Protective film and anti-collision assembly process for medical pump rotor using the same

Abstract

The present invention discloses a protective film and a collision-proof assembly process for a medical pump rotor using the protective film. The protective film is provided with a tubular membrane main body. The peripheral wall of the membrane main body is provided with at least two first-point break lines spaced axially. The ends of the first-point break lines extend to the upper and lower ends of the membrane main body, respectively, and separate the membrane main body into a plurality of main membrane parts. The tops of the plurality of main membrane parts all extend upward as a whole to form a plurality of handheld membrane parts. When the protective film is built into the inner tube, the plurality of handheld membrane parts protrude from the top of the inner tube, and then applying a pulling force to the plurality of handheld membrane parts can cause the membrane main body to break into a plurality of parts along the first-point break lines. The protective film of the present invention and the collision-proof assembly process for a medical pump rotor using the protective film can not only effectively prevent collisions between the rotor and the inner tube of the medical pump, but also are easy to assemble and remove.

Description

Technical Field

[0001] The present invention relates to the technical field of medical pumps, in particular to a protective film and an anti-collision assembly process for a medical pump rotor using the protective film. Background Art

[0002] Artificial heart assist devices, often referred to as "blood pumps," are considered the most important and promising treatment for many patients with advanced heart failure. The implanted blood pump's inlet is connected to the left ventricle at the apex of the heart, and its outlet is connected to the aorta via a graft. During operation, the blood pump's rotor drives the impeller, pumping blood from the left ventricle through the blood pump and graft to the aorta.

[0003] As a medical pump implanted in the body, a blood pump must meet extremely stringent quality requirements. During assembly, existing medical pumps can collide with the rotor and inner tube. This is especially true due to the magnetic forces between the inner magnetic core assembly within the rotor and the outer magnetic ring assembly outside the inner tube. Furthermore, collisions between the rotor and inner tube are also inevitable during transportation. These collisions can directly affect the surface roughness of the rotor and inner tube, leading to the formation of blood clots during blood flow and potentially causing complications. Therefore, preventing collisions between the rotor and inner tube is a pressing technical issue facing those skilled in the art. Summary of the Invention

[0004] In order to solve the above technical problems, the present invention provides a protective film and an anti-collision assembly process for a medical pump rotor using the protective film, which can not only effectively prevent the rotor and the inner tube of the medical pump from colliding, but also is easy to assemble and remove.

[0005] The technical solution adopted by the present invention to solve its technical problems is: a protective film, which is used to be placed in the inner tube of a medical pump to separate the inner tube from the rotor extending therein; the protective film is provided with a tubular membrane main body, and the peripheral wall of the membrane main body is provided with at least two first point break lines along the axial direction, and the two ends of the first point break lines respectively extend to the upper and lower ends of the membrane main body, and separate the membrane main body into a number of main diaphragm parts, and the tops of several main diaphragm parts are integrally extended upward to form a number of handheld diaphragm parts; when the protective film is built into the inner tube, several of the handheld diaphragm parts protrude from the top of the inner tube, and then applying tension to the several handheld diaphragm parts can cause the membrane main body to be broken into several parts along the first point break lines.

[0006] As a further improvement of the present invention, the protective film is further provided with an annular bottom film portion, the inner ring of the bottom film portion is integrally connected to the lower end of the film main body portion and the bottom film portion is vertically distributed to each other.

[0007] As a further improvement of the present invention, at least two second dotted lines are radially spaced apart on the bottom diaphragm portion, and both ends of the second dotted lines extend to the inner and outer circles of the bottom diaphragm portion respectively.

[0008] As a further improvement of the present invention, the first dotted lines are connected to the second dotted lines in a one-to-one correspondence.

[0009] As a further improvement of the present invention, a plurality of the handheld diaphragm parts are distributed in a ring-shaped manner, and an avoidance hole is formed between two adjacent handheld diaphragm parts. The avoidance hole is used for the pump inlet bracket above the inner tube to pass through.

