Percutaneous blood pump with spill-blocking sleeve

Abstract

A spill-blocking sleeve is a removable sleeve that surrounds the blood outlet of a percutaneous blood pump located at the distal end of a catheter. The spill-blocking sleeve is configured to prevent blood from leaking out of the blood outlet when the blood pump is inserted into the vascular system at the vascular access site. The blood pump is sized to pass distally through the lumen of the elongated shaft of the introducer sheath through the elastomer seal of the introducer sheath, and the spill-blocking sleeve prevents the blood pump from passing through the elastomer seal as the blood pump advances through it.

Description

[Technical Field]

[0001] The present disclosure relates to a percutaneous blood pump provided with an outflow blocking sleeve. More specifically, the present disclosure relates to a percutaneous blood pump provided with a sleeve for blocking blood flow through an outflow port of the blood pump during insertion into a vascular access site. [Background Art]

[0002] In various procedures for delivering an intravascular medical device, an introducer sheath is inserted into a patient's blood vessel, for example, the femoral artery, and one or more medical devices can be advanced through the sheath into the patient's vasculature. In various cases, the medical device includes other devices such as catheters or blood pumps. In some cases, when the blood pump is being advanced within the introducer sheath, there may occur a moment when the blood inlet of the blood pump is located distal to the hemostatic valve of the introducer sheath, and the blood outlet of the blood pump is located proximal to the hemostatic valve and outside the patient's body. In this position, blood may pass through the blood pump, through the blood outlet of the blood pump, and leak out of the patient's body. Therefore, when inserting the blood pump across the hemostatic valve into the patient's vasculature, it is necessary to prevent blood from leaking outward through the blood pump from the blood outlet. [Summary of the Invention]

[0003] The present disclosure provides alternatives relating to designs, materials, manufacturing methods, and methods of use for medical devices including percutaneous blood pumps and devices related thereto. The first example is a system comprising an introducer sheath and a catheter. The introducer sheath comprises a hub, an elongated shaft extending distally from the hub, and an elastomer seal positioned within the hub. The catheter comprises an elongated shaft and a percutaneous blood pump positioned at the distal end of the elongated shaft. The percutaneous blood pump comprises a blood inlet, a blood outlet, and an impeller assembly positioned between the blood inlet and blood outlet for pumping blood from the blood inlet to the blood outlet during use. A spill-blocking sleeve removably surrounds the blood outlet. The blood pump is sized to pass distally through the lumen of the elongated shaft of the introducer sheath through the elastomer seal, and the spill-blocking sleeve prevents the blood pump from passing through the elastomer seal as it advances through it.

[0004] In an alternative or additional example to any one of the above examples, the spill-blocking sleeve includes a distal end region having an inner diameter and a proximal end region having a reduced inner diameter smaller than the inner diameter of the distal end region.

[0005] In an alternative or additional example to any one of the above examples, the distal end region tightly surrounds the blood outlet to occlude blood flow from the blood outlet, and the proximal end region extends over the distal portion of the elongated shaft of the catheter.

[0006] In any of the above examples, either as an alternative or in addition, in the other examples, the spill-blocking sleeve has a length of 7 cm or less. In an alternative or additional example to any one of the above examples, the system includes a guidewire extending outward from the outflow window of the blood outlet and proximal to the outer surface of the blood pump from the outflow window.

[0007] In an alternative or additional example to any one of the above examples, the spill-blocking sleeve surrounds a guidewire that extends along the outer surface of the blood pump. In an alternative or additional example to any one of the above examples, the spill-blocking sleeve includes a priority separation line extending along the length of the spill-blocking sleeve.

[0008] In an alternative or additional example to any one of the above examples, the spill-stopping sleeve includes a material strip configured to separate from the tubular wall of the spill-stopping sleeve when pulled.

[0009] In an alternative or additional example to any one of the above examples, the spill-blocking sleeve includes a flared distal end configured to abut the proximal surface of the elastomer sleeve. In an alternative or additional example to any one of the above examples, the spill-blocking sleeve includes a spherical distal end configured to abut the proximal surface of the elastomer sleeve.

[0010] Another example is a system including a catheter and an outflow-blocking sleeve. The catheter includes a long shaft and a percutaneous blood pump located at the distal end of the long shaft. The percutaneous blood pump includes a blood inlet, a blood outlet, an impeller located between the blood inlet and the blood outlet for pumping blood from the blood inlet to the blood outlet during use, and a motor housing located proximal to the impeller. The motor housing includes a motor that rotates the impeller. The outflow-blocking sleeve tightly surrounds the blood outlet and extends proximal to the blood outlet, surrounding the motor housing. The outflow-blocking sleeve is configured to prevent blood from flowing out of the blood outlet as the blood pump advances into the vascular system at the vascular access site.

[0011] In an alternative or additional example to any one of the above examples, the spill-blocking sleeve includes a distal end region having an inner diameter and a proximal end region having a reduced inner diameter smaller than the inner diameter of the distal end region.

[0012] In an alternative or additional example to any one of the above examples, the distal end region tightly surrounds the blood outlet to occlude blood flow from the blood outlet, and the proximal end region extends over the distal portion of the elongated shaft of the catheter proximal to the motor housing.

[0013] In any of the above examples, either as an alternative or in addition, in the other examples, the spill-blocking sleeve has a length of 7 cm or less. In an alternative or additional example to any one of the above examples, the system includes a guidewire extending outward from the blood outlet window and proximal to the outer surface of the motor housing, the outflow blocking sleeve surrounding the guidewire extending along the outer surface of the motor housing.

