Adhesive anchors for wearable medical sensors

Abstract

A fastening device for attaching a wearable sensor to a patient's body is disclosed, the wearable sensor comprising a sensor configured to measure a characteristic inside the patient's body. The fastening device includes a bondable anchor configured to attach the wearable sensor to the patient's body via an adhesive surface and a handle configured to expose the adhesive surface when pulled following attachment of the bondable anchor to the wearable medical sensor. The bondable anchor includes an attachment portion configured to fasten the bondable anchor to the wearable medical sensor and an adhesive surface configured to attach the bondable anchor to the patient's body. The handle is attached to the adhesive surface.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 479,261, entitled "ADHERABLE ANCHOR FOR WEARABLE MEDICAL SENSOR," filed January 10, 2023, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] The present disclosure relates generally to wearable medical sensors, and more particularly to adhering wearable medical sensors to a patient for long-term monitoring.

[0003] Various wearable medical sensors are used in hospital and outpatient settings for long-term continuous or intermittent motoring. While wearable medical sensors do not require operator assistance to maintain contact between the wearable medical sensor and the patient's skin, they often require an adhesive mechanism to firmly attach the wearable medical sensor to the skin. Adhesive patches or bandages can be applied over wearable medical sensors with some success, but they can be difficult to apply properly. Many sensors require movement on the patient to identify the target location for monitoring before being adhered in place. Sensors that include adhesive features may require lifting the sensor from the patient's body to expose the adhesive, which risks losing track of the target location and can increase the time to deployment. In preparation for surgery, reducing the risk of improper placement and the time required for deployment can be particularly important. Summary of the Invention [Means for solving the problem]

[0004] A fastening device for attaching a wearable sensor to a patient's body is disclosed, the wearable sensor comprising a sensor configured to measure a characteristic inside the patient's body. The fastening device includes a bondable anchor configured to attach the wearable sensor to the patient's body via an adhesive surface and a handle configured to expose the adhesive surface when pulled following attachment of the bondable anchor to the wearable medical sensor. The bondable anchor includes an attachment portion configured to fasten the bondable anchor to the wearable medical sensor and an adhesive surface configured to attach the bondable anchor to the patient's body. The handle is attached to the adhesive surface.

[0005] A method for attaching a wearable sensor to a patient's body is disclosed, the wearable sensor comprising a sensor configured to measure an internal characteristic of the patient. The method includes attaching a fastening device to the wearable sensor. The fastening device includes a bondable anchor configured to attach the wearable sensor to the skin of the patient's body and a handle comprising a release liner attached to the bondable anchor. The method further includes placing the wearable sensor on the patient's body and pulling the handle of the fastening device to remove the release liner from the adhesive surface of the bondable anchor.

[0006] This Summary is provided by way of example only, not by way of limitation. Other aspects of the present disclosure will be understood in light of the entire disclosure, including the entire text, claims, and accompanying drawings. [Brief explanation of the drawings]

[0007] [Figure 1] FIG. 1 is a perspective bottom view of a fastening device for securing a wearable sensor to a patient's body. [Figure 2] FIG. 2 is a perspective side view of the fastening device of FIG. 1. [Figure 3] FIG. 2 is a perspective top view of the fastening device of FIG. 1. [Figure 4]FIG. 4 is a perspective side view of the fastening device of FIGS. 1-3 coupled to a wearable medical sensor. [Figure 5] FIG. 10 is a perspective top view of a bondable anchor of a fastening device coupled to a wearable sensor after deployment. [Figure 6A] 4A-4C are perspective views of method steps for attaching the wearable sensor of FIG. 3 to a patient's body using a fastening device. [Figure 6B] 4A-4C are perspective views of method steps for attaching the wearable sensor of FIG. 3 to a patient's body using a fastening device. [Figure 6C] 4A-4C are perspective views of method steps for attaching the wearable sensor of FIG. 3 to a patient's body using a fastening device. [Figure 7A] FIG. 1 is a schematic diagram of a wearable medical sensor attached to a patient's body by a fastening device. [Figure 7B] FIG. 1 is a schematic diagram of a wearable medical sensor attached to a patient's body by a fastening device and angled toward a target area of ​​interest. [Figure 8A] FIG. 1 is a schematic diagram of a wearable medical sensor attached to a patient's body by an adhesive anchor with an inflatable bladder in a deflated position. [Figure 8B] 8B is a schematic diagram of the wearable medical sensor attached to the patient's body by the adhesive anchor of FIG. 8A, with the inflatable bladder in an inflated position. [Figure 8C] FIG. 8C is a top view of the inflatable bladder of FIGS. 8A and 8B positioned over a wearable medical sensor. [Figure 8D] FIG. 8C is a top view of an alternative inflatable bladder positioned over the wearable medical sensor of FIGS. 8A and 8B for application with a bondable anchor. [Figure 8E] FIG. 8C is a top view of yet another alternative inflatable bladder positioned over the wearable medical sensor of FIGS. 8A and 8B for application with a bondable anchor. [Figure 9A]FIG. 1 is a schematic diagram of a wearable medical sensor attached to a patient's body by an adjustable adhesive anchor having one or more screw fasteners for tilting the sensor face of the wearable medical sensor toward a target area of ​​interest. [Figure 9B] 9B is a schematic diagram of the wearable medical sensor attached to the patient's body by the adhesive anchor of FIG. 9A, with one or more screw fasteners adjusted to tilt the sensor face toward the target area of ​​interest. [Figure 9C] FIG. 9C is a top view of the adhesive anchor of FIGS. 9A and 9B applied to a wearable medical sensor. [Figure 10] FIG. 10 is a schematic diagram of another embodiment of a wearable medical sensor attached to a patient's body by an adhesive anchor. [Figure 11A] 11 is a schematic diagram of the wearable medical sensor and adhesive anchor of FIG. 10 having a wedge-shaped block disposed therebetween to tilt a sensor face of the wearable medical sensor at a first tilt angle. [Figure 11B] FIG. 11B is a side view of the wedge-shaped block of FIG. 11A. [Figure 11C] FIG. 11B is a top view of the wedge-shaped block of FIG. 11A. [Figure 12A] 11 is a schematic diagram of the wearable medical sensor and adhesive anchor of FIG. 10 with a wedge-shaped block disposed therebetween to tilt the sensor surface of the wearable medical sensor at a second tilt angle. [Figure 12B] FIG. 12B is a side view of the wedge-shaped block of FIG. 12A. [Figure 12C] FIG. 12B is a top view of the wedge-shaped block of FIG. 12A. [Figure 13A] 1 is a schematic diagram of another embodiment of a wearable medical sensor and an adhesive anchor applied to a patient's body. FIG. [Figure 13B] FIG. 13B is a schematic top view of the adhesive anchor of FIG. 13A. DETAILED DESCRIPTION OF THE INVENTION

[0008] While the above figures set forth embodiments of the present invention, as noted in the discussion, other embodiments are contemplated. In all cases, the present disclosure presents the invention by way of representation and not limitation. It will be understood that those skilled in the art can devise numerous other modifications and embodiments which fall within the scope and spirit of the principles of the present invention. The drawings may not be drawn to scale, and applications and embodiments of the present invention may include features, steps and / or components not specifically shown in the drawings.

[0009] The present disclosure relates to a fastening device for attaching wearable medical sensors to a patient's body for long-term monitoring. As used herein, long-term monitoring refers to monitoring for a period of more than a few minutes and that does not require operator assistance to maintain contact between the wearable sensor and the patient's skin. The wearable sensors can be secured to the skin for continuous or intermittent monitoring at their target locations.

[0010] Wearable medical sensors can include, but are not limited to, ultrasound sensors used to track vascular pulsatility, blood flow within a blood vessel or vascular network, and other biological features such as organ movement or respiratory rate, photoplethysmogram (PPG) sensors for monitoring pulse rate (PR), heart rate (HR), variability, pulse oximetry (SpO2), cardiac output (C), and blood pressure (BP), near-infrared spectroscopy (NIRS) sensors for monitoring hemoglobin (Hb), hematocrit (HCT), and tissue oximetry (StO2), temperature sensors, electrocardiogram (ECG) sensors, electroencephalogram (EEG) sensors, acoustic sensors, ballistocardiogram (BCG) sensors, minimally invasive sensors such as glucose monitors (CGM) and lactate monitors, and combinations thereof. For example, a wearable medical sensor according to the present disclosure can include multiple sensors within a single patch (e.g., sensors monitoring PPG, ECG, and temperature, or multiple vital signs). The present disclosure describes a fastening device configured for use with a wearable ultrasound transducer. Information obtained by the ultrasound transducer can be utilized to infer and / or predict possible conditions of the human and / or animal body, such as hypertension and bleeding, as well as other physiological variables, such as stroke volume, stroke volume variation, and cardiac output. Those skilled in the art will appreciate that the disclosed fastening device can be configured for use with a wide variety of wearable medical sensors, including, but not limited to, those listed above.

[0011] The fastening device of the present disclosure has a relatively thin and flat profile and is configured for use with a wearable medical sensor that can be disposed over the wearable medical sensor and secured to a patient's body by adhesive anchors that extend to the skin surrounding the wearable medical sensor.

[0012] Figure 1 is a perspective bottom view of a fastening device 10 for securing a wearable medical sensor to a patient's body. Figure 2 is a perspective side view of the fastening device 10. Figure 3 is a perspective top view of the fastening device 10. Figures 1-3 are discussed together herein. Shown are the fastening device 10, adhesive anchor 12, handle 14, release liner 16, release strip 18, joint 20, top surface 22, bottom surface 24, attachment portion 26, arms 28, adhesive layer 30, holes 32, slits 34, anti-rotation member 36, end body 38, inner edge 40, outer edge 42, and struts 44.

