Fixation device for intracardiac blood pump system

Abstract

The present disclosure relates to devices for securing intravenous or intra-arterial medical devices. Improved securing devices are provided for use with intracardiac blood pump assemblies. The present technology provides securing devices that can be used with sheath assemblies (e.g., introducer sheath assemblies, repositioning sheath assemblies) and are configured to limit movement of an object (e.g., a catheter of a pump assembly) within the sheath assembly unless a mechanism (e.g., a button) of the securing device is actively actuated (e.g., depressed, held down, etc.).

Description

[0001] Cross-reference to related applications This application claims priority to U.S. Provisional Application No. 63 / 058,003, filed July 29, 2020, the entire contents of which are incorporated herein by reference. Background Technology

[0002] Intracardiac pump assemblies can be surgically or percutaneously introduced into the heart and used to deliver blood from one location in the heart or circulatory system to another. For example, when deployed 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 accompanying drive cable) located outside the patient or via an onboard motor located inside the patient. Some intracardiac pump systems can operate in parallel with the heart to supplement cardiac output and partially or completely unload components from the heart. Examples of such systems include the IMPELLA® series of devices (Abiomed, Inc., Danvers Mass.).

[0003] In a common approach, the intracardiac pump is inserted via catheterization using a sheath (e.g., a peel-off guide sheath) inserted through the femoral artery. The sheath can alternatively be inserted at other locations, such as the femoral vein or any pathway used to deliver the pump to support the left or right side of the heart.

[0004] An arteriotomy can be performed to insert a guide sheath into the femoral artery to create an insertion path for the pump assembly. A portion of the pump assembly is then advanced through the guide's inner lumen and into the artery. In some cases, once the pump assembly is inserted, a narrower repositioning sheath can be inserted into the guide sheath, and the guide sheath can be dissected. The repositioning sheath may be equipped with structures for securing the repositioning sheath assembly to the patient. For example, the proximal hub of the repositioning sheath assembly may have a butterfly-shaped structure that can be sutured to the patient's skin.

[0005] In some cases, the guide 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 guide sheath. When a repositioning sheath is used, it can be inserted, for example, into the guide sheath. In some cases, the repositioning sheath can be configured to fit within the lumen of the guide sheath. In some cases, the lumen of the guide sheath can be configured to expand to allow insertion of the repositioning sheath therein. In some cases, the guide sheath can be configured such that the repositioning sheath is not inserted into the lumen of the guide sheath. When the guide sheath remains in place, it may also be equipped with structures for securing the guide sheath assembly to the patient (e.g., suture butterfly).

[0006] Regardless of whether the guide sheath, repositioning sheath, or both are still in use after the pump assembly has been inserted, a securing device can be used to hold the pump assembly catheter relative to the sheath(s) through which it has been inserted. For example, the Tuohy-Borst device can be attached to or incorporated into the hub of a guide sheath or repositioning sheath. Rotating the cylinder of the Tuohy-Borst device in one direction compresses deformable internal components (e.g., deformable rings or sleeves), which can therefore be used to form a seal against the pump assembly catheter and prevent catheter movement within the Tuohy-Borst device. Rotating the cylinder of the Tuohy-Borst device in the other direction loosens the deformable internal components, allowing catheter movement. However, because the Tuohy-Borst device does not restrict catheter movement without operator intervention, it may be unintentionally left in an open or partially open position. Similarly, because the Tuohy-Borst device can provide variable resistance, the operator may accidentally not tighten it enough or it may unintentionally loosen (e.g., due to patient movement), causing the catheter to move after it has been positioned as intended. Summary of the Invention

[0007] This technology relates to improved fixation devices for use with intracardiac blood pump assemblies. More specifically, this technology provides fixation devices that can be used with sheath assemblies (e.g., guide sheath assemblies, repositioning sheath assemblies) and are configured to restrict movement of the pump assembly's catheter within the sheath assembly unless a mechanism of the fixation device (e.g., a button) is actively actuated (e.g., pressed, held, etc.). As will be explained in further detail below, the fixation device of this technology can be provided as a modular unit that can be attached to the hub or hemostatic valve of a guide sheath or repositioning sheath assembly. Similarly, the fixation device of this technology can also be provided as a component of a hemostatic valve, or as a component of a guide sheath assembly or repositioning sheath assembly.

