Pressure detection assembly, and method for manufacturing pressure detection assembly

Abstract

The present disclosure relates to a pressure sensing assembly for use in a non-invasive blood pressure device and a method of manufacturing such a pressure sensing assembly. As described herein, the pressure sensing assembly includes an impermeable film covering one or more cavities and / or channels formed within a semi-rigid sheet. An interface connector is disposed within at least one of the cavities and / or channels and can connect the one or more cavities and / or channels to a tube assembly disposed outside of the pressure sensing assembly. The fluid path, including the cavities and / or channels, defined by the pressure sensing assembly is filled with at least a first pressure sensing fluid and is used to hydraulically convey pressure changes generated by an adjacent blood vessel to a related pressure conversion assembly of the non-invasive blood pressure device.

Description

Technical Field

[0001] The present disclosure generally relates to a pressure sensing assembly for a non-invasive blood pressure cuff, and more specifically, to a method of manufacturing such a pressure sensing assembly.

Background Art

[0002] To detect and record a patient's arterial pressure, a pressure sensing mechanism that is applied invasively or non-invasively to the patient is required. In one method of manufacturing a non-invasive rigid shell blood pressure cuff, the rigid shell is formed in a conical shape, and the sensor pad assembly is positioned inside the rigid shell by rotating the sensor pad assembly and feeding the assembly into a hole in the rigid shell. The sensor pad assembly is then filled with a pressure sensing fluid and adhered to a predetermined position on the inner surface of the rigid shell.

Summary of the Invention

Problems to be Solved by the Invention

[0003] However, these manufacturing methods are complex and can result in various potential failures of the end device that are not immediately obvious or easy to repair.

Means for Solving the Problems

[0004] The present invention is defined by the independent claims. The dependent claims define advantageous embodiments.

[0005] 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 within an opening of the second cavity of the semi-rigid sheet, A tube assembly connected to an interface connector on a second surface of the semi-rigid sheet, and An impermeable film attached to at least a portion of the first surface of the semi-rigid sheet The impermeable film forms a fluid-tight seal over at least the first cavity, the second cavity, and the channel of the semi-rigid sheet.

[0006] Advantages of certain embodiments of the disclosed invention include that they provide a pressure sensing assembly with fewer components compared to known pressure sensing assemblies, resulting in lower costs due to fewer components and fewer potentially failing components, making them more robust. The embodiments also reduce errors that can occur with current manufacturing methods. Further, the embodiments solve the problems caused by forming holes in the semi-rigid shell, which results in non-supportiveness of the shell and thus the need to fill the holes.

[0007] In one embodiment, the tube assembly has a tube and a first adapter, the interface connector is connected at a first end of the tube, and the first adapter is connected to a second end of the tube.

[0008] In one embodiment, the pressure sensing assembly can form a continuous, leak-free fluid path between the first cavity, the channel, the second cavity, and the tube assembly.

[0009] In one embodiment, the pressure sensing assembly can further include a first fluid contained within the continuous, leak-free fluid path.

[0010] In one embodiment, the first fluid is silicone oil.

[0011] In one embodiment, the pressure sensing assembly may further include at least one of a plurality of protrusions and / or spacer devices disposed within the first cavity of the semi-rigid sheet.

[0012] According to another aspect of the present disclosure, a non-invasive blood pressure cuff having the pressure sensing assembly is provided.

[0013] In one embodiment, the non-invasive blood pressure cuff can further include a pressure conversion assembly having a second adapter connected to a pressure transducer, wherein the first adapter of the tube assembly is connected to the second adapter of the pressure conversion assembly.

[0014] According to yet another aspect of the present disclosure, a method of manufacturing a pressure sensing assembly for a non-invasive blood pressure cuff is provided. The method includes (1) forming, on a first surface of a semi-rigid sheet, a first cavity, a second cavity, and a channel connecting the first cavity and the second cavity, wherein the second cavity has an opening that extends through the semi-rigid sheet to a second surface of the semi-rigid sheet; (2) fixing an interface connector within the opening 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 film to at least a portion of the first surface of the semi-rigid sheet, wherein the impermeable film forms a fluid-tight seal over 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 the pressure sensing assembly. having.

