surfaces that contact tissue, blood, or other bodily fluids in the course of their operation, which fluids are subsequently used in patients. This may include, for example, extracorporeal devices for use in surgery such as blood oxygenators, blood pumps, tubing used to carry blood and the like which contact blood which is then returned to the patient.
-
FIG. 6 shows ablood oxygenator 30. Blood oxygenators are well known in the medical field. Usually they are disposable components of so-called “heart-lung machines.” These machines mechanically pump a patient'sblood 32 and oxygenate the blood during major surgery such as a heart bypass operation. The oxygenatedblood 34 is then returned to the patient. - The physiological parameter sensing element may be placed in the
blood oxygenator 30 in order to detect oxygen or other physiological parameters in the patient's blood. Alternatively, the physiological parameter sensing element may be placed in an input line which feeds the patient'sblood 32 to theblood oxygenator 30 or an output line that delivers the oxygenatedblood 34 to the patient. In this manner, the physiological parameter sensing element may sense a physiological parameter in the blood. - Other embodiments of the present invention address the problems described above in relation to the placement of a sensor in non-vascular areas of a body. As discussed above, when the sensing element is used in a vascular area of the body, the sensing element senses an homogenous amount of oxygen or other physiological parameter as it flows past the sensing element. However, the amount of a physiological parameter in non-vascular areas of the body may be more heterogeneous. In such a case, the sensing element may sense the physiological parameter through diffusion from, for example, fluid around the sensing element.
- Thus, when the sensing element is located in non-vascular areas of the body, the heterogeneous nature of a physiological parameter in that area may result in varying amounts of the physiological parameter. In other words, the amount of a physiological parameter sensed may vary depending on the location of the sensing element within that particular area of the body. As an example, when the particular area of the body is the peritoneum and the physiological parameter is oxygen, the capillaries of the peritoneum are the sources of the oxygen. The topology of capillaries within the peritoneum may vary in different areas of the peritoneum. Thus, the oxygen levels may also vary in different areas of the peritoneum.
- Therefore, using only one sensing element it may be difficult to accurately determine an “overall amount” of the physiological parameter in the non-vascular areas of the body, i.e., an amount that accurately represents, for example, an average amount or other suitable statistical measure of the physiological parameter in the particular area of the body. This is because the amount of the physiological parameter may vary depending on the location of the sensing element in the particular area of the body. In addition, another problem results from the fact that the heterogeneous nature of the physiological parameter being sensed by the sensing element may induce noise in the signal obtained from the sensing element.
- In order to more accurately determine the overall amount of the physiological parameter in a particular area of the body and to reduce the amount of noise in the obtained signal, according to another embodiment of the present invention shown in
FIG. 7 ,sensor lead 40 may include two or more sensing elements. As shown inFIG. 7 , one sensing element may be aproximal sensing element 42, i.e., one located closest to an end of thesensor lead 40 that is attached to theimplant unit 10. The other sensing element may be adistal sensing element 44, i.e., one located closest to an end of thesensor lead 40 furthest away from the point of attachment of thesensor lead 30 to implantunit 10. In other embodiments, there may be further sensing elements located between theproximal sensing element 42 and thedistal sensing element 44. In some embodiments, the distance between one sensing element and another sensing element may be approximately 5 or 6 inches. However, the distance between sensing elements may vary depending on the particular application in which the sensing elements are used, as well as the location of the sensing elements. - The spatial separation of
sensing elements sensor lead 40 is employed in order to sense the physiological parameters at different locations within the environment in which thesensor lead 40 is situated. For example, thesensing elements sensor lead 40, each of the sensing elements may generate a signal representing an amount of oxygen at different spatial points within the peritoneum. Thus, at any one time, or in succession within a given time period, signals representing sensed amounts of oxygen may be taken from the two or more sensing elements. The individual sensed amounts of oxygen may then be used to determine an overall amount of the physiological parameter. - This may be done, as an example, through use of an algorithm or algorithms which determine the overall amount based on the individual sensed amounts at the different locations within the environment. The algorithm or algorithms, for example, may determine the overall amount of the physiological parameter by calculating a statistical measurement of the individual sensed amounts represented by the generated signals. The statistical measurement may be, but is not limited to, a maximum amount for the individual sensed amounts, an average amount of the individual sensed amounts, a median of the individual sensed amounts, an arithmetic mean of the individual sensed amounts, or a weighted arithmetic mean of the individual sensed amounts.
