Inflatable radial artery compression device with cinch wristband and method of use

Abstract

Radial artery compression devices are disclosed. Some embodiments include an inflatable chamber and a frame. Also disclosed are securement bands including a securement band having a free end that passes through a portion of the frame. Systems and methods for securing and / or positioning the securement device with one hand are also disclosed.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 065,318, filed August 13, 2020, entitled “Inflatable Radial Artery Compression Device with Cinching Wristband and Method of Use,” which is hereby incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally pertains to the field of medical devices. More specifically, some embodiments relate to compression devices, including radial artery compression devices having an inflatable chamber and a wristband. Attached Figure Description

[0004] The written disclosure herein describes non-limiting and non-exhaustive illustrative embodiments. Referring to some of these illustrative embodiments depicted in the accompanying drawings, wherein:

[0005] Figure 1 An embodiment of a radial artery compression device fixed to a patient's wrist is depicted.

[0006] Figure 2 yes Figure 1 A three-dimensional view of the underside of the radial artery compression device.

[0007] Figure 3A yes Figures 1 to 2 A side view of a radial artery compression device, in which the inflatable chamber is in an uninflated state.

[0008] Figure 3B yes Figures 1 to 2 A front view of the radial artery compression device, showing the outside of the wristband.

[0009] Figure 4 yes Figures 1 to 3B A side view of a portion of a radial artery compression device, in which the inflatable chamber is fully inflated.

[0010] Figure 5A It is on the patient's wrist. Figures 1 to 4 A cross-sectional side view of the radial artery compression device, in its initial placement state.

[0011] Figure 5B yes Figures 1 to 4 A cross-sectional side view of the radial artery compression device, showing a wristband (without tension) wrapped around the wrist and the free end of the wristband inserted into an elongated slot through the frame of the radial artery compression device.

[0012] Figure 5C yes Figures 1 to 4 A cross-sectional side view of a radial artery compression device shows the wristband wrapped around the wrist in a stretched state. Different directions in which the wristband can be pulled to create tension within it are also shown.

[0013] Figure 5D yes Figures 1 to 4 A cross-sectional side view of the radial artery compression device, showing the wristband being tensioned and the free end fixed to the portion of the wristband extending around the wrist.

[0014] Figure 5E yes Figures 1 to 4 A cross-sectional side view of the radial artery compression device, showing the wristband being tensioned and secured and the inflatable chamber being inflated.

[0015] Figure 6 yes Figures 1 to 5E A three-dimensional diagram of the radial artery compression device, showing the relative positioning of the markers with respect to the puncture site and the arterial incision site.

[0016] Figure 7 yes Figures 1 to 6 A cross-sectional view of the radial artery compression device, showing the puncture site and the arterial incision site.

[0017] Figure 8 yes Figures 1 to 7 A perspective view of the radial artery compression device, showing the battery removal mechanism.

[0018] Figure 9 This is a perspective view of an embodiment of a solar-powered radial artery compression device.

[0019] Figure 10 This is a perspective view of another embodiment of the radial artery compression device.

[0020] Figure 11 This is a side view of another embodiment of the radial artery compression device.

[0021] Figure 12 This is a perspective view of the frame of another embodiment of the radial artery compression device.

[0022] Figure 13 yes Figure 12 The side view of the frame.

[0023] Figure 14 yes Figure 12 A cross-sectional side view of the frame.

[0024] Figure 15 yes Figures 11 to 14A cross-sectional view of the radial artery compression device, showing the wristband being tensioned and the free end fixed to a portion of the wristband's extension around the wrist. Detailed Implementation

[0025] Various medical procedures involve inserting one or more elongated medical devices into a patient's vascular system. Some such interventional procedures involve delivering the medical device via the patient's radial artery. Compression can be used to facilitate hemostasis during and / or after interventional procedures involving puncture of the vascular system. In some embodiments within the scope of this disclosure, a compression device is involved that is configured to compress a patient's radial artery. The use of such or similar devices to provide compression along other parts of the vascular system (including the vascular system within the arm, leg, or other parts of the body) is also within the scope of this disclosure. Therefore, the disclosure described herein in connection with compression of the radial artery can be similarly applied to devices configured to compress other parts of the vascular system.

[0026] To facilitate hemostasis at the radial approach site, pressure can be applied at the arterial incision site, which may be located slightly upstream of the skin puncture site. Such pressure can prevent or reduce blood leakage from the arterial incision site and promote hemostasis. Some embodiments described herein facilitate the application of pressure to promote hemostasis at the radial approach site.

[0027] In some cases, the application of devices wrapped around limbs (e.g., the wrist) can present various challenges for medical practitioners. Compression devices used for hemostasis can cause discomfort to patients. Compression devices secured around limbs (e.g., the wrist) can be configured to minimize such discomfort by controlling the tension on the bands of the compression device—that is, sufficient tension to induce pressure from the compression device for hemostasis, while minimizing or avoiding tension that leads to unnecessary or undesirable contractions. In some cases, establishing and maintaining accurate placement of the hemostatic device at the site of arterial incision or skin puncture while generating the desired tension can be challenging for medical practitioners. The use of hook and loop fastening systems allows for a range of attachment lengths that are relevant to a range of patient body sizes. Hook and loop fastening systems can also be an economical fastening solution. However, hook and loop fastening systems consist of two separate bands (each with a free end), one with a hook component and the other with a loop, which can complicate the fastening of the bands. For example, connecting two separate bands (each with a free end) may require two hands and / or may be difficult or clumsy to do while maintaining the desired placement and / or tension. As described herein, a compression device that includes a band with two hook-and-loop components (which are associated with a band having a free end) facilitates the connection, placement, and tensioning of the compression device on the patient.

[0028] The components of the embodiments generally described and illustrated in the accompanying drawings can be arranged and designed in a wide variety of different configurations. Therefore, the following more detailed description of the various embodiments illustrated in the drawings is not intended to limit the scope of this disclosure, but merely to illustrate various embodiments. Although various aspects of the embodiments are presented in the drawings, the drawings are not necessarily drawn to scale unless explicitly indicated.

[0029] The phrase “connected to” is broad enough to refer to any suitable connection or other form of interaction between two or more entities. Thus, two components can be connected to each other even if they are not in direct contact. For example, two components can be connected to each other via an intermediate component. The phrase “attached to” refers to an interaction between two or more entities that are in direct contact with each other and / or separated only by any suitable kind of fastener (e.g., adhesive). The phrase “fluidly connected” is used in its ordinary sense and is broad enough to refer to an arrangement in which a fluid (e.g., gas or liquid) can flow from one component to another when the components are in fluid communication with each other.

[0030] The terms “proximal” and “distal” are opposite directional terms and are given their common meaning in the field of medical devices. That is, these terms are used to indicate the orientation of a medical device or multiple parts thereof, where one end (labeled proximal) is closest to the practitioner during routine use. Additionally, this disclosure uses the terms radius and ulna to refer to directions along the patient’s arm. When used as directional terms, the term “radial” refers to the direction from the center of the arm or hand toward the thumb-side portion of the arm or hand. The term “ulnar” refers to the opposite direction. The specific volume described herein refers to the volume of fluid delivered from a syringe that holds the described fluid volume at atmospheric pressure. For example, if an inflatable chamber is capable of receiving 15 mL of air from a syringe that holds 15 mL of air at atmospheric pressure, then its capacity is 15 mL.

