CN218620772U - Micro-operation needle and micro-operation device comprising same - Google Patents

Abstract

The utility model provides a micro-operation needle and contain its micro-operation device, wherein, the micro-operation needle includes needle body and cutting member, the needle body can supply the drive arrangement centre gripping, in order to remove under drive arrangement's effect, the cutting member has the cutting plane that is used for cutting target biopsy cell and blastocyst embryo body separation, and the cutting member links to each other with the needle body, in order to cut target biopsy cell from the blastocyst embryo body, and not "tear", effectively avoid wiping formula mechanical separation easy to take place repeatedly many times tear but be difficult to take off the biopsy sample or peel off the scene of whole blastocyst embryo from the transparent band, and whole process time spent is short, reducible embryo exposes the time outside the incubator; in addition, the whole biopsy process is carried out through a cutting piece which is a cold knife tool not externally connected with an energy source, so that the damage of burning and the like to peripheral tissues caused by laser cutting does not exist, and the micro-operation needle realizes the beneficial effects of high-efficiency and thorough separation and small damage to blastocysts.

Description

Micro-operation needle and micro-operation device comprising same

Technical Field

The utility model relates to an apparatus technical field for supplementary reproduction especially relates to a micro-operation needle and contain its micro-operation device.

Background

The genetic testing (PGT) before embryo implantation refers to an assisted reproduction technology which is used for carrying out biopsy on an oocyte or an embryo before implantation on the basis of in vitro fertilization and embryo transfer (IVF-ET), utilizing a molecular biological method for testing, and selecting an embryo with normal or hereditary phenotype to implant into a uterus, thereby obtaining healthy offspring, and effectively preventing the birth of children with genetic diseases.

The three stages of the ovum, the cleavage stage embryo and the blastocyst can be subjected to biopsy to obtain genetic materials, and the genetic materials are divided into polar body biopsy, blastomere biopsy and blastocyst biopsy according to different biopsy objects. Blastocyst biopsy is used by more reproductive medicine centers because it can isolate up to 10 cells from trophectoderm, provides more material for detection, and improves the accuracy and effectiveness of PGT, and is trophectoderm cells, which will eventually develop into the placental portion, where the inner cell mass of the fetus is not affected.

However, the blastocyst biopsy in the PGT process is still a traumatic in vitro micromanipulation, and the quality of the implementation of the micromanipulation will have an important influence on the success of PGT, and unnecessary damage to the embryo caused by the blastocyst biopsy should be reduced as much as possible.

At present, two methods for obtaining trophoblast cells by blastocyst biopsy mainly comprise a laser method and a mechanical method. The laser method is to separate part of trophoblast cells sucked by the biopsy needle from the blastocyst body by using a laser cutting technology, and then to put the blastocyst into a tube for inspection. However, the laser cutting needs to control the laser beating intensity and duration, the sample is not easily fused from the connection part of the body when the energy is too low, and peripheral cells are easily burnt and even an inner cell mass of a blastocyst core is damaged when the energy is too high. The mechanical method is that after the biopsy needle sucks a cell sample, the fixed needle is close to the biopsy needle and rubs against the end of the biopsy needle, and the mechanical force generated by the rubbing of the fixed needle and the biopsy needle is utilized to tear and separate the sample from the blastocyst body. However, the method has high requirements on operator microtechnology, the precision, force and speed of operation need to be controlled well, if the operation is unskilled and the method is inappropriate, and additionally, the tips of the current commercialized fixing needle and biopsy needle are subjected to arc smooth treatment, the situation that the biopsy sample is difficult to take down due to repeated tearing can occur, the situation that the whole blastocyst is stripped from the transparent belt and the biopsy part is still connected to the body can occur more seriously, and the external friction and collision type mechanical cutting method has long exposure time outside the incubator and is unfavorable for embryo development.

SUMMERY OF THE UTILITY MODEL

In view of this, the present invention provides a micro-needle and a micro-operation device comprising the same, so as to solve the problems of low operation efficiency and easy damage to the blastocyst of the method for obtaining trophoblast cells by blastocyst biopsy in the prior art.

