Manufacturing process of a safe biopsy needle

Abstract

The present invention discloses a manufacturing process for a safety biopsy needle. A glass capillary is passed through a heating platinum sheet frame and fixed on the left and right needle pulling arms of a needle pulling instrument. Two needle blanks with the same shape are drawn out using the following parameters; needle pulling parameters: according to different specifications of raw glass capillaries (RAMP650-690), the data is selected and determined within the parameter range of reference Figure 2; a needle calcining instrument is used to set a U-shaped heating platinum wire and a negative pressure pump to draw negative pressure to make an oblate narrow part on the needle tip of the needle blank. This design can ensure that the embryonic tissue collected during the biopsy stays in the narrow part without causing tissue loss due to improper pressure control in the tube. The oblate narrow part of the present invention has the same function of blocking tissue as the circular narrow part of the existing manufacturing process, but the absolute value of the cross-sectional area is larger, the liquid (non-tissue) passes more smoothly, and the biopsy tissue is more effectively sucked into and discharged from the biopsy needle.

Description

Technical Field

[0001] The present invention relates to the field of embryo biopsy needles, in particular to a manufacturing process of a safety biopsy needle. Background Art

[0002] Currently commonly used biopsy tubes, whether for polar body biopsy, cleavage-stage embryo biopsy, or blastocyst biopsy, are all cylindrical hollow structures with different inner diameters, and the opening can be flat or oblique.

[0003] A biopsy needle is an instrument used to collect tissue from living animals. An embryo biopsy needle is a device specifically used to collect partial cells from in vitro cultured embryos. It is used in preimplantation genetic testing (PGT) in human assisted reproductive technology to biopsy polar bodies, blastomere cells, or blastocyst trophoblast cells. Blastocyst trophoblast cell biopsy is currently the mainstream technology. Most biopsy tubes of biopsy needles are cylindrical hollow structures with different inner diameters.

[0004] Publication (Announcement) No. CN214965967U discloses an embryo biopsy tube comprising a tube body, a suction port at one end of the tube body, and a negative pressure air source connected to the other end of the tube body. The tube body is characterized by a narrowed portion within the lumen of the tube body, located adjacent to the suction port. With this structure, cells drawn into the lumen are blocked by the narrowed portion, significantly reducing the probability of sample loss compared to existing biopsy tubes.

[0005] The existing manufacturing process uses a circular shape for the narrow part of the biopsy needle body. The cross-sectional area of ​​the narrow part is sharply smaller than the area of ​​the upstream lumen. Although it can block tissue, it also limits the amount of liquid that can pass through. The oblate narrow part has the same tissue-blocking function as the circular narrow part, but the absolute value of the cross-sectional area is larger, and the liquid (non-tissue) passes through more smoothly. When the biopsy tissue is sucked into the needle mouth to reach the narrow part and the sample is discharged from the biopsy needle, the pressure (negative pressure / positive pressure) generated is large and rapid, which speeds up the biopsy operation. Summary of the Invention

[0006] Therefore, in order to solve the above-mentioned shortcomings, the present invention provides a manufacturing process for a safe biopsy needle.

[0007] The present invention is realized by constructing a manufacturing process of a safe biopsy needle, characterized in that: a glass capillary is passed through a heating platinum sheet frame and then fixed horizontally on the left and right needle pulling arms of a needle pulling instrument, using the following parameters ( Figure 2 ) Two needle blanks with the same shape are drawn out.

[0008] Preferably, a needle blank is fixed horizontally on the needle holder of the needle calcining instrument, the temperature of the needle calcining instrument is set to 40-50 units, the needle holder is moved to bring the needle tip close to and 10-20 μm away from the glass heating ball, and after heating is started, the needle tip end is observed to be closed.