[0014] Another example is a method for percutaneously inserting a blood pump into the vascular system at a vascular access site. The method includes advancing a catheter, which includes a blood pump positioned at the distal end of the elongated shaft of the catheter, into an introducer sheath having an elastomer seal. The blood pump includes a blood inlet, a blood outlet, and an impeller assembly positioned between the blood inlet and the blood outlet for pumping blood from the blood inlet to the blood outlet during use. When the blood outlet is located proximal to the elastomer seal and the blood inlet is located distal to the elastomer seal, the blood pump is advanced through the elastomer seal with an outflow-blocking sleeve occluding the blood outlet to prevent blood from flowing out of the blood outlet. The blood pump is then advanced further through the elastomer seal with the outflow-blocking sleeve in contact with the proximal surface of the elastomer sleeve and remaining outside the elastomer seal, so that the blood outlet moves through the elastomer seal to a distal position.

[0015] In an alternative or additional example to any one of the above examples, the blood pump is advanced along a guidewire extending outward from the outflow window of the blood outlet, and the guidewire extends proximal to the outflow window along the outer surface of the blood pump.

[0016] In an alternative or additional example to any one of the above examples, the spill-blocking sleeve surrounds a guidewire that extends along the outer surface of the blood pump. In an alternative or additional example to any one of the above examples, the method includes the step of laterally removing the outflow-blocking sleeve from the catheter after the blood outlet of the blood pump has advanced to a distal position of the elastomer seal.

[0017] In an alternative or additional example to any one of the above examples, the spill-blocking sleeve is separable along its length in order to separate the spill-blocking sleeve from the catheter.

[0018] The above summary of some embodiments is not intended to describe each disclosed embodiment or all implementations of this disclosure. The following drawings and detailed description illustrate some of these embodiments more specifically. [Brief explanation of the drawing]

[0019] This disclosure can be better understood by considering the following detailed description together with the accompanying drawings. [Figure 1] A perspective view of an exemplary catheter including a percutaneous blood pump. [Figure 2] This figure shows the distal end region of the catheter in Figure 1, including the percutaneous blood pump. [Figure 3] Figure 1 is a side view of a portion of the percutaneous blood pump. [Figure 4] Figure 3 is a cross-sectional view of a portion of a percutaneous blood pump having a blocking sleeve positioned on the percutaneous blood pump. [Figure 5] This is an illustrative perspective of an introducer. [Figure 6] This figure shows the steps involved in inserting the percutaneous blood pump shown in Figure 1 through the introducer sheath shown in Figure 5 at the vascular access site. [Figure 7]A diagram illustrating the step of inserting the percutaneous blood pump of Figure 1 through the introducer sheath of Figure 5 at a vascular access site. [Figure 8] A diagram illustrating the step of inserting the percutaneous blood pump of Figure 1 through the introducer sheath of Figure 5 at a vascular access site. [Figure 9] A diagram illustrating various features of an occlusion sleeve for use with the percutaneous blood pump of Figure 1. [Figure 10] A diagram illustrating various features of an occlusion sleeve for use with the percutaneous blood pump of Figure 1. [Figure 11] A diagram illustrating various features of an occlusion sleeve for use with the percutaneous blood pump of Figure 1. [Figure 12] A diagram illustrating various features of an occlusion sleeve for use with the percutaneous blood pump of Figure 1. [Figure 13] A diagram illustrating various features of an occlusion sleeve for use with the percutaneous blood pump of Figure 1. [Figure 14] A diagram illustrating various features of an occlusion sleeve for use with the percutaneous blood pump of Figure 1. DETAILED DESCRIPTION OF EMBODIMENTS

[0020] While the present disclosure is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the present disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0021] For terms defined below, these definitions shall apply unless a different definition is provided in the claims or elsewhere in the present specification. All numerical values ​​in this specification, whether expressly indicated or not, are assumed to be modified by the term “about.” The term “about” generally refers to a range of numbers that a person skilled in the art would consider equivalent to the listed values ​​(e.g., having the same function or result). In many cases, the term “about” may include numerical values ​​rounded to the nearest significant figure.

[0022] Numerical ranges indicated by endpoints include all numbers within that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Where used herein and in the appended claims, the singular forms “a,” “an,” and “the” include multiple references unless otherwise explicitly indicated herein. Where used herein and in the appended claims, the term “or” is generally adopted in its meaning including “and / or” unless otherwise explicitly indicated herein.

[0023] Please note that references in this specification to “one embodiment,” “several embodiments,” and “other embodiments” indicate that the embodiments described may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily mean that all embodiments include specific features, structures, and / or characteristics. In addition, if specific features, structures, and / or characteristics are described in relation to one embodiment, please understand that such features, structures, and / or characteristics may also be used in relation to other embodiments, whether explicitly described or not, unless explicitly stated otherwise.

[0024] The following detailed description should be read with reference to the drawings, where similar configurations in different drawings are numbered accordingly. The drawings are not necessarily to scale and illustrate exemplary embodiments; they are not intended to limit the scope of this disclosure.

[0025] Figure 1 shows a perspective view of a catheter 10 including a percutaneous blood pump 50 positioned in the distal end region of the catheter 10. The catheter 10 comprises an elongated shaft 12 of the catheter 10 extending proximal to the percutaneous blood pump 50 and a distal end 40 extending distal to the blood pump 50, and may be connected to or include the blood pump 50. For example, the proximal end 16 of the elongated shaft 12 may be connected to a control module 14, and the distal end 18 of the elongated shaft 12 may be connected to the percutaneous blood pump 50. An electrical cable 22 may extend from the control module 14 to a connector 24 at its proximal end. The connector 24 may be configured to connect to a controller (not shown) for controlling the blood pump 50, such as supplying power to the blood pump 50. The catheter 10 may also include an extension 26 connectable to the controller for transmitting and / or receiving signals from one or more sensors, etc., while the blood pump 50 is operating.