- The algorithm may be executed, for example, by a computing element comprising software, hardware, firmware or a combination of software, hardware, and firmware. In one embodiment, the computing element for executing the algorithm or algorithms may be implemented by electronics within an implant unit associated with the
sensing elements implant unit 10 described above. In alternative embodiments the sensing elements may be used in or with an extracorporeal device such as a blood oxygenator and the algorithm or algorithms may be executed by a computing element associated with the extracorporeal device or by a dedicated computing element associated with the sensing elements. - As discussed above, the variance of oxygen levels may induce noise in the
individual sensing elements sensor lead 40. InFIG. 8 , a graphical representation of glucose data over a period of several days may be seen forsensor lead 40 implanted into the peritoneum. The glucose data is shown for both theproximal sensing element 42 and thedistal sensing element 44. The glucose data was obtained by detecting a first and a second signal from theproximal sensing element 42 and thedistal sensing element 44, respectively. The first and second signals represent, respectively, first and second individual amounts of glucose. As can be seen inFIG. 8 , the first and second signals contain a first and a second noise level, respectively. - In
FIG. 9 , a graphical representation of glucose data over the same period for both the distal and proximal sensing elements is shown. The glucose data shown inFIG. 9 is a third signal representing an average amount of glucose calculated using the first and second signals representing individual sensed amounts of glucose. This average amount may be calculated using an algorithm, according to an embodiment of the present invention described above. As can be seen inFIG. 9 , an average noise level of the third signal (a third noise level) is less than that of the first and second noise levels of the first and second signals, according to embodiments of the present invention. Thus, by averaging the output signals from two or more sensing elements, the noise level of the averaged signal produced by the sensing elements may be reduced, producing a smoother signal. Although the statistical measurement used to obtain the third signal above is an average amount of the individual sensed amounts, other statistical measurements may be used, including, but not limited to, a maximum amount for the individual sensed amounts, a median of the individual sensed amounts, an arithmetic mean of the individual sensed amounts, and a weighted arithmetic mean of the individual sensed amounts. - Although in
FIG. 7 the sensing elements are shown in a one-dimensional straight line, the invention is not so limited. In fact, the benefit of multiple element spatial sensing may be realized using any geometry or array of sensing elements, including two and three-dimensional arrays. Furthermore, multiple element spatial sensing may be performed when the sensing elements are used in a vascular area of the body and is not restricted to use in the peritoneum or other non-vascular area. - According to embodiments of the present invention, digital signal processing may also be used either alone or in combination with a multiple element spatial sensing method according to embodiments of the present invention to reduce the noise level of the signal produced by the sensing elements, producing a smoother signal. A digital signal processor (“DSP”) may use known noise reduction techniques such as filtering, as well as other signal smoothing techniques. The DSP may be located within an implant unit associated with the
sensing elements implant unit 10. In alternative embodiments where the sensing elements are used in an extracorporeal device such as a blood oxygenator, the DSP may be associated with the extracorporeal device or may be a dedicated DSP associated with the sensing elements. - In addition, according to other embodiments of the invention, more aggressive frequency based filtering may be used either alone or in combination with the multiple element spatial sensing and/or digital signal processing to reduce the noise level. Thus, the central frequency of the noise may be determined and the filter may be used to cut off the noise at that frequency. In one embodiment, a single-pole IIR filter is used for this purpose. However, other filters may be used depending on the application.
- In
FIG. 10 , a graphical representation of unfiltered glucose data over a period of several days may be seen forproximal sensing element 42 ofsensor lead 40 implanted into the peritoneum. InFIG. 11 , a graphical representation of filtered glucose data may be seen forproximal sensing element 42 over the same period. As can be seen inFIG. 11 , the noise level of the signal produced byproximal sensing element 42 has been reduced by filtering the signal according to embodiments of the present invention. - In
FIG. 12 , a graphical representation of the unfiltered average of the glucose data over the same period for both the distal and proximal sensing elements is shown. InFIG. 13 , a graphical representation of the filtered average of the glucose data over the same period for both the distal and proximal sensing elements is shown. As can be seen inFIG. 13 , the noise level of the signal representing the average of the glucose data has been reduced by filtering the signal according to embodiments of the present invention. - According to other embodiments of the present invention, in vivo calibration may be used alone or in combination with the multiple element spatial sensing, digital signal processing and/or filtering to reduce the noise level.
