Packaging device for a catheter pump

Abstract

Disclosed is a packaging device for a catheter pump, comprising a blister box with a substantially flat box bottom surface, a first boss arranged in the blister box. The upper end of the first boss is concave downward to form a first groove for embedding a cannula, the depth of the first groove gradually decreases in the direction from the proximal end to the distal end. When the catheter pump is in a packaged state with the cannula embedded in the first groove, the proximal straight section of the cannula and the distal section of the catheter are coaxial and substantially parallel to the box bottom surface, and the distal straight section of the cannula is obliquely tilted upward.

Description

Technical Field

[0001] This utility model belongs to the field of medical devices, specifically relating to a packaging device for a catheter pump. Background Technology

[0002] US20240366914A1 discloses a method for setting a catheter assembly to a desired anatomical shape during a heat cycling (sterilization) process using a packaging device. Because the catheter is sensitive to heat cycling, the cycling causes the catheter material to loosen. Once the heat cycling is complete, the catheter is set to a new stationary shape at a lower temperature. To ensure that the new stationary shape set by the heat-cycled catheter matches the patient's anatomy, a protrusion for placing a cannula is provided within the packaging device housing. The protrusion has a recessed groove at its tip for inserting the curved portion of the cannula. Before heat cycling, the catheter assembly is placed within the packaging device housing with the catheter curved and coiled around the plane of the packaging device tray (i.e., the longitudinal axis of the catheter is formed as a curve within a second plane). The curved portion of the cannula is inserted into the groove of the protrusion, and then rotated so that the distal portion of the cannula lies within a first plane offset at approximately 92° from the second plane. This offset angle between the two planes is equal to the angle between the plane defined by the aortic arch and the plane defined by the ascending aorta and the apex of the heart. In this way, the offset angle places the distal portion of the cannula in a different plane from the proximal portion of the catheter and deflects the cannula toward the apex, keeping the distal portion of the cannula away from the chordae tendineae of the mitral valve, thereby reducing the risk of the pump assembly being stuck, aspirated, and ingested by biomaterials after being delivered to the left ventricle.

[0003] Compared to the tray portion for placing the sleeve in existing technology (see its appendix) Figure 1 The structure of 116 in the figure is flat. The core of this design is to set a protrusion with a top groove inside the packaging device box to lift the sleeve away from or above the tray plane. This will increase the height of the packaging device box and make the structure more complex than the prior art. Furthermore, when placing the catheter assembly into the packaging device box, it is necessary to rotate it to position the sleeve in a twisted position (see Figure 7). However, before the heat cycle, the catheter assembly has not adapted to this curved configuration, and its stress release will cause the sleeve to tend to disengage from the groove, making the positioning operation of the catheter assembly in the packaging device box more cumbersome. In addition, after placement and heat setting, the bending direction of the insertion tube is opposite to the bending direction of the distal transition section of the catheter (see Figure 7). Figure 3 This design may be intended to give the catheter sufficient resilience to allow for proper positioning of the pump assembly within the patient's left ventricle after the catheter assembly has been inserted. However, this design violates the anatomy of the heart and aorta; the greater resilience of the catheter would cause the cannula to exert greater force on the aortic valve, potentially leading to aortic valve damage. Utility Model Content

[0004] In view of this, the present invention provides a packaging device for a catheter pump, which uses a simpler packaging device to place the catheter pump, reduces the difficulty of positioning the catheter pump, and heat-sets it into a static shape that adapts to the anatomical structure of the heart.

[0005] To address the aforementioned issues, the following solution is provided: The cannula of the catheter pump includes a distal straight section and a proximal straight section connected to the distal end of the catheter. The packaging device includes a blister pack with a substantially flat bottom surface and a first boss disposed within the blister pack. The upper end of the first boss is recessed downward to form a first groove for inserting the cannula, and the depth of the first groove gradually decreases along the direction from the proximal end to the distal end. When the catheter pump is in the packaged state where the cannula is inserted into the first groove, the proximal straight section of the cannula and the distal section of the catheter are coaxial and substantially parallel to the bottom surface of the pack, while the distal straight section of the cannula tilts upward at an angle. Attached Figure Description

[0006] Figure 1 This is a schematic diagram of a catheter pump being inserted into the left ventricle.

