Secure attachment device for intracardiac blood pumps

Abstract

An improved positive fixation device is provided for use with an intracardiac blood pump assembly. The present technology provides a positive fixation device that may be used with a sheath assembly (e.g., an introducer sheath assembly, a repositioning sheath assembly) configured to limit movement of an object (e.g., a catheter of a pump assembly) within the sheath assembly except when a mechanism (e.g., a button) of the positive fixation device is actively actuated (e.g., pressed, held, etc.). TIFF2023536095000002.tif140166

Description

[Technical Field]

[0001] Cross-Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 058,003, filed on July 29, 2020, the entire disclosure of which is incorporated herein by reference. [Background Art]

[0002] Background Intracardiac heart pump assemblies can be introduced into the heart either surgically or percutaneously, and used to deliver blood from one location in the heart or circulatory system to another location in the heart or circulatory system. For example, when placed in the heart, an intracardiac pump can pump blood from the left ventricle into the aorta, or from the inferior vena cava into the pulmonary artery. Intracardiac pumps can be powered by a motor (and associated drive cable) located outside the patient's body, or by an on-board motor located inside the patient's body. Some intracardiac blood pumps can operate in parallel with the patient's native heart to supplement cardiac output and partially or fully unload the components of the heart. Examples of such systems include the IMPELLA® family of devices (Abiomed, Inc., Danvers Mass.).

[0003] In one common approach, an intracardiac blood pump is inserted via a catheter procedure through the femoral artery using a sheath such as a peel-away introducer sheath. The sheath may alternatively be inserted at other locations, such as into the femoral vein, or along any route for delivering a pump supporting either the left or right side of the heart.

[0004] The introducer sheath may be inserted into the femoral artery through an arterial incision to create an insertion route for the pump assembly. A portion of the pump assembly is then advanced through the lumen of the introducer into the artery. In some cases, once the pump assembly is inserted, a thinner repositioning sheath may be inserted into the introducer sheath, and the introducer sheath may be removed. The repositioning sheath may have a structure to securely fix the repositioning sheath assembly to the patient. For example, the proximal hub of the repositioning sheath assembly may have a butterfly structure that can be sutured to the patient's skin.

[0005] In some cases, the introducer sheath may remain in place even after the pump assembly has been inserted. In such cases, a repositioning sheath may or may not be used in addition to the introducer sheath. If used, the repositioning sheath may be inserted into the introducer sheath. In some cases, the repositioning sheath may be configured to fit into the lumen of the introducer sheath. In some cases, the lumen of the introducer sheath may be configured to extend in order to allow the repositioning sheath to be inserted into it. In some cases, the introducer sheath may be configured so that the repositioning sheath is not inserted into the lumen of the introducer sheath. If the introducer sheath remains in place, it may also have a structure (e.g., a suture butterfly) for securely fixing the introducer sheath assembly to the patient.

[0006] After insertion of the pump assembly, a secure fixation device may be used to hold the catheter of the pump assembly against the sheath through which it is inserted, regardless of whether the introducer sheath, repositioning sheath, or both remain in use. For example, a Tuohy-Borst device may be attached to or incorporated into the hub of the introducer sheath or repositioning sheath. Turning the barrel of the Tuohy-Borst device in one direction compresses a deformable internal component (e.g., a deformable ring or sleeve), which can thus be used to form a seal against the catheter of the pump assembly and to resist the movement of the catheter within the Tuohy-Borst device. Turning the barrel of the Tuohy-Borst device in the other direction allows the deformable internal component to relax, thus allowing the catheter to move. However, since the Tuohy-Borst device does not restrict catheter movement without intentional action by the operator, it may be inadvertently left in an open or partially open position. Similarly, because Tuohy-Borst devices can offer varying degrees of resistance, the operator may accidentally under-tighten them or they may unintentionally loosen (for example, due to patient movement), which could cause the catheter to move after it has been placed in the desired position. [Overview of the Initiative]

[0007] overview This technology relates to an improved secure fixation device for use with an intracardiac blood pump assembly. More specifically, the technology provides a secure fixation device, which may be used with a sheath assembly (e.g., an introducer sheath assembly, a repositioning sheath assembly), configured to restrict the movement of the catheter of the pump assembly within the sheath assembly except when the mechanism of the secure fixation device (e.g., a button) is activated (e.g., pressed, held, etc.). As will be described in more detail below, the secure fixation device of the technology may also be provided as a modular unit that can be attached to the hub or hemostatic valve of an introducer sheath or a repositioning sheath assembly. Similarly, the secure fixation device of the technology may also be provided as an integral part of a hemostatic valve, or as an integral part of an introducer sheath assembly or a repositioning sheath assembly.