[0015] In one embodiment, the method can further include installing a spacer device within at least the first cavity of the semi-rigid sheet before attaching the impermeable film to the first surface of the semi-rigid sheet.

[0016] In one embodiment, the method can further include forming a plurality of protrusions within at least a first cavity of the semi-rigid sheet before attaching the impermeable film to the first surface of the semi-rigid sheet.

[0017] In one embodiment, one or more of the first cavity, the second cavity, and the channel can be formed using injection molding and / or thermoforming.

[0018] In one embodiment, the step of connecting the tube assembly to the interface connector can form a fluid path between the tube assembly, the second cavity, the channel, and the first cavity.

[0019] In one embodiment, the tube assembly can have a tube and a first adapter, the interface connector is connected at a first end of the tube, and the first adapter is connected to a second end of the tube. The method then further includes connecting the first adapter of the tube assembly to a second adapter of the pressure conversion assembly, where the pressure conversion assembly has the second adapter and a pressure transducer filled with a second fluid, and the first and second adapters form a leak-free boundary between the first fluid of the tube assembly and the second fluid of the pressure conversion assembly.

[0020] In one embodiment, the pressure conversion assembly can be disposable, and the first adapter of the tube assembly may be connected to the second adapter of the pressure conversion assembly.

[0021] These and other aspects and embodiments will become apparent from and be elucidated with reference to the embodiments described hereinafter.

Brief Description of the Drawings

[0022] In the figures, like reference characters generally refer to the same parts throughout the different figures. Also, the figures are not necessarily drawn to scale, and instead, emphasis is placed on illustrating the principles of the various embodiments.

Figure 1

Figure 2

Figure 3

Figure 4A

Figure 4B

Figure 5

Figure 6

Figure 7

Figure 8

DETAILED DESCRIPTION OF THE INVENTION

[0023] The present disclosure relates to a non-invasive blood pressure cuff, a pressure sensing assembly for use with a non-invasive blood pressure cuff, and a method of manufacturing such devices. When the blood pressure cuff of the present disclosure is non-invasively attached to a patient, the pressure sensing assembly of the blood pressure cuff hydraulically transmits changes in arterial pressure generated by arterial pulsations. Further, as described herein, the pressure sensing assembly is reversibly connected to a pressure transducer for measuring and recording a patient's blood pressure.

[0024] Referring to FIG. 1, in accordance with various aspects of the present disclosure, a pressure sensing assembly 100 is provided. As shown, the pressure sensing assembly 100 can include a sheet 102 having at least a first surface 104 and a second surface 106. The sheet 102 is a semi-rigid sheet having a polymer composition that, when heated, bends, rounds, and / or rolls into a circular shape (as shown in FIG. 7), but otherwise maintains a high rigidity. The sheet 102 can have a thickness ranging from 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 any combination of their endpoints. Although illustrated as having a rectangular shape, the sheet 102 can have other shapes and is not limited to any particular geometric shape, except as otherwise discussed herein.

[0025] In an embodiment, the first surface 104 of the sheet 102 can be disposed on a patient's body (e.g., around a 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 that hydraulically transmits arterial pulsations to the pressure sensing assembly 100.

[0026] According to 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 can 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 embodiments, each of the cavities 108, 110 and / or the channel 112 can be formed with the sheet 102 using injection molding and / or thermoforming. In further embodiments, the cavities 108, 110 and the channel 112 can have a depth less than the thickness of the sheet 102. In other embodiments, the cavities 108, 110 and the channel 112 may form protrusions extending from the second surface of the sheet 102. Although illustrated as having a rectangular shape, the cavities 108, 110 and the channel 112 can have other shapes and are not limited to any particular geometric shape, unless otherwise discussed herein. For example, but not limited to, the cavities 108, 110 can be circular and / or can have rounded or curved edges to facilitate pressure sensing features when the sheet 102 is rounded into a circular shape.

