Conveying device for implanting intrusive axial flow blood pump into aorta abdominalis

Abstract

The utility model discloses a conveying device for implanting an intrusive axial flow blood pump into an aorta abdominalis. The conveying device comprises a sheath tube, a sheath base assembly and a bypass extension tube assembly. The sheath base assembly comprises an operating handle, a sealing gasket and a gland, the bypass extension tube assembly comprises a Luer taper and a drainage tube, the operating handle is provided with a through hole, a drainage hole communicated with the through hole is formed in one side of the operating handle, the drainage tube is installed in the drainage hole, the sheath tube is installed at the far end of the operating handle, and the gland is connected with the near end of the operating handle by pressing the sealing gasket. The gland is connected with the locking cap through threads, the locking cap is connected with the handle end of the axial flow blood pump through the sterile sleeve, the axial flow blood pump penetrates through the sheath base assembly, is arranged in the sheath tube and is connected and positioned through the gland, and then the axial flow blood pump and the conveying device are implanted into the body of a patient in a percutaneous mode. And the sterile sleeve is operated to slowly withdraw the conveying device, so that the elastic bracket of the axial flow blood pump is released.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and more specifically, to a delivery device for implanting an interventional axial flow blood pump into the abdominal aorta. Background Technology

[0002] In patients with acute decompensated heart failure, approximately 25% cannot be successfully treated with standard care and lack effective treatment options, resulting in less than ideal outcomes. Therefore, percutaneous implantation of an axial flow pump within the abdominal aorta can increase blood flow to vital organs (such as the kidneys), while simultaneously reducing cardiac workload and improving cardiac function. Furthermore, implantation at this location offers other advantages, including eliminating the potential risks of thrombosis and aortic valve injury. Utility Model Content

[0003] The purpose of this invention is to provide a delivery device for implanting an interventional axial flow blood pump into the abdominal aorta, ensuring that the risk of blood leakage is reduced during the implantation procedure, facilitating clinical operation, and reducing the risk of surgical complications.

[0004] To achieve the above objectives, the present invention adopts the following technical solution:

[0005] A delivery device for implanting an interventional axial flow blood pump into the abdominal aorta includes a sheath, a sheath seat assembly, and a bypass extension tube assembly. The sheath seat assembly includes an operating handle, a sealing gasket, and a pressure cap. The bypass extension tube assembly includes a Luer connector and a drainage tube. The operating handle has a perforation through which the distal end of the axial flow blood pump passes. A drainage hole communicating with the perforation is provided on one side of the operating handle, through which the drainage tube is installed. The sheath is installed at the distal end of the perforation on the operating handle, and the sealing gasket is installed at the proximal end of the perforation. The pressure cap is connected to the operating handle by pressing the sealing gasket. The proximal end of the handle is connected, and the pressure cap and locking cap are connected by threads. The locking cap is connected to the handle end of the axial flow blood pump through a sterile sleeve. The axial flow blood pump is inserted through the sheath assembly and placed inside the sheath, and is positioned by the pressure cap. The axial flow blood pump is then percutaneously implanted into the patient along with the delivery device. After the axial flow blood pump is placed at the designated position in the patient's abdominal aorta, the sterile sleeve is operated to slowly withdraw the delivery device, thereby releasing the elastic stent of the axial flow blood pump. This causes the elastic stent to expand and adhere to the inner wall of the blood vessel, at which point the axial flow blood pump reaches the working state.

[0006] An installation groove is provided outside the perforation of the operating handle. The installation groove has an installation post for installing a sealing gasket and a positioning post. The sealing gasket has multiple installation holes arranged around its circumference, which match the installation posts of the operating handle. The sealing gasket has a small installation hole that corresponds to the positioning post. The outer wall of the sealing gasket has cuts on opposite sides, and a convex wall is formed between the two cuts. After the sealing gasket is installed on the operating handle, the convex wall corresponds to the cut groove on the outer wall of the installation groove. The bottom surface of the sealing gasket is pressed against the top surface of the inner wall of the installation groove. The pressure cap includes two identical semi-circular split structures with inverted concave sides and J-shaped latches at both ends, which facilitates the installation and fixation of the pressure cap on the J-shaped groove on the outer wall of the operating handle.

[0007] The locking cap includes a frustum tube and a cylindrical tube. The inner wall of the large end of the frustum tube is provided with an internal thread for engaging with the external thread of the gland.

[0008] The sealing gasket is made of silicone or polyurethane material, and has a cross or rice-shaped hole in the center.

[0009] The total length of the sheath ranges from 40 to 60 cm, the wall thickness ranges from 0.2 to 0.4 mm, and it is made of biocompatible material. The distal end of the sheath is chamfered, and the chamfer angle α ranges from 20° to 45°.

[0010] The mounting holes of the sealing gasket, which are arranged symmetrically around the circumference, can be circular or elliptical.

