KR102459763B1 - Hemostatic pad wound in circular shape, and device for inserting the same into the human body - Google Patents

Abstract

A device for inserting a hemostatic pad into a human body according to the present invention is for inserting the hemostatic pad, wound in a circular shape, into the human body, and can be effectively used for hemostasis during laparoscopic surgery, and the like. The device for inserting a hemostatic pad of the present invention includes a pipe member and a rod member.

Description

Hemostatic pad wound in circular shape, and device for inserting the same into the human body

The present invention relates to a device for inserting a circularly wound hemostatic pad into a human body, and more particularly, to a device for inserting a hemostatic pad into a human body through a trocar during laparoscopic surgery or the like.

In addition, the present invention also includes a hemostatic pad wound in a circle so that it can be used in the device.

In general, laparoscopic surgery, unlike laparotomy, which is performed by opening a large incision in the abdomen, makes one or several small holes (incisions) with a size of 0.5 to 1.5 cm in the abdomen, and puts a camera and various instruments into it. It is also called 'minimally invasive surgery'.

To outline laparoscopic surgery, after the patient is anesthetized, a needle is inserted into the navel area of the patient to create a relief (inflating the abdominal cavity by putting carbon dioxide in the abdominal cavity), and the necessary number of trocars (instruments) A thin tube that can be moved in and out of the ship) is drilled. When the camera is inserted through the trocar, the intra-abdominal image is projected on the monitor in front of the operator, and the operator performs the desired operation using an appropriate laparoscopic instrument while looking at the monitor.

Meanwhile, in order to assist in surgical hemostasis during a surgical operation, biologically absorbable hemostatic sponges made of appropriately sized blocks, plates, and films may be applied to the bleeding site.

These hemostatic sponges are often used in surgical procedures for large abdominal organs (liver, spleen or small intestine), lung surgery, neurosurgery to prevent pressure-induced damage to the brain or nerve tissue, and other methods that are difficult to control and frequently occur. It is useful to enhance the suppression of bleeding in some cases of orthopedic surgery with extensive bleeding, vascular surgery to stop bleeding from the suture site, oral or dental surgery such as tooth extraction, or other injuries.

However, since the hemostatic sponge mainly has a pad shape, there is a problem in that it is difficult to insert it into the human body during laparoscopic surgery. In addition, even when the hemostatic sponge is inserted into the human body, there is a problem in that it does not adhere to the bleeding site and floats upward.

The present invention has been proposed to solve the above problems, and an object of the present invention is to provide a device for inserting a hemostatic pad into a human body through a trocar when performing laparoscopic surgery or the like.

Another object of the present invention is to provide a hemostatic pad that is used in this device and does not float upward because it is in close contact with the bleeding site when applied to the bleeding site.

In order to achieve the above object, the insertion mechanism 100 according to the present invention may include a tube member 10 and a rod member 30 . The tube member 10 may have an elongated tube 11 and a first handle 15 on the upper end of the tube 11 . The rod member 30 may have a rod 31 having a diameter inserted into the tube 11 and elongated in the longitudinal direction of the tube 11 , and a second handle 32 at the top of the rod 31 .

The through hole 16 is formed to penetrate the first handle 15 up and down, and the through hole 16 is connected to and communicates with the tube 11 .

The tube 11 may be inserted into the trocar and inserted into the human body. In a state in which at least a portion of the tube 11 is inserted into the human body, the rod 31 is inserted into the tube 11 through the through-hole 16 to push the hemostatic pad inside the tube 11 down to the inside of the human body. discharged with The discharged hemostatic pad may be unfolded in its original state by restoring force or may be unfolded in its original state by a user's manipulation using an endoscope. In addition, the unfolded hemostatic pad may be in close contact with the bleeding site by a user's manipulation.

The hemostatic pad may be made by lyophilizing a mixed solution having a hemostatic component to include a plurality of pores, and a sponge pad having a structure in which at least a portion of the pores are connected to each other is wound in a circular shape.

The wound hemostatic pad is inserted into the tube 11 , and after the hemostatic pad is inserted into the tube 11 , the hemostatic pad is fixed inside the tube 11 due to friction between the hemostatic pad and the tube 11 . However, it may be discharged down the pipe 11 by the pushing force of the rod 31 .

The tube 11 may be made of a transparent or translucent material. Thus, the hemostatic pad inside the tube 11 can be seen from the outside.

Holes 12 may be formed at predetermined intervals in the longitudinal direction of the tube 11 .

The hemostatic pad may be prepared by freeze-drying a mixture of thrombin, collagen, and a carboxymethyl cellulose-based compound.