[0031] Figures 1 to 4 An alternative view of the radial artery compression device 100 is provided. More specifically, Figure 1 A radial artery compression device 100 is depicted, which is fixed to the wrist of a patient 50. Figure 2 A three-dimensional view of the underside of the radial artery compression device 100 is provided. Figure 3A A side view of the radial artery compression device 100 is provided. Figure 3B A front view of the radial artery compression device 100 is provided, and a front view of the wristband 130 is shown. Figure 4 A side view of the radial artery compression device 100 is provided, wherein the inflatable chamber 126 is inflated.

[0032] like Figures 1 to 4As shown, the radial artery compression device 100 may include a substantially rigid frame 110, a flexible sheet 120, and a wristband 130.

[0033] The substantially rigid frame 110 may include an outer surface 111 and an inner surface 113. In some embodiments, the substantially rigid frame 110 is contoured to bend around the thumb-side portion of the patient 50's wrist 54. For example, in some embodiments, the substantially rigid frame 110 includes a curved portion 112 (see...). Figure 3A and Figure 4 ).exist Figures 1 to 4 In the illustrated embodiment, frame 110 is shaped as a curved (e.g., arched) member. The outer surface 111 of frame 110 (or a portion thereof) may be convex, while the inner surface 113 of frame 110 (or a portion thereof) may be concave. In some embodiments, the substantially rigid frame 110 further includes a substantially straight portion 114 opposite the curved portion 112, the straight portion 114 being configured to be positioned adjacent to the underside (i.e., palm side) of the patient 50's wrist 54. In some embodiments, the substantially rigid frame 110 (or a portion thereof) is transparent. Other shapes and designs of frames (including shapes and designs configured to conform to the contours of other parts of the body) are within the scope of this disclosure.

[0034] In some embodiments, the curved portion 112 may have a radius of curvature (r) between 1.5 cm and 2.5 cm (see...). Figure 3A Additionally or alternatively, the degree measurement (θ) of the arc formed by the curved portion 112 may be between 45 degrees and 100 degrees. For example, in some embodiments, the curved portion 112 is between 80 degrees and 95 degrees (e.g., approximately 90 degrees).

[0035] The flexible sheet 120 may be attached to the frame 110. For example, in some embodiments, the flexible sheet 120 includes a peripheral portion 122 attached to the frame 110 and a central portion not attached to the frame 110. In some embodiments, the peripheral portion 122 of the flexible sheet 120 is attached to the frame 110 via welding or adhesive. The flexible sheet 120 may be made of any suitable material, such as polyurethane or PVC. In some embodiments, the material of the flexible sheet is stretchable. In the depicted embodiments, the flexible sheet 120 is substantially rectangular in shape, although other shapes are also within the scope of this disclosure. In some embodiments, the flexible sheet 120 (or a portion thereof) is transparent. For example, in some embodiments, both the substantially rigid frame 110 (or a portion thereof) and the flexible sheet 120 (or a portion thereof) are transparent, thereby allowing an practitioner to observe the radial approach site through the frame 110 and the flexible sheet 120. In some embodiments, an practitioner may need to observe the radial approach site through only two layers (e.g., the frame 110 and the flexible sheet 120). Compared to embodiments where the radial approach is observed through more than two layers or partially, observation through only two layers provides improved visual clarity. Embodiments where the flexible sheet or airbag completely surrounds and defines the inflation volume and the airbag is attached to the frame are also within the scope of this disclosure.

[0036] A substantially rigid frame 110 and a flexible sheet 120 can form an inflatable chamber 126. For example, the inner surface 113 of the frame 110 and the flexible sheet 120 can at least partially define the inflatable chamber 126. In other words, the walls of the inflatable chamber 126 can be defined by the frame 110. In this way, the inflatable chamber 126 can be defined by both: a first portion of the radial artery compression device 100 (e.g., the substantially rigid frame 110) that does not change size or shape when the inflatable chamber 126 is inflated; and a second portion of the radial artery compression device 100 (e.g., the flexible sheet 120) that does change size or shape when the inflatable chamber 126 is inflated.

[0037] In some embodiments, the radial artery compression device 100 includes a single inflatable chamber 126. Such embodiments can be configured to be easy to construct and / or easy to use. Embodiments having multiple chambers and embodiments in which a single chamber has multiple protrusions or portions configured to provide compression at multiple points on the body are within the scope of this disclosure.

[0038] In some embodiments (e.g., the illustrated embodiment with inflatable chamber 126), the maximum capacity of the inflatable chamber can be between 3 mL and 30 mL. For example, in some embodiments, the maximum capacity of inflatable chamber 126 is between 3 mL and 12 mL, between 3 mL and 20 mL, between 3 mL and 25 mL, between 5 mL and 15 mL, between 10 mL and 20 mL, between 10 mL and 30 mL, or between 15 mL and 30 mL. Inflatable chamber 126 can be configured to apply varying amounts of pressure to the radial approach site of patient 50. In some embodiments, inflatable chamber 126 provides pressure to the radial approach site in a manner that avoids restricting the ulnar artery.

[0039] In some embodiments, the radial artery compression device 100 includes a first opening 116 in a substantially rigid frame 110 (see...). Figures 5A to 5E A conduit 145 extends to valve 140. Conduit 145 and valve 140 are in fluid communication with an inflatable chamber 126 formed by a substantially rigid frame 110 and a flexible sheet 120. In some embodiments, valve 140 is configured to open and allow fluid flow through valve 140 when coupled to an inflation device (e.g., a syringe), but close and prevent fluid flow through valve 140 when disconnected (i.e., as a result of disconnection from or removal from the inflation device). In other words, attaching an inflation device to valve 140 opens valve 140, and removing the inflation device from valve 140 closes valve 140. Thus, after the inflation device has been disconnected from valve 140, valve 140 can maintain a positive fluid pressure within the inflatable chamber 126.

[0040] In the depicted embodiments, conduit 145 is connected to frame 110 via connector 150 protruding from outer surface 111 of frame 110. In some embodiments, conduit 145 extends from connector 150 to the following lengths: 5cm to 15cm, 6cm to 15cm, 8cm to 15cm, 10cm to 15cm, 12cm to 15cm, 6cm to 12cm, 6cm to 10cm, 6cm to 8cm, or 8cm to 10cm. In other words, in some embodiments, conduit 145 is between about 5cm and about 15cm. In other embodiments, conduit 145 has some other length. In still other embodiments, valve 140 may be directly connected to connector 150, thus eliminating the need for conduit 145.

[0041] In some embodiments, the radial artery compression device 100 may further include a retainer 160 (e.g., a clamp) configured to secure the free end of the conduit 145 to the frame 110. In some embodiments, when the radial artery compression device 100 is secured to the right arm of the patient 50, the retainer 160 may be positioned (1) on the ulnar or radial side of the connector 150 and / or (2) proximal or distal to the connector 150 (along the length of the patient's arm). For example, when the depicted embodiment is secured to the right arm of the patient 50 (e.g.) Figure 1 As shown in the diagram, retainer 160 is positioned on the radial and distal sides of connector 150. Retainer 160 and connector 150 can be positioned at a distance from each other such that when a portion of the adjacent free end of conduit 145 is attached to retainer 160, only a short length of conduit 145 protrudes from radial artery compression device 100, thereby minimizing the bulk of radial artery compression device 100.