[0007] Figure 2 and Figure 3 A three-dimensional view of the packaging device;

[0008] Figure 4 An exploded view of the packaging assembly;

[0009] Figure 5 This is an exploded view of the cover plate and the vacuum forming plate. Detailed Implementation

[0010] The terms "first," "second," etc., are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. The directional terms "upper," "lower," "top," and "bottom" refer to the direction shown in the attached diagram or to the vertical, perpendicular, or gravitational direction of the components themselves. "Inner" and "outer" refer to the inside and outside of the contours of each component itself. "Near" and "far" refer to the location relative to the physician operating the catheter pump. "Near" refers to the part relatively close to the physician, and "far" refers to the part relatively far from the physician, for example, when the catheter is located at the proximal end of the pump assembly. It should be understood that these directional terms are defined for ease of description and are not restrictive or absolute.

[0011] like Figure 1As shown, the catheter pump 900 includes a pump assembly 910 and a catheter 920. The pump assembly 910 includes a motor 913 connected to the distal end of the catheter 920, a bleeding window 914 connected to the distal end of the motor 913, an insertion cannula 911 connected to the distal end of the bleeding window 914, an inlet window 915 connected to the distal end of the insertion cannula 911, and a flexible member 912 connected to the distal end of the inlet window 915. The bleeding window 914 contains an impeller (not shown) connected to the motor 913. The bleeding window 914 and the inlet window 915 each have a bleeding port and an inlet port, respectively. The pump assembly 910 can pass through the aortic valve AV to enter the left ventricle LV, with the insertion cannula 911 traversing the aortic valve AV, the inlet window 915 located in the left ventricle LV, and the bleeding window 914 located in the aorta AO. The impeller is driven to rotate by the motor 913, pumping blood from the inlet window 915 to the bleeding window 914, thus achieving the function of assisting the heart's pumping function. The cannula 911 includes a proximal straight section 9111, a distal straight section 9112, and a curved section 9113 connecting the proximal straight section 9111 and the distal straight section 9112. The proximal straight section 9111 is connected to the distal end of the bleeding window 914, the distal straight section 9112 is connected to the proximal end of the blood inlet window 915, and the curved section 9113 forms an angle of approximately 135° to 155° between the proximal straight section 9111 and the distal straight section 9112.

[0012] like Figures 2 to 5 As shown, the packaging device includes a blister pack 100 for housing the tubing pump 900. The blister pack 100 has a first boss 210, the upper end of which is recessed downwards to form a first groove 211 for inserting the cannula 911. The depth of the first groove 211 gradually decreases in the direction from proximal to distal. When the tubing pump 900 is in the packaged state where the cannula 911 is inserted into the first groove 211, the proximal straight section 9111 of the cannula 911 and the distal section 921 of the tubing 920 are coaxial and approximately parallel to the substantially flat bottom surface of the blister pack 100, while the distal straight section 9112 tilts upwards at an angle. "Approximately" can be understood as close to, approximately, or within a predetermined range from a target value. The proximal straight section 9111 and the distal section 921 are approximately parallel to the bottom surface of the blister box 100. The angle between the proximal straight section 9111 and the distal section 921 and the bottom surface of the blister box 100 is between 0 and 5°, and further between 0 and 2°.

[0013] Therefore, in the packaged state, the proximal straight section 9111 and the distal section 921 are axially aligned without any angular offset, eliminating any bends between them. This prevents stress release caused by bending at the connection between the catheter 920 and the cannula 911, which could make it difficult for the pump assembly 910 to be positioned within the blister pack 100. The distal straight section 9112 of the cannula 911 is tilted upwards. During heat cycling, the sterilization temperature heat-sets the cannula 911, shaping it into a static shape that conforms to the anatomy of the heart. This allows the pump assembly 910 to maintain optimal positioning within the ventricle during operation (primarily meaning the flexible pigtail tube 912 points towards the apex of the heart, and the blood inlet window 915 is centrally located within the left ventricle (LV) and against the ventricular wall). Furthermore, the pump assembly 900 is placed flat, minimizing the vertical space occupied by the cannula 911, reducing the height of the blister pack 100 and simplifying its structure.

