Pressure sensing assembly and manufacturing method thereof

Abstract

The present disclosure relates to a pressure sensing assembly (100) for a non-invasive blood pressure device and a method of manufacturing such a pressure sensing assembly. As described herein, a pressure sensing assembly (100) includes an impermeable membrane (130) covering one or more cavities (108, 110) and / or channels (112) formed within a semi-rigid sheet (102). An interface connector (114) may be located within at least one of the cavities (108, 110) and / or channels (112) and connect one or more of the cavities and / or channels to a tube assembly (118) located outside the pressure sensing assembly (100). A fluid flow path defined by the pressure sensing assembly (100), including a cavity (108, 110) and / or a channel (112), is filled with at least a first pressure sensing fluid and is used to hydraulically transfer a pressure change generated by an adjacent blood vessel to an associated pressure transduction assembly of the non-invasive blood pressure device.

Description

Technical Field

[0001] The present disclosure relates generally to pressure sensing assemblies for non-invasive blood pressure cuffs and, more particularly, to methods of making such pressure sensing assemblies. Background Art

[0002] In order to detect and record a patient's arterial blood pressure, a pressure sensing mechanism that can be applied to the patient in an invasive or non-invasive manner is needed. In one method of manufacturing a non-invasive hard shell blood pressure cuff, the hard shell is formed into a cone and a sensor pad assembly is positioned within the hard shell by wrapping the sensor pad assembly through a hole in the hard shell. The sensor pad assembly can then be filled with a pressure sensing fluid and bonded to the inner surface of the hard shell. However, these manufacturing methods are complex and introduce multiple potential failure points to the end device that may not be easily discovered or repaired. Summary of the invention

[0003] The invention is defined by the independent claim. The dependent claims define advantageous embodiments.

[0004] According to one aspect of the present disclosure, a pressure sensing assembly is provided. The pressure sensing assembly includes: a semi-rigid sheet having a first cavity, a second cavity, and a channel connecting the first cavity and the second cavity formed on a first surface of the semi-rigid sheet; an interface connector disposed in an orifice of the second cavity of the semi-rigid sheet; a tube assembly connected to the interface connector at the second surface of the semi-rigid sheet; and an impermeable membrane attached to at least a portion of the first surface of the semi-rigid sheet, wherein the impermeable membrane forms a fluid-tight seal on at least the first cavity, the second cavity, and the channel of the semi-rigid sheet.

[0005] Advantages of some of the disclosed embodiments of the invention include that they provide a pressure sensing assembly having a reduced number of parts compared to known pressure sensing assemblies, which reduces costs due to having fewer parts, and are more robust due to having fewer parts that can potentially fail. Embodiments also reduce errors that can occur with current manufacturing methods. In addition, embodiments address challenges caused by forming holes in a semi-rigid shell, which creates an unsupported nature in the shell and therefore requires it to be filled.

[0006] In one embodiment, the tube assembly may include a tube and a first adapter, the interface connector being connected at a first end of the tube and the first adapter being connected to a second end of the tube.

[0007] In one embodiment, the pressure sensing assembly may form a continuous leak-free fluid path between the first lumen, the passageway, the second lumen, and the tube assembly.

[0008] In one embodiment, the pressure sensing assembly may further include a first fluid contained within a continuous, leak-free fluid path.

[0009] In one embodiment, the first fluid is silicone oil.

[0010] In one embodiment, the pressure sensing assembly may further include at least one of a plurality of protrusions and / or spacers disposed within the first cavity of the semi-rigid sheet.

[0011] According to another aspect of the present disclosure, a non-invasive blood pressure cuff including the above-mentioned pressure sensing assembly is provided.

[0012] In one embodiment, the non-invasive blood pressure cuff may further include a pressure transducer assembly having a second adapter connected to the pressure transducer, wherein the first adapter of the tube assembly is connected to the second adapter of the pressure transducer assembly.

[0013] According to another aspect of the present disclosure, a method for manufacturing a pressure sensing assembly for a non-invasive blood pressure cuff is provided. The method includes: (1) forming a first cavity, a second cavity, and a channel connecting the first cavity and the second cavity on a first surface of a semi-rigid sheet, wherein the second cavity includes an orifice extending through the semi-rigid sheet to the second surface of the semi-rigid sheet; (2) fixing an interface connector in the orifice of the second cavity; (3) connecting a tube assembly to the interface connector, wherein the tube assembly is adjacent to the second surface of the semi-rigid sheet; (4) attaching an impermeable membrane to at least a portion of the first surface of the semi-rigid sheet, wherein the impermeable membrane forms a fluid-tight seal on at least the first cavity, the second cavity, and the channel of the semi-rigid sheet; and (5) filling the first cavity, the second cavity, and the channel of the semi-rigid sheet and the tube of the tube assembly with a first fluid to form a pressure sensing assembly.