[0008] In one aspect, the present disclosure describes a device for securely securing an intravenous medical device, comprising: (i) a flexible sleeve having a first lumen configured to receive at least a portion of an intravenous medical device; (ii) a button having a bore configured to receive at least a portion of the flexible sleeve; (iii) a spring element; and (iv) a housing comprising a housing having a second lumen configured to house the flexible sleeve and a cavity configured to house the button and the spring element; wherein the spring element is configured to exert a force on the button that tends to compress the flexible sleeve into the bore unless the button is held in a pressed position. In some aspects, the housing comprises at least one projection having at least one eyelet, the at least one projection configured to allow the housing to be sutured to the patient's skin. In some aspects, the housing further comprises a hemostatic valve. In some aspects, the housing is configured to connect with the hemostatic valve. In some aspects, the housing comprises at least one slot configured to receive at least one peg of the hemostatic valve when the housing is connected to the hemostatic valve. In some aspects, the at least one slot and the at least one peg are connected by a bayonet connection. In some aspects, the at least one slot further comprises at least one eyelet configured to engage with the at least one peg. In some aspects, the at least one slot further comprises at least one detent configured to engage with the at least one peg. In some aspects, the housing further comprises a seal configured to deform when the housing is connected to the hemostatic valve.

[0009] In another aspect, the present disclosure describes a sheath assembly comprising: (a) a sheath body configured for insertion into a patient's vascular structure and to receive at least a portion of an intravenous medical device; (b) a sheath hub connected to the proximal end of the sheath body; (c) a flexible sleeve having a first lumen configured to receive at least a portion of an intravenous medical device; (ii) a button having a bore configured to receive at least a portion of the flexible sleeve; (iii) a spring element; and (iv) a secure fixation device configured to be integrated with or connected to the sheath hub, the housing comprising a second lumen configured to house the flexible sleeve and a cavity configured to house the button and the spring element; wherein the spring element is configured to exert a force on the button that tends to compress the flexible sleeve into the bore unless the button is held in a pressed position. In some aspects, the housing of the secure fixation device comprises at least one projection having at least one eyelet, the at least one projection being configured to allow the housing of the secure fixation device to be sutured to the patient's skin. In some aspects, the sheath hub comprises at least one projection having at least one eyelet, the at least one projection being configured to allow the sheath hub to be sutured to the patient's skin. In some aspects, the housing of the secure fixation device further comprises a hemostatic valve. In some aspects, the sheath hub further comprises a hemostatic valve. In some aspects, the housing of the secure fixation device is configured to connect with a hemostatic valve. In some aspects, the housing of the secure fixation device comprises at least one slot configured to receive at least one peg of the hemostatic valve when the housing of the secure fixation device and the hemostatic valve are connected. In some aspects, the at least one slot and the at least one peg are connected by a bayonet connection.In some aspects, the at least one slot further comprises at least one eyelet configured to engage with the at least one peg. In some aspects, the at least one slot further comprises at least one detent configured to engage with the at least one peg. In some aspects, the housing of the secure fixation device further comprises a seal configured to deform when the housing of the secure fixation device and the hemostatic valve are connected. [Brief explanation of the drawing]

[0010] [Figure 1] An exemplary system, including a blood pump repositioning sheath assembly and an introducer sheath assembly, is shown based on the aspects of this disclosure. [Figure 2] Figure 1 shows a magnified view of the blood pump repositioning sheath assembly. [Figure 3] An enlarged view of a blood pump repositioning sheath assembly using an exemplary button-operated secure locking device, based on the aspects of this disclosure, is shown. [Figure 4] Figure 3 shows an isometric view of a three-dimensional model of an exemplary button-operated secure fastening device. [Figure 5] Figure 3 shows a line drawing of an example of a button-operated secure fixing device. [Figure 6] Figure 3 shows an exploded view of an example button-operated secure fastening device. [Figure 7] Figure 3 shows a cross-sectional profile of an exemplary button-operated secure fastening device. [Figure 8] An enlarged view of a blood pump repositioning sheath assembly using an exemplary button-operated secure locking device, based on the aspects of this disclosure, is shown. [Figure 9] An enlarged view of a blood pump repositioning sheath assembly using an exemplary button-operated secure locking device, based on the aspects of this disclosure, is shown. [Figure 10]Figures 10A to 10D are exploded views of the device shown in Figure 6, but featuring different retention pin designs and different designs for the second bore of the button. [Modes for carrying out the invention]

[0011] Detailed explanation The aspects of this disclosure will be described in detail with reference to the drawings; in the drawings, similar reference numerals refer to the same or identical elements. It should be understood that the aspects of this disclosure are merely examples and can be embodied in various forms. To avoid obscuring the disclosure with unnecessary details, well-known functions or construction patterns will not be described in detail. Accordingly, the specific structural and functional details disclosed herein should not be construed as restrictive, but rather as representative grounds for the claims and for teaching those skilled in the art that the disclosure can be used in various ways in virtually any structure, provided that the structure is reasonably detailed.

