Application systems for use with medical devices

An application or an attachment device for attaching a medical device includes a base layer and an adhesive layer on a rearward side of the base layer. The adhesive layer is adapted to removably attach the base layer. The adhesive layer can be adapted to removably attach the base layer to a patient (either a human patient or a lower animal patient). The device also includes a medical device attachment mechanism on a forward side of the base layer, The attachment mechanism is adapted to attach the medical device to the base layer. The medical device can, for example, be a sensor. The medical device attachment mechanism can, for example, include a mechanical attachment mechanism. The medical device attachment mechanism can additionally or alternatively include at least one adhesive layer on the base layer. The adhesive layer can, for example, be positioned on the base layer so that it does not extend beyond a footprint of the medical device when the medical device is attached to the base layer.

BACKGROUND OF THE INVENTION

The present invention relates generally to application devices, systems and methods for use with medical devices and, particularly, to application or attachment devices, systems and methods for use in the medical field to releasably attach a medical device such as a sensor to a patient (either a human patient or a so called lower animal patient).

Adhesive sheets or adhesive materials such as adhesive tapes are widely used in the medical field. For example, adhesive tapes are used to maintain certain medical devices (for example, catheters, sensors etc.) in close proximity to the body of a patient.

One type of sensor that can be adhered to patient is an extravasation sensor. Extravasation or infiltration is the accidental infusion or leakage of an injection fluid such as a contrast medium or a therapeutic agent into tissue surrounding a blood vessel rather than into the blood vessel itself. Extravasation can be caused, for example, by rupture or dissection of fragile vasculature, valve disease, inappropriate needle placement, or patient movement resulting in the infusing needle being pulled from the intended vessel or causing the needle to be pushed through the wall of the vessel. High injection pressures and/or rates of some modern procedures can increase the risk of extravasation. In computed tomography, for example, contrast injection flow rates can be in the range of 0.1 to 10 ml/s. Extravasation can cause serious injury to patients. In that regard, certain injection fluids such as contrast media or chemotherapy drugs can be toxic to tissue. It is, therefore, very important when performing fluid injections to detect extravasation as soon as possible and discontinue the injection upon detection.

Several extravasation detection techniques are known in the art. Two simple and very useful techniques for detecting extravasation are palpation of the patient in the vicinity of the injection site and simple visual observation of the vicinity of the injection site by a trained health care provider. In the palpation technique, the health care provider manually senses swelling of tissue near the injection site resulting from extravasation. By visual observation, it is also sometimes possible to observe directly any swelling of the skin in the vicinity of an injection site resulting from extravasation.

In addition to palpation and observation, there are a number of automated or sensor-base methods of detecting extravasation that may include automatic triggering of an alarm condition upon detection. Sensor configurations that also provide an area for palpation and/or observation are discussed, for example, in U.S. Pat. No. 6,408,204, assigned to the assignee of the present invention, the disclosure of which is incorporated herein by reference.

Several plethysmographic extravasation detection techniques and sensors are available. For example, mercury strain gauge plethysmographs measure the volume change resulting from venous blood flow in a cross sectional area of a limb of a patient. Air cuff or pulse volume recorder plethysmographs measure the changes in pressure within a recording cuff.

Impedance plethysmographs use low-frequency electromagnetic energy transmitted via galvanic contact with the skin to measure changes in the electrical impedance in a defined tissue volume of a limb. Detection of extravasation via impedance changes is disclosed, for example, in U.S. Pat. Nos. 5,964,703 and 5,947,910.

Photo-plethysmographs measure the optical scattering properties of capillary blood to detect the presence of extravasated fluids in tissue. An example of a photo-plethysmograph is described in U.S. Pat. No. 4,877,034.

A number of extravasation detection devices attempt to measure temperature differences to determine if an extravasation has occurred. For example, U.S. Pat. No. 4,647,281 discloses subcutaneous temperature sensing of extravasation to trigger an alarm. U.S. Pat. No. 5,954,668 also discloses use of a microwave antenna to sense temperature of tissue to detect extravasation.

In addition, U.S. Pat. No. 5,334,141 discloses a microwave extravasation detection system employing a reusable microwave antenna and a disposable attachment element for releasably securing the microwave antenna to a patient's skin over an injection site. The attachment element holds the antenna in intimate contact with the patient's skin to optimize microwave transfer therebetween. The sensor detect changes from normal microwave emissions from a patient that result from extravasation.

Published PCT International Application Nos. WO 03/009753 and WO 03/009752, assigned to the assignee of the present invention, the disclosures of which are incorporated herein by reference, disclose sensors that use electromagnetic energy such as microwave energy to sense changes in permittivity of tissue to sense buildup of fluids within the tissue to determine, for example, if extravasation or edema is present. The sensors include at least one electromagnetic energy transmitter for directing energy into a volume of tissue and at least one electromagnetic energy receiver to measure a resultant signal.

In many instances in which a medical device such as an extravasation sensor must be held in contact with a patient, adhesive tape is simply pulled over a device and adhered to the patient to maintain the device in connection with the patient. Likewise, many bandages or other tissue coverings include an adhesive material. Often it is difficult to remove such adhesive tapes, strips or sheets from connection with the patient. Moreover, removal of such adhesive materials from the patient is often a painful experience for the patient. U.S. patent application Ser. No. 11/082,209, entitled RELEASABLE APPLICATION SYSTEMS AND RELEASABLE MEDICAL DEVICE SYSTEMS, filed Mar. 16, 2005, assigned to the assignee of the present invention, the disclosure of which is incorporate herein by reference, discloses the use of releasable adhesive devices to attach various sensors to a patient and to provide a tissue covering after a sensor is removed.