[0013] The handle 14 is attached to the bondable anchor 12 via a release liner 16 and is configured for use in deploying the bondable anchor 12. The handle 14 includes a release strip 18 connected at a joint 20. The release strip 18 is connected to the release liner 16. The bondable anchor 12 has a top surface 22 and a bottom surface 24. The handle 14 extends above and is spaced apart from the top surface 22 of the bondable anchor 12. The bondable anchor 12 includes an attachment portion 26, arms 28, and an adhesive layer 30. The attachment portion 26 may include holes 32 and slits 34. The adhesive layer 30 is disposed on the bottom surface 24 of the arms 28. The release liner 16 is disposed on the adhesive layer 30. The adhesive layer 30 may be disposed on an end body 38 of the arms 28. The end body 38 may include an inner edge 40 and an outer edge 42. The arms 28 may include struts 44.

[0014] The bondable anchor 12 is configured to be deployed over the upper surface of the wearable medical sensor so that the bondable anchor 12 does not interfere with the sensor surface or function of the wearable medical sensor when placed against the patient's body. The adhesive layer 30 is configured to attach the bondable anchor 12, and therefore the wearable medical sensor, to the patient's body. The bondable anchor 12 can be a unitary body formed of a material that is rigid enough to maintain the shape and position of the arms 28 relative to the attachment portion 26 when the force is removed, yet flexible enough to allow movement of the arms 28 relative to the attachment portion 26. Thus, the practitioner does not need to position the arms 28 for deployment. The arms 28 are automatically positioned for deployment when the fastening device 10 is attached to the wearable medical sensor.

[0015] The fastening device 10 can be used to easily attach a wearable medical sensor to a patient's body. As described further herein, the adhesive anchor 12 can be fastened to the patient's body by simply pulling on the handle 14 once the wearable medical sensor with the attached fastening device 10 is in a deployed position. Unlike prior art adhesive patches or bandages, the fastening device 10 does not require the practitioner to independently remove multiple release liners or adjust, position, or stretch the adhesive patch or bandage to fasten the wearable medical sensor with the optimal applied force needed to maintain a connection between the sensor surface and the patient's body.

[0016] The adhesive anchor 12 includes an attachment portion 26. The attachment portion 26 is configured to fasten the adhesive anchor 12 to the wearable medical sensor. In some examples, the attachment portion 26 can include a hole 32 and a plurality of slits 34 configured to receive an attachment member protruding from the top surface of the wearable medical sensor. The slits 34 are cuts in the adhesive anchor 12 configured to temporarily expand the size of the hole 32 for attachment and / or detachment of the wearable medical sensor. The slits 34 extend outward from the hole 32. The slits 34 can be uniformly spaced around the hole 32. The amount and length of the slits 34 can be selected to properly hold the adhesive anchor 12 on the wearable medical sensor and allow a practitioner to attach and detach the adhesive anchor 12 from the wearable medical sensor without significant difficulty. In some examples, the wearable medical sensor can include a raised nub having a diameter or circumference larger than the diameter or circumference of the hole 32, as described further herein. The attachment portion is not limited to the combination of the hole 32 and the slits 34. Other mechanical attachment mechanisms are contemplated. Any attachment mechanism must be capable of securely fastening to the wearable medical sensor, and the attachment must not be disrupted or compromised by patient movement.

[0017] Alternatively, or in addition to a mechanical fastening mechanism, the attachment portion 26 can include an adhesive layer. To limit damage to the wearable medical sensor, the adhesive layer can be, for example, a removable pressure sensitive adhesive (PSA).

[0018] The mounting portion 26 can have a planar surface configured to interface with the top surface of the wearable medical sensor. The mounting portion 26 can have any suitable shape. As described further herein, the mounting portion 26 can be designed to substantially cover the top surface of the wearable medical sensor such that the mounting portion 26 exerts a downward force across the surface of the wearable medical sensor when the adhesive anchor 12 is attached to the patient's body. As shown in FIG. 1 , the mounting portion has a substantially circular shape, although other shapes are contemplated and may vary depending on the shape of the wearable medical sensor.

[0019] The bondable anchor 12 may include one or more anti-rotation members 36 configured to prevent rotation of the bondable anchor 12 relative to the wearable medical sensor after the fastening device 10 is secured to the wearable medical sensor and to prevent rotation of the wearable medical sensor after the bondable anchor 12 is attached to the patient's body. The anti-rotation members 36 may include, for example, tabs that extend outward from the attachment portion 26 of the bondable anchor 12 to either side of a feature of the wearable medical sensor (e.g., the cable junction shown in FIG. 4 ) to limit movement of the feature relative to the bondable anchor 12, and vice versa, to maintain the position of the wearable sensor relative to the bondable anchor 12.

[0020] A plurality of arms 28 extend outward from the mounting portion 26. Typically, at least three arms 28 may be included to provide two-dimensional axial control and prevent sliding of the wearable medical sensor after it is attached to the patient's body. The arms may be evenly spaced around the mounting portion 26 to balance tension forces applied in multiple directions. In some embodiments, it may be desirable to limit the number of arms to three or fewer to provide space for cables that may extend from the wearable medical sensor. However, more than three arms may be provided and may be preferred in some applications. Adjacent arms 28 may be separated, as shown in FIG. 1, and may be free to move independently (e.g., up and down) to conform to the patient's body when deployed.

[0021] The arm 28 may include an end body 38 disposed at the end of the arm 28 opposite the mounting portion 26. The end body 38 includes an adhesive layer 30 on the bottom surface 24 and is configured to attach the bondable anchor 12 to the patient's body. The end body 38 may have a flat surface. The end body may have any shape suitable for fastening the wearable medical sensor to the patient's body. The end body 38, and thus the adhesive layer 30, may have a surface area designed to provide a long-term bond that is not compromised by movement of the patient's body. The end body 38 may extend outward from the side of the arm 28 such that the end body 38 is wider than the arm 28, as shown in FIG. 1. In some embodiments, adjacent end bodies 38 may be connected to form a single adhesive end body that extends completely around the fastening device 10, as shown by the dashed line in FIG. 1. Any number of arms 28 may extend from the mounting portion 26 to a single end body. The arm 28 may be sufficiently rigid to maintain the end body 38. The edges of the end body 38 may be rounded to limit skin irritation and provide a more comfortable fit.

[0022] The adhesive layer 30 is disposed on the bottom surface 24 of the end body 38. The adhesive layer 30 can completely cover the bottom surface 24 of the end body 38. The adhesive layer 30 can include one or more layers of material, including different adhesive materials. The adhesive layer 30 includes a biocompatible adhesive suitable for adhesion to a patient's skin and capable of providing the desired adhesive strength for long-term monitoring. The adhesive layer 30 can include, for example, 3M™ Medical Tape 1527ENP (single-coated medical plastic tape). The adhesive layer 30 can further include a layer of adhesive material suitable for adhering the biocompatible adhesive material to the bottom surface 24 of the end body 38. A suitable adhesive can include, for example, 3M™ 200MP double-sided PSA. In some embodiments, a third interface layer can be provided between the adhesive materials.

[0023] In some embodiments, the arm 28 can include one or more notches where there is no material extending between the attachment portion 26 and the end body 38. The notches can provide additional flexibility to the arm 28 to conform to a patient's body. The notches can have any shape suitable to provide the desired flexibility.

[0024] As shown in FIG. 1 , the notch can be defined by a plurality of struts 44 connecting the mounting portion 26 to the end body 38. Each arm 28 can have two or more struts 44. The struts 44 can vary in width between the mounting portion 26 and the end body 38. For example, the width of the struts 44 adjacent to the mounting portion 26 can be greater than the width of the struts 44 adjacent to the end body 38. As shown in FIG. 1 , the struts 44 can extend around the circumference of the mounting portion 26 such that the struts 44 of adjacent arms 28 are connected at the mounting portion 26. The shape, width, number, and spacing of the struts 44 can be selected to provide the desired flexibility to the arm 28 while maintaining sufficient stiffness of the arm 28 to maintain the position of the end body 38 relative to the mounting portion 26 when an external force (greater than gravity) is removed. The length of the arm 28 or struts 44 can be selected based on the width, shape, and thickness of the wearable medical sensor. Generally, the arm 28 is adjacent to the periphery of the wearable medical sensor on the patient's body, but can be designed to position the end body 38 outward from the periphery.

[0025] The bondable anchor 12 can be formed from a plastic material, including, but not limited to, PETG plastic. The bondable anchor 12 can be formed from a clear or translucent material that allows a user to view or monitor the wearable medical sensor. The bondable anchor 12 can have a uniform thickness. For example, the bondable anchor 12 can be formed from 0.03 inch clear PETG plastic. The bondable anchor 12 can be laser cut and cold formed or molded into a predetermined shape. As shown in FIG. 2 , the bondable anchor 12 can be cold formed or molded such that a portion of each arm 28 (i.e., strut 44) extending between the mounting portion 26 and the end body 38 curves downward between the mounting portion 26 and the end body 38. The mounting portion 26 and the end body 38 can be substantially planar with the end body 38 oriented substantially parallel to the mounting portion 26. The curvature of the arm 28 can be designed to position the end body 38 in a desired position relative to the sensor face of the wearable medical sensor, as further described herein.

[0026] The handle 14 extends above the upper surface 22 of the bondable anchor 12 and is configured to allow a practitioner to remove the release liner 16 from the adhesive layer 30 on the end body 38 in a single motion (i.e., by pulling the handle upward, away from the wearable medical sensor and the bondable anchor 12). The handle can include a junction 20 disposed above the attachment portion 26. The junction 20 can be the location where multiple release strips 18 are joined. The release strips 18 can extend from the junction 20 to the end body 38. During deployment, a practitioner can grasp the junction 20 and pull the handle 14 upward, away from the bondable anchor 12. The junction 20 can have any shape, configuration, or additional features to aid in deployment of the bondable anchor 12. As shown in FIGS. 1 and 2 , the junction 20 is a ring. In other embodiments, the junction 20 can be formed by the intersection of the release strips 18. Other configurations are also contemplated.