[0010] As a further improvement of the present invention, the thickness of the protective film is 0.05-0.15 mm.

[0011] As a further improvement of the present invention, the protective film is made of biaxially oriented polypropylene film.

[0012] The present invention also provides a medical pump rotor anti-collision assembly process, which is implemented using the above-mentioned protective film and includes the following steps:

[0013] S1, inserting the protective film into the inner tube of the medical pump from bottom to top;

[0014] S2, allowing the plurality of handheld membrane portions on the top of the protective membrane to extend outward through the pump inlet bracket above the inner tube;

[0015] S3, inserting the rotor into the inner tube and placing it in the protective film;

[0016] S4, assemble the pump chamber housing and weld it to complete the assembly;

[0017] Before the medical pump is put into use, the handheld diaphragm portion is torn outward by hand, so that the protective film is broken along the first breaking line thereon and then drawn out from the inner tube.

[0018] As a further improvement of the present invention, the protective film is provided with a bottom diaphragm portion. In S1, the protective film penetrates into the inner tube until the bottom diaphragm portion abuts against the pump chamber cover fixed to the lower end of the inner tube.

[0019] As a further improvement of the present invention, the bottom film portion is provided with second break lines connected one-to-one with the first break lines, and the protective film can be broken along the first break lines and the second break lines during the tearing process.

[0020] The beneficial effects of the present invention are as follows: the present invention provides a protective film and an anti-collision assembly process for a medical pump rotor using the protective film, the protective film is provided with a membrane main body and a bottom membrane sheet portion, the protective film is installed in the inner tube of the medical pump, the inner wall of the inner tube is protected by the membrane main body portion, and the bottom surface of the pump chamber cover is protected by the bottom membrane sheet portion, thereby preventing collision between the rotor and the inner tube, the impeller and the pump chamber cover, and having a good impact resistance effect during the assembly of parts, effectively avoiding the situation in which the surface roughness increases due to the collision of parts and the formation of thrombus during the blood flow flushing process, and the assembly is convenient; at the same time, the protective film is also provided with a handheld membrane sheet portion extending out of the inner tube, and the membrane main body portion and the bottom membrane sheet portion are respectively provided with a first point break line and a second point break line. Before the medical pump is put into use, the handheld membrane sheet portion is torn outward by hand, so that the protective film is broken into several parts along the first point break line and the second point break line thereon, and then pulled out from the inner tube, which is very convenient to remove. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a three-dimensional diagram of the protective film of the present invention;

[0022] Figure 2 A bottom view of the protective film of the present invention;

[0023] Figure 3 A cross-sectional view of the protective film of the present invention assembled in a medical pump;

[0024] Figure 4 A perspective view of the assembly of the protective film, inner tube, outer tube and rotor of the present invention;

[0025] Figure 5 A bottom view of the assembly of the protective film, inner tube, rotor, impeller and pump chamber cover of the present invention;

[0026] Figure 6 This is a flowchart of the steps of the anti-collision assembly process for the medical pump rotor of the present invention.

[0027] The following description is made with reference to the accompanying drawings:

[0028] 1. Protective membrane; 101. Membrane body; 1011. Main diaphragm; 1012. Hand-held diaphragm; 1013. Avoidance hole; 102. First point break line; 103. Bottom diaphragm; 104. Second point break line; 2. Inner tube; 3. Rotor; 4. Pump inlet bracket; 5. Pump chamber housing; 6. Pump chamber cover; 7. Outer tube; 8. Impeller. DETAILED DESCRIPTION

[0029] A preferred embodiment of the present invention is described in detail below with reference to the accompanying drawings.

[0030] Example 1

[0031] See Figures 1 to 5The present invention provides a protective film for being placed in a medical pump to protect the surfaces of relevant parts in the medical pump from collision.