Although some advances have been made in the attachment of medical devices, including sensors, to patients, a number of problems persist. For example, in a number of such devices such as the sensors disclosed in Published PCT International Application Nos. WO 03/009753 and WO 03/009752, a number of factors including, but not limited to, the nature of the contact (direct or indirect) of the sensor with the patient's tissue (for example, skin) and the position and/or orientation of the sensor(s) with respect to the patient and other medical devices can be important to the operation of the sensor. Moreover, many sensors and other medical devices have a number of operating components that are preferably attached to the patient or otherwise stabilized for proper operation and/or stabilization. Typically, attachment of such components requires the use of multiple strips of adhesive tape, which may not be readily available to medical personnel or may be cumbersome to obtain and apply. Moreover, such strips are typically not sterile and their use does not follow good aseptic technique.

It thus remains desirable to develop devices, systems and methods whereby a medical device can be releasably or removably attached to a patient.

SUMMARY OF THE INVENTION

In one aspect, the present invention provides an application or an attachment device for attaching a medical device. The device includes a base layer and an adhesive layer on a rearward side of the base layer. The adhesive layer is adapted to removably attach the base layer. The adhesive layer can be adapted to removably attach the base layer to a patient (either a human patient or a lower animal patient). The device also includes a medical device attachment mechanism on a forward side of the base layer, The attachment mechanism is adapted to attach the medical device to the base layer. The medical device can, for example, be a sensor. The medical device attachment mechanism can, for example, include a mechanical attachment mechanism. The medical device attachment mechanism can additionally or alternatively include at least one adhesive layer on the base layer. The adhesive layer can, for example, be positioned on the base layer so that it does not extend beyond a footprint of the medical device when the medical device is attached to the base layer.

In one embodiment, the medical device is an extravasation sensor for use in an procedure in which a fluid path is used to transport a fluid into a patient. In this and other embodiments, the base layer can include at least one open area to, for example, enable at least one of palpation or visualization of an area of the patient. In several embodiments, two open areas are provided. A first open area can, for example, be positioned to encompass an end of a catheter needle when the device is attached to a patient. A second open area can, for example, be positioned to be toward the heart of the patient relative to the first open area when the device is attached to a patient. A transparent, flexible material can cover one or more of such open areas to, for example, assist in preventing contamination.

The device can further include at least one application guide to position the device at a desired position on the patient. Likewise, the device can further include at least one medical device guide to position the medical device at a desired position on the device. In the case of, for example, an extravasation sensor for use in an procedure in which a catheter is used to transport a fluid into a patient, the application guide can assist in positioning the device relative to the catheter. The application guide can, for example, include an indicator on the base layer of the device.

The device can further include at least one adhesive strip removably attached to the base layer. The adhesive strip has an adhesive on a rearward side thereof. The adhesive strip can, for example, include an indicator or indicators thereon representative of a proposed use thereof or representative of a recommended or proposed order of use thereof. A plurality of adhesive strip can be removably attached to the base layer.

The device can further include a section adapted to cover at least a portion of a catheter when the device is attached to a patient. The section can, for example, cover an area in which a catheter enters (or punctures the skin of) the patient when the device is attached to a patient.

In other aspects, the present invention provides methods of attachment of medical devices using a device as described above.

In another aspect, the present invention provides a device for dispensing adhesive strips in a medical setting. The adhesive strip dispensing device includes a backing layer; and a plurality of adhesive strips removably adhered to a forward side of the backing layer. Each of the adhesive strips includes a base layer and an adhesive layer on the rearward side of the base layer. The adhesive layer removably adheres the adhesive strip to the backing layer. At least a portion of the adhesive layer remains in contact with the base layer after removal of the adhesive strip from the backing layer. The remaining adhesive layer is suitable to adhere the adhesive strip to, for example, an object and/or a patient. The dispensing device can be fabricated from sterilizable materials. Each of the plurality of adhesive strips can include a tab connected to the base layer that can be grasped by a user to remove each of the adhesive strips from the backing layer. The dispensing device can further include a layer of adhesive over at least a portion of a rearward side of the backing layer to enable removable attachment of the dispensing device to an article to enable ready access to the adhesive strips. Such attachment to an article (for example, a table) frees a practitioner's hands to use in other tasks and thereby decreases procedure time. As compared to current practices in dispensing adhesive tape (typically, cut to size from a roll of adhesive tape), the adhesive strip dispensing devices of the present invention decrease time, decrease steps, and generally decrease operator frustration, particularly when such operators perform multiple (for example, 25 or more) of the same procedures in a single day.

The backing layer can, for example, have a stiffness greater than each of the plurality of adhesive strips to, for example, facilitate removal of such adhesive strips. The adhesive strips can, for example, be fabricated of materials having sufficient thickness and tensile modulus to resist curling when subjected to the peel force required to remove each of the plurality of adhesive strips from the backing layer.

In other aspects, the present invention provides methods of providing adhesive tape strips including the step of providing a dispensing device as described above. Such methods are quite useful in the medical arts, and particularly useful in repetitive medical procedures in which similar adhesive strips (for example, similar in size, shape, peel strength etc.) are required repeatedly between procedures.

In a further aspect, the present invention provides a system for attaching a medical device, including a medical device attachment device and a device for dispensing adhesive strips. As described above, the medical device attachment device includes a base layer and an adhesive layer on a rearward side of the base layer. The adhesive layer is adapted to removably attach the base layer. The medical device attachment device further includes a medical device attachment mechanism on a forward side of the base layer. The attachment mechanism is adapted to attach the medical device to the base layer. The device for dispensing adhesive strips includes a backing layer and a plurality of adhesive strips removably adhered to a forward side of the backing layer. Each of the adhesive strips includes a base layer and an adhesive layer on the rearward side of the base layer. The adhesive layer removably adheres the adhesive strip to the backing layer. At least a portion of the adhesive layer remains in contact with the base layer after removal of the adhesive strip from the backing layer.