[0008] In one aspect, this disclosure describes a device for securing an intravenous medical device, comprising: (i) a flexible sleeve having a first lumen configured to receive at least a portion of the intravenous medical device; (ii) a button having an orifice configured to receive at least a portion of the flexible sleeve; (iii) a spring element; and (iv) a housing comprising: a second lumen configured to receive the flexible sleeve; and a cavity configured to receive the button and the spring element, wherein the spring element is configured to apply a force to the button, the force tending to cause the orifice to compress the flexible sleeve unless the button is held in a pressed state. In some aspects, the housing includes at least one protrusion with at least one eyelet, the at least one protrusion being configured to allow the housing to be sutured to a patient's skin. In some aspects, the housing further includes a hemostatic valve. In some aspects, the housing is configured to engage with a hemostatic valve. In some aspects, the housing includes at least one slot configured to receive at least one stud of the hemostatic valve when the housing is engaged with the hemostatic valve. In some aspects, the at least one slot and the at least one stud include a bayonet connection. In some aspects, the at least one slot further includes at least one eye configured to engage with the at least one stud. In some aspects, the at least one slot further includes at least one pawl configured to engage with the at least one stud. In some aspects, the housing further includes a seal configured to deform when the housing is connected to the hemostatic valve.

[0009] On the other hand, this disclosure describes a sheath assembly comprising: (a) a sheath body configured for insertion into a patient's vascular system and configured to receive at least a portion of an intravenous medical device; (b) a sheath hub coupled to the proximal end of the sheath body; and (c) a fixation device integrated with or configured to be coupled to the sheath hub, the fixation device comprising: (i) a flexible sleeve having a first lumen configured to receive at least a portion of the intravenous medical device; (ii) a button having an orifice configured to receive at least a portion of the flexible sleeve; (iii) a spring element; and (iv) a housing comprising: a second lumen configured to receive the flexible sleeve; and a cavity configured to receive the button and the spring element, wherein the spring element is configured to apply a force to the button, the force tending to cause the orifice to compress the flexible sleeve unless the button is held in a pressed state. In some aspects, the housing of the fixation device includes at least one protrusion with at least one eyelet, the at least one protrusion being configured to allow the housing to be sutured to the patient's skin. In some aspects, the sheath hub includes at least one protrusion with at least one eyelet, the at least one protrusion being configured to allow the sheath hub to be sutured to the patient's skin. In some aspects, the housing of the fixation device also includes a hemostatic valve. In some aspects, the sheath hub also includes a hemostatic valve. In some aspects, the housing of the fixation device is configured to engage with a hemostatic valve. In some aspects, the housing of the fixation device includes at least one slot, the at least one slot being configured to receive at least one stud of the hemostatic valve when the housing of the fixation device is engaged with the hemostatic valve. In some aspects, the at least one slot and the at least one stud include a bayonet connection. In some aspects, the at least one slot also includes at least one eyelet, the at least one eyelet being configured to engage with the at least one stud. In some aspects, the at least one slot also includes at least one pawl, the at least one pawl being configured to engage with the at least one stud. In some respects, the housing of the fixation device also includes a seal configured to deform when the housing of the fixation device is connected to the hemostatic valve. Attached Figure Description

[0010] Figure 1 An exemplary system according to various aspects of this disclosure is shown, which includes a blood pump and a repositioning sheath assembly, as well as a guide sheath assembly; Figure 2 It shows Figure 1 Enlarged view of the blood pump and repositioning sheath assembly; Figure 3 An enlarged view of a blood pump and repositioning sheath assembly of a fixation device actuated by an exemplary button according to various aspects of this disclosure is shown; Figure 4 It shows Figure 3 A perspective view of a three-dimensional model of an exemplary button-actuated fixed device; Figure 5 It shows Figure 3 Line diagram of an exemplary button-actuated fixed device; Figure 6 It shows Figure 3 An exploded view of an exemplary button-actuated fixed device; Figure 7 It shows Figure 3 A cross-sectional profile view of an exemplary button-actuated fixed device; Figure 8 An enlarged view of a blood pump and repositioning sheath assembly of a fixation device actuated by an exemplary button according to various aspects of this disclosure is shown; Figure 9 An enlarged view of a blood pump and repositioning sheath assembly of a fixation device actuated by an exemplary button according to various aspects of this disclosure is shown; and Figure 10A-10D yes Figure 6 An exploded view of the features of the device, but the device has a different retaining pin design and a different design for the second hole for the button. Detailed Implementation

[0011] Embodiments of this disclosure are described in detail with reference to the accompanying drawings, in which similar reference numerals identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of this disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid unnecessary obscuring of this disclosure. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but only as the basis for the claims and as a representative basis for teaching those skilled in the art to employ this disclosure in different ways with virtually any suitably detailed structure.