Preferably, the thrombin per 1 mg of the hemostatic pad may be 10 to 1000 IU, and the weight ratio of collagen to the carboxymethyl cellulose compound may be 1:9 to 9:1.

The hemostatic pad, which is another aspect of the present invention, has a structure in which a sponge pad is wound in a circle. Since the sponge pad is made by freeze-drying a mixed solution containing a hemostatic component, it has a structure including a plurality of pores, at least some of the pores are connected to each other, and has a predetermined cushioning and restoring force. The wound sponge pad may be inserted into a tube of a predetermined diameter and inserted into the human body.

Preferably, the mixed solution may include thrombin and collagen.

More preferably, the mixed solution may further include a carboxymethyl cellulose-based compound.

Thrombin per 1 mg of the hemostatic pad may be 10 to 1000 IU, and the weight ratio of collagen and carboxymethyl cellulose compound may be 1:9 to 9:1.

1 is an exploded perspective view showing an insertion device and a circularly wound hemostatic pad according to a preferred embodiment of the present invention;
Figure 2 is a perspective view showing a state in which the circularly wound hemostatic pad is inserted into the tube member.
3 is a flow chart showing a process for manufacturing a circularly wound hemostatic pad.
Figure 4 is a perspective view showing a hemostatic pad wound in a circle.

Hereinafter, the present invention will be described in detail with reference to the accompanying drawings. Prior to this, the terms or words used in the present specification and claims should not be construed as being limited to conventional or dictionary meanings, and the inventor should properly understand the concept of the term in order to best describe his invention. Based on the principle that it can be defined, it should be interpreted as meaning and concept consistent with the technical idea of the present invention. Accordingly, the embodiments described in the present specification and the configurations shown in the drawings are merely embodiments of the present invention and do not represent all of the technical spirit of the present invention, so various equivalents that can be substituted for them at the time of the present application It should be understood that there may be variations and examples.

[insertion mechanism]

1 is an exploded perspective view showing an insertion device and a hemostatic pad according to a preferred embodiment of the present invention, and FIG. 2 is a perspective view showing a state in which the hemostatic pad is inserted into the tube member. A portion indicated by a dotted line in FIGS. 1 and 2 indicates an interior seen through a transparent tube.

As shown in the drawing, the insertion device 100 includes a tube member 10 and a rod member 30 inserted into the tube member 10 to push down the hemostatic pad 200 and discharge it.

The tube member 10 includes a tube 11 and a first handle 15 at an upper end of the tube 11 .

The tube 11 is formed to be elongated along its longitudinal direction. The upper end of the tube 11 is connected to the through hole 16 and the lower end of the tube 11 is open. The hemostatic pad 200 may be inserted into the tube 11 through the lower end or through hole 16 of the tube 11 .

The tube 11 may be made of a metal such as stainless steel or a synthetic resin such as PC, PVC, PP, PET, PE, or the like. Preferably, the tube 11 is transparent or translucent so that the interior can be seen.

The tube 11 may be inserted into a trocar (instrument used during laparoscopic surgery, not shown in the drawing) and inserted into the human body. Thus, the tube 11 has an outer diameter that can be inserted into the trocar. And, the tube 11 has an inner diameter that is the same as the outer diameter of the rod 31 or greater than the outer diameter of the rod 31 so that the rod 31 can be inserted.

Holes 12 may be formed at predetermined intervals along the longitudinal direction of the tube 11 . When the hemostatic pad 200 is inserted or discharged into the tube 11 , the insertion and discharge of the hemostatic pad 200 may be smoothly performed by the air being discharged or introduced through the hole 12 . In addition, a scale (not shown in the drawing) may be formed along the longitudinal direction of the tube 11 . The scale indicates the depth into which the tube 11 is inserted.

The first handle 15 is provided at the upper end of the tube 11 as a part to be grasped by the user. The through hole 16 has a diameter equal to or greater than the outer diameter of the rod 31 so that the rod 31 can be inserted.

The through hole 16 is formed to penetrate the first handle 15 up and down, and is connected to the tube 11 to communicate. Thus, the rod 31 can be inserted into the tube 11 through the through hole 16 . The first handle 15 may be made of metal or synthetic resin.

The first handle 15 preferably has a diameter greater than the inner diameter of the trocar. This is to prevent the tube 11 from being accidentally completely inserted into the human body by allowing the first handle 15 to be caught on the upper end of the trocar.

The rod member 30 may include a rod 31 and a second handle 32 formed on the upper end of the rod 31 .

The rod 31 is formed to be long in the longitudinal direction of the tube 11 . The lower end of the rod 31 is preferably formed in a round shape.