[0014] like Figure 5 As shown, the first groove 211 includes a proximal portion 2111 into which the proximal straight flat section 9111 is inserted, a distal portion 2112 into which the distal straight flat section 9112 is inserted, and a curved portion 2113 into which the curved section 9113 is inserted. The proximal portion 2111 has a uniform depth, which gradually decreases from the curved portion 2113 to the distal portion 2112. The uniform depth of the proximal portion 2111 defines a flat placement of the proximal straight flat section 9111 and a non-kinked connection with the distal section 921, while the gradually decreasing depth of the curved portion 2113 and the distal portion 2112 defines a gradually upward-curving placement of the distal straight section 9112.

[0015] like Figure 3 As shown, a hinged opening and closing fixing component 330 is detachably installed inside the blister box 100. The specific structure can be found in Figure 11 of US20240366914A1. The fixing component 330 is located on the second surface 112, near the third protrusion 230, and is used to clamp and fix the distal section 921 of the catheter 920, preventing undesirable movement of the distal section 921 that would affect its kinked placement relative to the proximal straight section 9111 of the cannula 911.

[0016] The blister pack 100 also includes a second boss 220 and a third boss 230 located at the distal and proximal ends of the first boss 210, respectively. The height of the second boss 220 is greater than the height of the first boss 210. When the tubing pump 900 is in the packaged state, the flexible member 912 is supported on the second boss 220. Supporting the flexible member 912 helps maintain its original shape during thermal cycling, preventing it from changing shape due to the combined effects of gravity and heat caused by being suspended. The upper end of the third boss 230 is recessed downward to form a second groove 231 for the distal section 921 of the tubing 920 to be inserted. The second groove 231 is on the same straight line as the proximal portion 2111 of the first groove 211, and their depths are approximately the same. The second groove 231 limits the distal section 921 of the tubing 920, allowing it to stably maintain a straight state without kinking connection with the proximal straight section 9111.

[0017] The cannula 911 is equipped with a proximal sensor and a distal sensor (both not shown) at its proximal and distal ends, respectively. The proximal and distal sensors can be specifically located on the bleeding window 914 and the blood inlet window 915, respectively. The second protrusion 220 and the third protrusion 230 are located on either side of the first protrusion 210 and are spaced apart from it. When the catheter pump 900 is in its packaged state, the proximal sensor is located between the third protrusion 230 and the first protrusion 210, and the distal sensor is located between the second protrusion 220 and the first protrusion 210, forming an overhead design to prevent sensor damage.

[0018] like Figure 4 and Figure 5 As shown, three protrusions 210, 220, and 230 are formed on the blister panel 200, which is detachably housed within the blister box 100. Specifically, the bottom surface of the blister box 100 has a protrusion 150, and the bottom surface of the blister panel 200 has a snap-fit ​​groove 151; the two work together to allow the blister panel 200 to be detachable. The design of the protrusions 210, 220, and 230 forming on the blister panel 200 provides double protection for the insertion tube 911 from below. Furthermore, the three protrusions 210, 220, and 230 are formed together on the blister panel 200 through a simple process, and then the blister panel 200 is uniformly installed into the blister box 100, offering advantages such as simple manufacturing and convenient assembly. Figures 3 to 5 As shown, a cover plate 310 is detachably connected to the top of the blister pack 200, which limits the insertion tube 911 from above and clamps and fixes the insertion tube 911 between the two. The detachable arrangement of the cover plate 310 and the blister pack 200 can be referred to the implementation of the blister pack 200 and the blister box 100, and will not be described in detail here.

[0019] like Figure 2 and Figure 4As shown, the edge of the blister pack 100 (the right edge as shown) has a raised portion 110 for holding the intermediate section 922 of the catheter 920. The raised portion 110 is located proximal to the first boss 210 and further proximal to the third boss 230. Both the raised portion 110 and the first groove 211 are curved toward the interior of the blister pack 100. Since the intermediate section 922 of the catheter 920 is approximately located at the aortic arch when the catheter pump 900 is in operation, the raised portion 110 and the first groove 211 are curved inward in the same direction, so that the intermediate section 922 of the catheter 920 after heat cycling has the same curvature as the cannula 911. In this way, the correct positioning of the pump assembly 910 in the left ventricle (LV) is maintained by the directional curvature of the static shapes of both the cannula 911 and the catheter 920, thereby avoiding aspiration events caused by poor positioning of the pump assembly 910.

