JP2017051408A - Medicine subcutaneous infusion system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medicine subcutaneous infusion system with a reduced pain in administration of a medicine and a reduced infection risk.SOLUTION: The system comprises: a cylinder 2 with a first opening 3 and a second opening 4; and a self sealing film 5 fixed to the first opening 3 so as to seal the first opening 3. The system can be indwelled such that the self sealing film 5 may be located outside the body of a patient when the second opening 4 is located in a subcutaneous tissue C.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a subcutaneous drug injection system.

  2. Description of the Related Art Conventionally, an injection port that is placed under the skin of a patient in order to repeatedly administer a drug to the patient using a syringe is known (for example, see Patent Document 1). There is also known a medical device that has a port to which a syringe can be connected and a catheter connected to the port, and can be adhered to the patient's skin surface with the tip of the catheter held subcutaneously (for example, Patent Document 2).

US Pat. No. 5,137,529 International Publication No. 2008/114218

Since the injection port disclosed in Patent Document 1 is used in a state where it is implanted subcutaneously, it is possible to send a daily life while indwelling. However, in the case of injecting a drug into the injection port disclosed in Patent Document 1, since the injection needle is inserted so as to penetrate the skin and the septum, there is a pain when the drug is administered.
In addition, the device disclosed in Patent Document 2 includes a stopper that covers a port for attaching a syringe to a catheter when not in use. However, there is a possibility that the inside of the port may be contaminated when the stopper is attached / detached. Is expensive.

  The present invention has been made in view of the above-described circumstances, and an object of the present invention is to provide a subcutaneous drug injection system with low pain at the time of drug administration and low risk of infection.

  One aspect of the present invention includes a cylindrical portion having a first opening and a second opening, and a self-sealing film fixed to the first opening so as to seal the first opening, A subcutaneous drug injection system characterized in that the self-sealing membrane can be placed outside the body when the opening is located in the skin.

  The cylindrical portion may have an inner tapered portion whose inner diameter gradually decreases from the first opening toward the second opening.

  The cylindrical portion may have a straight tubular shape on the first opening side and a curved tubular shape on the second opening side.

  The cylinder part may have an anchor extending from the outer periphery of the cylinder part toward the radially outer side of the cylinder part between the first opening and the second opening.

  The subcutaneous drug injection system of the above aspect may further include an adhesive layer that is interposed between the self-sealing film and the first opening and is larger than the outer diameter of the cylindrical portion in the first opening.

  The adhesive layer may be breathable and waterproof.

  The cylindrical portion may have an outer tapered portion whose outer diameter gradually decreases from the first opening toward the second opening.

  The subcutaneous drug injection system according to the aspect described above may further include a one-way valve that seals the second opening of the cylindrical portion and can send liquid from the second opening to the outside of the cylindrical portion. .

  The cylindrical portion may include at least one of stainless steel, cobalt alloy, titanium, and titanium alloy.

  According to the present invention, it is possible to provide a subcutaneous drug injection system with less pain when administering a drug and a low risk of infection.

It is sectional drawing which shows the subcutaneous medicine injection system of 1st Embodiment of this invention in the cross section containing the centerline of a pipe part. It is sectional drawing which shows the subcutaneous medicine injection system of the modification of the embodiment in the cross section containing the centerline of a pipe part. It is sectional drawing which shows the subcutaneous medicine injection system of 2nd Embodiment of this invention by the cross section containing the centerline of a pipe part. It is sectional drawing which shows the subcutaneous medicine injection system of the modification of the embodiment in the cross section containing the centerline of a pipe part. It is sectional drawing which shows the subcutaneous medicine injection system of 3rd Embodiment of this invention in the cross section containing the centerline of a pipe part. It is sectional drawing which shows the subcutaneous medicine injection system of 4th Embodiment of this invention by the cross section containing the centerline of a pipe part. It is sectional drawing which shows the subcutaneous medicine injection system of 5th Embodiment of this invention in the cross section containing the centerline of a pipe part.