The rod 31 can move up and down while being inserted into the through hole 16 and the tube 11 . The rod 31 may be made of a metal such as stainless steel or a synthetic resin such as PC, PVC, PP, PET, PE, or the like.

A scale (not shown in the drawing) may be formed in the longitudinal direction of the rod 31 . The scale indicates the depth into which the rod 31 is inserted.

The second handle 32 may be provided on the upper end of the rod 31 as a part to be grasped by the user. The second handle 32 may be made of metal or synthetic resin. The diameter of the second handle 32 is preferably larger than the diameter of the through hole 16 .

[Circular wound hemostatic pad]

3 is a flow chart showing a process for manufacturing a hemostatic pad. Hereinafter, the process will be sequentially described.

First, collagen, preferably a collagen sponge, is mixed with water to make a 0.5-2 wt% mixture of collagen, preferably a 1 wt% mixture, and a carboxymethyl cellulose compound (for example, Sodium CMC) is mixed with water to form carboxymethyl A 0.5 to 2wt% mixed solution of the cellulosic compound is prepared, preferably a 1wt% mixed solution.

Then, the collagen mixture solution and the carboxymethyl cellulose-based compound mixture solution are mixed in a 1:1 volume ratio, and thrombin is added to the mixture solution, followed by stirring (S310). The input amount of thrombin may be mixed so that the amount of thrombin per 1 mg of the freeze-dried sponge pad is 10 ~ 1000 IU. In addition, thrombin per 1 mg of the freeze-dried sponge pad may be 10 to 1000 IU, and the weight ratio of collagen and carboxymethyl cellulose compound may be 1:9 to 9:1.

As an alternative to this ratio, the hemostatic sponge may be composed of 20-40 wt% of thrombin, 20-40 wt% of collagen, and 20-40 wt% of a carboxymethyl cellulose compound. If the amount of thrombin is less than 10 IU or less than 20 wt%, there is a problem that the hemostatic effect is lowered. It cannot function properly such as regeneration and recovery of damaged tissue, suppression of scar formation, etc., which are the effects of This can make it difficult to hold.

As an alternative to this, thrombin may be added to the mixed solution so as to be 2 to 50% by weight of the hemostatic sponge pad. At this time, when thrombin is included in an amount of less than 2% by weight, the hemostatic effect may be very poor, and when it is included in an amount exceeding 50% by weight, relatively small amounts of collagen and carboxymethyl cellulose compounds are included, so the chemical stability of the overall hemostatic sponge is poor. It is undesirable because it may decrease the hemostatic effect or decrease the fluid absorption and retention performance.

As the collagen, type 1 collagen made using pig dermis may be used. For this purpose, commercially available collagen may be used. This collagen is suitable for medical use as telopeptide is removed by treating the dermis with pepsin. In addition, collagen may be lyophilized to have a sponge form. The collagen sponge has a structure including many pores, and at least some of the pores are connected to each other.

The carboxymethyl cellulose-based compound refers to carboxymethyl cellulose or a salt thereof, and such salts include sodium carboxymethyl cellulose (Sodium CMC), potassium carboxymethyl cellulose, or mixtures thereof, but must be limited thereto. it's not going to be Preferably, the carboxymethyl cellulosic compound is sodium carboxymethyl cellulose (Sodium CMC).

The carboxymethyl cellulose compound has excellent liquid absorption performance and liquid retention performance at the same time. Therefore, when used as a component of a hemostatic sponge, a large amount of blood or exudate from the bleeding site can be absorbed and retained. Therefore, the hemostatic pad made of this sponge can adhere to the bleeding site.

For reference, the degree of absorption was calculated by measuring the weight of the hemostatic sponge (weight before absorption), immersing it in 0.9% physiological saline at 25° C. for 10 minutes, and measuring the weight after absorption, respectively.

The degree of retention was measured by measuring the weight (weight before absorption) of the hemostatic sponge, immersing it in 0.9% physiological saline at 25°C for 10 minutes, and then applying a pressure of 40 mmHg to the absorbed porous structure (sponge) for 1 minute. Then, the weight (weight after pressing) of the porous structure was measured and calculated by the following formula.

For example, if the hemostatic pad (sponge) is 'a sponge made by freeze-drying a mixture of collagen, thrombin, and sodium CMC', the absorption degree is 18 and the retention degree is 12, which is 'made by freeze-drying the mixture of collagen and thrombin. It is much better than the case of 'sponge' (the degree of absorption and retention of liquid cannot be measured). Therefore, when the hemostatic agent (hemostatic sponge) contains a carboxymethyl cellulose-based compound such as Sodium CMC, it has excellent absorbency and excellent morphological stability to maintain a high level of liquid absorption characteristics even after pressurization, thereby exhibiting excellent liquid retention. This indicates that when the hemostatic pad according to the present invention is applied to a bleeding site, it can be in close contact with the bleeding site and can be prevented from floating upward by blood or the like from the bleeding site.