[0027] The peel strip 18 may be an elongated rectangular strip, as shown in Figures 1-3. The peel strip 18 extends from the joint 20 to an inner edge 40 of the bottom surface 24 of the end body 38. Thus, the peel strip 18 extends across the end body 38 from an outer edge 42 to the inner edge 40. The inner edge 40 is disposed between the attachment portion 26 and the outer edge 42. The outer edge 42 forms the outermost extent of the arm 28. As shown in Figures 1-3, the peel strip 18 can extend from the joint 20 to the outer edge 42 of the end body, be folded under the end body 38 at the outer edge 42, and extend to the inner edge 40.

[0028] The release strips 18 are connected to the release liners 16 at their inner edges 40. The release liners 16 are disposed on the adhesive layer 30 of the end body 38. Each release liner 16 covers the adhesive layer 30 on the end body 38. The release liners 16 can be shaped to match the shape of the end body 38. Each release liner 16 can extend from the inner edge 40 to the outer edge 42 of the end body 38. Each release strip 18 can be connected to the release liner 16 adjacent to the inner edge 40. As shown in FIGS. 1-3 , the release strips 18 can be folded at the inner edge 40 to form the release liner 16. The release liners 16 are formed of a material that can be separated cleanly from the adhesive layer 30 or without removing the adhesive layer 30.

[0029] The handle 14 can be a unitary body with all portions of the handle 14 formed from a material suitable for functioning as a release liner. The handle 14 can be formed, for example, from silicone-coated PETG plastic.

[0030] 4 is a perspective side view of the fastening device 10 coupled to a wearable medical sensor 46. Shown are the fastening device 10, adhesive anchor 12, handle 14, release liner 16, release strip 18, joint 20, top surface 22, bottom surface 24, attachment portion 26, arms 28, adhesive layer 30, holes 32 and slits 34, anti-rotation member 36, end body 38, inner edge 40, outer edge 42, struts 44, wearable medical sensor 46, sensor head 48, sensor surface 50, mounting member 52, cable 54, and skin 56.

[0031] The fastening device 10 can be used to easily and securely attach a variety of wearable medical sensors to a patient's body and is not limited to use with the disclosed wearable medical sensor 46. The wearable medical sensor 46 shown in FIG. 4 is an ultrasound transducer configured for long-term monitoring. The wearable medical sensor 46 includes a sensor head 48 having a sensor surface 50 positioned to contact the skin 56 of the patient's body. The sensor head 48 may include an attachment member 52 disposed on a surface opposite the sensor surface 50 and configured to connect with the attachment portion 26 of the adhesive anchor 12. The wearable medical sensor 46 may include one or more cables 54 connecting the sensor head 48 to a controller and / or monitoring unit (not shown). As shown in FIG. 4, the attachment portion 26 extends across the top surface of the sensor head 48 and is fastened to the sensor head 48 via the attachment member 52. The bottom surface 24 of the attachment portion 26 is disposed adjacent to the sensor head 48. Anti-rotation members 36 may be positioned on either side of the joint between the cable 54 and the sensor head 48 to limit movement of the transducer 46 relative to the adhesive anchor 12, or vice versa.

[0032] The arm 28 curves around the side of the sensor head 48 to position the end body 38 below the mounting portion 26 and at a height relative to the sensor surface 50, which may be equal to or above the sensor surface 50. The end body 38 is disposed in a plane substantially parallel to the mounting portion 26 and can be spaced from the mounting portion 26 by a distance less than the thickness or height of the sensor head 48 such that the end body 38 is disposed above the sensor surface 50. The sensor surface 50 can be disposed in a plane substantially parallel to the plane in which the end body 38 is disposed. The height position of the end body 38 relative to the sensor surface 50 is shown as distance d. The end body 38 anchors the wearable medical sensor 46 to the skin 56. The height position of the end body 38 relative to the sensor surface 50 determines the force applied by the adhesive anchor to the wearable medical sensor 46 after deployment and during long-term monitoring. In some applications, it is necessary to apply force to the wearable medical sensor to ensure complete and continuous contact between the sensor surface 50 and the skin 56. For example, pulse oximetry (SpO2) sensors function best when sufficient pressure (10 mmHg to 20 mmHg) is applied to push venous blood out of the tissue volume being sampled. For such applications, the adhesive anchor 12 can be cold-formed or molded to position the end body 38 slightly above the sensor surface 50, a distance determined to provide adequate pressure to the wearable medical sensor 46 without compromising adhesion to the skin 56. In other applications, it may be desirable to position the end body 38 in the same plane as the sensor surface 50 to firmly attach the wearable medical sensor 46 to the skin 56 without applying significant pressure to the wearable medical sensor 46. As described further herein, the lifting handle 14 lifts the end body 38 from the skin 56. When the release liner 16 is released, the arm 28 can return to its predetermined shape, snapping the end body 38 against the skin 56.

[0033] 5 is a top perspective view of the adhesive anchor 12 coupled to a deployed wearable medical sensor 46. The adhesive anchor 12, top surface 22, mounting portion 26, arms 28, adhesive layer 30, holes 32, slits 34, anti-rotation members 36, end body 38, struts 44, wearable medical sensor 46, sensor head 48, mounting member 52, cable 54, and skin 56 are shown.

[0034] As shown in FIG. 5 , the adhesive device is formed of a transparent material, allowing the practitioner to see the wearable medical sensor 46 during the long-term monitoring process. The mounting portion 26 extends across the top surface of the sensor head 48. The attachment member 52 is held through the hole 32 in the mounting portion 26. The arms 28 curve around the sides of the sensor head 48, positioning the end body 38 outward from the sensor surface 50 on the skin 56. Both the sensor surface 50 and the end body 38 are fastened to the skin 56. The adhesive anchors 12 are designed to be substantially taut when the arms 28 are attached to the skin 56. The anti-rotation member 36 can prevent rotation of the sensor head 48 after the wearable medical sensor 46 is attached to the skin 56 via the adhesive anchors 12.

[0035] 6A-6C are perspective views of steps in a method for attaching a wearable medical sensor 46 to a patient's body using the fastening device 10. Shown are the fastening device 10, adhesive anchor 12, handle 14, release liner 16, release strip 18, joint 20, top surface 22, bottom surface 24, attachment portion 26, arms 28, adhesive layer 30, holes 32 and slits 34, end body 38, inner edge 40, outer edge 42, struts 44, wearable medical sensor 46, sensor head 48, sensor surface 50, mounting member 52, and skin 56.

[0036] At step 60 shown in FIG. 6A , the fastening device 10 is attached to the wearable medical sensor 46. The fastening device 10 can be attached to the wearable medical sensor 46 by pressing the mounting member 52 of the sensor head 48 through the hole 32 of the attachment portion 26 of the adhesive anchor. The slit 34 can widen the hole 32 to fit over the mounting member 52. The mounting member 52 can be retained in the hole 32. As mentioned above, the attachment portion 26 can include other attachment means in addition to or in place of the hole 32 and slit 34. For example, the attachment portion 26 can include an adhesive on the bottom surface 24 configured to adhere to the sensor head 48. Other mechanical attachment mechanisms known in the art are contemplated. Step 60 can be performed while the wearable medical sensor 46 is positioned on the skin 56 in a target area of ​​interest for long-term monitoring, or the fastening device 10 can be fastened to the wearable medical sensor 46 before the wearable medical sensor 46 is applied to the skin 56.

[0037] 6B , the handle 14 is pulled to detach the release liner 16 from the adhesive layer 30 on the adhesive anchor 12. As shown, the handle 14 can be pulled upward from the joint 20, away from the mounting portion 26, the wearable medical sensor 46, and the patient's body. Generally, the practitioner can use one hand to position the wearable medical sensor 46 on the skin 56 (e.g., by pressing the sensor head 48, thereby pressing the mounting portion 26) and pull the handle 14 with the other hand. In some cases, it may be feasible for the practitioner to fasten the wearable medical sensor 46 and pull the handle 14 with the same hand.

[0038] When handle 14 is pulled upward and away from attachment portion 26, release strip 18 pulls release liner 16 from inner edge 40 of end body 38. This movement can bend arm 28 and end body 38 upward and away from skin 56, as shown in FIG. 6B. Because handle 14 is attached to all release liners 16, pulling handle 14 straight up can cause release strip 18 to remove all release liners 16 simultaneously.

[0039] 6C, the end bodies 38, which were lifted above the skin 56 when the handle 14 was pulled, can snap against the skin 56 when the arms 28 return to their predetermined shape. The exposed adhesive layer 30 on the end bodies 38 contacts the skin 56, adhering the wearable medical sensor 46 to the skin 56. Depending on the starting position of the end bodies 38 relative to the sensor surface 50, the practitioner may need to apply little or no additional pressure to the end bodies 38 to ensure attachment. However, the practitioner can press down on each end body 38 to ensure it is firmly attached to the skin 56.

[0040] Once long-term monitoring is complete, the wearable medical sensor 46 can be removed by removing the end body 38 from the skin 56. The end body 38 can typically be released by pulling from the edge of the end body 38.

[0041] The disclosed fastening device can be used to easily and securely attach various wearable medical sensors to a patient's body for long-term monitoring. The disclosed fastening device can be adapted for use with wearable medical sensors of various shapes and sizes, requiring various degrees of downward pressure to ensure proper function. The embodiments disclosed herein are intended to provide an explanation of the invention and are not intended to limit the invention. The invention is not limited to the disclosed embodiments. It will be understood by those skilled in the art that various modifications and variations can be made to the present invention without departing from the scope and spirit of the invention.

