Adhesive anchor for wearable medical sensor

Abstract

A fastening device is disclosed for attaching a wearable sensor to a patient's body, the wearable sensor including a sensor configured to measure a characteristic inside the patient's body. The fastening device includes an adhesive anchor configured to adhere the wearable sensor to a patient's body via an adhesive surface and a handle configured to expose the adhesive surface when pulled after the adhesive anchor is attached to the wearable medical sensor. The adhesive anchor includes an attachment portion configured to secure the adhesive anchor to the wearable medical sensor and an adhesion surface configured to adhere the adhesive anchor to a patient's body. The handle is attached to the adhesion surface.

Description

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

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

[0003] A variety of wearable medical sensors are used in hospital and outpatient settings for long-term continuous or intermittent monitoring. Wearable medical sensors do not require operator assistance to maintain contact between the wearable medical sensor and the patient's skin, but often require an adhesive mechanism to firmly adhere the wearable medical sensor to the skin. Adhesive patches or bandages can be applied to wearable medical sensors with some success; however, they can be difficult to apply correctly. Many sensors need to be moved over the patient to identify the target location for monitoring before being adhered in place. Sensors that include adhesive features may require the sensor to be lifted from the patient's body to expose the adhesive, which risks losing track of the target location and can increase deployment time. It is particularly important to reduce the risk of improper placement and the time required for deployment in preparation for a surgical procedure. Summary of the Invention

[0004] A fastening device for attaching a wearable sensor to a patient's body is disclosed. The wearable sensor includes a sensor configured to measure a characteristic of the patient's body. The fastening device includes an adherent anchor configured to adhere the wearable sensor to the patient's body via an adhesive surface, and a handle configured to expose the adhesive surface when pulled after the adherent anchor is attached to the wearable medical sensor. The adherent anchor includes an attachment portion configured to secure the adherent anchor to the wearable medical sensor and an adhesive surface configured to adhere the adherent 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 includes a sensor configured to measure a property inside the patient's body. The method includes attaching a fastening device to the wearable sensor. The fastening device includes an adhesive anchor configured to adhere the wearable sensor to the patient's skin and a handle including a release liner attached to the adhesive anchor. The method further includes positioning 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 adhesive anchor.

[0006] This summary of the present invention is provided by way of example only and not limitation. Other aspects of the present disclosure will be appreciated in view of the entirety of the present disclosure, including the full text, claims, and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 is a perspective bottom view of a fastening device used to anchor the wearable sensor to the patient's body.

[0008] Figure 2 yes Figure 1 A perspective side view of a fastening device.

[0009] Figure 3 yes Figure 1 A perspective top view of a fastening device.

[0010] Figure 4 is coupled to wearable medical sensors Figure 1-Figure 3 A perspective side view of a fastening device.

[0011] Figure 5 is a perspective top view of an adhesive anchor coupled to a fastening device of a wearable sensor after deployment.

[0012] Figures 6A-6C It is used to use the fastening device to Figure 3 A perspective view of the steps of a method of affixing a wearable sensor to a patient's body.

[0013] Figure 7A is a schematic diagram of a wearable medical sensor attached to a patient's body via a fastening device.

[0014] Figure 7B 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.

[0015] Figure 8A is a schematic diagram of a wearable medical sensor attached to a patient's body via an adherent anchor having an inflatable balloon in a deflated position.

[0016] Figure 8B is a schematic diagram of a wearable medical sensor, which Figure 8A The adherent anchor having the inflatable balloon in the inflated position is attached to the patient's body.

[0017] Figure 8C It is located on a wearable medical sensor Figure 8A and Figure 8B A top view of an inflatable airbag.

[0018] Figure 8Dis located in Figure 8A and Figure 8B A top view of an alternative inflatable balloon for use with an adherent anchor on a wearable medical sensor.

[0019] Figure 8E is located in Figure 8A and Figure 8B A top view of yet another alternative inflatable balloon for use with an adhesive anchor on a wearable medical sensor.

[0020] Figure 9A is a schematic diagram of a wearable medical sensor attached to a patient's body via an adjustable adherent anchor having one or more threaded fasteners for tilting a sensor face of the wearable medical sensor toward a target area of ​​interest.

[0021] Figure 9B is through Figure 9A Schematic diagram of a wearable medical sensor attached to a patient's body by an adhesive anchor, wherein one or more threaded fasteners are adjusted to tilt the sensor face toward a target area of ​​interest.

[0022] Figure 9C It is used in wearable medical sensors Figure 9A and Figure 9B A top view of an adhesive anchor.

[0023] Figure 10 is a schematic diagram of another embodiment of a wearable medical sensor attached to a patient's body via an adhesive anchor.

[0024] Figure 11A yes Figure 10 Schematic diagram of a wearable medical sensor and an adhesive anchor having a wedge-shaped block disposed therebetween such that a sensor face of the wearable medical sensor is inclined at a first tilt angle.

[0025] Figure 11B yes Figure 11A Side view of the wedge block.

[0026] Figure 11C yes Figure 11A Top view of the wedge block.

[0027] Figure 12A yes Figure 10 Schematic diagram of a wearable medical sensor and an adhesive anchor having a wedge-shaped block disposed therebetween so that a sensor face of the wearable medical sensor is inclined at a second inclination angle.

[0028] Figure 12B is a side view of a wedge block of Figure 12A

[0029] Figure 12C is a top view of a wedge block of Figure 12A

[0030] Figure 13A is a schematic illustration of another embodiment of an adherable anchor applied to a wearable medical sensor and a patient's body.

[0031] Figure 13B is a schematic top view of an adherable anchor of Figure 13A

[0032] While the above-identified figures set forth embodiments of the application, other embodiments can be considered, as indicated in the discussion. In all cases, this disclosure presents the application by way of representation and not limitation. It is contemplated that those skilled in the art can devise other modifications and embodiments that fall within the spirit and scope of the principles of the application. The drawings can not be drawn to scale and the application and embodiments of the application can include features, steps, and / or components not specifically shown in the drawings. DETAILED DESCRIPTION

[0033] The present disclosure relates to a fastening device for affixing a wearable medical sensor to a patient's body for long-term monitoring. As used herein, long-term monitoring refers to monitoring over a period of time that exceeds a few minutes and does not require operator assistance to maintain contact between the wearable sensor and the patient's skin. The wearable sensors can be anchored to the skin for continuous or intermittent monitoring at the target site at which they are placed.

[0034] ​​​Wearable medical sensors may include, but are not limited to: ultrasound sensors, such as those used to measure vascular pulsatility, blood flow within a vessel or vascular network, and to track other biometrics such as organ movement or respiratory rate; photoplethysmography (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; ballistocardiography (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 may include multiple sensors (e.g., PPG, ECG, and temperature sensors, or sensors that monitor multiple vital signs) in a single patch. The present disclosure illustrates a fastening device configured for use with a wearable ultrasound transducer. The information obtained by the ultrasonic transducer can be used to infer and / or predict possible conditions of the human and / or animal body (e.g., hypertension and bleeding) and other physiological variables, such as stroke volume, stroke volume variability, and cardiac output. Those skilled in the art will appreciate that the disclosed fastening device can be configured for use with a variety of wearable medical sensors, including but not limited to those listed above.

[0035] The fastening device of the present disclosure is configured for use with a wearable medical sensor that is relatively thin and flat in profile and can be secured to a patient's body via an adhesive anchor disposed over the top of the wearable medical sensor and extending to the skin surrounding the wearable medical sensor.

[0036] Figure 1 is a perspective bottom view of a fastening device 10 for anchoring 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 . Figure 1-Figure 3 Shown are fastening device 10, adherable anchor 12, handle 14, release liner 16, release strip 18, junction 20, top side 22, bottom side 24, attachment portion 26, arm 28, adhesive layer 30, aperture 32, slit 34, anti-rotation member 36, end body 38, inner edge 40, outer edge 42, and strut 44.

[0037] The handle 14 is attached to the adherable anchor 12 via a release liner 16 and is configured for deploying the adherable anchor 12. The handle 14 includes a release strip 18 connected at a junction 20. The release strip 18 is connected to the release liner 16. The adherable anchor 12 has a top side 22 and a bottom side 24. The handle 14 extends over the top side 22 of the adherable anchor 12 and is spaced apart from the top side 22. The adherable anchor 12 includes an attachment portion 26, an arm 28, and an adhesive layer 30. The attachment portion 26 may include a hole 32 and a slit 34. The adhesive layer 30 is disposed on the bottom side 24 of the arm 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 arm 28. The end body 38 may include an inner edge 40 and an outer edge 42. The arm 28 may include a strut 44.