[0014] In one embodiment, the method may further include installing a spacer within at least the first cavity of the semi-rigid sheet before attaching the barrier membrane to the first surface of the semi-rigid sheet.

[0015] In one embodiment, the method may further include forming a plurality of protrusions in at least the first cavity of the semi-rigid sheet before attaching the anti-permeation membrane to the first surface of the semi-rigid sheet.

[0016] In one embodiment, one or more of the first cavity, the second cavity, and the channel may be formed using injection molding and / or thermoforming.

[0017] In one embodiment, connecting the tube assembly to the interface connector may form a fluid path between the tube assembly, the second lumen, the passageway, and the first lumen.

[0018] In one embodiment, the tube assembly may include a tube and a first adapter, the interface connector being connected at a first end of the tube, and the first adapter being connected to a second end of the tube. The method may then further include connecting the first adapter of the tube assembly to a second adapter of a pressure transducer assembly, wherein the pressure transducer assembly includes the second adapter and a pressure transducer filled with a second fluid, the first adapter and the second adapter forming a leak-free boundary between the first fluid of the tube assembly and the second fluid of the pressure transducer assembly.

[0019] In one embodiment, the pressure transducer assembly may be disposable, and the first adapter of the tube assembly may be connected to the second adapter of the pressure transducer assembly.

[0020] These and other aspects and embodiments will be apparent from and elucidated with reference to the embodiment(s) described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In the drawings, like reference numerals generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the various embodiments.

[0022] Figure 1 is a partially exploded perspective view of a pressure sensing assembly shown according to aspects of the present disclosure.

[0023] Figure 2 is a side view of a cross-section of a pressure sensing assembly shown in accordance with aspects of the present disclosure.

[0024] Figure 3 is an illustration of a tube assembly of a pressure sensing assembly shown in accordance with aspects of the present disclosure.

[0025] Figure 4A is a partially exploded view of a pressure sensing assembly shown in accordance with aspects of the present disclosure.

[0026] Figure 4B is a top plan view of an impermeable membrane for use in a pressure sensing assembly according to aspects of the present disclosure.

[0027] Figure 5 is a perspective view of a portion of a pressure sensing assembly having a plurality of protrusions according to aspects of the present disclosure.

[0028] Figure 6 is a top view showing a spacer within a cavity of a pressure sensing assembly according to aspects of the present disclosure.

[0029] Figure 7 is a diagram of a non-invasive blood pressure cuff having a pressure sensing assembly and a pressure transducing assembly according to aspects of the present disclosure.

[0030] Figure 8 is a flow chart illustrating a method of manufacturing a pressure sensing assembly for a non-invasive blood pressure cuff according to aspects of the present disclosure. DETAILED DESCRIPTION

[0031] The present disclosure relates to a non-invasive blood pressure cuff, a pressure sensing assembly for a non-invasive blood pressure cuff, and a method of manufacturing such a device. When the blood pressure cuff of the present disclosure is non-invasively applied to a patient, the pressure sensing assembly of the blood pressure cuff hydraulically transmits arterial pressure changes generated by an arterial pulse. In addition, as described herein, the pressure sensing assembly can be reversibly connected to a pressure transducer to measure and record the patient's blood pressure.

[0032] Go to Figure 1 According to various aspects of the present disclosure, a pressure sensing assembly 100 is provided. As shown, the pressure sensing assembly 100 may include a sheet 102 having at least a first surface 104 and a second surface 106. The sheet 102 is a semi-rigid sheet including a polymer component, and when heated, the sheet 102 can be bent, rolled and / or curled into a donut-shaped configuration (e.g., Figure 6 ), but otherwise maintains high stiffness. The thickness of the sheet 102 can be about 0.5 mm to about 5 mm, including about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, and ranges formed by any combination of these endpoints. Although shown as having a rectangular shape, the sheet 102 can have other shapes and is not limited to any specific geometric shape unless otherwise discussed herein.

[0033] In various embodiments, the first surface 104 of the sheet 102 can be placed against the patient's body (e.g., around the patient's upper arm) when used as part of the pressure sensing assembly 100 of the non-invasive blood pressure cuff 200. Thus, when used as part of the pressure sensing assembly 100 of the non-invasive blood pressure cuff 200, the sheet 102 provides a rigid structure against which the arterial pulse can be hydraulically transmitted to the pressure sensing assembly 100.