[0026] Further features of the blood pump 50 are shown in Figure 2. The blood pump 50 may generally include a flexible cannula 30, an impeller housing 60, and a motor housing 70. In some embodiments, the flexible cannula 30, the impeller housing 60, and / or the motor housing 70 may be constructed integrally or monolithically. In other embodiments, the flexible cannula 30, the impeller housing 140, and / or the motor housing 70 may be separate components. The impeller housing 60 houses an impeller assembly 65 inside. The impeller assembly 65 may include an impeller fixed to an impeller shaft that rotates relative to the impeller housing 60 to drive blood through the blood pump 50. In some embodiments, the impeller shaft and impeller of the impeller assembly 65 may be integrally formed, while in other embodiments, the impeller shaft and impeller may be separate components.

[0027] As the impeller rotates, blood flows in through a blood inlet 80 of the blood pump 50, such as at the distal end of the flexible cannula 30, through the flexible cannula 30 and the impeller housing 60, and out through a blood outlet 90 near the impeller, such as through a side wall formed on the impeller housing 60. In some embodiments, the blood inlet 80 may include multiple blood inflow windows arranged around the circumference of the blood pump 50 (e.g., the flexible cannula 30). In some embodiments, the blood outlet 90 may include multiple blood outflow windows arranged around the impeller housing 60. In other embodiments, the inlet 80 and / or outlet 90 may be formed in other parts of the blood pump 50.

[0028] Continuing to refer to Figure 2, the motor housing 70 houses a motor configured to rotatably drive the impeller of the impeller assembly 65 relative to the impeller housing 60. For example, power may be supplied to the motor via wiring extending through a long shaft 12. In some cases, the motor may be physically connected to the impeller. For example, in some embodiments, the impeller may be mounted on the motor's drive shaft. In other embodiments, the impeller shaft may be directly or indirectly connected to the motor's drive shaft. In some cases, the drive assembly may include magnetic coupling between the motor and the impeller. For example, a drive magnet may be mounted on the motor's drive shaft. The rotation of the drive magnet causes the driven magnet connected to the impeller assembly 65 to rotate. More specifically, in embodiments incorporating an impeller shaft, the impeller shaft and impeller of the impeller assembly 65 are configured to rotate together with the driven magnet. In other embodiments, the motor may be connected to the impeller assembly 65 via other components.

[0029] Furthermore, as shown in Figure 2, the blood pump 50 may include a guidewire loading aid 44 to facilitate the loading of the catheter 10 onto the guidewire for the introduction of the blood pump 50 into the vascular system. For example, the guidewire loading aid 44 may be a tubular member extending over at least a portion of the length of the blood pump 50, and the guidewire may be fed through the catheter when loading the catheter onto the guidewire. In some cases, the guidewire loading aid 44 may have a distal end (not shown) located inside the blood pump 50 and a proximal end located outside the blood pump 50. The proximal end of the guidewire loading aid 44 may extend outward through one of the outflow windows of the blood outlet 90 and proximal to the outflow window. In some cases, the proximal end of the guidewire loading aid 44 may extend along the outer surface of the motor housing 70 located proximal to the blood outlet 90. The guidewire, inserted through the guidewire lumen of the distal tip 40, is guided into the lumen of the guidewire loading aid 44, advanced proximally along the impeller assembly 65, and led outward through one of the outflow windows of the blood outlet 90 located within the lumen of the guidewire loading aid 44. After the guidewire is properly guided through the blood pump 50, the guidewire loading aid 44 is removed, and the guidewire remains in place through the blood pump 50, allowing the catheter 10 to be advanced into the vascular system along the guidewire.

[0030] Figure 3 is a side view of a portion of the catheter 10, showing a portion of the percutaneous blood pump 50 and a guidewire 46, which extends outward from one of the outflow windows of the blood outlet 90 of the impeller housing 60 and along the outer surface of the motor housing 70 and the elongated shaft 12. The proximal end of the impeller of the impeller assembly 65 is also visible through the outflow window of the blood outlet 90.

[0031] When inserting the blood pump 50 into the patient's vascular system, it is desirable to block or occlude the blood outlet 90 to prevent blood from leaking out through the cannula of the blood pump 50 and out through the outflow window of the blood outlet 90. Therefore, the outflow blocking sleeve 200 shown in Figure 4 may be placed over the blood outlet 90 to block or occlude the outflow window of the blood outlet 90. The outflow blocking sleeve 200 may be a tubular member 215 having a distal end 212 and a proximal end 214. The outflow blocking sleeve 200 may be formed from a polymer material such as an elastic polymer. Some preferred materials include fluorinated ethylene propylene (FEP), high-density polyethylene (HDPE), polyether block amide (e.g., PEBAX®), polyurethane, and polyamide (e.g., VESTAMID®). The tubular member 215 may have an inner surface that is in close contact with the portion of the blood pump 50 surrounded by the outflow blocking sleeve 200. For example, the distal end of the tubular member 215 of the spill-blocking sleeve 200 may extend distal to the blood outlet 90 so that the distal end region of the tubular member 215 tightly surrounds the impeller housing 60 that forms the blood outlet 90, thereby closing or blocking the outflow window of the blood outlet 90. The spill-blocking sleeve 200 may be formed from a polymer material having the desired elasticity to stretch or tightly conform to the outer surface of the impeller housing 60 and / or the motor housing 70. As shown in Figure 4, the spill-blocking sleeve 200 may also extend outward from the outflow window of the blood outlet 90 and surround a guide wire 46 that extends along the outside of the motor housing 70. In some cases, the inner surface of the spill-blocking sleeve 200 exerts force on the guide wire 46, pressing it against the outer surface of the motor housing 70, while allowing the blood pump 50 to move axially along the guide wire 46. In some cases, the tubular member 215 may have a tapered or reduced-diameter region 216 located at an intermediate position along the tubular member 215 between a distal end region extending to the distal end 212 and a reduced-diameter proximal end region extending to the proximal end 214.The tapered region 216 can be positioned at the proximal end of the motor housing 70 at the connection point where the elongated shaft 12 is connected to the motor housing 70. As a result, the reduced diameter proximal end region of the tubular member 215 of the outflow prevention sleeve 200 is in close contact with the outer surface of the elongated shaft 12 proximal to the connection point with the motor housing 70.