In view of the above, in a first aspect, embodiments of the present application provide a micro-needle for obtaining biopsy cells in a blastocyst body during blastocyst biopsy, the micro-needle comprising:

the needle body can be clamped by the driving device and moves under the action of the driving device; the cutting part is provided with a cutting surface for cutting and separating the target biopsy cells from the blastocyst body, and the cutting part is connected with the needle body.

Further, the needle body comprises an inserting section and a working section which are connected, wherein the rear end of the inserting section is connected with the front end of the working section in a bending mode, and an included angle formed between the inserting section and the working section ranges from 100 degrees to 150 degrees;

the inserting section is used for clamping a driving device, the cutting piece is connected with the front end of the working section, and the cutting surface is located on one side of the working section.

Further, the cutting surface is perpendicular to the axial direction of the working section.

Furthermore, the needle body is also provided with a mark for marking the position of the cutting part.

Furthermore, grafting section and working section all link up, just the rear end of grafting section with the rear end of working section communicates, be equipped with on the front end of working section and adsorb the mouth, the rear end of grafting section can communicate with negative pressure equipment, in order to give adsorb the mouth and provide the negative pressure of adsorbing the blastocyst.

Furthermore, the opening area of the rear end of the insertion section is larger than that of the adsorption port.

Furthermore, one end of the cutting part, which is provided with a cutting surface, extends to one axial side of the working section, so that the cutting surface is positioned between part of the biopsy cells and the blastocyst body, and the cutting part and the working section enclose to form a folding angle for enclosing the blastocyst body, so as to accommodate and fix the blastocyst body.

Further, the cutting piece is in a sheet shape perpendicular to the axial direction of the working section.

Furthermore, the cutting piece is sleeved outside the adsorption port.

In a second aspect, the present application further provides a micromanipulation apparatus for blastocyst biopsy, comprising a micromanipulator and the micromanipulator, wherein the micromanipulator comprises a needle holding arm and a negative pressure connection lumen, wherein the needle holding arm is used for holding the micromanipulator and driving the micromanipulator to move, and the negative pressure connection lumen is used for communicating with the micromanipulator to provide negative pressure to the micromanipulator.

By adopting the technical scheme provided by the embodiment of the application, the method at least has the following technical effects:

(1) According to the micro-operation needle provided by the embodiment, the cutting part is arranged on the needle body, and the cutting part is provided with the cutting surface for cutting and separating the target biopsy cells and the blastocyst body, so that the target biopsy cells can be quickly and efficiently cut from the blastocyst body instead of being torn, and the situation that repeated tearing easily occurs in wiping type mechanical separation is effectively avoided, but the biopsy sample is difficult to take down or the whole blastocyst is difficult to strip from the transparent band; for operators, the microscopic operation needle is used for blastocyst biopsy, so that the technical difficulty is greatly reduced, the operation is easier, the time for the whole process is shorter, the time for exposing embryos outside the incubator is reduced, and the subsequent development of the embryos is facilitated; in addition, the whole biopsy process is carried out by a cutting piece which is a cold knife tool not externally connected with an energy source, so that the damage of burning and the like to peripheral tissues caused by laser cutting is avoided, and the beneficial effects of high efficiency and thoroughness in separation and small damage to the blastocyst are realized.

(2) The needle body includes grafting section and the working segment that links to each other, and wherein, grafting section and working segment bending joint to match different micro-operation appearance and hold the needle arm, cater to different operating personnel's operation custom.

(3) Still be equipped with on the needle body and be used for the sign the mark of cutting member position to the position of suggestion cutting member avoids the orientation mistake and the mechanical damage that the needle in-process that falls takes place caused cutting member.

(4) The micromanipulation needle for blastocyst biopsy integrates the functions of fixing blastocyst and cutting blastocyst, can reduce operation tools and is convenient for single-person operation.