[0012] To provide a general understanding of the systems, methods, and devices described herein, certain illustrative embodiments will be described. Although the embodiments and features described herein are specifically described for use with intracardiac cardiac pump systems, it should be understood that all components and other features outlined below can be combined with each other in any suitable manner and can be adapted and applied to other types of medical devices, such as electrophysiological research 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, cardiac therapy and cardiac assist devices (including balloon pumps, cardiac assist devices implanted through surgical incisions), and any other venous or arterial-based insertion catheters and devices.

[0013] The systems, methods, and apparatus described herein provide a fixation device that can be used with a sheath assembly (e.g., a guide sheath assembly, a repositioning sheath assembly) and is configured to restrict movement of the catheter of the pump assembly within the sheath assembly unless a mechanism of the fixation device (e.g., a button) is actively actuated (e.g., pressed down, held down, etc.). In this regard, the fixation device of this technology can be configured to allow catheter movement only when the mechanism (e.g., a button) is pressed and automatically return to a fixed or “locked” state when the mechanism is released. Such a configuration advantageously prevents the operator from forgetting to fix the pump assembly after it has been positioned in the patient and reduces the risk that the fixation device may be unintentionally unlocked (e.g., due to patient movement). Additionally, by providing full resistance in its stationary state, the fixation device of this technology prevents the operator from accidentally undertightening the fixation device, as might occur with a Tuohy-Borst device.

[0014] Figure 1 An exemplary system 100 according to various aspects of this disclosure is shown, which includes a blood pump and repositioning sheath assembly 110 and a guide sheath assembly 150.

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

[0016] Between the handle 138 and the 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 system. The protective sleeve 136 may be made of any suitable material and may be secured at its proximal and distal ends in any suitable manner. The distal end of the protective sleeve 136 is coupled to the fixation device 132. In this respect, for a button-actuated fixation device of the present technology, the protective sleeve 136 may be coupled proximally to the button (e.g., as shown in the image). Figure 3 and Figure 4 (as shown), or it can be coupled to the far side of the button so that the button is held within the protective sleeve 136 and contamination is avoided around the edge of the button (e.g., as shown). Figure 8 and Figure 9 (As shown). In Figure 1In the example, the fixation device is coupled at its distal end to a hemostatic valve 131, which in turn is attached to a butterfly member 130. The hemostatic valve 131 may be integrated with or removably coupled to the butterfly member 130. Alternatively, as discussed above and below, the hemostatic valve 131 and the fixation device 132 may be combined into a single unit. The butterfly member 130 is coupled at its distal end to the proximal end 128 of a 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 at least the catheter 122, but may otherwise be of any suitable length and configuration.

[0017] The distal end of catheter 122 is connected to the proximal end of motor housing 120. In some aspects of this technology, motor housing 120 may include a motor and an impeller. In other aspects of this technology, the motor may be external to the patient, in which case catheter 122 may encapsulate a flexible drive shaft / cable, and motor housing 120 may encapsulate an impeller connected to that drive shaft / cable. It should be understood that the fixation device of this technology can be used with any intracardiac blood pump or other intravenous medical device with which the operator wishes to restrict movement.

[0018] exist Figure 1 In the example, the distal end of the motor housing 120 is connected to a blood outflow cage 118. The distal end of the blood outflow cage 118 is connected to a cannula 116, which in turn is connected at its distal end to a blood inflow cage 114. When the pump is running, blood is pumped from the blood inflow cage 114 through the cannula 116 into the blood outflow cage 118 in a proximal direction. However, in some aspects of this art, the pump can alternatively be configured to pump blood in a distal direction (e.g., for applications where the pump is used for right ventricular support), in which case element 118 will operate as a blood inflow cage and element 114 will operate as a blood outflow cage. Finally, in some aspects of this art, the distal end of the blood inflow cage 114 may include a non-invasive extension, such as... Figure 1 The example shows the pigtail extension 112.

