Blood leakage prevention assembly, heart assist system, and blood leakage prevention guiding method

Abstract

The application discloses a blood leakage prevention assembly, a heart auxiliary system and a blood leakage prevention guiding method. The blood leakage prevention assembly comprises a bushing, and a cavity suitable for accommodating at least part of a catheter pump is formed in the bushing. A side wall of the cavity is tightly attached to an outer side wall of the catheter pump, and a first opening is arranged at a distal end of the bushing corresponding to the cavity. The catheter pump is suitable for entering and exiting the cavity from the first opening, and the distal end of the bushing is suitable for being tightly attached to a proximal end face of a guiding sheath. In use, the catheter pump is assembled in the cavity first, at this time, the side wall of the cavity covers and blocks a blood outlet on the catheter pump, then the distal end of the bushing is abutted against the proximal end of the guiding sheath, and the catheter pump is pushed into the guiding sheath. During the pushing process of the catheter pump, the side wall of the cavity is always tightly attached to the outer side wall of the catheter pump, so that the risk of blood spouting from the blood outlet on the catheter pump can be effectively reduced. In addition, the bushing can play a good guiding role, so that the catheter pump can be axially pushed along the bushing step by step, and the operation is simple.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to a blood leakage prevention component, a cardiac assist system, and a blood leakage prevention guidance method. Background Technology

[0002] Heart failure is a common cardiovascular disease that may appear as a complication or acute symptom in clinical practice. For example, patients with high-risk coronary artery disease who require percutaneous coronary intervention (PCI) often experience acute heart failure, and the treatment process may lead to myocardial ischemia or arrhythmias, posing a risk of malignant hemodynamic events. Therefore, ventricular assist devices are needed to maintain cardiac function during treatment. Compared to traditional left ventricular assist devices (LVADs), interventional left ventricular assist devices (PLVADs) offer shorter treatment times, are easier to operate, have higher implantation efficiency, and are less invasive. They reduce the difficulty and time required for PCI procedures, significantly lowering the surgical risks for heart failure patients. Therefore, PLVADs have a very broad application prospect in the treatment of heart failure.

[0003] During the implantation of a PLVAD (Plug-in Vascular Drainage Device), the catheter pump establishes a connection with the cardiovascular system. Because the blood pressure within the blood vessels is higher than atmospheric pressure, blood flows through the guide sheath into the catheter pump under the pressure difference and then flows out in large quantities from the outflow chamber, causing significant blood loss in the patient. This adversely affects the clinician's procedure and the patient's treatment. Reducing blood leakage during catheter pump implantation is crucial for lowering the difficulty of the surgical procedure and improving clinical treatment outcomes.

[0004] Therefore, how to improve the technical defects existing in the prior art has always been a problem that ordinary people skilled in the art need to solve. Summary of the Invention

[0005] The purpose of this invention is to provide a blood leakage prevention component, a cardiac assist system, and a blood leakage prevention guidance method, which can reduce the possibility of blood entering the catheter pump through the guide sheath and gushing out in large quantities from the blood outlet on the catheter pump, thereby reducing the difficulty of surgical procedures.

[0006] The technical solution provided by this invention is as follows:

[0007] A blood leakage prevention component for catheter pumps, comprising:

[0008] Bushing, having a distal end and a proximal end;

[0009] A chamber is formed within the bushing, adapted to accommodate at least a portion of the tubing pump, and the sidewall of the chamber is in close contact with the outer wall of the tubing pump;

[0010] The distal end of the bushing is adapted to fit closely against the proximal end face of the guide sheath, and the chamber is provided with a first opening corresponding to the distal end of the bushing, and the chamber is provided with a second opening corresponding to the proximal end of the bushing. The proximal end of the catheter pump is adapted to enter and exit the chamber through the first opening.

[0011] When the proximal end of the catheter pump abuts against the end wall of the chamber near the proximal end of the bushing, the side wall of the chamber at least covers and seals the blood outlet on the catheter pump.

[0012] In some embodiments, the bushing has an annular abutment at its distal end, the distal end face of which is adapted to abut against the proximal end face of the guide sheath.

[0013] In some embodiments, the chamber includes a first cavity, a second cavity, and a third cavity that are connected sequentially from the distal end to the proximal end;

[0014] The first cavity is a cylindrical cavity, and the diameter of the first cavity is adapted to the outer diameter of the tubing pump;

[0015] The inner wall profile of the second cavity is adapted to the outer profile of the motor tail cover of the duct pump.

[0016] The third cavity is a cylindrical cavity, and the diameter of the third cavity is adapted to the outer diameter of the cable conduit.

[0017] In some embodiments, the first cavity sidewall is provided with a clearance groove, and the clearance groove extends axially along the bushing to both ends of the first cavity to avoid the protective structure on the outer sidewall of the tubing pump used for mounting sensors.

