Tibio-pedicular vascular closure band

Abstract

The present application discloses a hemostatic device comprising a flexible and adjustable closure device adapted to fit the lower leg and foot of patients with various anatomical variations in leg and foot shape and size, and further comprising at least one compression element adapted to apply targeted pressure to a surgical vascular access site located in the patient's lower leg or foot. In some embodiments, the compression element is movable so that it can be used to apply pressure to a selected one of the common arterial access points located in the lower leg or foot.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 16 / 442,009, filed June 14, 2019, which is incorporated by reference in its entirety.

[0002] The present invention relates to a closure band adapted to function as a compression device for promoting hemostasis at a surgical access site, and more particularly to a vascular closure band adapted for use especially in the lower leg and foot of a patient. [Background technology]

[0003] Following a surgical procedure involving arterial or venous access, it may be desirable or necessary to apply pressure to the access site to promote hemostasis. To date, existing closure bands, some of which are annular in shape, have been used to apply pressure to the access site regardless of the access site's location on the body. When used in some areas of the body, such as the lower leg and / or foot, such bands may tend to shift, thereby reducing the compressive effect of the device. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 7,498,477 Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, there is a need for a vascular occlusion band that addresses these and other shortcomings of the prior art. [Means for solving the problem]

[0006] In this regard, the present disclosure includes a closure device adapted to fit simultaneously around at least a portion of a patient's lower leg and at least a portion of their foot, the closure device comprising at least one compression element adapted to apply targeted pressure to at least one artery or vein located within at least one of the lower leg and the foot.

[0007] In another respect, the present disclosure includes a hemostatic device comprising a flexible element adapted to be wrapped around and releasably secured to at least a portion of a patient's lower leg and at least a portion of the foot, and at least one compression element adapted to apply targeted pressure to at least one artery or vein located within at least one of the lower leg and the foot, the at least one compression element being fixedly or removably attached to the flexible element.

[0008] In still another respect, the present disclosure includes a method of forming a closure device, the method comprising: forming a closure device having a first portion adapted to be wrapped around and releasably secured to at least a portion of a patient's lower leg; forming a closure device having a second portion adapted to be wrapped around and releasably secured to at least a portion of the patient's foot; and providing at least one attachment element to the closure device, the at least one attachment element being adapted to either fixedly or removably attach at least one compression element adapted to apply a target pressure to at least one artery or vein located within at least one of the lower leg and the foot.

[0009] The present disclosure is hereinafter described in conjunction with the accompanying drawings, in which like numerals refer to like elements and in which: [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a front perspective view of a closure band according to one embodiment of the present disclosure in an unrolled configuration. [Figure 2] FIG. 1 is a front perspective view of a compression element according to one embodiment of the present disclosure in an undeployed position, separate from a closure band. [Figure 3] 2 is a front perspective view of the closure band of FIG. 1 with an exemplary lower leg and foot of a human patient placed over a portion of the closure band. [Figure 4] FIG. 1 is a front perspective view of the closure band shown in a partially wrapped configuration. [Figure 5] FIG. 1 is a front perspective view of a closure band shown in a fully wrapped configuration positioned around a patient's lower leg and foot. [Figure 6] FIG. [Figure 7] 3 is a side perspective view of the compression element according to FIG. 2 attached to a closure band in a first deployed position. [Figure 8] 1 in a second, deployed position, with a compression element according to FIG. 2 attached to the closure band; [Figure 9] 1 in a third deployed position, with a compression element according to FIG. 2 attached to the closure band; DETAILED DESCRIPTION OF THE INVENTION

[0011] The ensuing detailed description is merely an example of exemplary embodiments and is not intended to be limiting on the scope, applicability, or configuration thereof. Rather, the ensuing detailed description of exemplary embodiments provides an enabling description for those skilled in the art to practice these embodiments. It should be understood that various changes can be made in the function and arrangement of elements of the embodiments without departing from the spirit and scope of the invention as set forth in the appended claims.

[0012] Directional terms (e.g., up, down, left, right, etc.) may be used herein. These directional terms are intended merely to aid in disclosing embodiments and claiming the invention and are not intended to limit the claimed invention in any way. Additionally, a reference number employed in the specification with respect to a drawing may be repeated in one or more subsequent drawings without further description in the specification to provide context for other features.

[0013] For purposes of this specification and claims, the term "ankle" should be understood to form part of the patient's "lower leg."