[0042] In the illustrated embodiment, the rod 118 is disposed along a second peripheral side of the frame 110 opposite to the first peripheral side. The rod 118 is coupled to the frame 110 at each end. The rod 118 is spaced apart from the frame 110 to define an elongated slot 119. The length of the elongated slot 119 can be determined to accommodate the width of the wristband 130, and the width of the elongated slot 119 can be determined to accommodate the thickness of the wristband 130. Thus, the wristband 130 can pass through the elongated slot 119 and wrap around the rod 118. In some embodiments, the rod 118 can be configured to minimize friction with the wristband 130 and thereby minimize sliding resistance. More specifically, the circumference of the rod 118 may include a smooth surface to minimize friction. In other embodiments, the rod 118 can be configured to enhance friction with the wristband 130 and thereby define sliding resistance. More specifically, the circumference of the rod 118 may include a rough surface, sharp edges, or any other suitable feature to resist slippage of the wristband 130. In other embodiments, the circumference of the rod 118 may include both smooth and rough portions. Thus, when the wristband 130 is pulled in one direction, the wristband 130 can slide freely on the circumference of the rod 118, and when the wristband 130 is pulled in different directions, the wristband can be prevented from sliding.

[0043] As noted above, in the illustrated embodiment, the rod 118 is coupled to the frame 110 such that the elongated slot 119 is closed on all sides. Embodiments in which the rod 118 is coupled at only one end and the elongated slot 119 is open to the periphery of the frame 110 are also within the scope of this embodiment. In embodiments where the elongated slot 119 is closed (e.g., the illustrated embodiment), a portion of the wristband 130 can travel through the elongated slot 119 during use. In embodiments where the elongated slot 119 is open to the periphery of the frame 110 (e.g., when only one end of the rod 118 is coupled to the frame 110), a loop or bend in the wristband can slide on the rod 118 via the open side of the elongated slot 119.

[0044] like Figure 3A and Figure 3B As shown, wristband 130 can be attached to frame 110 at a fixed end 138 of wristband 130. Wristband 130 may consist of a single strap attached to a first peripheral side of frame 110. Wristband 130 may be configured to secure frame 110 to the wrist 54 of patient 50. In some embodiments, the entire wristband 130 (or a portion thereof) is opaque. In some embodiments, wristband 130 is colored and / or decorated. In the illustrated embodiment, wristband 130 includes a hook-and-loop fastener system (e.g., Velcro). In some embodiments, wristband 130 is a single integrated Velcro strap having a single fixed end and a single free end.

[0045] In the illustrated embodiment, the wristband 130 includes a fastener system, which may be a hook-and-loop fastener system (e.g., Vericos). The wristband 130 includes an inner surface 131 extending from the inner surface 113 of the frame 110, an outer surface 132 extending from the outer surface 111 of the frame 110, and a free end 133. In the illustrated embodiment, a hook portion 134 and a loop portion 135 of the fastener system are disposed on the outer surface 132 of the wristband 130. In the illustrated embodiment, the hook portion 134 is disposed adjacent to the free end 133, and the loop portion 135 is disposed between the hook portion 134 and the fixed end 138 or the frame 110. In some embodiments, the loop portion 135 may extend from the hook portion 134 to the fixed end 138. The hook portion 134 and the loop portion 135 may be located at other locations along the wristband 130 and / or on the inner surface 131 of the wristband 130 or on both the inner surface 131 and the outer surface 132 without deviating from the function of the wristband 130. Thus, these and all other potential locations of the hook portion 134 and the loop portion 135 are within the scope of this disclosure.

[0046] The wristband 130 may include different characteristics along its length. For example, in some embodiments, some portions of the wristband 130 may be more flexible than others. In some embodiments, the wristband 130 may be stretchable or substantially non-stretchable, or some portions of the wristband 130 may be stretchable while others may be substantially non-stretchable. In some embodiments, the loop portion 135 may be spaced apart from the hook portion 134 such that, in use, the loop portion 135 does not pass through the elongated slot 119. Thus, the more flexible portions of the wristband 130 may be positioned or configured to wrap around the rod 118.

[0047] In the illustrated embodiment, the wristband 130 may include a semi-rigid portion 137 adjacent to the free end 133. The semi-rigid portion 137 facilitates insertion of the free end 133 through the elongated slot 119 when the wristband 130 is passed through it. Additionally or alternatively, the wristband 130 may include a tapered or conical portion 139 at the free end 133 to further facilitate insertion of the free end 133 through the elongated slot 119. In some cases, the semi-rigid portion 137 and / or the tapered portion 139 may facilitate a medical practitioner inserting the free end 133 through the elongated slot 119 and / or passing the wristband 130 through the elongated slot 119 with one hand.

[0048] The hook portion 134 may be configured to face away from the terminal portion of the free end 133 and thereby define the pull tab 136. Therefore, the pull tab 136 may lack the hook section 134 and the loop section 135. The pull tab 136 may include ribs, protruding bumps, rough surfaces, or any other suitable features provided on either or both of the inner surface 131 and the outer surface 132 to enhance the gripping ability of the pull tab 136.

[0049] Figures 5A to 5E A cross-sectional side view of the radial artery compression device 100 at the wrist 54 of the patient 50 is provided in different attachment and usage states. Figures 5A to 5E The configuration sequence shown represents an embodiment of a sequence using the compression device 100. During some use cases, when the wristband 130 is secured to the wrist 54 of the patient 50, the inflatable chamber 126 can be positioned adjacent to the radial artery 10 of the patient 50.

[0050] refer to Figure 5A The radial artery compression device 100 can be placed or positioned on the wrist 54 of the patient 50 such that the inflatable chamber 126 (which may be in an uninflated state) is located above the radial artery 10. In the illustrated embodiment, the curved portion 112 of the frame 110 is positioned adjacent to the thumb-side portion of the wrist 54, and the straight portion 114 is positioned along the underside portion of the wrist 54. The wristband 130 is shown attached to the frame 110 at a fixed end 138.

[0051] Figure 5B A radial artery compression device 100 is shown in a further secured position to the wrist 54. The free end 133 of the wristband 130 is shown inserted through or through an elongated slot 119. In use, a medical practitioner can insert the free end 133 into the slot 119 with one hand. The semi-rigid portion 137 of the wristband 130 at the free end 133 facilitates insertion of the free end 133 through the elongated slot 119. In this secured position, the medical practitioner can realign or confirm the alignment of the inflatable chamber 126 with the radial artery 10.

[0052] Figure 5C This demonstrates the state in which tension is applied to the wristband 130. Figure 5C The wristband 130 is shown being tensioned such that the inner surface 131 of the wristband 130 contacts the wrist 54. A medical practitioner can apply tension to the wristband 130 by pulling the free end 133. The medical practitioner can hold or maintain the frame 110 in a position aligned with the radial artery 10 and / or tension the wristband 130 by pulling the free end 133 with only one hand. That is, the compression device 100 can be configured for single-handed tensioning and positioning. For example, applying tension to the free end 133 with one hand can be used to both tension and position the compression device 100. For example, the direction in which tension is applied to the free end 133 may tend to position the compression device 100 and tighten the wristband 130. As described below, differences in the direction in which the free end 133 is tensioned may tend to maintain the position of the compression device 100 on the wrist 54 while tensioning the wristband 130, or may tend to cause the compression device 100 to rotate or shift about the wrist 54 during tensioning. In some cases, tensioning the compression device 100 and maintaining its position or shifting its position can be accomplished by the practitioner simply by gripping the compression device 100 or interacting with it with one hand.