[0038] The adhesive anchor 12 is configured for deployment over the top surface of the wearable medical sensor such that the adhesive anchor 12 does not interfere with the sensor face positioned against the patient's body or interfere with the functionality of the wearable medical sensor. The adhesive layer 30 is configured to affix the adhesive anchor 12, and thereby the wearable medical sensor, to the patient's body. The adhesive anchor 12 can be a unitary body formed of a material that is sufficiently flexible to allow the arms 28 to move relative to the attachment portion 26, while being sufficiently rigid to maintain the shape and position of the arms 28 relative to the attachment portion 26 when the force is removed. Thus, a practitioner does not need to position the arms 28 for deployment. When the fastening device 10 is attached to the wearable medical sensor, the arms 28 are automatically positioned for deployment.

[0039] The fastening device 10 can be used to easily attach a wearable medical sensor to a patient's body. As further described herein, once the wearable medical sensor with the attached fastening device 10 is in a deployed position, the adherent anchor 12 can be secured to the patient's body by simply pulling the handle 14. Unlike prior art adhesive patches or bandages, the fastening device 10 does not require the practitioner to individually remove multiple release liners or adjust, position, or stretch the adhesive patch or bandage to secure the wearable medical sensor with the optimal applied force required to maintain a connection between the sensor face and the patient's body.

[0040] Adhesive anchor 12 includes an attachment portion 26. Attachment portion 26 is configured to secure adhesive anchor 12 to a wearable medical sensor. In some examples, attachment portion 26 may include a hole 32 and a plurality of slits 34 configured to receive a mounting member protruding from a top surface of the wearable medical sensor. Slits 34 are cutouts in adhesive anchor 12 that are configured to temporarily enlarge the size of hole 32 for attaching and / or detaching the wearable medical sensor. Slits 34 extend outward from hole 32. Slits 34 may be evenly spaced around hole 32. The number and length of slits 34 may be selected to provide adequate retention of adhesive anchor 12 on the wearable medical sensor and to allow a practitioner to attach and detach adhesive anchor 12 from the wearable medical sensor without significant difficulty. In some examples, the wearable medical sensor may include a protrusion having a diameter or circumference greater than the diameter or circumference of hole 32, as discussed further herein. The attachment portion is not limited to the combination of holes 32 and slits 34. Other mechanical attachment features are contemplated. Any attachment feature should be capable of being securely fastened to the wearable medical sensor, and the attachment should not be interrupted or compromised by movement of the patient.

[0041] Alternatively, or in addition to the mechanical fastening features, the attachment portion 26 may include an adhesive layer. To limit damage to the wearable medical sensor, the adhesive layer may be, for example, a removable pressure sensitive adhesive (PSA).

[0042] The attachment portion 26 can have a planar surface that is configured to interface with the top surface of the wearable medical sensor. The attachment portion 26 can have any suitable shape. As discussed further herein, the attachment portion 26 can be designed to substantially cover the top surface of the wearable medical sensor so that the attachment portion 26 exerts a downward force on the surface of the wearable medical sensor when the adhesive anchor 12 is affixed to the patient's body. Figure 1 As shown, the attachment portion has a substantially circular shape, however, other shapes are also contemplated and may vary depending on the shape of the wearable medical sensor.

[0043] Adhesive anchor 12 may include one or more anti-rotation members 36 configured to prevent rotation of adhesive anchor 12 relative to the wearable medical sensor after fastening device 10 has been secured to the wearable medical sensor, and to prevent rotation of the wearable medical sensor once adhesive anchor 12 has been attached to the patient's body. Anti-rotation members 36 may include, for example, features of the wearable medical sensor (e.g., Figure 4A wing extending outwardly from the attachment portion 26 of the adherent anchor 12 on the opposite side of the cable junction shown in the figure) to limit movement of the feature relative to the adherent anchor 12 and vice versa and to maintain the position of the wearable sensor relative to the adherent anchor 12.

[0044] A plurality of arms 28 extend outwardly from the attachment 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 once affixed to the patient's body. The arms may be evenly spaced around the attachment portion 26 to balance tension applied in multiple directions. In some embodiments, it may be desirable to limit the number of arms to no more than three in order 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 spaced as shown in FIG. Figure 1 As shown separated, and free to move independently (eg, up and down) to conform to the patient's body when deployed.

[0045] The arm 28 may include an end body 38 disposed at an end of the arm 28 opposite the attachment portion 26. The end body 38 includes an adhesive layer 30 on the bottom side 24 and is configured to adhere the adhered 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 securing the wearable medical sensor to the patient's body. The end body 38, and therefore the adhesive layer 30, may have a surface area designed to provide long-term adhesion that is not impaired by movement of the patient's body. The end body 38 may extend outward from the side of the arm 28 and such that the end body 38 is wider than the arm 28, as shown in FIG. Figure 1 In some embodiments, adjacent end bodies 38 may be connected to form a single adhesive end body that extends completely around the perimeter of the fastening device 10, as shown. Figure 1 Any number of arms 28 may extend from the attachment portion 26 to a single end body. The arms 28 may have sufficient rigidity to maintain the end body 38. The edges of the end body 38 may be rounded to limit irritation to the skin and provide a more comfortable fit.

[0046] The adhesive layer 30 is disposed on the bottom side 24 of the end body 38. The adhesive layer 30 may completely cover the bottom side 24 of the end body 38. The adhesive layer 30 may include one or more material layers, including different adhesive materials. The adhesive layer 30 includes a biocompatible adhesive suitable for adhering to the patient's skin and capable of providing the required adhesive strength for long-term monitoring. The adhesive layer 30 may include, for example, 3M TMMedical tape 1527ENP (single coated medical plastic tape). The adhesive layer 30 may additionally include an adhesive material layer suitable for bonding a biocompatible adhesive material to the bottom side 24 of the end body 38. Suitable adhesives may include, for example, 3M TM 200MP double-sided PSA. In some embodiments, a third interface layer may be provided between the adhesive materials.

[0047] In some embodiments, the arm 28 may include one or more cutouts where no material extends between the attachment portion 26 and the end body 38. The cutouts may provide additional flexibility to the arm 28 to conform to the patient's body. The cutouts may have any shape suitable for providing the desired flexibility.

[0048] like Figure 1 As shown, the cutout can be defined by a plurality of struts 44 connecting the attachment portion 26 to the end body 38. Each arm 28 can have two or more struts 44. The width dimension of the struts 44 between the attachment portion 26 and the end body 38 can vary. For example, the width of the struts 44 adjacent to the attachment portion 26 can be greater than the width of the struts 44 adjacent to the end body 38. Figure 1 As shown, struts 44 can extend through the periphery of the attachment portion 26 so that struts 44 of adjacent arms 28 are connected at the attachment portion 26. The shape, width, number, and spacing of the struts 44 can be selected to provide the desired flexibility to the arms 28 while maintaining sufficient stiffness in the arms 28 to maintain the position of the end body 38 relative to the attachment portion 26 when external forces (beyond gravity) are removed. The length of the arms 28 or struts 44 can be selected based on the width, shape, and thickness of the wearable medical sensor. Generally, the arms 28 can be designed to position the end body 38 adjacent to the periphery of the wearable medical sensor on the patient's body but outward therefrom.

[0049] The adhesive anchor 12 can be formed from a plastic material including, but not limited to, PETG plastic. The adhesive anchor 12 can be formed from a clear or transparent material, allowing the user to view or monitor the wearable medical sensor. The adhesive anchor 12 can have a uniform thickness. For example, the adhesive anchor 12 can be formed from 0.03 inch clear / clear PETG plastic. The adhesive anchor 12 can be laser cut and cold formed or molded into a predetermined shape. Figure 2As shown, the adherent anchor 12 can be cold formed or molded so that a portion of each arm 28 (i.e., struts 44) extending between the attachment portion 26 and the end body 38 bends downwardly between the attachment portion 26 and the end body 38. The attachment portion 26 and the end body 38 can be substantially planar, with the end body 38 oriented substantially parallel to the attachment portion 26. The curvature of the arms 28 can be designed to position the end body 38 in a desired position relative to the sensor face of a wearable medical sensor, as discussed further herein.