[0034] According to various aspects of the present disclosure, the first surface 104 of the sheet 102 has one or more cavities and channels formed thereon. For example, the first surface 104 may have at least a first cavity 108, a second cavity 110, and a channel 112 connecting the first cavity 108 and the second cavity 110. In various embodiments, each of the cavities 108, 110, and / or the channels 112 may be formed with the sheet 102 using injection molding and / or thermoforming. In other embodiments, the depth of the cavities 108, 110, and the channels 112 may be less than the total thickness of the sheet 102. In other embodiments, the cavities 108, 110, and the channels 112 may form a protrusion extending from the second surface of the sheet 102. Although illustrated as having a rectangular shape, the cavities 108, 110, and the channels 112 may have other shapes and are not limited to any specific geometric shape unless otherwise discussed herein. For example, and without limitation, the cavities 108, 110 may be donut-shaped and / or have rounded or curved edges to facilitate pressure sensing features when the sheet 102 is rolled into a donut-shaped configuration.

[0035] In various embodiments, at least one of the cavities 108, 110 includes an aperture 116 extending through the entire thickness of the sheet 102 (ie, from the first surface 104 to the second surface 106). In particular embodiments, the second cavity 110 may include the aperture 116, such as Figure 1 and Figure 2 In addition, Figure 2 As shown, pressure sensing assembly 100 includes an interface connector 114 positioned or secured within aperture 116. Interface connector 114 may be, for example and without limitation, a fitting or other adapter having a hole 120 configured to receive and / or secure at least a portion of a tube.

[0036] For example, refer to Figure 3 , the pressure sensing assembly 100 includes a tube assembly 118, which is connected to the interface connector 114 at the second surface 106 of the sheet 102. The tube assembly 118 can include at least a tube 122 and a first adapter 124. In some aspects, the interface connector 114 can be connected to a first end 126 of the tube 122, and a second end 128 of the tube 122 is connected to the first adapter 124. In various embodiments, the first adapter 124 is a fluid-tight adapter, such as a Luer lock adapter or a portion thereof. In a specific embodiment, the first adapter 124 can be a female Luer lock adapter.

[0037] Go to Figure 4A and Figure 4B The pressure sensing assembly 100 also includes a membrane (eg, a diaphragm) 130 attached to at least a portion of the first surface 104 of the sheet 102. Figure 4AAs shown, the pressure sensing assembly 100 is shown in a partially exploded view, wherein the membrane 130 is located above the cavities 108, 110 and the channel 112. In a particular embodiment, the membrane 130 can cover at least the cavities 108, 110 and the channel 112. For example, the membrane 130 can cover the cavities 108, 110 and the channel 112 and an amount 132 of the first surface 104 surrounding the cavities 108, 110 and the channel 112.

[0038] The film 130 can be attached to the first surface 104 of the sheet 102 in a variety of ways. For example, Figure 4B As shown, the membrane 130 may be attached to the first surface 104 of the sheet 102 by an adhesive extending along a perimeter 132 of the membrane 130. Although the membrane 130 is shown as having a geometric shape that approximates the shapes of the cavities 108, 110 and the channels 112, the membrane 130 may have other shapes and sizes unless otherwise discussed herein.

[0039] However, in particular, the membrane 130 forms a fluid-tight seal on one or more of the cavities 108, 110 and the channel 112. When the membrane 130 is attached to the surface 104 of the sheet 102, the pressure sensing assembly 100 forms a continuous, leak-free fluid path between one or more cavities and / or channels (e.g., the first cavity 108, the channel 112, and the second cavity 110). Therefore, the membrane 130 is an impermeable membrane, wherein the concept of "impermeable" means that the membrane at least prevents the first fluid from escaping from the fluid path. In a specific embodiment, the fluid path may also include a tube assembly 118 (e.g., the tube 122 and / or the first adapter 124).

[0040] According to various aspects of the present disclosure, the fluid path surrounded by the sheet 102 and the membrane 130 may be filled with at least a first fluid, which may be a pressure sensing fluid. In other words, the pressure sensing assembly 100 may include at least a first pressure sensing fluid that fills one or more cavities and / or channels (e.g., cavities 108, 110, and channel 112). Therefore, the membrane 130 may be impermeable to at least the first fluid (including at least the first pressure sensing fluid). In multiple embodiments, at least the first pressure sensing fluid includes a liquid or aqueous solution capable of transmitting a pressure difference generated by blood flow in adjacent blood vessels along the fluid path. In a specific embodiment, the first pressure sensing fluid may include silicone oil.

