Pressure device for surgical vascular closure

Abstract

Various embodiments include a vascular closure pressure device configured to pass a suture extending from a closure in a patient's blood vessel and maintain tension on the suture between the patient and the vascular closure pressure device to apply pressure to the patient and apply a closure pressure to the blood vessel to promote clotting.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 314,030, entitled "SURGICAL VESSEL CLOSING PRESSURE DEVICE," filed February 25, 2022, and U.S. Non-Provisional Patent Application No. 17 / 867,205, entitled "SURGICAL VESSEL CLOSING PRESSURE DEVICE," filed July 18, 2022, the entire contents of both of which are incorporated by reference herein for all purposes. [Background technology]

[0002] Currently, many medical procedures involve the insertion of catheters through the skin into blood vessels (such as veins and arteries) to reach various organs in the body. In these procedures, an incision is made in the skin to "cut" the blood vessels to allow the insertion of an introducer port, through which the catheter is inserted. The most common procedures involving the insertion of catheters into blood vessels are cardiac electrophysiology procedures and structural cardiac procedures. An example of structural cardiac procedures would be percutaneous access to the femoral artery to insert a prosthetic heart valve or left atrial appendage closure device.

[0003] A challenge faced in medical procedures involving percutaneous vascular approaches is the closure of the vascular and skin incisions after the withdrawal of the catheter and introducer. Several products have been designed to address this challenge and can be used during the procedure. One such device is called Perclose® and is sold by Abbott Laboratories, Inc. Another device that can be used for both arterial and venous access sites is the Vascade®, recently introduced by Haemonectics Corporation, a division of Cardiva Medical, Inc. DISCLOSURE OF THEINVENTION [Problem to be solved by the invention]

[0004] Although these vascular closure devices aid in the closure process, one significant problem remains: continued bleeding at the insertion site. This bleeding is sometimes exacerbated by the anticoagulant therapy that some patients routinely undergo. To address this issue, a caregiver must remain with the patient until the bleeding has stopped. Compressions are often performed for 20 minutes or more using a weighted bag or two or three finger compressions by the caregiver. During this time, the patient is unable to move from the operating table to a recovery area. As a result, operating rooms remain in use after surgery has concluded, potentially resulting in fewer surgeries per day. [Means for solving the problem]

[0005] Various embodiments include an apparatus for maintaining pressure on a blood vessel (e.g., an artery or vein) following an intravascular procedure. Various embodiments can include a pressure applying surface coupled to a mechanism for maintaining tension on a suture extending from an occlusion in the blood vessel. [Brief description of the drawings]

[0006] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments and, together with the general description given above and the detailed description given below, serve to explain features of various embodiments.

[0007] [Figure 1A] FIG. 1A is a perspective view of a vascular closure compression device according to some embodiments. [Figure 1B] FIG. 1B is a cross-sectional view of a vascular closure compression device according to some embodiments. [Figure 1C] FIG. 1C is a cross-sectional view of a vascular closure compression device according to some embodiments. [Figure 1D]FIG. 1D is a cross-sectional view of the embodiment of the vascular closure compression device shown in FIG. 1C, showing a portion of the device from a different angle. [Figure 1E] FIG. 1E is a cross-sectional view of a vascular closure compression device illustrating an alternative configuration of a suture fastening mechanism according to some embodiments. [Figure 1F] FIG. IF is a cross-sectional view of a vascular closure compression device illustrating an alternative configuration of a suture fastening mechanism according to some embodiments. [Figure 1G] FIG. 1G is a cross-sectional view of a vascular closure compression device illustrating an alternative configuration of a suture fastening mechanism according to some embodiments. [Figure 1H] FIG. 1H is a cross-sectional view of a vascular closure compression device illustrating an alternative configuration of a suture fastening mechanism according to some embodiments. [Figure 2A] FIG. 2A is a perspective view of a vascular closure compression device according to some embodiments. [Figure 2B] FIG. 2B is a cross-sectional view of a vascular closure compression device according to some embodiments. [Figure 2C] FIG. 2C is a perspective view of a vascular closure compression device according to another embodiment. [Figure 2D] FIG. 2D is a perspective view of an alternative configuration of a spindle of a vascular closure compression device according to some embodiments. [Figure 2E] FIG. 2E is a perspective view illustrating an alternative configuration of a spindle of a vascular closure compression device according to some embodiments. [Figure 2F] FIG. 2F is a perspective view illustrating an alternative configuration of a spindle of a vascular closure compression device according to some embodiments. [Figure 2G] FIG. 2G is a perspective view illustrating an alternative configuration of a spindle of a vascular closure compression device according to some embodiments. [Figure 2H] FIG. 2H is a perspective view illustrating an alternative configuration of a spindle of a vascular closure compression device according to some embodiments. [Figure 2I] FIG. 2I is a perspective view illustrating an alternative configuration of a spindle of a vascular closure compression device according to some embodiments. [Diagram 3] FIG. 3 is a cross-sectional view of a vascular closure compression device illustrating use with a patient in accordance with some embodiments. [Figure 4A] 4A-4D are perspective views of several alternative configurations of a vascular closure compression device according to some embodiments. [Figure 4B] 4A-4B are perspective views of several alternative configurations of a vascular closure compression device according to some embodiments. [Figure 4C] 4A-4C are perspective views of several alternative configurations of a vascular closure compression device according to some embodiments. [Figure 4D] 4A-4D are perspective views of several alternative configurations of a vascular closure compression device according to some embodiments. [Figure 5A] FIG. 5A is a process flow diagram of an exemplary method for using a compression device for vascular closure according to some embodiments. [Figure 5B] FIG. 5B is a process flow diagram of an exemplary method for using a compression device for vascular closure according to some embodiments. [Figure 6] FIG. 6 is a perspective view of a prototype vascular closure compression device according to some embodiments. [Figure 7] FIG. 7 is a perspective view of a prototype vascular closure compression device according to some embodiments. [Figure 8] FIG. 8 is a side view of a blood vessel closure compression device according to another embodiment. [Figure 9] FIG. 9 is a perspective view of the embodiment of the blood vessel closure pressure device shown in FIG. [Figure 10] FIG. 10 is a perspective view of the embodiment of the blood vessel closing pressure device shown in FIG. [Figure 11] 11 is a perspective view of a spindle component of the embodiment of a vascular closure compression device shown in FIG. 8. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Various embodiments are described in detail below with reference to the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. References to specific examples and embodiments are for illustrative purposes only and are not intended to limit the scope of the claims.