[0042] In one embodiment, the wearable medical sensor 46 may be an ultrasound transducer array configured to measure Doppler flow signals of blood flow to the patient's abdominal organs, such as (but not limited to) the kidneys, liver, pancreas, and spleen. To detect and measure Doppler flow signals of blood flow to the patient's abdominal organs, such as the kidneys, the elements of the ultrasound transducer array may have a low operating frequency of 0.5 MHz to 4.0 MHz and a size greater than one wavelength in soft tissue. With an operating frequency of 0.5 MHz to 4.0 MHz and an element size greater than one wavelength in soft tissue, the ultrasound transducer array can generate ultrasound beams that penetrate greater than 15 cm into the patient, which is deep enough to measure renal blood flow, hepatic blood flow, splenic blood flow, and pancreatic blood flow.

[0043] FIG. 7A is a schematic diagram of a wearable medical sensor 46 attached to a patient's abdomen by an adhesive anchor 12 to monitor the patient's left kidney 70L. The wearable medical sensor 46 is an ultrasound transducer configured to monitor the Doppler flow signal of the left kidney 70L, which can be measured from the renal artery RA as blood enters the left kidney 70L from the patient's aorta via the renal artery RA, or from the renal vein RV as blood exits the left kidney 70L via the renal vein RV into the patient's vena cava. FIG. 7A shows an outgoing wave OW from the wearable medical sensor 46 and a return wave identified as a Doppler signal BW of blood flow in the renal artery RA and a Doppler signal RW of blood flow in the renal vein RV. Due to Doppler physics, the Doppler signal BW of blood flow in the renal artery RA is "blue-shifted" when blood flow in the renal artery RA is moving toward the ultrasound transducer probe (sensor head 48 of the wearable medical sensor 46). The Doppler signal RW of blood flow in the renal vein RV is "red-shifted" as the blood flow in the renal vein RV moves away from the ultrasound transducer. Because the Doppler signal BW is blue-shifted and the Doppler signal RW is red-shifted, the wearable medical sensor 46 can easily distinguish between renal arterial and venous blood flow. In a human subject, the renal artery RA and renal vein RV are closely spaced and aligned parallel, allowing the wearable medical sensor 46 to simultaneously capture both arterial and venous flow in the left kidney 70L.

[0044] As shown in FIG. 7A , the sensor surface 50 of the wearable medical sensor 46 is positioned flat on the patient's abdomen over the left kidney 70L and at least one intercostal space between adjacent ribs 72A, 72B. As shown, the sensor surface 50 is oriented substantially perpendicular to the renal artery RA and renal vein RV to direct the transmitted wave OW substantially parallel to the blood flow in the renal artery RA and renal vein RV. The adhesive anchor 12, including the attachment portion 26, arms 28, and end body 38, extends over the top of the sensor head 48 to secure the sensor head 48 to the skin 56, as previously described. The arms 28 connecting the attachment portion 26 to the end body 38 are equal in length, thereby causing the adhesive anchor 12 to distribute pressure substantially evenly across the sensor head 48 and the patient's abdomen.

[0045] In some applications, it may be necessary to apply increased force to one or more locations of the wearable medical sensor 46 that are offset from the center to tilt the sensor surface 50 toward the area of ​​interest (e.g., the kidney). For example, by placing the sensor surface 50 under the ribs and tilting the sensor surface 50 upward toward the kidney, it may be possible to obtain an improved Doppler signal in ultrasound monitoring of renal perfusion. This orientation may be particularly useful for monitoring the right kidney 70R, as shown in FIG. 7B, because a slight bend is observed in the renal artery RA and renal vein RV of the right kidney 70R.

[0046] 7B is a schematic diagram of a wearable medical sensor 46 attached by an adhesive anchor 76 to the patient's side or flank below the ribs 72C, 72D to monitor perfusion of a right kidney 70R. As described with respect to FIG. 7A, the wearable medical sensor 46 may be an ultrasound transducer configured to monitor the Doppler flow signal of the right kidney 70R, which may be measured from the renal artery RA as blood enters the right kidney 70R from the patient's aorta via the renal artery RA, or from the renal vein RV as blood exits the right kidney 70R via the renal vein RV into the patient's vena cava.

[0047] As shown in FIG. 7B , the adhesive anchor 76 is configured to apply increasing pressure to the upper surface of the end 78 (opposite the cable 54) of the sensor head 48, forcing the sensor head 48 inward on the patient's body and orienting the sensor face 50 toward the right kidney 70R and approximately perpendicular to the renal artery RA and renal vein RV. FIG. 7B illustrates the tilt angle θ, which is the degree to which the sensor face 50 is tilted relative to the nominal surface (i.e., the flat orientation of FIG. 7A ). The appropriate or optimal tilt angle θ can be determined by observing the signals received by the wearable medical sensor 46 in real time. The tilt angle θ can vary depending on the application and the patient's anatomy. For long-term monitoring applications, it may be desirable to minimize the tilt angle θ to limit patient injury. For example, the tilt angle θ may be limited to approximately 30 degrees in most applications.

[0048] As described further herein, additional pressure can be applied to any location on the top surface of the sensor head 48 that is offset from the center to cause tiling of the sensor surface 50. It will be appreciated that the cable 54 can limit the amount of tilt that can be achieved by applying increased pressure to the surface of the sensor head 48 adjacent to the cable 54. Therefore, if the option is available, it may be preferable to apply increased pressure to the end 78 of the sensor head 48 located opposite the cable 54.

[0049] The bondable anchor 76 can be substantially similar to the bondable anchor 12, with one or more additional and / or alternative features disclosed herein for tilting and maintaining the tilt of the wearable medical sensor 46. The bondable anchor 76 can be any of the bondable anchor embodiments and combinations thereof disclosed herein and is configured to apply and maintain the tilt of the sensor face 50 toward the area of ​​interest for long-term monitoring.

[0050] 8A and 8B are schematic diagrams of a wearable medical sensor 46 and an adhesive anchor 80 applied to a patient's skin 56. Shown is a wearable medical sensor 46 including a sensor head 48, a sensor surface 50, a mounting member 52, and a cable 54. Those skilled in the art will appreciate that the adhesive anchor 80 can be applied to or adapted for use with wearable medical sensors of different shapes and / or configurations and is not limited to the illustrated embodiment.

[0051] FIG. 8A shows the wearable medical sensor 46 in a substantially flat orientation on the patient's body, with pressure from the adhesive anchors 80 distributed approximately evenly across the sensor head 48. FIG. 8B shows the wearable medical sensor 46 in a tilted orientation, with increased pressure applied to the end 78 of the wearable medical sensor 46, as described with respect to FIG. 7B. The end 78 is pressed into the patient's body, causing the sensor face 50 to tilt relative to the nominal surface (i.e., the flat orientation of FIG. 7A) by a tilt angle θ. Those skilled in the art will recognize that a patient's body is generally not flat, and the tilt angle θ described herein is an approximation. Additionally, some of the embodiments disclosed herein may allow tilting about multiple axes.

[0052] The bondable anchor 80 can be substantially similar to the bondable anchor 12 with the addition of an inflatable bladder 82. For simplicity, only the mounting portion 26, the arm 28, the end body 38, and the inflatable bladder 82 are shown. The inflatable bladder 82 is disposed under the mounting portion 26 such that when the bondable anchor 80 is assembled with the wearable medical sensor 46, the inflatable bladder 82 is positioned between the mounting portion 26 and the sensor head 48. The inflatable bladder 82 can be securely attached to the underside of the mounting portion 26, for example, by adhesive.

[0053] The adhesive anchor 80 can be used with the inflatable bladder 82 in a deflated state as shown in Figure 8A, or with any amount of expansion necessary to adjust the sensor surface 50 to the desired tilt angle θ. Figure 8B shows the inflatable bladder 82 in a fully inflated state.

[0054] The inflatable bladder 82 can be formed from a semi-rigid plastic that is collapsible upon deflation but resistant to stretching upon inflation. The inflatable bladder 82 can have an asymmetric design configured to allow asymmetric expansion with increased expansion adjacent the end 78. As shown in FIG. 8B, the inflatable bladder 82 extends from an end 84 to an opposite end 86 and between sidewalls 88 (one shown). The end 86 is disposed adjacent the end 78 of the sensor head 48 and can include accordion folds or bellows 90. The bellows 90 allows the end 86 to expand to various heights upon inflation and to collapse to the substantially flat configuration shown in FIG. 8A upon deflation. The sidewalls 88 can taper in height from the end 84 to the end 86 and can also include accordion folds or bellows to allow the sidewalls 88 to expand upon inflation and collapse to a substantially flat configuration upon deflation. The number of folds or bellows can be selected to reduce the height of end 86 in the folded configuration so that the thickness or height of inflatable bladder 82 is substantially uniform from end 84 to end 86 in the folded configuration.

[0055] The inflatable bladder 82 can be inflated through a port 92 that opens into the interior cavity of the inflatable bladder 82. The port 92 can be located through the attachment portion 26 or adjacent to the attachment portion 26, as shown in Figures 8A and 8B. Preferably, the port 92 opens into the top of the adhesive anchor 80 or the inflatable bladder 82 for ease of access, although the port 92 can be located in any area of ​​the inflatable bladder 82 that is accessible for inflating and deflating the inflatable bladder 82.