(5) The opening area of the rear end of the insertion section is larger than that of the adsorption port, so that larger negative pressure is obtained by reducing the cross section, and the adsorption port is matched with the blastocyst size.

(6) The cutting member extends to one axial side of working segment for cutting member and working segment form L clamp angle, can effectually enclose the blastocyst body and close here, neither take place excessive extrusion to the blastocyst body, also let the blastocyst take place the too big displacement of range, separate partial biopsy cell to the opposite side of cutting member simultaneously, the cutting plane accuracy alignment cutting position of cutting member, through quick rip cutting motion, can follow the cutting of this partial biopsy cell on the blastocyst body.

(7) The cutting piece is in a sheet shape perpendicular to the axial direction of the working section so as to increase the enclosed area of the folded angle to the blastocyst, so that the micromanipulation needles connected with the cutting sheet do not extrude the blastocyst body too much in the process of aligning the cutting point.

(8) The adsorption port is a flat port to effectively adsorb the blastocyst under the action of negative pressure.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

FIG. 1 is a schematic view of a micromanipulation needle configuration in one implementation of the present application;

FIG. 2 is an enlarged view of the structure at A in FIG. 1;

FIG. 3 is a top view of a portion of the structure of the micro-needle shown in FIG. 2;

FIG. 4 is a first schematic view of a micro-needle in an embodiment of the present application;

FIG. 5 is a second schematic view of the working state of the micro-needle in the practice of the present application;

fig. 6 is a third schematic view of the working state of the micro-needle in the practice of the present application.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in detail with reference to the accompanying drawings.

It should be noted that unless otherwise defined, technical or scientific terms used in the embodiments of the present invention should have the ordinary meaning as understood by those having ordinary skill in the art to which the present disclosure belongs. The use of "first," "second," and the like in this disclosure is not intended to indicate any order, quantity, or importance, but rather is used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that the element or item listed before the word covers the element or item listed after the word and its equivalents, but does not exclude other elements or items. The terms "connected" or "coupled" and the like are not restricted to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", and the like are used merely to indicate relative positional relationships, and when the absolute position of the object being described is changed, the relative positional relationships may also be changed accordingly.

The blastocyst comprises a blastocyst body 31 and trophoblast cells 32, i.e. biopsy cells, located on the inner wall of the blastocyst body 31, wherein the inside of the blastocyst body 31 is provided with an inner cell mass 33, and when in vitro blastocyst biopsy, a part of the biopsy cells need to be obtained. The present embodiment provides a micro-needle for cutting and separating a target biopsy cell from a blastocyst body 31 at the time of blastocyst biopsy, thereby obtaining the target biopsy cell. In some embodiments, the micro-needle may also be used to cut other cells or tissues in vitro.

As shown in fig. 1 to 3, the micro-needle in the embodiment of the present application comprises a needle body and a cutting member 24, wherein the needle body can be held by a driving device to move under the action of the driving device, the cutting member 24 has a cutting surface 26 for cutting and separating the biopsy cells of interest from a blastocyst body 31, and the cutting member 24 is connected with the needle body so as to operate the cutting member 24 to perform a cutting operation by holding the needle body by the driving device.

As can be seen from the above description, the micro-needle provided in this embodiment, by providing the cutting member 24 on the needle body, since the cutting member 24 has the cutting surface 26 for cutting and separating the target biopsy cells from the blastocyst body 31, the target biopsy cells can be quickly and efficiently cut off from the blastocyst body 31, rather than being "torn", thereby effectively avoiding the situation that repeated tearing easily occurs in the rubbing mechanical separation but the biopsy sample is difficult to be taken off or the whole blastocyst is difficult to be peeled off from the transparent tape; for operators, the microscopic operation needle is used for blastocyst biopsy, so that the technical difficulty is greatly reduced, the operation is easier, the time for the whole process is shorter, the time for exposing embryos outside the incubator is reduced, and the subsequent development of the embryos is facilitated; in addition, the whole biopsy process is carried out by the cutting piece 24 which is a cold knife tool not externally connected with an energy source, so that the damage of burning and the like to peripheral tissues caused by laser cutting is avoided, and the beneficial effects of high efficiency and thoroughness in separation and small damage to blastocysts are realized.