[0009] In overview, various embodiments include a vascular closure pressure device that applies tension to the sutures used to close the blood vessel, thereby exerting a clamping force on the vascular sutures by physically contacting the pressure device with the patient's skin. The vascular closure pressure device according to various embodiments mechanically applies pressure to the vascular suture closure to promote clotting, stop bleeding from the blood vessel, and allows caregivers to avoid having to spend extra time with the patient after closure. In addition to providing effective pressure to the vascular sutures, the device can allow the patient to be moved from the operating room to a recovery area more quickly than if pressure was applied by a caregiver or an external weight.

[0010] To close the vessel and incision site, threaded sutures are typically passed through or around the vessel, often with a figure-of-eight threading, and knotted with proximal and distal portions of the suture remaining outside the skin. In various embodiments, rather than tying off and cutting the suture, the suture is passed through a vessel closure pressure device that includes a suture tensioning mechanism that maintains tension on the suture to apply clamping pressure to the patient's skin to close the suture within the vessel.

[0011] Various embodiments of the pressure application device for vascular closure may include a pressure application surface coupled to a shaft that includes a mechanism for maintaining tension on the suture so that the pressure application surface presses against the patient's skin. The surface area of ​​the pressure application surface of the surgical instrument may be 1-2 inches square, which corresponds approximately to the area of ​​a conventional caregiver's finger that applies pressure to the incision site after closure. The pressure application surface may include a passageway, such as a hole or slit, on the bottom surface through which the suture may be passed. The pressure application surface may have a shape selected to conform to the contours of the patient's skin at the incision site. For example, the pressure application surface may have a rounded or spherical shape to conform to the indentation of the patient's body at the incision site. As another example, the pressure application surface may have a flat, cylindrical, or elliptical shape to conform to the various contours of the patient's body at the incision site.

[0012] In some embodiments of the vascular closure pressure device, the suture tensioning mechanism can include a suture clamping mechanism operable by a clinician to maintain tension on the suture between the blood vessel and the vascular closure pressure device. In such embodiments, the suture clamping mechanism can include a thread gripping mechanism configured to maintain tension on the suture after the clinician tightens the thread. In such embodiments, the clinician can thread the suture through the vascular closure pressure device (e.g., before or after suturing the blood vessel), slide the device over the thread against the patient's skin while pulling the suture to tension the thread, and operate the thread gripping mechanism to maintain tension on the thread. Tensioning the suture and holding the taut thread via the thread gripping mechanism causes the pressure application surface to press against the patient's skin, thereby applying a clamping pressure to the closure of the suture in the blood vessel. Different thread gripping mechanisms can be used, such as a rotating clamping mechanism or a sliding clamping mechanism, as described herein with reference to Figures 1A-1I.