[0056] The inflatable bladder 82 can be inflated with any suitable fluid (e.g., air, compressed gas, biocompatible liquid). The port 92 can include a valve (not shown) to prevent the release of fluid from the inflatable bladder 82. The port 92 can be configured to accept a needle for filling the inflatable bladder 82, for example, with a syringe. Fluid can be supplied to the inflatable bladder 82 until the sensor surface 50 is oriented at the desired tilt angle θ. The use of the inflatable bladder 82 allows the practitioner to fine-tune the tilt angle θ of the sensor surface 50 based on the sensor signal observed in real time.

[0057] FIG. 8C is a top view of the inflatable bladder 82 disposed on the wearable medical sensor 46. FIGS. 8D and 8E show alternative configurations of the inflatable bladder 82, including inflatable bladders 94 and 96. The remaining features of the adhesive anchor 80 are omitted from the illustration. The inflatable bladder 82 can have a ring shape with an opening 98 provided to accommodate the mounting member 52. The mounting member 52 can be used to position the adhesive anchor 80 on the wearable medical sensor 46, as described with respect to the adhesive anchor 12. Once the adhesive anchor 80 is fastened to the skin 56 as previously disclosed, the mounting member 52 may not need to maintain the position of the wearable medical sensor 46 relative to the adhesive anchor 80. Thus, upon inflation of the inflatable bladder 82, the mounting member 52 can be released from the adhesive anchor 80 and displaced, as shown in FIG. 8B. In some embodiments, one or more retention features (not shown) can be provided, for example, on the underside of the mounting portion 26, to maintain the position of the sensor head when the mounting member 52 is released from the mounting portion 26. One or more retention mechanisms can further help maintain the position of the sensor head 48 during long-term monitoring. The retention mechanisms can include, for example, ridges or protruding features configured to capture the sensor head 48.

[0058] In other embodiments, the inflatable bladder 82 may be adhered to the sensor head 48 with a removable and / or repositionable adhesive, and the adhesive anchor 80 may be placed on the sensor head 48 to maintain alignment of the inflatable bladder 82 with the sensor head 48 during inflation. In some embodiments, one or more additional retention features (not shown) may be provided on the underside of the adhesive anchor 80 (e.g., on the underside of the mounting portion 26) to prevent the sensor head 48 from slipping or to maintain the position of the inflatable bladder 82 relative to the sensor head 48 during inflation.

[0059] 8B and 8C, the bellows 90 is located at the end 86 of the inflatable bladder 82 opposite the cable 54 because this end is least restricted in movement by the cable 54. In other embodiments, the bellows 90 can be located at either the side 88 or the end 84, although it may be preferable to avoid the end 84 unless required for a particular application where access is limited.

[0060] 8D and 8E are top views of alternative inflatable bladder configurations for use in combination with the adhesive anchor 80. As shown in FIG. 8D, the adhesive anchor 80 can include an inflatable bladder 94 that covers only a portion of the top surface of the sensor head 46. The inflatable bladder 94 has a U-shape to accommodate the mounting member 52. The inflatable bladder 94 can have substantially the same configuration as the inflatable bladder 82, with a bellows 90' located at the end 86' and a sidewall 88' that tapers in height, and can also include folds or bellows for folding the inflatable bladder 94.

[0061] As shown in FIG. 8E , the bondable anchor 80 can include an inflatable bladder 96 that can be positioned at one end or side (e.g., end 78) of the top surface of the sensor head 48. To accommodate inflation, the entire periphery of the inflatable bladder 96 (both sides 88″ and ends 84″ and 86″) can include bellows 90″. The inflatable bladders 94 and 96 cover only a portion of the top surface of the sensor head 48. Thus, a gap can form between the mounting portion 26 of the bondable anchor 80 and the sensor head 48 in areas not covered by the inflatable bladders 94 and 96 during inflation.

[0062] The bondable anchor 80 can replace the bondable anchor 12 of the fastening device 10 (shown in FIGS. 1-5 and 6A-6C ). As previously described, the fastening device 10 (including the bondable anchor 80) can be applied to the wearable medical sensor 46 when the wearable medical sensor 46 is placed on the skin 56 in a target area of ​​interest for long-term monitoring. The practitioner can place the fastening device 10 on the wearable medical device 46 in an orientation that corresponds to the inclination of the sensor head 48 (i.e., the bellows 90 is positioned over the inwardly pressed portion of the sensor head 48). Alternatively, the fastening device 10 can be clipped to the wearable medical sensor 46 before the wearable medical sensor 46 is applied to the skin 56. The practitioner can place the sensor head 48 in the target area of ​​interest at the appropriate inclination angle θ before attaching the bondable anchor 80 to the skin 56. The practitioner can orient sensor head 48 to ensure that the increased pressure necessary to tile sensor surface 50 is applied to end 78 corresponding to the region of inflatable bladder 82, 94, or 96 that is experiencing the greatest expansion. Once adhesive anchor 80 is fastened to skin 56, the practitioner can inflate inflatable bladder 82, 94, or 96 to reach the desired tilt angle θ.

[0063] 9A and 9B are schematic diagrams of a bondable anchor 100 applied to a wearable medical sensor 46 and a patient's skin 56. The bondable anchor 100 may be substantially similar to the bondable anchor 80 described above with reference to FIGS. 8A-8B. Instead of the inflatable bladder 82 of the bondable anchor 80, the bondable anchor 100 includes one or more threaded fasteners 102 disposed offset from the center of the sensor head 48 (e.g., adjacent the end 78 of the sensor head 48) to adjust the tilt angle θ of the sensor surface 50. The one or more threaded fasteners 102 may be received in threaded holes 104 in a rigid member 106. FIG. 9C is a top view of the bondable anchor 100 applied to the wearable medical sensor 46.

[0064] The rigid member 106 can be, for example, a rigid plate configured to fasten to the attachment portion 26 of the adhesive anchor and maintain the position of the adhesive anchor 100 and one or more screw fasteners 102 on the sensor head 48. The screw fasteners 102 can be, for example, set screws that can be rotated by hand and / or with a screwdriver for adjustment. As shown in FIGS. 9A-9C , the rigid member 106 can be a rectangular plate positioned over the end 78 of the sensor head 48. In alternative embodiments, the rigid member 106 can be any shape, including, for example, a ring circumscribing the mounting member 52, to accommodate screw fasteners 102 at different locations on the top surface of the sensor head 48. The rigid member 106 can include multiple screw holes 104 (not shown) configured to receive the screw fasteners 102, allowing the practitioner to select one or more locations to apply additional pressure to the sensor head 48 to achieve a desired tilt of the sensor surface 50.

[0065] The sensor head 48 may include one or more depressions or recesses 108 configured to position the ends 110 of the one or more threaded fasteners 102 and prevent the one or more threaded fasteners 102 from slipping out of position during adjustment and long-term monitoring. The one or more recesses 108 may be, for example, circular or hemispherical in shape to match the shape of the ends 110, or may be troughs configured to capture the ends 110 of the threaded fasteners 102. The ends 110 of the threaded fasteners 102 may be rounded to prevent damage to the sensor head 48.

[0066] As shown in FIG. 9C , two screw fasteners 102 can be positioned adjacent the end 78 of the sensor head 48 on opposite sides of the cable 54. In alternative embodiments, a single screw fastener 102 or three or more screw fasteners 102 can be used. The single screw fastener 102 can be positioned in the center of an end (e.g., end 78) or side of the top surface of the sensor head 48 to distribute pressure evenly across the end or side, can be positioned at a corner between adjacent ends or sides, or can be positioned anywhere else to obtain a desired tilt of the sensor face 50. Those skilled in the art will understand that the number and location of the screw fasteners 102 can vary based on the size and shape of the sensor head 48.

[0067] The adhesive anchor 100 can replace the adhesive anchor 12 in the fastening device 10. As described above, the fastening device 10 (including the adhesive anchor 100) can be applied to the wearable medical sensor 46 when the wearable medical sensor 46 is placed on the skin 56 in a target area of ​​interest for long-term monitoring. The practitioner can place the fastening device 10 on the wearable medical device 46 in an orientation that corresponds to the tilt of the sensor head 48 (i.e., the screw fastener 102 or screw hole 104 is positioned over the inwardly pressed portion of the sensor head 48). Alternatively, the fastening device 10 can be fastened to the wearable medical sensor 46 before the wearable medical sensor 46 is applied to the skin 56. The practitioner can place the sensor head 48 in the target area of ​​interest at the appropriate tilt angle θ while the fastening device 10 is fastened to the wearable medical sensor 46, but before attaching the adhesive anchor 100 to the skin 56. The practitioner can orient the sensor head 48 to ensure that the increased pressure required to tilt the sensor head 48 is applied to a portion of the sensor head 48 that corresponds to the location of the one or more screw fasteners 102 or screw holes 104. Once the adhesive anchor 100 is fastened to the skin 56, the practitioner can rotate the one or more screw fasteners 102 to press a portion of the sensor head 46 into the patient's body until a desired tilt angle θ of the sensor surface 50 is reached. The use of the one or more screw fasteners 102 allows the practitioner to fine-tune the tilt angle θ of the sensor surface 50 based on the sensor signal observed in real time.

[0068] As the one or more screw fasteners 102 are threaded further into the rigid member 106, the mounting portion 26 (including the rigid member 106) is displaced from the sensor head 48 in at least the region of the one or more screw fasteners 102. Increasing the tilt angle θ can cause the mounting member 52 of the sensor head 48 to detach from the mounting portion 26 of the adhesive anchor 100. To maintain the position of the sensor head when the mounting member 52 is released from the mounting portion 26, one or more retention features (not shown) can be provided, for example, on the underside of the mounting portion 26. The one or more retention features can further help maintain the position of the sensor head 48 during long-term monitoring. The retention feature can include, for example, a ridge or protruding feature configured to capture the sensor head 48.