[0050] The handle 14 extends above the top side 22 of the adherent 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., pulling the handle upward from the wearable medical sensor and the adherent anchor 12). The handle may include a joint 20 disposed above the attachment portion 26. The joint 20 may be the location at which multiple release strips 18 are joined. The release strips 18 may extend from the joint 20 to the end body 38. During deployment, a practitioner may grasp the joint 20 to pull the handle 14 upward and away from the adherent anchor 12. The joint 20 may have any shape, configuration, or additional features to assist in the deployment of the adherent anchor 12. As Figure 1 and Figure 2 As shown, the joint 20 is a circular ring. In other embodiments, the joint 20 can be formed by the intersection of the release strips 18. Other configurations are contemplated.

[0051] The release strip 18 may be narrow, rectangular, or Figure 1-Figure 3 The release strip 18 extends from the joint 20 to an inner edge 40 on the bottom side 24 of the end body 38. Thus, the release strip 18 extends from the outer edge 42 through the end body 38 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. Figure 1-Figure 3 As shown, the release strip 18 may extend from the joint 20 to the outer edge 42 of the end body, fold under the end body 38 at the outer edge 42 , and extend to the inner edge 40 .

[0052] The release strip 18 is connected to the release liner 16 at the inner edge 40. The release liner 16 is 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 liner 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 the inner edge 40. Figure 1-Figure 3As shown, the release strip 18 can be folded over at the inner edge 40 to form the release liner 16. The release liner 16 is formed of a material that can be separated from the adhesive layer 30 cleanly or without removing the adhesive layer 30.

[0053] The handle 14 may be a one-piece body in which all portions of the handle 14 are formed from a material suitable for use as a release liner. The handle 14 may be formed from silicone-coated PETG plastic, for example.

[0054] Figure 4 is a perspective side view of fastening device 10 coupled to wearable medical sensor 46. Shown are fastening device 10, adherable anchor 12, handle 14, release liner 16, release strip 18, junction 20, top side 22, bottom side 24, attachment portion 26, arm 28, adhesive layer 30, hole 32 and slit 34, anti-rotation member 36, end body 38, inner edge 40, outer edge 42, post 44, wearable medical sensor 46, sensor head 48, sensor face 50, mounting member 52, cable 54, and skin 56.

[0055] The fastening device 10 may 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 . Figure 4 The wearable medical sensor 46 shown is an ultrasound transducer configured for long-term monitoring. The wearable medical sensor 46 includes a sensor head 48 having a sensor face 50 configured to contact the skin 56 of the patient's body. The sensor head 48 may include a mounting member 52 disposed on a surface opposite the sensor face 50 and configured to connect to the attachment portion 26 of the adherent anchor 12. The wearable medical sensor 46 may include one or more cables 54 that connect the sensor head 48 to a controller and / or monitoring unit (not shown). Figure 4 As shown, attachment portion 26 extends through the top surface of sensor head 48 and is secured to sensor head 48 via mounting member 52. Bottom side 24 of attachment portion 26 is disposed adjacent sensor head 48. Anti-rotation members 36 may be positioned on either side of the junction between cable 54 and sensor head 48 to limit movement of transducer 46 relative to adherable anchor 12, and vice versa.

[0056] Arm 28 bends around the sides of sensor head 48, positioning end body 38 below attachment portion 26 and at a height relative to sensor face 50 that can be equal to or higher than sensor face 50. End body 38 can be positioned in a plane substantially parallel to attachment portion 26 and separated from attachment portion 26 by a distance less than the thickness or height of sensor head 46, such that end body 38 is positioned above sensor face 50. Sensor face 50 can be positioned in a plane substantially parallel to the plane in which end body 38 is positioned. The height of end body 38 relative to sensor face 50 is illustrated as distance d. End body 38 secures wearable medical sensor 46 to skin 56. The height of end body 38 relative to sensor face 50 determines the force applied to wearable medical sensor 46 by the adhesive anchor 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 sensor face 50 and skin 56. For example, pulse oximetry (SpO2) sensors work best if sufficient pressure (10-20 mmHg) is applied to push venous blood out of the sampled tissue volume. For such applications, the adherent anchor 12 can be cold-formed or molded to position the end body 38 slightly above the sensor face 50 at a distance determined to provide appropriate pressure on 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 face 50 to securely adhere the wearable medical sensor 46 to the skin 56 without applying significant pressure to the wearable medical sensor 46. As discussed further herein, lifting the handle 14 causes the end body 38 to be lifted away from the skin 56. When the release liner 16 is released, the arms 28 are able to return to their predetermined shape, causing the end body 38 to snap against the skin 56.

[0057] Figure 5 is a perspective top view of adhesive anchor 12 coupled to wearable medical sensor 46 after deployment. Adhesive anchor 12, top side 22, attachment portion 26, arm 28, adhesive layer 30, hole 32, slit 34, anti-rotation member 36, end body 38, strut 44, wearable medical sensor 46, sensor head 48, mounting member 52, cable 54, and skin 56 are shown.

[0058] like Figure 5As shown, the adherent device is formed of a transparent material, allowing the practitioner to see the wearable medical sensor 46 during the long-term monitoring process. The attachment portion 26 extends through the top surface of the sensor head 48. The mounting member 52 extends through the hole 32 of the attachment portion 26 and is retained by the hole 32 of the attachment portion 26. The arm 28 bends around the side of the sensor head 48, positioning the end body 38 outward from the sensor face 50 on the skin 56. Both the sensor face 50 and the end body 38 are fixed to the skin 56. The adherent anchor 12 is designed so that the arm 28 is substantially taut when attached to the skin 56. After the wearable medical sensor 46 has been affixed to the skin 56 via the adherent anchor 12, the anti-rotation member 36 can prevent the sensor head 48 from rotating.

[0059] Figures 6A-6C is a perspective view of steps of a method for affixing a wearable medical sensor 46 to a patient's body using fastening device 10. Fastening device 10, adherable anchor 12, handle 14, release liner 16, release strip 18, junction 20, top side 22, bottom side 24, attachment portion 26, arm 28, adhesive layer 30, hole 32 and slit 34, end body 38, inner edge 40, outer edge 42, strut 44, wearable medical sensor 46, sensor head 48, sensor face 50, mounting member 52, and skin 56 are shown.

[0060] In step 60, if Figure 6A As shown, 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 in the attachment portion 26 of the adhesive anchor. The slit 34 can expand the hole 32 to fit the mounting member 52. The mounting member 52 can be retained in the hole 32. As previously discussed, the attachment portion 26 can include other attachment means in addition to or in place of the hole 32 and the slit 34. For example, the attachment portion 26 can include an adhesive configured to adhere to the bottom side 24 of 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 the target area of ​​interest for long-term monitoring, or the fastening device 10 can be secured to the wearable medical sensor 46 before the wearable medical sensor 46 is applied to the skin 56.

[0061] In step 62, if Figure 6BAs shown, the handle 14 is pulled to remove the release liner 16 from the adhesive layer 30 on the adherable anchor 12. As shown, the handle 14 can be pulled upward from the joint 20 away from the attachment portion 26, the wearable medical sensor 46, and the patient's body. Typically, the practitioner can use one hand to secure the position of the wearable medical sensor 46 on the skin 56 (e.g., by pressing the sensor head 48 and thereby the attachment portion 26) while pulling the handle 14 with the other hand. In some cases, it may be feasible for the practitioner to secure the wearable medical sensor 46 and pull the handle 14 with the same hand.

[0062] When the handle 14 is pulled upward and away from the attachment portion 26, the release strip 18 pulls the release liner 16 out of the inner edge 40 of the end body 38. This movement can cause the arms 28 and end body 38 to flex upward and away from the skin 56, as shown in FIG. Figure 6B Because the handle 14 is attached to all of the release liners 16 , pulling the handle 14 straight up can cause the release strip 18 to remove all of the release liners 16 simultaneously.

[0063] In step 64, if Figure 6C As shown, when the handle 14 is pulled, the end body 38, which is lifted above the skin 56, can snap against the skin 56 as the arms 28 return to their predetermined shape. The exposed adhesive layer 30 on the end body 38 contacts the skin 56 and adheres the wearable medical sensor 46 to the skin 56. Depending on the starting position of the end body 38 relative to the sensor face 50, the practitioner may need to apply little or no additional pressure to the end body 38 to ensure attachment. Nevertheless, the practitioner can press each end body 38 to ensure it is firmly adhered to the skin 56.