[0012] Certain exemplary embodiments are described to ensure that the systems, methods, and devices described herein can be understood in their entirety. While the embodiments and features described herein specifically describe their use in relation to intracardiac pump systems, it should be understood that all components and other features outlined below may be combined with each other in any preferred manner and may be adapted and applied to other types of medical devices, such as electrophysiological testing and catheter ablation devices, angioplasty and stent placement devices, angiography catheters, peripherally inserted central catheters, central venous catheters, midline catheters, peripheral catheters, inferior vena cava filters, abdominal aortic aneurysm treatment devices, thrombectomy devices, TAVR delivery systems, and cardiac treatment and cardiac support devices; such devices also include balloon pumps, cardiac support devices implanted using surgical incisions, and any other catheters and devices introduced intravenously or arterially.

[0013] The systems, methods, and devices described herein are secure fixation devices that may be used with a sheath assembly (e.g., an introducer sheath assembly, a repositioning sheath assembly), and are configured to restrict the movement of the catheter of a pump assembly within the sheath assembly except when the mechanism of the secure fixation device (e.g., a button) is activated (e.g., pressed, held, etc.). In this regard, the secure fixation devices of the present invention may be configured to allow catheter movement only when the mechanism (e.g., a button) is pressed, and to automatically return to a secure fixation or "locked" state when the mechanism is released. Such a configuration has the benefit of preventing the operator from forgetting to securely fix the blood pump assembly after it has been positioned in the patient's body, and reducing the risk of the secure fixation device being unintentionally unlocked (e.g., by patient movement). In addition, the secure fixation devices of the present invention prevent accidental undertightening when the operator tightens the secure fixation device, which can occur in devices such as Tuohy-Borst devices, by providing full resistance in a stationary state.

[0014] Figure 1 shows an exemplary system 100 comprising a blood pump repositioning sheath assembly 110 and an introducer sheath assembly 150, based on the aspects of this disclosure.

[0015] An exemplary blood pump repositioning sheath assembly 110 includes a handle 138 at its proximal end. The handle 138 is connected to the proximal end of the catheter 122. In addition, in the embodiment of Figure 1, a purge fluid port 140 is connected to the handle 138 to provide a purge fluid (e.g., a solution of dextrose or glucose with heparin) to a purge lumen (not shown) within the catheter 122. The purge lumen of the catheter 122 is configured to deliver the purge fluid to the motor housing 120.

[0016] Between the handle 138 and the secure fixation device 132, the catheter 122 is enclosed within a protective sleeve 136. The protective sleeve 136 is configured to prevent contamination of the catheter 122 as it is advanced distally for insertion into the patient's vascular structure. The protective sleeve 136 may be constructed of any suitable material and may be securely fixed at its proximal and distal ends in any suitable manner. The distal end of the protective sleeve 136 is connected to the secure fixation device 132. In this regard, for a button-operated secure fixation device of the present technology, the protective sleeve 136 may be connected proximal to the button (for example, as shown in Figures 3 and 4), or distal to the button (for example, as shown in Figures 8 and 9) so that the button is kept within the protective sleeve 136 and contamination around the edge of the button is avoided. In the embodiment of Figure 1, the secure fixation device is connected at its distal end to a hemostatic valve 131, which is attached to a butterfly 130. The hemostatic valve 131 may be integrated with the butterfly 130, or it may be detachably connected. In addition, as described above and below, the hemostatic valve 131 and the secure fixation device 132 may be incorporated into a single unit. The butterfly 130 is connected at its distal end to the proximal end 128 of the repositioning sheath 126. The distal end of the repositioning sheath 126 is indicated by reference numeral 124. The repositioning sheath 126 is configured with a lumen sized to allow passage of the catheter 122, but may otherwise have any preferred length and construction.

[0017] The distal end of the catheter 122 is connected to the proximal end of the motor housing 120. In some aspects of the present technology, the motor housing 120 may include a motor and an impeller. In other aspects of the present technology, the motor may be located outside the patient's body, in which case the catheter 122 may enclose a flexible drive shaft / cable, and the motor housing 120 may enclose an impeller connected to the drive shaft / cable. As will be appreciated, the anchoring device of the present technology may be used with any intracardiac blood pump or other intravenous medical device for which an operator desires to restrict movement of the device.

[0018] In the embodiment of Figure 1, the distal end of the motor housing 120 is coupled to the blood outflow cage 118. The distal end of the blood outflow cage 118 is coupled to a cannula 116, and the cannula 116 is coupled at its distal end to the blood inflow cage 114. When the pump is in operation, blood is pumped proximally from the blood inflow cage 114, through the cannula 116, to the blood outflow cage 118. However, in some aspects of the present technology, the pump may be configured to pump blood distally (e.g., for applications where the pump is used for right heart support), in which case element 118 operates as a blood inflow cage and element 114 operates as a blood outflow cage. Furthermore, in some aspects of the present technology, the distal end of the blood inflow cage 114 may include an atraumatic extension, such as the pigtail extension 112 shown in the embodiment of Figure 1.