Next, the stirred mixture is poured into a tray and freeze-dried to prepare a sponge pad (S320). The sponge pad has a structure in which the pores are connected to each other (ie, a sponge structure) and is formed to be flat.

After the freeze-drying is completed, the sponge pad is cut into a rectangle of a predetermined width (S330). The width may be determined in consideration of the thickness of the sponge pad and the inner diameter of the tube 11 . That is, after the wound sponge pad is inserted into the tube 11 in a slightly compressed state, the sponge pad returns to its original state and generates a frictional force with the inner surface of the tube and can be fixed inside the tube 11, such frictional force The sponge pad can be cut so that it is wide enough for this to occur.

Then, the hemostatic pad 200 is manufactured by winding the cut sponge pad in a circle. 4 shows the hemostatic pad 200 that has been manufactured. When the hemostatic pad 200 is inserted into the tube 11 in a slightly compressed state, the hemostatic pad 200 returns to its original state and generates a frictional force with the inner surface of the tube, and thus the hemostatic pad 200 is fixed inside the tube. can On the other hand, when the hemostatic pad 200 is pushed down using the rod 31, the hemostatic pad 200 overcomes friction and is discharged downward.

The hemostatic pad discharged into the human body can be unfolded in its original state (flat state) by restoring force or unfolded in its original state by a user's manipulation using an endoscope. In addition, the unfolded hemostatic pad may be in close contact with the bleeding site by a user's manipulation.

Meanwhile, in the above description, the case where the hemostatic pad is prepared by freeze-drying a mixed solution of thrombin, collagen, and a carboxymethyl cellulose-based compound is described, but the present invention is not limited thereto and the hemostatic pad is a mixed solution containing a hemostatic component, for example, collagen A mixture of thrombin may be prepared by freeze-drying.

10: tube member 11: tube
12: hole 15: first handle
16: through hole 30: rod member
31: rod 32: second handle
100: a device for inserting a hemostatic pad into the body
200: hemostatic pad wound in a circle

Claims (11)

A tube member (10) formed to be elongated and having a first handle (15) at the top of the tube (11) and the tube (11) which is inserted into the trocar for laparoscopic surgery and is inserted into the abdominal cavity; and,
A rod 31 having a diameter inserted into the tube 11 and formed long in the longitudinal direction of the tube 11, and a rod member 30 having a second handle 32 at the top of the rod 31; includes;
The through-hole 16 is formed to penetrate the first handle 15 up and down, and the through-hole 16 is connected to and communicates with the tube 11,
In a state in which at least a portion of the tube 11 is inserted into the human body, the rod 31 is inserted into the tube 11 through the through-hole 16 to push the hemostatic pad inside the tube 11 down to the inside of the human body. discharged with
The hemostatic pad is made by lyophilizing a mixed solution having a hemostatic component, comprising a plurality of pores, and a sponge pad having a structure in which at least a portion of the pores are connected to each other is wound in a circle,
The wound hemostatic pad is inserted into the tube 11, and due to the frictional force between the hemostatic pad and the tube 11, the hemostatic pad is fixed inside the tube 11, but by the pushing force of the rod 31, the tube 11 ) is discharged downwards,
Holes 12 are formed at predetermined intervals in the longitudinal direction of the tube 11, and air can move in and out of the tube 11 through the holes 12,
The hemostatic pad has a certain cushion and restoring force, and after being inserted into the tube, frictional force with the tube is generated by the restoring force, so it is fixed inside the tube. A device for inserting a hemostatic pad into the human body, characterized in that it is flattened by the restoring force afterward. delete The method of claim 1,
The tube 11 is made of a transparent or translucent material, and the hemostatic pad inside the tube 11 is visible from the outside. delete The method of claim 1,
The hemostatic pad is a device for inserting a hemostatic pad into the human body, characterized in that it has a sponge structure made by freeze-drying a mixture of thrombin, collagen, and carboxymethyl cellulose-based compound. 6. The method of claim 5,
A device for inserting a hemostatic pad into the human body, characterized in that the thrombin per 1 mg of the hemostatic pad is 10 to 1000 IU, and the weight ratio of collagen to the carboxymethyl cellulose compound is 1:9 to 9:1. delete delete delete delete delete

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