[0064] 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 an edge of the end body 38.

[0065] The disclosed fastening device can be used to simply and securely attach a variety of 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 that require varying degrees of downward pressure to ensure proper function. The embodiments disclosed herein are intended to illustrate the present invention and not to limit the present invention. The present invention is not limited to the disclosed embodiments. Those skilled in the art will appreciate that various modifications and variations may be made to the present invention without departing from the scope and spirit of the present invention.

[0066] In one embodiment, the wearable medical sensor 46 may be an ultrasound transducer array configured to measure Doppler flow signals of blood flow to organs in the patient's abdomen, such as, but not limited to, the kidneys, liver, pancreas, and spleen. To detect and measure Doppler flow signals of blood flow to organs in the patient's abdomen, such as the kidneys, the elements of the ultrasound transducer array may have a low operating frequency between 0.5 MHz and 4.0 MHz and an element size greater than one wavelength in soft tissue. With an operating frequency between 0.5 MHz and 4.0 MHz and an element size greater than one wavelength in soft tissue, the ultrasound transducer array is capable of generating an ultrasound beam that penetrates more than 15 cm into the patient's body, a sufficient depth for measuring blood flow to the kidneys, liver, spleen, and pancreas.

[0067] Figure 7A is a schematic diagram of a wearable medical sensor 46 attached to a patient's abdomen via an adherent anchor 12 to monitor the patient's left kidney 70L. The wearable medical sensor 46 is an ultrasound transducer configured to monitor a 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 leaves the left kidney 70L via the renal vein RV to the patient's vena cava. Figure 7A The diagram shows an initial wave OW from the wearable medical sensor 46 and a return wave, identified as a Doppler signal BW for blood flow in the renal artery RA and a Doppler signal RW for blood flow in the renal vein RV. Due to Doppler physics, as blood flow in the renal artery RA moves toward the ultrasound transducer probe (the sensor head 48 of the wearable medical sensor 46), the Doppler signal BW for blood flow in the renal artery RA "blue-shifts." As blood flow in the renal vein RV moves away from the ultrasound transducer, the Doppler signal RW for blood flow in the renal vein RV "red-shifts." Due to the blue-shifted Doppler signal BW and the red-shifted Doppler signal RW, the wearable medical sensor 46 can easily distinguish between renal arterial and renal venous blood flow. In human subjects, the renal artery RA and renal vein RV are located in close proximity and parallel alignment, enabling the wearable medical sensor 46 to simultaneously capture both arterial and venous flow in the left kidney 70L.

[0068] like Figure 7AAs shown in FIG, the sensor face 50 of the wearable medical sensor 46 is positioned flat on the patient's abdomen, above the left kidney 70L and above at least one intercostal space between adjacent ribs 72A, 72B. As shown, the sensor face 50 is oriented approximately perpendicular to the renal artery RA and renal vein RV to direct the onset wave OW substantially parallel to the blood flow in the renal artery RA and renal vein RV. The adherent 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 described above. The arms 28 connecting the attachment portion 26 to the end body 38 are equal in length, so that the adherent anchor 12 distributes pressure substantially evenly across the sensor head 48 and the patient's abdomen.

[0069] In some applications, it may be desirable to apply increased force to one or more off-center locations of the wearable medical sensor 46 to tilt the sensor face 50 toward the region of interest (e.g., the kidneys). For example, by positioning the sensor face 50 below the ribs and tilting the sensor face 50 upward toward the kidneys, an improved Doppler signal may be obtained in ultrasound monitoring of renal perfusion. This orientation may be particularly useful for monitoring renal perfusion, as slight curvature is observed in the renal artery RA and renal vein RV of the right kidney 70R. Figure 7B The right kidney 70R is shown.

[0070] Figure 7B FIG is a schematic diagram of a wearable medical sensor 46 attached to the side or flank of a patient below ribs 72C, 72D via an adhesive anchor 76 to monitor perfusion of the right kidney 70R. Figure 7A As discussed, the wearable medical sensor 46 can be an ultrasound transducer configured to monitor the Doppler flow signal of the right kidney 70R, which can 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 leaves the right kidney 70R to the patient's vena cava via the renal vein RV.

[0071] like Figure 7B As shown, the adherent anchor 76 is configured to apply increasing pressure to the top surface of the end 78 (opposite the cable 54) of the sensor head 48, causing the sensor head 48 to be pressed inwardly against the patient's body and orienting the sensor face 50 toward the right kidney 70R and generally perpendicular to the renal artery RA and renal vein RV. Figure 7B The tilt angle θ is shown, which is the tilt angle θ of the sensor face 50 relative to the nominal surface (ie, Figure 7AThe degree of tilt (in a flat orientation) can be determined by observing the appropriate or optimal tilt angle θ in real time from the wearable medical sensor 46. 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 harm to the patient. For example, in most applications, the tilt angle θ can be limited to approximately 30 degrees.

[0072] As further described herein, additional pressure may be applied to any portion of the top surface of the sensor head 48 that is off-center to induce tilting of the sensor face 50. It will be appreciated that the cable 54 may limit the amount of tilting that can be achieved by applying increased pressure at the surface of the sensor head 48 adjacent the cable 54. Thus, when this option is available, it may be preferable to apply increased pressure to the end 78 of the sensor head 48 that is located opposite the cable 54.

[0073] Adhesive anchor 76 can be substantially similar to adhesive anchor 12 with one or more additional and / or alternative features disclosed herein to tilt wearable medical sensor 46 and maintain the tilt of wearable medical sensor 46. Adhesive anchor 76 can be any one or a combination of the plurality of adhesive anchor embodiments disclosed herein configured to apply and maintain the tilt of sensor face 50 toward the region of interest for long-term monitoring.

[0074] Figure 8A and Figure 8B is a schematic diagram of an adhesive anchor 80 applied to a wearable medical sensor 46 and a patient's skin 56. The wearable medical sensor 46 is shown as including a sensor head 48, a sensor face 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.

[0075] Figure 8A Wearable medical sensor 46 is shown in a substantially flat orientation on a patient's body, with pressure from adherent anchor 80 generally evenly distributed across sensor head 48 . Figure 8B The wearable medical sensor 46 is shown in an inclined orientation, wherein increased pressure is applied to the end 78 of the wearable medical sensor 46, as shown in FIG. Figure 7B The end 78 is pressed into the patient's body, causing the sensor face 50 to be relatively close to the nominal surface (ie, Figure 7AThe patient's body is generally not planar and the tilt angle θ described herein is approximate. In addition, several embodiments disclosed herein may allow for tilting about multiple axes.

[0076] The adhesive anchor 80 can be substantially similar to the adhesive anchor 12 with an additional inflatable bladder 82. For simplicity, only the attachment portion 26, the arm 28, the end body 38, and the inflatable bladder 82 are shown. The inflatable bladder 82 is disposed on the underside of the attachment portion 26 such that when the adhesive anchor 80 is assembled with the wearable medical sensor 46, the inflatable bladder 82 is positioned between the attachment portion 26 and the sensor head 48. The inflatable bladder 82 can be securely attached to the underside of the attachment portion 26, for example, by an adhesive.

[0077] Adhesive anchor 80 may be used with inflatable balloon 82 in a manner such as Figure 8A The deflated state shown may have any inflation amount as needed to adjust the sensor face 50 to the desired tilt angle θ. Figure 8B The inflatable airbag 82 is shown in a fully inflated state.

[0078] The inflatable bladder 82 may be formed of a semi-rigid plastic that is capable of shrinking as it deflates but resists stretching as it inflates. The inflatable bladder 82 may have an asymmetric design configured to allow for asymmetric expansion with increased expansion adjacent the end 78. Figure 8B As shown, the inflatable bladder 82 extends from an end 84 to an opposite end 86 and between side walls 88 (one shown). The end 86 is located adjacent the end 78 of the sensor head 48 and may include a collapsible fold or bellows 90. The bellows 90 allows the end 86 to expand to different heights as it is inflated and to collapse to a desired height as it is deflated. Figure 8A 86 and may further include foldable folds or bellows to allow sidewall 88 to expand with inflation and collapse to a substantially flat configuration with deflation. The number of folds or bellows may be selected to reduce the height of end 86 in the collapsed configuration so that the thickness or height of inflatable bladder 82 is substantially uniform from end 84 to end 86 in the collapsed configuration.