[0041] Now go to Figure 5 and Figure 6, at least a portion of the fluid path may include a spacer and / or a plurality of protrusions. That is, a plurality of protrusions 134 and / or spacers 136 may be formed and / or disposed within at least a portion of the space defining the fluid path. For example (and not limited to), a plurality of protrusions 134 may be formed and / or disposed within one or more cavities and / or channels (e.g., first cavity 108, second cavity 110, and / or channel 112) of sheet 102. Alternatively, or in combination with protrusions 134, a spacer 136 may be formed and / or disposed within one or more cavities and / or channels (e.g., first cavity 108, second cavity 110, and / or channel 112) of sheet 102. In various embodiments, protrusions 134 and / or spacers 136 may be used to prevent membrane 130 from adhering or attaching to cavities 108, 110, and / or channels 112.

[0042] like Figure 5 As shown, a plurality of protrusions 134 are formed in the first cavity 108, which will allow the first fluid to flow through the fluid path as described above, but will also prevent the membrane 130 ( Figure 5 (not shown) is attached to cavity 108. Similarly, Figure 6 In the embodiment, a spacer 136 is provided in the first chamber 108, which allows the first fluid to flow through the fluid path as described above, while also preventing the membrane 130 ( Figure 6 108. In a specific embodiment, the spacer 136 can be a mesh screen.

[0043] According to other aspects of the present disclosure, a non-invasive blood pressure cuff 200 including a pressure sensing assembly 100 is provided. Figure 7 , shows one such non-invasive blood pressure cuff 200 that may be applied to a patient's body part 202 (eg, the patient's upper arm).

[0044] As described below, the pressure sensing assembly 100 can be heated and rolled, coiled, or otherwise bent into a donut-shaped configuration during the manufacturing process (i.e., before the cuff 200 is applied to the patient's body 202). In various embodiments, one or more cavities and channels (e.g., cavities 108, 110, and channels 112) can be formed with the sheet 102 of the pressure sensing assembly 100 rolled or unfolded. Similarly, the membrane 130 can be attached and the fluid path filled with the sheet 102 of the pressure sensing assembly 100 rolled or unfolded. However, when rolled, the sheet 102 and / or the non-invasive blood pressure cuff 200 can have a circular and / or substantially donut-shaped cross-section. Once the pressure sensing assembly 100 is rolled, the sheet 102 is flexible enough to allow placement on the patient's body 202, but rigid enough so that the pressure differential generated by the flow of blood through the blood vessel 204 adjacent to the pressure sensing assembly 100 can be hydraulically transmitted to the pressure sensing fluid of the pressure sensing assembly 100.

[0045] like Figure 7 As shown, the pressure sensing assembly 100 is rolled so that the second surface 106 of the sheet 102 faces away from the patient's body part 202. In other words, the first surface 104 of the sheet 102 non-invasively contacts the surface of the patient's body part 202. When an arterial pulse is generated within a blood vessel 204 adjacent to the non-invasive blood pressure cuff 200, the generated wave / signal can propagate through the pressure sensing fluid filling the fluid path.

[0046] Also like Figure 7 As shown, the non-invasive blood pressure cuff 200 may also include a pressure transducer assembly 206. The pressure transducer assembly 206 may include, but is not limited to: a second adapter 208 configured to be connected to the first adapter 124 of the tube assembly 118; a pressure transducer 210 configured to convert a pressure change into an electrical signal; and / or a cable 212 configured to measure the electrical signal using the pressure transducer 210. In some embodiments, the second adapter 208 may be a fluid-tight adapter, such as a Luer lock adapter or a portion thereof. In a specific embodiment, the second adapter 208 may be a male Luer lock adapter configured to engage with the first adapter 124 of the tube assembly 118.

[0047] In other embodiments, tube assembly 118 may not include first adapter 124, and tube 122 of tube assembly 118 may be directly connected to pressure transducer assembly 206. For example, second end 128 of tube 122 may be directly connected to pressure transducer 210 of pressure transducer assembly 206. In some embodiments, tube assembly 118 may be irreversibly connected and / or secured to pressure transducer assembly 206.

[0048] In various embodiments, the pressure transducer assembly 206 may contain or otherwise include at least a second fluid. For example, the pressure transducer 210 of the pressure transducer assembly 206 may be filled with at least a certain amount of the second fluid. In some embodiments, the second fluid of the pressure transducer assembly 206 may be at least a second pressure sensing fluid. In various embodiments, at least the second pressure sensing fluid includes a liquid or aqueous solution capable of transmitting a pressure differential generated by the flow of at least the first fluid along the fluid path of the pressure sensing assembly 100. In a specific embodiment, the second pressure sensing fluid may include glycerol.

[0049] In various embodiments, the first adapter 124 and the second adapter 208 can form a leak-free boundary between at least the first fluid of the tube assembly 118 and at least the second fluid of the pressure transducer assembly 206. Thus, when the first adapter 124 and the second adapter 208 are connected, different fluids (e.g., at least the first fluid and the second fluid) do not mix. In embodiments where the tube assembly 118 does not include the first adapter 124 and is irreversibly connected to the pressure transducer assembly 206, the irreversible connection can form a leak-free boundary between at least the first fluid of the tube assembly 118 and at least the second fluid of the pressure transducer assembly 206.