[0013] In some embodiments, the suture gripping mechanism can have the form of a suture clamping mechanism coupled to a shaft that the clinician can manipulate to tension the suture between the vessel and the vessel closure pressure device, as described herein with reference to Figures 2A-3. In such embodiments, the suture clamping mechanism can include a spindle in or coupled to a central shaft, the spindle including a structure for engaging the suture, such as a passageway through which the suture can be threaded when the passageway (e.g., hole or slit) is aligned with the lumen of the central shaft. The spindle can include or be coupled to a handle that can be rotated to rotate the spindle, thereby tying up the suture or winding up the slack to apply tension to the suture leading to the vessel. The spindle and / or shaft can include features or mechanisms (e.g., friction, ratchet, etc.) that resist or prevent the spindle from rotating or unwinding. In some uses, the clinician can pull on the suture to take up slack, slide the vascular closure pressure device into contact with the patient's skin, and then rotate the spindle to tie or take up slack in the suture to maintain tension on the suture and apply additional tension to the suture between the device and the vessel. In some applications, the clinician can rotate the spindle to take up slack in the suture and apply the appropriate amount of tension without pulling on the suture. Tensioning the suture in this manner forces the pressure application surface against the patient's skin, applying a clamping pressure to the incision site of the vessel and the suture.

[0014] The vascular closure compression device according to various embodiments can be configured as a one-time disposable device and can be sealed in a sterile package prior to use.

[0015] 1A illustrates an example of a vascular closure pressure device 100 according to some embodiments. As illustrated, the vascular closure pressure device can include a central shaft 102 that includes a suture clamping mechanism 104 and is connected to a pressure application surface 106. The central shaft 102 can include a passageway shaped as a lumen 108 through which a suture 110 can be passed. The suture clamping mechanism 104 can be configured to allow a physician to engage the suture clamping mechanism to maintain tension on the suture 110 connected to a stitch in a blood vessel.

[0016] In various embodiments, the area of ​​the pressure application surface 106 that contacts the patient's skin may be approximately 1 to 2 square inches. As described in more detail herein, the pressure application surface 106 may have an exterior contour selected to match the typical contour of a patient's body at the location of a vascular incision. For example, the pressure application surface 106 of the embodiment shown in FIG. 1A is hemispherical in shape to match the contour of a typical patient's thigh at the location where a cardiac catheter may be inserted into the femoral artery. As described below with reference to FIGS. 4B, 4C, and 4D, the pressure application surface 106 may have different shapes or contours, including flat, spherical, elliptical, and irregular. In certain embodiments, the vascular closure pressure device 100 may be manufactured to have different shapes of pressure application surface 106 to allow a clinician to select the appropriate shaped model for use with a patient depending on the location and surface contour of the incision site of a particular patient. In one embodiment, the vascular closure pressure device 100 can be configured to have pressure application surfaces 106 of different shapes attached to a common shaft 102, allowing a clinician to select an appropriate shape of pressure application surface depending on the location and surface contours of the incision site for a particular patient.

[0017] The shaft 102 may include a chamber for mounting a suture clamping mechanism 104. As previously mentioned, the suture clamping mechanism 104 may take any of a variety of forms. Figures 1B-1D show a non-limiting example of a suture clamping mechanism 104 shaped as a rotating spindle 105 having a passageway in the shape of a bore 114 that allows a suture to be threaded through the device when the spindle 105 is rotated and oriented in alignment with a lumen 108 of the bore, and that may hook or grip the suture when the spindle is rotated and oriented out of alignment with a complementary space in the shaft 102. 1E-1H show a non-limiting example of a suture clamping mechanism 104 having a spring-loaded translation bar 122 having a passage in the shape of a hole 114 through which a suture 110 can be threaded when the translation bar is depressed or pulled out so that it is aligned with the lumen 108, and which pinches or grips the suture against a portion of the shaft 102 when the translation bar is released so that it is not aligned with the lumen 108.

[0018] 1B-1D show cross-sectional views of one embodiment of a vascular closure compression device 100 in which the suture clamping mechanism 104 includes a spindle 105 having a passage in the shape of a bore 114 sized to receive a suture 110 therethrough, and uses rotation to align the bore 114 with a lumen and to press the suture against a complementary surface of the shaft 102, thereby gripping the suture to maintain tension on the suture. As shown in FIG. 2B, the suture 110 can be threaded through a passage in the shape of an opening 116 in the pressure application surface 106, through the lumen 108 of the central shaft 102, and through the bore 114 in the spindle 105 when the spindle is rotated to orient the bore in line with the lumen. The passageway in the shape of the opening 116 in the pressure application surface 106 can have a diameter smaller than the diameter of the lumen 108 of the shaft 102 so as to apply even pressure to the patient's skin, thereby allowing even pressure to be applied to the patient's skin.

[0019] 1C and 1D, rotation of the spindle 105 rotates (i.e., moves) the bore 114 out of alignment with the lumen 108, and the suture 110 engages a complementary surface 118 on the shaft 102 (indicated by arrow 120). As shown in FIG. 1D, the complementary surface 118 may be in the form of a circular cavity having a diameter approximately equal to the diameter of the suture clamping mechanism 104 plus twice the diameter of the suture. Thus, rotation of the spindle 105 compresses the suture 110 between the spindle 105 and the complementary surface 118, which provides a clamping force that maintains tension on the thread between the pressure application surface 106 and the blood vessel.