[0032] The spill-blocking sleeve 200 may have a length L measured from the distal end 212 to the proximal end 214. In some embodiments, the length L may be in the range of, for example, 0.5 cm to 10 cm, 0.5 cm to 8 cm, 0.5 cm to 6 cm, 1.0 cm to 6 cm, or 1.0 cm to 5 cm. In some cases, the length L may be 8 cm or less, 7 cm or less, 6 cm or less, or 5 cm or less. In some cases, the spill-blocking sleeve 200 may have a length L longer than the length of the motor housing 70. In some cases, since the motor housing 70 may be about 4 cm long, the spill-blocking sleeve 200 may have a length greater than 4 cm such that the distal end of the spill-blocking sleeve 200 extends distally to the motor housing 70 to block or occlude the blood outlet 90, and the proximal end of the spill-blocking sleeve 200 extends proximal to the motor housing 70 to surround the elongated shaft 12.

[0033] The outflow-blocking sleeve 200 can be slidably positioned on the elongated shaft 12 of the catheter 10, thereby selectively sliding over the blood outlet 90 to block blood flow through the blood outlet 90 and selectively detaching from the blood outlet 90 to allow blood flow through the blood outlet 90. For example, when introducing a blood pump 50 into the vascular system through a vascular access site, it is desirable to position the outflow-blocking sleeve 200 over the outflow window of the blood outlet 90 to prevent blood from the patient from flowing out of the blood outlet 90 through the blood pump 50. For example, during the introduction process, at the moment when the blood inlet 80 is exposed to blood in the patient's vascular system and the blood outlet 90 is still located outside the patient's vascular system, a path is formed through the blood pump 50 from the blood inlet 80 to the blood outlet 90, and blood flow may flow through that path. In this process, if the blood outlet 90 is not occluded, blood may flow out of the blood outlet 90 outside the patient's body. Therefore, the outflow-blocking sleeve 200 may be used to occlude the blood outlet 90 when the blood pump 50 is inserted into the patient's vascular system through the vascular access site. In some cases, the blood pump 50 may be inserted through an introducer sheath at the vascular access site. An example of such an introducer sheath is shown in Figure 5.

[0034] Figure 5 is a perspective view of an introducer sheath 100 used to provide vascular access for introducing the percutaneous blood pump of Figure 1 into the vascular system at a vascular access site. The introducer sheath 100 includes a hub 120 and an elongated shaft 114 extending distally from the hub 120 to a distal end region 108, the elongated shaft 114 defining the main body portion 110 of the sheath 100. The sheath 100 may also include a flush line 190 extending from the hub 120. The flush line 190 may include a tubular member 192 extending from the hub 120 and in fluid communication with the lumen of the hub 120. The tubular member 192 may extend to a stopcock 194, such as a three-way stopcock. The stopcock 194 may include a first leg 196, a second leg 197, a third leg 198, and a lever 195 rotatable to selectively open and close fluid access between the first leg 196, the second leg 197, and / or the third leg 198, respectively. Each of the legs 196, 197, and 198 may optionally include a connector such as a Luer connector.

[0035] The hub 120 may also include a strain relief section 126 configured to provide a flexible transition along the proximal end region 106 of the elongated shaft 114. The strain relief section 126 may include a body attached to the body of the hub 120, as further described herein. The strain relief section 126 may include one or more suture pads 128 extending outward from the strain relief section 126. For example, the strain relief section 126 may include first and second suture pads 128 extending from both sides of the strain relief section 126. The suture pads 128 may allow the hub 120 to be fixed to the patient after the introducer sheath 100 has been placed in the patient's blood vessel. For example, each suture pad 128 may include at least one opening extending through the suture pad 128 to receive sutures used to suture the hub 120 to the patient's skin.

[0036] The hub 120 may include a main port 122 and a side port 124 extending from the main port 122. In some cases, the side port 124 may extend acutely from the main port 122. The main port 122 and / or the side port 124 may provide access to one or more lumens extending through the main body portion 110 of the sheath 100 (for example, through a long shaft 114). In some cases, the main port 122 may be a clamping port 130.

[0037] Further details of the components of the hub 120 are shown in the cross-sectional views of Figures 6 to 8. The main port 122 of the hub 120 may include the hub body 210. In some cases, the hub body 210 may be a molded, one-piece structure. For example, the hub body 210 may be molded from a polymer material. In other cases, the hub body 210 may be formed from two or more components that are attached to each other. In some cases, the hub body 210 may also include or be connected to the hub body of the side port 124.