[0079] The inflatable bladder 82 can be inflated via a port 92 that opens into the interior cavity of the inflatable bladder 82. The port 92 can be Figure 8A and Figure 8BThe port 92 is shown provided by the attachment portion 26, or adjacent the attachment portion 26. Preferably, the port 92 opens to the top of the adherable anchor 80 or inflatable bladder 82 for ease of access, although the port 92 can be located in any region of the inflatable bladder 82 that is accessible for inflating and deflating the inflatable bladder 82.

[0080] The inflatable bladder 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 release of the fluid from the inflatable bladder 82. The port 92 can be configured to receive, for example, a needle for filling the inflatable bladder 82 by a syringe. Fluid can be supplied to the inflatable bladder 82 until the sensor face 50 is oriented at the desired tilt angle Θ. The use of the inflatable bladder 82 allows a practitioner to fine-tune the tilt angle Θ of the sensor face 50 based on real-time observed sensor signals.

[0081] Figure 8C is a top view of the inflatable bladder 82 positioned on the wearable medical sensor 46. Figure 8D and Figure 8E An alternative configuration of the inflatable bladder 82 including inflatable bladders 94 and 96 is shown. The remaining features of the adherable anchor 80 are omitted from the view. The inflatable bladder 82 can have a circular ring shape, with an opening 98 provided to accommodate the mounting member 52. The mounting member 52 can be used to position the adherable anchor 80 on the wearable medical sensor 46, as described with respect to the adherable anchor 12. Once the adherable anchor 80 is secured to the skin 56 as previously disclosed, the mounting member 52 can not be needed to maintain the position of the wearable medical sensor 46 relative to the adherable anchor 80. As such, the mounting member 52 can be released and displaced from the adherable anchor 80 when the inflatable bladder 82 is inflated, as shown in Figure 8B In some embodiments, one or more retention features (not shown) can be provided, for example, on the underside of the attachment portion 26, to maintain the position of the sensor head when the mounting member 52 is released from the attachment portion 26. The one or more retention features can additionally help maintain the position of the sensor head 48 during long-term monitoring. The retention features can include, for example, ridges or protruding features configured to capture the sensor head 48.

[0082] In other embodiments, the inflatable bladder 82 may be adhered to the sensor head 48 via a removable and / or repositionable adhesive to position the adhesive anchor 80 on the sensor head 48 and 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., the underside of the attachment portion 26) to prevent the sensor head 48 from sliding or to maintain the position of the inflatable bladder 82 relative to the sensor head 48 during inflation.

[0083] exist Figure 8B and Figure 8C In the illustrated embodiment, the bellows 90 is located at the end 86 of the inflatable bladder 82, opposite the cable 54, because movement of that end is least restricted by the cable 54. In other embodiments, the bellows 90 can be located on either side 88 or the end 84, although it is preferred to avoid the end 84 unless required for a particular application where access is restricted.

[0084] Figure 8D and Figure 8E is a top view of an alternative inflatable balloon configuration for use with the adherent anchor 80. Figure 8D As shown, the adherable anchor 80 may include an inflatable bladder 94 that covers only a portion of the top surface of the sensor head 96. The inflatable bladder 94 has a U-shape to accommodate the mounting member 52. The inflatable bladder 94 may have substantially the same configuration as the inflatable bladder 82, with a bellows 90' at the end 86' and a highly tapered sidewall 88', and may also include folds or bellows for collapsing the inflatable bladder 94.

[0085] like Figure 8E As shown, the adherent anchor 80 may include an inflatable bladder 96 that may be positioned on one end or side (e.g., end 78) of the top surface of the sensor head 48. To accommodate expansion, the entire perimeter of the inflatable bladder 96 (two sides 88" and ends 84" and 86") may include a bellows 90". The inflatable bladders 94 and 96 only cover a portion of the top surface of the sensor head 48. This allows a gap to form between the attachment portion 26 of the adherent anchor 80 and the sensor head 48 during inflation in the areas not covered by the inflatable bladders 94 and 96.

[0086] Adhesive anchor 80 may replace adhesive anchor 12 (e.g., Figure 1-Figure 5 and Figures 6A-6CAs previously described, when the wearable medical sensor 46 is positioned on the skin 56 in a target area of ​​interest for long-term monitoring, the fastening device 10 (including the adhesive anchor 80) can be applied to the wearable medical sensor 46. The practitioner can position the fastening device 10 on the wearable medical sensor 46 in an orientation corresponding to the tilt of the sensor head 48 (i.e., with the bellows 90 positioned over the portion of the sensor head 48 that is pressed inward). Alternatively, the fastening device 10 can be secured 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 before attaching the adhesive anchor 80 to the skin 56. The practitioner can orient the sensor head 48 to ensure that the increased pressure required to tilt the sensor face 50 is applied to the end 78 corresponding to the area of ​​the inflatable bladder 82, 94, or 96 that is most inflated. Once adherent anchor 80 is secured to skin 56, the practitioner may inflate inflatable balloon 82, 94, or 96 to achieve the desired tilt angle θ.

[0087] Figure 9A and Figure 9B is a schematic diagram of an adhesive anchor 100 applied to a wearable medical sensor 46 and a patient's skin 56. The adhesive anchor 100 may be substantially similar to the previously described adhesive anchor 100. Figure 8A-8B Adhesive anchor 80 is depicted. In place of the inflatable balloon 82 of the adhesive anchor 80, the adhesive 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 face 50. The one or more threaded fasteners 102 may be received in a threaded hole 104 of a rigid member 106. Figure 9C is a top view illustration of an adhesive anchor 100 applied to a wearable medical sensor 46 .

[0088] For example, the rigid member 106 can be a rigid plate secured to the attachment portion 26 of the adherable anchor and configured to maintain the position of one or more threaded fasteners 102 on the adherable anchor 100 and the sensor head 48. The threaded fastener 102 can be, for example, a set screw that can be turned by hand and / or with a screwdriver for adjustment. Figures 9A-9CAs shown, 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 surrounding the mounting member 52, to accommodate the threaded fasteners 102 at various locations on the top surface of the sensor head 48. The rigid member 106 can include a plurality of threaded holes 104 (not shown) configured to receive the threaded fasteners 102, enabling a practitioner to select one or more locations at which to apply additional pressure to the sensor head 48 to achieve a desired tilt of the sensor face 50.

[0089] The sensor head 48 may include one or more indentations or recesses 108 configured to locate the ends 110 of the one or more threaded fasteners 102 and prevent the one or more threaded fasteners 102 from sliding out of position during adjustment and long-term monitoring. The one or more recesses 108 may be, for example, rounded or hemispherical in shape to match the shape of the ends 110, or may be grooves 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.

[0090] like Figure 9C As shown, two threaded fasteners 102 can be positioned adjacent to the end 78 of the sensor head 48 opposite the cable 54. In alternative embodiments, a single threaded fastener 102 or more than two threaded fasteners 102 can be used. A single threaded fastener 102 can be located at the center of an end or side (e.g., end 78) of the top surface of the sensor head 48 to evenly distribute pressure on that end or side, can be located at a corner between adjacent ends or sides, or can be located at any other location to achieve the desired tilt of the sensor face 50. Those skilled in the art will appreciate that the number and location of the threaded fasteners 102 can be modified based on the size and shape of the sensor head 48.

[0091] Adhesive anchor 100 can replace adhesive anchor 12 in fastening device 10. As previously described, when wearable medical sensor 46 is positioned on skin 56 in a target area of ​​interest for long-term monitoring, fastening device 10 (including adhesive anchor 100) can be applied to wearable medical sensor 46. A practitioner can position fastening device 10 on wearable medical device 46 in an orientation corresponding to the tilt of sensor head 48 (i.e., with threaded fastener 102 or threaded hole 104 positioned over the portion of sensor head 48 that is pressed inward). Alternatively, fastening device 10 can be secured to wearable medical sensor 46 before wearable medical sensor 46 is applied to skin 56. When fastening device 10 is secured to wearable medical sensor 46 but before attaching adhesive anchor 100 to skin 56, a practitioner can position sensor head 48 in the target area of ​​interest at an appropriate tilt angle θ. The practitioner can orient sensor head 48 to ensure that the increased pressure required to tilt sensor head 48 is applied to the portion of sensor head 48 corresponding to the location of the one or more threaded fasteners 102 or threaded holes 104. Once the adherable anchor 100 is secured to the skin 56, the practitioner can rotate the one or more threaded fasteners 102 to press a portion of the sensor head 46 into the patient's body until the desired tilt angle θ of the sensor face 50 is achieved. The use of the one or more threaded fasteners 102 allows the practitioner to fine-tune the tilt angle θ of the sensor face 50 based on the sensor signals observed in real time.