[0014] For purposes of this specification and the claims, the term "target pressure" should be understood to refer to a force distributed to a defined area, which force is directed in a direction substantially toward the center of the respective body part and has a value that substantially exceeds the value of the standard force exerted by the closure device against the remainder of the respective body part.

[0015] The increasing prevalence of peripheral arterial disease (PAD) among patients is accompanied by an increased need for peripheral interventions to attempt to clear blockages or surgically introduce stents into vascular pathways. When antegrade passage cannot be achieved, vascular access is generally achieved via a retrograde approach, from below the patient's knee upward. The three primary arterial access sites for retrograde approaches are the dorsalis pedis (DP), anterior tibial (AT), and posterior tibial (PT) arteries. Vascular access is generally achieved using ultrasound guidance techniques, similar to traditional radial artery access from the wrist. After the procedure, the vascular access site is typically closed by applying pressure to promote hemostasis.

[0016] Hemostatic devices are known in the art that include one or more inflatable balloons or bladders wrapped around the area of ​​a patient's limb where bleeding is to be stopped and direct pressure at an arterial vascular access site. Several embodiments of one such hemostatic device, and methods for using such a device, are described in U.S. Patent Application Publication No. 2007 / 0129994, which is incorporated by reference in its entirety as if set forth herein.

[0017] Such devices are generally ring-shaped or cuff-like and may be prone to migration (i.e., movement) when deployed on a patient's limb, particularly the leg, thus reducing the effectiveness of the device. A hemostatic device having flexible elements specially shaped to fit or conform around a particular body part would be less prone to migration and thus represent an improvement over known devices.

[0018] Currently, there are believed to be no hemostatic closure devices specifically designed for the anatomy of the lower leg (e.g., ankle) and foot. The present disclosure describes a novel compression band specifically shaped to support patent hemostasis of the tibial arteries, namely the dorsalis pedis (DP), anterior tibial (AT), and posterior tibial (PT) arteries.

[0019] 1-9, one embodiment of a closure band 20 in accordance with the above-described inventive concepts will now be described in detail. In this embodiment, as shown in FIGS. 3-9, the closure band 20 is designed to be wrapped and secured in place around portions of a patient's lower leg 2 and foot 4, where the lower leg 2 includes the ankle 3, and the foot 4 includes the heel 5, bridge 6, and arch 7, as will be understood by those skilled in the art.

[0020] In this embodiment, the closure band 20 comprises two halves (not numbered) connected by a central seam 26. In alternative embodiments, the closure band 20 may be formed from a single piece of material or more than two sections of material. In this embodiment, the central seam 26 generally corresponds to the sub-arch portion 28 of the closure device. As shown in the drawings, the arch 7 of the patient's foot 4 is placed over the sub-arch portion 28 before the closure band 20 is wrapped around the foot 4.

[0021] Referring back to FIG. 1 , the closure band 20 is shown in an undeployed or unwrapped state lying flat on a surface. The closure band 20 has an inner surface 22 that faces the patient's lower leg 2 and foot 4 when wrapped around the patient's lower leg 2 and foot 4, and an outer surface 24 (see FIG. 5 ) that faces away from the patient's lower leg 2 and foot 4. When assembled, the closure band 20 includes a strap 29 (see FIG. 6 ) made up of strap half 30 and strap half 34 that corresponds to a wrap location around the posterior portion of the patient's ankle 3. When assembled, the closure band 20 further includes a strap 37 (see FIG. 5 ) made up of strap half 38 and strap half 42 that corresponds to a wrap location around the anterior portion of the patient's ankle 3 and / or the upper portion of the bridge 6 of the patient's foot 4. When assembled, the closure band 20 further includes a strap 45 (see FIG. 5 ) made up of strap half 46 and strap half 50 that corresponds to a wrap location around the lower portion of the bridge 6 of the patient's foot 4. In this embodiment, each of the six strap halves 30, 34, 38, 42, 46, 50 that make up the three straps 29, 37, 45 includes a respective fastener half 32, 36, 40, 44, 48, 52 that mates with its respective complementary fastener half to form a respective finished fastener 31, 39, 49 (see FIGS. 4-6). Specifically, fastener half 32 of strap half 30 mates with fastener half 36 of strap half 34 to form finished fastener 31 for strap 29, fastener half 40 of strap half 38 mates with fastener half 44 of strap half 42 to form finished fastener 39 for strap 37, and fastener half 48 of strap half 46 mates with fastener half 52 of strap half 50 to form finished fastener 49 for strap 45. Strap 29 is adapted to fit around at least a portion of the patient's lower leg 2, and straps 37, 45 are adapted to fit around at least a portion of the patient's foot 4. Strap 29 may also be referred to as the "first strap," one of straps 37, 45 may also be referred to as the "second strap," and the other of straps 37, 45 may also be referred to as the "third strap."In this embodiment, the fasteners 31, 39, 49 comprise patches of hook and loop fastener (e.g., Velcro®). In alternative embodiments, the fasteners may be formed from any suitable type of fastener, for example, snaps, buttons, laces, zippers, or hook and eyelet combinations.

