JP2006349354A - Residual contaminant extracting bag of medical instrument, and residual contaminant extraction method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a residual contaminant extraction bag, suitable for easily and sure determining the presence of residual contaminants on medical instruments, cleaned after use by an extraction method. <P>SOLUTION: The residual contaminant extracting bag 1A, comprising a thermoplastic resin and having a contact bonding zipper 2 on the side of its opening part 1a, has a constricted part 3 of a bag inner space 10, on the way reaching the bottom part of the bag from the opening part 1a and the bag inner space 10 has a shape contracted to the constricted part 3 from the opening part 1a in its left and right width, and expanded toward the bottom part of the bag from the constricted part 3. When the residual contaminant extracting bag is used, an extraction liquid L is housed in the extraction bag 1A and opens the opening part 1a upward and a hemostatic forceps 20 is inserted in the extraction bag 1A from its clamp parts 22 and 22, while the pivotal part 24 of the hemostatic forceps 20 is positioned in the vicinity of the constricted part 3 and the clamp parts 22 and 22 are subjected to on-off operation by operating the handle parts 23 and 23 of the hemostatic forceps 20 that is out of the extraction bag 1A. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a medical device including medical forceps and the like, and a residual contaminant extraction bag used for examining the presence or absence of residual contaminants after cleaning after use, and a residue using this extraction bag The present invention relates to a contaminant extraction method.

  Equipment used repeatedly in the medical field, such as surgical instruments, adheres to body fluid components such as patient's blood and body tissue. For completeness, it is necessary to confirm that there is no residual contaminant before reuse. There are many methods for the confirmation, but the methods are roughly classified into a visual confirmation method, a wiping method, and an extraction method.

  In the visual confirmation method, in order to make it easy to visually recognize the dirt adhered to the surface of the equipment, it is common to apply a staining solution that is reactive or adsorbable to proteins and fats to the equipment surface. In the wiping method, the surface of the device is wiped with a cotton swab, and a coloring reagent such as a ninhydrin reagent that develops color in the presence of protein is dropped to check the presence or absence and degree of color development. A reagent is added to a test tube or the like to chemically measure substances such as proteins contained in the dirt.

  However, particularly in the case of a saddle-shaped surgical instrument such as forceps, the slidably contacting portion of the pivot pin in the pivot portion of the blade pair and the overlapping portion of the adjacent blades are less likely to have a cleaning effect in form. Contaminants are likely to be generated, but since these portions are not exposed to the outside, the presence or absence of residual contaminants cannot be determined by the visual confirmation method or the wiping method. Therefore, for this type of surgical instrument, the presence or absence of residual contaminants has been determined exclusively by the extraction method.

  In this extraction method, for example, a bag or syringe containing an extraction solution for protein extraction such as physiological saline, an aqueous solution of an anionic surfactant such as sodium dodecyl sulfate, and an alkaline aqueous solution is contained and sealed, It is common to add the operation of shaking the whole, shaking, or squeezing the bag to promote the movement of the liquid inside and elute the residual contaminants attached to the equipment.

  However, in the conventional extraction method, if the size of the device to be judged is large, the amount of the extracted liquid increases when the entire device is immersed. Therefore, if the amount of residual contaminants attached to the device is small, In addition, there is a problem that the concentration of contaminants eluted in the extract is lowered and the determination accuracy is deteriorated. In particular, the saddle-shaped surgical instrument requires a large extraction bag or syringe to accommodate the entire handle, including the handle, and the amount of extract used increases, but residual contaminants. Is a small amount adhering only to the sliding contact part of the pivot pin or the overlapping part of the adjacent blades, and the contaminant concentration of the extract is less than the detection limit due to the fact that it is difficult to extract structurally. However, the reliability of the judgment was poor.

  In view of the above situation, the present invention is intended to easily and reliably detect the presence or absence of residual contaminants for medical instruments that have undergone cleaning after use, in particular, scissors-shaped surgical instruments such as forceps. It is an object of the present invention to provide a residual contaminant extraction bag suitable for determination and a residual contaminant extraction method using the extraction bag.

  A residual contaminant extraction bag for a medical device according to claim 1 of the present invention is a bag made of a thermoplastic resin (residual contaminant) having a crimping zipper 2 on the opening 1a side, if indicated by the reference numeral in the drawing. Extraction bag 1A, 1B), which has a constricted portion 3 of the bag internal space 10 in the middle from the opening 1a to the bag bottom 1b, and the lateral width of the bag internal space 10 extends from the opening 1a to the constricted portion 3 And a shape that expands from the constricted portion 3 toward the bag bottom portion 1b.