[0019] Generally, the blood pump is first inserted into the patient's vascular structure via an introducer sheath, such as the exemplary introducer sheath assembly 150. In this regard, the introducer sheath assembly 150 comprises an introducer sheath body 152, a hub 154, and a perfusion line 156. The introducer sheath body 152 may be any preferred type of sheath. For example, in some aspects of the art, the introducer sheath body 152 may be a peel-off sheath configured to be torn or stripped off and discarded along its length after the repositioning sheath 126 has been inserted into the patient's vascular structure. However, in other aspects of the art, the introducer sheath body 152 may be an expandable sheath configured to stretch and then contract to allow the passage of the largest portion of the blood pump, in which case the introducer sheath may remain in place even after the pump has been inserted into the patient's vascular structure. In the embodiment of Figure 1, the hub 154 is shown with an optional butterfly 154a which may be used to securely fasten the introducer sheath assembly 150 to the patient (e.g., using adhesive or sutures). The hub 154 may further include a hemostatic valve (not shown). In addition, the perfusion line 156 is shown with an optional stopcock assembly 156a which includes two ports in the embodiment of Figure 1.

[0020] Once the blood pump is inserted into the patient's vascular structure, the operator may advance the blood pump to a desired location within the body (e.g., the left or right heart). As the catheter 122 advances further into the patient's vascular structure, the distal end 124 of the repositioning sheath 126 may be inserted into the introducer sheath assembly 150. In this regard, the introducer sheath body 152 acts as a conduit for the repositioning sheath 126 to enter the patient's vascular structure. In other cases, the repositioning sheath 126 may remain outside the introducer 150 as the catheter 122 is advanced into the patient's vascular structure. As already mentioned, if the introducer sheath assembly 150 is of a tearable design, the introducer sheath assembly 150 may be removed by tearing the hub 154 and tearing the introducer sheath body 152 along its length after the repositioning sheath 126 has been inserted into the patient's vascular structure. However, if the introducer sheath assembly 150 is of an expandable design, the introducer sheath assembly 150 may remain in the body either enclosing part or all of the repositioning sheath 126, or enclosing the catheter 122 if the repositioning sheath 126 remains outside the body.

[0021] Once the repositioning sheath 126 is fully inserted, the operator may securely fix it to the patient at or near the insertion site using the butterfly 130. In this regard, the butterfly 130 may be secured to the patient (e.g., using an adhesive or a suture) to securely fix the repositioning sheath 126 and the secure fixation device 132 relative to the patient. Alternatively, if the repositioning sheath 126 remains outside the body, the introducer sheath 150 may be fixed to the patient using butterfly 154a, and a secure fixation device similar to 132 may be located on the introducer hub 154, which may likewise allow the pump to be securely fixed relative to the patient. Thereafter, once the blood pump has been advanced to the desired position within the patient's body, the operator may use the secure fixation device 132 to restrict further movement of the blood pump within the patient's body. In this regard, the secure fixation device 132 may be any device suitable for selectively permitting and restricting movement of the catheter 122 passing therethrough. Although the specific secure fixation device 132 depicted in the exemplary system 100 of Figure 1 is a conventional Tuohy-Borst type device, any of the improved secure fixation devices depicted and described with reference to Figures 3-9 may be used in place of secure fixation device 132. In addition, although the secure fixation devices of Figures 1-8 are shown as modular units that connect to a hemostatic valve of a repositioning sheath assembly, the secure fixation devices of the present technology may alternatively be provided as: (1) a modular unit that connects to a hemostatic valve of an introducer sheath assembly; (2) a modular unit that incorporates a hemostatic valve and connects to a hub of a repositioning sheath assembly or an introducer sheath assembly; or (3) an integral portion of a repositioning sheath assembly or an introducer sheath assembly.

[0022] Figure 2 shows a magnified view of the blood pump repositioning sheath assembly of Figure 1. In this regard, all reference numerals shared between Figure 1 and Figure 2 are intended to indicate the same features and will not be repeated unless necessary to illustrate additional features shown in Figure 2. Figure 2 reproduces a portion of the blood pump repositioning sheath assembly 110 with its distal end on the left, as if the repositioning sheath 126 were passed from right to left across the patient's skin surface (indicated by the dashed line 160). In this orientation, the proximal end 128 of the repositioning sheath 126 remains outside the patient's body, and the butterfly 130 may be securely fixed to the patient's skin using sutures passed through suture eyelets 130a, 130b, 130c, and 130d.