It should be noted that, in the embodiment of the present application, the driving device may be a micromanipulator, and the micromanipulator includes a needle holding arm, and the needle holding arm can hold the micromanipulator needle and drive the micromanipulator needle to move. The micromanipulator in the embodiment of the present application adopts a mature product on the market, for example, an Eppendorf (Ai Bende) micromanipulator, related technologies thereof are widely disclosed, and for a principle that a needle holding arm of the micromanipulator controls a needle to move and a related setting mode of the micromanipulator, reference is made to the prior art, and details are not repeated here.

In an embodiment of the present application, as shown in fig. 1 and 2, the needle body includes an insertion section 1 and a working section 2 connected to each other, wherein the insertion section 1 and the working section 2 are connected in a bending manner, an included angle formed between the insertion section 1 and the working section 2 ranges from 100 ° to 150 °, the cutting member 24 is connected to the working section 2, and the cutting surface 26 is located on one axial side of the working section 2.

Specifically, during operation, the needle holding arm can be controlled to clamp the plugging section 1, and the cutting surface 26 on the working section 2 is kept aligned with the cutting point, so that the cutting separation is conveniently implemented. In order to match with different needle holding arms of the micromanipulator and meet the operation habits of different operators, the size of an included angle formed between the insertion section 1 and the working section 2 can be determined according to specific use occasions, and in addition, the included angle between the insertion section 1 and the working section 2 is preferably 135 degrees.

As shown in fig. 1 and 2, in an embodiment of the present application, the cutting surface 26 is perpendicular to the axial direction of the working section 2, so that the working section 2 can be moved back and forth by holding the insertion section 1, thereby performing an efficient cutting operation.

As shown in fig. 2 and 3, the needle body is further provided with a mark 25 for marking the position of the cutting member 24. For example, in one embodiment of the present application, the indication is an indication line extending axially along the needle body, and the indication line extends from the insertion section 1 to the working section 2. For example, if the mark is located on the upper side of the micro-operation needle in the use state, the indication line is consistent with the tilting direction of the working section 2, the position of the cutting piece 24 can be prompted, and mechanical damage to the cutting piece 24 in the needle descending process caused by the wrong direction can be avoided.

Of course, the mark 25 may have other shapes or structures, such as a protrusion disposed on the needle body, etc., as long as it can indicate the position of the cutting element 24 relative to the needle body, and is not limited herein.

Before the cutting operation is performed on the blastocyst, the target blastocyst needs to be stabilized in advance, and in order to reduce the number of operating tools, in an embodiment of the application, the micro-operation needle is further integrated with a function of fixing the blastocyst. Specifically, as shown in fig. 2, the insertion section 1 and the working section 2 are both through, the front end 12 of the insertion section 1 is communicated with the rear end 21 of the working section 2, the front end 22 of the working section 2 is provided with an adsorption port 23, and the rear end 11 of the insertion section 1 can be communicated with a negative pressure connection tube cavity of a micro-manipulator (or other negative pressure devices) to provide negative pressure for adsorbing the blastocysts to the adsorption port 23, so as to adsorb and fix the target blastocysts. Therefore, the micromanipulation needle for blastocyst biopsy integrates the functions of fixing blastocyst and cutting blastocyst, can reduce operation tools and is convenient for single-person operation.

Here, when the biopsy needle is used to obtain the target biopsy cells, the end close to the target biopsy cells is a tip, and the end opposite to the tip is a rear end, and the terms "tip" and "rear end" are used only to indicate a relative positional relationship, and the present invention is not limited to this.

Further, as shown in fig. 1, the opening area of the rear end 11 of the insertion section 1 is larger than the opening area of the suction port 23, so as to obtain a larger negative pressure by reducing the cross section and simultaneously enable the suction port 23 to be matched with the size of the blastocyst.