  Further, the invention of claim 2 is configured such that in the residual contaminant extraction bag of claim 1, the extract L is enclosed in the bag.

  On the other hand, a residual contaminant extraction method for a medical instrument according to claim 3 of the present invention is directed to the opening 1a of the residual contaminant extraction bag 1A, 1B according to claim 1 or 2 containing the extract L. Opened from the opening 1a, a scissors-shaped medical surgical instrument (forceps 20) having a pair of blades 21 and 21 pivoted at an intermediate portion in the extraction bags 1A and 1B is opened at one end. Inserted from the clamps 22, 22), with the other end handles 23, 23 coming out of the extraction bag 1, the pivoting part 24 of the medical surgical instrument is connected to the constricted part 3 of the extraction bags 1 A, 1 B. It is characterized in that it is located in the vicinity and the action part is opened and closed by operating the handle parts 23 and 23.

  According to a fourth aspect of the present invention, in the residual contaminant extraction method according to the third aspect, the medical surgical instrument is a forceps (hemostatic forceps 20) or / and a needle holder.

  According to the residual contaminant extraction bag of the medical instrument according to the invention of claim 1 and the residual contaminant extraction bag of the medical instrument according to the invention of claim 4, the bag interior space of the residual contaminant extraction bag extends from the opening to the bottom of the bag. In order to provide a shape that is constricted in the middle, the scissors-shaped medical surgical instrument is inserted into the extraction bag containing the extract from the opening opened upward, and the other end side The part that can come into contact with bodily fluids and body tissues such as blood during use of the device by positioning the pivotally attached portion of the device in the vicinity of the constricted portion of the extraction bag with the handle portion of the device coming out of the extraction bag Can be opened and closed without any trouble, so that the residual contaminants in the vicinity of the pivot part of the instrument can be easily extracted with a small amount of the extract, even when the residual contaminants are small. It can be reliably detected.

  In addition, the residual contaminant extraction bag for the medical device according to the invention of claim 1 can be easily handled with the extract in the bag by sealing with a crimping zipper provided on the opening side. The extracted liquid after the operation can be transported to and stored in the inspection department while being stored in the extraction bag without being transferred to another container or the like.

  According to the invention of claim 3, since the extraction liquid is sealed in the residual contaminant extraction bag, when the presence or absence of residual contaminants in the medical surgical instrument is determined, the extraction liquid is injected into the extraction bag. There is an advantage that it is excellent in convenience at a medical institution because no operation is required and it can be used immediately by opening and opening the opening.

  According to the invention of claim 5, since the residual contaminant extraction bag is used for extracting residual contaminants of forceps and / or needle holders, the extraction operation can be performed easily and efficiently, and High reliability in determining the presence or absence of contaminants.

  Hereinafter, embodiments of a residual contaminant extraction bag and a residual contaminant extraction method using the extraction bag according to the present invention will be specifically described with reference to the drawings. FIG. 1 shows a residual contaminant extraction bag 1A of the first embodiment, FIG. 2 shows a residual contaminant extraction bag 1B of the second embodiment, and FIG. 3 shows a residual contaminant of a forceps using these residual contaminant extraction bags 1A and 1B. Each extraction method is shown.

  As shown in FIG. 1, the residual contaminant extraction bag 1A of the first embodiment is made of a slightly elongated rectangular and thick polyethylene bag, and a crimping zipper 2 is formed on the opening 1a side which is the upper side of the figure. The constricted portion 3 of the bag inner space 10 is formed on the way from the opening 1a to the bag bottom 1b by the pair of left and right rectangular heat seals 4 and 4 indicated by the satin in the figure. The left and right widths are reduced from the opening 1a toward the constricted portion 3, and are enlarged from the constricted portion 3 toward the bag bottom 1b. When the residual contaminant extraction bag 1A is used, the crimping zipper 2 is opened, and a predetermined amount of the required extraction liquid is injected into the bag inner space 10 from the opening 1a.

  In order to manufacture such a residual contaminant extraction bag 1A, a commercially available polyethylene bag having a crimping zipper 2 is used, and the left and right square heat seals 4 and 4 need only be applied to the bag by a heat sealer. Thus, the triangular spaces 5 and 5 between the left and right side edges of the bag and the heat seals 4 and 4 become a closed space that does not communicate with either the bag internal space 10 or the outside. The crimping zipper 2 has a groove portion where one side to be joined is continuous in the width direction, and the other side has a protruding edge that fits into the groove portion by forced press-fitting.