[0069] FIG. 10 is a schematic diagram of a wearable medical sensor 120 and a bondable anchor 12 applied to a patient's skin 56. The wearable medical sensor 120 is substantially similar to the wearable medical sensor 46, including a sensor head 48, a sensor face 50, and a cable 54. The wearable medical sensor 120 can have a mounting member 122 modified to accommodate an angling block used to adjust the tilt angle θ of the sensor face 50 for long-term monitoring, as shown in FIGS. 11A and 11B. In other embodiments, the mounting member 122 can be substantially similar to the mounting member 52 of the wearable medical sensor 46. The mounting member 122 can be configured to retain the attachment portion 26 of the bondable anchor 12 when the wearable medical sensor 120 is positioned in a flat or non-angled orientation, as shown in FIG. 10. In an alternative embodiment, the wearable medical sensor 120 can be used with a flat block (not shown) of uniform thickness positioned thereon and having a mounting member shaped to retain the bondable anchor 12. FIG. 10 shows the wearable medical sensor 120 in a substantially flat orientation with the adhesive anchors 12 exerting a substantially uniform pressure across the sensor head 48, as described with respect to FIG. 7A.

[0070] FIG. 11A is a schematic cross-sectional view of a wearable medical sensor 120 and an adhesive anchor 12 applied to skin 56, with the addition of a block 124 configured to orient the sensor surface 50 at a first tilt angle θ. FIGS. 11B and 11C are side and top views, respectively, of block 124. FIG. 12A is a schematic cross-sectional view of a wearable medical sensor 120 and an adhesive anchor 12 applied to skin 56, with the addition of a block 126 configured to orient the sensor surface 50 at a second tilt angle θ′ that is greater than the first tilt angle θ. FIGS. 12B and 12C are side and top views, respectively, of block 126. FIGS. 11A-11C and 12A-12C will be described together.

[0071] Each of the blocks 124 and 126 is configured to attach to the mounting member 122 and adhesive anchor 12 of the sensor head 48. The blocks 124 and 126 are interchangeable and determine the degree to which the sensor surface 50 is inclined (i.e., the inclination angle θ and the inclination angle θ′, respectively). The blocks 124 and 126 may be generally wedge-shaped. The block 124 includes a bottom wall 128, a top wall 130, opposing end walls 131 and 132, opposing side walls 133, a slot or receptacle 134, and a mounting member 136. The bottom wall 128 is substantially flat, with the slot or receptacle 134 formed therein and opening into the bottom wall 128. The top wall 130 is inclined relative to the bottom wall 128 and includes the mounting member 136 protruding therefrom. The opposing end walls 131 and 132 connect the bottom wall 128 and the top wall 130 and have unequal heights. Opposing side walls 133 connect the bottom and top walls 128, 130 to opposing end walls 131, 132 and taper in height from end wall 131 to end wall 132. Block 126 includes a bottom wall 138, a top wall 140, opposing end walls 141, 142, opposing side walls 143, a slot or receptacle 144, and a mounting member 146. Bottom wall 138 is substantially flat and includes a slot or receptacle 144 therein that opens to the bottom wall 138. Top wall 140 is angled relative to bottom wall 138 and includes a mounting member 146 protruding therefrom. Opposing end walls 141, 142 connect the bottom and top walls 138, 140 and have unequal heights. Opposing side walls 143 connect the bottom and top walls 138, 140 to the opposing end walls 141, 142 and taper in height from end wall 141 to end wall 142. The bottom walls 128 and 138, the slots 134 and 144, and the mounting members 136 and 146 can be substantially identical. The slots 134 and 144 are configured to receive the mounting member 122 of the wearable medical sensor 120. The mounting members 136 and 146 are configured to be received by the attachment portion 26 of the adhesive anchor 12.

[0072] Blocks 124 and 126 are two examples of multiple wedge-shaped blocks that can be used with the wearable medical sensor 120 and adhesive anchor 12 to tilt the sensor surface 50 toward an area of ​​interest. Each block can be configured to provide a particular tilt angle θ of the sensor surface 50 defined by the angle of the top wall relative to the bottom wall. As shown in FIG. 11B , the top wall 130 of block 124 is angled relative to the bottom wall 128 by a first tilt angle θ′. As shown in FIG. 12B , the top wall 140 of block 126 is angled relative to the bottom wall 138 by a second tilt angle θ′ that is greater than the first tilt angle θ.

[0073] As shown in FIGS. 11A and 12A , the mounting member 122 of the wearable medical sensor 120 can be a nail-like protruding member with a stem extending from the sensor head 48 and a wider head at its outermost end. The slots 134 and 144 can be shaped and sized to facilitate assembly with and retention of the mounting member 122. The slots 134 and 144 can have a shape that substantially matches the shape of the mounting member 122. The slots 134 and 144 can extend through the entire width of the blocks 124, 126 (between the side walls 133), as shown in FIGS. 11B and 12B , or can extend through a partial width of the blocks 124, 126. The slots 134 and 144 can be configured to receive the mounting member 122 by sliding the blocks 124, 126 over the top surface of the sensor head 48. In some embodiments, the slot walls can be tapered to provide a friction fit with the mounting member 122 when placed in a fully assembled position. In alternative embodiments, the slots 134 and 144 can be configured to attach to the mounting member 122 from above. For example, the slots 134 and 144 can have a keyhole fastener configuration, as known in the art, in which the mounting member 122 is received into the slots 134, 144 from below and slid into a locked position. In some embodiments, the mounting member 122 can be substantially similar to the mounting member 52 of the wearable medical device 46, and the slots 134, 144 can have a geometric shape that substantially matches the geometric shape of the mounting member 122 configured to receive it. The size, shape, and location of the mounting member 122 and the slots 134, 144 are not limited to the embodiments shown or described herein. Although not fully described herein, alternative configurations are contemplated in which the block 124 or 126 can be positioned and retained on the wearable medical sensor 120 for long-term monitoring.

[0074] The mounting members 136 and 146 are configured to be received in the attachment portion 26 of the adhesive anchor 12, as described with respect to the mounting member 52 of the wearable medical sensor 46 shown in FIG. 4. The mounting members 136 and 146 can be substantially the same as the mounting member 52 of the wearable medical sensor 46. The mounting members 136 and 146 extend perpendicular to the top walls 130 and 140, respectively, such that the mounting members 136 and 146 are oriented perpendicular to the attachment portion 26 when deployed. As shown in FIGS. 11C and 12C, the mounting members 136 and 146 can be centrally positioned on the top walls 130 and 140, respectively.

[0075] The blocks 124 and 126 may have a shape and size that substantially matches the shape of the sensor head 48 such that the bottom walls 128 and 138 substantially cover the sensor head 48 .

[0076] Multiple blocks of various tilt angles may be available for use with the adhesive anchor 12 and wearable medical sensor 120. For example, blocks may be available in sizes with tilt angle increments of 5 degrees (e.g., 5°, 10°, 15°...30°). Smaller increments may be provided to provide finer adjustment of the tilt angle θ, although a coarse adjustment may be sufficient for many applications.

[0077] Although blocks 124 and 126 provide tilt about a single axis, alternative blocks including opposing side walls 133 of different heights can provide tilt about a second axis.

[0078] The fastening device 10 (including the adhesive anchor 12) can be applied to the wearable medical sensor 120 along with a block (e.g., block 124 or 126) of a desired tilt angle when the wearable medical sensor 120 is placed on the skin 56 within a target area of ​​interest for long-term monitoring. The practitioner can position the sensor head 48 within the target area of ​​interest at the appropriate tilt angle θ. Based on the observed tilt of the sensor head 48, the practitioner can determine which block is appropriate for maintaining the desired tilt angle. The selected block can be attached to the sensor head 48 while the sensor head 48 is placed over the target area of ​​interest. The adhesive anchor 12 can then be fastened to the block (e.g., via the mounting member 136 or 146) and fastened to the patient's skin 56 for long-term monitoring. Alternatively, the fastening device 10 and selected block can be fastened to the wearable medical sensor 46 before the wearable medical sensor 46 is applied to the skin 56. The practitioner can position the sensor head 48 within the target area of ​​interest while the fastening device 10 and selected blocks are fastened to the wearable medical sensor 46, but before attaching the adhesive anchor 12 to the skin 56.

[0079] FIG. 13A is a schematic diagram of a wearable medical sensor 46 and a bondable anchor 150 applied to a patient's skin 56. The sensor head 48, sensor surface 50, mounting member 52, and cable 54 of the wearable medical sensor 46 are shown. The bondable anchor 150 can be substantially similar to the bondable anchor 12, with the addition of a fastening member 152 configured to fasten one or more arms of the bondable anchor 150 to tilt the sensor surface 50 toward a target area of ​​interest. FIG. 13B is a schematic top view of the bondable anchor 150. FIG. 13B shows the attachment portion 154 having a hole 156 and a slit 158, the arm 160 having inner and outer wings 162, 164, an optional strut 166 (shown in phantom), the fastening member 152, and the end body 168. The bondable anchor 150 can include other features of the bondable anchor 12, including, but not limited to, an anti-rotation feature not shown for simplicity. Figures 13A and 13B are now discussed together.

[0080] The mounting portion 154 and arm 160 may be substantially similar to the mounting portion 26 and arm 28, respectively, of the adhesive anchor 12, with the addition of a fastening member 152 and inner and outer wings 162, 164 to the arm 160. The inner and outer wings 162, 164 may provide attachment points for the fastening member 152. The inner wing 162 extends from the mounting portion 154. The outer wing extends from an end body 168. The fastening member 152 connects the inner wing 162 and the outer wing 164.