[0022] In this embodiment, intermediate portion 54 is located on one side of sub-arch portion 28 and intermediate portion 60 is located on the opposite side of closure band 20 from sub-arch portion 28. Three strap halves 30, 38, 46 extend from intermediate portion 54 and three other strap halves 34, 42, 50 extend from intermediate portion 60. Intermediate portion 54 includes two additional fastener halves 56, 58. As described in more detail below, fastener halves 56, 58 are used for releasable attachment of a compression element 62 that is used to deliver targeted pressure to a desired vascular access site in lower leg 2 or foot 4.

[0023] FIG. 2 shows a compression element 62, which in this embodiment includes an inflatable double-balloon structure similar to the embodiment taught in U.S. Patent No. 6,277,693. The pneumatic double-balloon design aids in the process of titrating air and reducing compression (pressure) so that the artery or vein can remain open for a period of time during recovery. In this embodiment, the compression element 62 comprises a body 64 including a fastener half 66, a main balloon 70, a secondary balloon 72, and a connector 68 that serves as an intermediate joint between the body 64 and the main and secondary balloons 70 and 72. An opening 76 is provided between the interior of the main balloon 70 and the interior of the secondary balloon 72, allowing the secondary balloon 72 to inflate when the main balloon 70 is inflated, thus providing efficient and easy use. A tube 82 enters the interior of the main balloon 70 through a port 78, and the opposite end of the tube 82 is connected to an inflator 80. The inflator 80 includes a bulb 84 and a connector 86. Inflation of the balloons 70, 72 is accomplished by inserting the protruding tip of a syringe (not shown) into the connector 86 and depressing the syringe plunger to introduce fluid (e.g., air) from the syringe into the balloons 70, 72 through the inflator 80. When the fluid is injected into the balloons 70, 72 and the protruding tip of the syringe is withdrawn from the connector 86, a check valve (not shown) within the connector 86 closes, thereby preventing fluid leakage and maintaining the balloons 70, 72 in an inflated state. In this embodiment, when both balloons 70, 72 are inflated, the secondary balloon 72 exerts an oblique pressure against the primary balloon 70, which in turn exerts a target pressure on the respective artery or vein, thereby promoting hemostasis.

[0024] In this embodiment, the compression element 62 further includes a marker 74 located on the inner edge of the secondary balloon 72 (and generally in the center of the primary balloon 70) that allows the clinician to align the balloons 70, 72 with the center of the vascular access site. In an alternative embodiment, the marker 74 can be omitted.

[0025] In additional alternative embodiments, compression element 62 can be formed with only one balloon and / or a balloon of a different size than balloons 70, 72 of the present embodiment. In further alternative embodiments, balloons can be omitted entirely, and hemostatic pressure can be achieved by a material pad or mechanical device that applies a targeted pressure to the desired vascular access site.

[0026] In this embodiment, both the closure band 20 and the compression element 62 are transparent to allow visualization of the vascular access site and monitor bleeding during hemostasis. Furthermore, in this embodiment, the closure band 20 is made of polyvinyl chloride (PVC). In alternative embodiments, all or some portions of the closure band 20 and / or compression element 62 may be formed from an opaque material and / or another type of material. In a further alternative embodiment, only the portion of the closure band 20 to be positioned around the tibial vascular access site may be formed from a transparent material, with the remaining portions of the closure band 20 being formed from an opaque and / or translucent material. The closure band 20 may further optionally include a patency monitoring sensor.