[0027] In embodiments, at least one of the cavities 108, 110 includes an opening 116 that extends through the thickness of the sheet 102 (i.e., from the first surface 104 to the second surface 106). In certain embodiments, the second cavity 110 may include the opening 116, as shown in FIGS. 1 and 2. Further, as shown in FIG. 2, the pressure sensing assembly 100 includes an interface connector 114 disposed or secured within the opening 116. This interface connector 114 can be, for example, but not limited to, a tube fitting or other adapter having a bore 120 configured to receive and / or secure at least a portion of a tube.

[0028] For example, referring to FIG. 3, the pressure sensing assembly 100 includes a tube assembly 118 that is connected to the interface connector 114 on 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 certain embodiments, the interface connector 114 can be connected to the first end 126 of the tube 122, while the second end 128 of the tube 122 is connected to the first adapter 124. In an embodiment, the first adapter 124 is a fluid-tight adapter such as, for example, a luer lock adapter or a part thereof. In a particular embodiment, the first adapter 124 can be a female luer lock adapter.

[0029] Referring to FIGS. 4A and 4B, the pressure sensing assembly 100 further includes a film (e.g., membrane) 130 that is attached to at least a portion of the first surface 104 of the sheet 102. As shown in FIG. 4A, the pressure sensing assembly 100 is shown in a partially exploded view with the film 130 above the cavities 108, 110, and the channel 112. In certain embodiments, the film 130 can cover at least the cavities 108, 110, and the channel 112. For example, the film 130 may cover the cavities 108, 110, and the channel 112, as well as a certain amount 132 of the first surface 104 surrounding the cavities 108, 110, and the channel 112.

[0030] The film 130 can be attached to the first surface 104 of the sheet 102 in various ways. For example, as shown in FIG. 4B, the film 130 may be attached to the first surface 104 of the sheet 102 via an adhesive that extends along the outer periphery 132 of the film 130. The film 130 is illustrated with a geometric shape that approximates the shape of the cavities 108, 110, and the channel 112, but the film 130 can have other shapes and sizes unless otherwise specifically described herein.

[0031] However, in particular, the film 130 forms a fluid-tight seal over one or more of the cavities 108, 110 and the channel 112. When the film 130 is attached to the first face 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, such as, for example, the first cavity 108, the channel 112, and the second cavity 110. Thus, the film 130 is an impermeable membrane, and the concept of "impermeable" means that the film prevents at least a first fluid from leaking out of the fluid path. In certain embodiments, this fluid path can further include a tube assembly 118 (e.g., the tube 122 and / or the first adapter 124).

[0032] According to various aspects of the present disclosure, the fluid path surrounded by the sheet 102 and the film 130 is filled with at least a first fluid that is a pressure sensing fluid. In other words, the pressure sensing assembly 100 can 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). Thus, the film 130 can be impermeable to at least a first fluid that includes at least a first pressure sensing fluid. In an embodiment, the at least first pressure sensing fluid has a liquid or aqueous solution capable of communicating a pressure difference generated by the flow of blood in adjacent blood vessels along the fluid path. In certain embodiments, the first pressure sensing fluid can include silicone oil.

[0033] Referring now to FIGS. 5 and 6, at least a portion of the fluid path can include a spacing device and / or a plurality of protrusions. That is, a plurality of protrusions 134 and / or a spacing device 136 can be formed and / or disposed within at least a portion of the space defining the fluid path. For example, but not limited to, a plurality of protrusions 134 can be formed and / or disposed within one or more of the cavities and / or channels of the sheet 102 (e.g., the first cavity 108, the second cavity 110, and / or the channel 112). Alternatively, or in combination with the protrusions 134, a spacing device 136 can be formed and / or disposed within one or more of the cavities and / or channels of the sheet 102 (e.g., the first cavity 108, the second cavity 110, and / or the channel 112). In embodiments, the protrusions 134 and / or the spacing device 136 can be used to prevent the film 130 from adhering or sticking to the cavities 108, 110, and / or the channel 112.