[0020] like Figure 4As shown, the raised portion 110 is roughly U-shaped, including a first surface 111 that protrudes above the bottom surface of the blister pack 100, a second surface 112 connecting the two ends of the first surface 111 to the bottom surface of the pack, and a third surface 113. The second surface 112 and the third surface 113 are slopes that gradually decrease in height in the direction away from the first surface 111. The second surface 112 and the third protrusion 230 are located on the same side of the blister pack 100, and the third surface 113 is located on the opposite side of the second surface 112. As described above, the middle section 922 of the catheter 920 is roughly located in the aortic arch when the catheter pump 900 is working, and the aortic arch connects the ascending aorta and the descending aorta, having a tortuous and complex spatial shape (specifically, the ascending aorta and the descending aorta are located in different planes). Therefore, the structural design of the first surface 111, which protrudes above the second and third surfaces 112 and 113 on both sides, is used for heat-forming the middle section 922 of the catheter 920, so that the middle section 922 conforms to the anatomical structure of the aortic arch. The raised portion 110, with its roughly U-shaped curvature, is used to achieve a static shape for the middle section 922 of the catheter 920 that matches the curvature of the aortic arch through heat forming. The gradually decreasing second and third surfaces 112 and 113 are used to bend the middle section 922 of the catheter 920 in different planes through heat forming to match the anatomical shapes of the ascending and descending aorta in different planes. This allows the middle section 922 of the catheter 920 to be positioned in the aortic arch with minimal stress during the operation of the catheter pump 900, which brings numerous benefits. For example, a small-angle bend in the aortic arch can cause severe bending of the catheter 920 and its internal wiring (including the cleaning fluid tubing, motor wires, and optical fibers). However, the low-stress positioning of the catheter 920 within the aortic arch after heat setting prevents kinking of the catheter 920 and its internal wiring, ensuring that the pump assembly 910 is supplied with cleaning fluid, electrical energy, and other substances necessary for its normal operation and for transmitting test signals. Furthermore, the low-stress positioning of the catheter 920 reduces the force exerted on the aortic valve AV due to rebound, thereby reducing damage to the aortic valve AV.

[0021] The inner edge of the first surface 111 is provided with a limiting protrusion 114 to restrict the middle section 922 of the conduit 920 onto the raised portion 222, ensuring that the middle section 922 can be heat-set to the desired static shape. Furthermore, the limiting protrusion 114 forms a corresponding groove at the bottom of the raised portion 110, which can serve as a handle for easy gripping by the user. Figure 3 As shown, a cover plate 320 is detachably provided on the raised portion 110. The opening end of the blister box 100 is provided with multiple buckles 120 that cooperate with the cover plate 320 to engage with the edge of the cover plate 320. This is used to limit the middle section 922 of the conduit 920 from above and press and fix the middle section 922 of the conduit 920 onto the raised portion 110.

[0022] like Figure 2 and Figure 4 As shown, the proximal section 923 of the conduit 920 is equipped with an accessory 930, including: an operating handle located at the proximal end of the conduit 920, and a cable connector (for connection to a control host) located near the operating handle. The cable connector is connected to the operating handle via a cable. The blister pack 100 has fourth protrusions 130 and 160 located inside the U-shaped protrusion 110. The fourth protrusions 130 and 160 are used for winding the proximal section 923 of the conduit 920 and the cable, and have a receiving groove at their upper end for receiving the accessory 930. For example, the receiving groove at the upper end of the fourth protrusion 130 is used to receive the cable connector, and the receiving groove at the upper end of the fourth protrusion 160 is used to receive the operating handle. The blister pack 100 also has an empty protrusion 170 located inside the U-shaped protrusion 110, which cooperates with the fourth protrusions 130 and 160 for winding the proximal section of the conduit 920 and the cable, and also supports the cover plate 320. The cover plate 320 extends from the raised portion 110 toward the interior of the blister box 100, and the fourth boss 160 and the empty boss 170 are located within the projection of the cover plate 320. This limits the conduit 920 and cable that are coiled around the fourth boss 160 and the empty boss 170.

[0023] The upper opening of the blister pack 100 is covered with a Tyvek lid 400, which is heat-sealed to the blister pack 100 after the tubing pump 900 is placed inside. Subsequently, during heat circulation, sterilizing gas passes through the lid 400 into the blister pack 100 to sterilize the tubing pump 900. After heat circulation is complete, the lid 400 maintains a sealed state inside the blister pack 100.