[0053] like Figure 5CAs shown, the free end 133 can be pulled in different directions. In some cases, the free end 133 can be pulled in a neutral direction 51A. The neutral direction 51A can be defined as perpendicular to the wrist 54 or in a direction that leads directly away from the center of the wrist 54. In other words, the neutral direction 51A can be substantially parallel to the line 53 extending through the center of the wrist 54 and the bar 118. Pulling the free end 133 in the neutral direction 51A can increase the tension in the wristband 130, causing the frame 110 to be pulled closer to the center of the wrist 54 in a neutral or balanced manner (as indicated by the force 52A located at the center) (i.e., increasing the pressure of the frame 110 on the wrist 54). In other words, the curved portion 112 and the straight portion 114 of the frame 110 can be pulled closer to the center of the wrist 54 by substantially equal amounts. Therefore, when the free end 133 is pulled in the neutral direction 51A, the frame 110 can be pulled closer to the center of the wrist 54 without causing the frame 110 to shift or tilt as tension is applied to the wristband 130. As used herein, the neutral direction 51A can define a range of directions that may include any direction more parallel to line 53 than perpendicular to line 53. In other words, around Figure 5C The angular range of the direction shown as the neutral direction may tend to tighten the wristband 130 without shifting the position of the compression device 100.

[0054] In some cases, the free end 133 can be pulled in a non-neutral direction (e.g., in the first tangential direction 51B). The first tangential direction 51B can be defined as substantially tangential to the wrist 54 and directed away from the outer surface 111 of the frame 110. In other words, the free end 133 is positioned above the outer surface 111 of the frame 110 and is pulled away from the outer surface 111. More specifically, the free end 133 is pulled in a direction substantially perpendicular to the line 53 on the frame side of the line 53. Pulling the free end 133 in the first tangential direction 51B can increase the tension in the wristband 130, causing the curved portion 112 of the frame 110 to be pulled closer to the center of the wrist 54 (i.e., increasing the pressure of the curved portion 112 of the frame 110 on the wrist 54), while the straight portion 114 is substantially unaffected by pulling the free end 133. The straight portion 114 can be substantially unaffected because the wristband 130 can slide freely across the elongated groove 119. In other words, the force 52B adjacent to the curved portion 112 can be greater than the force 52C adjacent to the straight portion 114. Therefore, when the free end 133 is pulled in the first tangential direction 51B, the frame 110 can be displaced as a medical practitioner might expect. In some cases, this displacement may include tilting of the frame 110, i.e., the curved portion 112 may move closer to the center of the wrist 54 than the straight portion 114. In other cases, alternatively and / or in addition to tilting, the frame 110 may slide along the circumference of the wrist 54 to a new position, such as rotating the compression device 100 around the circumference of the wrist 54. Pulling the free end 133 in the first tangential direction 51B can help the medical practitioner establish the desired position of the radial artery compression device 100. The first tangential direction 51B can define a range of directions that may include any direction more perpendicular to line 53 than parallel to line 53. In other words, around... Figure 5C The angular range of the direction shown as the first tangential direction may tend to tighten the wristband 130 while shifting the position of the compression device 100, as described above.

[0055] In some cases, the free end 133 can be pulled along a second tangential direction 51C, which may be substantially opposite to the first tangential direction 51B. The second tangential direction 51C can be defined as tangential to the wrist 54 and directed away from the inner surface 113 of the frame 110. In other words, the free end 133 is positioned below the inner surface 113 of the frame 110 and is pulled away from the inner surface 113. More specifically, the free end 133 is pulled along the non-frame side of the line 53 in a direction perpendicular to the line 53. Pulling the free end 133 along the second tangential direction 51C increases the tension in the wristband 130, causing the straight portion 114 of the frame 110 to be pulled closer to the center of the wrist 54 (i.e., increasing the pressure of the straight portion 114 of the frame 110 on the wrist 54), while the curved portion 112 is substantially unaffected by pulling the free end 133. In this configuration, force 52C is limited by the tension in the wristband 130 (when the wristband is wound around the bar 118). Thus, force 52C adjacent to the straight portion 114 can be limited by up to twice the tension in the wristband 130, while force 52B adjacent to the curved portion 112 can be limited by a single tension component in the wristband 130, as it is directly coupled to the frame 110 at the fixed end 138. Therefore, when the free end 133 is pulled in the second tangential direction 51C, the frame 110 can be displaced as a medical practitioner might expect. In some cases, this displacement may include tilting of the frame 110 (i.e., the straight portion 114 may move closer to the center of the wrist 54 than the curved portion 112). In other cases, alternatively and / or in addition to tilting, the frame 110 may slide along the circumference of the wrist 54 to a new position, such as rotating around the circumference of the wrist 54. Pulling the free end along the second tangential direction 51C can help medical practitioners establish the desired location of the radial artery compression device 100. The second tangential direction 51C can define a directional range that can include any direction more perpendicular to line 53 than parallel to line 53. In other words, around... Figure 5C The angular range of the direction shown as the second tangential direction may tend to tighten the wristband 130 while shifting the position of the compression device 100, as described above.

[0056] Therefore, tightening the wristband 130 in any of the directions 51A, 51B, and 51C described above facilitates the use of one hand to tighten the wristband 130 and position the compression device 100. Generally, the free end 133 can be manipulated to both control the position of the compression device 100 on the wrist 54 and tighten the wristband 130 of the compression device 100. In addition to the directions 51A, 51B, and 51C described above, the practitioner can also tighten the wristband 130 along the patient's arm proximally or distally. Figure 5C(Inside and outside the page) Tension is applied to the free end 133 to adjust the position of the compression device 100 on the wrist 54. The practitioner can tension and position the compression device 100 by pulling the free end 133 along any angle of a continuous range around the rod 118 (the angle extends from a point on either side of the range where the free end 133 will contact the top or side of the wrist 54 described above) (including directions 51A, 51B, 51C) and / or along a continuous range proximally and distally along the patient's arm. Again, this manipulation can be performed using only the practitioner's one hand that interacts with the compression device 100.

[0057] Furthermore, displacement of the free end 133 in multiple directions can be configured to circumferentially tension the wristband 130 around the patient's wrist. For example, the interaction between the lever 118 and the wristband 130 can convert a radial displacement of the free end 133 away from the wrist 54 into tension on the wristband 130 around the circumference of the wrist 54. This facilitates one-handed operation and allows the practitioner to pull the free end 133 in a convenient direction (avoiding interference from, for example, the patient's anatomy or other medical devices) while still providing tension around the circumference of the wrist 54.

[0058] Figure 5D The following states are shown, where the tension in the wristband 130 is established (as described above regarding...). Figure 5C Following the description, the wristband 130 can be further wrapped around the bar 118 such that the free end 133 is positioned adjacent to and overlaps the portion of the wristband 130 extending around the wrist 54. The free end 133 can then be attached to the portion of the wristband 130 extending around the wrist 54. In other words, and more specifically, the hook portion 134 positioned adjacent to the free end 133 can be attached to the loop portion 135. Thus, the wristband 130 is configured to allow a medical practitioner to attach the free end 133 to the portion of the wristband 130 extending around the wrist 54 with one hand.