[0023] An enlarged view of Figure 2 shows the bayonet connection between the hemostatic valve 131 and the secure fixation device 132. In this regard, the distal end of the secure fixation device 132 is configured to connect to the proximal end of the hemostatic valve 131 by pressing the two parts together and rotating them relative to each other. In the embodiment of Figure 2, the distal portion of the secure fixation device 132 has a cylindrical collar having one or more slots, and the proximal portion of the hemostatic valve 131 has a cylindrical projection having one or more pegs 131a. When the cylindrical collar of the secure fixation device 132 is advanced over the cylindrical projection of the hemostatic valve 131, each peg 131a enters one of the slots in the secure fixation device 132 at the entrance point 132a. Next, by rotating the secure fixation device 132 relative to the hemostatic valve 131, each peg 131a moves toward the endpoint 132b of the slot, thus preventing the secure fixation device 132 from being pulled away from the hemostatic valve 131 (unless the two components are initially rotated in opposite directions). In addition, the internal interface between the cylindrical collar of the secure fixation device 132 and the hemostatic valve 131 may include a deformable seal or gasket (e.g., a rubber washer) to provide a seal between the parts and to provide back pressure that tends to prevent the pegs 131a from moving easily within the slots of the secure fixation device 132. Furthermore, a detent may be provided at the endpoint 132b of each slot in the secure fixation device 132 so that the pegs 131a tend to remain locked.

[0024] As already mentioned, in the embodiments of Figures 1 and 2, the secure fixation device 132 is a conventional Tuohy-Borst device in which the barrel 132c is rotated to change the magnitude of the resistance applied to whatever object (e.g., catheter 122) is inside the secure fixation device 132. Here again, any of the improved secure fixation devices described and explained with respect to Figures 3-9, as will be discussed in more detail later, may be substituted in the systems shown in Figures 1 and 2. Furthermore, as also mentioned above, in all cases, the secure fixation device of this technology may be used in conjunction with a repositioning sheath (e.g., as part of or connected to the hub of the repositioning sheath) or in conjunction with an introducer sheath (e.g., as part of or connected to the hub of the introducer sheath).

[0025] Figure 3 shows an enlarged view of a blood pump repositioning sheath assembly using an exemplary button-operated secure fixation device, based on aspects of this disclosure. Similar to Figure 2, the embodiment in Figure 3 shows a portion of the blood pump repositioning sheath assembly oriented with its distal end to the left. All figures shared between Figure 3 and Figures 1 and 2 represent the same features. Thus, the catheter 122, repositioning sheath 126 (only its proximal end 128 is identified), butterfly 130, hemostatic valve 131, and protective sleeve 136 are all as described above. However, unlike Figure 2, the embodiment in Figure 3 utilizes a button-operated secure fixation device 200, rather than showing a conventional Tuohy-Borst type secure fixation device.

[0026] The secure fastening device 200 comprises a body 201 housing a button 202. The body 201 of the secure fastening device 200 includes two eyelets 204 (only one of which is visible in Figure 3), each configured to engage a peg 131a (as described above, though not shown) to achieve a snap fit between the hemostatic valve 131 and the secure fastening device 200. As will be further described with respect to Figure 6, the button 202 is spring-loaded to clamp onto an internal flexible sleeve 210 (not visible in Figure 3), and therefore, at any time when the button 202 is not pressed in an active state, it provides resistance to whatever object is inserted through the lumen of the flexible sleeve. If the flexible sleeve 210 is subjected to sustained pressure before use (for example, while the secure fixation device 200 is on the shelf as stock), it may cause some permanent deformation of the flexible sleeve. To prevent such sustained pressure and / or to make the pump easier to move at the start of the procedure, the exemplary secure fixation device 200 includes a retention pin 206. As will be further described with respect to Figure 6, the retention pin 206 may be inserted through bores in the body 201 and the button 202 to hold the button 202 in the pressed position so that the flexible sleeve 210 is not subjected to pressure from the button 202.

[0027] Figure 4 shows an isometric view of the three-dimensional model of the exemplary button-operated secure fixation device of Figure 3, and Figure 5 shows its line diagram. Figures 4 and 5 show the secure fixation device 200 isolated so that the distal lumen 228 of the body 201 can be seen in more detail. Specifically, two slots 204a corresponding to the diameter of the eyelets 204 are provided. The slots 204a are slightly sloped proximal, so that the resistance between the pegs 131a and the slots 204a gradually increases until both pegs 131a "snap" and engage with both eyelets 204 when the cylindrical projection of the hemostatic valve 131 is advanced into the cylindrical collar at the distal end of the body 201. The slope of the slots 204a can also be seen in the cross-sectional view of Figure 7.

[0028] The three-dimensional model in Figure 4 also more clearly shows that the body 201 has a proximal collar 208 configured to connect with a protective sleeve 136. The connection between the proximal collar 208 and the protective sleeve 136 may be achieved by any preferred method. For example, the protective sleeve 136 may be bonded to the collar 208 or fixed thereto using an adhesive or the like. In addition, the protective sleeve 136 may be detachably connected to the collar 208 using any preferred mechanical connection, such as a ring mounted on the collar 208 that can be screwed down to capture the end of the protective sleeve 136 or otherwise moved to engage with another surface of the body 201.