[0050] However, in some embodiments, the first adapter 124 and the second adapter 208 may be reversibly connected so that the pressure transducer assembly 206 may be disconnected from the pressure sensing assembly 100. In particular embodiments, the pressure transducer assembly 206 or one or more components of the pressure transducer assembly 206 may be disposable. For example, in some embodiments, the cable 212, the pressure transducer 210, and / or the second adapter 208 may be disposable.

[0051] Now go to Figure 8, the present invention also provides a method for manufacturing a pressure sensing assembly 100 for a non-invasive blood pressure cuff 200. According to an embodiment of the present disclosure, a method 300 for manufacturing a pressure sensing assembly 100 for a non-invasive blood pressure cuff 200 includes the following steps: forming 310 a first cavity 108, a second cavity 110, and a channel 112 connecting the first cavity 108 and the second cavity 110 on a first surface 104 of a semi-rigid sheet 102, wherein the second cavity 110 includes an orifice 116 extending through the semi-rigid sheet 102 to the second surface 106 of the semi-rigid sheet 102; fixing 320 an interface connector 114 in the orifice 116 of one of the cavities 108, 110; and connecting the tube assembly 118 to the first surface 104 of the semi-rigid sheet 102; 330 to the interface connector 114, wherein the tube assembly 118 is adjacent to the second surface 106 of the semi-rigid sheet 102; attaching 340 the impermeable membrane 130 to at least a portion of the first surface 104 of the semi-rigid sheet 102, wherein the impermeable membrane 130 forms a fluid-tight seal on at least the first cavity 108, the second cavity 110 and the channel 112 of the semi-rigid sheet 102; filling 350 at least the first cavity 108, the second cavity 110 and the channel 112 of the semi-rigid sheet 102 and the tube 122 of the tube assembly 118 with a first fluid to form the pressure sensing assembly 100.

[0052] More specifically, in a first step, the method 300 includes forming 310 one or more cavities and / or channels (e.g., cavities 108, 110, channels 112, etc.) on the first surface 104 of the semi-rigid sheet 102. The one or more channels and cavities may be interconnected such that when fully assembled, the cavities and channels (e.g., cavities 108, 110, channels 112, etc.) define a fluid flow path for at least a first pressure sensing fluid. In various embodiments, one or more of the cavities 108, 110, and / or channels 112 may include an orifice 116 extending through the sheet 102.

[0053] In various embodiments, each of one or more cavities and channels (e.g., cavities 108, 110, channels 112, etc.) can be formed 310 using injection molding, thermoforming, three-dimensional printing, or another similar production technology. For example, in the injection molding process, the components are heated to become molten components, and then injected into a prefabricated mold through a nozzle under a certain pressure. Once the molten components are solidified, the molded parts can be removed from the mold for further processing. In the thermoforming process, a sheet formed of a certain component is heated to a molding temperature and applied to a mold using pressure molding, vacuum molding, mechanical molding, etc. The sheet material is then cooled and trimmed to obtain a finished part. Alternatively, in a three-dimensional printing process, a digital model is used to deposit, connect, and / or solidify material components (e.g., in the form of solids, liquids, powders, etc.) in multiple layers or operations.

[0054] In specific embodiments, the components used in forming step 310 may include polymer components, including but not limited to acrylates, polyethylene, polystyrene, Lexan, polycarbonate, polypropylene, polyethylene terephthalate, acrylonitrile butadiene styrene, polymethyl methacrylate, polyvinyl chloride, etc. In some embodiments, the components used in forming step 310 may include a combination of two or more polymers, or may include one or more additives, such as pigments, fillers, and / or reinforcing agents.

[0055] In various embodiments, the cavities 108, 110, and / or channels 112 may be formed after the sheet 102 is formed, or simultaneously with the sheet 102. Additionally, the cavities 108, 110, and / or channels 112 may be formed when the sheet 102 is unrolled (i.e., flat) or when the sheet 102 is rolled (i.e., rolled into a donut-shaped configuration).

[0056] In other embodiments, at least one of the cavities and / or channels (eg, cavities 108 , 110 , channels 112 , etc.) may include an aperture 116 extending through the semi-rigid sheet 102 to the second surface 106 of the semi-rigid sheet 102 .