[0018] In some embodiments, a guide hole is formed in the side wall of the main bushing, one end of the guide hole is located at the proximal end face of the main bushing, and the other end of the guide hole is located at the side wall of the first cavity.

[0019] The guide hole is adapted for the guide wire to pass through.

[0020] In some embodiments, the bushing includes a first part and a second part in the radial direction;

[0021] The first part is provided with one of a positioning block or a positioning groove, and the second part is provided with the other of a positioning block or a positioning groove;

[0022] The positioning block is adapted to be inserted into the positioning groove, and the first and second parts together form the bushing.

[0023] In some embodiments, the anti-leakage component further includes:

[0024] A tightening sleeve is fitted onto the bushing;

[0025] The inner diameter of the tightening sleeve is smaller than the outer diameter of the bushing, which is suitable for pressing the bushing tightly against the conduit pump, and the side wall of the chamber is in close contact with the outer side wall of the conduit pump.

[0026] In some embodiments, the tightening sleeve is provided with a third opening;

[0027] The third opening is located on the side wall of the tightening sleeve and extends axially along the tightening sleeve to both ends of the tightening sleeve, and is adapted to allow a cable conduit connected to the conduit pump to pass through.

[0028] In some embodiments, the distal end face of the bushing has a first guide surface corresponding to the edge of the first opening, adapted to guide the catheter pump into the chamber.

[0029] In some embodiments, the bushing sidewall has a second guide surface at the proximal end, adapted to guide the tightening sleeve to be fitted onto the bushing.

[0030] The present invention also provides a cardiac assist system, comprising:

[0031] Guide sheath, catheter pump, and any of the above-mentioned leak-proof components;

[0032] The catheter pump is located in the chamber. When the distal end of the anti-leakage component abuts against the proximal end of the guide sheath, the catheter pump passes through the first opening from the chamber and enters the guide sheath.

[0033] This invention also provides a method for preventing blood leakage, applicable to the blood leakage prevention components provided in any of the above claims, comprising the following steps:

[0034] The bushing houses at least a portion of the tubing pump within the chamber, and a cable conduit connected to the proximal end of the tubing pump extends out from the second opening;

[0035] The distal end of the bushing abuts against the proximal end of the guide sheath;

[0036] The portion of the duct pump housed within the chamber extends out of the chamber through the first opening and enters the guide sheath.

[0037] The technical advantages of this invention are as follows:

[0038] 1. In this patent, when the catheter pump enters the guide sheath, the sidewall of the chamber inside the bushing always abuts against the outer wall of the catheter pump, sealing the portion of the outflow chamber window on the catheter pump located outside the guide sheath, i.e., the blood outlet on the catheter pump. This effectively reduces the risk of blood flowing into the cannula through the catheter pump and being ejected through the outflow chamber, thus reducing blood leakage. Furthermore, because the contact area between the bushing and the outer wall of the catheter pump in this patent is relatively large, even if the outflow chamber is completely inside the guide sheath, a portion of the catheter pump remains in close contact with the sidewall of the chamber. Therefore, the sealing effect between the bushing and the catheter pump is better, and correspondingly, the anti-leakage component has a stronger anti-leakage function. Furthermore, the bushing also provides a guiding function. Because the sidewall of the chamber within the bushing is tightly pressed against the outer wall of the catheter pump, the pump experiences significant radial pressure, which limits its radial sway. Conversely, the pump experiences less axial resistance, causing it to move more axially as it is advanced into the guide sheath, preventing deviation and facilitating manipulation by medical personnel, thus reducing surgical difficulty. Moreover, the bushing and guide sheath in this patent are independent components, meaning their assembly and disassembly do not affect each other. Medical personnel can directly use the anti-leakage component provided by this patent with existing guide sheaths, eliminating the need for a dedicated guide sheath designed specifically for this patent's anti-leakage component, thereby improving its versatility.

[0039] 2. In this patent, an annular abutment is provided at the distal end of the bushing. The purpose is to increase the contact area between the distal end face of the bushing and the proximal end face of the guide sheath, reduce the risk of blood flowing out through the gap between the guide sheath and the bushing, and further improve the ability of the anti-leakage component to reduce blood leakage.

[0040] 3. In this patent, to facilitate the assembly and disassembly of the bushing, the bushing includes a first part and a second part in the radial direction. Additionally, this patent also includes a tightening sleeve. After placing the first and second parts face to face, the tightening sleeve is placed over them, fixing the first and second parts together to form a complete bushing. Conversely, when the tightening sleeve is removed, the first and second parts separate and can be directly removed. Moreover, since the bushing is composed of the first and second parts, gaps inevitably exist between them. The tightening sleeve not only secures the first and second parts but also ensures close contact between them, thereby reducing the risk of blood leakage through the gaps. Furthermore, this patent includes a third opening on the tightening sleeve, allowing it to be directly removed after the catheter pump is fully inserted into the guide sheath, making the operation convenient and simple.