[0020] Threading the suture 110 through a passageway of a bore 114 formed in the spindle 105 of the suture clamping mechanism 104 provides a simple mechanism for gripping the suture by rotating the spindle.

[0021] 1E-1G, the suture clamping mechanism 104 includes a spring biased translation bar 122 positioned within a chamber 124 in the shaft 102 that intersects with the lumen 108. The translation bar 122 may be of sufficient length to extend beyond one side of the shaft 102. As shown in FIG. 1E, a spring 126 within the chamber 124 biases the translation bar 122 such that the member aperture 114 is normally misaligned with the lumen 108.

[0022] 1F, to thread the suture 110 through the vascular closure pressure device 100, for example, prior to suturing or after an incision has been closed, a clinician can push on the portion of the translation bar 122 that extends from the surface of the shaft 102 to compress the spring 126 and align the passageway in the form of the hole 114 in the translation bar 122 with the shaft lumen 108. In this configuration, the suture 110 is threaded through the opening 116 in the pressure application surface 106, through the lumen 108 of the shaft 102, through the hole 114 in the translation bar 122, and out the top of the vascular closure pressure device 100.

[0023] As shown in FIG 1F, to apply pressure to the incision site, the clinician can pull the suture threads to take up slack and press the vascular closure compression device 100 against the patient's skin. To maintain pressure on the incision site, the clinician then releases the translation bar 122, allowing the spring 126 to slide the member toward an unstressed position, which moves the aperture 114 of the member out of alignment with the lumen 108 of the shaft that secures the suture 110, as shown in FIG 1G. As shown, sliding the translation bar 122 to move the aperture 114 of the member out of alignment with the lumen 108 of the shaft 102 restrains the suture 110 threaded through the aperture between the translation bar and the chamber 124.

[0024] To release tension on the suture 110, e.g., after compressing the incision site for a suitable period of time and then removing the vascular closure compression device 100, the clinician can again press on the portion of the translation bar 122 that extends beyond the surface of the shaft 102 to compress the spring 126 and align the hole 114 of the translation bar 122 with the shaft lumen 108, as shown in FIG. 1F.

[0025] In another embodiment shown in FIG. 1H, the translation bar 122 may be oriented such that the spring 126 resists the pulling action of the translation bar, making it spring loaded in the opposite manner to that shown in FIGS. 1E-1G. In this embodiment, the clinician may pull the translation bar (rather than push it as shown in FIG. 1F) to align the passageway in the shape of the hole 128 with the lumen 108 of the shaft 102 to thread a suture through the vascular closure compression device 100. In this embodiment, pulling the translation bar 122 compresses the spring 124, which provides a force returning the translation bar to a position in which the hole 128 is offset from the lumen 108 as shown, thereby allowing the suture 110 threaded through the passageway to engage the passageway in the shape of the hole 128 between the translation bar and the chamber 124 in a manner similar to that shown in FIG. 1G.

[0026] 1H, a clinician can pull the translation bar 122 to thread the suture through the vascular closure compression device 100, hold the device against the patient's skin while applying tension to the suture with one hand, and then release the translation bar to maintain tension on the suture and therefore the clamping force of the sutured incision. To remove the vascular closure compression device 100, the clinician pulls the translation bar 122 to align the hole 114 with the lumen 108, allowing the suture 110 to be threaded through the hole and releasing the tension so that the suture can be removed from the device.

[0027] In various embodiments, the length of the shaft 102 above the spindle 104 or translation bar 122 may vary from the relative dimensions shown. For example, the shaft 102 may terminate directly above the spindle 104 or translation bar 122. Additionally, in some embodiments, the length of the shaft 102 between the spindle 104 or translation bar 122 and the pressure application surface 106 may vary from the relative dimensions shown. For example, the distance between the spindle 104 or translation bar 122 and the pressure application surface 106 may be sufficient to allow operation of the suture clamping mechanism 104.

[0028] 2A-2I show an example of a vascular closure pressure device 200 according to some further embodiments. As shown, the vascular closure pressure device 200 according to such embodiments can include a central shaft 202 that includes a rotatable spindle 204 and is coupled to a pressure application surface 106. Similar to the embodiment shown in FIGS. 1A-1G, the area of ​​the pressure application surface 106 that contacts the patient's skin can be approximately 1-2 square inches and has an exterior contour selected to match the typical contour of a patient's body at the location of an incision in a blood vessel.

[0029] The central shaft 202 may include a passageway in the form of a lumen 208 through which the suture 110 may pass. The spindle 204 may include a handle 212 or other structure that allows a clinician to rotate the spindle to tension (or maintain tension) the suture 110 within the vessel. The shaft 202 may include an opening for inserting the spindle 204 so that the spindle can be rotated about its long axis. The shaft 202 and / or spindle 204 may further include a mechanism (not shown separately) to limit unwinding of the spindle after the suture has been tightened. Any of a variety of unwind limiting mechanisms may be used, such as friction between the spindle and shaft, a ratchet mechanism that allows rotation in one direction but not the other, or a tooth and gear interface that allows rotation of the spindle when compressed but resists rotation when released.