[0038] The side port 124 may include a passage 224 extending through its interior and an elastomer seal 265 positioned along the passage 224 of the side port 124. For example, the hub body 210 may define the passage 224. The elastomer seal 265 may be a slit valve (e.g., a cross-slit valve), a dome valve, a duckbill valve, or any other desired valve configured to seal around a long shaft of a medical device as it passes through. In some cases, the elastomer seal 265 may include one or more slits (e.g., cross-slits) extending completely through the seal wall, and / or one or more slits (e.g., cross-slits) extending only partially through the seal wall. For example, the elastomer seal 265 may be a cross-slit valve having a first slit extending into the seal wall from a first side of the seal but not extending completely through the seal wall, and a second slit extending into the seal from a second opposite side of the seal but not extending completely through the seal wall. The first slit may intersect the second slit within the valve wall. In some cases, the first slit may be positioned perpendicular to the second slit. The elastomer seal 265 may be formed from any desired flexible material (e.g., silicone, polyurethane, etc.).

[0039] The side port 124 may also include a side port cover 275 that can be connected to the hub body 210. The elastomer seal 265 is housed within the side port cover 275, and the elastomer seal 265 is held between the top surface of the hub body 210 and the inner surface of the side port cover 275.

[0040] The side port 124 may also include a side port cap 280 configured to screw onto the side port cover 275. For example, the side port cap 280 may include a female thread configured to screw onto the male thread of the side port cover 275. Removal of the side port cap 280 provides access to the elastomer seal 265, allowing a medical device to pass through the elastomer seal 265 and into the side port passage 224.

[0041] The main port 122 may include a passage 222 extending through its interior. For example, the hub body 210 may define the passage 222. The passage 224 of the side port 124 may merge with the passage 222 of the main port 122 within the hub body 210. The passages 222 and / or 224 may be in fluid communication with the lumen 112 of the sheath 100 extending to the distal opening of the elongated shaft 114.

[0042] The main port 122 may include a primary seal and a secondary seal spaced apart from the primary seal along the length of the main port 122. For example, the main port 122 may include a compressible seal (e.g., a Tuohy seal) 220 and an elastomer seal 260 spaced apart from the compressible seal 220. The main port 122, which can be considered a clamping port, may further include a pusher 230, a holder 240, a lock nut 250, and / or a main port cover 270. By rotating the lock nut 250, the pusher 230 may act toward or away from the compressible seal 220 to adjust the size of the opening 228 through the compressible seal 220. As further described herein, the compressible seal 220 may be movable between an open state that allows a medical device to pass through the opening 228 and a closed state that seals the compressible seal 220 around the medical device. The compressible seal 220 can be formed from any desired flexible material (e.g., silicone, polyurethane, etc.).

[0043] The holder 240 can be fixed to the hub body 210 such that the edge of the holder 240 is adjacent to the proximal end face of the hub body 210. For example, the main port cover 270 can be connected to the hub body 210 with the holder 240 sandwiched between them, thereby fixing the holder 240 to the hub body 210.

[0044] The elastomer seal 260 may be housed within the main port cover 270 such that the elastomer seal 260 is held between the end face of the holder 240 and the inner surface of the main port cover 270. The main port cover 270 may extend distally beyond the elastomer seal 260 such that the distal end region of the main port cover 270 surrounds the holder 240. The elastomer seal 260 may be a slit valve (e.g., a cross-slit valve), a dome valve, a duckbill valve, or any other desired valve configured to seal around a long shaft of a medical device as it passes through. In some cases, the elastomer seal 260 may include one or more slits (e.g., cross-slits) that extend completely through the seal wall, and / or one or more slits (e.g., cross-slits) that extend only partially through the seal wall. For example, the elastomer seal 260 may be a cross-slit valve having a first slit extending into the wall of the seal from a first side of the seal but not extending completely through the wall of the seal, and a second slit extending into the wall of the seal from a second opposite side of the seal but not extending completely through the wall of the seal. The first slit may intersect the second slit within the wall of the valve. In some cases, the first slit may be positioned perpendicular to the second slit. The elastomer seal 260 may be formed from any desired flexible material (e.g., silicone, polyurethane, etc.). The pusher 230 may be positioned entirely between the compressible seal 220 and the elastomer seal 260.

[0045] The lock nut 250 may be assembled such that it surrounds the proximal portion of the hub body 210. The lock nut 250 may include a female thread that engages with a male thread provided on the outer surface of the proximal portion of the hub body 210.

[0046] As shown in the cross-sectional views of Figures 6 to 8, the components of the main port 122 can form a hemostatic valve. Thus, by rotating the lock nut 250 in a first rotational direction, the lock nut 250 moves distal to the hub body 210, and by rotating the lock nut 250 in a second opposite rotational direction, the lock nut 250 moves proximal to the hub body 210. The lock nut 250 may be configured to engage with the pusher 230 when the lock nut 250 is rotated, causing axial motion in the pusher. For example, when the lock nut 250 rotates and moves axially along the hub body 210, the lock nut drives the pusher 230 axially. For example, when the lock nut 250 is rotated in a first rotational direction relative to the hub body 210, the lock nut 250 moves distally, causing the pusher 230 to move distally relative to the hub body 210, thereby applying a compressive force to the compressible seal 220, and thereby reducing the diameter of the opening 228 through the compressible seal 220. When the lock nut 250 is rotated in a second rotational direction relative to the hub body 210, the lock nut 250 moves proximal, allowing the pusher 230 to move proximal to the hub body 210, thereby reducing and / or eliminating the compressive force acting on the compressible seal 220, and thereby increasing the diameter of the opening 228 through the compressible seal 220.