[0029] The three-dimensional models and line drawings in Figures 4 and 5 also show a retention pin 206 that is slightly different from the one shown in Figure 3. As with Figure 3, the retention pin 206 is arbitrary, and any suitable shape or configuration of the retention pin may be used.

[0030] Figure 6 shows an exploded view of an exemplary button-operated secure locking device of Figure 3. In this exploded view, it can be seen that the button 202 has two bores. Bore 216 is configured to allow the retention pin 206 to pass through a portion of the button 202. The body 201 has two bores 218 that are the same or similar in size. Thus, bores 216 and 218 allow the retention pin 206 to pass through both the body 201 and the button 202, thereby allowing the button 202 to be held in the pressed position.

[0031] Button 202 also has a second bore 220 sized to allow passage of the flexible sleeve 210. The flexible sleeve 210 may be constructed of any suitable material, such as silicone. The flexible sleeve 210 has a lumen 212 sized to allow passage of whatever device is intended to be passed through the secure fixation device 200. Thus, if the secure fixation device 200 is used in a blood pump repositioning sheath assembly as shown in Figures 1-3, the lumen 212 may be sized to allow passage of the catheter 122 when the flexible sleeve 210 is relaxed and uncompressed. The dimensions and materials used for the flexible sleeve 210 may be selected in part to provide a desirable amount of friction between the lumen 212 and whatever medical device is intended to pass through the secure fixation device 200, and / or to provide sufficient cushioning to the medical device to prevent damage to the medical device when the button 202 of the secure fixation device 200 is not pressed. For example, if the secure fixation device 200 is used in a blood pump repositioning sheath assembly as shown in Figures 1-3, the flexible sleeve 210 may be configured by selecting specific materials, wall thickness, etc., to provide sufficient friction to the catheter 122 to prevent movement of the catheter 122 when the button 202 is not pressed, while at the same time avoiding crimping of the catheter 122 and / or avoiding adverse effects on wires, purging tubing, flexible drive shafts, etc., that may pass through the catheter 122.

[0032] Different configurations of the retention pin are illustrated in Figures 10A to 10D. As shown in Figures 10A, 10B, and 10C, the retention pin 206 has a curved handle 207 that allows the user to remove the pin 206 by simply inserting a finger behind the handle 207 and removing the pin 206 from the bore 216 in the button 202 and the bore 218 in the body 201. As shown in Figure 10D, the second bore 220 in the button 202 tapers toward the lower portion of the button 202 that is received within the body 201. Thus, the second bore 220 has a larger diameter in the upper portion and a smaller diameter in the lower portion; the "top" and "lower" portions of the button 202 are in relation to the "top" portion of the body 201 in which the button 202 is received. As described in detail above, this design encourages the button to operate on the catheter in such a way that the catheter is held securely but not crimped when button 202 is in a compressed (pressed) state.

[0033] As will be further explained below with respect to Figure 7, the body 201 includes an intermediate lumen 226 (not visible in Figure 6) sized to hold the flexible sleeve 210. In addition, the body 201 includes a recess 213 (also not visible in Figure 6) configured to hold a spring 214 below the button 202. Although the spring 214 is depicted as a coil spring, any suitable spring member may be substituted, such as a leaf spring, an elastomer element, or an integrated hinge. When the secure fastening device 200 is assembled such that the spring 214 is held in the recess 213 and the flexible sleeve 210 passes through the bore 220 of the button 202 and the intermediate lumen 226 of the body 201, the spring 214 is compressed and therefore provides a force that tends to push the button 202 upward so that it exits the button cavity 219. This force causes the bore 220 to exert an upward force on the flexible sleeve 210, thereby pressing and trapping the flexible sleeve 210 against the upper part of the intermediate lumen 226. By selecting a spring 214 of sufficient strength and a flexible sleeve 210 that is sufficiently flexible, this upward force applied to the button 202 deforms the flexible sleeve 210 and pinches whatever object is inserted through the lumen 212 (e.g., catheter 122) against the lumen 212, thus resisting the movement of the object through the lumen 212. Conversely, pressing the button 202 further compresses the spring 214 and reduces or removes the force on the flexible sleeve 210, allowing the flexible sleeve 210 to return to a relaxed state, at which point the lumen 212 allows whatever object is inserted through it (e.g., catheter 122) to pass through. Either or both of the alternative retention pin designs and alternative second bore designs described herein with respect to Figures 10A to 10D may be combined with other embodiments of the button-operated secure locking device described herein.