[0030] Figure 2B illustrates a cross-sectional view of one embodiment of the vascular closure pressure device 200 shown in Figure 2A. As shown, the suture 110 can be threaded through passages in the form of openings 116 in the pressure application surface 106, through a lumen 208 in the central shaft 202, and through a hole 214 in the spindle 204. The passages or openings 116 in the pressure application surface 106 can have a smaller diameter than the diameter of the lumen 208 in the shaft 202 to provide an even pressure to the patient's skin.

[0031] As shown in FIG. 3, threading the suture 110 through hole 214 in the spindle 204 provides a simple mechanism for tying the suture to the spindle such that as the spindle rotates, it tightens the suture between the spindle and the vessel.

[0032] In various embodiments, the length of shaft 202 above spindle 204 may be different than the relative length shown. For example, shaft 202 may terminate just above spindle 204. Additionally, in some embodiments, the length of shaft 202 between spindle 204 and pressure application surface 106 may be different than the relative length shown. For example, the spacing between spindle 204 and pressure application surface 106 may be large enough to accommodate winding of suture 110 on spindle 204.

[0033] In some embodiments, the shaft 202 may not be tubular as shown in the drawings, but may instead be any of a variety of structures that support the spindle 204 and connect to the pressure application surface 106. For example, as shown in FIG. 2C, the shaft 210 may be a solid rod coupled to one or more bearings 218, 220 via a support structure 222, which may be configured to provide rotational support to the spindle 204. In such an embodiment, the suture 110 may be threaded through a passage in the shape of the opening 116 in the pressure application surface 106 and through a passage in the shape of the hole 214 in the spindle 204, without being threaded through a lumen in the shaft 210. In some embodiments, the shaft 210 may be shorter relative to the pressure application surface 106 than shown, and may be configured to support the bearings 218, 220 on the pressure application surface 106 to allow rotation of the spindle 204.

[0034] Spindle 204 can include a variety of features for securing suture 110 for winding. Three non-limiting alternatives are shown in Figures 2D-2I.

[0035] 2D and 2E show embodiments of a spindle 204 that includes a passageway having the shape of a bore 214 through which the suture 110 can be passed. In such embodiments, the bore 214 can have a diameter sufficient to pass the suture 110 through. In some embodiments, the bore 214 can have a diameter similar to or the same as the diameter of the lumen 208 of the shaft 202. When the handle 212 of the spindle 204 is rotated (e.g., as shown in FIG. 2B), the suture 110 is wound onto the spindle, as shown in FIG.

[0036] 2F and 2G show an embodiment of a spindle 204 that includes a ring 224 or similar structure having a passageway in the shape of a hole 226 through which a suture 110 can be threaded. In this embodiment, the suture can be threaded through hole 226 when spindle 204 is rotated such that ring 224 is oriented approximately perpendicular to the longitudinal axis of shaft 202, such that the centerline of hole 226 is oriented approximately parallel to the longitudinal axis of shaft 202. As with the embodiment shown in FIGS. 2A-2E, rotating spindle 204 winds suture 110 onto the spindle in a manner similar to the example shown in FIG.

[0037] 2H and 2I show embodiments of the spindle 204 having a structure, such as a knob 228 as shown, a hook, or similar structure, that can hook or secure the suture 110 so that the suture 110 is wound around the spindle when the spindle 204 is rotated. For example, in an embodiment of the vascular closure pressure device 200 in which the spindle 204 includes a knob 228, the suture 110 may be wound around the knob to secure the thread to the spindle prior to rotating the spindle. Such an embodiment of the spindle 204 is useful in an embodiment of the vascular closure pressure device 200 having a solid shaft 210 as shown in FIG. 2C in which the knob 228 is not hidden from view or accessible within the shaft lumen 208. When suture 110 is wound around or otherwise tied to knob 228 (or a similar structure) and spindle 204 is rotated, suture 110 will wind around the spindle in a manner similar to the example shown in FIG. 3.

[0038] 1A-2I, a tool such as a straight needle can be used to push or pull the suture 110 through the passages of the vascular closure compression device 100, 200, including the holes 114 in the spindles 105, 204 or translation bar 122, which may not be visible depending on the material used for the central shaft 102. Alternatively, the suture 110 can be threaded through the passages of the vascular closure compression device 100, 200 prior to (or in preparation for) using the suture to suture or close an incision in a blood vessel.