[0041] 4. In this patent, the side wall of the first cavity is provided with a clearance groove, which extends axially along the bushing to both ends of the first cavity to avoid the protective structure on the outer wall of the duct pump used for mounting sensors. At the same time, the clearance groove also plays a certain guiding role, guiding the duct pump to move along the length of the clearance groove and restricting the duct pump from rotating circumferentially, which is highly practical.

[0042] 5. In this patent, a guide hole is formed inside the side wall of the bushing. One end of the guide hole is located on the proximal end face of the bushing, and the other end is located on the side wall of the first cavity, suitable for the guide wire to pass through. The guide wire is used to guide the catheter pump into the human body. By setting the guide hole, this patent can ensure that the side wall of the bushing cavity is in close contact with the outer wall of the catheter pump, and can also lead the guide wire out to the outside of the anti-leakage component. The structure is reasonable and highly practical. Attached Figure Description

[0043] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0044] Figure 1 This is a three-dimensional assembly diagram of the anti-leakage component, catheter pump, and guide sheath provided in one embodiment of the present invention;

[0045] Figure 2 yes Figure 1 Cross-sectional view of the anti-leakage assembly, catheter pump, and guide sheath shown;

[0046] Figure 3 This is a three-dimensional structural schematic diagram of the anti-leakage component provided in one embodiment of the present invention;

[0047] Figure 4 This is a three-dimensional structural schematic diagram of the tightening sleeve provided in one embodiment of the present invention;

[0048] Figure 5 This is a three-dimensional assembly diagram of the anti-leakage component, catheter pump, and guide sheath provided in another embodiment of the present invention;

[0049] Figure 6 This is a three-dimensional structural schematic diagram of the tightening sleeve provided in another embodiment of the present invention;

[0050] Figure 7 This is a schematic diagram of the three-dimensional structure of the first split component provided by the present invention;

[0051] Figure 8 This is a three-dimensional structural diagram of the second component provided by the present invention;

[0052] Figure 9 This is an assembly diagram of the anti-leakage component and catheter pump provided by the present invention, as observed from the distal end face.

[0053] Explanation of icon numbers:

[0054] 100. Bushing; 110. First split part; 111. First groove; 112. Second groove; 113. Third groove; 114. Positioning block; 120. Second split part; 121. Fourth groove; 122. Fifth groove; 123. Sixth groove; 124. Positioning groove; 130. First opening; 140. Second opening; 150. Annular abutment; 151. First section; 152. Second section; 160. Clearance groove; 170. Guide hole; 180. First guide surface; 190. Second guide surface;

[0055] 200. Shrink sleeve; 210. Third opening;

[0056] 300. Guided pump; 310. Protective structure;

[0057] 400. Cable conduit;

[0058] 500. Guiding sheath. Detailed Implementation

[0059] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of the invention. However, those skilled in the art will understand that the invention can be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, circuits, and methods have been omitted so as not to obscure the description of the invention with unnecessary detail.

[0060] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0061] To keep the drawings concise, each figure only schematically shows the parts relevant to the invention, and these do not represent the actual structure of the product. Furthermore, to facilitate understanding, in some figures, only one of components with the same structure or function is schematically depicted, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0062] It should also be further understood that the term "and / or" as used in this specification and the appended claims refers to any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0063] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0064] In the embodiments shown in the accompanying drawings, the directional indications (such as up, down, left, right, front, and back) used to explain the structure and movement of the various components of the invention are relative rather than absolute. These descriptions are appropriate when these components are in the positions shown in the drawings. If the descriptions of the positions of these components change, these directional indications also change accordingly.

[0065] In this document, "proximal end" refers to the end along the length of the tubing pump that is closer to the operator, and "distal end" refers to the end along the length of the tubing pump that is farther from the operator.

[0066] Furthermore, in the description of this invention, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0067] According to a specific embodiment provided by the present invention, see [link to specific embodiment]. Figures 1 to 9 A blood leakage prevention assembly includes a bushing 100 having a distal end and a proximal end, the distal end of which is adapted to abut against the proximal end face of a guide sheath 500. A chamber is formed within the bushing 100, adapted to accommodate at least a portion of a catheter pump 300, and the sidewall of the chamber is adapted to abut against the outer sidewall of the catheter pump 300. Furthermore, the chamber has a first opening 130 corresponding to the distal end of the bushing 100, and a second opening 140 corresponding to the proximal end of the bushing 100, the proximal end of the catheter pump 300 being adapted to enter and exit the chamber through the first opening 130, and the second opening 140 for a cable conduit 400 to pass through. When the proximal end of the catheter pump 300 abuts against the end wall of the chamber near the proximal end of the bushing 100, the sidewall of the chamber at least covers and seals the blood outlet on the main catheter pump 300.