In another aspect, the present invention provides a system for detection of extravasation including a sensor having at least one transmitting antenna to apply electromagnetic energy in the frequency range of approximately 300 MHz to approximately 30 GHz a first volume of the body over a period of time and at least one receiving antenna to measure a resultant signal. The system also includes a device for attaching the sensor to a patient. The attachment device includes a base layer and an adhesive layer on a rearward side of the base layer. The adhesive layer is adapted to removably attach the base layer. The attachment device further includes a sensor attachment mechanism on a forward side of the base layer. The sensor attachment mechanism is adapted to removably attach the sensor to the base layer.

The sensor attachment mechanism can, for example, include at least one adhesive layer on the base layer. The adhesive layer can be positioned on the base layer so that it does not extend beyond a footprint of the sensor when the sensor is attached to the base layer.

The base layer of the sensor attachment device can include at least one open area to enable at least one of palpation or visualization of an area of the patient. The sensor attachment device can further include at least one application guide to position the sensor attachment device at a desired position on the patient. The sensor attachment device can include at least one sensor guide to position the sensor at a desired position on the sensor attachment device. The application guide can, for example, assist in positioning the sensor attachment device relative to a catheter. The application guide can include at least one indicator on the base layer of the device.

The sensor attachment device can further include at least one adhesive strip removably attached to the base layer. The adhesive strip has an adhesive on a rearward side thereof. The adhesive strip can include an indicator or indicators thereon representative of a proposed use thereof and/or representative of a recommended order of user thereof relative to another section of the sensor attachment device.

The system can include a device for dispensing adhesive strips as described above.

In another aspect, the present invention provides a device for attaching a medical device including a base layer. The base layer is divided into a plurality of base layer sections. A adhesive layer is provided on a rearward side of each of the base layer sections. The adhesive layer is adapted to removably attach each of the base layer sections. The device also includes a medical device attachment mechanism on a forward side of one of the base layer sections. The attachment mechanism is adapted to attach the medical device to one of the base layer sections. The base layer sections can be detachable from each other for separate application. One or more of the base layer sections can also remain connected during and or after application thereof. At least one of the base layer sections can include an indicator providing information such as a recommended use of the base layer section. At least one of the base layer sections can include an indicator providing information as to a recommended order of use of the base layer section relative to at least one other base layer section.

In still a further aspect, the present invention provides a device for attaching a medical device including a base layer suitable to reduce passage of contaminants between patient and the medical device. The device also includes an adhesive layer on a rearward side of the base layer. The adhesive layer is adapted to removably attach the base layer to a patient. The device further includes a medical device attachment mechanism on a forward side of the base layer. The attachment mechanism is adapted to attach the medical device to the base layer. The adhesive layer of this device and other devices of the present invention can include a bioactive agent.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1A through 1Cillustrate an embodiment of a system of the present invention including an application or attachment device10of the present invention for use with a medical device such a extravasation sensor300as described in Published PCT International Application Nos. WO 03/009753 and WO 03/009752. Extravasation sensor300can, for example, include a transmitting unit302including two transmitting antennae310aand310bwhich are attached via a bridging member320. Bridging member320can, for example, appropriately space transmitting antennae310aand310bwith respect to each other and provide a conduit, pathway or support for electrical connection of transmitting antenna310bto a controller (not shown inFIGS. 1A through 1C). Extravasation sensor300can further include a receiving unit304including two receiving antennae330aand330bwhich are attached via a bridging member340, which can operate in a manner similar to bridging member320. Sensor300can, for example, operate by applying electromagnetic energy (for example, in the frequency range of approximately 300 MHz to approximately 30 GHz) via transmitting antennae310aand310bof transmitting unit302to a volume of the body between transmitting unit302and receiving unit304and measuring a resultant or returned signal received by receiving antennae330aand330bof receiving unit304. The measured signal can, for example, be compared to a reference signal to determine if the fluid level in the tissue has changed in a manner associated with an extravasation event. It is apparent to one skilled in the art that various other medical devices, including other sensor configurations are suitable for use with the attachment devices of the present invention.

As illustrated, for example, inFIGS. 1A and 1B, attachment device or applicator10can include a base layer14upon which various templates, guides and/or informational elements are positioned (for example, by printing thereof on base layer14). As illustrated, for example, inFIG. 1B, on a first, rearward or lower major surface of base layer14, an adhesive layer18can cover a portion or all of base layer14. Adhesive layer18is suitable to attach application device10to a patient (for example, to a patient's skin). A cover or protective layer22can be attached to adhesive layer18on a side thereof opposite base layer14to protect adhesive layer14until device10or parts thereof are to be attached to a patient.

Device10is divided into several connected sections. A first section or catheter attachment section40is adapted (for example, appropriately dimensioned etc.) to cooperate with the hub110of a catheter100to hold catheter100in place in operative connection with the patient's skin. First section10can, for example, include a symbol42of a catheter hub to indicate the use thereof. First section40can also include an indicator44to inform an operator of a recommended relative order of attachment or use of first section40with respect to the other sections of device10. In the case of attachment device10, first section40is preferably used to attached catheter hub100to the patient before the other sections of device10are used. First section40thus includes an indicator such as an “A” or a “1”. As clear to one skilled in the art, the order of use or attachment of the various sections of device10can be altered.

Prior to application, the user or operator can detach first section40from the remainder of device10or section40can be attached to catheter hub110and to the patient while it remains in contact with one other section of, more than one other section of or the entirety of device10. The user must first remove at least a first section22aof protective layer22from connection with a first section18aof adhesive layer18over the area of first section40to expose first section18aadhesive layer18. Removal of first cover section22acan be accomplished while allowing the remainder of cover section22to remain in contact with adhesive layer18. Device10can, for example, be die stamped to create separations between the sections thereof. Likewise, perforations can be formed along section separations of cover layer22(and other layers of device10) to facilitate removal of cover layer22(and other layers of device10) in sections. Cover section22can also be removed as a whole and all the sections of device10attached to the patient simultaneously.