[0047] In other embodiments, the positions of the elastomer seal 260 and the compressible seal 220 may be modified so that the elastomer seal 260 is positioned distal to the compressible seal 220. In some such embodiments, the pusher 230 may be positioned entirely between the compressible seal 220 and the elastomer seal 260. In such cases, when the lock nut 250 is rotated in a first rotational direction relative to the hub body 210, the lock nut 250 moves proximal, biasing the pusher 230 to move proximal to the hub body 210, applying a compressive force to the compressible seal 220 (located proximal to the pusher 230), thereby reducing the diameter of the opening 228 through the compressible seal 220. When the lock nut 250 is rotated in a second rotational direction relative to the hub body 210, the lock nut 250 moves distally, allowing the pusher 230 to move distally relative to the hub body 210, thereby reducing and / or eliminating the compressive force acting on the compressible seal 220, and thereby increasing the diameter of the opening 228 through the compressible seal 220. Other configurations are also conceivable for positioning the pusher 230 relative to the compressible seal 220 in order to apply a compressive force to the compressible seal 220.

[0048] Figures 6 to 8 further illustrate the process of inserting the blood pump 50 of the catheter 10 into the patient's vascular system through the introducer sheath 100. Figures 6 to 8 show the components of the blood pump 50 in plan view, and the components of the introducer sheath 100 and the outflow prevention sleeve 200 in cross-sectional view.

[0049] During use, the blood pump 50 of the catheter 10 can be inserted through the introducer sheath 100 along the guidewire 46. For example, the blood pump 50 can be advanced through the elastomer seal 260, through the lumen of the pusher 230, through the opening 228 of the compressible seal 220, into the passage 222 of the main port 122, and further into the lumen of the elongated shaft 114 of the introducer sheath 100. For example, as shown in Figure 6, the distal tip 40 and the blood pump 50 can pass through the opening of the elastomer seal 260, causing the elastomer seal 260 to bend and / or deform, allowing the blood pump 50 to be advanced through the elastomer seal 260. The elastomer seal 260 seals around the outer circumference of the cannula 30 of the blood pump 50, substantially preventing blood from leaking from the main port 122.

[0050] As shown in Figure 6, during the advancement of the blood pump 50 through the introducer sheath 100, there is a moment when the blood inlet 80 is located distal to the compressible seal 220 and / or elastomer seal 260, while the blood outlet 90 is located proximal to the compressible seal 220 and / or elastomer seal 260, i.e., outside the patient's body. While in this position, the outflow-blocking sleeve 200 blocks or occludes the outflow window of the blood outlet 90, preventing blood from flowing out of the outflow window of the blood outlet 90, which would otherwise be able to flow to the outside through the outlet 90.

[0051] As shown in Figure 7, the blood pump 50 is advanced distally together with the outflow-blocking sleeve 200 until the distal end 212 of the outflow-blocking sleeve 200 contacts the proximal surface of the elastomer seal 260. At this point, the outflow window of the blood outlet 90 is still located proximal to the elastomer seal 260, so the outflow-blocking sleeve 200 extends distal to the outflow window of the blood outlet 90 (for example, across the outflow window) and occludes the outflow window of the blood outlet 90, thereby preventing blood from flowing out of the outflow window of the blood outlet 90 and maintaining hemostasis.

[0052] As the blood pump 50 is advanced further distally to the introducer sheath 100 and inserted into the patient's vascular system, the outflow-blocking sleeve 200 can be kept stationary relative to the introducer sheath 100. In other words, as shown in Figure 8, with the entire length of the outflow-blocking sleeve 200 remaining proximal to the elastomer seal 260, the blood pump 50 can be advanced further distally through the elastomer seal 260. Thus, as the blood pump 50 is advanced through the elastomer seal 260 of the introducer sheath 100, the outflow-blocking sleeve 200 does not pass through the elastomer seal 260. Therefore, the leakage-blocking sleeve 200 effectively prevents blood from leaking out of the main port 122 and maintains hemostasis by blocking the outflow window of the blood outlet 90 while the blood outlet 90 is proximal to the elastomer seal 260, and then the elastomer seal 260 seals and surrounds the outer circumference of the motor housing 70 of the blood pump 50 proximal to the blood outlet 90.

[0053] The elongated shaft 12 of the catheter 10 is advanced further into the patient's body through the introducer sheath 100, allowing the blood pump 50 to be positioned in a desired location, for example, across the aortic valve between the left ventricle of the heart and the aorta. After the blood pump 50 is positioned in the desired location within the patient's vascular system (e.g., within the patient's heart), the compressible seal 220 can be compressed or tightened around the outer circumference of the elongated shaft 12 of the catheter 10 to prevent blood from leaking out of the main port 122 along the elongated shaft 12 and / or lock the elongated shaft 12 of the catheter 10 to prevent axial movement relative to the hub 120. For example, as described above, the lock nut 250 can be rotated to advance the pusher 230 distally, thereby applying a compressive force to the compressible seal 220, reducing the diameter of the opening 228 through the compressible seal 220, so that the compressible seal 220 seals around the elongated shaft 12 of the catheter 10 and maintains hemostasis.

[0054] Figures 9 to 14 illustrate various features and / or modifications of the spill-blocking sleeve 200. Note that the spill-blocking sleeve may include any combination of the various features and / or modifications described herein.