[0039] 3 illustrates a cross-sectional view of one embodiment of a vascular closure pressure device 200 after the spindle 204 has rotated several times and wrapped enough suture 110 around the spindle to tighten the suture 110 between the spindle 204 and the blood vessel 304. As shown in FIG. 3, the slack in the suture 110 between the spindle 204 and the blood vessel 304 is taken up around the spindle wraps 312. Tightening the suture 110 draws the vascular closure pressure device 200 towards the blood vessel 304, thereby forcing the pressure application surface 106 against the skin 302 of the patient 300 at the incision site closure portion 308. The suture 110 extends from the blood vessel 304, e.g., from the suture 306 within the vessel, thereby inducing a clamping force between the blood vessel 304 and the pressure application surface 106 (and the patient's skin 302) that can stop or minimize bleeding and promote clotting at the incision site within the vessel, without the need for the clinician to apply external pressure to the incision site closure.

[0040] Various embodiments of vascular closure compression devices 100, 200 may differ in form and construction from those shown in Figures 1A-3, some non-limiting examples of which are shown in Figures 4A-4D.

[0041] 4A, the vascular closure pressure device 100, 200 can include a case or shell 400 that encompasses the central shaft 102, 202 that fits against the pressure application surface 106. In some embodiments, the central shaft 102, 202 can have an outer diameter (or outer contour) that matches the pressure application surface 106, in which case the central shaft 102, 202 would have the shape of the shell 400. By hiding surface contours where bacteria may grow, such a configuration of the vascular closure pressure device 100, 200 can facilitate sterilization of the device prior to packaging, as well as after use of a device configured for reuse (i.e., not a one-time disposable model).

[0042] As discussed above, the pressure application surface 106 can have a variety of shapes and contours that can be selected to conform to the patient's skin at the incision site, some non-limiting examples of which are shown in Figures 4B-4D. As shown in Figure 4B, the pressure application surface 402 can be flat or nearly flat, such as a disk having an area of ​​about 1-2 square inches. As shown in Figure 4C, the pressure application surface can be a solid shape, such as a sphere 404, with a radius selected such that the portion of the solid shape that contacts the patient's skin has a surface area of ​​about 1-2 square inches. As shown in Figure 4D, the pressure application surface can be a complex shape, such as an elongated ellipsoid 406 with major, minor and major axes selected such that the portion of the shape that contacts the patient's skin has a surface area of ​​about 1-2 square inches.

[0043] 5A is a process flow diagram illustrating a method 500 for using the blood vessel closure compression device 100 according to some embodiments. With reference to FIGS. 1A-11, the method 500 may be performed as part of the closure of a blood vessel following a catheter procedure.

[0044] At block 502, the clinician may close the incision in the blood vessel with sutures, extending sutures (eg, 110) through the sutures at the entry incision, and then suturing the entry incision closed.

[0045] At block 504, the clinician may thread a suture (e.g., 110) through a passageway through the vascular closure pressure device 100. As described herein, this action may include threading the suture through holes 116 in the pressure application surface (e.g., 106, 402, 404, 406), through holes in / on the suture clamping mechanism 104 (e.g., 114, 228), and out the top of the vascular closure pressure device 100. As described with reference to the figures, this action may include sliding the suture through a slit that provides a passageway through the vascular closure pressure device 800.

[0046] In block 506, the clinician can pull the suture extending from the vascular closure pressure device to place tension on the thread while pressing the vascular closure pressure device against the patient to apply pressure to the incision site, and then operate a thread tension holding mechanism (e.g.: 104, 105, 122) to maintain tension in the thread, and therefore pressure against the incision site. As described herein, in some embodiments, operating the thread tension holding mechanism can include rotating a spindle (e.g., 105) having a hole (e.g., 114) through which the suture (e.g., 110) is threaded, to grip the thread between the spindle and a corresponding surface within the shaft (e.g., 102) of the vascular closure pressure device. Also, as discussed herein, in some embodiments, tensioning the thread while pressing the vascular closure pressure device against the patient in block 506 includes pushing or pulling the translation bar (e.g., 122) to align a hole (e.g., 144) in the bar with a lumen (e.g., 108) in the shaft (e.g., 102) to allow the suture to pass through the hole, and activating the thread tensioning mechanism can include releasing the translation bar to misalign the hole and lumen and grip the thread between the translation bar and a chamber (e.g., 124) in the shaft of the vascular closure pressure device.

[0047] The clinician may leave the vascular closure compression device at the incision site for the necessary clotting period, block 508. At this point, the patient may be transferred from the operating room to a recovery room.

[0048] At block 510, after a sufficient time has elapsed, the clinician may release the tension on the suture by activating a suture tension holding mechanism to cut the suture beneath the vascular closure pressure device. As described herein, in some embodiments, operating the suture tension holding mechanism to release the tension on the suture may include rotating a spindle (e.g., 105) to align a passage in the shape of a hole (e.g., 114) in the spindle with a lumen of the shaft to allow the suture to pass through the hole. Also, as described herein, in some embodiments, operating the suture tension holding mechanism to release the tension on the suture may include pushing or pulling a translation bar (e.g., 122) to align a passage in the shape of a hole (e.g., 144) in the bar with a lumen of the shaft to allow the suture to pass through the hole.