First section40also includes positioning indicators46aand46bthat assist in properly positioning one or more sections of attachment device10with respect to catheter100. In that regard, properly positioning third section or sensor section60of attachment device10with respect to catheter100results in proper or preferred positioning of sensor300with respect to catheter100and can result in improved measurements by sensor300. Third section60, which can remain in connection with first section40during attachment of those sections, is discussed further below. In the embodiment ofFIGS. 1A through 1C, first section40includes two indicator designations46aand46bto properly or desirably position first section40with respect to a catheter needle130having a standard length 1.25 in. or a catheter needle130having a standard lengths and 1.0 in., respectively. As clear to one skilled in the art, additional and/or alternative indicators can be provided for catheter needles of other lengths. First section40can also include slits48formed therein to assist in conforming first section40to the shape of catheter hub110.

After attachment of first section40to catheter100and to the patient, a tubing section or second section50of attachment device10can be attached to tubing120(which transports fluid to catheter100) and to the patient. Second section50can operate to assist in maintaining catheter100in place, keep tubing120in a desired position relative to the patient and to relieve stress in tubing120. Before application of second section50, protective layer section22bis first removed to expose adhesive layer section18b. Second section50can include a symbol52of a tubing section to indicate the use thereof. Second section50can also include an indicator44to inform an operator of the relative order of attachment, application or use of second section50with respect to the other sections of device10. In the case of attachment device10, second section50is preferably removed from connection with first section40prior to application of first section40and used to attach tubing120to the patient after first section40of device10is applied to catheter100. Second section50thus includes an indicator such as a “B” or a “2”.

Third section or sensor section60can, for example, be attached after second section50. Preferably, third section60is positioned on the patient adjacent first section40as illustrated inFIG. 1Ato assist in properly positioning third section60to properly position third section60(and, subsequently, sensor300) with respect to catheter needle130. As described above, first section40and third section60can be applied or attached simultaneously in a connected state to accomplish this result. In that regard, as illustrated inFIG. 1B, in one embodiment third section60includes a third section22cof protective layer which can be removed separately from first protective layer section22a, but first section40and third section60include an integral adhesive layer18aand an integral base layer. In this embodiment, second section50and fourth section70(discussed further below) can first be separated from device10. First section40is then applied to catheter100as described above. During application of first section40, third protective layer section22cremains in connection with third section60. After application of first section40(and possibly after subsequent attachment of second section50), third section60can be folded upward relative to first section40and third protective layer section22cremoved to expose adhesive layer section18ain the area of third section60. Third section60is then applied to arm5(seeFIG. 1C), taking care to avoid wrinkles and air pockets.

Third section60can include one or more guides, templates or alignment elements62aand62bthat provide guidance to the user of how to attach sensor300to third section60. In that regard, after attachment of third section60to the patient, a user simply places transmitting unit302within the bounds or guides of guiding element62aand receiving unit304within the bounds or guides of guiding element62b. Transmitting antennae310aand320band receiving antennae330aand330bof sensor300can be made to have somewhat directional transmission and reception, respectively. It can thus be important that the antennae be oriented properly with respect to each other and with respect to the catheter needle. Proper use of guide elements62aand62bensure proper position and orientation. Bridge members320and340operate to properly space transmitting antennae310aand310band receiving antennae330and330b, respectively, in a longitudinal or up and down direction. Guide elements62aand62bcan operate to properly space transmitting unit302and receiving unit304, respectively, in a latitudinal, lateral or side-to-side direction. Guide elements62aand62bcan include adhesive layers24which are generally coextensive with the area of contact of antennae310a,310b,330aand330bwith base layer14to removably connect antennae310a,310b,330aand330bto base layer14of third section60. Cover layers26(seeFIG. 1B) can be placed over adhesive layers24to protect adhesive layers24until use thereof.

Third section60further include one or more indicators such as arrow66aand heart66bthat provide an indication of the direction in which device10should be applied to the body (for example, to a patient's arm). Arrow66aand heart66bindicate the direction in which device10should be place with direction of blood flow back to the heart. In that regard, the upper end of third section60(including arrow66aand heart66b) should be placed higher up on the arm of the patient, while the opposite or lower end of third section60should be placed lower on the arm.

Third section60also includes at least one “open” area68to enable visualization and/or palpation of the injection site as described, for example, in U.S. Pat. No. 6,408,204. Preferably, no adhesive is present in area68. Area68can, for example, include an area of flexible, transparent polymeric material through which an operator can visualize and palpate the injection site. Preferably, no adhesive is present on the surface of area68to be palpated or on the rearward surface thereof. Area68can also be a cutaway section formed in third section60through which the operator can directly visualize and/or palpate the injection site. Third section60can further include a notch or opening69in the area of the site where catheter100punctures the skin of the patient (marked with an “x” inFIG. 1A) to facilitate positioning of third section60adjacent catheter100.

As with the other sections of device10, third section60can includes an indicator such as an “C” or a “3” to indicate the recommended or possible order of its use or application. An indicator such as “A/C” can be provided to indicate the use or application of third section60in connection with first section40as described above.

Device40further includes at least a fourth section70that can be used to attach cable leads303and305to, for example, the patient. Fourth section70includes a fourth protective layer section22d, which is removed to expose a fourth adhesive layer section18dprior to application of fourth section70. Fourth section70also includes an indicator72representing cable leads to indicate the user thereof. Fourth section70further includes an indicator such as a “D” or a “4” to indicate a recommended or possible order of use thereof with respect to the other sections of device10. In the case of certain sensors, precaution should be taken to prevent contact between and/or excessive motion of the cable leads. As set forth in Published PCT International Application Nos. WO 03/009753 and WO 03/009752, for example, such precautions may decrease motion artifact with the extravasations sensors thereof.