[0032] The medical pump in this embodiment comprises an inner tube 2, a rotor 3, a pump inlet bracket 4, a pump chamber housing 5, a pump chamber cover 6, an outer tube 7, and an impeller 8. The outer tube 7 is coaxially mounted on the outer side of the inner tube 2. An outer magnetic ring assembly and stator windings (not shown) are mounted between the inner and outer tubes 2 and 7. The pump inlet bracket 4 is seamlessly welded to the upper ends of the inner and outer tubes 2 and 7. It is equipped with three upwardly arched support claws, each with one end extending above the inner tube 2 and interconnected. This prevents negative pressure from sucking the ventricular septum during blood pump operation, potentially leading to pump failure or embolism.

[0033] Furthermore, the pump chamber cover 6 is seamlessly welded to the lower ends of the inner tube 2 and the outer tube 7; wherein, a hole is provided in the middle of the pump chamber cover 6 for the lower end of the inner tube 2 to pass through. The pump chamber housing 5 is seamlessly welded to the pump chamber cover 6 and, together with the pump chamber cover 6, forms a pump chamber for blood flow, which is connected to the inner tube 2. The rotor 3 and the impeller 8 are seamlessly welded together, with the rotor 3 extending into the inner tube 2 and the impeller 8 located within the pump chamber. The rotor 3 has an inner magnetic core group and rotor magnets (not shown in the figure). The inner magnetic core group is arranged opposite to the outer magnetic ring group, and the rotor magnets are arranged opposite to the stator winding.

[0034] See Figure 1 and Figure 2 The protective membrane 1 of the present invention is used to be placed in the inner tube 2 of a medical pump to separate the inner tube 2 from the rotor 3 extending therein. The protective membrane 1 is provided with a membrane body 101. The membrane body 101 is in the shape of a circular tube, and its outer diameter is adapted to the inner diameter of the inner tube 2, so that when the protective membrane 1 is placed in the inner tube 2, the membrane body 101 can fit on the inner wall of the inner tube 2. At least two first point break lines 102 are provided at intervals along the axial direction on the circumferential wall of the membrane body 101. Since there are three support claws on the pump inlet bracket 4, preferably, in this embodiment, three first point break lines 102 are provided, distributed at equal intervals in a circular pattern, and correspond one-to-one to the three support claws.

[0035] It is understandable that the number of first point break lines 102 may be adjusted accordingly according to different specifications and models of the medical pump.

[0036] The ends of the three first-point break lines 102 extend to the upper and lower ends of the membrane main body 101, respectively, and separate the membrane main body 101 into three main diaphragm sections 1011. The tops of the three main diaphragm sections 1011 extend upward to form three handheld diaphragm sections 1012. The three handheld diaphragm sections 1012 are arranged in a circular pattern, and a clearance hole 1013 is formed between each adjacent handheld diaphragm section 1012. The width of the clearance hole 1013 is greater than the width of the support claw on the pump inlet bracket 4, so as to allow the support claw on the pump inlet bracket 4 to pass through.

[0037] The avoidance hole 1013 extends from top to bottom to the upper end of the first point break line 102 .

[0038] Furthermore, the protective film 1 is also provided with an annular bottom diaphragm portion 103, the inner circle of the bottom diaphragm portion 103 is integrally connected to the lower end of the membrane main body 101 and is distributed vertically with each other. At least two second point breaks 104 are provided on the bottom diaphragm portion 103 along the radial interval. Preferably, in this embodiment, the second point breaks 104 are provided as three equally spaced ring-shaped lines, and correspond one-to-one with the three first point breaks 102. The two ends of each of the three second point breaks 104 extend to the inner and outer circles of the bottom diaphragm portion 103, respectively, and are connected one-to-one with the second point breaks 104. The connected first point breaks 102 and second point breaks 104 are located on the same vertical plane, dividing the entire protective film 1 into three equal parts.