[0034] Figure 7 shows a cross-sectional profile of the exemplary button-operated secure fixation device of Figure 3. All reference numerals common to Figures 3-6 identify the same features as described above. As can be seen from the cross-sectional view of Figure 7, the body 201 has a proximal lumen 222 which is substantially the same size as the lumen 212, an intermediate lumen 226 which is substantially the same size as the outer diameter of the flexible sleeve 210 when relaxed, and a distal lumen 226 which is substantially the same size as the cylindrical projection of the hemostatic valve 131. Figure 7 shows the secure fixation device 200 with the retention pin 206 inserted through bores 216 and 218, and therefore with the button 202 pressed. As described above, when the retention pin 206 is removed, the spring 214 begins to press upward against the bottom surface of the button 202, causing the bore 220 of the button 202 to press the flexible sleeve 210 against the upper part of the intermediate lumen 226, resulting in compression between the flexible sleeve 210 and its lumen 212.

[0035] Figure 8 shows an enlarged view of a blood pump repositioning sheath assembly using an exemplary button-operated secure fixation device based on aspects of the present disclosure. In this regard, as with Figures 2 and 3, the embodiment in Figure 8 shows a portion of the blood pump repositioning sheath assembly oriented with its distal end to the left. All figures shared between Figure 8 and Figures 1-3 represent the same features. Thus, the catheter 122, repositioning sheath 126 (and its proximal end 128), butterfly 130, hemostatic valve 131, and protective sleeve 136 are all as described above. As with Figures 3-7, Figure 8 also shows a secure fixation device 300, which includes a button 302 and is configured to restrict the movement of an object inserted through it in the same manner as described above with respect to Figures 3-7. However, unlike in Figures 3-7, the secure fixation device 300 in Figure 8 is configured to be connected to the hemostatic valve using a bayonet connection similar to that described above with respect to Figure 2.

[0036] In this regard, in Figure 8, the distal end of the body 301 of the secure fixation device 300 is configured to connect to the proximal end of the hemostatic valve 131 by pushing the two parts together and rotating them relative to each other. Similar to the embodiments in Figures 1 and 2, the distal portion of the secure fixation device 300 has a cylindrical collar having one or more slots, and the proximal portion of the hemostatic valve 131 has a cylindrical projection having one or more pegs 131a. When the cylindrical collar of the secure fixation device 300 is advanced over the cylindrical projection of the hemostatic valve 131, each peg 131a enters one of the slots in the secure fixation device 300 at the entrance point 304a. Next, by rotating the secure fixation device 300 relative to the hemostatic valve 131, each peg 131a moves toward the endpoint 304b of the slot, thus preventing the secure fixation device 300 from being pulled away from the hemostatic valve 131 (unless the two components are initially rotated in opposite directions). In addition, the internal interface between the cylindrical collar of the secure fixation device 300 and the hemostatic valve 131 may include a deformable seal or gasket (e.g., a rubber washer) to provide a seal between the parts and to provide back pressure that tends to prevent the pegs 131a from moving easily within the slots of the secure fixation device 300. Furthermore, a detent may be provided at the endpoint 304b of each slot in the secure fixation device 300 so that the pegs 131a tend to remain locked.

[0037] In addition, in the embodiment shown in Figure 8, a protective sleeve 136 extends over the button 302 to prevent the possibility of fluids, microorganisms, etc., entering the secure fixation device 300 around the edge of the button 302, and thus contaminating the catheter 122 as it passes through the secure fixation device 300. The secure fixation device 300 has a retaining ring 306 configured to capture the end of the protective sleeve 136 by pressing it against the opposing surface of the body 301. As described above, this capture arrangement may be implemented in any preferred manner. Similarly, in some aspects of the present technology, the protective sleeve 136 may be directly bonded to the ring 306 and / or the body 301, or fixed thereto using an adhesive.

[0038] Figure 9 shows an enlarged view of a blood pump repositioning sheath assembly using an exemplary button-operated secure fixation device based on aspects of the present disclosure. Here again, the embodiment in Figure 8 shows a portion of the blood pump repositioning sheath assembly oriented with its distal end to the left. All figures shared between Figure 9 and Figures 1-3 represent the same features. Thus, the catheter 122, repositioning sheath 126 (and its distal end 124 and proximal end 128), butterfly 130, and protective sleeve 136 are all as described above. Figure 9 also shows a secure fixation device 400, which includes a button 402 and is configured to restrict the movement of an object inserted through it in the same manner as described above with respect to Figures 3-7. However, unlike Figures 1-8, the secure fixation device 400 in Figure 9 includes a hemostatic valve (not shown). Therefore, the portion of the blood pump repositioning sheath assembly shown in Figure 9 does not require a separate hemostatic valve 131, and thus the body 401 of the secure fixation device 400 does not require any features to enable connection between it and the hemostatic valve 131 (e.g., bayonet connection, snap-fit ​​connection, etc.). In this regard, in some aspects of the art, the secure fixation device 400 may be a modular unit that is directly attached to the butterfly 130 using any preferred coupling arrangement. However, in other aspects of the art, the secure fixation device 400 may be integrated with the hub of the repositioning sheath assembly, and thus the repositioning sheath 126, the butterfly 130, and the secure fixation device 400 may be part of a single repositioning sheath assembly. Similarly, as described above, the secure fixation device 400 may also be configured to work with or be an integral part of an introducer sheath assembly (e.g., introducer sheath assembly 150).