- A
placement site structure 110 used to structurally engineer a sensor placement site according to an embodiment of the present invention is shown inFIG. 14 . Theplacement site structure 110 may be viewed as a mechanical “scaffold” within a tissue mass around which forms a vascular bed in close proximity to the sensor. A sensor (not shown inFIG. 14 ) may be placed within aninterior space 116 of theplacement site structure 110, providing easy sensor removal and reinsertion into a non-vascular area of the body. Theplacement site structure 110 may be formed into a variety of shapes to accommodate any of a variety of sensors. InFIG. 14 , theplacement site structure 110 is formed as a right circular cylinder having aninterior space 116. According to one embodiment of the invention, theplacement site structure 110 may be a tube or a stent. In the embodiment shown, an interior diameter of theplacement site structure 110 may be 0.010″ to 0.030′ greater than an outer diameter of the sensor. A layer ofsilicone rubber tubing 112 may surround the body of theplacement site structure 110, except in a region of the sensor containing an opening to an enzyme electrode. Thesilicone rubber tubing 112 may provide a barrier for tissue ingress and may also provide direction for tissue growth between the outer surface of the sensor and inner surface of theplacement site structure 110.Openings 114 in theplacement site structure 110 may also be positioned about 0.60″ away from a sensor electrode to facilitate tissue anchoring. Vascularization around theplacement site structure 110 may be promoted by coating thesilicone rubber tubing 112 with angiogenic factors or endothelial cells. Openings or holes 114 may be provided in thesilicone rubber tubing 112 as an additional pathway to the implant site for angiogenic factors or plasmids which encode such factors. The size of theholes 114 may be in the mil or micron range. Theholes 114 may also provide openings for tissue ingress into the area between the sensor and the interior walls of theplacement site structure 110. Hole density and placement may be designed to satisfy both the need for tissue growth in the interior portion of theplacement site structure 110 and the need to direct blood vessels feeding the tissue to the openings of theplacement site structure 110 closest to the sensor electrodes. Theopening 114 in theplacement site structure 110 near the sensor electrodes may be exposed to an infusion of angiogenic factors, plasmids encoding for angiogenic factors, and endothelial cells. Infusion may be timed to occur at some time after implant which is suitable for the healing of the implant wound to begin. Infusion of angiogenic factors, plasmids encoding for angiogenic factors, and endothelial cells to a region close to sensor electrodes may promote vascular growth near the active enzyme of the sensor. Angiogenic factors, plasmids encoding for angiogenic factors, and endothelial cells may actually be incorporated within an enzyme matrix to promote blood vessel growth into the enzyme region of the sensor. Blood vessel density may be maximized in areas of theplacement site structure 110 not covered with asilicone rubber tubing 112. Blood flow rate through any openings in theplacement site structure 110 should be sufficient to supply the tissue growing in the interior portion of theplacement site structure 110 between the interior walls of theplacement site structure 110 and the sensor. Also, the size and spacing between anchor openings in theplacement site structure 110 and the sensor opening may be optimized to allow sufficient analyte flux to the sensor. For sensors requiring oxygen, the sensor itself may be designed to overcome oxygen deficit through its own design or by its design in connection with the design of theplacement site structure 110. - Embodiments of the present invention may be used in a variety of ways. For example, embodiments of the present invention may be used in connection with THERACYTE, INC. products. THERACYTE, INC., develops and manufactures biocompatible medical device implants that deliver therapies for treatment of chronic and/or deficiency diseases, such as, for example, diabetes. THERACYTE, INC., implants may include biocompatible membranes that induce the development of capillaries close to the membranes, i.e., the implant may be vascularized. Such vascularization promotes a supply of blood to nourish the tissues within the membranes. In addition, the implant may have a thin fluid layer around a sensor placed inside of the implant or infusion site. Current products available from THERACYTE, INC., include 4.5, 20 and 40 microliter size implants. However, embodiments of the present invention can be used in connection with modifications to these products, such as, for example, implants with fewer or greater layers than the implants currently available from THERACYTE, INC.