[0034] As shown in FIG. 5, a plurality of protrusions 134 are formed within the first cavity 108, which allow the first fluid to flow through the fluid path as described above, but also prevent a film 130 (not shown in FIG. 5) from adhering to the cavity 108. Similarly, in FIG. 6, a spacing device 136 is disposed within the first cavity 108, which allows the first fluid to flow through the fluid path as described above, but also prevents a film 130 (not shown in FIG. 6) from adhering to the cavity 108. In certain embodiments, the spacing device 136 can be a mesh screen.

[0035] According to a further aspect of the present disclosure, a non-invasive blood pressure cuff 200 having a pressure sensing assembly 100 is provided. Referring to FIG. 7, one such non-invasive blood pressure cuff 200 is illustrated as being attached to a body part 202 of a patient (e.g., the upper arm of the patient).

[0036] As described below, the pressure sensing assembly 100 can be heated, wound to become round, or bent in another way to a circular shape during manufacture (i.e., before the cuff 200 is applied to the patient's body 202). In an embodiment, the one or more cavities and channels (e.g., cavities 108, 110 and channel 112) can be formed while the sheet 102 of the pressure sensing assembly 100 is either wound or not wound. Similarly, the film 130 can be attached and the fluid path can be filled while the sheet 102 of the pressure sensing assembly 100 is either wound or not wound. However, when wound, the sheet 102 and / or the non-invasive blood pressure cuff 200 can have a round and / or substantially circular cross-section. When the pressure sensing assembly 100 is wound, the sheet 102 is flexible enough to be placed on the patient's body 202, but rigid enough for the pressure difference generated by the blood flow through the blood vessel 204 adjacent to the pressure sensing assembly 100 to be hydraulically transmitted to the pressure sensing fluid of the pressure sensing assembly 100.

[0037] As shown in FIG. 7, the pressure sensing assembly 100 is wound such that the second face 106 of the sheet 102 faces away from the patient's body part 202. In other words, the first face 104 of the sheet 102 non-invasively contacts the surface of the patient's body part 202. When an arterial pulse is generated in the blood vessel 204 adjacent to the non-invasive blood pressure cuff 200, the resulting wave / signal can propagate through the pressure sensing fluid filling the fluid path.

[0038] As also shown in FIG. 7, the non-invasive blood pressure monitor cuff 200 can further include a pressure conversion assembly 206. This pressure conversion assembly 206 can include, but is not limited to, a second adapter 208 configured to connect to the first adapter 124 of the tube assembly 118, a pressure transducer 210 configured to convert a change in pressure into an electrical signal, and / or a cable 212 configured to measure the electrical signal using this pressure transducer 210. In some embodiments, the second adapter 208 can be a fluid-tight adapter, such as, for example, a luer lock adapter or a part thereof. In a particular embodiment, the second adapter 208 is a male luer lock adapter configured to engage the first adapter 124 of the tube assembly 118.

[0039] In other embodiments, the tube assembly 118 may not include the first adapter 124, and the tube 122 of the tube assembly 118 is directly connected to the pressure conversion assembly 206. For example, the second end 128 of the tube 122 may be directly connected to the pressure transducer 210 of the pressure conversion assembly 206. In some embodiments, the tube assembly 118 may be irreversibly connected and / or fixed to the pressure conversion assembly 206.

[0040] In an embodiment, the pressure conversion assembly 206 can include or otherwise have at least a second fluid. For example, the pressure transducer 210 of the pressure conversion assembly 206 is filled with at least a second fluid. In some embodiments, the second fluid of the pressure conversion assembly 206 is at least a second pressure-sensing fluid. In an embodiment, at least the second pressure-sensing fluid has a liquid or aqueous solution that can convey a pressure difference generated by at least the flow of the first fluid along the fluid path of the pressure sensing assembly 100. In a particular embodiment, the second pressure-sensing fluid can include glycerin.

[0041] In an embodiment, 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 conversion 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 an embodiment where the tube assembly 118 does not include the first adapter 124 and is irreversibly connected to the pressure conversion assembly 206, this irreversible connection forms a leak-free boundary between at least the first fluid of the tube assembly 118 and at least the second fluid of the pressure conversion assembly 206.