[0027] In this embodiment, fastener half 66 allows compression element 62 to be releasably attached to either of fastener halves 56, 58 located on intermediate portion 54 of closure band 20. Balloons 70, 72 of compression element 62 are positioned offset from fastener half 66, and fastener halves 56, 58 of closure band 20 are positioned away from arterial access sites 10, 12, 14, so that balloons 70, 72 of compression element 62 can be deployed over selected ones of arterial access sites 10, 12, 14 without interfering with the respective arterial access sites 10, 12, 14. In this embodiment, fastener halves 56, 58, 66 comprise hook-and-loop (e.g., Velcro®) patches. In alternative embodiments, the fastener halves may be formed from any suitable type of fastener, such as snaps, buttons, laces, zippers, or hook-and-eyelet combinations. In a further alternative embodiment, one or more balloons may be integrated with one or more strap halves 30, 34, 38, 42, 46, 50, thereby eliminating the need for compression element 62 as a separate unit and the need for fastener halves 56, 58 altogether.

[0028] The locations of the fastener halves 56, 58 and the dimensions of the body 64 of the compression element 62 are carefully selected so that the compression element 62 can be attached to different fastener halves 56, 58 and oriented in different directions so that the balloons 70, 72 are positioned over one of three selected arterial access sites: the dorsalis pedis (DP) artery access site 10, the anterior tibial (AT) artery access site 12, and the posterior tibial (PT) artery access site 14. In alternative embodiments, the closure band 20 can include additional fastener halves so that multiple compression elements can be attached to the closure band 20 at one time, for example, if dual tibial or tibio-pedicular access is performed during a procedure.

[0029] Returning to this embodiment, FIG. 4 shows the completed strap 45 wrapped around the bridge 6 of the patient's foot 4 and positioned over the DP artery access site 10. As shown in FIG. 9 , when the DP artery access site 10 is used in a procedure and it is necessary to apply hemostatic pressure to the site 10, fastener half 66 of the compression element 62 is attached to fastener half 58 so that balloons 70, 72 of the compression element 62 are positioned below the strap 45 and over the DP artery access site 10, and the remainder of the compression element 62 extends over the bridge 6 of the foot 4. The compression element 62 is then inflated as described above. When the compression element 62 is positioned over the DP artery access site 10, as shown in FIG. 9 , the straps 29, 37 can be unattached around the patient's ankle 3 and the bridge 6 of the patient's foot 4, or they can be wrapped around the closure band 20 and compression element 62 to help hold them in place during hemostasis.

[0030] 5 and 6 show the completed straps 29, 37 wrapped around the ankle 3 and the upper portion of the bridge 6 of the patient's foot 4. The completed straps 29, 37 are positioned over the AT artery access site 12 and the PT artery access site 14. FIGS. 7-9 show diagrams of the compression element 62 from FIG. 2 attached to the closure band 20 in various deployed positions. As shown in FIG. 8, if the AT artery access site 12 is used in the procedure and requires application of hemostatic pressure to this site 12, fastener half 66 of the compression element 62 is attached to fastener half 56 so that balloons 70, 72 of the compression element 62 are positioned below the straps 37 and above the AT artery access site 12, and the remainder of the compression element 62 extends over the bridge 6 of the foot 4 (i.e., the front of the foot 4). The compression element 62 is then inflated as described above. As further shown in FIG. 8 , when the compression element 62 is placed over the AT artery access site 12 or the PT artery access site 14, the strap 45 may not be attached around the patient's foot 4, or the strap 45 may be wrapped around the closure band 20 and compression element 62 to help hold them in place during the hemostasis period.

[0031] 7 , if the procedure involves a PT artery access site 14 and requires the application of hemostatic pressure to the site 14, fastener half 66 of compression element 62 is attached to fastener half 56, and the remainder of compression element 62 is extended around ankle 3 (i.e., toward the posterior side of foot 4) so ​​that balloons 70, 72 of compression element 62 are positioned below strap 29 and above PT artery access site 14. Compression element 62 is then inflated as described above. If compression element 62 is positioned over AT artery access site 12 or PT artery access site 14, strap 45 may not be attached around the patient's foot 4, or strap 45 may be wrapped around closure band 20 and compression element 62 to help hold them in place during hemostasis.

