CN107174400A - Human retina cavity of resorption needle for injection and its application - Google Patents

Abstract

The invention relates to a needle for human subretinal cavity injection and its application, which is characterized in that it comprises a needle barrel connecting cap, a needle tail and a needle head arranged on the needle barrel connecting cap; the needle tail is straight , the needle head is straight or curved to one side. When the needle head is straight, the model of the needle head is 30-35G, and the length of the needle head is 4-7mm. When the needle head is bent towards one side, the model of the needle head is 30-35G, and the length of the needle head is 5-10mm. The model of the tail of the needle is 20-25G, and the length of the tail of the needle is 40mm. The present invention also provides an application of the needle for injecting cell suspension, gas and liquid into the human subretinal cavity. The human subretinal cavity injection needle of the present invention can not only facilitate the positioning of the subretinal cavity, facilitate the stripping of retinal scar tissue and prevent the reflux of the injection, but also hardly damage the cell viability when the injection is cells.

Description

Needle for human subretinal injection and its application

technical field

The invention relates to a needle and its application, in particular to a needle for human subretinal cavity injection and its application, and belongs to the technical field of medical instruments.

Background technique

Retinal degenerative diseases are the main cause of irreversible blindness, including age-related macular degeneration, retinitis pigmentosa, and Stargardt disease. Among them, there are about 30 to 50 million patients with age-related macular degeneration worldwide, and about 1 million patients with retinitis pigmentosa. At present, there are more than 20 million patients with age-related macular degeneration in my country, and it is expected to double in 2050. Since retinal degeneration is mainly manifested as damage to the retinal pigment epithelium (RPE) in the macula, the replacement transplantation of RPE cells in regenerative medicine has become the main direction of treatment research.

At present, the syringes commonly used by ophthalmology clinicians and researchers at home and abroad for subretinal cell transplantation mainly include micropipettes, subretinal space stem cell transplantation devices, etc. The needles of these syringes are all between 30-50mm long and the models are 28-35G. Because the needle is slender, it is easy to bend during puncture, and it is difficult for the operator to control the strength, and it is also easy to fail the puncture. In addition, the inner diameter of the needle is too small, which often leads to cell damage and decreased cell viability during the injection process, which also reduces the efficacy of the injection. At the same time, patients who need subretinal injection often have a large number of retinal scars (such as patients with age-related macular degeneration). During the injection process, separating the retinal scars and positioning them in the subretinal space has become a difficulty in subretinal cell transplantation. In addition, cell reflux has always been a difficulty in subretinal space stem cell injection, and it is also the main cause of postoperative complications such as postoperative cataract, postoperative disorder, and epiretinal membrane. Therefore, clinically, there is an urgent need for a needle with a tough body and a fine tip, which is convenient for the operator to locate the subretinal cavity, peel off the retinal scar, avoid the reflux of the injected product, and minimize the damage to the vitality of the injected cells. At the same time, the design is simple and convenient for large-scale Manufactured, special injection needles for human subretinal space.

Contents of the invention

The purpose of the present invention is to overcome the deficiencies in the prior art, to provide a needle for human subretinal injection and its application, which is suitable for clinically injecting cell suspension, gas and liquid into the human subretinal cavity, and the design is simple and convenient for large-scale The production is convenient for the operator to locate the subretinal space, peel off the retinal scar, avoid the reflux of the injection, and minimize the damage to the vitality of the injected cells.

According to the technical solution provided by the present invention, the needle for human subretinal injection is characterized in that it includes a needle barrel connection cap, a needle tail and a needle head arranged on the needle barrel connection cap; the needle tail is Straight, the tip of the needle is straight or curved towards one side.

Further, when the needle head is straight, the model of the needle head is 30-35G, and the length of the needle head is 4-7mm.

Further, when the needle head is bent toward one side, the model of the needle head is 30-35G, and the length of the needle head is 5-10 mm.

Further, the model of the tail of the needle is 20-25G, and the length of the tail of the needle is 40mm.

Further, the needle head adopts a flat head structure.

The present invention also provides an application of the needle for injecting cell suspension, gas and liquid into the human subretinal space.

Further, the viability of the cell suspension passing through the needle reaches 90% or above.

The needle for human subretinal injection according to the present invention can not only facilitate the positioning of the subretinal space, facilitate the peeling of retinal scar tissue and prevent the reflux of the injection, but also hardly damage the cell viability when the injection is cells (the cells pass through the needle). After the activity can be unchanged and up to 90% or more).