  As shown in FIG. 2, the residual contaminant extraction bag 1B of the second embodiment is a thick polyethylene bag provided with a crimping zipper 2 similar to the extraction bag 1A of the first embodiment. The edge 1c on the 2 side is sealed with a heat seal 6 in the left-right direction indicated by a matte surface in the figure, and about 2 to 5 ml of the extract L is enclosed in the bag space 10 in advance, and the broken line in the figure As shown by the cut line c shown in FIG. 1, the opening 1a is cut by cutting at a portion between the crimping zipper 2 and the heat seal 6. Thus, in the same way as the extraction bag 1A of the first embodiment, the bag inner space 10 is placed in the bag on the way from the opening 1a to the bag bottom 1b by a pair of left and right heat seals 4, 4. A constricted portion 3 of the space 10 is formed. In addition, b in a figure shows the bubble enclosed with the extract L. FIG.

  In order to manufacture the residual contaminant extraction bag 1B of the second embodiment, a commercially available polyethylene bag having the same crimping zipper 2 as that of the extraction bag 1A of the first embodiment is used. After applying the shape heat seals 4 and 4, a predetermined amount of the required extract L is injected into the in-bag space 10, and the opened edge 1 c side is sealed with the heat seal 6. .

  With respect to the method for extracting residual contaminants of a medical surgical instrument using the residual contaminant extraction bags 1A and 1B of the first and second embodiments, an example in which the medical surgical instrument is a hemostatic forceps 20 is shown in FIG. Will be described.

  The hemostatic forceps 20 is of a type called Kochel, and has a saddle shape in which a pair of blades 21 and 21 is pivotally attached at an intermediate portion via a pivot pin 24a, and one end side is a notch 22a on the opposite surface. Clamping parts 22, 22 engraved with the other end are ring-shaped handle parts 23, 23, and the locking protrusions that can be engaged with each other by engagement of tooth shapes at the bases of the handle parts 23, 23 The pieces 25 are projected inwardly facing each other. In the vicinity of the pivoting portion 24 of the hemostatic forceps 20, that is, the pivoting pin 24 a, there is a surface region in which both the blades 21, 21 overlap and are not exposed to the outside due to the width of both the blades 21, 21. . Thus, in such a hemostatic forceps 20, when used for surgery, the portions from the clamp portions 22, 22 to the pivot attachment portion 24 inevitably come into contact with body fluids and body tissues containing blood, such as proteins and fats. However, if the cleaning after use is incomplete, the form around the pivot pin 24a, between the blades 24, 24 of the pivot portion 24, and the notches 22a of the clamp portions 22, 22 ... Residual contaminants are likely to be generated in the groove and the like.

  In order to extract such residual contaminants, first, in the residual contaminant extraction bag 1A, about 2 to 5 ml of the required extraction liquid L is put into the bag space 10, and in the residual contaminant extraction bag 1B, a cut line c. The bag is cut in the vicinity, and as shown in the drawing, the clamp parts 22 and 22 of the hemostatic forceps 20 are inserted from the opening 1a which is opened with the crimping zipper 2 opened, and the pivoting part 24 is brought near the constricted part 3 Positioning, gripping the handle parts 23 and 23 outside the bag, and repeating the operation of opening and closing the clamp parts 22 and 22 as shown by the solid and broken lines in the figure.

  When residual contaminants are attached to the portions from the clamp portions 22 and 22 to the pivot attachment portion 24 of the hemostatic forceps 20, the residual contaminants are released from the surface of the hemostatic forceps 20 by the above operation, and the extract L To elute. Therefore, the presence or absence of residual contaminants can be determined by detecting contaminant-containing components such as proteins and fats contained in the extract L after this extraction operation using the necessary reagents and measuring instruments. Based on this, it is possible to evaluate the cleaning method after surgical use.