For example, the plug section 1 and the working section 2 are straight circular tubes. Connect the section of inserting 11 long 50mm, the external diameter is 1mm, and the internal diameter is 0.8mm, and its rear end 11 can match to connect and insert the negative pressure connecting pipe intracavity of micro-operation appearance, connect the front end 12 of section of inserting 1 to narrow to the external diameter is 100um ~ 140um (preferably 120 um), the internal diameter is 30um ~ 60um (preferably 40 um). The outer diameter of the working section 2 is 120um, the inner diameter is 40um, the outer diameter is consistent with the front end 12 of the narrowed plugging section 1, and the length of the working section 2 is 0.5 mm-1 mm.

In one embodiment, as shown in fig. 2, one end of the cutting member 24 having the cutting surface 26 extends to one side of the working section 2 along the axial direction, so that the cutting surface 26 is located between a part of the biopsy cells and the blastocyst body 31, and the cutting member 24 and the working section 2 enclose to form a folded corner for enclosing the blastocyst body 31 to accommodate and fix the blastocyst body 31.

Specifically, the cutting member 24 and the working segment 2 form an L-shaped clip angle, so that the blastocyst body 31 can be effectively enclosed, the blastocyst body 31 is not excessively extruded, the blastocyst is not excessively displaced, meanwhile, a part of the biopsy cells are separated to the other side of the cutting member 24, the cutting surface 26 of the cutting member 24 is accurately aligned with the cutting position, and the part of the biopsy cells can be cut from the blastocyst body 31 through rapid longitudinal cutting movement.

Further, as shown in fig. 2, the cutting member 24 is in a sheet shape perpendicular to the axial direction of the working section to increase the enclosed area of the folded angle to the blastocyst, so that the micromanipulation needles connected to the cutting sheet do not press the blastocyst body 31 too much during the process of aligning the cutting point. Specifically, the thickness of the cutting thin sheet 24 is 1um to 10um, preferably 5um, and the width is 120um, which is consistent with the outer diameter of the adsorption port 23; the length beyond the working section 2 is 75-150 um, preferably 100um.

In one embodiment of the present application, as shown in fig. 2, the cutting element 24 is sleeved outside the absorption opening 23. Specifically, a through hole penetrating through the adsorption port 23 is formed in the cutting piece 24, and the cutting piece 24 is fixedly sleeved outside the adsorption port 23 to be fixed on the needle body.

In one embodiment of the present application, as shown in FIG. 2, the suction port 23 is a flat port to effectively hold the blastocyst under negative pressure. Specifically, the adsorption port 23 is a flat port, that is, the end surface of the adsorption port 23 is perpendicular to the central axis of the working section 2. The inner diameter of the adsorption port 23 is 30-60 um, preferably 40um, which is larger than the diameter of a common fixing needle, considering that the biopsy object is a blastocyst, but not an ovum or a cleavage stage embryo, and the blastocyst can expand in the development process, so that the expanded inner diameter of the adsorption port 23 can perform more stable adsorption type fixing on the blastocyst, and the damage to the blastocyst caused by overlarge negative pressure is avoided.

In addition, the embodiment of the application also provides a limiting operation device for blastocyst biopsy, which comprises the micro-operation needle and the micro-operation instrument in any one of the previous embodiments, wherein the micro-operation needle is communicated with the negative pressure connecting lumen of the micro-operation instrument.