[0024] like Figure 3 and Figure 5 As shown, the bottom surface of the blister box 100 has an upward-protruding heat-sealing area 140 that mates with the cover layer 400, thereby increasing the heat-sealing area between the cover layer 400 and the blister box 100 and improving the connection reliability between the cover layer 400 and the blister box 100. The heat-sealing area 140 extends along the long side contour of the blister board 200. Specifically, the upper right region of the blister board 200 has a notch 240, and one end of the heat-sealing area 140 that mates with the notch 240 is formed with an "L"-shaped hook 141. The heat-sealing area 140 not only defines the installation position of the blister board 200 within the blister box 100, but also restricts the degree of freedom of the blister board 200 on the bottom surface of the box, facilitating the installation of the blister board 200.

[0025] The above embodiments are merely preferred embodiments of this utility model, and not all embodiments. Therefore, those skilled in the art can make other variations or modifications without creative effort, and all such variations should fall within the scope of protection of this utility model.

Claims

1. A packaging device for a catheter pump, the catheter pump cannula comprising a distal straight section and a proximal straight section connected to the distal end of the catheter; characterized in that, The packaging device includes: Blister boxes have a basically flat bottom surface; The first protrusion is located inside the blister pack, with its upper end recessed downward to form a first groove for inserting the cannula. The depth of the first groove gradually decreases in the direction from the proximal end to the distal end. When the catheter pump is in the packaged state with the cannula inserted in the first groove, the proximal straight section of the cannula and the distal section of the cannula are coaxial and approximately parallel to the bottom surface of the pack, and the distal straight section of the cannula tilts upward at an angle.

2. The packaging apparatus as described in claim 1, characterized in that, The cannula also includes a curved section connecting the proximal straight section and the distal straight section; the first groove includes a proximal portion for embedding the proximal straight section, a distal portion for embedding the distal straight section, and a curved portion for embedding the curved section; the proximal portion of the first groove has a uniform depth, and the depth gradually decreases from the curved portion to the distal portion.

3. The packaging apparatus as described in claim 1, characterized in that, The distal end of the cannula is provided with a flexible component; the blister pack also has a second protrusion located at the distal end of the first protrusion, the height of the second protrusion being greater than the height of the first protrusion; when the cannula pump is in the packaged state, the flexible component is supported on the second protrusion.

4. The packaging apparatus as described in claim 3, characterized in that, The blister pack also has a third protrusion located near the first protrusion. The third protrusion has a second groove for embedding the distal section of the conduit. The proximal portions of the second groove and the first groove are on the same straight line, and the depth of the second groove is the same as the depth of the first groove.

5. The packaging apparatus as described in claim 4, characterized in that, The proximal end of the cannula is equipped with a proximal sensor, and the distal end is equipped with a distal sensor. When the cannula pump is in the packaged state, the proximal sensor is located between the third protrusion and the first protrusion, and the distal sensor is located between the second protrusion and the first protrusion.

6. The packaging apparatus as claimed in claim 4, characterized in that, The blister box is detachably equipped with a blister board, and a first protrusion, a second protrusion and a third protrusion are formed on the blister board. A cover plate is detachably provided on the blister board.

7. The packaging apparatus as claimed in claim 1, characterized in that, The blister pack also has raised sections distributed along its edge. The raised sections are located near the end of the first protrusion and are used to support the middle section of the conduit. Both the raised sections and the first groove are curved toward the inside of the blister pack.

8. The packaging apparatus as claimed in claim 7, characterized in that, The raised part is roughly "U" shaped, including a first surface that is higher than the bottom surface of the box, a second surface and a third surface that connect the two ends of the first surface to the bottom surface of the box; the second surface and the third surface are slopes that gradually decrease in height in the direction away from the first surface, the second surface and the third protrusion are located on the same side of the blister box, and the third surface is located on the opposite side of the second surface.

9. The packaging apparatus as claimed in claim 7, characterized in that, A limiting protrusion is provided on the inner edge of the first surface to restrict the middle section of the catheter to the raised part.

10. The packaging apparatus as claimed in claim 7, characterized in that, The proximal section of the catheter is equipped with accessories; the blister pack has a fourth protrusion located inside the raised part for the proximal section of the catheter to be wound around, and the upper end of the fourth protrusion has a receiving groove for storing accessories.

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