[0039] From the above description and the various drawings, it will be recognized that certain modifications to this disclosure can also be made without departing from the scope of this disclosure. The drawings illustrate some aspects of this disclosure, but this disclosure is not intended to be limited thereto; this disclosure is as broad as the art allows, and this specification is intended to be read in that manner. Therefore, the above description should be considered not as an extenuating statement, but merely as an example of certain aspects of the art.

Claims

1. A flexible sleeve having a first lumen configured to receive at least a portion of an intravenous medical device; A button having a first bore configured to receive a removable retention pin and a second bore configured to receive at least a portion of the flexible sleeve; Spring element and; A second lumen configured to house the flexible sleeve; A cavity configured to house the button and the spring element A device for securely securing an intravenous medical device, comprising a housing comprising a housing that defines a button cavity configured to house the button and the spring element, the housing having opposing holes on opposing sides of the button cavity, the opposing holes being aligned with a first bore of the button and receiving the removable retention pin, A device wherein, when the spring element is held in a compressed state by the removable retention pin, the second bore of the button is aligned with the second lumen of the housing, and when the removable retention pin is removed, the spring element exerts force on the button, thereby compressing the flexible sleeve against the second bore.

2. The device according to claim 1, wherein the housing comprises at least one projection having at least one eyelet, the at least one projection being configured to allow the housing to be sutured to the patient's skin.

3. The device according to any one of claims 1 to 2, wherein the housing further comprises a hemostatic valve.

4. The device according to any one of claims 1 to 2, wherein the housing is configured to connect to a hemostatic valve.

5. The device according to claim 4, wherein the housing comprises at least one slot configured to receive at least one peg of the hemostatic valve when the housing is connected to the hemostatic valve.

6. The device according to claim 5, wherein the at least one slot and the at least one peg are provided with a bayonet connection.

7. The device according to any one of claims 5 to 6, further comprising at least one eyelet configured to engage with the at least one peg in the at least one slot.

8. The device according to any one of claims 5 to 6, further comprising at least one detent configured to engage with the at least one peg in the at least one slot.

9. The device according to claim 4, further comprising a seal configured to deform when the housing is connected to a hemostatic valve.

10. A sheath body configured to be inserted into the patient's vascular structure and to receive at least a portion of an intravenous medical device; A sheath hub connected to the proximal end of the sheath body; A flexible sleeve having a first lumen configured to receive at least a portion of the intravenous medical device; A button having a first bore configured to receive a removable retention pin and a second bore configured to receive at least a portion of the flexible sleeve; Spring element and; A second lumen configured to house the flexible sleeve; A cavity configured to house the button and the spring element A housing comprising a button cavity configured to house the button and the spring element, the housing having opposing holes on opposing sides of the button cavity, the opposing holes being aligned with the first bore of the button and receiving the removable retention pin, and A sheath assembly comprising a secure fastening device configured to be integrated with or connected to the sheath hub, A sheath assembly in which, when the spring element is held in a compressed state by the removable retention pin, the second bore of the button is aligned with the second lumen of the housing, and when the removable retention pin is removed, the spring element exerts force on the button, thereby compressing the flexible sleeve against the second bore.

11. The sheath assembly according to claim 10, wherein the housing of the secure fixation device comprises at least one projection having at least one eyelet, the at least one projection being configured to allow the housing of the secure fixation device to be sutured to the patient's skin.

12. The sheath assembly according to any one of claims 10 to 11, wherein the sheath hub comprises at least one projection having at least one eyelet, the at least one projection being configured to allow the sheath hub to be sutured to the patient's skin.

13. The sheath assembly according to any one of claims 10 to 12, wherein the housing of the secure fixation device further comprises a hemostatic valve.

14. The sheath assembly according to any one of claims 10 to 13, wherein the sheath hub further comprises a hemostatic valve.

15. The sheath assembly according to any one of claims 10 to 12 or 14, wherein the housing of the secure fixation device is configured to connect with a hemostatic valve.

16. The sheath assembly according to claim 15, wherein the housing of the secure fixation device comprises at least one slot configured to receive at least one peg of the hemostatic valve when the housing of the secure fixation device is connected to the hemostatic valve.

17. The sheath assembly according to claim 16, wherein the at least one slot and the at least one peg are provided with a bayonet connection.

18. The sheath assembly according to any one of claims 16 to 17, further comprising at least one eyelet configured to engage with the at least one peg in the at least one slot.

19. The sheath assembly according to any one of claims 16 to 17, further comprising at least one detent configured to engage with the at least one peg in the at least one slot.

20. The sheath assembly according to claim 15, wherein the housing of the secure fixation device further comprises a seal configured to deform when the housing of the secure fixation device and the hemostatic valve are connected.

Images