[0068] The blood leakage prevention component provided in this embodiment is used to prevent blood from entering the catheter pump 300 through the guide sheath 500 under the action of blood pressure when the catheter pump 300 establishes a connection with the cardiovascular system, and from flowing out of the catheter pump 300 in large quantities.

[0069] Specifically, before the catheter pump 300 enters the guide sheath 500, the catheter pump 300 is placed within the chamber of the bushing 100, and the cable conduit 400 connected to the catheter pump 300 can extend through the second opening 140 to the outside of the bushing 100. At this time, the sidewall of the chamber inside the bushing 100 is pressed against the outer wall of the catheter pump 300, and the sidewall of the chamber at least covers and seals the blood outlet on the catheter pump 300, forming a seal between the bushing 100 and the catheter pump 300. Medical personnel advance the anti-leakage component and the catheter pump 300 until the distal end face of the bushing 100 is tightly against the proximal end face of the guide sheath 500. The anti-leakage component remains stationary, and the catheter pump 300 continues to be advanced into the guide sheath 500. Before the catheter pump 300 enters the guide sheath 500, the proximal end of the catheter pump 300 is adapted to abut against the end wall of the chamber near the proximal end of the bushing 100 (i.e., the proximal end wall of the chamber). In this way, when medical staff advance the anti-leakage component and the catheter pump 300, they can directly advance the bushing 100, and push the catheter pump 300 in the chamber through the proximal end wall of the chamber inside the bushing 100 to move together, which is convenient to operate.

[0070] In this embodiment, the duct pump 300 includes an inflow chamber, a cannula, an outflow chamber, a motor housing, and a motor tail cover, connected sequentially from the distal end to the proximal end. The duct pump 300 can be entirely housed within the chamber or only partially housed within it. If the duct pump 300 is entirely housed within the chamber, then the inflow chamber, cannula, outflow chamber, motor housing, and motor tail cover of the duct pump 300 are all housed within the chamber. If the duct pump 300 is only partially housed within the chamber, then the outflow chamber window, motor housing, and motor tail cover of the duct pump 300 are housed within the chamber. That is, when the duct pump 300 is installed within the chamber and its proximal end abuts against the proximal end wall of the chamber, the distal end face of the bushing 100 is adapted to be located at an intermediate position between the distal edge of the outflow chamber and the distal edge of the outflow chamber window of the duct pump 300.

[0071] In this embodiment, the blood outlet on the catheter pump 300 is the outflow chamber window. Specifically, during the process of the catheter pump 300 entering the guide sheath 500, the side wall of the chamber inside the bushing 100 is always in contact with the outer wall of the catheter pump 300, which can block the part of the outflow chamber window of the catheter pump 300 located outside the guide sheath 500, thereby effectively reducing the risk of blood flowing into the chamber through the catheter pump 300 and entering the cannula, and then being ejected through the outflow chamber. At the same time, the bushing 100 is pressed tightly against the guide sheath 500, which can also reduce the possibility of blood flowing out through the gap between the guide sheath 500 and the bushing 100, thereby reducing the amount of blood leakage.

[0072] In existing technologies, the risk of blood leakage is often reduced by placing a baffle on the side of the inflow chamber (i.e., the inlet where blood enters the catheter pump 300) away from the outflow chamber, or by placing a hemostatic valve near the proximal end of the guide sheath 500. However, both the contact area between the baffle and the guide sheath 500, and the contact area between the hemostatic valve and the catheter pump 300, are relatively limited, resulting in a less than ideal sealing effect. In particular, placing the baffle on the side of the inflow chamber away from the outflow chamber makes it highly susceptible to being breached by the flow of blood, leading to blood leakage. Furthermore, this structural design also presents the problem of failing to expel air from the cannula. However, in this embodiment, the contact area between the bushing 100 and the outer wall of the catheter pump 300 is relatively large. Even if the outflow chamber is completely inside the guide sheath 500, a significant portion of the catheter pump 300 remains tightly attached to the side wall of the chamber. This indicates that the sealing effect between the bushing 100 and the catheter pump 300 is better. Consequently, the anti-leakage component also has a stronger anti-leakage function and is highly practical. Furthermore, in this embodiment, the outflow chamber window of the catheter pump 300 is sealed, thus eliminating the problem of air not being able to escape from the cannula.