Description of drawings

Fig. 1 is a schematic diagram of the first embodiment of the needle for human subretinal injection according to the present invention.

Fig. 2 is a schematic diagram of the second embodiment of the needle for human subretinal injection according to the present invention.

Fig. 3 is a comparison result of cell viability before and after human retinal pigment epithelial cells at a concentration of 1×10 ⁶ /ml pass through 4 different needles.

Fig. 4 is a comparison result of cell viability before and after human retinal pigment epithelial cells at a concentration of 2×10 ⁶ /ml pass through 4 different needles.

Explanation of reference signs: 1-needle head, 2-needle tail, 3-needle barrel connection cap.

detailed description

The present invention will be further described below in conjunction with specific drawings.

Example 1:

As shown in Figure 1, the needle for human subretinal injection according to the present invention includes a needle barrel connection cap 3, a needle tail 2 and a needle head 1 arranged on the needle barrel connection cap 3, and the needle head 1 faces one side. The side is bent to prevent the reflux of the injection. The model of the needle head 1 is 30-35G, the length of the needle head 1 is 5-10mm, the needle tail 2 is straight, and the model of the needle tail 2 is 20-25G. The length of the tail part 2 is 40 mm, and the needle head 1 adopts a flat head structure.

For the needle for human subretinal injection described in Example 1, the model of the needle head 1 is 30-35G, which is relatively soft, and the model of the needle tail 2 is 20-25G. It is relatively rough and can pass through the corneoscleral limbus to the retinal injection area.

Example 2

As shown in Figure 2, the needle for human subretinal injection according to the present invention comprises a needle barrel connecting cap 3, a needle tail 2 and a needle head 1 arranged on the needle barrel connecting cap 3, and the needle head 1 is in the shape of Straight, the model of the needle head 1 is 30-35G, the length of the needle head 1 is 4-7mm, the needle tail 2 is straight, the model of the needle tail 2 is 20-25G, the length of the needle tail 2 is 40mm, The needle head 1 adopts a flat head structure.

For the needle for human subretinal injection described in Example 2, the model of the needle head 1 is 30-35G. It is relatively soft, and the model of the needle tail 2 is 20-25G, which is relatively thick and hard, and can pass through the corneoscleral limbus to the retinal injection area for retinal scar separation, but it is difficult to locate the human subretinal space.

Comparative example 1:

Common medical injection needles in the prior art have a model of 25G and a length of 15mm, and the needles are straight pointed. Because the needle is shorter than the axis of the eye and the needle is thick, it cannot be used for human subretinal injection.

Comparative example 2:

Commercially available commercial micropipette needles, model 30G, length 40mm, flat head. It can pass through the corneoscleral limbus to reach the retinal injection area. Because the needle is soft and long, it is difficult to locate the human subretinal space and separate the scar, and it is often bent during the clinical injection process, making it difficult for the surgeon to exert force and position. Not suitable for human subretinal injection.

Embodiment 3: The needles of Embodiment 1 and Embodiment 2 are used for subretinal injection of clinical patients, comprising the following steps:

a. Fill the syringe with the injected cell suspension, gas or liquid, and connect it with the needle barrel connection cap 3 of the needle, and then confirm the tightness of the needle barrel and the injection dose; the frozen retina The concentration of pigment epithelial cells is 1×10 ⁵ -10 ⁷ cells/ml, preferably 5×10 ⁵ -5×10 ⁶ cells/ml;

b. After the patient underwent vitrectomy, insert the needle from the corneoscleral limbal foramen and directly reach the retinal injection area;

c. Use a curved needle to gently separate the retinal scar tissue, stir up the retinal tissue, and inject the cell suspension, gas or liquid that needs to be injected into the subretinal space to prevent the reflux of the injection.

Example 4: The needles of Example 1, Example 2, Comparative Example 1 and Comparative Example 2 were used to test inject human retinal pigment epithelial cells (RPE) at a concentration of 1×10 ⁶ cells/ml.

Add 1 ml of 0.25% trypsin to each well of a six-well plate to digest P3 human retinal pigment epithelial cells obtained after 1 week of culture, and put them in a 37-degree incubator for 1 minute for digestion. After the cells were observed to become round and suspended, immediately add 10ml medium to dilute and stop the digestion. Pipette the culture plate repeatedly to help the cells to suspend, and suck the cells into a 15ml centrifuge tube, and centrifuge at 1000 rpm for 5 minutes. After centrifugation, discard the supernatant, add PBS to resuspend the cells, and count. At a concentration of 1×10 ⁶ cells/ml, resuspend the cells in the pre-prepared freezing solution. Then draw 100ul of the cell suspension with a needle, and then inject the cell suspension into the EP tube for testing.

