Introducer Assembly and Methods of Use

Abstract

Method and apparatus for inserting at least a portion of a sensor into a patient is provided.

Description

BACKGROUND

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.

SUMMARY OF THE INVENTION

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.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of the overall assembly for sensor insertion and positioning system in accordance with one embodiment of the present invention;

FIG. 2A illustrates a perspective view of the insertion device for use in the sensor insertion and positioning system in accordance with one embodiment of the present invention;

FIG. 2B illustrates a perspective view of the plunger coupled with the sensor and sensor introducer of the insertion device shown in FIG. 2A in one embodiment of the present invention;

FIG. 2C illustrates a perspective view of the analyte sensor for use in the sensor insertion and positioning system in accordance with one embodiment of the present invention;

FIG. 2D illustrates an adhesive patch with a receiving structure of the insertion and positioning system in accordance with one embodiment of the present invention;

FIG. 3A illustrates a side cross sectional view of the plunger movement during the sensor insertion process in the sensor insertion and positioning system in accordance with one embodiment of the present invention;

FIG. 3B illustrates a side cross sectional view of the plunger substantially at the final position for placement of the sensor in the sensor insertion and positioning system in accordance with one embodiment of the present invention;

FIG. 3C illustrates a side cross sectional view of the plunger of the insertion device in retracted position during the insertion device removal process in the sensor insertion and positioning system in accordance with one embodiment of the present invention;

FIG. 3D is a cross sectional perspective view of the plunger of the insertion device in retracted position during the insertion device removal process shown in FIG. 3C in accordance with one embodiment of the present invention;

FIG. 4A illustrates a side perspective view of the sensor positioned in the patient and the insertion device removed from the receiving structure in the sensor insertion and positioning system in accordance with one embodiment of the present invention;

FIG. 4B illustrates a cross sectional perspective view of the sensor positioned and secured to the retaining pin on the adhesive patch as shown in FIG. 4A in accordance with one embodiment of the present invention;

FIG. 4C illustrates a side cross sectional view of the sensor positioned and secured to the retaining pin on the adhesive patch shown in FIG. 4B in accordance with one embodiment of the present invention; and

FIG. 5 illustrates a perspective view of the transmitter unit mounted on the adhesive patch for signal communication with the sensor in the sensor insertion and positioning system in accordance with one embodiment of the present invention.

DETAILED DESCRIPTION

FIG. 1 illustrates a perspective view of the overall assembly for sensor insertion and positioning system in accordance with one embodiment of the present invention. Referring to FIG. 1, the sensor insertion and positioning system 100 in one embodiment of the present invention includes an insertion device comprising, for example, a plunger handle portion 101 and a plunger body portion 102, and coupled therewith an introducer such as a sharp or a needle (not shown) and a sensor (not shown). The insertion device further includes a sleeve portion 103 which is configured to mate with a receiving structure 104 disposed on an adhesive layer 105. The adhesive layer 105 is configured to be fixedly positioned on the skin of a patient, and further, where the receiving structure 104 in one embodiment is positioned on a predetermined position on the adhesive layer 105.

Referring to FIG. 1, in one embodiment of the present invention, the handle portion of the plunger 101, the body portion 102 of the plunger 102, the sensor and introducer provided substantially within the body portion 102 of the plunger and the sleeve 103 are provided as a single integrated insertion device for use by patients, for example. The adhesive layer 105 with the receiving structure 104 are further provided in one embodiment as a separate integrated device such that the patient may in one embodiment, position the adhesive layer 105 at a desired location on the patient's skin, with relative ease, and where the position of the receiving structure 104 disposed on the adhesive layer 105 substantially defines the position where the sensor is to be placed in the patient.

Referring again to FIG. 1, as discussed in further detail below, the receiving structure 104 in one embodiment of the present invention is configured to align the insertion device (for example, the sleeve portion 103 of the insertion device so as to accurately position the sensor and the sensor introducer prior to the insertion process. That is, the sleeve portion 103 of the insertion device is configured to substantially mate or securely latch with the receiving structure 104 such that, upon placement of a predefined length of the sleeve portion 103 in the receiving structure 104, the insertion device is securely positioned with the sensor and the introducer aligned for proper subcutaneous placement in the patient.

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.

Referring back to FIG. 1, in one embodiment of the present invention, when the patient removes the applied pressure on the handle portion 101 of the insertion device (for example, after fully driving the sensor and introducer to the predetermined depth under the skin layer), a retraction mechanism (not shown) within the insertion device may be configured to automatically withdraw the body portion 102 (as well as the introducer coupled to the body portion) of the insertion device such that the positioned sensor is retained in place while the introducer is removed from the patient. Referring yet again to FIG. 1, upon retraction of the introducer from the patient, the insertion device may be removed from the receiving structure 104 and discarded.

