US 20090105569 A1
Method and apparatus for inserting at least a portion of a sensor into a patient is provided.
1. An introducer system, comprising:
an insertion device; and
a base section including a receiving structure configured to receive at least a portion of the insertion device, the receiving structure configured to substantially retain at least a portion of the insertion device at a predetermined position relative to the base section.
2. The system of
3. The system of
3. The system of
4. The system of
a sensor; and
an introducer substantially engaged with at least a portion of the sensor.
5. The system of
6. The system of
7. The system of
8. The system of
9. The system of
10. A method of positioning a sensor, comprising:
aligning a sensor relative to an insertion site;
coupling the sensor to a receiving structure; and
deploying the sensor.
11. The method of
12. The method of
13. The method of
14. The method of
15. The method of
detecting one or more analyte related signals associated with an analyte level of the patient; and
transmitting the detected one or more analyte related signals.
16. The method of
17. The method of
coupling an introducer to the sensor; and
retracting the introducer after deploying the sensor.
18. The method of
19. An insertion kit, comprising:
an insertion unit including an introducer coupled to a sensor; and
a base unit substantially configured to be aligned with a portion of the introducer, the base unit configured to couple to the insertion unit during sensor insertion, wherein the insertion unit is substantially entirely detached from the base unit when the sensor is placed at a predetermined position under a skin layer of a patient.
Analyte monitoring systems generally include a sensor such as a subcutaneous analyte sensor, at least a portion of which is inserted under the skin for fluid contact with interstitial fluid, for detecting analyte levels such as glucose levels, a transmitter (such as an RF transmitter) in communication with the sensor and configured to receive the sensor signals and to transmit them to a corresponding receiver unit by for example, using RF data transmission protocol. The receiver may be operatively coupled to a glucose monitor that performs glucose related calculations and data analysis.
The transmitter is in signal communication with the sensor. Generally, the sensor is configured to detect and measure the glucose levels of the patient over a predetermined period of time, and the transmitter is configured to transmit data corresponding to or associated with the measured glucose levels over the predetermined period of time for further analysis. To initially deploy the sensor so that the sensor contacts and electrodes are in fluid contact with the patient's analyte fluids, a separate deployment mechanism such as a sensor inserter or introducer is used. More specifically, the introducer includes a sharp needle shaped inserter that is configured to pierce through the skin of the patient and substantially concurrently guide the sensor through the patient's skin so as to place at least a portion of the sensor in fluid contact with the target biological fluid of the patient.
The inserter is typically used only during the sensor insertion process, and once the sensor is properly and accurately positioned, the inserter and the introducer are discarded. This requires a level of care as the inserter is sharp and may damage other parts of the patient's skin if not properly handled. Further, since the tip of the inserter has come into fluid contact with the patient's biological fluids, it is important to take particular precautions in the handling of the inserter.
Further, to minimize data errors in the continuous or semi-continuous monitoring system, it is important to properly insert the sensor through the patient's skin and securely retain the sensor during the time that the sensor is configured to detect analyte levels. Additionally, for the period of continuous or semi-continuous monitoring which can include, for example, 3 days, 5 days or 7 days, it is important to have the transmitter in proper signal contact with the analyte sensor so as to minimize the potential errors in the monitored data.
In view of the foregoing, it would be desirable to have method and apparatus for providing simple, easy to handle and accurate sensor introduction and retention mechanism for use in an analyte monitoring system. More specifically, it would be desirable to have method and apparatus that minimizes the number of components which the patient has to handle, and which also reduces the number of required steps to properly and accurately position the analyte sensor in fluid contact with the patient's analytes.
In one embodiment, there is provided a method and apparatus for providing an a sensor introduction and retention mechanism for use in continuous or semi-continuous monitoring systems such as analyte monitoring systems which includes a sensor loaded insertion device which is configured to align and correspondingly mate with a base section disposed on the patient's skin (such as for example, a transmitter mount unit provided on an adhesive patch that is attached or otherwise fixedly positioned on the desired location on the patient's skin).
In one embodiment of the present invention, the base section is provided with a receiving structure that is configured to align with a corresponding section of the insertion device so as to accurately position the sensor relative to the patient's skin for proper insertion through the skin of the patient. In one aspect, the activation of the pre-loaded trigger mechanism by the patient displaces the sensor in the insertion device from the insertion device and places at least a portion of the sensor in fluid contact with the patient's analytes. Upon sensor deployment, the insertion device may be removed from the base section and discarded (in case of disposable insertion devices), while the base section may be configured to retain the sensor in proper position until the transmitter unit is mounted or coupled to the base section so as to be in signal contact with the deployed sensor.
These and other features and advantages of the present invention will be understood upon consideration of the following detailed description of the invention and the accompanying drawings.
Referring again to
In this manner, in one embodiment of the present invention, the patient may easily and with relative simple process, accurately position the sensor for placement under the skin layer. Moreover, in one embodiment, the insertion device is configured to predefine the depth of insertion of the introducer and sensor. As discussed in further detail below, in one embodiment of the present invention, after positioning the sleeve portion 103 of the insertion device so as to be aligned with the receiving structure 104, the patient applies pressure upon the handle portion 101 of the insertion device which in turn displaces the body portion 102 of the insertion device (which also correspondingly moves the sensor and the introducer provided therein).
When the body portion 102 of the insertion device has traveled a predetermined distance in response to the applied pressure on the handle portion 101 of the insertion device, in one embodiment, the body portion 102 is configured to so that additional application of pressure on the handle portion 101 of the insertion device will not displace the body portion 102 (and thus the introducer and the sensor). Accordingly, in one embodiment, the patient may conveniently and accurately position the sensor to a desired and/or predetermined depth under the skin, and thus substantially remove significant variation in the sensor insertion depth.