[0009] Preferably, after the needle tip is sealed, the needle holder rod (with the needle blank installed) is turned to a vertical position, the needle tip is downward and passed through the center of the U-shaped heating platinum wire (the distance between the two arms of the U-shaped platinum wire is 1.5-2.0mm), and the narrow part to be made is located according to the design position of the narrow part under the eyepiece ruler. This position is equidistant from the front and rear arms of the U-shaped platinum wire; the tail end of the needle blank is connected to the foot-controlled negative pressure pump through a silicone tube, and the temperature of the needle calcining instrument is set to 45-60 units. The needle calcining instrument is heated and the negative pressure pump is started at the same time. The front and rear diameters of the glass tube of the narrow part set by the needle blank gradually become smaller under negative pressure, and the left and right diameters become larger, gradually becoming oblate; the deformation process is observed under the eyepiece, and the needle holder rod is rotated to observe only the short diameter of the oblate part. When the short diameter reaches 5-12μm, heating and negative pressure are stopped to complete the production of the narrow part.

[0010] Preferably, after the narrow part is made, the needle rod (with the needle blank) is turned to a horizontal position with the needle tip facing to the right. The broken needle position is located according to the designed needle tip diameter. The broken needle position is placed directly above the glass heating ball. The temperature of the needle forging instrument is set to 35-45 units. After starting heating, the needle rod is quickly moved down in parallel. When the set breaking point of the needle blank lightly touches the heated glass ball, the heating is stopped and the needle blank will break at the set breaking point.

[0011] Preferably, after the needle is broken, the needle rod is equipped with the needle blank and kept in a horizontal position, and is moved vertically downward to the position where the needle tip is aligned with the left side of the heated glass ball. The temperature of the needle calcining instrument is set to 40-60 units, the needle calcining instrument is heated, and the needle blank is moved horizontally to the right so that the needle tip slowly approaches the glass heating ball. The needle tip fracture changes from a right angle to a rounded blunt end and the inner diameter shrinks under the eyepiece. When the design value is reached, the heating is stopped to complete the polishing of the needle tip opening.

[0012] Preferably, after the polishing of the needle tip opening is completed, the needle holder rod (equipped with the needle blank) is turned to a vertical position with the needle tip facing downward; the temperature of the needle forging instrument is set to 50-60 units, the bending needle position is located, and the bending needle position is close to and 50-100 μm away from the glass heating ball (dynamic adjustment), the longitudinal axis of the eyepiece ruler is parallel to the longitudinal axis of the needle blank, the angle scale is placed in the fourth quadrant, and after heating is started, the glass tube at the bending needle position is bent toward the glass heating ball, and the heating position is bent to the right in a fan-sweep shape as far as the needle tip opening. After reaching the designed angle, heating is stopped to complete the bending needle.

[0013] The present invention has the following advantages: The present invention provides a manufacturing process for a safe biopsy needle by improving the process. Compared with similar processes and equipment, the present invention has the following improvements:

[0014] 1) When making the narrow part, the heating platinum wire is made into a U shape, and the glass tube to be processed is placed between the two arms of the U-shaped platinum wire. The existing process uses a V-shaped platinum wire, and the glass tube to be processed is placed at the top of the V-shaped platinum wire.

[0015] 2) When creating the stenosis, the pre-set stenosis is heated while a negative pressure pump is used to apply negative pressure to the needle blank, resulting in an oblate stenosis. Existing processes for creating stenosis only heat the exterior of the pre-set stenosis without the negative pressure pumping step, resulting in a circular tubular lumen.

[0016] 3) The oblate stenosis has the same function of blocking tissue as the circular stenosis, but the absolute value of the cross-sectional area is larger, and the liquid (non-tissue) passes through more smoothly. When the biopsy tissue is sucked into the needle mouth to reach the stenosis and the sample is discharged from the biopsy needle, the pressure (negative pressure / positive pressure) generated is large and rapid, which speeds up the biopsy operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a process flow chart of the present invention;

[0018] Figure 2 It is the needle drawing parameter data diagram of the present invention;

[0019] Figure 3 This is a parameter diagram of the finished product of the present invention (excluding packaging and irradiation sterilization steps);

[0020] Figure 4 This is a process diagram of drawing a needle blank using a numerically controlled needle drawing apparatus according to the present invention;

[0021] Figure 5 This is a process diagram of sealing the needle tip of the needle calcining instrument of the present invention;

[0022] Figure 6 This is a process diagram of the needle calcining instrument of the present invention for making a narrow part;

[0023] Figure 7 This is a process diagram for breaking needles in a needle calcining instrument according to the present invention;

[0024] Figure 8 This is a process diagram of polishing the needle tip opening of the needle calcining instrument of the present invention;