[0019] Typically, the blood pump is initially inserted into the patient's vascular system via a guide sheath, such as the exemplary guide sheath assembly 150. In this regard, the guide sheath assembly 150 includes a guide sheath body 152, a hub 154, and a flushing line 156. The guide sheath body 152 can be any suitable type of sheath. For example, in some aspects of the present technology, the guide sheath body 152 can be a tearable sheath configured to tear or peel along its length and be discarded after the repositioning sheath 126 has been inserted into the patient's vascular system. However, in other aspects of the present technology, the guide sheath body 152 can be an expandable sheath configured to stretch to allow the maximum portion of the blood pump to pass through, and then contract, in which case the guide sheath can remain in place even after the pump has been inserted into the patient's vascular system. Figure 1 In the example, hub 154 is shown with an optional butterfly member 154a, which can be used to secure guide sheath assembly 150 to the patient (e.g., using adhesive or sutures). Hub 154 may also include a hemostatic valve (not shown). Additionally, flushing line 156 is shown with an optional stopcock valve assembly 156a, in... Figure 1 In the example, the plug valve assembly 156a includes two ports.

[0020] Once the blood pump has been inserted into the patient's vascular system, the operator can advance the pump to its desired location in the body (e.g., left or right heart). As the catheter 122 is further advanced into the patient's vascular system, the distal end 124 of the repositioning sheath 126 can be inserted into the guide sheath assembly 150. In this respect, the guide sheath body 152 will act as a conduit for the repositioning sheath 126 to enter the patient's vascular system. In other cases, the repositioning sheath 126 may remain outside the guide sheath 150 while the catheter 122 is being advanced into the patient's vascular system. As previously described, in cases where the guide sheath assembly 150 is a tear-away design, after the repositioning sheath 126 has been inserted into the patient's vascular system, the guide sheath assembly 150 can be removed by breaking the hub 154 and tearing the guide sheath body 152 along its length. However, if the guide sheath assembly 150 is of an expandable design, it can remain inside the body to enclose some or all of the repositioning sheath 126, or enclose the catheter 122 if the repositioning sheath 126 is retained outside the body.

[0021] Once the repositioning sheath 126 has been fully inserted, the operator can use the butterfly member 130 to secure it to the patient at or near the insertion site. In this regard, the butterfly member 130 can be adhered to the patient (e.g., using adhesive or sutures) to secure the repositioning sheath 126 and the fixation device 132 relative to the patient. Alternatively, if the repositioning sheath 126 remains outside the body, the guide sheath 150 can be adhered to the patient using the butterfly member 154a, and a fixation device similar to 132 can be located at the guide hub 154, similarly allowing the pump to be fixed relative to the patient. Thereafter, once the blood pump has been advanced to the desired location within the patient, the operator can use the fixation device 132 to restrict further movement of the blood pump within the patient. In this regard, the fixation device 132 can be any device suitable for optionally allowing and restricting movement of the catheter 122 therefrom. Although in Figure 1 The specific fixed device 132 depicted in the exemplary system 100 is a conventional Tuohy-Borst type device, but references Figure 3-9 Any improved fixing device depicted and described can be used to replace fixing device 132. Additionally, although... Figure 1-8 The fixation device is shown as a modular unit of a hemostatic valve connected to a repositioning sheath assembly, but the fixation device of the present technology may alternatively be provided as: (1) a modular unit of a hemostatic valve connected to a guide sheath assembly; (2) a modular unit comprising a hemostatic valve and connected to a hub of a repositioning sheath assembly or a guide sheath assembly; or (3) as part of a repositioning sheath assembly or a guide sheath assembly.

[0022] Figure 2 It shows Figure 1 An enlarged view of the blood pump and repositioning sheath assembly. In this regard, Figure 1 and Figure 2 All reference numerals shared between them are intended to indicate the same features, and unless it is necessary to explain them. Figure 2 The additional features shown will not be mentioned again otherwise. Figure 2 A portion of the blood pump and repositioning sheath assembly 110 is reproduced, oriented with its distal end facing left, as if the repositioning sheath 126 had already passed through the patient's skin surface from right to left (indicated by dashed line 160). Oriented in this manner, the proximal end 128 of the repositioning sheath 126 will remain outside the patient's body, and the butterfly member 130 can be secured to the patient's skin using sutures passing through suture holes 130a, 130b, 130c, and 130d.