[0011] The outer wall of the cylindrical tube of the locking cap and the handle end of the axial flow blood pump are respectively provided with annular grooves, and the two annular grooves are of equal size.

[0012] The sterile sleeve is made of medical transparent flexible material.

[0013] The sterile sleeve is fixed to the handle end and the sheath assembly respectively by a silicone ring within the annular groove.

[0014] The elastic support of the axial flow blood pump retracts and is fixed inside the sheath, and the maximum implantation diameter of the axial flow blood pump is 0.2-0.3 mm smaller than the inner wall diameter of the sheath.

[0015] The beneficial effects of this utility model are as follows: The delivery device of this utility model can be implanted together with the axial flow blood pump with elastic support into the abdominal aorta, and the sealing gasket structure of the delivery device reduces the risk of blood leakage from the delivery device; in addition, the connection between the delivery device and the handle end of the axial flow blood pump is simple, which facilitates the control of the positioning, adjustment and withdrawal of the axial flow blood pump in the body. Attached Figure Description

[0016] To more clearly illustrate the embodiments of this utility model, the embodiments will be described below in conjunction with the accompanying drawings.

[0017] Figure 1 This is a schematic diagram of an axial flow blood pump implanted via a delivery device;

[0018] Figure 2 This is a schematic diagram of the conveying device;

[0019] Figure 3 This is a cross-sectional view of the conveying device;

[0020] Figure 4 This is a partial structural cross-sectional view of the sheath assembly in the conveying device;

[0021] Figure 5 This is an exploded view of the sheath assembly structure.

[0022] Figure 6 This is a schematic diagram of the operating handle in the sheath assembly;

[0023] Figure 7 This is a top view of the sealing gasket in the sheath assembly;

[0024] Figure 8 This is a schematic diagram of the pressure cap structure in the sheath assembly;

[0025] Figure 9 This is a schematic diagram of the structure at the distal end of the sheath in the conveying device;

[0026] Figure 10 This is a schematic diagram showing the connection position between the axial flow blood pump and the delivery device;

[0027] Figure 10a yes Figure 10 Enlarged cross-sectional view at point A in the middle.

[0028] Figure 10b yes Figure 10 Enlarged cross-sectional view at point B.

[0029] Figure 11 This is a schematic diagram of the elastic support of an axial flow blood pump in its contracted state within the sheath;

[0030] Figure 12 This is a schematic diagram of the locking cap structure;

[0031] Figure 13 This is a schematic diagram showing the connection between the locking cap and the sterile sleeve;

[0032] Figure 14 This is a schematic diagram of the structure of the delivery device releasing the axial flow blood pump. Detailed Implementation

[0033] The following examples illustrate possible implementations of the present invention, but are not intended to limit the scope of protection of the present invention.

[0034] The embodiments of this utility model will be described in detail below, as illustrated in the accompanying drawings. In the following description, when referring to the drawings, unless otherwise stated, the same numerals in different drawings denote the same or similar structures. In this utility model application, the terms "proximal" and "distal" are relative to the operator of the interventional axial flow blood pump; the direction closer to the operator is defined as "proximal," and the direction farther from the operator is defined as "distal."

[0035] This invention proposes a delivery device for implanting an interventional axial flow blood pump into the abdominal aorta, such as... Figure 1 As shown,

[0036] The delivery device 1 of this utility model embodiment is used to deliver the interventional axial flow blood pump 2. For example... Figure 2 As shown, the conveying device 1 includes a sheath tube 11, a sheath seat assembly 12, and a bypass extension tube assembly 13; wherein, one end of the sheath seat assembly 12 is connected to the sheath tube 11, and the side is connected to the bypass extension tube assembly 13. Combined with... Figure 3 As shown, the total length L of the sheath 11 ranges from 40 to 60 cm, with different lengths selected based on the patient's body size and implantation location; the wall thickness of the sheath 11 ranges from 0.2 to 0.4 mm. Since the sheath 11 is inserted percutaneously into the patient's body, it must be made of biocompatible materials such as Pebax, FEP, and PTFE. Furthermore, to ensure smooth delivery of the axial flow pump 2 within the delivery device 1, the inner wall of the sheath 11 needs to be smoothed. Figure 3 As shown, the bypass extension tube assembly 13 includes a Luer connector 131 and a drainage tube 132, which are bonded together with biocompatible adhesive. The Luer connector 131 can also be replaced by a standard three-way valve containing a Luer connector. The bypass extension tube assembly 13 is mainly used to inject anticoagulants or saline solution during implantation.