[0042] However, in certain embodiments, the first adapter 124 and the second adapter 208 can also be reversibly connectable such that the pressure conversion assembly 206 is disconnected from the pressure sensing assembly 100. In certain embodiments, the pressure conversion assembly 206, or one or more portions of this pressure conversion assembly 206, can be disposable. For example, in some embodiments, the cable 212, the pressure converter 210, and / or the second adapter 208 may be disposable.

[0043] Referring now to FIG. 8, a method of manufacturing the pressure sensing assembly 100 of the non-invasive blood pressure cuff 200 is also provided herein. According to an embodiment of the present disclosure, a method 300 of manufacturing the pressure sensing assembly 100 of the non-invasive blood pressure cuff 200 includes the following steps Step 310 of forming a first cavity 110, a second cavity 110, and a channel 112 connecting the first cavity 110 and the second cavity 110 on a first surface 104 of the semi-rigid sheet 102, wherein the second cavity 110 has an opening 116 extending through the semi-rigid sheet 102 to a second surface 106 of the semi-rigid sheet 102; step 310 Step 320 of fixing an interface connector 114 within an opening 116 of one of the cavities 108, 110 Step 330 of connecting tube assembly 118 to interface connector 114, wherein the tube assembly 118 is adjacent to the second surface 106 of the semi-rigid sheet 102, step 330, Step 340 of attaching an impermeable film 130 to at least a portion of the first surface 104 of the semi-rigid sheet 102, wherein the impermeable film 130 forms a fluid-tight seal over at least the first cavity 108, the second cavity 110 and the channel 112 of the semi-rigid sheet 102, step 340, and Step 350 of filling 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 at least a first fluid to form the pressure sensing assembly 100.

[0044] More specifically, in a first step, method 300 includes step 310 of forming one or more cavities and / or channels (e.g., cavities 108, 110, channel 112, etc.) on the first surface 104 of the semi-rigid sheet 102. When fully assembled, the one or more channels and cavities (e.g., cavities 108, 110, channel 112, etc.) are interconnected such that they define a fluid path for at least a first pressure sensing fluid. In an embodiment, one or more of the cavities 108, 110 and / or the channel 112 can include an opening 116 that penetrates the sheet 102.

[0045] In embodiments, each of the one or more cavities and channels (e.g., cavities 108, 110, channel 112, etc.) is formed (310) using any of injection molding, thermoforming, 3D printing, or other similar manufacturing techniques. For example, in an injection molding process, the composition is heated to a molten composition, which is then injected through a nozzle under a predetermined pressure into a prefabricated mold. When the molten composition hardens, the molded part can be removed from the mold for further processing. In a thermoforming process, a sheet formed from the composition is heated to a forming temperature and applied to a mold using pressure forming, vacuum forming, mechanical forming, or the like. The sheet material is then cooled and trimmed to form a finished part. Alternatively, in a 3D printing process, a digital model is used to deposit, bond, and / or solidify a material composition in multiple layers or operations (e.g., in the form of solids, liquids, powders, etc.).

[0046] In certain embodiments, the composition used in step 310 of forming can have a polymer composition including, but not limited to, acrylate, polyethylene, polystyrene, Lexan, polycarbonate, polypropylene, polyethylene terephthalate glycol, acrylonitrile butadiene styrene, polymethyl methacrylate, and polyvinyl chloride. In certain embodiments, the composition used in step 310 of forming can include a combination of two or more polymers, or can include one or more additives such as, for example, pigments, fillers, and / or reinforcing agents.

[0047] In embodiments, cavities 108, 110 and / or channel 112 may be formed after forming sheet 102, or simultaneously with sheet 102. Further, cavities 108, 110 and / or channel 112 may be formed while sheet 102 is being unrolled (i.e., flat), or while sheet 102 is being rolled up (i.e., curled into a circular shape).

[0048] In a further embodiment, at least one of the cavities and / or channels (e.g., cavities 108, 110, channel 112, etc.) can have an opening 116 that extends through the semi-rigid sheet 102 to the second face 106 of the semi-rigid sheet 102.