[0023] Figure 2 The enlarged view shows the bayonet connection between the hemostatic valve 131 and the fixation device 132. In this respect, the distal end of the fixation device 132 is configured such that it can be coupled to the proximal end of the hemostatic valve 131 by pushing the two parts together and rotating them relative to each other. Figure 2 In the example, the distal portion of the fixation device 132 has a cylindrical collar with one or more slots, while the proximal portion of the hemostatic valve 131 has a cylindrical protrusion with one or more studs 131a. As the cylindrical collar of the fixation device 132 advances over the cylindrical protrusion of the hemostatic valve 131, each stud 131a will enter one of the slots in the fixation device 132 at an inlet point 132a. Then, by rotating the fixation device 132 relative to the hemostatic valve 131, each stud 131a will move toward the end point 132b of the slot, thereby preventing the fixation device 132 from being pulled away from the hemostatic valve 131 (without first rotating the two components in opposite directions). Additionally, the internal interface between the cylindrical collar of the fixation device 132 and the hemostatic valve 131 may include a deformable seal or gasket (e.g., a rubber gasket) to provide a seal between the two portions and to provide back pressure that tends to prevent easy movement of the studs 131a within the slots of the fixation device 132. In addition, pawls can be provided at the end point 132b of each slot in the fixing device 132, so that the stud 131a will tend to remain in the locked state.

[0024] As mentioned earlier, in Figure 1 and Figure 2 In the example, the fixing device 132 is a conventional Tuohy-Borst device, in which the cylinder 132c is rotated to change the amount of resistance applied to any object (e.g., conduit 122) within the fixing device 132. Similarly, as will be discussed in more detail below, see [reference to...]. Figure 3-9 Any improved fixed equipment depicted and described can be replaced with Figure 1 and Figure 2 The system shown. Furthermore, as also described above, in all cases, the fixing device of this technology can be used in conjunction with a repositioning sheath (e.g., as part of the hub of the repositioning sheath or connected to the hub of the repositioning sheath) or in conjunction with a guide sheath (e.g., as part of the hub of the guide sheath or connected to the hub of the guide sheath).

[0025] Figure 3 An enlarged view is shown of a blood pump and repositioning sheath assembly of a fixation device actuated by an exemplary button according to various aspects of this disclosure. Like Figure 2 Same, Figure 3 The example shows a portion of a blood pump and repositioning sheath assembly, which is oriented with its distal end facing left. Figure 3 and Figure 1 and Figure 2 All shared numbers represent the same characteristics. Therefore, catheter 122, repositioning sheath 126 (of which only the proximal end 128 is identified), butterfly element 130, hemostatic valve 131, and protective sleeve 136 are all as previously described. However, unlike... Figure 2 , Figure 3The example does not show a traditional Tuohy-Borst type fixture, but rather a button-actuated fixture 200.

[0026] The fixing device 200 includes a body 201 that accommodates the button 202. The body 201 of the fixing device 200 includes two holes 204. Figure 3 Only one is visible in the image. Each eyelet is configured to engage a stud 131a (not shown, but as described above) to achieve a snap-fit ​​engagement between the hemostatic valve 131 and the fixation device 200. Reference will be made below. Figure 6 As further described, button 202 is spring-loaded, so that it will be clamped in the inner flexible sleeve 210. Figure 3 (Not visible in the center) and therefore provides resistance to any object inserted through the lumen of the flexible sleeve whenever button 202 is not actively pressed. To avoid applying continuous pressure to the flexible sleeve 210 before use (e.g., when the fixation device 200 is stored in stock), which could cause some permanent deformation of the flexible sleeve, and / or to allow the pump to move more easily at the start of surgery, the exemplary fixation device 200 includes a retaining pin 206. Reference will be made below. Figure 6 As further described, the retaining pin 206 can be inserted through a hole in the body 201 and the button 202 to hold the button 202 in the pressed state, so that the flexible sleeve 210 is not subjected to pressure from the button 202.