(First embodiment)
A first embodiment of the present invention will be described. FIG. 1 is a cross-sectional view showing the subcutaneous drug injection system of the present embodiment in a cross section including the center line of the tube portion.
As shown in FIG. 1, the subcutaneous drug injection system 1 of this embodiment is a system for injecting a drug solution into the subcutaneous tissue C in a state of being implanted so as to penetrate the epidermis A and dermis B to reach the subcutaneous tissue C. It is.
The subcutaneous drug injection system 1 according to the present embodiment includes a cylindrical portion 2, a self-sealing film 5, and an adhesive layer 6.

  The cylindrical portion 2 is formed in a cylindrical shape having a first opening 3 and a second opening 4. The dimension of the cylinder part 2 is such that the first opening 3 is located outside the body when the second opening 4 is located in the subcutaneous tissue, depending on the site where the cylinder part 2 is assumed to be placed. Is done. For example, the cylinder part 2 has a length in the center line direction of 2 mm or more and 3 mm or less.

  The cylinder part 2 has biocompatibility. For example, the material of the cylinder part 2 may include at least one of stainless steel, cobalt alloy, titanium, and titanium alloy. Moreover, the cylinder part 2 may consist of resin which has biocompatibility. Moreover, the material of the cylinder part 2 may contain ceramics. Moreover, the cylinder part 2 may consist of the composite material with which said metal, resin, and ceramics were combined. For example, when a hard metal material is used in the vicinity of the first opening 3 of the cylindrical portion 2 and a flexible resin material is used in the vicinity of the second opening 4 of the cylindrical portion 2, the cylindrical portion 2 is placed in the patient. When this is done, the vicinity of the second opening 4 is less likely to irritate the patient's tissue.

  The self-sealing film 5 is an elastic member that can be punctured by the injection needle 7 and that seals the first opening 3 after the injection needle 7 is removed. In addition, the self-sealing film 5 is capable of being adhered to the outer surface of the injection needle 7 so that it is difficult to scrape when puncturing with the injection needle 7 and the drug solution is difficult to leak between the injection needle 7 and the self-sealing film 5. Is preferred. The sealing performance of the self-sealing film 5 has sufficient durability for a plurality of punctures during a period in which the subcutaneous drug injection system 1 is placed on a patient and used, and the plurality of times Even if the puncture is performed, the entry of bacteria or the like through the self-sealing film 5 does not substantially occur. For example, the self-sealing film 5 is preferably configured so that infection caused by bathing of the patient, cleaning of the indwelling site, and the like is unlikely to occur.

The adhesive layer 6 is interposed between the self-sealing film 5 and the cylinder part 2, and adheres the self-sealing film 5 to the cylinder part 2, and the subcutaneous drug injection system 1 of the present embodiment is attached to the patient's skin. It is a layer having adhesiveness to adhere to the surface.
The adhesive layer 6 has an adhesive surface larger than the outer diameter of the first opening 3. The portion of the adhesive surface of the adhesive layer 6 outside the first opening 3 is large enough to cover the incised portion of the patient's skin when the subcutaneous drug injection system 1 is placed in the patient. Is preferred.
The pressure-sensitive adhesive layer 6 has air permeability and waterproofness. Thereby, the adhesion layer 6 is hard to inhibit the fusion | bonding of the incision part of a patient's skin.

  The self-sealing film 5 or the adhesive layer 6 may have a hardness that is unlikely to be deformed due to an increase in internal pressure of the cylindrical portion 2. For example, the self-sealing film 5 may be flexible and the adhesive layer 6 may be hard, or conversely, the self-sealing film 5 may be hard and the adhesive layer 6 may be flexible.