[0039] See Figures 3 to 5 During the assembly of the medical pump, the main membrane portion 101 of the protective membrane 1 is inserted from bottom to top into the inner tube 2, and the three handheld membrane portions 1012 are extended upward from the gaps between the three support claws, so that all three handheld membrane portions 1012 protrude above the top of the inner tube 2 until the bottom membrane portion 103 rests on the bottom surface of the pump chamber cover 6. This completes the assembly of the protective membrane 1, and then the rotor 3 is assembled. After assembly, before debugging or using the medical pump, a tensile force is applied to the three handheld membrane portions 1012, causing the main membrane portion 101 to break along the first break line 102 and the bottom membrane portion 103 to break along the second break line 104. This tears the protective membrane 1 into three parts and allows them to be pulled out of the inner tube 2. Thus, the protective membrane 1 of the present invention not only protects the inner wall of the inner tube 2 and the bottom surface of the pump chamber cover 6, preventing collisions between the rotor 3 and the inner tube 2, and between the impeller 8 and the pump chamber cover 6, but also facilitates assembly and removal.

[0040] The protective film 1 is preferably made of BOPP film (Biaxially Oriented Polypropylene) with a thickness of 0.05-0.15 mm, preferably 0.1 mm, which can ensure sufficient high tensile strength, impact strength, rigidity, toughness and good transparency, and can provide good impact resistance during the assembly of parts, thereby effectively avoiding the formation of blood clots during blood flow due to increased surface roughness caused by collision of parts.

[0041] In addition, the use of other material films with basically the same characteristics as BOPP films should also be allowed.

[0042] Example 2

[0043] See Figures 1 to 6 The present invention also provides a medical pump rotor anti-collision assembly process, which is implemented using the above-mentioned protective film 1 and medical pump, including steps S1 to S4.

[0044] S1 , insert the protective film 1 into the inner tube 2 of the medical pump from bottom to top until the bottom diaphragm portion 103 on the protective film 1 abuts against the bottom surface of the pump chamber cover 6 .

[0045] The inner tube 2, pump inlet bracket 4, pump chamber cover 6, and outer tube 7 are pre-assembled into a single unit according to conventional assembly techniques. The protective membrane 1 has three first break lines 102 defined on its main membrane portion 101, and three second break lines 104 defined on its bottom membrane portion 103, corresponding one-to-one with the three first break lines 102.

[0046] S2, during the process of assembling the protective film 1 in S1, the three handheld film parts 1012 on the top of the protective film 1 are respectively extended outward through the gaps between the three supporting claws of the pump inlet bracket 4 above the inner tube 2.

[0047] S3 , insert the rotor 3 into the inner tube 2 and place it inside the protective film 1 .

[0048] The rotor 3 and the impeller 8 are connected together in advance by a seamless welding process, and the rotor 3 is inserted into the inner tube 2 until the impeller 8 rests on the bottom diaphragm portion 103 .

[0049] S4, assemble the pump chamber housing 5, and seamlessly weld the pump chamber housing 5 to the pump chamber cover 6 to complete the assembly.

[0050] Before the medical pump is put into use, the handheld diaphragm portion 1012 is torn outwards by hand. During the tearing process, the protective film 1 is broken into three parts along the first break line 102 and the second break line 104 thereon, and then pulled out from the inner tube 2.

[0051] Thus, it can be seen that the present invention adopts the method of installing the protective film 1 into the inner tube 2 of the medical pump, protecting the inner wall of the inner tube 2 by the membrane main body 101, and protecting the bottom surface of the pump chamber cover 6 by the bottom diaphragm part 103, thereby preventing the rotor 3 from colliding with the inner tube 2, and the impeller 8 from colliding with the pump chamber cover 6. It can play a good impact resistance effect during the assembly of parts, effectively avoiding the situation where the surface roughness increases due to the collision of parts and then the formation of thrombus during the blood flow flushing process, and the assembly is convenient; at the same time, the protective film 1 is also provided with a handheld diaphragm part 1012 extending out of the inner tube, and the membrane main body 101 and the bottom diaphragm part 103 are respectively provided with a first point break line 102 and a second point break line 104. Before the medical pump is put into use, the handheld diaphragm part 1012 is torn outward by hand, so that the protective film 1 is broken into three parts along the first point break line 102 and the second point break line 104 thereon, and then pulled out from the inner tube 2, which is very convenient to remove.