Referring yet again to FIG. 1, as discussed in further detail in conjunction with FIG. 5, upon removal of the insertion device, a transmitter unit may be positioned on the adhesive layer 105 such that the electrical contacts on the transmitter unit are in signal communication with the electrodes of the sensor, and where the sensor is in fluid communication with the patient's analytes.

Referring still again to FIG. 1, the insertion device may be provided with a spring loaded retraction mechanism with forward biasing, such that, when the patient applies pressure on the handle portion 101, the body portion (including the introducer and the sensor) are driven substantially towards the patient's skin to pierce the desired location on the skin so that the sensor and the introducer are placed at a predetermined depth under the skin layer. Thereafter, by simply removing the applied pressure on the handle portion 101 of the insertion device, the body portion 102 and the coupled introducer are removed or retracted.

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.

FIG. 2A illustrates a perspective view of the insertion device for use in the sensor insertion and positioning system in accordance with one embodiment of the present invention. Referring to FIG. 2A, in one embodiment of the present invention, the body portion 102 of the insertion device as shown is configured to slidably move relative to the sleeve portion to displace introducer 201 coupled to the body portion 102 of the insertion device.

FIG. 2B illustrates a perspective view of the plunger coupled with the sensor and sensor introducer of the insertion device shown in FIG. 2A in one embodiment of the present invention. Referring to FIG. 2B, it can be seen that the introducer 201 is positioned and aligned such that the sensor comprising the insertion section 202B, is configured to move with the movement of the introducer 201. In addition, as can be seen, in one embodiment, the contact section 202A of the sensor is positioned substantially within the body portion 102 of the insertion device.

Moreover, referring again to FIG. 2B, the contact section 202A of the sensor is provided with an engagement element 202C such as a hole which is configured to correspondingly mate with a retainer element (not shown) provided on the receiving structure 104. Accordingly, upon final positioning of the sensor, the engagement element 202C in one embodiment is configured to engage the retainer element so that the sensor may be substantially fixedly positioned to minimize potential error or undesirable displacement when the transmitter unit is mounted on the adhesive layer 105 to establish electrical contact with the sensor electrodes.

FIG. 2C illustrates a perspective view of the analyte sensor for use in the sensor insertion and positioning system in accordance with one embodiment of the present invention. As can be seen, in one embodiment, the sensor is provided with a contact section 202A which is substantially retained outside of the patient's body, while the insertion section 202B is configured to be substantially positioned under the skin layer of the patient so as to be in fluid contact with the patient's analytes for monitoring. The sensor electrodes are configured to be in signal communication with the corresponding contact points on the transmitter unit for each of the working, counter and reference electrode of the sensor. Moreover, the engagement element 202C as shown in FIG. 2C is configured to retain the sensor substantially in the inserted position upon deployment by, for example, engaging with the retainer element disposed on the receiving structure 104 (FIG. 1) on the adhesive layer 105.

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.

FIG. 2D illustrates an adhesive patch with a receiving structure of the insertion and positioning system in accordance with one embodiment of the present invention. As shown in FIG. 2D, the receiving structure 104 is configured to receive the sleeve portion 103 of the insertion device so as to substantially fixedly retain the insertion device in position during the sensor placement and introducer removal process. For example, in one embodiment, the receiving structure 104 may be biased with a latch mechanism such that when the sleeve portion 103 of the insertion device is cooperatingly aligned and coupled to with the receiving structure 104, the receiving structure may be configured to fixedly retain the sleeve portion 103 of the insertion device with the pre-configured biasing force to retain the walls of the insertion device in position, and thereafter, to release the sleeve portion 103 of the insertion device when the patient pull the insertion device away from the receiving structure 104 after sensor deployment and introducer retraction.

FIG. 3A illustrates a side cross sectional view of the plunger movement during the sensor insertion process in the sensor insertion and positioning system in accordance with one embodiment of the present invention. In particular, referring to FIG. 3A, the retainer element 301 is shown. As can be seen from the Figure, as the sensor and the introducer 201 is driven through the skin layer of the patient, the engagement element 202C of the sensor contacts the retainer element 301. In one embodiment, the retainer element 301 is configured with a predefined groove or indentation substantially around the outer surface thereof, which is configured to retain the engagement element 202C in a substantially fixed position relative to the retainer element 301.