[0049] In a second step, method 300 includes step 320 of securing at least one interface connector 114 within the opening 116 of the pressure sensing assembly 100. In an embodiment, the interface connector can be, for example, a pipe fitting such as connector 114 shown in FIG. 2. The interface connector 114 may be secured 320 within the opening 116 so as to form a fluid tight seal over the corresponding opening 116. In an embodiment, the interface connector 114 can include a hollow bore 120 configured to receive a tube 122. Although shown as a separate component in FIG. 2, the interface connector 114 or a portion thereof may be formed together with the cavities 108, 110 and / or channel 112 during step 310. Alternatively, the connector 114 may be irreversibly secured within the corresponding opening 116 by a bonding process.

[0050] Next, method 300 includes step 330 of connecting a tube assembly (e.g., tube assembly 118) to the interface connector 114. In an embodiment, the tube assembly 118 can include at least a first adapter 128, as well as a tube 122 having a first end 126 and a second end 128. The assembly 118 may be connected to the interface connector 114 such that the tube assembly 118 is adjacent to the second face 106 of the sheet 102. In other words, when the pressure sensing assembly 100 is rolled up into a circular shape and applied to the patient's body part 202, the first face 104 faces the patient's body part 202, the second face 106 faces away from the patient's body part 202, and the tube assembly 118 is outside the second face 106 of the sheet 102.

[0051] Method 300 then includes step 340 of attaching 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 one or more of the cavities 108, 110 and / or channels 112. The film 130 can be attached to the sheet 102 via an adhesive as described above, although other methods are contemplated.

[0052] After attachment, the film 130 forms a fluid path between one or more of the cavities 108, 110 and channels 112 and the tube assembly 118. Thus, in step 350, method 300 includes the step of filling the formed fluid path with at least a first fluid to form the pressure sensing assembly 100. In an embodiment, the film 130 may be a flexible thin film capable of transmitting a pressure difference generated by adjacent blood vessels 204 to the fluid, and the fluid may move through one or more of the cavities 108, 110 and channels 112 and through the tube assembly 118.

[0053] In certain embodiments, method 300 can further include steps 325 and / or 326, where a spacer device 136 is disposed and / or a plurality of protrusions 134 are formed with one or more of the cavities 108, 110 and / or channels 112 of the sheet 102. In certain embodiments, the spacer device 136 can be disposed only within the first cavity 108 of the sheet 102. In other embodiments, the plurality of protrusions 134 are formed only within the first cavity 108. In yet other embodiments, the cavities 108, 110 and / or channels 112 can include a combination of the spacer device 136 and / or the protrusions 134. As shown in FIG. 8, steps 325, 326 can be performed individually and / or simultaneously with one or more other steps of method 300 including, but not limited to, steps 320, 330. In certain embodiments, for example, the plurality of protrusions 134 can be formed simultaneously (326) with one or more of the cavities 108, 110 and channels 112 in step 310. In other embodiments, steps 325, 326 are performed prior to attaching the film 130 in step 340.

[0054] Next, at step 360, method 300 can include connecting pressure sensing assembly 100 to pressure conversion assembly 206. In an embodiment, pressure conversion assembly 206 can have at least a second adapter 208 and a pressure transducer 210 having at least a second fluid as described above, such that step 360 includes connecting the second adapter 208 to the first adapter 124. The second fluid can be a pressure sensing fluid like the first fluid, the same fluid as the first fluid, or a different fluid from the first fluid. By connecting pressure sensing assembly 100 to pressure conversion assembly 206, adapters 124, 208 can form a leak - free boundary between the first fluid of tube assembly 118 and the second fluid of pressure conversion assembly 206. In some embodiments, pressure conversion assembly 206 or its components are disposable, and the first adapter 124 of tube assembly 118 can be reversibly connected to the second adapter 208 of pressure conversion assembly 206. In a particular embodiment, the first adapter 124 can be a female luer - lock adapter and the second adapter 208 can be a male luer - lock adapter.