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Referring yet again to
Referring still again to
In the manner described above, accordance with the various embodiments of the present invention, there are provided simple and easy to use mechanism to position the sensor or any other device accurately with minimal complication. Moreover, with the forward biasing mechanism in the insertion device for automatically retracting the introducer after sensor position, among other features, within the scope of the present invention, the patient may position the sensor and mount the transmitter unit using one hand. Moreover, the receiving structure 104 provided on the adhesive layer 105 in one embodiment provides simple insertion process without significant visual aid—that is, a patient is able to position the sensor by simply aligning the insertion device with the receiving structure 104 and drive the handle portion 102 of the insertion device to accurately position the sensor, remove the introducer, and subsequently couple the transmitter unit so as to be in signal communication with the sensor.
In addition, by reducing the number of components needed for sensor placement, within the scope of the present invention, other benefits such as reduction in material cost, weight, packaging, and associated handling and disposal may be achieved.
Moreover, referring again to
While a circular engagement element 202C and a substantially circular contact section 202A of the sensor are shown in the Figures, within the scope of the present invention, the engagement element 202C and the contact section 202A of the sensor may comprise any other shapes.
Referring back to
More specifically, in
In this manner, in one embodiment, the sensor detected analyte levels are provided to the transmitter unit 501, for example, as current signals, and which are in turn, converted to respective digital signals for transmission (including, for example, RF transmission) to a receiver unit for further data processing and data analysis (including drug (e.g., insulin) therapy management, infusion control, and health monitoring and treatment, for example). That is, the monitored analyte data may be used by the patient and/or the patient's healthcare provider to modify the patient's therapy such as an infusion protocol (such as basal profile modifications in the case of diabetics) as necessary to improve insulin infusion therapy for diabetics, and further, to analyze trends in analyte levels for better treatment.
While glucose is described as an example of the detected and/or monitored analyte, within the scope of the present invention, analytes that may be detected or monitored also include, for example, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormones, hormones, ketones, lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. The concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be detected and/or monitored.
While the sensor is described as substantially transcutaneously placed in the patient, within the scope of the present invention, the sensor may be wholly implantable under the skin of the patient, or at least a portion of the sensor may be provided under the skin of the patient so as to be in fluid contact with the patient's analyte.
Referring back to
Within the scope of the present invention, the receiver unit functions may be integrated into portable electronic devices such as a watch, a pager, a mobile telephone, and a personal digital assistant. Additional information on the detection, monitoring and analysis of analyte levels are described in further detail in U.S. Pat. No. 6,175,752 entitled “Analyte Monitoring Device and Methods of Use”. In certain embodiments, the transmitter may also be capable of wirelessly or otherwise receiving signal from a receiver such that a receiver may also be capable of transmitting information to the transmitter.
In a further embodiment, the transmitter unit 501 may includes a wireless communication unit for wireless transmission of the signal, where the wireless communication unit may include one or more of a radio frequency (RF) communication unit, a Bluetooth communication unit, an infrared communication unit, an 801.11x communication unit, or a Zigbee communication unit. Similarly, the receiver unit may be configured to support one more or of the above-referenced wireless communication protocols to communicate with the transmitter unit.
Accordingly, an introducer system in accordance with one embodiment of the present invention includes an insertion device, and a base section including a receiving structure configured to receive at least a portion of the insertion device, the receiving structure configured to substantially retain at least a portion of the insertion device at a predetermined position relative to the base section.
The base section may include an adhesive layer, where the receiving structure may be disposed on the adhesive layer.
In one embodiment, the receiving structure may include a retention element configured to substantially mate with the insertion device, where the insertion device may further include a sensor and an introducer substantially engaged with at least a portion of the sensor. Moreover, the sensor may include an engagement element, said engagement element configured to substantially couple to the retention element.
The introducer may include a piercing member, said piercing member coupled to at least a portion of the sensor, where the piercing member and the at least the portion of the sensor may be configured to pierce through a skin layer of a patient, and further, where the at least the portion of the sensor is maintained in fluid contact with an analyte of the patient.
The sensor may include an analyte sensor.
A method of positioning a sensor in accordance with another embodiment of the present invention includes aligning a sensor relative to an insertion site, coupling the sensor to a receiving structure, and deploying the sensor.
In addition, aligning may include positioning the sensor substantially at a predetermined angle relative to the surface of the insertion site, where the predetermined angle may include one or substantially less than 90 degrees.
Also, coupling may include mating a portion of the sensor with a portion of the receiving structure.
The method may also include maintaining at least a portion of the sensor in fluid contact with an analyte of a patient. Moreover, the method may also include detecting one or more analyte related signals associated with an analyte level of the patient, and transmitting the detected one or more analyte related signals. Also, detected one or more analyte related signals may be wirelessly transmitted at a predetermined transmission rate.
The method may also include coupling an introducer to the sensor, and retracting the introducer after deploying the sensor, where the introducer may be substantially decoupled from the sensor.
An insertion kit in accordance with a further embodiment of the present invention includes an insertion unit including an introducer coupled to a sensor, and a base unit substantially configured to be aligned with a portion of the introducer, the base unit configured to couple to the insertion unit during sensor insertion, wherein the insertion unit is substantially entirely detached from the base unit when the sensor is placed at a predetermined position under a skin layer of a patient.
Various other modifications and alterations in the structure and method of operation of this invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. It is intended that the following claims define the scope of the present invention and that structures and methods within the scope of these claims and their equivalents be covered thereby.