[0092] As the one or more threaded fasteners 102 are further threaded into the rigid member 106, the attachment portion 26 (including the rigid member 106) is displaced from the sensor head 48 at least in the area of ​​the one or more threaded fasteners 102. As the tilt angle θ increases, the mounting member 52 of the sensor head 48 can be released from the attachment portion 26 of the adherent anchor 100. One or more retention features (not shown) can be provided, for example, on the underside of the attachment portion 26 to maintain the position of the sensor head when the mounting member 52 is released from the attachment portion 26. The one or more retention features can additionally help maintain the position of the sensor head 48 during long-term monitoring. The retention features can include, for example, ridges or protruding features configured to capture the sensor head 48.

[0093] Figure 10 FIG is a schematic diagram of an adhesive anchor 12 applied to a wearable medical sensor 120 and a patient's skin 56. The wearable medical sensor 120 is substantially identical to the wearable medical sensor 46, having a sensor head 48, a sensor face 50, and a cable 54. The wearable medical sensor 120 may have a modified mounting member 122 to accommodate an angled block for adjusting the tilt angle θ of the sensor face 50 for long-term monitoring, as shown. Figure 11A and Figure 11B In other embodiments, the mounting member 122 can be substantially identical to the mounting member 52 of the wearable medical sensor 46. When the wearable medical sensor 120 is positioned in a flat orientation or a non-angled orientation, the mounting member 122 can be configured to retain the attachment portion 26 of the adherent anchor 12, as shown. Figure 10 In an alternative embodiment, the wearable medical sensor 120 may be used with a flat block of uniform thickness (not shown) that is disposed over the wearable medical sensor 120 and has a mounting member shaped to retain the adherent anchor 12 . Figure 10 The wearable medical sensor 120 is shown in a substantially flat orientation, with the adherent anchor 12 applying substantially uniform pressure on the sensor head 48, as shown in FIG. Figure 7A described.

[0094] Figure 11A is a schematic cross-sectional view of an adherent anchor 12 applied to a wearable medical sensor 120 and skin 56 with the addition of a block 124 configured to orient the sensor face 50 at a first tilt angle θ. Figure 11B and Figure 11C They are a side view and a top view of block 124, respectively. Figure 12A is a schematic cross-sectional view of an adherent anchor 12 applied to a wearable medical sensor 120 and skin 56 with the addition of a block 126 configured to orient the sensor face 50 at a second tilt angle θ′ that is greater than the first tilt angle θ. Figure 12B and Figure 12C They are a side view and a top view of block 126, respectively. Figures 11A-11C and Figures 12A-12C Be discussed together.

[0095] Each of blocks 124 and 126 is configured to attach to mounting member 122 of sensor head 48 and to adherent anchor 12. Blocks 124 and 126 are interchangeable and determine the degree of tilt of sensor face 50 (i.e., tilt angle θ and tilt angle θ′, respectively). Blocks 124 and 126 may be generally wedge-shaped. Block 124 includes a bottom wall 128, a top wall 130, opposing end walls 131, 132, opposing side walls 133, a slot or receptacle 134, and a mounting member 136. Bottom wall 128 is substantially flat with slot or receptacle 134 provided therein and opening into bottom wall 128. Top wall 130 is angled relative to bottom wall 128 and includes a mounting member 136 protruding from top wall 130. Opposing end walls 131, 132 connect bottom wall 128 and top wall 130 and have unequal heights. Opposite side walls 133 connect bottom wall 128 and top wall 130, as well as opposite end walls 131, 132, and taper in height from end wall 131 to end wall 132. Block 126 includes bottom wall 138, top wall 140, opposite end walls 141, 142, opposite side walls 143, a slot or receptacle 144, and a mounting member 146. Bottom wall 138 is substantially flat, with slot or receptacle 144 provided therein and open to bottom wall 138. Top wall 140 is angled relative to bottom wall 138 and includes a mounting member 146 projecting from top wall 140. Opposite end walls 141, 142 connect bottom wall 138 and top wall 140 and have unequal heights. Opposing side walls 143 connect bottom wall 138 and top wall 140, as well as opposing end walls 141 and 142, and taper in height from end wall 141 to end wall 142. Bottom walls 128 and 138, slots 134 and 144, and mounting members 136 and 146 can be substantially identical. Slots 134 and 144 are configured to receive mounting member 122 of wearable medical sensor 120. Mounting members 136 and 146 are configured to be received by attachment portion 26 of adherable anchor 12.

[0096] Blocks 124 and 126 are two examples of a plurality of wedge-shaped blocks that may be used with the wearable medical sensor 120 and the adhered anchor 12 to tilt the sensor face 50 toward the region of interest. Each block may be configured to provide the sensor face 50 with a specific tilt angle θ defined by the angle of the top wall relative to the bottom wall. Figure 11B As shown, the top wall 130 of the block 124 is at a first inclined angle relative to the bottom wall 128. Figure 12B As shown, the top wall 140 of the block 126 is inclined at a second angle θ′ relative to the bottom wall 138 , which is greater than the first angle θ.

[0097] like Figure 11A and Figure 12AAs shown, the mounting member 122 of the wearable medical sensor 120 can be a protruding member having a nail-like shape with a handle extending from the sensor head 48 and a head that is wider at the outermost end. The shape and size of the grooves 134 and 144 can be set to facilitate assembly with the mounting member 122 and retaining the mounting member 122. The grooves 134 and 144 can have a shape that substantially matches the shape of the mounting member 122. Figure 11B and Figure 12B As shown, slots 134 and 144 can extend across the entire width of blocks 124 and 126 (between sidewalls 133), or can extend across a portion of the width of blocks 124 and 126. Slots 134 and 144 can be configured to receive mounting member 122 by sliding blocks 124 and 126 across the top surface of sensor head 48. In some embodiments, when positioned in a fully assembled position, the slot walls can taper to provide a friction fit with mounting member 122. In alternative embodiments, slots 134 and 144 can be configured to attach to mounting member 122 from above. For example, slots 134 and 144 can have a keyhole fastener configuration, wherein mounting member 122 is received in slots 134 and 144 from below and slid into a locked position as is known in the art. In some embodiments, mounting member 122 can be substantially identical to mounting member 52 of wearable medical device 46, and slots 134 and 144 can have a geometry configured to receive mounting member 122 that substantially matches the geometry of mounting member 122. 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 for positioning and retaining the block 124 or 126 on the wearable medical sensor 120 for long-term monitoring.

[0098] The mounting members 136 and 146 are configured to be received in the attachment portion 26 of the adherable anchor 12, as described with respect to FIG. Figure 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 perpendicularly to the top walls 130 and 140, respectively, such that the mounting members 136 and 146 are oriented perpendicularly to the attachment portion 26 when deployed. Figure 11C and Figure 12C As shown, mounting members 136 and 146 may be centrally located on top walls 130 and 140 , respectively.

[0099] Blocks 124 and 126 may have a shape and size that substantially matches the shape of sensor head 48 such that bottom walls 128 and 138 substantially cover sensor head 48 .

[0100] Multiple blocks of varying tilt angles can be used with the adhered anchor 12 and the wearable medical sensor 120. For example, the blocks can be sized to increase the tilt angle in 5-degree increments (e.g., 5°, 10°, 15°, ... 30°). Smaller increments can be provided to provide finer adjustment of the tilt angle θ, however, in many applications, coarse adjustment is sufficient.

[0101] While blocks 124 and 126 provide tilt about a single axis, an alternative block including opposing sidewalls 133 that are of different heights from one another may provide tilt about a second axis.

[0102] When the wearable medical sensor 120 is positioned on the skin 56 in a target area of ​​interest for long-term monitoring, the fastening device 10 (including the adhesive anchor 12) can be applied to the wearable medical sensor 120 with a block (e.g., block 124 or 126) at a desired tilt angle. A practitioner can position the sensor head 48 in 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 to maintain the desired tilt angle. Once the sensor head 48 is positioned over the target area of ​​interest, the selected block can be attached to the sensor head 48. The adhesive anchor 12 can then be secured to the block (e.g., via mounting member 136 or 146) and secured to the patient's skin 56 for long-term monitoring. Alternatively, the fastening device 10 and the selected block can be secured to the wearable medical sensor 46 before the wearable medical sensor 46 is applied to the skin 56. While fastening device 10 and the selected mass are secured to wearable medical sensor 46 , but before attaching adherent anchor 12 to skin 56 , the practitioner may position sensor head 48 in the target area of ​​interest.