In addition, the embodiment of the present application further provides a method for using the micro-needle, which is applicable to the micro-needle in any of the foregoing embodiments, and includes the following steps:

step S1: when the blastocyst is biopsied, firstly observing the mark 25 above the micro-operation needle, judging the bending and tilting direction of the working section 2, installing the rear end 11 of the inserting section 1 into a negative pressure connecting pipe cavity of a micro-operation instrument, and descending the micro-operation needle, so that the working section 2 and the blastocyst to be biopsied are positioned on the same visual field plane, ensuring that the edge of the blastocyst and the tangent line of the front end 22 of the working section 2 are clearly visible, and completing microscope focusing;

step S2: fixing the blastocyst with the suction port 23 by negative pressure, keeping the inner cell mass 33 as far as possible toward the suction port (avoiding accidental injury of the inner cell mass 33 during biopsy), as shown in fig. 4;

and step S3: operating the biopsy needle 4 to punch a hole in the blastocyst on the side away from the inner cell mass 33 and then to aspirate a portion of the trophoblast cells 32; releasing the negative pressure in the suction port 23 to release the micro-needle from contact with the blastocyst, moving the working section 2 of the micro-needle to align the cutting surface 26 of the cutting member 24 with the cutting point, so that the cutting member 24 and the working section 2 form an "L" shaped structure to surround the blastocyst body 31, and the target biopsy cell (biopsy sample) is located on the other side of the cutting member 24, as shown in fig. 5;

and step S4: the cutting member 24 is moved rapidly to perform a longitudinal cut to remove the target biopsy cells from the blastocyst body 31, as shown in FIG. 6, which may be subsequently cannulated for subsequent testing.

Those of ordinary skill in the art will understand that: the discussion of any embodiment above is meant to be exemplary only, and is not intended to intimate that the scope of the disclosure, including the claims, is limited to these examples; within the idea of the invention, also technical features in the above embodiments or in different embodiments can be combined, steps can be implemented in any order, and there are many other variations of the different aspects of the invention as described above, which are not provided in detail for the sake of brevity.

The embodiments of the invention are intended to embrace all such alternatives, modifications and variances which fall within the broad scope of the appended claims. Therefore, any omission, modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included within the protection scope of the present invention.

Claims (10)

1. A micro-needle for obtaining biopsied cells from a blastocyst body during blastocyst biopsy, the micro-needle comprising:

the needle body can be clamped by the driving device and moves under the action of the driving device;

the cutting part is provided with a cutting surface used for cutting and separating the target biopsy cells from the blastocyst body, and the cutting part is connected with the needle body.

2. The micro-needle according to claim 1, wherein the needle body comprises an insertion section and a working section which are connected, wherein the rear end of the insertion section is connected with the front end of the working section in a bending manner, and an included angle formed between the insertion section and the working section ranges from 100 degrees to 150 degrees;

the inserting section is used for clamping a driving device, the cutting piece is connected with the front end of the working section, and the cutting surface is located on one side of the working section.

3. The micro-needle of claim 2, wherein the cutting surface is perpendicular to an axial direction of the working section.

4. The micro-needle of claim 1, wherein the needle body is further provided with indicia for identifying the position of the cutting member.

5. The micro-needle of claim 2, wherein the insertion section and the working section are both through, the rear end of the insertion section is communicated with the rear end of the working section, the front end of the working section is provided with an adsorption port, and the rear end of the insertion section can be communicated with a negative pressure device to provide negative pressure for adsorbing blastocysts to the adsorption port.

6. The micro-needle of claim 5, wherein the opening area of the rear end of the insertion section is larger than the opening area of the suction port.

7. The micro-needle as claimed in claim 5, wherein the cutting member has an end with a cutting surface extending to one side of the working section along the axial direction, such that the cutting surface is located between a portion of the biopsy cells and the blastocyst body, and the cutting member and the working section enclose to form a folded angle for enclosing the blastocyst body to receive and fix the blastocyst body.

8. The micro-needle of claim 7, wherein the cutting element is in the form of a plate perpendicular to the axial direction of the working section.

9. The micro-needle of claim 7, wherein the cutting element is sleeved outside the suction port.

10. A micromanipulation apparatus for blastocyst biopsy, comprising a micromanipulator and the micromanipulator needle of any one of claims 1 to 9, wherein the micromanipulator comprises a needle holding arm for holding the micromanipulator needle and driving the micromanipulator needle to move, and a negative pressure connection lumen for communicating with the micromanipulator needle to supply negative pressure to the micromanipulator needle.

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