[0025] Figure 9 It is a needle bending process diagram of a needle calcining instrument of the present invention. DETAILED DESCRIPTION

[0026] The following will be combined with the Figure 1-9 The present invention is described in detail, and the technical solutions in the embodiments of the present invention are clearly and completely described. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0027] See also Figures 1 to 9 The manufacturing process of a safety biopsy needle of the utility model is as follows:

[0028] The CNC needle puller draws the needle blank. Specifically, a glass capillary is passed through the heating platinum frame and then fixed horizontally on the left and right needle pulling arms of the needle puller. The following parameters are used ( Figure 2 ) draw out two needle blanks of the same shape;

[0029] The needle tip is sealed by the needle calcining instrument. Specifically, a needle blank is fixed horizontally on the needle holder of the needle calcining instrument. The temperature of the needle calcining instrument is set to 40-50 units. The needle holder is moved so that the needle tip is close to and 10-20 μm away from the glass heating ball. After heating is started, the needle tip end is observed to be sealed.

[0030] The needle calcination instrument is used to make the stenosis. Specifically, after the needle tip is sealed, the needle holder (with the needle blank) is turned to a vertical position, with the needle tip facing downward and inserted into the center of the U-shaped heating platinum wire (the distance between the two arms of the U-shaped platinum wire is 1.5-2.0 mm). The stenosis to be made is located under the eyepiece ruler according to the designed position of the stenosis. This position is equidistant from the front and rear arms of the U-shaped platinum wire. The tail end of the needle blank is connected to a foot-controlled negative pressure pump through a silicone tube, and the temperature of the needle calcination instrument is set to 45-60 units. The needle calcination instrument is heated and the negative pressure pump is started at the same time. Under negative pressure, the front-back diameter of the glass tube of the stenosis set by the needle blank gradually decreases, and the left-right diameter increases, gradually becoming oblate. The deformation process is observed under the eyepiece, and the needle holder is rotated to observe only the short diameter of the oblate circle. When the short diameter reaches 5-12 μm, heating and negative pressure are stopped to complete the production of the stenosis.

[0031] The needle of the needle forging instrument breaks. Specifically, after completing the production of the narrow part, turn the needle holder (with the needle blank) to a horizontal position, with the needle tip facing the right. Locate the needle breaking position according to the designed needle tip diameter and place the needle breaking position directly above the glass heating ball. Set the temperature of the needle forging instrument to 35-45 units. After starting heating, quickly move the needle holder downward in parallel. Stop heating when the set breaking point of the needle blank lightly touches the glass heating ball. The needle blank will break at the set breaking point.

[0032] The needle calcining instrument polishes the needle tip opening. Specifically, after the needle is broken, the needle holder with the needle blank is kept in a horizontal position and moved vertically downward until the needle tip is aligned with the left side of the glass heating ball. The temperature of the needle calcining instrument is set to 40-60 units, the needle calcining instrument is heated, and the needle blank is moved horizontally to the right, so that the needle tip slowly approaches the glass heating ball. Under the eyepiece, observe that the needle tip end changes from a right angle to a rounded blunt end and the inner diameter decreases. When the design value is reached, stop heating and the needle tip opening polishing is completed.

[0033] To bend a needle using a needle bending instrument, after polishing the needle tip opening, rotate the needle holder (with the needle blank) to a vertical position with the needle tip pointing downward. Set the needle bending instrument temperature to 50-60 units, locate the needle bending position, and bring the needle close to and 50-100μm away from the glass heating ball (dynamic adjustment). Align the longitudinal axis of the eyepiece ruler with the longitudinal axis of the needle blank, with the angle scale set to the fourth quadrant. After heating begins, bend the needle bending position glass tube toward the glass heating ball. Bend to the right in a fan-shaped manner from the heating position to the needle tip opening. Stop heating when the designed angle is reached, and the needle is bent.

[0034] The present invention employs a U-shaped heating platinum wire, with the processed glass tube placed between its two arms. This heats the constricted area while simultaneously applying negative pressure to the needle blank using a negative pressure pump, creating an oblate constriction. This design not only prevents tissue loss during the biopsy procedure, but also generates greater and more rapid pressure (negative / positive) than existing safety biopsy needles (circular constrictions). This allows for faster aspiration of biopsy tissue into the needle opening, into the constricted area, and expulsion of the specimen from the needle, improving biopsy efficiency.