[0103] Figure 13A FIG2 is a schematic diagram of an adhesive anchor 150 applied to a wearable medical sensor 46 and a patient's skin 56. The diagram shows the sensor head 48, sensor face 50, mounting member 52, and cable 54 of the wearable medical sensor 46. The adhesive anchor 150 can be substantially similar to the adhesive anchor 12, with the addition of a tightening member 152 configured to tighten one or more arms of the adhesive anchor 150 to tilt the sensor face 50 toward a target area of ​​interest. Figure 13B is a schematic top view of an adhesive anchor 150 . Figure 13BShown are attachment portion 154 having aperture 156 and slot 158, arm 160 having inner and outer wings 162, 164, optional strut 166 (shown in phantom), lacing member 152, and end body 168. Adhesive anchor 150 may include other features of adhesible anchor 12, including but not limited to anti-rotation features, which are not shown for simplicity. Figure 13A and Figure 13B are discussed together in this article.

[0104] Attachment portion 154 and arm 160 can be substantially similar to attachment portion 26 and arm 28, respectively, of adherable anchor 12, with lacing member 152 and inner and outer wings 162, 164 added to arm 160. Inner and outer wings 162, 164 can provide attachment points for lacing member 152. Inner wing 162 extends from attachment portion 154. Outer wing extends from end body 168. Lacing member 152 connects inner and outer wings 162, 164.

[0105] Adhesive anchor 150 can be configured for use with handle 14, as described with respect to fastening device 10. In some embodiments, cinching member 152 can be formed of a rigid material capable of maintaining the shape of adherable anchor 150 and / or the position of end body 168 during deployment, as described with respect to adherable anchor 12. In some embodiments, arm 160 can include struts 166. Struts 166 can be substantially identical to struts 44 of adherable anchor 12 and can be configured to provide increased rigidity to adherable anchor 150 to ensure that adherable anchor 150 returns to a preset shape when handle 14 is removed during application to a patient's body.

[0106] The tightening member 152 may be an adjustable strapping type strap having teeth in a locked position. The tightening member 152 may include an end 170 that can be pulled by a practitioner to tighten the tightening member 152. Figure 13B As shown, the lacing member 152 can be passed through holes 172 in the inner and outer wings 162, 164, with the ends 170 being fed through connecting receptacles on the opposite ends to form a loop as is known in the art. In an alternative embodiment, one of the inner and outer wings 162, 164 can include a lacing strap (e.g., attached to or co-molded with the inner or outer wings 162, 164), and the other of the inner and outer wings 162, 164 can include a connecting receptacle configured to capture and lock the lacing strap (e.g., attached to or co-molded with the inner or outer wings 162, 164).

[0107] Each arm 160 can include one or more lacing members 152. In some embodiments, each arm 160 can include a single, centrally located lacing member 152, with or without struts 166 disposed on either side of the lacing member 152. In other embodiments, each arm 160 can include two lacing members 152, for example, positioned in the location of the struts 166.

[0108] One or more tightening members 152 can be tightened to adjust the pressure of the sensor face 50 on the patient's skin 56 and adjust the tilt angle θ of the sensor face 50. The tightening members 152 allow the practitioner to finely adjust the tilt angle θ of the sensor face 50 and / or the pressure applied by the sensor face 50 based on real-time observed sensor signals. Tightening the tightening members 152 on the plurality of arms 160 can allow the sensor face 50 to tilt about multiple axes.

[0109] Adhesive anchor 150 can replace adhesive anchor 12 in fastening device 10. As previously described, fastening device 10 can be applied to wearable medical sensor 46 when it is positioned on skin 56 in a target area of ​​interest for long-term monitoring. A practitioner can position fastening device 10 on wearable medical device 46 in an orientation corresponding to the tilt of sensor head 48 (i.e., with tightening member 152 positioned adjacent to the portion of sensor head 48 that is pressed inward). Alternatively, fastening device 10 can be secured to wearable medical sensor 46 before it is applied to skin 56. When fastening device 10 is secured to wearable medical sensor 46 but before attaching adhesive anchor 150 to skin 56, a practitioner can position sensor head 48 in the target area of ​​interest at an appropriate tilt angle θ. The practitioner can orient sensor head 48 to ensure that the increased pressure required to tilt sensor head 48 is applied to the end corresponding to the location of tightening member 152 (i.e., end 78). Once the adherent anchor 150 is secured to the skin 56, the practitioner can pull on one end 170 of the tightening member 152 to tighten the arm 160 and press the end of the sensor head 46 (i.e., end 78) into the patient's body until the desired tilt angle θ of the sensor face 50 is achieved. Other tightening members 152 can also be tightened as needed to maintain the position of the sensor head 48 for long-term monitoring or to provide tilt about a second axis. The struts 166 (if present) can bend to accommodate the tightening of the arm 160 as the tightening member 152 is tightened.

[0110] Those skilled in the art will appreciate that the adherent 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.

[0111] The embodiments disclosed herein are intended to provide an explanation of the present invention, not 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 may be made to the present invention without departing from the scope and spirit of the present invention. In addition, it will be understood by those skilled in the art that the features of one embodiment may be combined with the features of another embodiment, although not explicitly described in combination herein.

[0112] Any of the various systems, devices, apparatuses, etc. of the present disclosure may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use by patients, and the methods herein may include sterilization (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of the associated systems, devices, apparatuses, etc.

[0113] Any relative terms or terms of degree used herein (such as "substantially," "essentially," "generally," "approximately," and the like) should be interpreted in accordance with and subject to any applicable limitations or restrictions expressly set forth herein. In all cases, any relative terms or terms of degree used herein should be interpreted as broadly encompassing any relevant disclosed embodiment as well as ranges or variations that would be understood by a person skilled in the art in light of the disclosure as a whole, such as to encompass ordinary manufacturing tolerance variations, accidental alignment variations, transient alignment or shape variations induced by thermal, rotational, or vibrational operating conditions, and the like. Furthermore, any relative terms or terms of degree used herein should be interpreted as encompassing ranges that explicitly include the specified quality, characteristic, parameter, or value without variation, as if no limiting relative term or term of degree were used in a given disclosure or statement.

[0114] Discussion of Detailed Embodiments The following is a non-exclusive description of possible embodiments of the invention.

[0115] A fastening device for attaching a wearable sensor to a patient's body is disclosed. The wearable sensor includes a sensor configured to measure a characteristic of the patient's body. The fastening device includes an adherent anchor configured to adhere the wearable sensor to the patient's body via an adhesive surface, and a handle configured to expose the adhesive surface when pulled after the adherent anchor is attached to the wearable medical sensor. The adherent anchor includes an attachment portion configured to secure the adherent anchor to the wearable medical sensor and an adhesive surface configured to adhere the adherent anchor to the patient's body. The handle is attached to the adhesive surface.

[0116] The fastening device of the preceding paragraph may optionally additionally and / or alternatively include any one or more of the following features, configurations and / or additional components: In the aforementioned embodiments of the fastening device, the adhesive surface can be disposed on a bottom surface of the adherable anchor, and the handle can extend above and be spaced apart from a top surface of the adherable anchor.

[0117] In any of the foregoing fastening device embodiments, the adherable anchor may include an arm extending outwardly from the attachment portion.The adhesive surface may be located on the arm.

[0118] In any of the foregoing fastening device embodiments, the adherable anchor can include a plurality of arms.

[0119] In any of the aforementioned fastening device embodiments, each arm of the plurality of arms may include an end body disposed distal to the attachment portion.The adhesive surface may be located on the end body.

[0120] In any of the aforementioned embodiments of the fastening device, the handle may include a release liner.The release liner may be disposed on the adhesive surface of the end body and may cover the adhesive surface.

[0121] In any of the foregoing fastening device embodiments, the adhesive surface can be located on a first side of the adherable anchor.The handle can extend from the release liner to a second side of the adherable anchor opposite the first side.

[0122] In any of the aforementioned embodiments of the fastening means, the handle may comprise a plurality of strips joined at a junction.Each strip may extend from a release liner provided on the adhesive surface of the end body.