The operation of the subcutaneous drug injection system 1 of this embodiment will be described.
In order to place the subcutaneous drug injection system 1 in a patient, first, the patient's skin is incised, and the cylindrical portion 2 is inserted until the second opening 4 reaches the skin. Next, by attaching the adhesive layer 6 to the skin surface so that the adhesive layer 6 adhered to the first opening 3 covers the incised portion of the patient's skin, the incised portion is hemostatic, and infection through the incised portion is prevented. Can prevent.
Thus, the subcutaneous drug injection system 1 of this embodiment is placed in a state where the second opening 4 is located subcutaneously and the self-sealing film 5 is located outside the body.
In addition, after the placement of the subcutaneous drug injection system 1, the inside of the cylinder portion 2 may be filled with physiological saline or other liquid as necessary so that air does not remain in the cylinder portion 2.

When a drug solution is injected subcutaneously using the subcutaneous drug injection system 1 of the present embodiment, a necessary amount of drug solution is sucked into a syringe 8 to which the injection needle 7 is attached, and the injection needle 7 is inserted into the self-sealing film 5. Then, the chemical solution is injected into the cylinder portion 2. By puncturing the injection needle 7 to such a depth that the tip of the injection needle 7 does not reach the subcutaneous tissue, the injection needle 7 does not contact the patient's tissue and pain does not occur. When the chemical solution is injected into the cylinder portion 2 using the syringe 8, the self-sealing film 5 is pushed by the injection needle 7, and the chemical solution in the cylinder portion 2 moves the self-sealing film 5 into the cylinder portion 2. Deformation hardly occurs due to the pushing force toward the outside.
When the chemical solution in the syringe 8 is injected into the cylindrical portion 2, the chemical solution in the cylindrical portion 2 diffuses from the second opening 4 to the subcutaneous tissue. Thereby, administration similar to subcutaneous injection is possible.

  After indwelling of the subcutaneous drug injection system 1, the inside of the cylindrical portion 2 is filled with a liquid such as a drug solution, a tissue solution, or the above-described physiological saline. At the time of the second and subsequent drug injections using the subcutaneous drug injection system 1, the same amount of liquid as that injected into the cylinder portion 2 moves from the second opening 4 to the subcutaneous tissue. In a plurality of times of injecting the chemical solution, the amount of the active ingredient in the liquid that moves from the cylindrical portion 2 to the subcutaneous tissue is substantially constant. Further, when the chemical liquid is not injected into the cylindrical portion 2, there is no pressure difference between the inside and the outside of the cylindrical portion 2, and the chemical liquid remains in the cylindrical portion 2.

  As described above, the subcutaneous drug injection system 1 of the present embodiment has less pain at the time of drug administration because the injection needle 7 does not contact the patient when the drug solution is injected. Furthermore, since the self-sealing film 5 prevents the internal and external communication of the cylindrical part 2 after the injection of the chemical solution using the injection needle 7 in the subcutaneous drug injection system 1 of the present embodiment, the inside of the cylindrical part 2 is kept clean. Risk is low.

  In addition, in the subcutaneous drug injection system 1 of the present embodiment, if the injection needle 7 having an appropriate length is used, the tip of the injection needle 7 does not contact the subcutaneous tissue when the injection needle 7 is inserted into the cylindrical portion 2. Even if an accidental needle stick occurs due to the injection needle 7 after the injection of the chemical solution, the risk of infection is low.

  In addition, in the subcutaneous drug injection system 1 of the present embodiment, if the injection needle 7 having an appropriate length is used, the tip of the injection needle 7 does not contact the subcutaneous tissue when the injection needle 7 is inserted into the cylindrical portion 2. The injection needle 7 after the injection of the chemical solution can be disposed as non-infectious waste.

  In addition, in the subcutaneous drug injection system 1 of the present embodiment, there is no need to puncture the skin tissue after the subcutaneous drug injection system 1 is placed, so that even when multiple drug administrations are performed, scars on the patient's skin are present. Hard to occur.

  Note that the subcutaneous drug injection system 1 of the present embodiment can be extracted from the subcutaneous tissue as necessary.