The results are shown in Figure 2. The results of the detection of human retinal pigment epithelial cell viability before and after injection by flow cytometry show that the needle of Example 1 (ie, the curved needle of the present invention) has no significant decrease in cell viability before and after injection. However, when the needles of Example 2 (that is, the straight needles of the present invention) and the needles of the comparative example were used, the cell viability decreased (*, P<0.05; **, P<0.01, n=3). That is, as a needle for human subretinal injection, human retinal pigment epithelial cells at a concentration of 1×10 ⁶ /ml passed through the needle of Example 1 (ie, the curved needle of the present invention), without damaging the cell viability. Next is the needle of Example 2 (ie the straight needle of the present invention), which can damage the cell viability. In the past, the needle commonly used by clinicians (Comparative Example 1) and researchers (Comparative Example 2) had the greatest damage to cell viability.

Example 5: The needles of Example 1, Example 2, Comparative Example 1 and Comparative Example 2 were used to inject human retinal pigment epithelial cells (RPE) at a concentration of 2×10 ⁶ cells/ml.

Add 1ml of 0.25% trypsin to each well of a six-well plate to digest P3 human retinal pigment epithelial cells obtained after 1 week of culture, and put them in a 37-degree incubator for 1 minute. After the cells were observed to become round and suspended, immediately add 10ml medium to dilute and stop the digestion. Blow and beat the culture plate repeatedly to help the cells to suspend, suck the cells into a 15ml centrifuge tube, and centrifuge at 1000 rpm for 5 minutes. After centrifugation, discard the supernatant, add PBS to resuspend the cells, and count. At a concentration of 2×10 ⁶ cells/ml, resuspend the cells in the pre-prepared freezing solution. Then draw 100ul of the cell suspension with each needle, and then inject the cell suspension into the EP tube for testing.

The results are shown in Figure 3. The results of the detection of human retinal pigment epithelial cell viability before and after injection by flow cytometry show that the needle injections of Example 1, Example 2, Comparative Example 1 and Comparative Example 2, the cell viability before and after injection All decreased in different degrees (*, P<0.05; **, P<0.01; ***, P<0.001; ****, P<0.0001, n=3). That is, as a needle for human subretinal injection, human retinal pigment epithelial cells at a concentration of 2×10 ⁶ cells/ml pass through the needle of Example 1 (that is, the curved needle of the present invention), and the cell viability is minimally damaged, and the cell viability can still be maintained Above 90%. Next is the needle of embodiment 2 (i.e. the straight needle of the present invention). The needle commonly used by clinicians and researchers in the past (Comparative Example 2) had the greatest damage to cell viability.

Claims (7)

1. a kind of human retina cavity of resorption needle for injection, it is characterized in that：Including syringe needle syringe attachment cap（3）, be arranged at syringe needle pin Cylinder attachment cap（3）On syringe needle afterbody（2）With syringe needle head（1）；The syringe needle afterbody（2）For straight, syringe needle head（1）For Straight or towards side be in bending.

2. human retina cavity of resorption needle for injection as claimed in claim 1, it is characterized in that：The syringe needle head（1）To be straight During shape, syringe needle head（1）Model 30-35G, syringe needle head（1）Length be 4-7mm.

3. human retina cavity of resorption needle for injection as claimed in claim 1, it is characterized in that：The syringe needle head（1）Towards one When side is in bending, syringe needle head（1）Model 30-35G, syringe needle head（1）Length be 5-10mm.

4. the human retina cavity of resorption needle for injection as described in claim any one of 1-3, it is characterized in that：The syringe needle afterbody （2）Model 20-25G, syringe needle afterbody（2）Length be 40mm.

5. the human retina cavity of resorption needle for injection as described in claim any one of 1-3, it is characterized in that：The syringe needle head （1）Using flush configuration.

6. a kind of syringe needle as described in claim any one of 1-5 human retina cavity of resorption inject cell suspension, gas, liquid should With.

7. application as claimed in claim 6, it is characterized in that：The cell suspension by the syringe needle vigor reach 90% and with On.