[0059] Figure 5E The following state is illustrated, in which, after positioning the radial artery compression device 100, tension is established in the wristband 130 and the wristband 130 is secured, as described above, allowing inflation of the inflatable chamber 126. In some cases, the above description can be repeated during or after inflation. Figures 5A to 5D One or more of the described programs. In some cases, in Figures 5A to 5D Before or after any of the processes shown, the inflatable chamber 126 can be inflated or partially inflated. The inflation of the inflatable chamber 126 can be configured to provide and control pressure on the arterial incision site.

[0060] In some cases, after completing the above regarding Figures 5A to 5EAfter one or more of the described processes, the medical practitioner can adjust the tension in the wristband 130. In such cases, the medical practitioner can detach the free end 133 from the portion of the wristband 130 extending around the wrist 54 while grasping the free end 133, pull the free end 133 to increase tension or move the free end 133 toward the lever 118 to decrease tension, and reattach the free end 133 to the portion of the wristband 130 extending around the wrist 54. Such adjustments can be made using only one hand of the practitioner that interacts with the compression device 100.

[0061] In some other cases, after completing the above regarding Figures 5A to 5E After one or more of the described procedures, the medical practitioner can adjust the position of the radial artery compression device 100. In such cases, the medical practitioner can detach the free end 133 from the portion of the wristband 130 extending around the wrist 54 while grasping the free end 133, pull the free end 133 in a direction configured to adjust the position of the compression device on the wrist 54 (including examples of such directions described above), and reattach the free end 133 to the portion of the wristband 130 extending around the wrist 54. Such adjustments can be made using only one hand of the practitioner that interacts with the compression device 100.

[0062] Figure 6 and Figure 7 An embodiment of a radial artery compression device 100 is shown positioned relative to a radial approach, which includes a skin puncture site 70 and an arterial incision site 80. More specifically, Figure 6 A radial artery compression device 100 is shown, which is fixed at a specific location relative to the skin puncture site 70 to the wrist 54 of the patient 50. Figure 7 Provided Figure 6 The cross-sectional view of the penetrating plane 7–7.

[0063] When an elongated device (e.g., a needle, sheath, or catheter) is introduced into the radial artery 10 for an interventional procedure, the device may be inserted at an angle such that the point where the device passes through the skin (i.e., the skin puncture site 70) is not directly above the point where the device passes through the arterial wall (i.e., the arterial incision site 80). In other words, the skin puncture site 70 may be separated from the arterial incision site 80 by a distance (d). In some embodiments, the distance (d) is from 1 mm to 10 mm, including from 2 mm to 5 mm and from 3 mm to 4 mm.

[0064] In some cases, concentrating pressure on the arterial incision site 80 rather than the skin puncture site 70 can facilitate hemostasis. In other words, by applying pressure to the arterial incision site 80 in a relatively direct manner, hemostasis can be achieved more quickly and effectively. To assist practitioners in positioning the radial artery compression device 100 at a location that provides appropriate pressure to the arterial incision site 80, the radial artery compression device 100 may include markings on the frame 110. The markings on the frame 110 may be designed to facilitate identification of the arterial incision site 80 relative to the visible skin puncture site 70 of the patient 50.

[0065] For example, in the depicted embodiment, a first mark 115a is disposed on the frame 110. In the depicted embodiment, the first mark 115a is located at the intersection of the T-shaped marks on the frame 110. When the first mark 115a is aligned with the skin puncture site 70 visible through the transparent frame 110 and the transparent flexible sheet 120, the second mark 117 is disposed directly above the (invisible) arterial incision site 80. In the depicted embodiment, the second mark 117 is the center of the target-shaped mark on the frame 110. In some embodiments, the second mark 117 is disposed directly above the center of the flexible sheet 120. In other words, the second mark 117 may be disposed directly above the area of ​​the inflatable chamber 126, which is designed to extend furthest from the frame 110 when the inflatable chamber 126 is inflated. In some embodiments, the first mark 115a and the second mark 117 may be disposed on the flexible sheet 120. In some embodiments, the first mark 115a and the second mark 117 may be disposed on the inner or outer surface of the flexible sheet 120 (i.e., inside or outside the inflatable chamber 126). In other embodiments, the first mark 115a and the second mark 117 may be disposed on both the frame 110 and the flexible sheet 120.

[0066] In some embodiments, the radial artery compression device 100 may additionally or alternatively include a mark 115b, which may also be disposed on the inner or outer side of the flexible sheet 120. When the radial artery compression device 100 is placed on the left hand of the patient 50, the mark 115b may be aligned with the skin puncture site 70. In other words, in some embodiments, the radial artery compression device 100 may include a mark to facilitate alignment with the skin puncture site 70, regardless of the arm on which the radial artery compression device 100 is placed. In some aspects with Figure 6 The different markings shown can be used for similar purposes. In other words, various forms of marking can be used to facilitate the proper alignment of the radial artery compression device 100. In some cases, the above description can be performed and / or repeated while aligning one or more markings with the skin puncture site 70. Figures 5A to 5E One or more of the programs described.

[0067] In some embodiments, the radial artery compression device 100 may include one or more of the following components: a pressure sensor, a timer, an alarm, a control unit, a power supply, a wireless connection, and / or a display 180. In some embodiments, one or more of these components are enclosed within and / or supported by a housing 170. The housing 170 may be fixedly or detachably coupled to a frame 110. For example, in the depicted embodiment, the housing 170 is fixedly coupled to and extends from the frame 110. In embodiments in which the housing 170 is detachably coupled to the frame 110, the housing 170 and / or one or more components disposed therein (e.g., a pressure sensor, pulse oximeter, timer, alarm, control unit, power supply, wireless connection, or display 180) may be repaired and / or refurbished for further use.

[0068] In some embodiments, including a pressure sensor or pressure transducer (not shown), the pressure sensor may be in fluid communication with the inflatable chamber 126. For example, the pressure sensor may be in fluid communication with the inflatable chamber 126 through a second orifice (not shown) in a substantially rigid frame 110. The pressure 126 within the inflatable chamber, as measured by the pressure sensor, can inform a medical protocol for the use of the radial artery compression device 100. For example, the pressure measurement obtained by the pressure sensor may be relayed to a display 180. A practitioner may use the pressure information on the display 180 to increase or decrease the amount of fluid within the inflatable chamber 126 as needed. In some embodiments, the pressure sensor may be detachable from the rest of the radial artery compression device 100. In other embodiments, the pressure transducer may not be detachable from the radial artery compression device 100.

[0069] As noted above, some radial artery compression devices include a timer. In some embodiments, the timer is a countdown timer. In other or further embodiments, the timer is a stopwatch (i.e., a count-up timer). The timer can be configured to measure time from a reference period, such as when an actuator (e.g., a button or pull tab) is actuated. In some embodiments, time is measured from the moment the radial artery compression device 100 is positioned on the patient's arm 50 and initially inflated. The timer can additionally or alternatively begin measuring time from the moment fluid is initially removed from the inflatable chamber 126 during deflation. In some embodiments, the timer can be configured to measure the amount of time the inflatable chamber 126 has been held at a specific pressure.