[0027] Figure 4 It shows Figure 3 A perspective view of a three-dimensional model of an exemplary button-actuated fixed device, and Figure 5 Its line graph is shown. Because... Figure 4 and Figure 5 The fixation device 200 is shown separately, allowing for a more detailed view of the distal lumen 228 of the body 201. Specifically, two slots 204a corresponding to the diameter of the orifices 204 are provided. The slots 204a are slightly inclined proximally, such that as the cylindrical protrusion of the hemostatic valve 131 is advanced into the cylindrical collar at the distal end of the body 201, the resistance between the studs 131a and the slots 204a gradually increases until the two studs 131a "lock" into engagement with the two orifices 204. The ramps of the slots 204a may also be... Figure 7 As seen in the cross-sectional view.

[0028] Figure 4The three-dimensional model also shows more clearly that the body 201 has a proximal collar 208 configured to engage with the protective sleeve 136. The engagement between the proximal collar 208 and the protective sleeve 136 can be achieved by any suitable means. For example, the protective sleeve 136 can be coupled to the collar 208 or adhered thereto using an adhesive or similar means. Furthermore, the protective sleeve 136 can be removably engaged with the collar 208 using any suitable mechanical connection, such as a ring mounted on the collar 208, which can be screwed or otherwise moved to engage with another surface of the body 201 to capture the end of the protective sleeve 136.

[0029] Figure 4 and Figure 5 The 3D model and line drawing also show the relationship with Figure 3 The retaining pin 206 shown is slightly different. For example... Figure 3 As shown, retaining pin 206 is optional and can be any suitable shape or construction of retaining pin.

[0030] Figure 6 It shows Figure 3 An exploded view of an exemplary button-actuated fixing device. In this exploded view, button 202 can be seen to have two holes. Hole 216 is configured to allow retaining pin 206 to pass through a portion of button 202. Body 201 has two holes 218 of the same or similar size. Therefore, holes 216 and 218 allow retaining pin 206 to pass through body 201 and button 202, thus holding button 202 in the pressed state.

[0031] Button 202 also has a second hole 220, sized to allow the flexible sleeve 210 to pass through. The flexible sleeve 210 can be made of any suitable material, such as silicone. The flexible sleeve 210 has a lumen 212, sized to allow any device intended to pass through the fixation device 200. Therefore, if the fixation device 200 is used in a blood pump and repositioning sheath assembly, for example... Figure 1-3 As shown, the size of the lumen 212 can be designed to allow the catheter 122 to pass through when the flexible sleeve 210 is in a relaxed, uncompressed state. The size and material of the flexible sleeve 210 can be selected in part to provide a desired amount of friction between the lumen 212 and any medical device intended to pass through the fixation device 200, and / or to provide sufficient cushioning for the medical device to prevent damage when the button 202 of the fixation device 200 is not pressed. For example, if the fixation device 200 is used in a blood pump and repositioning sheath assembly, such as... Figure 1-3As shown, the flexible sleeve 210 can be configured by selecting specific materials, wall thickness, etc. to provide sufficient friction to the conduit 122 to prevent the conduit 122 from moving when the button 202 is not pressed, while also avoiding coiling of the conduit 122 and / or adversely affecting any wires, purification lumens, flexible drive shafts, etc. that may pass through the conduit 122.

[0032] Different configurations for retaining pins Figure 10A-10D As shown in the diagram. Figure 10A , Figure 10B and Figure 10C As shown, the retaining pin 206 has a curved handle 207, which allows the user to easily remove the pin 206 by inserting their fingers behind the handle 207 and removing the pin 206 from the hole 216 in the button 202 and from the hole 218 in the body 201. Figure 10D As shown, the second hole 220 in button 202 gradually tapers towards the lower part of button 202 received in body 201. Therefore, the second hole 220 has a larger diameter at its top and a smaller diameter at its bottom, with the "top" and "bottom" of button 202 relating to the "top" of body 201 in which button 202 is received. As described in detail above, this design facilitates button movement on the guide tube when button 202 is in a compressed (pressed) state, ensuring the guide tube is securely held rather than curled.