[0123] In any of the aforementioned embodiments of the fastening device, the release liner can extend from the first edge of the end body to the second edge. The first edge can be disposed between the attachment portion and the second edge. Each of the plurality of strips can be connected to the release liner adjacent to the first edge.

[0124] In any of the foregoing fastening device embodiments, the handle can be configured to remove the release liner in response to the handle being pulled away from the adherable anchor, thereby exposing the adhesive surface of each arm.

[0125] In any of the foregoing fastening device embodiments, each arm may include a cutout extending between the attachment portion and the end body.

[0126] In any of the foregoing fastening device embodiments, each arm may include a plurality of struts connecting the attachment portion to the end body.

[0127] In any of the foregoing fastening device embodiments, the attachment portion and the arms may have a formed shape and may be made of a flexible material configured to return to the formed shape when the force is removed.

[0128] In any of the foregoing fastening device embodiments, the attachment portion may be disposed in a first plane and the end body of each arm may be disposed in a second plane substantially parallel to and separated from the first plane by a distance.

[0129] In any of the foregoing fastening device embodiments, the distance may be equal to a thickness of the wearable sensor.

[0130] In any of the foregoing fastening device embodiments, the distance may be less than a thickness of the wearable sensor.

[0131] In any of the foregoing embodiments of the fastening arrangement, the distance may be less than a thickness of the wearable sensor, such that the end body is disposed above a sensor face of the wearable sensor when assembled with the wearable sensor.

[0132] In any of the foregoing embodiments of the fastening arrangement, the attachment portion may include a hole configured to receive a mounting member protruding from a surface of the wearable sensor.

[0133] In any of the aforementioned embodiments of the fastening device, the end body may 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 the adhesive surface.

[0134] In any of the foregoing fastening device embodiments, the adherable anchor may include an anti-rotation member configured to maintain a position of the wearable sensor relative to the adherable anchor.

[0135] In any of the foregoing fastening device embodiments, the anti-rotation member may include a tab extending outwardly from the attachment portion.

[0136] In any of the foregoing fastening device embodiments, the plurality of arms may include an end body disposed distal to the attachment portion and extending along a periphery of the fastening device, wherein the adhesive surface is located on the end body.

[0137] In any of the foregoing fastening device embodiments, the adherable anchor may be formed from a plastic material.

[0138] In any of the foregoing fastening device embodiments, the adherable anchor may be transparent.

[0139] In any of the foregoing fastening device embodiments, the adherable anchor may include three arms.

[0140] In any of the foregoing fastening device embodiments, the arms can be evenly spaced apart.

[0141] Any of the foregoing fastening device embodiments may further include an inflatable bladder disposed beneath the attachment portion and configured to apply pressure to one end of the wearable sensor toward a target area of ​​interest.

[0142] Any of the foregoing embodiments of the fastening device may further include a rigid plate disposed on the attachment portion, the rigid plate having a threaded hole, and 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.

[0143] Any of the foregoing embodiments of the fastening device may further include a wedge disposed between the attachment portion and the wearable sensor. The wedge may be configured to tilt a sensor face of the wearable sensor toward the target area of ​​interest.

[0144] A method for attaching a wearable sensor to a patient's body is disclosed. The wearable sensor includes a sensor configured to measure a property inside the patient's body. The method includes attaching a fastening device to the wearable sensor. The fastening device includes an adhesive anchor configured to adhere the wearable sensor to the patient's skin and a handle including a release liner attached to the adhesive anchor. The method further includes positioning 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 adhesive anchor.

[0145] The method of the preceding paragraph may optionally additionally and / or alternatively include any one or more of the following features, configurations, additional components and / or steps: In an embodiment of the foregoing method, the adherent anchor may include an attachment portion having a hole, and wherein attaching the fastening device to the wearable sensor may include pressing a mounting member of the wearable sensor through the hole.

[0146] In embodiments of any of the foregoing methods, a handle can be disposed above the wearable sensor and the adherable anchor, and can be pulled upward away from the patient’s body.

[0147] In embodiments of any of the foregoing methods, the adherable anchor can include a central attachment portion configured to secure the adherable anchor to the wearable sensor, and a plurality of arms. Each arm of the plurality of arms can extend outward from the central attachment portion, and can include an end body separate from the central attachment portion. The end body can include an adhering surface.

[0148] In embodiments of any of the foregoing methods, pulling the handle upward can cause the plurality of arms to flex, and removing the release liner can cause the end body to contact the skin of the patient’s body.

[0149] In embodiments of any of the foregoing methods, the adherable anchor can exert a downward force on the wearable sensor toward the patient’s body.

[0150] Embodiments of any of the foregoing methods can further include tilting the sensor toward a target region of interest by one of: (1) inflating a bladder disposed between an attachment portion of the adherable anchor and a top surface of the wearable sensor to exert pressure on a portion of the top surface of the wearable sensor, (2) turning a threaded fastener disposed through the adherable anchor and in contact with the top surface of the wearable sensor to exert pressure on a portion of the top surface of the wearable sensor, (3) tightening a cinching member of the adherable anchor to exert pressure on a portion of the top surface of the wearable sensor, and (4) providing a wedge between the adherable anchor and the top surface of the wearable sensor.

[0151] While the application has been described with reference to example embodiments, it will be understood by those skilled in the art that various changes can be made and equivalents can be substituted for elements thereof without departing from the scope of the application. In addition, many modifications can be made to adapt a particular situation or material to the teachings of the application without departing from the central scope thereof. Therefore, the application is not limited to the particular embodiments disclosed, but will include all embodiments falling within the scope of the appended claims.

Claims

1. A fastening device for attaching a wearable sensor to a patient's body, the wearable sensor being configured to measure a property inside the patient's body, the fastening device comprising: an adhesive anchor configured to affix the wearable sensor to the patient's body, the adhesive anchor comprising: an attachment portion configured to secure the adherent anchor to the wearable sensor; and an adhesive surface configured to affix the adherable anchor to the patient's body; and A handle is attached to the adhesive surface, the handle being configured to expose the adhesive surface when pulled after the adhesive anchor is attached to the wearable sensor.

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

3. The fastening device of claim 1, wherein the adherable 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 of the attachment portion, and wherein the adhesive surface is located on the end body.

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

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

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

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, and wherein each of the plurality of strips is connected to the release liner adjacent the first edge, and wherein the handle is configured to remove the release liner in response to pulling the handle away from the adherable anchor, thereby exposing the adhesive surface of each arm.

9. The fastening device of claim 5, wherein each arm comprises at least one of: a cutout extending between the attachment portion and the end body; and A plurality of struts connect the attachment portion to the end body.

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

11. The fastening device of claim 10 , wherein the attachment portion is disposed in a first plane and the end body of each arm is disposed in a second plane, the second plane being substantially parallel to the first plane and separated from the first plane by a distance, wherein the distance is less than a thickness of the wearable sensor, such that the end body is disposed above a sensor face of the wearable sensor when assembled with the wearable sensor.

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

13. The fastening device of claim 5, wherein the end body comprises: a first adhesive layer disposed in contact with the end body; as well as A second adhesive layer is provided on the first adhesive layer, the second adhesive layer forming the adhesive surface.

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

15. The fastening device of claim 5, further comprising a plurality of tightening members, each tightening member being 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. The fastening device of claim 1 , further comprising an inflatable bladder disposed below the attachment 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.

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

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

19. A method of attaching a wearable sensor to a patient's body, the wearable sensor comprising a sensor configured to measure a property inside the patient's body, the method comprising: Attaching a fastening device to the wearable sensor, the fastening device comprising: an adhesive anchor configured to adhere the wearable sensor to the skin of the patient's body; and a handle comprising a release liner attached to the adherable anchor; positioning the wearable sensor on the patient's body; and The handle of the fastening device is pulled to remove the release liner from the adhesive surface of the adherable anchor.

20. The method of claim 19, further comprising tilting the sensor toward a target area of ​​interest by one of: inflating a bladder disposed between an attachment portion of the adherent anchor and a top surface of the wearable sensor to apply pressure to a portion of the top surface of the wearable sensor; rotating a threaded fastener disposed through the adherent 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 tightening member of the adherent anchor to apply pressure to a portion of the top surface of the wearable sensor; as well as A wedge is provided between the adherent anchor and the top surface of the wearable sensor.

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