[0070] In some cases, the timer can communicate with the display 180. In some embodiments, the display 180 shows the elapsed time in minutes and seconds. In other or further embodiments, the display 180 can show the elapsed time in hours and minutes. In some embodiments, once one hour has elapsed, the display 180 can be switched from displaying minutes and seconds to displaying hours and minutes. In some embodiments, the timer is detachable from the rest of the radial artery compression device 100. In other embodiments, the timer is non-detachable.

[0071] In some embodiments, the radial artery compression device 100 includes an alarm. In some cases, the alarm may be a visual alarm (e.g., a flashing LED). In other or further embodiments, the alarm may be audible. The alarm may alert the patient 50 and / or practitioner to certain information (e.g., the length of time the radial artery compression device 100 has been held in a specific state). Based on this information, the practitioner and / or patient 50 may make any necessary changes.

[0072] In some embodiments, the radial artery compression device 100 may include a wireless connection (e.g., via Bluetooth or Wi-Fi). Information from the radial artery compression device 100 (e.g., information relating to pressure or elapsed time) may be wirelessly transmitted to one or more other devices to alert healthcare practitioners to treatment needs, such as the need to modify the amount of pressure delivered to the radial artery at a specific time.

[0073] The radial artery compression device 100 can be used at or near the end of a medical procedure to facilitate hemostasis of the radial artery 10. In some procedures, the radial artery compression device 100 can be secured to the patient's wrist 54, for example, via a wristband 130. The practitioner can secure the radial artery compression device 100 to the patient's wrist 54 such that the inflatable chamber 126 of the radial artery compression device 100 is positioned adjacent to the radial approach site. For example, in some embodiments, the radial artery compression device 100 is placed on the wrist 54 around a portion of an elongated medical device that enters the radial artery of the patient 50 through the radial approach site.

[0074] In some cases, the practitioner can align a first mark 115a on the frame 110 of the radial artery compression device 100 with the skin puncture site 70 of the patient 50. For example, the practitioner can view the skin puncture site 70 through the frame 110 and the flexible sheet 120 and align the first mark 115a on the frame 110 with the skin puncture site 70. When the first mark 115a is aligned with the skin puncture site 70, the inflatable chamber 126 of the radial artery compression device 100 can be positioned to provide pressure to the arterial incision site 80 located upstream of the skin puncture site 70. In other words, when the first mark 115a of the radial artery compression device 100 is aligned with the skin puncture site 70 of the patient 50, the inflatable chamber 126 can be directly positioned over the arterial incision site 80 of the patient 50. In some embodiments, when the first mark 115a is aligned with the skin puncture site 70, a second mark 117 is directly positioned over the arterial incision site 80.

[0075] Once the radial artery compression device 100 is properly positioned on the patient's arm 50, the inflatable chamber 126 can be inflated in any suitable manner. For example, in some embodiments, the practitioner can connect an inflation device (e.g., a syringe) to a valve 140. Connecting the inflation device to the valve 140 opens the valve 140, allowing the practitioner to deliver fluid into the inflatable chamber 126. For example, the practitioner can advance the plunger of the syringe connected to the valve 140, causing fluid to pass through the valve 140, the conduit 145, and the first orifice 116 into the inflatable chamber 126. The delivery of fluid to the inflatable chamber 126 may cause the inflatable chamber 126 to expand, thereby increasing the amount of pressure applied to the radial approach site. In other words, inflating the inflatable chamber 126 may increase the pressure applied to the radial approach site.

[0076] In some cases, the inflatable chamber 126 can be partially inflated first to provide a certain pressure to the radial approach site. With the inflatable chamber 126 partially inflated, the elongated medical device partially inserted into the radial artery 10 can be withdrawn from the radial artery 10, so that no medical device extends through the skin puncture site 70 of the patient 50 to the arterial incision site 80.

[0077] After the elongated medical device has been removed, fluid can then be delivered to the inflatable chamber 126 in an amount sufficient to stop bleeding at the arterial incision site 80. For example, in some embodiments, sufficient fluid can be provided to inflate the inflatable chamber 126. Once sufficient fluid has been delivered to the inflatable chamber 126 to stop bleeding, the fluid in the inflatable chamber 126 can be slowly withdrawn until a trace of blood is visible through the frame 110 and flexible sheet 120 at the skin puncture site 70. At this stage, additional fluid (e.g., 1 to 2 mL) can be injected back into the inflatable chamber 126 to stop bleeding. This process provides sufficient pressure to achieve hemostasis while maintaining the patency of the radial artery 10. In other words, this medical approach can be used to ensure that sufficient pressure is provided to prevent bleeding while avoiding the application of excessive force (which would unduly restrict blood flow through the radial artery 10).

[0078] As the arterial incision site 80 and / or skin puncture site 70 begin to heal, the amount of pressure required to maintain hemostasis can be reduced. Therefore, the practitioner can deflate the inflatable chamber 126 in a series of stages. Such deflation can follow a specific, predetermined medical protocol. For example, in some embodiments, after the radial artery compression device 100 has been used to apply pressure for a period of time (e.g., 5 minutes to 5 hours), a predetermined volume of fluid (e.g., 0.5 mL to 3 mL) can be removed every 2 to 3 minutes until all air has been removed. If the removal of pressure does not result in further bleeding, the radial artery compression device 100 can then be removed from the patient 50. In other words, the radial artery compression device 100 can be removed from the patient 50 once pressure is no longer needed to ensure hemostasis.

[0079] In some cases, fluid can be removed from the inflatable chamber 126 based on information provided by the radial artery compression device 100. For example, in some embodiments, the inflatable chamber 126 can be deflated based on information obtained from a timer or alarm of the radial artery compression device 100. For example, the radial artery compression device 100 can count the amount of time that has elapsed since the radial artery compression device 100 was placed on the patient 50 and alert the practitioner to the correct time to begin removing fluid from the inflatable chamber 126. The timer can be activated by an actuator (e.g., a button or pull tab). In some embodiments, the timer can count forward. In other or further embodiments, the timer can count down. The radial artery compression device 100 can also indicate the timing of staged deflation. In some cases, the practitioner or patient 50 is alerted to the need for fluid removal based on a visible indicator (e.g., information provided on the display 180). Information from the visible indicator can be provided on the display 180 via a light (e.g., a light-emitting diode) or in some other way. In other or further embodiments, the practitioner or patient 50 is alerted to the need for fluid removal based on one or more sounds emitted from the radial artery compression device 100 (e.g., the sound of an audible alarm). In some embodiments, a light (e.g., an LED) or other markings inform the practitioner of the deflation phase. For example, in some embodiments, a light may be used to indicate the number of times fluid has been removed from the inflatable chamber 126.

[0080] The radial artery compression device 100 can be powered by any suitable power source. For example, in Figures 1 to 8 In the embodiments depicted, the radial artery compression device 100 includes a battery 195 disposed within a housing 170. The battery 195 can provide power to a pressure sensor, timer, alarm, and / or display 180. In some embodiments, the radial artery compression device 100 is configured to facilitate removal of the battery 195 from the housing 170. For example, the radial artery compression device 100 may include a battery latch 190 rotatably coupled to the housing 170. The battery latch 190 can be opened (e.g., Figure 8 (As shown in the diagram) to remove battery 195 from radial artery compression device 100. In other words, radial artery compression device 100 can be configured to facilitate the removal of one or more batteries 195 from housing 170. Easy removal of batteries 195 allows radial artery compression device 100 to be disposed of separately from waste batteries.