[0073] More importantly, this embodiment reduces the risk of blood leakage by adding an additional anti-leakage component, rather than modifying the catheter pump 300 itself. This results in low manufacturing costs, wide applicability, and mass production capability. In contrast, the bushing 100 and guide sheath 500 in this embodiment are independent components, and their assembly and disassembly do not affect each other. Therefore, medical personnel can directly use the anti-leakage component provided in this embodiment with their existing guide sheath 500, eliminating the need to design a dedicated guide sheath 500 for this embodiment's anti-leakage component, effectively improving the universal applicability of the anti-leakage component.

[0074] In addition, the bushing 100 also plays a guiding role. Specifically, because the sidewall of the chamber inside the bushing 100 is in close contact with the outer wall of the catheter pump 300, the catheter pump 300 will be subjected to greater pressure in the radial direction. This pressure can limit the radial sway of the catheter pump 300. Meanwhile, the catheter pump 300 is subjected to less resistance in the axial direction. Thus, when the catheter pump 300 is pushed into the guide sheath 500, the catheter pump 300 tends to move along the axis under the action of the bushing 100 and will not deviate. This makes it easier for medical staff to push the catheter pump 300, effectively reducing the difficulty of the operation and speeding up the operation process.

[0075] In one specific embodiment, see Figures 1 to 3 and Figure 5The bushing 100 has an annular abutment 150 at its distal end, the distal end face of which is adapted to fit snugly against the proximal end face of the guide sheath 500. The diameter of the annular abutment 150 should be larger than the diameter of the guide sheath 500, preferably 2-3 times the diameter of the guide sheath 500, increasing the contact area between the distal end face of the bushing 100 and the proximal end face of the guide sheath 500, reducing the risk of blood leakage through the gap between the guide sheath 500 and the bushing 100, and further improving the ability of the anti-leakage component to reduce blood leakage. Furthermore, the annular abutment 150 also facilitates the gripping and movement of the bushing 100 by medical personnel, thereby improving the delivery of the catheter pump 300 and enhancing its practicality.

[0076] Furthermore, a flexible sealing gasket is provided on the distal end face of the annular abutment 150 and / or the proximal end face of the guide sheath 500. In this embodiment, flexible contact is used instead of rigid contact, which reduces the difficulty of the surface processing of the bushing 100 and can improve the adaptability of the distal end face of the annular abutment 150 and / or the proximal end face of the guide sheath 500 to different contact surfaces, thereby enhancing the anti-leakage performance.

[0077] See Figure 3 and Figures 7 to 9 To enable quick assembly and disassembly of the bushing 100, in one specific embodiment, the bushing 100 includes a first part 110 and a second part 120 in the radial direction. The first part 110 is provided with either a positioning block 114 or a positioning groove 124, and the second part 120 is provided with the other of the positioning block 114 or positioning groove 124. The positioning block 114 is adapted to be inserted into the positioning groove 124, so that the first part 110 and the second part 120 together form the bushing 100.

[0078] At this time, see Figure 3 and Figures 7 to 9 The annular abutment 150 includes a first portion 151 and a second portion 152 in the radial direction. The first portion 151 is located at the distal end of the first portion 110, and the second portion 152 is located at the distal end of the second portion 120. When the first portion 110 and the second portion 120 are fixedly connected, the first portion 151 and the second portion 152 together form the aforementioned annular abutment 150. In this case, one of the positioning block 114 or the positioning groove 124 is preferably fixed on the side of the first portion 151 facing the second portion 152, and the other of the positioning block 114 or the positioning groove 124 is fixed on the side of the second portion 152 facing the first portion 151.

[0079] Specifically, the positioning block 114 and the positioning groove 124 can be engaged to form a connection structure similar to a snap-fit, so as to fix the first part 110 and the second part 120 together.

[0080] Or see Figures 1 to 8In one specific embodiment, the anti-leakage component further includes a shrink sleeve 200, which can be fitted over the first part 110 and the second part 120 to fix the first part 110 and the second part 120 together to form the bushing 100.

[0081] In this embodiment, the first component 110 and the second component 120 are an assembly. The first component 110 and the second component 120 are assembled together through the cooperation of the positioning block 114 and the positioning groove 124. Then, a tightening sleeve 200 is fitted onto the outside of the assembly formed by the first component 110 and the second component 120. The contraction force of the tightening sleeve 200 tightens the first component 110 and the second component 120, achieving a fixed connection and forming a complete bushing 100. The mating surface of the first component 110 and the second component 120 is a plane passing through the central axis of the bushing 100. At this point, the first component 110 and the second component 120 together form a chamber for accommodating the tubing pump 300, which is surrounded between the first component 110 and the second component 120. In contrast, since the first part 110 and the second part 120 are not fixed by a fixed structure and are only fixed by the tightening sleeve 200, the first part 110 and the second part 120 can be detached from the catheter pump 300 after the medical staff removes the tightening sleeve 200, making disassembly and assembly convenient.