[0057] In a second step, the method 300 includes securing 320 at least one interface connector 114 within the aperture 116 of the pressure sensing assembly 100. In various embodiments, the interface connector may be a pipe fitting, such as Figure 2 The interface connector 114 can be secured 320 within the orifice 116 such that it forms a fluid-tight seal on the corresponding orifice 116. In various embodiments, the interface connector 114 can include a hollow bore 120 configured to receive a tube 122. Although in Figure 2 Although shown as a separate component in FIG, the interface connector 114 or a portion thereof may be formed together with the cavities 108, 110 and / or the channels 112 during step 310. Alternatively, the connector 114 may be irreversibly fixed within the corresponding aperture 116 by a bonding process.

[0058] Next, the method 300 includes connecting 330 a tube assembly (e.g., the tube assembly 118) to the interface connector 114. In various embodiments, the tube assembly 118 may include at least a first adapter 128 and a tube 122 having a first end 126 and a second end 128. The tube assembly 118 may be connected to the interface connector 114 such that the tube assembly 118 is adjacent to the second surface 106 of the sheet 102. In other words, when the pressure sensing assembly 100 is rolled into a donut-shaped configuration and applied to the patient's body part 202, the first surface 104 faces the patient's body part 202, the second surface 106 faces away from the patient's body part 202, and the tube assembly 118 is located outside the second surface 106 of the sheet 102.

[0059] The method 300 then includes attaching 340 a film (e.g., film 130) to at least a portion of the first surface 104 of the sheet 102 such that the film 130 forms a fluid-tight seal over at least one or more of the cavities 108, 110, and / or channels 112. The film 130 may be attached to the sheet 102 by an adhesive, as described above, but other methods are also contemplated.

[0060] After being attached, the membrane 130 forms a fluid path between the one or more cavities 108, 110 and the channel 112 and the tube assembly 118. Thus, in step 350, the method 300 includes filling the formed fluid path with at least a first fluid to form the pressure sensing assembly 100. In various embodiments, the membrane 130 can be a flexible film that can transmit a pressure differential generated by an adjacent blood vessel 204 to a fluid that can be transferred through the one or more cavities 108, 110 and the channel 112 and through the tube assembly 118.

[0061] In particular embodiments, method 300 may further include steps 325 and / or 326, wherein spacers 136 are placed and / or a plurality of protrusions 134 are formed with one or more cavities 108, 110, and / or channels 112 of sheet 102. In particular embodiments, spacers 136 may be placed only within first cavities 108 of sheet 102. In other embodiments, a plurality of protrusions 134 are formed only within first cavities 108. In further embodiments, cavities 108, 110, and / or channels 112 may include a combination of spacers 136 and / or protrusions 134. Figure 8 As shown, steps 325, 326 may be performed separately and / or simultaneously with one or more other steps of method 300, including but not limited to steps 320, 330. In some embodiments, for example, a plurality of protrusions 134 may be formed 326 simultaneously with one or more cavities 108, 110 and channels 112 in step 310. In other embodiments, steps 325, 326 are performed before attaching the film 130 in step 340.

[0062] Next, in step 360, the method 300 may include connecting the pressure sensing assembly 100 to the pressure transducing assembly 206. In various embodiments, the pressure transducing assembly 206 may include at least the second adapter 208 and the pressure transducer 210 including at least the second fluid, as described above, such that step 360 includes connecting the second adapter 208 to the first adapter 124. The second fluid may be a pressure sensing fluid similar to the first fluid, may be the same fluid as the first fluid, or may be a different fluid than the first fluid. By connecting the pressure sensing assembly 100 to the pressure transducing assembly 206, the adapters 124, 208 may form a leak-free boundary between the first fluid of the tube assembly 118 and the second fluid of the pressure transducing assembly 206. In some embodiments, the pressure transducing assembly 206 or components thereof may be disposable, and the first adapter 124 of the tube assembly 118 may be reversibly connected to the second adapter 208 of the pressure transducing assembly 206. In a particular embodiment, the first adapter 124 may be a female Luer lock adapter, and the second adapter 208 may be a male Luer lock adapter.

[0063] Finally, in some embodiments, method 300 may include step 370, wherein pressure sensing assembly 100 is rolled, coiled, or otherwise formed into a donut-shaped configuration that can be worn on a patient's body part 202, such as Figure 7 As described above, the pressure sensing assembly 100 can be formed when it is already in a donut-shaped configuration. In other embodiments, the sheet 102 of the pressure sensing assembly 100 can be formed when the sheet 102 is flat (e.g., one or more of steps 310 to 360), and then subsequently formed into a donut-shaped configuration in step 370. In other embodiments, the sheet 102 can first be formed into a donut-shaped configuration and then reversibly unfolded to perform one or more of steps 310 to 360. Therefore, it is contemplated that one or more of steps 310 to 360 can be performed when the pressure sensing assembly 100 is in a donut-shaped configuration or a flat configuration.