FIG. 1Cillustrates a portion of attachment device10in operative connection with the skin of a patient's arm5. Base layer14and adhesive layers18and24preferably ensure good operative connection or coupling between sensors310a,310b,330aand330band the patient's skin. In that regard, wrinkles in base layer14should be avoided, Moreover, air pockets between the sensors and base layer14as well as between base layer14and the patients skin should be avoided. Air pockets can, for example, scatter energy, negatively affect coupling of the sensors with the skin and can cause increased artifacts as a result of subject/patient motion.

Materials used in device10are thus preferably chosen to prevent wrinkling upon application to the patient. As such materials contact the skin of the patient, they should be suitably biocompatible and not cause adverse reaction(s). The materials should not attenuate or scatter the energy applied to the patient's skin via sensor300. Preferably, device10is made as thin as possible to avoid redirection of energy laterally. Adhesive layers18and24should provide suitable bond strength to maintain sensor300in connection with the patient during normal use of device10, including during normal patient movement and during clinical interaction (for example, palpation). Base layer14should likewise be of sufficient strength to remain intact during normal use of device10. The adhesive materials used in adhesive tape nos. 1513 and 1522 available from 3M of Saint Paul, Minn. are examples of adhesives suitable for use in the present invention. An example of a suitable material for base layer14is a polyester.

FIG. 2illustrates a device10aincluding most of the same components of device10, and such like components are numbered the same as inFIGS. 1A through 1C. In the embodiment ofFIG. 2, device10afurther includes mechanical guides63in addition to printed guides62aand62b. Mechanical guides63can, for example, contact and form a snap fit with each of antennae310a,310b,330aand330b. Adhesive layers24can be eliminated if mechanical guides or connectors63form a suitable removable connection between antennae310a,310b,330aand330band device10.

FIGS. 3A and 3Billustrate a device10bincluding most of the same components of device10, and like such components are numbered the same as inFIGS. 1A through 1C. In the embodiment ofFIGS. 3A and 3Bdevice10bincludes mechanical attachment elements65. Mechanical attachment elements65form a snap fit with recesses314aformed in, for example, a sensor antennae310aaas illustrated inFIG. 3B. Adhesive layers24are absent in the embodiment ofFIGS. 3A and 3B.

FIG. 4illustrates a device10cincluding most of the same components of device10, and such like components are numbered the same as inFIGS. 1A through 1C. In the embodiment ofFIG. 4, device10cincludes attachment elements67(connected to device10cvia flexible arms67a) that attach to the top of antennae310a,310b,330aand330b(for example, via an adhesive) to maintain sensor300in operative connection with attachment device10c.

FIG. 5illustrate a device10dincluding most of the same components of device10, and such like components are numbered the same as inFIGS. 1A through 1C. In the embodiment ofFIG. 5, device10dincludes guide/attachment elements62a′,62b′,62c′ and62d′ that are uniquely shaped (and marked with unique indicators—numbers in the embodiment ofFIG. 5) to correspond with uniquely shaped (and numbered) antennae310a′,310b′,310c′ and310d′ of sensor300′ to ensure proper relative spacing, orientation and positioning of antennae310a′,310b′,310c′ and310d′. Guide elements62a′,62b′,62c′ and62d′ can include an adhesive and/or a mechanical attachment element or elements as described above to maintain antennae310a′,310b′,310c′ and310d′ in operative connection with attachment device10d.

FIG. 6illustrates another embodiment of a sensor attachment device410including many components that operate in a same manner to corresponding components of device10ofFIGS. 1A through 1C, and such like components are numbered similarly to corresponding components of device10with the addition of400thereto. In the embodiment ofFIG. 6, first section440, second section450and third section460are not separable. Third section460is very similar in operation to third section60of device10. Unlike first section40and second section50of device10, first section440and second section450are folded to the right (in the orientation ofFIG. 6) to attach to catheter hub110and tubing120, respectively, without disconnection thereof. Fourth section470is removably attached to third section460as described above in connection with fourth section70.

Sensor attachment device410further includes a fifth section480removably attached thereto that can be used in connection with, for example, a cotton ball to perform the function of a bandage after catheter100and the remainder of device410are removed from connection with the patient. Fourth section480includes an indicator482(for example, representative of a cotton ball) to set forth the recommended use thereof. Fourth section480also includes an indicator484(for example, the numeral “4”) to set forth the recommended order of the user thereof.

FIGS. 7A and 7Billustrate another embodiment of a system of the present invention including an application or attachment device610for use with an extravasation sensor500which operates in the manner described in Published PCT International Application Nos. WO 03/009753 and WO 03/009752. Extravasation sensor500includes a transmitting unit502including two transmitting antennae510aand510b. Extravasation sensor500further includes a receiving unit504including two receiving antennae530aand530b. Antennae510a,510b,530aand530bare interconnected and spaced by bridging members520. Sensor500further includes a cable carrying section550which operates to orient and or space cables or wiring503and505connecting to the sensor antennae. Cable carrying section550can, for example, be fabricated from flex cable as used, for example, in the computer and other arts. One or more cabling systems such as coaxial cable systems can be in operative connection with cable carrying section550to connect sensor500to a control system.