[0037] like Figure 4 , Figure 5As shown, the sheath assembly 12 includes an operating handle 121, a sealing gasket 122, and a pressure cap 123. The operating handle has a through hole in its center, forming a mounting groove 1210 outside the through hole. This mounting groove is located near the end of the operating handle, and its inner wall is lower than its outer wall. A sealing gasket is installed in this mounting groove and fixed by the pressure cap. The sheath is installed at the distal end of the through hole in the operating handle. The two wings of the operating handle 121 are arc-shaped and have symmetrical protrusions 1211, mainly to facilitate the operation of the push-pull conveying device. Simultaneously, a drainage hole 1212 is provided on one side of the operating handle 121, communicating with a drainage tube 132. The diameter of the drainage hole 1212 is set to 1.0-2.0 mm. The pressure cap 123 is connected to the operating handle 121 by pressing the sealing gasket 122. To ensure a tight fit between the sealing gasket 122 and the operating handle 121 without gaps or blood leakage, the thickness h1 of the sealing gasket 122 is 0.5-1.0 mm greater than the depth h2 of the mounting groove 1210 of the operating handle 121. Figure 6 and Figure 7 As shown, anti-slip textures 1213 are provided on both sides of the operating handle 121 to improve friction during operation. An mounting post 1214 and a positioning post 1215 are provided in the mounting groove of the operating handle 121, mainly for mounting the sealing gasket 122. The end face of the mounting post 1214 can be circular or elliptical, and they are arranged evenly and symmetrically around the circumference; the positioning post 1215 is used to determine the installation direction of the sealing gasket 122. Similarly, multiple mounting holes 1222 are symmetrically arranged around the circumference of the sealing gasket 122. The shape of the holes can be circular or elliptical, but they must correspond one-to-one with the shape of the mounting posts 1214 on the operating handle 121. A mounting hole 1221 is provided on one side of the sealing gasket 122, corresponding in size to the positioning post 1215, which can be used to distinguish the installation direction of the sealing gasket 122. In this embodiment of the invention, the heights of all mounting posts 1214 and positioning posts 1215 must be the same. The sealing gasket 122 is made of silicone or polyurethane material, with a cross or star-shaped hole 1223 in the center; alternatively, two sealing gaskets 122 of the same thickness can be used in combination. It should be noted that the thickness of both sealing gaskets 122 is h1 / 2. The outer walls of the sealing gasket 122 have cutouts, forming a convex wall 1220 between the two cutouts. After the sealing gasket is installed on the operating handle, the convex wall 1220 corresponds to the cutout on the outer wall of the mounting groove 1210. The sealing gasket presses against the top surface of the inner wall of the mounting groove. The pressure cap includes two identical semi-circular split structures with concave sides and J-shaped latches at both ends, facilitating the installation and fixation of the pressure cap onto the J-shaped groove on the outer wall of the operating handle.

[0038] like Figure 8As shown, the pressure cap 123 is manufactured by splitting it into two parts and is equipped with a "J"-shaped locking buckle 1233, which facilitates the installation and fixation of the pressure cap 123 onto the "J"-shaped groove 1216 of the sheath seat assembly 12. The pressure cap 123 is manufactured in two separate parts, which facilitates its installation on the sheath assembly 12, with a small gap 1232 formed between the two pressure cap parts. Figure 9 As shown, the distal end of the sheath 11 is chamfered, and the chamfer angle α is in the range of 20°-45°, which helps the axial flow blood pump 2 to be released and withdrawn in the body.

[0039] Combination Figure 8 , Figure 10 , Figure 10a and Figure 10b As shown, the pressure cap 123 of the sheath assembly 12 is connected to the locking cap 21 via threads 1231, and the locking cap 21 is connected to the handle end 23 of the axial flow blood pump via a sterile sleeve 22. The locking cap includes a frustum-shaped tube and a cylindrical tube. The inner wall of the larger end of the frustum-shaped tube has an internal thread for engaging with the threads of the pressure cap, and the outer wall of the cylindrical tube has an annular groove. In this embodiment, the axial flow blood pump 2 is inserted through the sealing gasket 122 of the sheath assembly 12 and placed inside the sheath tube 11, and positioned by the pressure cap 123. The axial flow blood pump 2 is then percutaneously implanted into the patient along with the delivery device 1. Figure 11 In this procedure, the axial flow blood pump 2 is placed inside the sheath 11, with its elastic stent 24 in a contracted state. The inner diameter of the sheath 11 depends primarily on the maximum implantation diameter of the axial flow blood pump 2; that is, the inner diameter of the sheath 11 must be 0.2-0.3 mm larger than the diameter of the axial flow blood pump to ensure that the axial flow blood pump 2 can be contracted and placed within the sheath 11. The distance L between the distal end of the elastic stent 24 and the distal outlet of the sheath 11 is 1-2 cm to ensure smooth implantation of the axial flow blood pump and to prevent premature release during implantation.