[0064] As described herein, the pressure sensing assembly 100 can form a portion of a non-invasive blood pressure cuff 200 that can be placed around a patient's body part 202 so as to be able to measure the patient's blood pressure. More specifically, the first surface 104 of the pressure sensing assembly 100 of the blood pressure cuff 200 can be placed around the patient's body part 202, adjacent to a blood vessel 204 (e.g., an artery). When arterial pressure changes, such as due to blood flowing through the blood vessel 204, the pressure is hydraulically transmitted through the pressure sensing assembly 100 and the pressure sensing fluid of the pressure transducer assembly 206.

[0065] It should be understood that the pressure sensing components of the present disclosure are not limited to the specific shapes, sizes and / or geometries shown in the accompanying drawings. Therefore, other combinations and configurations are expressly contemplated. It should also be understood that all combinations of the foregoing concepts and additional concepts discussed herein (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein. Specifically, all combinations of the claimed subject matter appearing at the end of this disclosure are considered part of the inventive subject matter disclosed herein. It should also be understood that terms explicitly used herein may also appear in any disclosure incorporated by reference, and such terms should have the meaning most consistent with the specific concepts disclosed herein.

[0066] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0067] The indefinite articles "a" and "an" as used herein in the specification and claims, unless expressly indicated to the contrary, should be understood to mean "at least one".

[0068] The term "and / or" as used herein in the specification and claims should be understood to refer to "either or both" of the elements so connected (i.e., elements that are present jointly in some cases and separately in other cases). Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so connected. In addition to the elements specifically identified by the "and / or" clause, other elements may optionally be present, whether related or unrelated to those elements specifically identified.

[0069] As used herein in the specification and claims, "or" should be understood to have the same meaning as "and / or" defined above. For example, when separating items in a list, "or" or "and / or" should be interpreted as inclusive, that is, the inclusion of at least one of multiple elements or lists of elements, and more than one, and optionally additional unlisted items. Only terms that are clearly pointed out to the contrary will refer to the inclusion of exactly one element in multiple elements or lists of elements. Generally, the term "or" used in this article should only be interpreted as indicating exclusive substitution (i.e., "one or the other but not both") when following an exclusive term (e.g., "select one of...", "one of...").

[0070] As used herein in the specification and claims, the term "at least one" when referring to a list of one or more elements should be understood to refer to at least one element selected from any one or more of the elements in the element list, but does not necessarily include each and every one of the elements specifically listed in the element list, and does not exclude any combination of elements in the element list. This definition also allows that in addition to the elements specifically identified in the element list to which the term "at least one" refers, elements may optionally be present, whether related or unrelated to those elements specifically identified.

[0071] In the claims and the above description, all transitional words, such as "include", "comprising", "having", "containing", etc., should be understood as open-ended, that is, meaning including and not limited to.

[0072] It should also be understood that in any method claimed herein that includes more than one step or action, the order of the method steps or actions is not necessarily limited to the order of the method steps or actions as recited unless clearly stated to the contrary.

[0073] Although multiple creative embodiments have been described and illustrated herein, a person of ordinary skill in the art will readily conceive of a variety of other devices and / or structures for performing the functions described herein and / or obtaining the results and / or one or more advantages described herein, and each of such variations and / or modifications is considered to be within the scope of the creative embodiments described herein. More generally, those skilled in the art will readily recognize that all parameters, dimensions, materials, and configurations described herein are exemplary, and that actual parameters, dimensions, materials, and / or configurations will depend on one or more specific applications in which the creative teachings are used. Those skilled in the art will recognize or be able to determine many equivalents of the specific creative embodiments described herein using only routine experiments. Therefore, it should be understood that the foregoing examples are presented only by way of example, and within the scope of the appended claims and their equivalents, these creative embodiments may be practiced in a manner different from that specifically described and claimed. The creative embodiments of the present disclosure relate to each individual feature, system, article, material, kit, and / or method described herein. In addition, if such features, systems, articles, materials, kits and / or methods are not inconsistent with each other, any combination of two or more such features, systems, articles, materials, kits and / or methods is also included in the inventive scope of the present disclosure.

[0074] In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. Measures recited in mutually different dependent claims may advantageously be used in combination.

Claims

1. A pressure sensing assembly (100), the assembly (100) comprising: A semi-rigid sheet (102) having a first cavity (108), a second cavity (110), and a channel (112) connecting the first cavity (108) and the second cavity (110) formed on a first surface (104) of the semi-rigid sheet (102); an interface connector (114) disposed within an opening (116) of the second cavity of the semi-rigid sheet (102); a tube assembly (118) connected to the interface connector (114) at the second surface (106) of the semi-rigid sheet (102); as well as A permeation barrier membrane (130) is attached to at least a portion of the first surface (104) of the semi-rigid sheet (102), wherein the permeation barrier membrane forms a fluid-tight seal on at least the first cavity (108), the second cavity (110), and the channel (112) of the semi-rigid sheet (102).