[0052] In the above description, many specific details are set forth in order to fully understand the present invention. However, the above description is only a preferred embodiment of the present invention. The present invention can be implemented in many other ways different from those described herein, so the present invention is not limited to the specific implementation disclosed above. At the same time, any person skilled in the art can make many possible changes and modifications to the technical solution of the present invention using the methods and technical contents disclosed above without departing from the scope of the technical solution of the present invention, or modify it into an equivalent embodiment of equivalent changes. Any simple modification, equivalent change and modification made to the above embodiment based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still falls within the scope of protection of the technical solution of the present invention.

Claims

1. A protective film for placement in an inner tube (2) of a medical pump to separate the inner tube (2) from a rotor (3) extending therein; characterized in that: The protective film (1) is provided with a tubular membrane main body (101), and the peripheral wall of the membrane main body (101) is provided with at least two first point break lines (102) at intervals along the axial direction, and the two ends of the first point break lines (102) respectively extend to the upper and lower ends of the membrane main body (101), and divide the membrane main body (101) into a plurality of main membrane sheet parts (1011), and the tops of the plurality of main membrane sheet parts (1011) are integrally extended upward to form a plurality of handheld membrane sheet parts (1012); when the protective film (1) is built into the inner tube (2), the plurality of handheld membrane sheet parts (1012) are protruding from the top of the inner tube (2), and then applying a pulling force on the plurality of handheld membrane sheet parts (1012) can make the membrane main body (101) break along the first point break lines (102). The protective film (1) is further provided with an annular bottom diaphragm portion (103), the inner ring of the bottom diaphragm portion (103) is integrally connected to the lower end of the membrane main body portion (101) and is vertically distributed to each other; at least two second dotted lines (104) are radially spaced apart on the bottom diaphragm portion (103), the two ends of the second dotted lines (104) respectively extend to the inner and outer rings of the bottom diaphragm portion (103), and the first dotted lines (102) and the second dotted lines (104) are connected in a one-to-one correspondence; a plurality of the handheld diaphragm portions (1012) are distributed in an annular manner, and a avoidance hole (1013) is formed between two adjacent handheld diaphragm portions (1012), and the avoidance hole (1013) is used for allowing the pump inlet bracket (4) above the inner tube (2) to pass through.

2. The protective film according to claim 1, wherein: The thickness of the protective film (1) is 0.05-0.15 mm.

3. The protective film according to claim 1, wherein: The protective film (1) is made of biaxially oriented polypropylene film.

4. A medical pump rotor anti-collision assembly process, characterized in that: The method is realized by using the protective film (1) as claimed in any one of claims 1 to 3, comprising the following steps: S1, inserting the protective film (1) into the inner tube (2) of the medical pump from bottom to top; S2, allowing the plurality of handheld membrane portions (1012) on the top of the protective membrane (1) to extend outward through the pump inlet bracket (4) above the inner tube (2); S3, inserting the rotor (3) into the inner tube (2) and placing it inside the protective film (1); S4, assemble the pump chamber housing (5) and weld it to complete the assembly; Before the medical pump is put into use, the handheld diaphragm portion (1012) is held and torn outwards, so that the protective film (1) is broken along the first breaking line (102) thereon, and then pulled out from the inner tube (2).

5. The anti-collision assembly process for a medical pump rotor according to claim 4, characterized in that: The protective film (1) is provided with a bottom diaphragm portion (103). In S1, the protective film (1) is inserted into the inner tube (2) until the bottom diaphragm portion (103) abuts against the pump chamber cover (6) fixed to the lower end of the inner tube (2).

6. The anti-collision assembly process for a medical pump rotor according to claim 5, characterized in that: The bottom film portion (103) is provided with a second break line (104) connected one-to-one with the first break line (102), and the protective film (1) can be broken along the first break line (102) and the second break line (104) during the tearing process.

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