[0081] Radial artery compression devices do not require power from one or more batteries. For example, Figure 9A perspective view of a radial artery compression device 200 is provided, which includes a solar panel 292 supported by a housing 270. The radial artery compression device 200 can use solar energy to power components such as pressure sensors, timers, alarms, lights, and / or displays. Alternatively, some radial artery compression devices can be powered by slow-discharging capacitors. Using slow-discharging capacitors allows the radial artery compression device to be discarded without concern for battery waste. In other embodiments (e.g., embodiments lacking components such as pressure sensors, timers, alarms, lights, and displays), the radial artery compression device 200 may not include a power source within the housing 270.

[0082] Figure 10 A perspective view of another embodiment of the radial artery compression device 300 is provided. The radial artery compression device 300 is generally similar to the radial artery compression devices 100 and 200 described above. (Related to...) Figures 1 to 9 The disclosure of the embodiments can be similarly applied to Figure 10 Examples of implementations. With Figure 9 The implementation is the same as the previous one. Figure 10 The components in are used with Figures 1 to 8 Implementation examples and Figure 9 Similar elements in the embodiments are designated by similar reference numerals; however, the leading numerals have been incremented between each embodiment. Figure 10 In the embodiment shown, when with Figures 1 to 9 When compared to the connector and retainer shown, connector 350 and retainer 360 are positioned in different locations.

[0083] When the radial artery compression device 300 is positioned on the right wrist 54 of the patient 50 to rest over the radial artery 10, the connector 350 is both proximal and radial to the retainer 360. The conduit 345 may initially extend radially from the connector 350 and then bend, such that a valve 340 at the free end of the conduit 345 is positioned on the ulnar side of the connector 350. The retainer 360 can secure the conduit 345 adjacent to the remainder of the radial artery compression device 300.

[0084] Figure 11 A side view of another embodiment of the radial artery compression device 400 is provided. The radial artery compression device 400 is generally similar to the radial artery compression devices 100, 200, and 300 described above. (Related to...) Figures 1 to 10 The disclosure of the embodiments can be similarly applied to Figure 11 An example of this embodiment. Similar to the previous embodiments, Figure 11 The components in are used with Figures 1 to 10 Similar reference numerals are used to denote similar elements in the embodiments; however, the leading numerals have been incremented. For example, lever 418 may be similar in some respects to lever 118 and include details regarding... Figures 1 to 8 The rod 118 describes some of the features. However, in Figure 11 In the embodiments shown, when with, as Figures 1 to 8 Compared to the rod 118 shown, rod 418 is positioned at a different location.

[0085] like Figure 11 As shown, the rod 418 is coupled to the outer surface 411 of the frame 410. Therefore, the rod 418 can be spaced apart from the outer surface 414 of the frame 410 to define an elongated slot 419. Thus, when the wristband 430 is inserted through the slot 419, the wristband 430 can extend through the slot 419 in a direction substantially parallel to the straight portion 414 of the frame 410. This parallel direction of the wristband 430 simplifies insertion of the wristband 430 into the slot 419 and also prevents or inhibits pulling or pinching of the patient's skin when tension is applied to the wristband 430. In some embodiments, the rod 418 can be disposed inwardly from the periphery of the frame 410. In other words, a portion of the frame 410 can extend outwardly or beyond the rod 418. Therefore, when the wristband 430 is inserted through the slot 419, the wristband 430 can be positioned above the outer surface 414 or extend along the outer surface before extending through the slot 419, which can limit or prevent pinching of the patient's skin when tension is applied to the wristband 430.

[0086] Figures 12 to 15 A frame 510 illustrates another embodiment of the radial artery compression device 500. The radial artery compression device 500 is generally similar to the radial artery compression devices 100, 200, 300, and 400 described above. (Related to...) Figures 1 to 11 The disclosure of the embodiments can be similarly applied to Figures 12 to 15 An example of this embodiment. Similar to the previous embodiments, Figures 12 to 15 The components in are used with Figures 1 to 11 Similar reference numerals are used to denote similar elements in the embodiments; however, leading numerals are incremented. For example, frame 510 may be similar to frame 110 in some respects and include references to... Figures 1 to 8 The framework 110 describes some of the features.

[0087] like Figure 12 and Figure 13As shown, rod 518 is coupled to frame 510. Rod 518 is spaced apart from the upper surface of frame 510 to define an elongated slot 519. Rod 518 may include retainer 560 configured to receive and retain a conduit coupled to connector 550. Extension 555 of frame 510 extends beyond rod 518, such that rod 518 is positioned away from the end periphery of frame 510. In some embodiments, extension 555 is formed as an integral part of frame 510. In other embodiments, extension 555 is formed of a flexible material different from the material of frame 510. For example, the flexible material may be a fabric of natural or polymer fibers or a polymer film. Other flexible materials are contemplated.

[0088] As shown, the extension 555 includes a curved section 556 and a straight, angled section 557 disposed between the curved section 556 and the rod 518, such that the free end of the extension 555 is above the plane extending from the straight section 514 of the frame 510. In other embodiments, the extension 555 may be configured with only the angled straight section or only the curved section. The curved section 556 includes: an outer radius r, ranging from approximately zero millimeters to approximately 15 millimeters and possibly approximately six millimeters; and a length L2, ranging from approximately zero millimeters to approximately 13 millimeters and possibly approximately six millimeters. The angled section 557 includes: an angle α relative to the plane extending from the straight section 514, ranging from zero degrees to approximately 45 degrees and possibly approximately 15 degrees; and a length L1, ranging from approximately zero millimeters to approximately 13 millimeters and possibly approximately two millimeters.

[0089] like Figure 14 As depicted, the extension 555 includes an engagement edge 558 disposed at its free end. In the depicted embodiment, the engagement edge 558 comprises the full radius. In another embodiment, the engagement edge 558 may include a straight edge oriented transversely to the longitudinal axis of the frame 510. In other embodiments, the engagement edge 558 may include serrated teeth disposed along the length of the engagement edge 558. Other embodiments of the engagement edge 558 are contemplated.

[0090] When the radial artery compression device 500 is applied to a patient's wrist 54 to provide hemostasis to the radial artery 10, the wristband 530 is wrapped around the wrist 54, inserted through the slot 519, and at least partially wrapped around the rod 518, as shown. Figure 15As shown in the diagram. The wristband 530 can extend over the extension portion 555 and through the slot 519 to form an angle β. The working range of angle β can be from approximately 45 degrees to approximately 180 degrees and can be approximately 100 degrees. Angle β can be adjusted by adjusting the outer radius r, length L1, length L2, the height of the bar 518 above the frame 510, or any combination thereof. For example, when L2 is relatively long, angle β can be relatively low, and when L2 is relatively short, angle β can be relatively high. When angle β is within its working range, the tightening force applied by the wristband 530 against the occlusal edge 558 is generally relatively high. This configuration results in the radial artery compression device 500 providing sufficient hemostatic pressure to the artery 10 without overtightening the wristband 530 and pinching the patient's skin between the wristband 530 and the frame 510. When the angle β is higher than the working range, the tightening force used to fix the wristband 530 against the bite edge 558 is relatively low, resulting in overtightening of the wristband 530 and pinching the patient's skin between the wristband 530 and the frame 110 to achieve sufficient hemostatic pressure on the artery 10.