(Modification)
A modification of the first embodiment will be described. FIG. 2 is a cross-sectional view showing the subcutaneous drug injection system of the present modification in a cross section including the center line of the tube portion.
As shown in FIG. 2, in this modification, a flange 9 is formed in the first opening 3 of the cylindrical portion 2.
The flange 9 abuts on the skin surface of the patient so as to prevent the tube portion 2 from being buried in the subcutaneous tissue.
According to the configuration of this modification, it is possible to prevent the cylindrical portion 2 from being displaced when the patient moves the body.
As another configuration example of the present modification, the adhesive layer 6 disclosed in the first embodiment may be provided on the lower surface 9a of the flange 9 (surface directed to the skin surface). In this case, the self-sealing film 5 may be directly fixed to the upper surface 9 b of the flange 9.

(Second Embodiment)
A second embodiment of the present invention will be described. In each embodiment described below, the same components as those disclosed in the first embodiment are denoted by the same reference numerals as those in the first embodiment, and redundant descriptions are omitted. FIG. 3 is a cross-sectional view showing the subcutaneous drug injection system of the present embodiment in a cross section including the center line of the tube portion.

As shown in FIG. 3, the subcutaneous drug injection system 10 of this embodiment includes a cylindrical portion 11 having an inner surface shape different from that of the cylindrical portion 2 disclosed in the first embodiment, and the cylindrical portion disclosed in the first embodiment. Instead of 2.
The cylindrical portion 11 has an inner tapered portion 13 whose inner diameter gradually decreases from the first opening 3 toward the second opening 4.

  The inner tapered portion 13 has a trumpet shape, the inner diameter of the first opening 3 is the largest, and the inner diameter is the largest between the first opening 3 and the second opening 4 (for example, the position indicated by reference numeral 12 in FIG. 3). It is getting smaller. The second opening 4 side of the inner tapered portion 13 may be a cylinder having a constant inner diameter.

  When using the subcutaneous drug injection system 10 of this embodiment, the injection needle 7 is punctured into the self-sealing film 5 as in the first embodiment. At this time, since the cylindrical portion 11 has the inner tapered portion 13, the first opening 3 has a large diameter, so that the injection needle 7 can be easily inserted. For example, when a patient self-injects a drug solution, there may be a case where an appropriate puncture position with respect to the self-sealing film 5 cannot be accurately punctured. However, in the present embodiment, the first opening 3 has a large diameter. But it can be punctured easily.

  Moreover, the 2nd opening 4 is the same thin cylinder shape as said 1st Embodiment, and the invasiveness with respect to the patient tissue at the time of indwelling is low.

(Modification)
A modification of the second embodiment will be described. FIG. 4 is a cross-sectional view showing the subcutaneous drug injection system of the present modification in a cross section including the center line of the tube portion.
As shown in FIG. 4, in the present modification, the cylindrical portion 11 has an outer tapered portion 14 whose outer diameter gradually decreases from the first opening 3 toward the second opening 4.
The outer tapered portion 14 has a trumpet shape that follows the inner tapered portion 13.
In the present modification, the inner diameter of the first opening 3 can be ensured to be large, and the volume occupied by the buried portion in the body can be reduced, and the invasiveness to the patient is low. Moreover, since the outer side taper part 14 is a trumpet shape, the outer surface of the cylinder part 11 is hard to irritate | stimulate a patient's tissue.

(Third embodiment)
A third embodiment of the present invention will be described. FIG. 5 is a cross-sectional view showing the subcutaneous drug injection system of the present embodiment in a cross section including the center line of the tube portion.
As shown in FIG. 5, the subcutaneous drug injection system 15 of this embodiment includes a cylindrical portion 16 having a shape different from that of the cylindrical portion 2 disclosed in the first embodiment, and the cylindrical portion 2 disclosed in the first embodiment. It has instead of.
The cylindrical portion 16 has a straight tubular shape on the first opening 3 side and a curved tubular shape on the second opening 4 side. For example, in the cylindrical portion 16, the opening direction of the second opening 4 is shifted by 90 degrees with respect to the opening direction of the first opening 3.