Sensor attachment device610includes a base layer614similar in purpose and operation to base layer14of device10. An adhesive layer618(seeFIG. 6B) is applied to a back or rearward major surface of base layer614. A removable protective or backing layer622protects adhesive layer618until device610or sections thereof is/are placed in use. A first or catheter section640operates similarly to first section40of device10to attach to a catheter hub (not shown inFIGS. 7A and 7B). Indicating elements such as indicators646aand646bcan be provided to properly position first section640with respect to different length catheters as described above in connection with first section40of device10. A second or sensor section660can, for example, remain in connection with first section640while first section640is applied to the catheter. As described above in connection with device10, protective layer622can be removed from connection with adhesive layer618over the area first section640, while protective layer622remains in connection with adhesive layer618over the area of second section660. Protective layer622can then be removed from second section660for attachment of second section660to the patient.

Second section660can include guide elements662which can, for example, be printed on base layer614or comprise upward extending elements to assist in properly aligning antennae610a,610b,630aand630bof sensor600with respect to each other and with respect the catheter. In that regard, the end of the catheter needle is preferably generally aligned with a center point of the sensor antennae. Guide elements662can also provide a signal that can be sensed by a user (for example, a tactile, a visual, an audible etc. signal) that sensor600is positioned and/or connected correctly. Second section660can also include an adhesive layer624to attach sensor500to device610. A removable cover or protective layer626(seeFIG. 7B) can be applied to adhesive layer624to protective adhesive layer624prior to use thereof. Adhesive layer624can be applied to base layer614so that adhesive does not extend beyond the footprint of sensor500to any substantial degree when sensor500is attached to device610. In that regard, adhesive extending beyond the footprint of sensor600can lead to a number of problems, including, for example, attracting debris/contaminants and/or sticking to clinician's glove and/other clothing. Mechanical guides such as guide elements662and other guides or abutment members can assist in maintaining an adhesive within the footprint of sensor600.

Second section660includes a first open area668afor visualization and/or palpation over the area of the end of the catheter needle. Second section660also includes a second open area668bfor visualization and/or palpation of an area of the patient further toward the heart of the patient. In that regard, extravasations can occur or are sometimes better detected via palpation and/or visualization “upstream” from the end of the catheter needle. Other open areas can be provided. Moreover, first and second open areas668aand668bcan be merged to form a single, larger open area.

Sensor attachment device610further includes a plurality of adhesive strip sections670that can, for example, be used to attach to sensor cabling, to attach to catheter tubing, and/or to form a bandage in connection with an absorbent materials such as cotton. Adhesive strip sections are removably attached to second section660and to each other.

FIGS. 8A and 8Billustrate an embodiment of an attachment system610′ of the present invention that operates in a number of manners similarly to sensor attachment system610. In that regard, attachment system610′ includes a sensor attachment section660′, which can include guide elements662′ to assist in properly aligning antennae510a,510b,530aand530bof sensor500with respect to each other and with respect the catheter. Sensor attachment section660′ also includes an adhesive layer624′ on base layer614′ to attach sensor500to sensor attachment section660′. A removable cover or protective layer (not shown) can be applied to adhesive layer624′.

As discussed above, in certain situations the end of the catheter needle is preferably aligned with the center point of the sensor antennae. Other devices may require other alignment locations. In the embodiment ofFIGS. 8A and 8B, attachment system610′ does not include a catheter section such as catheter section640of attachment device610including alignment indicators to position sensor attachment section660′ with respect to a catheter. Sensor attachment section660′ includes an open area668a′ that is reduced in area as compared to open area668of device610. Operators can typically accurately determine the location of the end of a catheter needle after a catheter has been set in place. In the embodiment ofFIGS. 8A and 8B, the operator simply aligns the center of open area668a′ with the end of the catheter needle. Indicia such as arrowheads as illustrated inFIG. 8Acan be provided to facilitate alignment. Open area668a′ can, for example, be of a shape other than square or rectangular (such as round or oval) to facilitate proper positioning. Sensor attachment section660′ also includes a second open area668b′ to, for example, visualization and/or palpation.

Base layer614′ can include a tab614a′ that can be used by an operator to remove base layer614′ from connection with protective layer622′.

Sensor attachment system610′ further includes an adhesive strip supply device690′ including a plurality of adhesive strips692athrough692fwhich are held upon a base, backing or protective layer694via an intermediate adhesive layer697(see, for example,FIG. 8B). Adhesive strips692athrough692fare preferably removable from backing layer694using a single hand and can be applied in any number of fashions to, for example, adhere to catheters, tubing, cabling, bandaging etc. In the embodiment ofFIGS. 8A through 8Ceach of adhesive strips692athrough692fincludes a tab696that includes no adhesive on a back or rear side thereof. Each tab696can be grasped using a single hand to remove one of adhesive strips692athrough692f.

System610′ or the components thereof (that is, sensor attachment section660and adhesive strip supply device690) can, for example, be sterilizable and can, for example, be supplied or distributed in one or more sterile packages as represented by dashed lines700inFIG. 8A. Use of tabs696to remove adhesive strips692athrough692ffrom backing layer694and tab614a′ to remove base layer614′ from backing622′ assists in maintaining sterile or aseptic technique by enabling the user to avoid contact with those portions of adhesive strips692athrough692fand attachment device610′ which contact a patient. As illustrated inFIG. 9, an adhesive strip supply device690′ can be provided including adhesive strips692a′ through692fof varied dimensions (for example, length, width etc.)

As illustrated inFIGS. 8B and 8C, at least a portion of a reverse side of backing layer694(opposite adhesive layer697) can be covered with an adhesive layer698. A cover or protective layer698acan cover adhesive layer698until use thereof. Adhesive layer698can, for example, be used to removably attach device690to an object such as a table (seeFIG. 8C) for convenient access by a user (similar to the manner in with a POST-IT® note as available from 3M of St. Paul, Minn. is attached to an object). Adhesive layer698can, for example, have a suitably high peel strength such that each of adhesive strips692athrough692fcan be removed from backing layer694with a single hand by grasping one of tags696without the requirement of using the other hand to stabilize device690. Although adhesive strip supply devices690and690′ are well suited for use with the sensor application devices of the present invention, such adhesive strip supply devices can be used in many medical and other procedures. As illustrate inFIG. 8C, backing layer694can be relatively stiff to support adhesive strips692athrough692fand prevent significant bending of backing layer694(for example, when attached to a surface).