2. The pressure sensing assembly (100) according to claim 1, wherein: The tube assembly (118) includes a tube (122) and a first adapter (124), the interface connector (114) being connected at a first end (126) of the tube (122), and the first adapter (124) being connected to a second end (128) of the tube (122).

3. The pressure sensing assembly (100) according to claim 1, wherein: The pressure sensing assembly (100) forms a continuous leak-free fluid path between the first chamber (108), the passage (112), the second chamber (110), and the tube assembly (118).

4. The pressure sensing assembly (100) according to claim 3, wherein: The pressure sensing assembly (100) also includes a first fluid contained within the continuous, leak-free fluid path.

5. The pressure sensing assembly (100) according to claim 4, wherein: The first fluid is silicone oil.

6. The pressure sensing assembly (100) according to claim 1, wherein: The pressure sensing assembly (100) further includes at least one of a plurality of protrusions (134) and / or spacers (136) disposed within the first cavity (108) of the semi-rigid sheet (102).

7. A non-invasive blood pressure cuff (200) comprising the pressure sensing assembly (100) according to any one of claims 1 to 6.

8. The non-invasive blood pressure cuff (200) according to claim 7, wherein: The non-invasive blood pressure cuff (200) also includes a pressure transducer assembly (206) having a second adapter (208) connected to a pressure transducer (210), wherein the first adapter (124) of the tube assembly (118) is connected to the second adapter (208) of the pressure transducer assembly (206).

9. A method (300) of manufacturing a pressure sensing assembly (100) for a non-invasive blood pressure cuff (200), the method comprising: forming (310) a first cavity (108), a second cavity (110), and a channel (112) connecting the first cavity (108) and the second cavity (110) on a first surface (104) of a semi-rigid sheet (102), wherein the second cavity (110) includes an orifice (116) extending through the semi-rigid sheet (102) to the second surface (106) of the semi-rigid sheet (102); securing (320) an interface connector (114) within the opening (116) of the second chamber (110); connecting (330) a tube assembly (118) to the interface connector (114), wherein the tube assembly (118) is adjacent to the second surface (106) of the semi-rigid sheet (102); attaching (340) a barrier membrane (130) to at least a portion of the first surface (104) of the semi-rigid sheet (102), wherein the barrier membrane (130) forms a fluid-tight seal across at least the first cavity (108), the second cavity (110), and the channel (112) of the semi-rigid sheet (102); The first cavity (108), the second cavity (110), and the channel (112) of the semi-rigid sheet (112) and the tube assembly (118) are filled (350) with a first fluid to form the pressure sensing assembly (100).

10. The method (300) of claim 9, wherein: The method (300) further comprises: Prior to attaching the impermeability barrier membrane (130) to the first surface (104) of the semi-rigid sheet (102), a spacer (136) is installed (325) within at least the first cavity (108) of the semi-rigid sheet (102).

11. The method (300) of claim 9, wherein: The method (300) further comprises: Prior to attaching the impermeability barrier film (130) to the first surface (104) of the semi-rigid sheet (102), a plurality of protrusions (134) are formed (326) at least within the first cavity (108) of the semi-rigid sheet (102).

12. The method (300) of claim 9, wherein: One or more of the first cavity (108), the second cavity (110), and the channel (112) are formed using injection molding and / or thermoforming.

13. The method (300) of claim 9, wherein: Connecting the tube assembly (118) to the interface connector (114) forms a fluid path between the tube assembly (118), the second chamber (110), the passageway (112), and the first chamber (108).

14. The method (300) of claim 9, wherein: The tube assembly (118) includes a tube (122) and a first adapter (124), the interface connector (114) being connected at a first end (126) of the tube (122), and the first adapter (124) being connected to a second end (128) of the tube (122), and the method (300) further includes: The first adapter (124) of the tube assembly (118) is connected (360) to the second adapter (208) of the pressure transducer assembly (206), wherein the pressure transducer assembly (206) includes the second adapter (208) and a pressure transducer (210) filled with a second fluid, and the first adapter (124) and the second adapter (208) form a leak-free boundary between the first fluid of the tube assembly (118) and the second fluid of the pressure transducer assembly (206).

15. The method (300) of claim 14, wherein: The pressure transducer assembly (206) is disposable, and the first adapter (124) of the tube assembly (118) is connected to the second adapter (208) of the pressure transducer assembly (206).

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