[0082] It is worth noting that the bushing 100 is formed by splicing the first part 110 and the second part 120. There is inevitably a gap between the first part 110 and the second part 120. At this time, the setting of the tightening sleeve 200 can not only fix the first part 110 and the second part 120, but also ensure that the first part 110 and the second part 120 are in close contact, with a high sealing effect, thereby reducing the risk of blood flowing out through the gap between the first part 110 and the second part 120.

[0083] Specifically, the inner diameter of the tightening sleeve 200 is smaller than the outer diameter of the bushing 100, which is suitable for pressing the bushing 100 tightly against the catheter pump 300, thereby ensuring that the sidewall of the chamber is tightly attached to the outer wall of the catheter pump 300. On the one hand, this can further enhance the tightness of the fit between the bushing 100 and the catheter pump 300, forming a seal between them; on the other hand, the bushing 100 applies greater radial pressure to the catheter pump 300, which can further limit the radial sway of the catheter pump 300 and make the catheter pump 300 more inclined to move along the axis under the action of the bushing 100, thereby facilitating the advancement of the catheter pump 300 by medical staff, reducing the difficulty of the operation, and speeding up the surgical process.

[0084] Specifically, see Figure 1 , Figure 3 and Figure 4The tightening sleeve 200 is provided with a third opening 210, which is located on the side wall of the tightening sleeve 200 and extends axially along the tightening sleeve 200 to both ends of the tightening sleeve 200, suitable for the cable conduit 400 connected to the conduit pump 300 to pass through. The size of the third opening 210 is equal to or slightly larger than the diameter of the cable conduit 400. In this case, the tightening sleeve 200 can not only pass through the cable conduit 400 and be assembled onto the bushing 100, but also be removed from the cable conduit 400 after the conduit pump 300 enters the guide sheath 500 and the human body, making disassembly and assembly convenient.

[0085] In this embodiment, the tightening sleeve 200 can be made of medical materials such as plastic or metal, and the wall thickness of the tightening sleeve 200 is relatively thin, preferably 1-2 mm. In this way, the clamping of the bushing 100 by the tightening sleeve 200 can be achieved by utilizing the easily deformable characteristics of thin-walled parts. Conversely, the bushing 100 can be made of materials such as stainless steel or HDPE (high-density polyethylene).

[0086] In one specific embodiment, see Figure 5 and Figure 6 Alternatively, the shrink sleeve 200 may not have a third opening 210. In this case, the shrink sleeve 200 should be made of a tearable insulating heat-shrink tubing material, and its initial inner diameter should be larger than the external contour dimensions of the catheter pump 300. The shrink sleeve 200 in its initial state is placed over the bushing 100, and then heated to shrink and adhere to the surface of the bushing 100. At this point, the inner diameter of the shrink sleeve 200 is equal to the outer diameter of the bushing 100, allowing the bushing 100 to be pressed tightly against the catheter pump 300. When the catheter pump 300 is delivered into the guide sheath 500, the shrink sleeve 200 can be directly torn open, and the bushing 100 removed, achieving complete removal of the anti-leakage component and completing the subsequent implantation of the catheter pump 300.

[0087] Specifically, see Figure 2 , Figure 7 and Figure 8 The chamber comprises a first chamber, a second chamber, and a third chamber connected sequentially from distal to proximal. The first chamber is cylindrical and its diameter is adapted to the outer diameter of the conduit pump 300. In this case, the first chamber extends to the distal end of the bushing 100 and forms a first opening 130 on the distal end face of the bushing 100. The inner wall contour of the second chamber is adapted to the outer contour of the motor tail cover of the conduit pump 300. The third chamber is cylindrical and its diameter is adapted to the outer diameter of the cable conduit 400. In this case, the third chamber extends to the proximal end of the bushing 100 and forms a second opening 140 on the proximal end face of the bushing 100.

[0088] In this embodiment, the first cavity is adapted to the outer diameter of the conduit pump 300, the second cavity is adapted to the outer contour of the motor tail cover, and the third cavity is adapted to the outer diameter of the cable conduit 400. All of these can achieve a good sealing effect under the tightening action of the shrink sleeve 200, preventing blood from flowing out from the gap between the conduit pump 300 and the bushing 100, and the gap between the cable conduit 400 and the bushing 100, thus preventing a large loss of blood.