Referring back to FIG. 3A, while a tapered structure is shown in the Figure for the retainer element 301, within the scope of the present invention, the retainer element 301 may include, for example, a barb, a miniature rivet, a hook, a button snap, a combination thereof, or any other equivalent alternatives. Similarly, the sensor engagement element 202C within the scope of the present invention may include a hole of any shape. In addition, the sensor engagement element 202C may, within the scope of the present invention, include a button snap, a socket, a lock washer, a combination thereof, or any other equivalent shape or structure to correspondingly mate with retainer element 301.

FIG. 3B illustrates a side cross sectional view of the plunger substantially at the final position for placement of the sensor in the sensor insertion and positioning system in accordance with one embodiment of the present invention, while FIG. 3C illustrates a side cross sectional view of the plunger of the insertion device in retracted position during the insertion device removal process in the sensor insertion and positioning system in accordance with one embodiment of the present invention.

More specifically, in FIG. 3B, the patient has applied sufficient pressure on the handle portion 101 of the insertion device to position the sensor and the introducer 201 at the desired position under the skin layer, and in FIG. 3C, upon release of the applied pressure on the handle portion 101 of the insertion device, the body portion 102 of the insertion device is retracted while removing the introducer 201 with the retraction of the body portion 102 of the insertion device. As shown in FIG. 3C, when the introducer 201 is removed, the insertion section 202B of the sensor is retained in position under the skin layer.

FIG. 3D a cross sectional perspective view of the plunger of the insertion device in retracted position during the insertion device removal process shown in FIG. 3C in accordance with one embodiment of the present invention. Referring to FIG. 3D, it can be seen that the engagement element 202C of the sensor is coupled to the retainer element 301 so as to substantially fixedly position the sensor post insertion process.

FIG. 4A illustrates a side perspective view of the sensor positioned in the patient and the insertion device removed from the receiving structure, FIG. 4B illustrates a cross sectional perspective view of the sensor positioned and secured to the retaining pin on the adhesive patch as shown in FIG. 4A, and FIG. 4C illustrates a side cross sectional view of the sensor positioned and secured to the retaining pin on the adhesive patch shown in FIG. 4B in accordance with one embodiment of the present invention.

FIG. 5 illustrates a perspective view of the transmitter unit mounted on the adhesive patch for signal communication with the sensor in the sensor insertion and positioning system in accordance with one embodiment of the present invention. Referring to FIG. 5, transmitter unit 501 in one embodiment is configured to be coupled to the sensor so as to be in electrical contact with the sensor electrodes which are in fluid contact with the patient's analytes. Upon deployment, the transmitter unit 501 is configured in one embodiment to be securely positioned on the adhesive layer, and in signal communication with the sensor.

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 FIG. 5, the detected analyte signals from the sensor are provided to transmitter unit 501, which is, in one embodiment, configured to wirelessly or otherwise transmit data corresponding to the detected analyte levels from the sensor to a receiver unit, where the receiver unit may include an analyte, e.g., glucose, monitor unit and/or an insulin pump unit and/or a computer terminal and/or any other electronic device capable of being configured for wireless communication. A physical connection may be provided in certain embodiments.

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.

Claims

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 claim 1 wherein the base section includes an adhesive layer.

3. The system of claim 2 wherein the receiving structure is disposed on the adhesive layer.

3. The system of claim 1 wherein the receiving structure includes a retention element configured to substantially mate with the insertion device.

4. The system of claim 3 wherein the insertion device further includes:

a sensor; and

an introducer substantially engaged with at least a portion of the sensor.

5. The system of claim 4 wherein the sensor includes an engagement element, said engagement element configured to substantially couple to the retention element.

6. The system of claim 4 wherein the introducer includes a piercing member, said piercing member coupled to at least a portion of the sensor.

7. The system of claim 6 wherein the piercing member and the at least the portion of the sensor are configured to pierce through a skin layer of a patient.

8. The system of claim 7 wherein the at least the portion of the sensor is maintained in fluid contact with an analyte of the patient.

9. The system of claim 4 wherein the sensor includes an analyte sensor.

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 claim 10 wherein the aligning step includes positioning the sensor substantially at a predetermined angle relative to the surface of the insertion site.

12. The method of claim 11 wherein the predetermined angle includes one or substantially less than 90 degrees.

13. The method of claim 10 wherein the step of coupling includes mating a portion of the sensor with a portion of the receiving structure.

14. The method of claim 10 further including maintaining at least a portion of the sensor in fluid contact with an analyte of a patient.

15. The method of claim 10 further including:

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 claim 15 wherein the detected one or more analyte related signals are wirelessly transmitted at a predetermined transmission rate.

17. The method of claim 10 further including:

coupling an introducer to the sensor; and

retracting the introducer after deploying the sensor.

18. The method of claim 17 wherein the introducer is substantially decoupled from the sensor.

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.