[0035] The above shows and describes the basic principles, main features and advantages of the present invention, and the equipment (CNC needle drawing machine and needle forging machine) and standard parts used in the present invention can be purchased from the market. Special-shaped parts can be customized according to the description in the instructions and the drawings. The specific connection methods of each part adopt mature conventional means such as bolts, rivets, welding, etc. in the existing technology. The machinery, parts and equipment all adopt conventional models in the existing technology, and the circuit connection adopts the conventional connection method in the existing technology, which will not be described in detail here.

[0036] The above description of the disclosed embodiments is intended to enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is intended to conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A manufacturing process for a safety biopsy needle, characterized by: A glass capillary is passed through a heating platinum sheet frame and fixed horizontally on the left and right needle pulling arms of a needle pulling instrument to draw out two needle blanks of the same shape. One needle blank is fixed horizontally on the needle holder of a needle forging instrument. The temperature of the needle forging instrument is set to 40-50 units. The needle holder is moved so that the needle tip is close to and 10-20 μm away from the glass heating ball. After starting heating, observe whether the needle tip end is completely closed. After the needle tip is sealed, turn the needle holder to the vertical position; Insert the needle tip downward into the center of the U-shaped heating platinum wire. Under the eyepiece ruler, locate the narrow part to be made according to the designed position of the narrow part. This position should be equidistant from the front and rear arms of the U-shaped platinum wire. Connect the tail end of the needle blank to the foot-controlled negative pressure pump through a silicone tube, and set the temperature of the needle calcining instrument to 45-60 units. Heat the needle calcining instrument and start the negative pressure pump at the same time. The front-to-back diameter of the narrow part of the glass tube set in the needle blank gradually decreases and the left-to-right diameter increases under negative pressure, gradually becoming oblate.

2. The manufacturing process of a safety biopsy needle according to claim 1, characterized in that: Observe the deformation process under the eyepiece and rotate the needle holder to observe only the short diameter of the oblate shape. When the short diameter reaches 5-12 μm, stop heating and pumping negative pressure to complete the production of the stenosis.

3. The manufacturing process of a safety biopsy needle according to claim 1, characterized in that: After completing the production of the narrow part, turn the needle holder rod to a horizontal position with the needle tip facing the right. Locate the needle breaking position according to the designed needle tip diameter and place the needle breaking position directly above the glass heating ball. Set the needle forging instrument temperature to 35-45 units. After starting heating, quickly move the needle holder rod down in parallel. Stop heating when the set needle breaking point of the needle blank lightly touches the glass heating ball. The needle blank will break at the set needle breaking point.

4. The manufacturing process of a safety biopsy needle according to claim 1, characterized in that: After the needle is broken, the needle holder rod is equipped with the needle blank and kept in a horizontal position. It is moved vertically downward to the position where the needle tip is aligned with the left side of the glass heating ball. The temperature of the needle forging instrument is set to 40-60 units, the needle forging instrument is heated, and the needle blank is moved horizontally to the right so that the needle tip slowly approaches the glass heating ball. Under the eyepiece, observe that the fracture of the needle tip changes from a right angle to a rounded blunt shape and the inner diameter shrinks. Stop heating when it reaches the designed value, and the needle tip opening polishing is completed.

5. The manufacturing process of a safety biopsy needle according to claim 1, characterized in that: After polishing the needle tip opening, turn the needle holder to a vertical position with the needle tip facing downwards; Set the needle calcining instrument temperature to 50-60 units, locate the curved needle position, and place the curved needle position close to and 50-100 μm away from the glass heating ball. Make the longitudinal axis of the eyepiece ruler parallel to the longitudinal axis of the needle embryo, and place the angle scale in the fourth quadrant.

6. The manufacturing process of a safety biopsy needle according to claim 1, characterized in that: After heating begins, the glass tube at the bending needle position bends toward the glass heating ball, and the heating position bends to the right in a fan-sweep shape as far as the needle tip opening. When the designed angle is reached, heating is stopped and the bending needle is completed.

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