[0089] Meanwhile, in this embodiment, because the outer diameters of the catheter pump 300 and the cable conduit 400 are different, the second cavity is a transition cavity, and the radial dimension of the end of the second cavity connecting to the third cavity is smaller than the radial dimension of the end of the second cavity connecting to the first cavity. Thus, when medical personnel advance the anti-leakage component and the catheter pump 300, they can only move the bushing 100. The contact action between the catheter pump 300 and the part of the second cavity near the third cavity restricts the axial position of the catheter pump 300, ensuring that the catheter pump 300 moves with the bushing 100. Conversely, when the bushing 100 abuts against the guide sheath 500, the annular abutment 150 restricts the bushing 100 from moving further. At this time, continuing to advance the catheter pump 300 allows it to enter the guide sheath 500 under the thrust.

[0090] Specifically, see Figure 2 , Figure 7 and Figure 8 The first segment 110 is provided with a first groove 111, a second groove 112, and a third groove 113 connected sequentially from the distal end to the proximal end; the second segment 120 is provided with a fourth groove 121, a fifth groove 122, and a sixth groove 123 connected sequentially from the distal end to the proximal end. When the first segment 110 and the second segment 120 are fixedly connected, the first groove 111 and the fourth groove 121 together form a first cavity, the second groove 112 and the fifth groove 122 together form a second cavity, and the third groove 113 and the sixth groove 123 together form a third cavity.

[0091] Specifically, see Figure 8 and Figure 9The first cavity has a clearance groove 160 on its side wall, which extends axially along the bushing 100 to both ends of the first cavity to avoid the protective structure 310 for mounting sensors on the outer side wall of the tubular pump 300. The clearance groove 160 is located on the fourth groove 121 of the second sub-body 120, and its axial shape conforms to the axial shape of the protective structure 310, allowing the bushing 100 to fit well against the surface of the tubular pump 300. When the tubular pump 300 moves within the bushing 100, the clearance groove 160 also provides a guiding function, guiding the tubular pump 300 along its length and restricting its circumferential rotation. The structure is rationally designed and highly practical.

[0092] In one specific embodiment, see Figures 1 to 3 and Figure 5 and Figure 7 A guide hole 170 is formed in the side wall of the bushing 100, which is suitable for the guide wire to pass through. One end of the guide hole 170 is located on the proximal end face of the bushing 100, and the other end is located on the side wall of the first cavity.

[0093] In this embodiment, the catheter pump 300 needs to be delivered into the human body using a guidewire. During delivery, the guidewire needs to exit through the outflow window of the catheter pump 300. In order to ensure a tight fit between the bushing 100 and the catheter pump 300 to reduce blood leakage, while also allowing the guidewire to exit through the anti-leakage component, this embodiment provides a guide hole on the side wall of the bushing 100. This allows the guidewire to exit from the outflow window into the guide hole 170 and then exit from the guide hole to the outside of the anti-leakage component during the delivery of the catheter pump 300.

[0094] Specifically, the guide hole 170 is provided on the side wall of the first split body 110, with one end of the guide hole 170 located in the first groove 111 and the other end located near the end of the first split body 110. The guide hole 170 is a straight oblique hole, and the end of the guide hole 170 located in the first groove 111 corresponds to the outlet chamber window of the duct pump 300.

[0095] There should be a small gap between the guide hole 170 and the guide wire. On the one hand, this allows the guide wire to pass through the guide hole 170, thus ensuring that the catheter pump 300 can smoothly pass out of the chamber of the bushing 100 and enter the guide sheath 500. On the other hand, it allows air in the guide sheath 500 and the catheter pump 300 to be discharged from the gap between the guide hole 170 and the guide wire, improving surgical safety and eliminating the dangers that may arise from instrument implantation.

[0096] Specifically, see Figure 7 and Figure 8The bushing 100 has a first guide surface 180 at its distal end corresponding to the edge of the first opening 130, which is suitable for guiding the tubing pump 300 into the chamber, thereby assembling the bushing 100 onto the tubing pump 300. Conversely, the bushing 100 has a second guide surface 190 at its proximal end on its sidewall, which is suitable for guiding the tightening sleeve 200 onto the bushing 100, making assembly convenient and quick.

[0097] This invention also provides a cardiac assist system, including a guide sheath 500, a catheter pump 300, and a leak-proof component provided in any of the above embodiments. Before the catheter pump 300 enters the guide sheath 500, it is located inside the leak-proof component. When the distal end of the leak-proof component abuts against the proximal end of the guide sheath 500, the catheter pump 300 passes through the first opening 130 from the chamber and enters the guide sheath 500. Throughout the process, the sidewall of the chamber within the bushing 100 remains in contact with the outer wall of the catheter pump 300, thereby reducing blood leakage during implantation and improving surgical safety. Simultaneously, the reduction in blood leakage and the guiding effect of the bushing 100 also reduce the difficulty of the procedure for medical personnel, allowing them to perform the implantation process more calmly and effectively, thus contributing to improved clinical implantation outcomes and patients' quality of life.