  The curved annular portion 17 in the cylindrical portion 16 serves as a stopper for removing the cylindrical portion 16 after the placement of the subcutaneous drug injection system 15, and the distal end of the injection needle 7 is attached to the subcutaneous tissue when the injection needle 7 is inserted into the cylindrical portion 16. It functions as a wall that protects the tissue from the injection needle 7 to prevent contact. When the drug solution is injected into the tube portion 16 of the present embodiment, the drug solution moves from the second opening 4 to the subcutaneous tissue as in the first embodiment.

  In the subcutaneous drug injection system 15 of the present embodiment, since the tip of the injection needle 7 does not contact the subcutaneous tissue when the injection needle 7 is inserted into the cylindrical portion 16, an accidental needle stick is accidentally caused by the injection needle 7 after injection of the drug solution. Even if it happens, the risk of infection is low.

  In the subcutaneous drug injection system 15 of the present embodiment, since the tip of the injection needle 7 does not contact the subcutaneous tissue when the injection needle 7 is inserted into the cylindrical portion 16, the injection needle 7 after injection of the drug solution is replaced with non-infectious waste. Can be disposed of as.

(Fourth embodiment)
A fourth embodiment of the present invention will be described. FIG. 6 is a cross-sectional view showing the subcutaneous drug injection system of the present embodiment in a cross section including the center line of the tube portion.
As shown in FIG. 6, the subcutaneous drug injection system 18 of the present embodiment includes a cylindrical portion 19 having a shape different from that of the cylindrical portion 2 disclosed in the first embodiment, and the cylindrical portion 2 disclosed in the first embodiment. It has instead of.
The cylindrical portion 19 has an anchor 20 extending from the outer periphery of the cylindrical portion 19 toward the radially outer side of the cylindrical portion 19 between the first opening 3 and the second opening 4.
The anchor 20 has an annular plate shape, for example, and is formed on the outer periphery of the cylindrical portion 19. The anchor 20 is disposed, for example, between the patient's epidermis A and dermis B (see FIG. 6) or subcutaneously (not shown). The anchor 20 functions as a retainer after the subcutaneous drug injection system 18 is placed in the patient.

(Fifth embodiment)
A fifth embodiment of the present invention will be described. FIG. 7 is a cross-sectional view showing the subcutaneous drug injection system of the present embodiment in a cross section including the center line of the tube portion.
As shown in FIG. 7, the subcutaneous drug injection system 21 of the present embodiment seals the second opening 4 of the cylindrical portion 2 and can send liquid from the second opening 4 to the outside of the cylindrical portion 2. A passage valve 22 is further provided.
The one-way valve 22 opens when a pressure difference between the inside and the outside of the cylinder part 2 is generated and the internal pressure of the cylinder part 2 becomes high, and when there is no pressure difference between the inside and outside of the cylinder part 2, and the inside of the cylinder part 2 is better. Closed when the pressure is lower than the outside of the tube part 2.
That is, in this embodiment, when the internal pressure of the cylinder part 2 is increased by the injection of the chemical liquid into the cylinder part 2, the same amount of the chemical liquid as the injection amount of the chemical liquid is transferred from the cylinder part 2 to the subcutaneous tissue. And the chemical | medical solution which transfered to the subcutaneous tissue cannot be returned in the cylinder part 2, but is absorbed by the subcutaneous tissue.

  According to the subcutaneous drug injection system 21 of the present embodiment, the drug solution remaining in the tube part 2 remains in the tube part 2 without diffusing into the subcutaneous tissue, and moves to the subcutaneous tissue at the next drug solution injection. Thereby, in this embodiment, a chemical | medical solution is inject | poured into a subcutaneous tissue at the time of injection | pouring of the chemical | medical solution using the injection needle 7, and after the injection | pouring using the injection needle 7 is complete | finished, the transfer of a chemical | medical solution to a subcutaneous tissue does not occur. As a result, in the subcutaneous administration using the subcutaneous drug injection system 21 of the present embodiment, the drug solution can be injected into the subcutaneous tissue at the same timing as the normal subcutaneous administration using the injection needle 7.