FIGS. 10A and 10Billustrate another embodiment of an adhesive strip supply device690″ including a plurality of adhesive strips692a″ through692e″ which are held upon a backing or protective layer694″ via an intermediate adhesive (not shown, but similar in design and operation to adhesive layer697ofFIG. 8B). Adhesive strips692a″ through692e″ can be removed from backing layer694″ using a single hand as described above. In that regard, similar to device690describe above, device690″ can be attached to a surface using an adhesive layer (not shown, but similar in design and operation to adhesive layer698of device690) on the back or rearward side thereof. As illustrated inFIG. 10B, the rearward adhesive layer can be protected by a cover layer698a″ until use thereof. In the embodiment ofFIGS. 10A and 10B, each of adhesive strips692athrough692fextends beyond the side edges of backing layer694″ to create tab sections696a″ through696e″ which can be grasped by a user to facilitate easy, quick and generally foolproof removal of adhesive strips692a″ through692e″ from backing layer694″. Preferably, the rearward side of tab sections696a″ through696e″ includes no adhesive thereon.

Backing of base layer material694″ is preferably stiffer than the material of adhesive strips692a″ through692f′. Backing or base layer material694″ is preferably sufficiently stiff to prevent bending of backing or release layer694″ as adhesive strips692a″ through692f′ are removed therefrom. The stiffness of backing layer694″ can be defined by or measured by paper gauge. The gauge of backing layer694″ is preferably at least 50. More preferably, the gauge is at least 75. In several embodiment, paper having a gauge was in the range of approximately 79 to 83 was used for backing layer694″. Moreover, the material(s) for adhesive strips692a″ through692f′ is/are preferably chosen so that that adhesive strips692a″ through692f′ do not curl upon removal from layer694. The adhesive tape material for adhesive strips692a″ through692f′ preferably has sufficient thickness and tensile modulus to reduce or preclude curling when subjected to the peel force required to remove adhesive strips692a″ through692f′ from the backing or base layer694″. One skilled in the art can readily determine a thickness/weight of material to meet the requirements of various uses. In several embodiments of the present invention the thickness of the material for adhesive strips692a″ through692f′ was in the range of approximately 0.005 to 0.0061 inches. The tensile modulus of the material for adhesive strips692a″ through692f′ was preferably in the range of approximately 80,000 to 120,000 psi. In several embodiment of the present invention, the material for adhesive strips692a″ through692f′ was a flexible polymeric material such as a polyethylene film. The peel strength for the adhesive in several embodiment was preferably in the range of 1400 to 2800 grams/inch. As clear to one skilled in the art, the peel strength can be modified to suit a particular application. The range of peel strength set forth above was found to be suitable for holding cables, catheters and other components for use in connection with various sensor application devices and sensors of the present invention. Moreover, as with the size and shape of the adhesive strips of the adhesive strip supply or dispensing devices of the present invention, the peel strength of the adhesive of the adhesive strips can be varied between adhesive strips in a single such dispensing device to, for example, adapt or “tune” each of the adhesive strips to various suggested uses of such adhesive strips.

As described above, indicia can be provided on the upper surface of the adhesive strips of the present invention to indicate a suggested use of each adhesive strip. For example, in the embodiment illustrated inFIG. 10A, adhesive strip692a″ includes an indication693a″ suggesting used in connection with a catheter hub. Adhesive strips692b″ and692c″ include indications693b″ and693c″, respectively, suggesting use in connection with low pressure tubing (for example, tubing connected to a catheter). Adhesive strips692d″ and692e″ include indications693d″ and693e″, respectively, suggesting use in connection with sensor cabling.

In the embodiment ofFIGS. 10A and 10B, each of adhesive strips692a″ through692f′ is illustrated to be adjacent to the neighboring adhesive strip without any intervening space. However, space can be provided between the adhesive strips and can, in certain circumstances, facilitate the independent removal of each adhesive strip. The base layers of the adhesive strip dispensing devices of the present invention can, for example, be formed such the adhesive strips are positioned or seated in wells or seatings formed therein.

FIG. 11illustrates an embodiment of a sensor attachment device660″ similar in many respects to that of sensor attachment device660′ ofFIG. 8A. Like components of device660″ are numbered similarly to corresponding components of device660′. In the embodiment ofFIG. 11, a package800or a portion of a packaging system includes guides810and820to ensure that sensor500is attached to device660″ in a proper position and with proper alignment while sensor attachment device660″ is still within or partially within the packaging800. Guides810surround the perimeter of sensor500, while guide820is positioned within cable guide550of sensor500when sensor500is place in contact with attachment device660″. After attachment of sensor500to attachment device660″, attachment device660″ (with sensor500attached thereto) can be attached to a patient. In the embodiment ofFIG. 11, there may be no need for printed or mechanical guides on attachment device660″ to guide the positioning of sensor500thereon as that function is performed by packaging800.