[0033] As will be referred to below Figure 7 As further explained, body 201 includes intermediate lumen 226 (in Figure 6 (Not visible in the middle), the size of the intermediate cavity 226 is designed to hold the flexible sleeve 210. In addition, the body 201 includes a groove 213 (in... Figure 6(Also not visible in the image), the groove 213 is configured to hold the spring 214 below the button 202. Although the spring 214 is depicted as a helical spring, it can be replaced by any suitable spring component, such as a leaf spring, an elastomer element, a movable hinge, etc. When the retaining device 200 is assembled such that the spring 214 is held within the groove 213 and the flexible sleeve 210 is screwed in through the hole 220 of the button 202 and through the intermediate cavity 226 of the body 201, the spring 214 will be compressed, thus providing a force that tends to push the button 202 upward out of the button cavity 219. This force will then cause the hole 220 to provide a force that tends to push the flexible sleeve 210 upward, thereby locking it at the top of the intermediate cavity 226. By selecting a spring 214 of sufficient strength and a flexible sleeve 210 of sufficient flexibility, the upward force on button 202 will cause the flexible sleeve 210 to deform, resulting in the lumen 212 clamping any object that might pass through it (e.g., conduit 122), thus preventing the object from moving through the lumen 212. Conversely, by pressing button 202, spring 214 will be further compressed, and the force on the flexible sleeve 210 will be reduced or removed, allowing the flexible sleeve 210 to return to a relaxed state, in which the lumen 212 will allow any object that passes through it (e.g., conduit 122) to pass through. (See reference...) Figure 10A-10D The alternative retaining pin design and alternative second hole design described herein, or either one thereof, can be combined with other embodiments of the button-actuated fixing device described herein.

[0034] Figure 7 It shows Figure 3 A cross-sectional view of an exemplary button-actuated fixed device. Figure 3-6 All common reference numerals identify the same features as described above. From Figure 7 As can be seen from the cross-sectional view, the main body 201 has a proximal lumen 222 that is basically similar in size to the lumen 212, an intermediate lumen 226 that is basically similar in size to the relaxed outer diameter of the flexible sleeve 210, and a distal lumen 226 that is basically similar in size to the cylindrical protrusion of the hemostatic valve 131. Figure 7 A fixing device 200 is shown, in which a retaining pin 206 has been inserted through holes 216 and 218, and thus a button 202 in a pressed state is shown. As described above, once the retaining pin 206 is removed, the spring 214 will begin to press upward against the bottom surface of the button 202, which in turn will cause the hole 220 of the button 202 to press the flexible sleeve 210 against the top of the intermediate cavity 226, thereby compressing the flexible sleeve 210 and its cavity 212.

[0035] Figure 8 An enlarged view is shown of a blood pump and repositioning sheath assembly of a fixation device actuated by an exemplary button according to various aspects of this disclosure. In this respect, like Figure 2and Figure 3 Same, Figure 8 A portion of the blood pump and repositioning sheath assembly is shown, oriented with its distal end facing left. Figure 8 and Figure 1-3 All shared numbers represent the same characteristics. Therefore, catheter 122, repositioning sheath 126 (and its proximal end 128), butterfly element 130, hemostatic valve 131, and protective sleeve 136 are all as previously described. Figure 3-7 Same, Figure 8 A fixing device 300 is also shown, which includes a button 302 and is configured to interact with the above reference. Figure 3-7 The same method described restricts the movement of objects inserted through it. However, unlike... Figure 3-7 , Figure 8 The fixed equipment 300 is configured to use a method similar to the one described above. Figure 2 The described bayonet connection is used to connect to the hemostatic valve.

[0036] In this regard, Figure 8 In this device, the distal end of the main body 301 of the fixation device 300 is configured such that it can be coupled to the proximal end of the hemostatic valve 131 by pushing the two parts together and rotating them relative to each other. Figure 1 and Figure 2 Similar to the example, the distal portion of the fixation device 300 has a cylindrical collar with one or more slots, while the proximal portion of the hemostatic valve 131 has a cylindrical protrusion with one or more studs 131a. As the cylindrical collar of the fixation device 300 advances over the cylindrical protrusion of the hemostatic valve 131, each stud 131a will enter one of the slots in the fixation device 300 at an inlet point 304a. Then, by rotating the fixation device 300 relative to the hemostatic valve 131, each stud 131a will move toward the end point 304b of the slot, thereby preventing the fixation device 300 from being pulled away from the hemostatic valve 131 (without first rotating the two parts in opposite directions). Additionally, the internal interface between the cylindrical collar of the fixation device 300 and the hemostatic valve 131 may include a deformable seal or gasket (e.g., a rubber gasket) to provide a seal between the two portions and to provide back pressure that tends to prevent easy movement of the studs 131a within the slots of the fixation device 300. In addition, pawls can be provided at the end point 304b of each slot of the fixing device 300, so that the stud 131a will tend to remain in the locked state.