- Embodiments of the present invention may also be used in connection with reusable and non-reusable implant sites or sensor sites. For example, embodiments of the present invention may be used in connection with single or one-time implantations. As another example, embodiments of the present invention may be used in connection with a reusable analyte sensor site for use with a replaceable analyte sensor for determining a level of an analyte includes a site housing. The site housing material may be formed to have an interior cavity with an opening and a conduit that is connected to the opening of the interior tissue ingrowth and vascularization, and yet be free of tissue ingress. Also, the site housing material may permit the analyte to pass through the site housing material to the interior cavity, thus permitting measurement by the replaceable analyte sensor. In addition, the conduit may have a predetermined length to inhibit trauma and encapsulation of tissue occurring at the conduit, which is associated with placing the replaceable analyte sensor in the interior cavity of the site housing, from interfering with the tissue ingrowth and vascularization surrounding the interior cavity of the site housing material. As another example, embodiments of the present invention may be used in connection with a closed vascularized site that includes a thin layer of fluid around the sensor, or a site that has a thin fluid layer on the interior of the site that is used to transmit an analyte to the sensor from the vascularized site in the body. Embodiments of the invention such as those described above are related to U.S. Pat. No. 6,368,274, Reusable Analyte Sensor Site and Method of Using The Same, which is hereby incorporated herein by reference.
- A
multi-analyte measuring device 120 according to an embodiment of the present invention may be seen inFIGS. 15 and 16 . Generally, themulti-analyte measuring device 120 includes, without limitation, asensor module 122 and aconnector 124. Themulti-analyte measuring device 120 may be used to measure a variety of analytes for diagnostics, monitoring, evaluation, or other tasks related to physiological or biochemical parameter sensing. The multi-analyte sensing device may be fabricated to be on the order of a few inches, thus making it useful in a variety of places, such as, for example, a hospital, a clinic, an ambulance, a doctor's office, a residence, or even within the body of a patient. Also, depending on the desired application, themulti-analyte measuring device 120 may be fabricated inexpensively enough such that it is disposable. - The
multi-analyte measuring device 120 may be self-powered. A power supply such as, for example, a battery or a capacitor, may be used to power the device when positioned in vivo for analyte sensing or measuring. Themulti-analyte measuring device 120 may be located in a variety of places in vivo, including, without limitation, in a non-vascular area of the body. - The
sensor module 122 may include, without limitation, anintegrated circuit 126 and anelectrode array 128, as shown inFIG. 16 . Theelectrode array 128 may include electrodes for sensing analytes. Theintegrated circuit 126 may address, stimulate, measure, and otherwise operate in connection with electrochemical events occurring at theelectrode array 128. Thesensor module 122 itself may be sized according to its intended application. For example, according to one embodiment of the present invention, a diameter of thesensor module 122 is less than 0.080″. According to an embodiment of the present invention, theelectrode array 128 may be in direct contact with theintegrated circuit 126. According to another embodiment of the present invention, theelectrode array 128 may be integral to theintegrated circuit 126. - The
integrated circuit 126 may be designed to facilitate a variety of applications. For example, according to one embodiment of the present invention, theintegrated circuit 126 may be designed such that signals of 1 pA can be detected at a signal-to-noise ration of 100:1. Theintegrated circuit 126 may also be provided with the capability to make potentiometer, current and coulomb measurements, and may include signal processing, analog-to-digital, and electromagnetic communication circuitry if so desired. - The
integrated circuit 126, according to an embodiment of the present invention, may be designed for low current or low charge detection in order to sense low frequency electrochemical events, possibly on the order of sub-ppm quantities for electrochemically active species of for low pulse frequency or low duration sampling of solutions containing concentrated electroactive species on the order of sub-ppm. - According to another embodiment of the present invention, the
electrode array 128 environment may be separated from the integrate circuit environment. The separation of the two environments may be facilitated by a three-dimensional structure having an electrical connection between theintegrated circuit 126 and theelectrode array 128, such as, for example, a multilayer substrate. The structure or device used to separate the two environments may be designed for complete separation or may be designed such that the two environments are permitted to periodically or permanently intermingle, depending on the application. - According to an embodiment of the present invention, the surface of the