[0055] As shown in Figure 9, the spill-blocking sleeve 200 may be a tubular member 215 having a distal end 212, a proximal end 214, and an inner wall surface 218, the inner wall surface 218 defining a lumen extending through the tubular member 215. The spill-blocking sleeve 200 may have a length L measured from the proximal end 214 to the distal end 212. An exemplary length L of the spill-blocking sleeve 200 is as described above. In some cases, the spill-blocking sleeve 200 may include a tapered region 216 positioned between a distal end region extending to the distal end 212 and a reduced-diameter proximal end region extending to the proximal end 214. Thus, the distal end region may have an inner diameter D1, and the proximal end region may have an inner diameter D2 smaller than the inner diameter D1. In some cases, the tubular member 215 defining the spill-blocking sleeve 200 may have a wall thickness of, for example, 0.005 inches (0.127 mm) to 0.015 inches (0.381 mm), or about 0.010 inches (0.254 mm). The tubular member 215 is flexible or pliable and can be radially stretched to fit around the rigid housing of the blood pump 50 that forms the blood outlet 90.

[0056] Another exemplary embodiment of the spill-stop sleeve 200, indicated as spill-stop sleeve 300, is shown in Figure 10. In many embodiments, spill-stop sleeve 300 may be similar to spill-stop sleeve 200. For example, spill-stop sleeve 300 may be a tubular member 315 having a distal end 312, a proximal end 314, and an inner wall surface 318, the inner wall surface 318 defining a lumen extending through the tubular member 315. Spill-stop sleeve 300 may include a tapered region 316 positioned between a distal end region extending to the distal end 312 and a reduced-diameter proximal end region extending to the proximal end 314. Spill-stop sleeve 300 may include a flared distal region 322 that flares radially outward so that the outer diameter is larger at the distal end 312. As shown in Figure 10, the inner diameter of the tubular member 315 defining the lumen may also taper radially outward distally through a flared distal region 322. The flared distal region 322 may be configured to abut the proximal surface of the elastomer seal 260 to further prevent the outflow-blocking sleeve 300 from advancing distally through the elastomer seal 260.

[0057] Another exemplary embodiment of the spill-blocking sleeve 200, indicated as spill-blocking sleeve 400, is shown in Figure 11. In many embodiments, spill-blocking sleeve 400 may be similar to spill-blocking sleeve 200. For example, spill-blocking sleeve 400 may be a tubular member 415 having a distal end 412, a proximal end 414, and an inner wall surface 418, the inner wall surface 418 defining a lumen extending through the tubular member 415. Spill-blocking sleeve 400 may include a tapered region 416 positioned between a distal end region extending to the distal end 412 and a reduced-diameter proximal end region extending to the proximal end 414. Spill-blocking sleeve 400 may include a spherical distal region 424 having a larger outer diameter at the distal end 412 compared to the rest of the length of the tubular member 415. As shown in Figure 11, the inner diameter of the tubular member 415 defining the lumen may be constant throughout the distal end region, including the region through the spherical distal region 424, while the proximal end region may include a reduced inner diameter. The spherical distal region 424 may be configured to abut the proximal surface of the elastomer seal 260 to further prevent the outflow-blocking sleeve 400 from advancing distally through the elastomer seal 260.

[0058] Another exemplary embodiment of the spill-stop sleeve 200, indicated as spill-stop sleeve 500, is shown in Figure 12. In many embodiments, spill-stop sleeve 500 may be similar to spill-stop sleeve 200. For example, spill-stop sleeve 500 may be a tubular member 515 having a distal end 512, a proximal end 514, and an inner wall surface 518, the inner wall surface 518 defining a lumen extending through the tubular member 515. Spill-stop sleeve 500 may include a tapered region 516 positioned between a distal end region extending to the distal end 512 and a reduced-diameter proximal end region extending to the proximal end 514. Spill-stop sleeve 500 may include priority separation lines 530. In some cases, spill-stop sleeve 500 may include multiple priority separation lines 530. The priority separation lines 530 may be arranged at desired intervals along the longitudinal and / or circumferential directions of the tubular member 515. The tubular member 515 of the spill-blocking sleeve 500 may be configured to preferentially separate along a preferential separation line 530 for removal from the elongated shaft 12 of the blood pump 50 and / or catheter 10. For example, the preferential separation line 530 may include one or more perforations, openings, notches, slits, slots, channels, grooves, gaps, stress concentration areas, or weakened areas, thereby allowing a portion of the tubular member 515 to separate from another portion of the tubular member 515 along its length, so that the longitudinal edge of the tubular member 515 faces another longitudinal edge of the tubular member 515 along the length of the spill-blocking sleeve 500. After the leakage prevention sleeve 500 is separated along the priority separation line 530, it is possible to laterally remove the leakage prevention sleeve 500 from the elongated shaft 12 of the blood pump 50 and / or catheter 10 by passing it through the gap formed between adjacent longitudinal edges of the tubular member 515.

[0059] Another exemplary embodiment of the spill-stop sleeve 200, indicated as spill-stop sleeve 600, is shown in Figure 13. In many embodiments, spill-stop sleeve 600 may be similar to spill-stop sleeve 200. For example, spill-stop sleeve 600 may be a tubular member 615 having a distal end 612, a proximal end 614, and an inner wall surface 618, the inner wall surface 618 defining a lumen extending through the tubular member 615. Spill-stop sleeve 600 may include a tapered region 616 positioned between a distal end region extending to the distal end 612 and a reduced-diameter proximal end region extending to the proximal end 614. Spill-stop sleeve 600 may include a tear strip 632 extending along the tubular member 615. The tear strip 632 may extend longitudinally and / or helically along the tubular member 615, for example, from the proximal end 614 to the distal end 612. The tear strip 632 is grasped by the user and pulled to split the tubular member 615, thereby allowing the outflow-blocking sleeve 600 to be removed laterally from the elongated shaft 12 of the blood pump 50 and / or catheter 10 through the gap formed by the removal of the tear strip 632. In some cases, the tear strip 632 may include a tab 634 configured to be grasped by the user. In some cases, the tab 634 may extend proximal to the proximal end 614 and / or distal to the distal end 612, as necessary.