[0037] In addition, Figure 8In the example, the protective sleeve 136 extends over the button 302 to prevent the possibility that fluids, microorganisms, etc., may enter the fixing device 300 around the edge of the button 302 and thus contaminate the conduit 122 if it passes through the fixing device 300. The fixing device 300 has a retaining ring 306 configured to engage the end of the protective sleeve 136 with the opposing surface of the body 301. As described above, this engaging arrangement can be achieved in any suitable manner. Similarly, in some aspects of this art, the protective sleeve 136 may be directly bonded to the ring 306 and / or the body 301, or adhered thereto using an adhesive.

[0038] Figure 9 An enlarged view is shown of a blood pump and repositioning sheath assembly of a fixation device actuated using an exemplary button according to various aspects of this disclosure. Similarly, here... Figure 8 The example shows a portion of a blood pump and repositioning sheath assembly, which is oriented with its distal end facing left. Figure 9 and Figure 1-3 All shared numbers represent the same characteristics. Therefore, catheter 122, repositioning sheath 126 (and its distal end 124 and proximal end 128), butterfly element 130, and protective sleeve 136 are all as previously described. Figure 9 A fixed device 400 is also shown, which includes a button 402 and is configured to interact with the above reference. Figure 3-7 The same method described restricts the movement of objects inserted through it. However, unlike... Figure 1-8 , Figure 9 The fixation device 400 includes a hemostatic valve (not shown) therein. Therefore, Figure 9 The portion of the illustrated blood pump and repositioning sheath assembly does not require a separate hemostatic valve 131, and therefore the body 401 of the fixation device 400 does not require any features to achieve its connection with the hemostatic valve 131 (e.g., bayonet connection, snap-fit ​​connection, etc.). In this regard, in some aspects of the present technology, the fixation device 400 can be a modular unit directly attached to the butterfly member 130 using any suitable connection arrangement. However, in other aspects of the present technology, the fixation device 400 can be integrated with the hub of the repositioning sheath assembly, and therefore the repositioning sheath 126, the butterfly member 130, and the fixation device 400 can be part of a single repositioning sheath assembly. Similarly, as mentioned above, the fixation device 400 can also be configured to work with or be part of a guide sheath assembly (e.g., guide sheath assembly 150).

[0039] From the foregoing and with reference to the various accompanying drawings, those skilled in the art will understand that certain modifications may be made to this disclosure without departing from its scope. While several aspects of this disclosure have been shown in the accompanying drawings, they are not intended to limit the disclosure thereto, as this disclosure is intended to have a broad scope within the permissible scope of the art and to be read in the same manner. Therefore, the foregoing description should not be construed as limiting, but merely as examples of specific aspects of the art.

Claims

1. A device for securing an intravenous or intra-arterial medical device, comprising: A flexible sleeve having a first lumen configured to receive at least a portion of the intravenous medical device; A button having an aperture configured to receive at least a portion of the flexible sleeve; Spring elements; and The housing includes a second cavity and a hollow space, the second cavity being configured to receive the flexible sleeve, and the hollow space being configured to receive the button and the spring element. The spring element is configured to apply a force to the button, the force tending to cause the orifice to compress the flexible sleeve unless the button is held in the pressed state. The housing may include a hemostatic valve or include at least one slot configured to receive at least one stud of the hemostatic valve when the housing is connected to the hemostatic valve.

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

3. The device according to claim 1 or 2, wherein, The at least one slot and the at least one stud include a bayonet connection.

4. The device according to claim 3, wherein, The at least one slot also includes at least one eyelet configured to engage with the at least one stud.

5. The device according to claim 3, wherein, The at least one slot also includes at least one pawl, which is configured to engage with the at least one stud.

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