[0081] The bondable anchor 150 can be configured for use with the handle 14, as described with respect to the fastening device 10. In some embodiments, the clamping member 152 can be formed of a rigid material that can maintain the shape of the bondable anchor 150 and / or the position of the end body 168 during deployment, as described with respect to the bondable anchor 12. In some embodiments, the arm 160 can include struts 166. The struts 166 can be substantially similar to the struts 44 of the bondable anchor 12 and can be configured to increase the rigidity of the bondable anchor 150 and ensure that the bondable anchor 150 returns to its preset shape when the handle 14 is removed during application to the patient's body.

[0082] The fastening member 152 may be an adjustable tie-wrap strap with teeth that lock the position. The fastening member 152 may include an end 170 that can be pulled by the practitioner to tighten the fastening member 152. As shown in FIG. 13B , the fastening member 152 may be threaded through holes 172 in the inner and outer wings 162, 164, with the end 170 threaded through a connecting receptacle on the opposite end to form a ring as known in the art. In an alternative embodiment, one of the inner and outer wings 162, 164 may include a fastening strap (e.g., attached to or co-molded with the inner or outer wing 162, 164), and the other of the inner and outer wings 162, 164 may include a connecting receptacle (e.g., attached to or co-molded with the inner or outer wing 162, 164) configured to capture and lock the fastening strap.

[0083] Each arm 160 can include one or more clamping members 152. In some embodiments, each arm 160 can include a single centrally located clamping member 152 with or without struts 166 located on either side of the clamping member 152. In other embodiments, each arm 160 can include two clamping members 152, for example, located at the location of a strut 166.

[0084] One or more clamping members 152 can be tightened to adjust the pressure of the sensor surface 50 against the patient's skin 56 and to adjust the tilt angle θ of the sensor surface 50. The clamping members 152 allow the practitioner to fine-tune the tilt angle θ of the sensor surface 50 and / or the applied pressure based on the sensor signal observed in real time. Tightening the clamping members 152 on multiple arms 160 can allow tilting of the sensor surface 50 about multiple axes.

[0085] The adhesive anchor 150 can replace the adhesive anchor 12 in the fastening device 10. As described above, the fastening device 10 can be applied to the wearable medical sensor 46 when the wearable medical sensor 46 is placed on the skin 56 in a target area of ​​interest for long-term monitoring. The practitioner can place the fastening device 10 on the wearable medical device 46 in an orientation that corresponds to the tilt of the sensor head 48 (i.e., the fastening member 152 is positioned adjacent to the inwardly pressed portion of the sensor head 48). Alternatively, the fastening device 10 can be fastened to the wearable medical sensor 46 before the wearable medical sensor 46 is applied to the skin 56. The practitioner can position the sensor head 48 in the target area of ​​interest at the appropriate tilt angle θ while the fastening device 10 is fastened to the wearable medical sensor 46, but before attaching the adhesive anchor 150 to the skin 56. The practitioner can orient the sensor head 48 to ensure that the increased pressure required to tile the sensor head 48 is applied to the end (i.e., end 78) corresponding to the position of the fastening member 152. Once the adhesive anchor 150 is secured to the skin 56, the practitioner can pull one end 170 of the fastening member 152 to tighten the arm 160 and press the end (i.e., end 78) of the sensor head 46 into the patient's body until the desired tilt angle θ of the sensor surface 50 is reached. The other fastening member 152 may also be tightened as needed to hold the sensor head 48 in place for long-term monitoring or to provide tilt about a second axis. Struts 166 (if present) can bend to accommodate the tightening of the arm 160 due to tightening of the fastening member 152.

[0086] Those skilled in the art will appreciate that the adhesive anchor 150 can be applied to or adapted for use with wearable medical sensors of different shapes and / or configurations and is not limited to the embodiments shown and described herein.

[0087] The embodiments disclosed herein are intended to provide an explanation of the present invention and are not intended to limit the present invention. The present invention is not limited to the disclosed embodiments. It will be understood by those skilled in the art that various modifications and variations can be made to the present invention without departing from the scope and spirit of the present invention. Furthermore, it will be understood by those skilled in the art that features of one embodiment can be combined with features of another embodiment, even though not explicitly described in combination herein.

[0088] Any of the various systems, devices, apparatus, etc. of the present disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can include sterilization (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of the associated systems, devices, apparatus, etc.

[0089] Any relative or degree term used herein, such as "substantially," "essentially," "generally," or "approximately," should be interpreted in accordance with and subject to any applicable definitions or limitations expressly set forth herein. In all cases, any relative or degree term used herein should be interpreted broadly to encompass any relevant disclosed embodiment, as well as ranges or variations as would be understood by one of ordinary skill in the art in light of this disclosure as a whole, such as normal manufacturing tolerance variations, accidental alignment variations, transient alignment or shape variations induced by thermal, rotational, or vibrational operating conditions, etc. Furthermore, any relative or degree term used herein should be interpreted to encompass a range that expressly includes the specified quality, characteristic, parameter, or value without variation, as if no limiting relative or degree term were utilized in a given disclosure or description.

[0090] Description of Detailed Embodiments The following is a non-exclusive description of possible embodiments of the present invention.

[0091] A fastening device for attaching a wearable sensor to a patient's body is disclosed, the wearable sensor comprising a sensor configured to measure a characteristic inside the patient's body. The fastening device includes a bondable anchor configured to attach the wearable sensor to the patient's body via an adhesive surface and a handle configured to expose the adhesive surface when pulled following attachment of the bondable anchor to the wearable medical sensor. The bondable anchor includes an attachment portion configured to fasten the bondable anchor to the wearable medical sensor and an adhesive surface configured to attach the bondable anchor to the patient's body. The handle is attached to the adhesive surface.

[0092] The fastening device of the preceding paragraph may additionally and / or alternatively optionally include any one or more of the following features, configurations, and / or additional components.

[0093] In one embodiment of the aforementioned fastening device, the adhesive surface can be disposed on a bottom surface of the bondable anchor, and the handle can extend above and be spaced apart from a top surface of the bondable anchor.

[0094] In one embodiment of any of the aforementioned fastening devices, the adhesive anchor can include an arm extending outwardly from the attachment portion. The adhesive surface can be located on the arm.

[0095] In one embodiment of any of the aforementioned fastening devices, the adhesive anchor can include multiple arms.

[0096] In one embodiment of any of the aforementioned fastening devices, each arm of the plurality of arms can include an end body disposed distally relative to the attachment portion. The adhesive surface can be located on the end body.

[0097] In one embodiment of any of the aforementioned fastening devices, the handle can include a release liner, which can be disposed on and cover the adhesive surface of the end body.

[0098] In one embodiment of any of the aforementioned fastening devices, the adhesive surface can be located on a first side of the bondable anchor, and the handle can extend from the release liner to a second side of the bondable anchor opposite the first side.

[0099] In one embodiment of any of the aforementioned fastening devices, the handle can include multiple strips joined at a joint, and each strip can extend from a release liner disposed on the adhesive surface of the end body.

[0100] In one embodiment of any of the aforementioned fastening devices, the release liner can extend from a first edge to a second edge of the end body. The first edge can be disposed between the attachment portion and the second edge. Each strip of the plurality of strips can be connected to the release liner adjacent to the first edge.

[0101] In one embodiment of any of the aforementioned fastening devices, the handle can be configured to remove a release liner in response to pulling the handle away from the bondable anchor, thereby exposing the adhesive surface of each arm.

[0102] In one embodiment of any of the aforementioned fastening devices, each arm may include a notch extending between the attachment portion and the end body.

[0103] In one embodiment of any of the aforementioned fastening devices, each arm can include a plurality of struts connecting the mounting portion to the end body.

[0104] In one embodiment of any of the aforementioned fastening devices, the attachment portion and the arms can have a formed shape and can be made of a flexible material configured to return to the formed shape when the force is removed.

[0105] In one embodiment of any of the aforementioned fastening devices, the mounting portion can be disposed in a first plane, and the end body of each arm can be disposed in a second plane substantially parallel to and a distance away from the first plane.

[0106] In one embodiment of any of the aforementioned fastening devices, the distance may be equal to the thickness of the wearable sensor.

[0107] In one embodiment of any of the aforementioned fastening devices, the distance can be less than the thickness of the wearable sensor.

[0108] In one embodiment of any of the aforementioned fastening devices, the distance can be less than the thickness of the wearable sensor such that after assembly with the wearable sensor, the end body is disposed above the sensor surface of the wearable sensor.

[0109] In one embodiment of any of the aforementioned fastening devices, the attachment portion can include an aperture configured to receive a mounting member that protrudes from a surface of the wearable sensor.

[0110] In one embodiment of any of the aforementioned fastening devices, the end body can include a first adhesive layer disposed in contact with the end body and a second adhesive layer disposed on the first adhesive layer and forming an adhesive surface.

[0111] In one embodiment of any of the aforementioned fastening devices, the adhesive anchor can include an anti-rotation member configured to maintain the position of the wearable sensor relative to the adhesive anchor.

[0112] In one embodiment of any of the aforementioned fastening devices, the anti-rotation member may include a tab extending outwardly from the mounting portion.

[0113] In one embodiment of any of the aforementioned fastening devices, the plurality of arms can include an end body disposed distal to the attachment portion and extending along a circumference of the fastening device, with the adhesive surface located on the end body.

[0114] In one embodiment of any of the aforementioned fastening devices, the bondable anchors can be formed from a plastic material.

[0115] In one embodiment of any of the aforementioned fastening devices, the adhesive anchors can be permeable.

[0116] In one embodiment of any of the aforementioned fastening devices, the adhesive anchor can include three arms.

[0117] In one embodiment of any of the aforementioned fastening devices, the arms may be evenly spaced apart.

[0118] An embodiment of any of the aforementioned fastening devices may further include an inflatable bladder disposed below the attachment portion and configured to apply pressure to one end of the wearable sensor toward the target area of ​​interest.