[0060] Another exemplary embodiment of the spill-stop sleeve 200, indicated as spill-stop sleeve 700, is shown in Figure 14. In many embodiments, spill-stop sleeve 700 may be similar to spill-stop sleeve 200. For example, spill-stop sleeve 700 may be a tubular member 715 having a distal end 712, a proximal end 714, and an inner wall surface 718, the inner wall surface 718 defining a lumen extending through the tubular member 715. Spill-stop sleeve 700 may include a tapered region 716 positioned between a distal end region extending to the distal end 712 and a reduced-diameter proximal end region extending to the proximal end 714. Spill-stop sleeve 700 may include a gripping structure on the outer surface of the tubular member 715 to facilitate gripping and thereby manipulating spill-stop sleeve 700 during use. For example, the gripping structure may include one or more raised ridges 740, as shown. In some cases, the raised ridge 740 may extend circumferentially and / or helically around the tubular member 715. In other cases, the raised ridge(s) 740 may be one or more projections or protrusions that rise above the rest of the outer surface of the tubular member 715. In other cases, the gripping structure may be one or more grooves, recesses, tabs, flaps, or other structures for gripping or otherwise improving the operation of the spill-stopping sleeve 700.

[0061] It should be understood that this disclosure is, in many respects, merely illustrative. Modifications may be made in detail, particularly with respect to shape, size, and step arrangement, without departing from the scope of this disclosure. This may include, to the appropriate extent, the use of any feature of one exemplary embodiment in other embodiments. The scope of this disclosure is, of course, defined by the language in which the appended claims are expressed.

Claims

1. It is a system, An introducer sheath including a hub, a long shaft extending distally from the hub, and an elastomer seal disposed within the hub, A catheter comprising an elongated shaft and a percutaneous blood pump positioned at the distal end of the elongated shaft, wherein the percutaneous blood pump comprises a blood inlet, a blood outlet, and an impeller assembly positioned between the blood inlet and the blood outlet for pumping blood from the blood inlet to the blood outlet during use, The blood outlet is detachably surrounded by an outflow-blocking sleeve, The blood pump is sized to pass distally through the elastomer seal into the lumen of the elongated shaft of the introducer sheath, and the outflow prevention sleeve is prevented from passing through the elastomer seal as the blood pump advances through the elastomer seal.

2. The system according to claim 1, wherein the outflow-blocking sleeve includes a distal end region having an inner diameter and a proximal end region having a reduced inner diameter smaller than the inner diameter of the distal end region.

3. The system according to claim 2, wherein the distal end region tightly surrounds the blood outlet to occlude blood flow from the blood outlet, and the proximal end region extends over the distal portion of the elongated shaft of the catheter.

4. The system according to any one of claims 1 to 3, wherein the outflow prevention sleeve has a length of 7 cm or less.

5. The system according to any one of claims 1 to 4, further comprising a guide wire extending outward from the outflow window of the blood outlet and extending proximal to the outer surface of the blood pump from the outflow window.

6. The system according to claim 5, wherein the outflow-blocking sleeve surrounds the guide wire extending along the outer surface of the blood pump.

7. The system according to any one of claims 1 to 6, wherein the outflow prevention sleeve includes a priority separation line extending along the length of the outflow prevention sleeve.

8. The system according to any one of claims 1 to 6, wherein the spill-blocking sleeve includes a material strip configured to separate from the tubular wall of the spill-blocking sleeve when pulled.

9. The system according to any one of claims 1 to 6, wherein the outflow-blocking sleeve includes a flared distal end configured to abut against the proximal surface of the elastomer sleeve.

10. The system according to any one of claims 1 to 6, wherein the outflow-blocking sleeve includes a spherical distal end configured to abut the proximal surface of the elastomer sleeve.

11. It is a system, A catheter comprising a long shaft and a percutaneous blood pump positioned at the distal end of the long shaft, wherein the percutaneous blood pump comprises a blood inlet, a blood outlet, an impeller positioned between the blood inlet and the blood outlet for pumping blood from the blood inlet to the blood outlet during use, and a motor housing positioned proximal to the impeller, the motor housing comprising a motor for rotating the impeller, the catheter and The system includes an outflow-blocking sleeve that tightly surrounds the blood outlet and extends proximal to the blood outlet, surrounding the motor housing, The outflow-blocking sleeve is configured to prevent blood from flowing out of the blood outlet when the blood pump is advanced into the vascular system at the vascular access site.

12. The system according to claim 11, wherein the outflow-blocking sleeve includes a distal end region having an inner diameter and a proximal end region having a reduced inner diameter smaller than the inner diameter of the distal end region.

13. The system according to claim 12, wherein the distal end region tightly surrounds the blood outlet to occlude blood flow from the blood outlet, and the proximal end region extends over the distal portion of the elongated shaft of the catheter proximal to the motor housing.

14. The system according to any one of claims 11 to 13, wherein the outflow prevention sleeve has a length of 7 cm or less.

15. The system according to any one of claims 11 to 14, further comprising a guide wire extending outward from the outflow window of the blood outlet and extending proximal to the outer surface of the motor housing from the outflow window, wherein the outflow blocking sleeve surrounds the guide wire extending along the outer surface of the motor housing.

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