As mentioned above, although embodiment of this invention was explained in full detail with reference to drawings, the concrete structure is not restricted to this embodiment, The design change etc. of the range which does not deviate from the summary of this invention are included.
For example, an injection needle that punctures the subcutaneous drug injection system of the present embodiment and injects a drug solution into a cylinder part may have a needle tube and a cylindrical leak-proof member that is in close contact with the outer periphery of the needle tube. The leak-proof member has a function of pressing down a chemical solution that leaks from between the self-sealing film and the needle tube by being in close contact with the self-sealing film.
In addition, if the length of an injection needle is appropriate, even if it pushes a well-known injection needle into a self-sealing film | membrane to the root, it can hold down a chemical | medical solution similarly.

  Further, the tip of the injection needle is not necessarily sharp as long as it can penetrate the self-sealing film and the adhesive layer. For example, an introduction hole for insertion of an injection needle is formed in advance in the self-sealing film and the adhesive layer, and the introduction hole may have a self-sealing function. In this case, when the tip of the injection needle is not sharp, a needle stick accident does not occur. In this case, the injection needle may not be made of metal.

  The subcutaneous drug injection system may be placed so that the position of the second opening is between the epidermis and the dermis.

  In addition, the adhesive layer may have a multilayer structure including a continuous adhesive layer that is always attached to the patient's skin surface and a renewal layer that is always overlapped with the adhesive layer. In this case, an indwelling site can be kept clean by always peeling off the replacement layer from the always applied layer and applying a new replacement layer each time.

  Moreover, it replaces with providing a self-sealing film | membrane and an adhesion layer, and may have the replaceable septum in a cylinder part. Further, the septum may be removed from the cylindrical portion so that the septum and the inside of the cylindrical portion can be sterilized.

In addition, the constituent elements shown in the above-described embodiments and modifications can be combined as appropriate.
In addition, the design change etc. with respect to the said specific structure are not limited to the said matter.

DESCRIPTION OF SYMBOLS 1 Subcutaneous medicine injection system 2 Cylinder part 3 1st opening 4 2nd opening 5 Self-sealing film 6 Adhesive layer 7 Injection needle 8 Syringe 9 Flange 10 Subcutaneous medicine injection system 11 Cylinder part 13 Inner taper part 14 Outer taper part 15 Subcutaneous medicine Injection system 16 Tube portion 17 Curved annular portion 18 Subcutaneous drug injection system 19 Tube portion 20 Anchor 21 Subcutaneous drug injection system 22 One-way valve

Claims (9)

A cylindrical portion having a first opening and a second opening;
A self-sealing film fixed to the first opening so as to seal the first opening;
With
A subcutaneous drug injection system, wherein the self-sealing film can be placed outside the body when the second opening is located in the skin. The subcutaneous drug injection system according to claim 1, wherein the cylindrical portion has an inner tapered portion whose inner diameter gradually decreases from the first opening toward the second opening. The subcutaneous drug injection system according to claim 1, wherein the cylindrical portion has a straight tubular shape on the first opening side and a curved tubular shape on the second opening side. The subcutaneous drug injection system according to claim 1, wherein the tubular portion has an anchor between the first opening and the second opening that extends from the outer periphery of the tubular portion toward the radially outer side of the tubular portion. The subcutaneous drug injection system according to claim 1, further comprising an adhesive layer that is interposed between the self-sealing film and the first opening and is larger than an outer diameter of the cylindrical portion in the first opening. The subcutaneous drug injection system according to claim 5, wherein the adhesive layer has air permeability and waterproofness. The subcutaneous drug injection system according to claim 1, wherein the cylindrical portion has an outer tapered portion whose outer diameter gradually decreases from the first opening toward the second opening. The subcutaneous drug injection system according to claim 1, further comprising a one-way valve that seals the second opening of the tubular portion and is capable of feeding a liquid from the second opening to the outside of the tubular portion. The subcutaneous drug injection system according to claim 1, wherein the cylindrical portion includes at least one of stainless steel, cobalt alloy, titanium, and titanium alloy.

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