[0040] like Figure 12 As shown, the locking cap 21 has an internal thread 212 for engaging with the thread 1231 of the pressure cap 123, and an annular groove 211 at the other end. Additionally, the handle end 23 of the axial flow blood pump has an annular groove of the same size. Figure 10 and Figure 13 As shown, the two ends of the sterile sleeve 22 are connected to the handle end 23 and the locking cap 21 of the axial flow blood pump respectively by silicone rings 25, which are secured in an annular groove to form a whole. The sterile sleeve 22 is made of medical transparent flexible material, which can be stretched arbitrarily to change the distance between the handle end 23 of the axial flow blood pump and the sheath assembly 12 of the delivery device.

[0041] like Figure 14As shown, after the axial flow blood pump 2 is placed at the designated position in the patient's abdominal aorta, the delivery device 1 is slowly withdrawn along the proximal direction until the elastic stent 24 of the axial flow blood pump is released, so that the elastic stent 24 expands radially and fits against the inner wall of the blood vessel. At this time, the axial flow blood pump 2 reaches the working state.

Claims

1. A delivery device for implanting an interventional axial flow blood pump into the abdominal aorta, characterized in that: The device includes a sheath, a sheath seat assembly, and a bypass extension tube assembly. The sheath seat assembly includes an operating handle, a sealing gasket, and a pressure cap. The bypass extension tube assembly includes a Luer connector and a drainage tube. The operating handle has a perforation through which the distal end of the axial flow blood pump passes. A drainage hole communicating with the perforation is provided on one side of the operating handle, through which the drainage tube is installed. The sheath is installed at the distal end of the perforation on the operating handle. The sealing gasket is installed at the proximal end of the perforation. The pressure cap is connected to the proximal end of the operating handle by pressing the sealing gasket. The pressure cap is connected to the locking cap by threads. The locking cap is connected to the handle end of the axial flow blood pump through a sterile sleeve. The axial flow blood pump passes through the sheath seat assembly and is placed inside the sheath, and is positioned by the pressure cap.

2. The delivery device for implanting an interventional axial flow blood pump into the abdominal aorta as described in claim 1, characterized in that, An installation groove is provided outside the perforation of the operating handle. The installation groove has an installation post for installing a sealing gasket and a positioning post. The sealing gasket has multiple installation holes arranged around its circumference, which match the installation posts of the operating handle. The sealing gasket has a small installation hole that corresponds to the positioning post. The outer wall of the sealing gasket has cuts on opposite sides, and a convex wall is formed between the two cuts. After the sealing gasket is installed on the operating handle, the convex wall corresponds to the cut groove on the outer wall of the installation groove. The bottom surface of the sealing gasket is pressed against the top surface of the inner wall of the installation groove. The pressure cap includes two identical semi-circular split structures with inverted concave sides and J-shaped latches at both ends, which facilitates the installation and fixation of the pressure cap on the J-shaped groove on the outer wall of the operating handle.

3. A delivery device for implanting an interventional axial flow blood pump into the abdominal aorta as described in claim 2, characterized in that, The locking cap includes a frustum tube and a cylindrical tube. The inner wall of the large end of the frustum tube is provided with an internal thread for engaging with the external thread of the gland.

4. A delivery device for implanting an interventional axial flow blood pump into the abdominal aorta as described in claim 1, characterized in that, The sealing gasket is made of silicone or polyurethane material, and has a cross or rice-shaped hole in the center.

5. A delivery device for implanting an interventional axial flow blood pump into the abdominal aorta as described in claim 1, characterized in that, The total length of the sheath ranges from 40 to 60 cm, the wall thickness ranges from 0.2 to 0.4 mm, and it is made of biocompatible material. The distal end of the sheath is chamfered, and the chamfer angle α ranges from 20° to 45°.

6. A delivery device for implanting an interventional axial flow blood pump into the abdominal aorta as described in claim 2, characterized in that, The mounting holes of the sealing gasket, which are arranged symmetrically around the circumference, can be circular or elliptical.

7. A delivery device for implanting an interventional axial flow blood pump into the abdominal aorta as described in claim 1, characterized in that, The outer wall of the cylindrical tube of the locking cap and the handle end of the axial flow blood pump are respectively provided with annular grooves, and the two annular grooves are of equal size.

8. A delivery device for implanting an interventional axial flow blood pump into the abdominal aorta as described in claim 1 or 7, characterized in that, The sterile sleeve is made of medical transparent flexible material.

9. A delivery device for implanting an interventional axial flow blood pump into the abdominal aorta as described in claim 7, characterized in that, The sterile sleeve is fixed to the handle end and the sheath assembly respectively by a silicone ring within the annular groove.

10. A delivery device for implanting an interventional axial flow blood pump into the abdominal aorta as described in claim 1, characterized in that, The elastic support of the axial flow blood pump retracts and is fixed inside the sheath, and the maximum implantation diameter of the axial flow blood pump is 0.2-0.3 mm smaller than the inner wall diameter of the sheath.

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