[0055] Finally, in a particular embodiment, method 300 can include step 370, where pressure sensing assembly 100 is formed to be wound, rounded, or otherwise shaped into a circular shape for attachment on a patient's body part 202 as shown in FIG. 7. As described above, pressure sensing assembly 100 may be formed while already in a circular shape. In other embodiments, sheet 102 of pressure sensing assembly 100 is formed while sheet 102 is flat (e.g., during one or more of steps 310 - 360), and then formed into a circular shape at step 370. In a further embodiment, sheet 102 can be first formed into a circular shape and then reversibly expanded to perform one or more of steps 310 - 360. Thus, it is contemplated that one or more of steps 310 - 360 are performed while pressure sensing assembly 100 is in a circular or flat shape.

[0056] As discussed herein, the pressure sensing assembly 100 forms part of a non-invasive blood pressure cuff 200 that is arranged around a patient's body part 202 such that the patient's blood pressure is measured. More specifically, a first face 104 of the pressure sensing assembly 100 of the non-invasive blood pressure cuff 200 is arranged around the patient's body part 202 adjacent to a blood vessel 204, such as an artery. For example, when the arterial pressure changes due to the flow of blood through the blood vessel 204, this pressure is transmitted hydraulically via the pressure sensing fluid of the pressure sensing assembly 100 and the pressure conversion assembly 206.

[0057] It should be understood that the pressure sensing assemblies of the present disclosure are not limited to the specific shapes, dimensions, and / or geometric configurations shown in the figures. Thus, other combinations and configurations are clearly contemplated. It should also be understood that all combinations of the above-described concepts and additional concepts discussed herein (provided such concepts are not mutually inconsistent) are considered to be part of the content of the invention disclosed herein. In particular, all combinations of the content of the claims at the end of the present disclosure are considered to be part of the content of the invention disclosed herein. It should also be understood that any technical terms explicitly used herein that also appear in any disclosure incorporated by reference have meanings that most closely match the specific concepts disclosed herein.

[0058] All definitions as defined and used herein are to be understood as being above the dictionary definitions, definitions in documents incorporated by reference, and / or the ordinary meaning of the defined terms.

[0059] Unless otherwise clearly stated, the indefinite articles "a" and "an" as used in the specification and claims are to be understood to mean "at least one".

[0060] As used in the specification and claims, the expression “and / or” should be understood to mean “either or both” of the elements so combined, i.e., elements that in some cases coexist and in other cases exist alternatively. Multiple elements listed using “and / or” should be construed in the same way, i.e., as “one or more” of the elements so combined. Other elements other than those specifically identified may optionally exist, whether or not in relation to the specifically identified elements, by virtue of the “and / or” clause.

[0061] As used 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” is inclusive, i.e., it includes at least one of a plurality of elements or a list of elements, but also includes more than one, and optionally also includes additional items not in the list. Only terms with specific descriptions clearly indicate that they refer to exactly one of a plurality of elements or a list of elements.

[0062] Generally, the term “or” as used in this specification should be construed as indicating exclusive alternative (i.e., “either one or the other, but not both”) only when followed by exclusive terms such as “either one” or “one of”.

[0063] As used in the specification and claims, "at least one" with respect to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of those elements, but it is not necessarily required to include at least one of every element specifically recited in the list of those elements, and it does not exclude any combination of the elements in the list of those elements. This definition allows that elements other than those specifically recited within the list of elements referred to by the expression "at least one" may optionally be present, whether or not in relation to specifically identified elements.

[0064] In the claims and the above specification, all transitional phrases such as, for example, "comprising", "including", "having", and "containing" are to be understood to be open-ended, i.e., to include but not be limited to those.

[0065] It should also be understood that, unless otherwise specified, in any method claimed in the specification that includes two or more steps or acts, the order of the steps or acts of the method is not necessarily limited to the order in which the steps or acts of the method are recited.