electrode array 128 may be processed in a manner that imparts specificity to detected events. The surface of theelectrode array 128 may include agents to impart specificity to detected events, the agents including, but not limited to, antigens, labeled antigens, antibodies, labeled antibodies, enzymes, membranes, size exclusion membranes, molecularly imprinted membranes, chelating agents, haptens, and other biomolecules such as DNA, for example, and the like. Furthermore, the ability to control electric potential as a function of time via the interaction of the a and an agent on any specific member to theelectrode array 128 provides additional capability for enhancing the sensitivity of themulti-analyte measuring device 120. - The substrate on which the
electrode array 128 resides may be processed in a manner to create one or more fluidic channels, i.e., gas or liquid channel structures, for example, for the samples containing the analytes. Samples may include, but are not limited to, blood, serum, urine, breath, stool, tissue, and the like. The fluid channel structures may be integral to the substrate containing theelectrode array 128 or may be a discrete entity. The properties of the fluid channel structures may depend on the amount of sample delivered to theelectrode array 128. - The
electrode array 128 may be processed using techniques that are common in the industry, such as, for example, photolithography, screen printing, direct writing and the like. A variety orelectrode array 128 properties may be controlled during processing, such as for example, electrode size, spacing, geometry, relative positioning, and the like. Insulators may also be used during processing if desired, and may be used, for example, to tune sensor response. Reference and auxiliary electrodes may be fabricated on the substrate containing theelectrode array 128. - The
multi-analyte measuring device 120 may also include aconnector 124 for interfacing to an electronic monitoring device or display 130 as shown inFIG. 17 . Theconnector 124 may provide access to theintegrated circuit 126. Theconnector 124 may be any type of connector commonly used in the art. The electronic monitoring device ordisplay 130 may monitor and/or display a variety of parameters, such as, for example, physiological or biochemical parameters or quantities. - While particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that the invention is not limited to the particular embodiments shown and described and that changes and modifications may be made without departing from the spirit and scope of the appended claims.
Claims (51)
1. A method for non-vascular implant of a sensor comprising
implanting an implant unit in an area of a body;
allowing a foreign body capsule to form around the area of the implant unit; and
directing the sensor into the foreign body capsule.
2. The method of claim 1 , wherein implanting an implant unit comprises incising an area of the body large enough for the implant unit.
3. The method of claim 1 , further comprising placing a material around the implant unit for promoting growth characteristics.
4. The method of claim 1 , wherein the implant unit comprises electronics.
5. The method of claim 1 , wherein the implant unit comprises a pump.
6. The method of claim 1 , wherein allowing a foreign body capsule to form comprises inserting materials around the implant unit to promote growth characteristics.
7. The method of claim 1 , further comprising attaching the sensor to the implant unit.
8. The method of claim 7 , wherein the sensor is attached to the implant unit prior to formation of the foreign body capsule.
9. The method of claim 7 , wherein the sensor is attached to the implant unit subsequent to formation of the foreign body capsule.
10. The method of claim 1 , further comprising incising an area of the body large enough for the sensor.
11. The method of claim 10 , wherein the incised area of the body large enough for the sensor is smaller than an incised area of the body large enough for the implant unit.
12. A method for non-vascular implant of a sensor comprising:
incising an area of a body large enough for inserting an implant unit;
incising an area remote from a sensor location for inserting a sensor;
directing the sensor into a body cavity;
connecting the sensor to the implant unit; and
inserting the implant unit into the body.
13. The method of claim 12 , wherein inserting the implant unit into the body comprises inserting the implant unit into a pocket formed when incising an area of the body large enough for inserting the implant unit.
14. The method of claim 12 , further comprising fixing the sensor in place using suture.
15. A non-vascular implant system comprising
an implant unit;
a sensor for detecting a physiological parameter, the sensor being separate from and connectable to the implant unit,
wherein the sensor is placed in a non-vascular area of the human body.