[0119] An embodiment of any of the aforementioned fastening devices may further include a rigid plate disposed on the mounting portion, the rigid plate having a screw hole and a screw fastener received in the screw hole and configured to apply pressure to the wearable sensor to tilt a sensor face of the wearable sensor toward the target area of ​​interest.

[0120] An embodiment of any of the aforementioned fastening devices may further include a wedge block disposed between the mounting portion and the wearable sensor. The wedge block may be configured to tilt a sensor face of the wearable sensor toward a target area of ​​interest.

[0121] A method for attaching a wearable sensor to a patient's body is disclosed, the wearable sensor comprising a sensor configured to measure an internal characteristic of the patient. The method includes attaching a fastening device to the wearable sensor. The fastening device includes a bondable anchor configured to attach the wearable sensor to the skin of the patient's body and a handle comprising a release liner attached to the bondable anchor. The method further includes placing the wearable sensor on the patient's body and pulling the handle of the fastening device to remove the release liner from the adhesive surface of the bondable anchor.

[0122] The method of the preceding paragraph may additionally and / or alternatively optionally include any one or more of the following features, configurations, additional components, and / or steps.

[0123] In one embodiment of the aforementioned method, the adhesiveable anchor can include an attachment portion having a hole, and attaching the fastening device to the wearable sensor can include pushing a mounting member of the wearable sensor through the hole.

[0124] In one embodiment of any of the foregoing methods, a handle can be disposed above the wearable sensor and the adhesive anchor and can be pulled upwardly away from the patient's body.

[0125] In one embodiment of any of the aforementioned methods, the bondable anchor can include a central attachment portion configured to fasten the bondable anchor to the wearable sensor and a plurality of arms. Each arm of the plurality of arms can extend outwardly from the central attachment portion and can include an end body separated from the central attachment portion. The end body can include an adhesive surface.

[0126] In one embodiment of any of the aforementioned methods, the handle can be pulled upward to cause the arms to bend, and the release liner can be removed to allow the end body to contact the skin of the patient's body.

[0127] In one embodiment of any of the aforementioned methods, the adhesive anchor can exert a downward force on the wearable sensor toward the patient's body.

[0128] An embodiment of any of the aforementioned methods may further include tilting the sensor toward the target area of ​​interest by one of: (1) inflating a bladder disposed between an attachment portion of the adhesive anchor and an upper surface of the wearable sensor to apply pressure to a portion of the upper surface of the wearable sensor; (2) screwing a threaded fastener disposed through the adhesive anchor and in contact with the upper surface of the wearable sensor to apply pressure to a portion of the upper surface of the wearable sensor; (3) tightening a clamping member of the adhesive anchor to apply pressure to a portion of the upper surface of the wearable sensor; or (4) providing a wedge-shaped block between the adhesive anchor and the upper surface of the wearable sensor.

[0129] While the invention has been described with reference to exemplary embodiments, those skilled in the art will recognize that various changes can be made and equivalents substituted for elements thereof without departing from the scope of the invention. In addition, many modifications can be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is not intended that the invention be limited to the particular embodiments disclosed, but rather that the invention will include all embodiments falling within the scope of the appended claims. [Explanation of symbols]

[0130] 10 fastening device, 12 bondable anchor, 14 handle, 16 release liner, 18 release strip, 20 joint, 22 top surface, 24 bottom surface, 26 mounting portion, 28 arm, 30 adhesive layer, 32 hole, 34 slit, 36 anti-rotation member, 38 end body, 40 inner edge, 42 outer edge, 44 strut, 46 wearable medical sensor, transducer, 48 sensor head, 50 sensor surface, 52 attachment member, 54 cable, 56 skin, 70L left kidney, 70R right kidney, 72A, 72B, 72C, 72D rib, 76 bondable anchor, 78 end, 80 bondable anchor, 82 inflatable bladder, 84, 86 end, 88 side wall, 90 bellows, 92 port, 94, 96 inflatable bladder, 98 Opening, 100, adhesive anchor, 102, screw fastener, 104, screw hole, 106, rigid member, 108, recess, 110, end, 120, wearable medical sensor, 122, mounting member, 124, 126, block, 128, bottom wall, 130, top wall, 131, 132, end wall, 133, side wall, 134, slot or receptacle, 136, mounting member, 138, bottom wall, 140, top wall, 141, 142, end wall, 143, side wall, 144, slot or receptacle, 146, mounting member, 150, adhesive anchor, 152, fastening member, 154, mounting portion, 156, hole, 158, slit, 160, arm, 162, inner wing, 164, outer wing, 166, strut, 168 End body, 170 end, 172 hole

Claims

1. 1. A fastening device for attaching a wearable sensor to a body of a patient, the wearable sensor configured to measure an internal characteristic of the patient, the fastening device comprising: an adhesive anchor configured to attach the wearable sensor to the body of the patient, an attachment portion configured to fasten the adhesive anchor to the wearable sensor; an adhesive surface configured to attach the adhesive anchor to the body of the patient; a bondable anchor comprising: a handle attached to the adhesive surface, the handle configured to expose the adhesive surface when pulled following attachment of the adhesive anchor to the wearable sensor; A fastening device comprising:

2. The fastening device of claim 1 , wherein the adhesive surface is disposed on a bottom surface of the bondable anchor and the handle extends above and is spaced apart from a top surface of the bondable anchor.

3. The fastening device of claim 1 , wherein the adhesive anchor comprises a plurality of arms extending outwardly from the attachment portion.

4. The fastening device of claim 3 , wherein each arm of the plurality of arms includes an end body disposed distally relative to the attachment portion, and the adhesive surface is located on the end body.

5. The fastening device of claim 4 , wherein the handle includes a release liner, the release liner being disposed on and covering the adhesive surface of the end body.

6. 6. The fastening device of claim 5, wherein the adhesive surface is located on a first side of the bondable anchor and the handle extends from the release liner to a second side of the bondable anchor opposite the first side.

7. The fastening device of claim 6 , wherein the handle comprises a plurality of strips joined at joints, each of the strips extending from a release liner disposed on the adhesive surface of the end body.

8. 8. The fastening device of claim 7, wherein the release liner extends from a first edge to a second edge of the end body, the first edge being disposed between the attachment portion and the second edge, each strip of the plurality of strips being connected to the release liner adjacent the first edge, and the handle is configured to remove the release liner in response to pulling the handle away from the bondable anchor to expose the adhesive surface of each of the arms.

9. Each of the arms a notch extending between the mounting portion and the end body; a plurality of struts connecting the mounting portion to the end body; The fastening device of claim 5 , comprising at least one of:

10. The fastening device of claim 5 , wherein the attachment portion and the arms are made of a flexible material having a formed shape and configured to return to the formed shape when a force is removed.

11. 11. The fastening device of claim 10, wherein the mounting portion is disposed in a first plane and the end body of each of the arms is disposed in a second plane, the second plane being substantially parallel to the first plane and spaced a distance from the first plane, the distance being less than a thickness of the wearable sensor such that the end body is disposed above a sensor surface of the wearable sensor after assembly with the wearable sensor.

12. The fastening device of claim 5 , wherein the attachment portion comprises an aperture configured to receive a mounting member protruding from a surface of the wearable sensor.

13. The end body is a first adhesive layer disposed in contact with the end body; a second adhesive layer disposed on the first adhesive layer, the second adhesive layer forming the adhesive surface; The fastening device of claim 5 , comprising:

14. 6. The fastening device of claim 5, wherein the adhesive anchor comprises an anti-rotation member configured to maintain the position of the wearable sensor relative to the adhesive anchor, the anti-rotation member comprising a tab extending outwardly from the attachment portion.

15. 6. The fastening device of claim 5, further comprising a plurality of clamping members, each clamping member disposed on an arm and configured to apply pressure to one or more locations of the wearable sensor to tilt a sensor face of the wearable sensor toward a target area of ​​interest.

16. 10. The fastening device of claim 1, further comprising an inflatable bladder disposed beneath the mounting portion and configured to apply pressure to one end of the wearable sensor to tilt a sensor face of the wearable sensor toward a target area of ​​interest. A method comprising:

17. a rigid plate disposed on the mounting portion, the rigid plate having a screw hole; a threaded fastener received in the threaded hole and configured to apply pressure to the wearable sensor to tilt a sensor face of the wearable sensor toward a target area of ​​interest; The fastening device of claim 1 further comprising:

18. 10. The fastening device of claim 1, further comprising a wedge-shaped block disposed between the mounting portion and the wearable sensor and configured to tilt a sensor face of the wearable sensor toward a target area of ​​interest.

19. 1. A method of attaching a wearable sensor to a body of a patient, the wearable sensor comprising a sensor configured to measure an internal property of the patient, the method comprising: - attaching a fastening device to the wearable sensor, the fastening device comprising: - an adhesive anchor configured to attach the wearable sensor to the skin of the body of the patient; a handle comprising a release liner attached to said bondable anchor; and - placing the wearable sensor on the body of the patient; - pulling the handle of the fastening device to remove the release liner from the adhesive surface of the adhesive anchor; A method comprising:

20. inflating a bladder disposed between an attachment portion of the adhesive anchor and an upper surface of the wearable sensor to apply pressure to a portion of the upper surface of the wearable sensor; driving a threaded fastener disposed through the adhesive anchor and in contact with the top surface of the wearable sensor to apply pressure to a portion of the top surface of the wearable sensor; tightening a clamping member of the adhesive anchor to apply pressure to a portion of the top surface of the wearable sensor; providing a wedge-shaped block between the adhesive anchor and the top surface of the wearable sensor; 20. The method of claim 19, further comprising tilting the sensor toward a target area of ​​interest by one of:

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