[0098] This invention also provides a method for preventing blood leakage, applicable to the blood leakage prevention components provided in any of the above embodiments. Specifically, medical personnel first install the catheter pump 300 in the chamber within the bushing 100. At this time, the distal end face of the bushing 100 should be located at the midpoint between the distal edge of the outflow chamber of the catheter pump 300 and the distal edge of the outflow chamber window, to seal the entire outflow chamber window. Then, medical personnel advance the catheter pump 300 by pushing the bushing 100 until the distal end face of the annular abutment 150 is pressed against the proximal end face of the guide sheath 500. Medical personnel then stop advancing the bushing 100 and only continue advancing the catheter pump 300. In this way, the portion of the catheter pump 300 contained within the chamber can gradually pass through the first opening 130 and into the interior of the guide sheath 500, and throughout the process, the bushing 100 can always seal the outflow chamber window, reducing the risk of blood spraying out through the outflow chamber window and reducing the amount of blood leakage.

[0099] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0100] It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of the present invention. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A blood leakage prevention component suitable for catheter pumps, characterized in that, include: Bushing, having a distal end and a proximal end; A tightening sleeve is fitted onto the bushing; A chamber is formed within the bushing, adapted to accommodate at least a portion of the tubing pump, and the sidewall of the chamber is in close contact with the outer wall of the tubing pump; The bushing has an annular abutment at its distal end, the distal end face of which is adapted to closely abut the proximal end face of the guide sheath. The chamber has a first opening corresponding to the distal end of the bushing and a second opening corresponding to the proximal end of the bushing. The proximal end of the catheter pump is adapted to enter and exit the chamber through the first opening. The distal end face of the bushing has a first guide surface corresponding to the edge of the first opening, adapted to guide the catheter pump into the chamber. When the proximal end of the catheter pump abuts against the end wall of the chamber near the proximal end of the bushing, the side wall of the chamber at least covers and blocks the blood outlet on the catheter pump; The bushing includes a first part and a second part in the radial direction. The first part is provided with either a positioning block or a positioning groove, and the second part is provided with either a positioning block or a positioning groove. The positioning block is adapted to be inserted into the positioning groove. The first part and the second part together form the bushing. The inner diameter of the tightening sleeve is smaller than the outer diameter of the bushing, which is adapted to press the bushing tightly against the tubing pump. The sidewall of the chamber is in close contact with the outer wall of the tubing pump. A guide hole is formed in the side wall of the bushing. The guide hole is a straight oblique hole, which is suitable for the guide wire to pass through. The chamber includes a first chamber, a second chamber and a third chamber connected sequentially from the distal end to the proximal end. One end of the guide hole is located on the proximal end face of the bushing, and the other end of the guide hole is located on the side wall of the first chamber and is set corresponding to the blood outlet of the catheter pump. There is a gap between the guide hole and the guide wire.

2. The anti-leakage component according to claim 1, characterized in that, The first cavity is a cylindrical cavity, and the diameter of the first cavity is adapted to the outer diameter of the tubing pump; The inner wall profile of the second cavity is adapted to the outer profile of the motor tail cover of the duct pump. The third cavity is a cylindrical cavity, and the diameter of the third cavity is adapted to the outer diameter of the cable conduit.

3. The anti-leakage component according to claim 2, characterized in that, The first cavity sidewall is provided with a clearance groove, and the clearance groove extends axially along the bushing to both ends of the first cavity to avoid the protective structure on the outer sidewall of the tubing pump used for installing sensors.

4. The anti-leakage component according to claim 1, characterized in that, The tightening sleeve is provided with a third opening; The third opening is located on the side wall of the tightening sleeve and extends axially along the tightening sleeve to both ends of the tightening sleeve, and is adapted to allow a cable conduit connected to the conduit pump to pass through.

5. The anti-leakage component according to claim 1 or 4, characterized in that, The bushing sidewall has a second guide surface at the proximal end, which is suitable for guiding the tightening sleeve to be fitted onto the bushing.

6. A cardiac assist system, characterized in that, include: Guide sheath, catheter pump, and the anti-leakage assembly according to any one of claims 1-5; The catheter pump is located in the chamber. When the distal end of the anti-leakage component abuts against the proximal end of the guide sheath, the catheter pump passes through the first opening from the chamber and enters the guide sheath.

7. A method for preventing blood leakage during guidance, characterized in that, The blood leakage prevention component according to any one of claims 1-5 includes the following steps: The bushing houses at least a portion of the tubing pump within the chamber, and a cable conduit connected to the proximal end of the tubing pump extends out from the second opening; The distal end of the bushing abuts against the proximal end of the guide sheath; The portion of the duct pump housed within the chamber extends out of the chamber through the first opening and enters the guide sheath.

Images