16. The system of claim 15 , wherein the implant unit comprises a pump.
17. The system of claim 15 , wherein the implant unit comprises electronics.
18. The system of claim 15 , wherein the implant unit delivers drug to a human body.
19. The system of claim 18 , wherein the drug is insulin.
20. The system of claim 15 , wherein the sensor comprises a biomolecule.
21. The system of claim 15 , wherein the sensor comprises a lead.
22. The system of claim 15 , wherein the sensor comprises a sensing element.
23. The system of claim 22 , wherein the sensing element is a biomolecule.
24. The system of claim 23 , wherein the biomolecule is a glucose oxidase enzyme.
25. The system of claim 15 , wherein the physiological parameter is oxygen.
26. The system of claim 15 , wherein the physiological parameter is glucose.
27. The system of claim 15 , wherein the non-vascular area of the human body is the peritoneum.
28. The system of claim 15 , wherein the non-vascular area of the human body is subcutaneous tissue.
29. A method for non-vascular implant of a sensor comprising:
incising an area of a body large enough for inserting an implant unit;
creating a tunnel in subcutaneous tissue;
directing the sensor through the tunnel;
connecting the sensor to the implant unit; and
inserting the implant unit into the body.
30. The method of claim 29 , wherein the tunnel is created using a blunt instrument.
31. The method of claim 30 , wherein the blunt instrument causes minimal trauma to the subcutaneous tissue.
32. The method of claim 30 , wherein the blunt instrument is a trocar.
33-68. (canceled)
69. A structure for defining an in vivo implant site comprising:
a cylinder having a hollow area in an interior portion thereof,
wherein a portion of the cylinder is covered with a coating.
70. The structure of claim 69 , wherein the coating is silicone rubber.
71. The structure of claim 69 , wherein the cylinder is a right circular cylinder.
72. The structure of claim 69 , wherein the hollow area is sufficiently large to accept a sensor.
73. The structure of claim 69 , wherein the cylinder has at least one hole in an outer surface thereof.
74. A multi-analyte measuring device comprising:
a substrate;
an electrode array on a first side of the substrate; and
an integrated circuit on a second side of the substrate.
75. The multi-analyte measuring device of claim 74 , wherein the electrode array and the integrated circuit are electrically connected.
76. The multi-analyte measuring device of claim 74 , wherein the integrated circuit processes signals.
77. The multi-analyte measuring device of claim 74 , wherein the integrated circuit monitors signals.
78. The multi-analyte measuring device of claim 74 , wherein the electrode array includes an agent.
79. The multi-analyte measuring device of claim 78 , wherein the agent is an enzyme.
80. The multi-analyte measuring device of claim 74 , wherein the substrate comprises channels.
81. The multi-analyte measuring device of claim 74 , further comprising a connector for providing access to the integrated circuit.
82. The multi-analyte measuring device of claim 81 , wherein the connector connects to a display device.
83. The multi-analyte measuring device of claim 81 , wherein the connector connects to a monitoring device.
84. The multi-analyte measuring device of claim 74 , further comprising a power supply.
85. The multi-analyte measuring device of claim 84 , wherein the power supply is a battery.
86. The multi-analyte measuring device of claim 84 , wherein the power supply is a capacitor.
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JP2006500170A (en) | 2006-01-05 |
CA2498351C (en) | 2012-07-31 |
WO2004028337A3 (en) | 2005-04-28 |
CA2498351A1 (en) | 2004-04-08 |
WO2004028337A2 (en) | 2004-04-08 |
DK1549242T3 (en) | 2013-10-28 |
EP1549242A4 (en) | 2006-06-07 |
US7736309B2 (en) | 2010-06-15 |
AU2003272516A8 (en) | 2004-04-19 |
US8292808B2 (en) | 2012-10-23 |
US20090030297A1 (en) | 2009-01-29 |
EP1549242A2 (en) | 2005-07-06 |
US20040064133A1 (en) | 2004-04-01 |
EP1549242B1 (en) | 2013-07-24 |
AU2003272516A1 (en) | 2004-04-19 |
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