[0091] Some of the radial artery compression devices described herein (e.g., radial artery compression devices 100, 200, 300, 400, and 500) can be placed on either arm of the patient 50. For example, while radial artery compression device 100 is... Figure 1 The radial artery compression device 100 is shown on the right arm of patient 50, but it can be used alternatively on the left arm of patient 50. When the radial artery compression device 100 is positioned on the left arm of patient 50, the frame 110 can be contoured to bend around the thumb-side portion of the left wrist 54 of patient 50. In other words, when Figure 1 The radial artery compression device 100 is correctly placed on the patient's left arm and can rotate. Figures 1 to 8 The radial artery compression device 100 is such that the connector 150 is located both on the ulnar side and distal side of the retainer 160.

[0092] Although the compression device described above is specifically a radial artery compression device, some compression devices can be additionally or alternatively adapted for compression of the ulnar artery. For example, the compression device can be placed on the patient such that the frame is bent around the ulnar side of the wrist. When placed on the patient in this manner, the inflatable chamber can be positioned adjacent to the ulnar artery, such that inflation of the inflatable chamber applies pressure to the entry site in the ulnar artery. Therefore, some of the compression devices described herein can be used to promote healing at the entry site in the ulnar artery.

[0093] Any method disclosed herein includes one or more steps or actions for performing the described method. These method steps and / or actions may be interchanged with each other. In other words, the order and / or use of a particular step and / or action may be modified unless a specific order of steps or actions is required for the correct operation of the embodiment. Furthermore, a subroutine or only a portion of the method described herein may be a separate method within the scope of this disclosure. In other words, some methods may include only a portion of the steps described in a more detailed method.

[0094] Throughout this specification, references to "an embodiment" or "embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Therefore, as described throughout this specification, references to phrases or variations thereof do not necessarily all refer to the same embodiment.

[0095] Similarly, those skilled in the art who benefit from this disclosure will understand that, in order to simplify this disclosure, various features are sometimes grouped together in a single embodiment, drawing, or description thereof in order to make the disclosure concise. However, this method of disclosure should not be construed as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as reflected in the following claims, the inventive aspect lies in a combination of fewer features than all the features of any single foregoing disclosed embodiment. Therefore, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, wherein each claim is considered independently as a separate embodiment. This disclosure includes all permutations of the independent claims and their dependent claims.

[0096] The use of the term "first" in the claims to describe a feature or element does not necessarily imply the presence of a second or additional such feature or element. It will be apparent to those skilled in the art that changes can be made to the details of the above embodiments without departing from the fundamental principles of this disclosure.

Claims

1. A radial artery compression device, comprising: The framework includes: outer surface, Inner surface, and The rod extends to connect to the frame, and the rod and the frame form an elongated groove between the rod and the frame; An inflatable chamber disposed on the inner surface of the frame; and A wristband, configured to secure the frame to the patient. The wristband is configured to insert through the elongated slot and wrap around the rod. The frame further includes: a curved portion, which is contoured and bends around the thumb side of the wrist; and a straight portion opposite the curved portion. The frame further includes an extension portion extending from the straight portion. The extension includes: Straight section; and curved section The straight section is positioned between the curved section and the straight portion of the frame. The straight section includes an angle relative to a plane extending from the straight section, the angle ranging from zero degrees to 45 degrees. The straight section includes lengths ranging from 0 mm to 13 mm, and The straight section is angled toward the rod.

2. The apparatus of claim 1, wherein, The wristband is configured to secure the frame to the patient's wrist, such that the inflatable chamber is positioned adjacent to the radial artery.

3. The apparatus of claim 1, wherein, The curved section bends toward the rod.

4. The apparatus of claim 1, wherein, The rod is adjacent to the straight section.

5. The apparatus of claim 1, wherein, The extension includes flexible material.

6. The apparatus of claim 1, wherein, The wristband is a single, continuous band, which includes: The inner surface, configured to contact the patient's wrist, outer surface, The fixed end, which is connected to the frame, and The free end is opposite to the fixed end.

7. The apparatus of claim 6, wherein, The wristband includes a fastening system configured to attach a first portion of the wristband to a second portion of the wristband.

8. The apparatus of claim 7, wherein, The first part and the second part are disposed on the outer surface of the wristband.

9. The apparatus of claim 7, wherein, The fastening system is a hook and loop fastening system, wherein the first part includes a hook section and the second part includes a loop section.

10. The apparatus of claim 9, wherein, The hook section is positioned adjacent to the free end, and the ring section is positioned between the hook section and the frame.

11. The apparatus of claim 9, wherein, The hook section is positioned away from the free end to limit the pull tab.

12. The apparatus of claim 1, wherein, The wristband consists of a flexible section and a semi-ridged section.

13. The apparatus of claim 6, wherein, The device is configured to allow healthcare professionals to position the frame on the patient's wrist and secure the wristband with one hand. The wristband is secured by: Pull the free end of the wristband to establish tension in the wristband, and The free end of the wristband is attached to a portion of the wristband that is set around the patient's wrist.

14. A radial artery compression device, comprising: The framework includes: The curved part, The straight portion, which is opposite to the curved portion, and A rod extending along the first peripheral edge of the frame, the rod being connected to the frame and forming an elongated groove between the rod and the first peripheral edge; An inflatable chamber disposed on the inner surface of the frame; and A wristband, configured to secure the frame to the patient's wrist. The wristband includes: A fixed end, which is connected to the frame along the second peripheral edge opposite to the first peripheral edge, and The free end, which is adjustablely connected to the frame along the first peripheral edge, The wristband is configured to insert through the elongated slot and wrap around the rod. The device is configured such that pulling the free end in a first direction increases the pressure of the frame on the wrist equally between the curved portion and the straight portion, and Wherein, the first direction is perpendicular to the wrist. The frame further includes an extension portion extending from the straight portion. The extension includes: Straight section; and curved section The straight section is positioned between the curved section and the straight portion of the frame. The straight section includes an angle relative to a plane extending from the straight section, the angle ranging from zero degrees to 45 degrees. The straight section includes lengths ranging from 0 mm to 13 mm, and The straight section is angled toward the rod.

15. The apparatus of claim 14, wherein, The device is configured such that pulling the free end in the second direction results in more pressure on the frame on the wrist along the curved portion than along the straight portion, and The second direction is perpendicular to the first direction.

16. The apparatus of claim 15, wherein, The device is configured such that pulling the free end upwards on a third party results in more pressure on the frame on the wrist along the straight portion than along the curved portion, and The third direction is opposite to the second direction.

17. The apparatus of claim 14, in, The curved section bends toward the rod.

18. A frame for a radial artery compression device, the frame comprising: The curved part; The straight portion is opposite to the curved portion; The extension portion extends from the straight portion; as well as A rod, oriented perpendicular to the longitudinal axis of the straight portion, and forming an elongated groove between the rod and the straight portion. The curved portion includes a contour configured to curve around the thumb-side portion of the wrist. The extension includes: Straight section; and curved section The straight section is positioned between the curved section and the straight portion of the frame. The straight section includes an angle relative to a plane extending from the straight section, the angle ranging from zero degrees to 45 degrees. The straight section includes lengths ranging from 0 mm to 13 mm, and The straight section is angled toward the rod.

19. The framework as described in claim 18, in, The curved section bends toward the rod.

20. The framework as described in claim 18, wherein, The extension includes flexible material.

Images