[0066] In this specification, although several inventive embodiments have been described and illustrated, those skilled in the art will readily conceive of various means and / or structures for performing the functions and / or obtaining the results and / or advantages described herein, and each such variation and / or modification is considered to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application for which the teachings of the invention are / is used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. Accordingly, the above-described embodiments are presented by way of example only, and it should be understood that inventive embodiments different from those specifically described and claimed may be practiced within the scope of the appended claims and their equivalents. The inventive embodiments of the present disclosure are directed to the individual features, systems, articles, materials, kits, and / or methods described herein. Additionally, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the inventive scope of the present disclosure if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent.

[0067] In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The means recited in mutually different dependent claims may advantageously be used in combination.

Claims

1. 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 within an opening of the second cavity of the semi-rigid sheet, A tube assembly connected to the interface connector on a second surface of the semi-rigid sheet, and An impermeable film attached to at least a portion of the first surface of the semi-rigid sheet In a pressure sensing assembly having the impermeable film forms a fluid-tight seal over at least the first cavity, the second cavity, and the channel of the semi-rigid sheet, a pressure sensing assembly.

2. The tube assembly has a tube and a first adapter, the interface connector is connected at a first end of the tube, the first adapter is connected to a second end of the tube, the pressure sensing assembly according to claim 1.

3. The pressure sensing assembly forms a continuous, leak-free fluid path between the first cavity, the channel, the second cavity, and the tube assembly, the pressure sensing assembly according to claim 1.

4. The pressure sensing assembly according to claim 3, further comprising a first fluid contained within the continuous, leak-free fluid path.

5. The pressure sensing assembly according to claim 4, wherein the first fluid is silicone oil.

6. The pressure sensing assembly according to claim 1, further comprising at least one of a plurality of protrusions and / or spacer devices disposed within the first cavity of the semi-rigid sheet.

7. A non-invasive blood pressure cuff having the pressure sensing assembly according to any one of claims 1 to 6.

8. The non-invasive blood pressure cuff according to claim 7, further comprising a pressure conversion assembly having a second adapter connected to a pressure transducer, the first adapter of the tube assembly being connected to the second adapter of the pressure conversion assembly.

9. A method of manufacturing a pressure sensing assembly for a non-invasive blood pressure cuff, Forming a first cavity, a second cavity, and a channel connecting the first cavity and the second cavity on a first surface of the semi-rigid sheet, wherein the second cavity has an opening extending through the semi-rigid sheet to a second surface of the semi-rigid sheet, Fixing an interface connector within the opening of the second cavity, Connecting a tube assembly to the interface connector, wherein the tube assembly is adjacent to the second surface of the semi-rigid sheet, Attaching an impermeable film to at least a portion of the first surface of the semi-rigid sheet, wherein the impermeable film forms a fluid-tight seal over at least the first cavity, the second cavity, and the channel of the semi-rigid sheet, and Filling the first cavity, the second cavity, the channel, and the tube assembly of the semi-rigid sheet with a first fluid to form the pressure sensing assembly A method having.

10. The method according to claim 9, further comprising the step of installing a spacer device in at least the first cavity of the semi-rigid sheet before attaching the impermeable film to the first surface of the semi-rigid sheet.

11. The method according to claim 9, further comprising the step of forming a plurality of protrusions in at least the first cavity of the semi-rigid sheet before attaching the impermeable film to the first surface of the semi-rigid sheet.

12. The method according to claim 9, wherein one or more of the first cavity, the second cavity, and the channel are formed using injection molding and / or thermoforming.

13. The step of connecting the tube assembly to the interface connector forms a fluid path between the tube assembly, the second cavity, the channel, and the first cavity, according to the method of claim 9.

14. The tube assembly has a tube and a first adapter, The interface connector is connected at a first end of the tube, and the first adapter is connected at a second end of the tube, The method is Connecting the first adapter of the tube assembly to a second adapter of a pressure conversion assembly, the pressure conversion assembly having the second adapter and a pressure converter filled with a second fluid, the first and second adapters forming a leak-free boundary between the first fluid of the tube assembly and the second fluid of the pressure conversion assembly The method of claim 9, further comprising Claim 15 The method of claim 14, wherein the pressure conversion assembly is disposable and the first adapter of the tube assembly is connected to the second adapter of the pressure conversion assembly

Images