[0049] After removal from the patient, the vascular closure compression device, configured as a single-use disposable item, can be disposed of.

[0050] 5B is a process flow diagram illustrating a method 520 for using the vascular closure pressure device 200 according to some embodiments. With reference to FIGS. 2A-5B, the method 500 may be performed as part of a vascular occlusion procedure following a catheterization procedure.

[0051] In block 502, the clinician closes the incision in the blood vessel with a suture, running a suture (eg: 110) through the open incision, and then suturing the open incision closed.

[0052] At block 504, the clinician may thread a suture (e.g., 110) through a passageway in the vascular closure pressure device 200. As described above, this may include threading the suture through holes 116 in the pressure application surface (e.g., 106, 402, 404, 406), through holes (e.g., 214, 228) in / on the spindle 204 (or engaging structures such as the knob 228 or hooks on the spindle), and out the top of the vascular closure pressure device 200. As described with reference to FIGS. 8-11, this may include sliding the suture through a slit that provides a passageway through the vascular closure pressure device 800.

[0053] At block 522, the clinician can rotate the spindle to tension the suture between the spindle 204 and the vessel, thereby drawing the pressure application surface of the vascular closure pressure device toward the patient and applying pressure to the incision site. This can include engaging a mechanism that prevents the spindle from unwinding, such as engaging a ratchet or tightening a tension nut on the spindle.

[0054] At block 508, the clinician may leave the vascular closure compression device at the incision site for the necessary clotting period, at which point the patient may be removed from the operating room for recovery.

[0055] At block 524, after a sufficient amount of time has elapsed, the clinician may rotate the spindle to release tension on the suture and cause the suture to be severed below the vessel closure compression device.

[0056] After removal from the patient, the vascular closure compression device, configured as a one-time disposable device, can be disposed of.

[0057] 6 and 7 are diagrams illustrating a prototype vascular closure pressure device 600 according to a non-limiting embodiment. In this prototype, a stopcock is used on the shaft 102 and spindle 104. FIG. 6 shows one embodiment of the prototype closure pressure device 600 with a suture 110 passing through the lumen 108 of the valve body, through the spindle 104 (i.e., through the hole in the valve plug), and through the exit hole 116 of the hemispherical pressure application surface 106. As described herein, as the spindle 104 (i.e., the valve plug) rotates, the suture 110 wraps around the spindle, thereby tightening (or maintaining tension on) the suture between the pressure application surface 106 and the patient. FIG. 7 shows the opposite side of the prototype closure pressure device 600 from an angle showing the handle 112 of the spindle 104 (i.e., the valve plug).

[0058] 8-11 are diagrams illustrating another embodiment of a pressure application device 800 for vascular closure. As with the other embodiments, the pressure application device 800 for vascular closure can include a central shaft 802 joined to the pressure application surface 106. In the embodiment shown in FIGS. 8-11, the central shaft 802 can have a rectangular cross-section as shown, or can have other configurations. In some embodiments, the central shaft 802 can be glued, fused, or otherwise rigidly coupled to the pressure application surface 106. In some embodiments, the central shaft 802 and the pressure application surface 106 can be manufactured as a single structure, such as in a single mold or using additive manufacturing techniques (known as 3D printing).

[0059] The spindle 804 may be configured to fit onto and rotate within the central shaft 802. The spindle 804 may include a handle 812 to facilitate rotation of the spindle 804. As shown in FIG 11, the spindle 804 may include an inner portion 810 that fits onto the central shaft 802 and includes a slit 814 that forms a spindle through passageway through which a suture may be passed.

[0060] 9 and 10, the central shaft 802 can include a passage in the shape of a slit 806 that matches the passage in the shape of a slit 808 in the pressure application surface 106. The through slits 806, 808 in the central shaft 802 and the pressure application surface 106 provide a passage for the suture through the vascular closure pressure device 800. The passage in the shape of a slit 808 in the central shaft 802 can be sized to match the spindle through passage in the shape of a slit 814 in the inner portion 810 of the spindle 804 when the spindle is positioned on the central shaft. The through slits 806, 808 and 814 in the central shaft 802, the pressure application surface 106 and the spindle inner portion 810 allow the vascular closure pressure device 800 to be attached to the suture without passing the suture through the inner passage as in other embodiments described herein.

[0061] To tie the vascular closure pressure device 800 to the suture, the clinician can rotate the spindle 804 to align the spindle through slits 814 in the inner portion 810 with the slits 806, 808 in the central shaft 802 and the pressure application surface 106, and then slide the suture through the passageway through the vascular closure pressure device 800 formed by the slits. This threads the suture through the spindle 804. The clinician can press the vascular closure pressure device 800 against the incision site while holding the suture taut above the device, and rotate the spindle 804 to tie the suture between the inner portion 810 and the corresponding surface on the central shaft 802. Tying the suture in this manner maintains tension in the suture between the vascular closure pressure device 800 and the suture site, thereby maintaining pressure applied to the incision site by the pressure application surface 106. To release pressure at the incision site, the clinician can rotate the spindle 804 to realign the slits 814 in the inner portion 810 with the slits 806, 808 in the central shaft 802 and the application surface 106, thereby releasing the sutures and allowing the vascular closure pressure device 800 to be removed from the sutures.