[0032] The inventors used anthropometric data from a group of human feet and ankles to select optimal strap dimensions and angles so that the closure band 20 according to the present disclosure can be used for a variety of patients with different foot and ankle shapes and sizes. Nevertheless, the inventors determined that it may be desirable to create closure bands 20 in different sizes (e.g., small, medium, and large) with slightly different strap angles to better accommodate an appropriate proportion of the range of human foot and ankle size variations. For example, it may be desirable to create various closure bands according to the present disclosure suitable to fit all individuals within 3, 4, 5, or 6 standard deviations from the average human foot and ankle size, or all individuals within a particular percentile range of foot and ankle size, e.g., the 5th to 95th percentiles or the 2nd to 98th percentiles. In a further alternative embodiment, the closure band 20 may be shaped and sized into left and right foot versions based on collected anthropometric data.

[0033] While the principles of the claimed invention have been described above in connection with specific embodiments, it should be clearly understood that this description is made by way of example only and is not intended to limit the scope of the invention as set forth in the appended claims. [Explanation of symbols]

[0034] 2 Lower Legs 3. Ankle 4 legs 5 heel 6 Bridge 7 Arch 10. Dorsal (DP) artery access site 12 Anterior tibial (AT) artery access site 14 Posterior tibial (PT) artery access site 20 Closure Band 22 Inner 24 Exterior 26 Center joint 28 Lower arch 29 Strap 30 Half strap 31 Completed fastener 32 Zipper half 34 Half strap 36 Fastener half 37 Strap 38 Half strap 39 Finished fastener 40 Fastener half 42 Half strap 44 Fastener half 45 Strap 46 Half strap 48 Fastener half 49 Finished Fastener 50 Half strap 52 Zipper half 54 Middle part 56 Fastener half 58 Fastener half 60 middle part 62 Compression Elements 64 Main Unit 66 Fastener half 68 Connector 70 Main Balloon 72 Secondary Balloon 74 Marker 76 Aperture 80 Inflator 82 tubes 84 Spherical part 86 Connector

Claims

1. 1. A closure device adapted to simultaneously fit around at least a portion of a patient's lower leg and at least a portion of the foot, comprising: at least one compression element adapted to apply pressure to at least one artery or vein located within the lower leg and foot; a first strap that fits around the at least a portion of the patient's lower leg; a second strap that fits around the at least a portion of the patient's foot; and a third strap that fits around at least one additional portion of the patient's lower leg or foot; Equipped with the at least one compression element is integral with the first strap and the second strap such that at least a portion of the compression element is disposed between the first strap and the patient's lower leg or foot or between the second strap and the patient's lower leg or foot; A closure device, wherein the second strap and the third strap are positioned on opposite sides of the lower leg from the first strap.

2. 10. The closure device of claim 1, wherein the first strap and the second strap are adjustable to fit around at least a portion of a lower leg and at least a portion of a foot of a plurality of patients having lower legs or feet of different sizes or shapes, respectively.

3. The closure device of claim 1 or 2, wherein the at least one compression element comprises at least one expandable element.

4. The closure device of claim 3 , wherein the at least one compression element comprises a plurality of expandable elements.

5. 5. The closure device of claim 4, wherein the plurality of expandable elements comprises at least two expandable balloons that push against each other when inflated to assist in applying the pressure to the at least one artery or vein.

6. The closure device of claim 1 or 2, wherein at least a portion of the closure device is transparent.

7. The closure device of claim 1 or 2, further comprising a patency monitoring sensor attached to the closure device, the patency monitoring sensor monitoring the patency of an artery or a vein.

8. a flexible element adapted to be wrapped around and releasably secured to at least a portion of the patient's lower leg and at least a portion of the foot; at least one compression element adapted to apply pressure to at least one artery or vein located in the lower leg and foot, the at least one compression element being integral with the flexible element; Equipped with The flexible element comprises: a first strap that fits around the at least a portion of the patient's lower leg; a second strap that fits around the at least a portion of the patient's foot; and a third strap that fits around at least one additional portion of the patient's lower leg or foot; Equipped with A hemostatic device, wherein the second strap and the third strap are positioned on opposite sides of the lower leg from the first strap.

9. 9. The hemostatic device of claim 8, wherein the flexible element has an inner surface that abuts against the at least a portion of the patient's lower leg and the at least a portion of the patient's foot when wrapped around and releasably secured thereto, and at least a portion of the at least one compression element is positioned between the inner surface and the at least a portion of the patient's lower leg or the at least a portion of the patient's foot.

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