FIGS. 12A through 12Fillustrate another embodiment of an attachment system910of the present invention that operates in a number of manners similarly to sensor attachment system610. Attachment system910includes a sensor attachment section960, which can include guide elements962(see,FIG. 12F) to assist in properly aligning, for example, antennae510a,510b,530aand530bof sensor500with respect to each other and with respect a catheter (not shown). Guide elements962can, for example, be printed guides or physical guides as described above. Sensor attachment section960also includes an upper adhesive layer or sensor adhesive layer924on base layer914(seeFIG. 12E) to attach a sensor such as sensor500to sensor attachment section960. Sensor adhesive layer924can cover the entire surface of sensor attachment section960, generally only those areas of sensor attachment section that are contacted by the sensor, or an intermediate area of the surface of sensor attachment section960. A transparent, removable cover or protective layer970can be applied to adhesive layer924. Providing a transparent cover layer can enable the user to see orientation indicia on sensor attachment section960as described above. Sensor attachment section960further includes a rearward, bottom or patient adhesive layer918adapted to attach sensor attachment section960to a patient. A cover or protective layer922is preferably removably attached to patient adhesive layer918.

As discussed above, in certain situations the end of the catheter needle is preferably aligned with the center point of the sensor antennae. Other devices may require other alignment locations. In the embodiment ofFIGS. 12A through 12F, sensor attachment section960includes an open area968a(similar, to open area668a′). In general, operators can determine the location of the end of a catheter needle after a catheter has been set in place. The operator simply aligns the center of open area968awith the end of the catheter needle. Indicia968a′ (arrows in the embodiment ofFIG. 12F) can be provided to facilitate the alignment. Visualization and/or palpation of the area of the catheter needle tip can be achieved through open area968. A second open area968bfor visualization and/or palpation can also be provided. Through second open area968b, an operator can also, for example, feel the flow of fluid through the blood vessel (sometimes referred to as the “thrill”), which can provide feedback of proper catheter insertion and operation. One or both of open areas968aand968bcan be provided with transparent cover layer969aand969b, respectively, (for example, a relatively thin polymeric film) which can assist in maintaining sterility. Preferably, transparent covers969aand969bare sufficiently transparent and sufficiently flexible so that they do not interfere to any substantial degree with visualization and/or palpation. Covering openings or palpation/visualization windows968aand969bwith, for example, a thin transparent membrane969aand969b, respectively, can assist in preventing contamination of the “cleansed” area of the IV site even if an operator palpates the site through the membrane without sterile gloves or using a non-covered hand.

As described above, in connection with attachment system610, attachment system910can further include alignment guides or indicia946aand946b(seeFIG. 12F) to assist in proper positioning of sensor attachment system910with respect to one or more standard catheter sizes. More than one attachment system910can be provided to facilitate use with a wide variety of catheter designs and sizes so that a catheter tip is appropriately positioned within opening968awithout interference with an attached sensor.

Sensor attachment section960further includes a catheter protective section948that is connected to the remainder of sensor attachment section960in, for example, the manner of a flap at area949. Catheter protective section948can, for example, be die cut. Catheter protective section948covers a portion of the catheter to, for example, cover the puncture site and assist in maintaining sterility.

In the embodiment ofFIGS. 12A through 12F, attachment system910also includes a removal tab section980to facilitate removal of sensor attachment section960from attachment to a patient after a procedure. Removal tab section980can, for example, be attached to sensor attachment section960via adhesive layer924. After a procedure, a user can simply grasp the end of removal tab section980an apply an upward force to remove sensor attachment section960from the patient.

In several embodiments of the sensor attachment devices of the present invention, the various layers of such sensor attachment devices were fabricated from a flexible polymeric material such as a polyester film material.

As described above, the attachment devices, systems and methods of the present invention can be used in attaching many medical devices to patient or to other articles. The attachment devices of the present invention, which can be provided in sterile condition can assist in preventing contaminants from passing from a reusable medical device to a patient. Likewise, the attachment devices of the present invention can prevent contaminants from passing from a patient to a reusable medical device.

The attachment devices, systems and methods of the present invention are particularly useful in attaching sensors such as disclosed in Published PCT International Application Nos. WO 03/009753 and WO 03/009752 to patients. In that regard, the sensor attachment devices, systems and methods of the present invention enable the ready attachment of such sensors and other medical devices to a patient and proper alignment thereof with respect to a volume of interest (for example, a volume surrounding or in the vicinity of the tip of a catheter needle). The attachment, devices, systems and methods of the present invention provide for secure, removable connection of the sensor or other medical device to the patient without the occurrence of wrinkles and/or air pockets that can result in artifacts or improper measurements by the sensor.

Moreover, the sensor can be readily removed from the attachment devices of the present invention for reuse. The attachment devices are removable from contact with the patient and are disposable after a single use. U.S. Provisional Patent Application No. 60/553,374 discloses removable adhesive systems for sensor attachment and other devices that can be used in connection with the present invention to facilitate removal of the attachment devices of the present invention from connection with the patient.

The adhesive layer or layers of the devices of the present invention which contact the patient can include one or more materials that can, for example, be biologically active (bioactive agents) or otherwise active, for example, to cause, to enhance, to accelerate, to decelerate, to inhibit or to prevent some action. In general, bioactive agent affect at least one of biological activity or chemical activity in an organism. Bioactive agents may be synthetic molecules, biomolecules or multimolecular agents and include, but are not limited to, enzymes, organic catalysts, ribozymes, organometallics, proteins, glycoproteins, peptides, polyamino acids, antibodies, nucleic acids, steroidal molecules, anesthetics, antibiotics, antivirals, analgesics, antimycotics, anticancer agents, antirejection agents, anticlotting agents, immunosuppressants, cytokines, carbohydrates (for example, saccharides, polysaccharide, starch etc.), oleophobics, lipids, and various other pharmaceuticals, chemotherapeutics and therapeutics.

Although the present invention has been described in detail in connection with the above embodiments and/or example, it should be understood that such detail is illustrative and not restrictive, and that those skilled in the art can make variations without departing from the invention. The scope of the invention is indicated by the following claims rather than by the foregoing description. All changes and variations that come within the meaning and range of equivalency of the claims are to be embraced within their scope.