[0062] The foregoing method descriptions and process flow diagrams are provided by way of example only and are not intended to require or imply that the operations of the various embodiments must be assembled or performed in the order presented. As will be appreciated by one of ordinary skill in the art, the order of operations in the foregoing embodiments may be performed in any order. Words such as "then," "after," and "next" are not intended to limit the order of operations, but rather, these words are used to guide the reader through the method description. Additionally, references to claim elements in the singular, for example, using the articles "a," "an," or "the," should not be construed as limiting the element to the singular.

[0063] The foregoing description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the claims. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments without departing from the scope of the claims. Thus, the present disclosure is not intended to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the following claims and the principles and novel features disclosed herein.

Claims

1. a suture tensioning mechanism; a pressure application surface coupled to the suture tensioning mechanism and including a through passageway through which a suture can be passed. Pressure devices for vascular closure.

2. a shaft coupled to the pressure application surface and to a support of the suture tensioning mechanism, the shaft including a shaft throughway; the tensioning mechanism includes a spindle having a spindle passageway through which a suture can be threaded when rotation of the spindle is adjusted such that the spindle passageway is aligned with the shaft passageway; The vascular closure compression device of claim 1 , wherein the shaft and spindle are configured to grip the suture when the spindle is rotationally adjusted such that the spindle throughpassage is offset from the shaft throughpassage.

3. The pressure application device for blood vessel closure according to claim 2 , wherein the through passage of the pressure application surface, the through passage of the shaft, and the through passage of the spindle are configured as slits.

4. a shaft coupled to the suture tensioning mechanism and to the pressure application surface; The suture tensioning mechanism includes: a translation bar having a through hole through which a suture can pass when the through hole is aligned with the lumen of the shaft; 2. The vascular closure compression device of claim 1, further comprising: a spring disposed between the shaft and the translation bar to apply a force returning the passageway to misalignment with a lumen within the shaft when the translation bar is released.

5. 5. The blood vessel closure pressure device of claim 4, wherein the through hole of the translation bar is a hole through which a suture thread passes.

6. 2. The vascular closure compression device of claim 1, wherein the tensioning mechanism comprises a spindle having structure for engaging a suture, the spindle being configured to wind the suture onto the spindle when rotated.

7. The blood vessel closure pressure device of claim 6 further comprising a shaft coupled to said spindle and said pressure application surface, said shaft rotatably supporting said spindle.

8. The vascular closure compression device of claim 7 , wherein the shaft has a central lumen through which a suture passes.

9. The vascular closure compression device of claim 6, wherein the structure for engaging a suture with the spindle includes a passageway through the spindle having a diameter and location sufficient to pass a suture therethrough.

10. the structure for engaging the suture with the spindle includes a ring on a surface of the spindle, the ring defining a passageway having a diameter sufficient to allow the passage of the suture; 7. The blood vessel closing pressure device according to claim 6.

11. The blood vessel closure pressure device according to claim 1 , wherein the pressure application surface is hemispherical.

12. The blood vessel closure pressure device of claim 1 , wherein the pressure application surface is spherical.

13. The blood vessel closure pressure device according to claim 1 , wherein the pressure application surface is flat.

14. The vascular closure pressure device of claim 1 , wherein the pressure application surface is elliptical.

15. 10. The vascular closure pressure device of claim 1, wherein the vascular clamping pressure device is configured as a single-use disposable item.

16. closing the incision in the blood vessel with a suture and extending the suture to the incision in the patient; Passing the suture through a blood vessel closure pressure device; applying tension to the suture between the vascular closure compression device and the patient; leaving the blood vessel closure pressure device in the incision for the required coagulation time; After a sufficient period of time has elapsed, tension on the suture is released and the suture is severed below the vessel closure pressure device. A method for closing a vascular incision in a patient.

17. When tensioning the suture between the vascular closure compression device and the patient, Pulling the suture extending from the blood vessel closure pressure device while pressing a pressure application surface against the patient's skin; The method of claim 16, further comprising engaging a suture clamping mechanism to maintain tension on the suture.

18. When the suture between the blood vessel closure pressure device is tensioned, 17. The method of claim 16, further comprising rotating a spindle of the vascular closure pressure device to pull the vascular closure pressure device against the patient and apply pressure to the incision.

19. a means for maintaining tension on the suture extending from the blood vessel; and means for applying pressure to the patient when the suture is tightened. Pressure devices for vascular closure.

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