  Thus, in the residual contaminant extraction bags 1A and 1B, the bag interior space 10 has a shape confined in the middle from the opening 1a to the bag bottom 1b, and therefore the amount of the extract L stored in the bag. In spite of the decrease, the clamp portions 22 and 22 can be opened and closed without any trouble in a state where the portion that can come into contact with bodily fluids or body tissues containing blood in the operation is securely immersed in the extract L, As the opening / closing operation is repeated, rapid liquid movement between the upper and lower sides is repeated through the constricted portion 3, so that the space between the blades 21, 21 not exposed to the outside in the pivot attachment 24, the sliding contact portion of the pivot attachment pin 24 a, etc. The existing residual contaminants are also efficiently extracted, and the amount of the extract L is small, so that even if the amount of residual contaminants eluted is small, the concentration becomes high and can be reliably detected. Further, since the residual contaminant extraction bags 1A and 1B can be sealed by the crimping zipper 2 on the opening 1a side, the extract L can be easily handled in the state in which the extract L is contained, and the extract L after the extraction operation can be stored in another container. It is very convenient because it can be transported to and stored in the inspection department while in a bag without being transferred to the same place.

  The extraction liquid L may be any liquid agent that can extract residual contaminants after washing the medical surgical instrument to be extracted, and various types can be used depending on the type of the residual contaminants. Solutions suitable for extraction of protein stains such as saline, aqueous anionic surfactants such as sodium dodecyl sulfate, and aqueous alkaline solutions are used. In addition, in the extract L, a PH indicator is added to check whether the residual contaminant is an alkaline component or an acidic component, and a Ca detection reagent is added to detect the presence of calcium by color change. Additives may be blended to obtain other findings simultaneously with the determination of the presence or absence of residual contaminants. Furthermore, in the case of an extract that does not use a surfactant, it is possible to investigate whether the rinse property after washing is good or bad by measuring the surfactant component after extraction.

  In addition, as a method for detecting proteins and the like, for example, a staining solution that is reactive or adsorbable to proteins and fats such as Amido Black 10B (a dark blue acidic dye that quantitatively binds to amino groups of proteins under acidic conditions) is used. Dye detection method to be used, occult blood reaction method to examine degree of color development by immersion of occult blood test paper using oxidase of oxidase contained in hemoglobin in blood, ATP (adenosine triphosphate) in residual contaminants as indicators There are ATP measurement methods, chemical analysis methods using various analyzers such as protein quantification by fluorescence analysis, and the like.

  The medical surgical instrument to which the residual contaminant extraction bag and the residual contaminant extraction method of the present invention are applied is a saddle-shaped device in which a pair of blades is pivotably attached at an intermediate portion, and is not limited to the illustrated hemostatic forceps, Vascular forceps, tube forceps, round chisel forceps, peeling / bonding forceps, organ / tissue gripping forceps, bulldog forceps, tongue forceps, forceps such as Magille catheter introduction forceps, needle holders, bone scissors, delicate scissors, incision scissors And scissors such as surgical scissors, deep surgical scissors, and gynecological surgical scissors. However, the present invention is particularly applicable to forceps and needle holders, and scissors require careful handling so that the extraction bag is not torn with a sharp blade edge. The residual contaminant extraction bag of the present invention is not necessarily applicable, but can also be used for extracting residual contaminants of other medical surgical instruments that are not saddle-shaped such as tweezers.

  What is necessary is just to set the magnitude | size of the residual contaminant extraction bag of this invention according to the size of the scissors-shaped medical operation instrument used as extraction object, and the position of a pivot part, but generally 5-15 cm long, The width is about 3 to 8 cm. Moreover, the range of the extract liquid accommodated in a bag is good about 1-10 ml. Thus, if the extraction liquid L is preliminarily sealed as in the residual contaminant extraction bag 1B of the second embodiment, the extraction liquid is not injected into the extraction bag when used, and the bag is opened. Since it can be used immediately just by opening the opening, convenience in medical institutions is further improved. The material of the extraction bag is preferably a thermoplastic resin such as polyethylene or polypropylene from the advantage that the constricted portion can be easily formed by heat sealing.

It is a front view which shows 1st embodiment of the residual contaminant extraction bag of the medical device which concerns on this invention. It is a front view showing a second embodiment of the residual contaminant extraction bag. It is a front view which shows the residual contaminant extraction method of the medical device which concerns on this invention.

Explanation of symbols

1A, 1B Residual contaminant extraction bag (bag)
DESCRIPTION OF SYMBOLS 1a Opening part 1b Bag bottom part 10 Bag inner space 2 Crimping zipper 3 Constriction part 4 Heat seal 20 Hemostatic forceps (acupuncture type instrument for medical operation)
21 Blade 22 Clamp part (action part)
23 handle part 24 pivot part 24a pivot pin L extract

Claims (5)

  A bag provided with an opening on the upper side, and has a constricted portion of the space in the bag in the middle from the opening to the bottom of the bag on the lower side, and the lateral width of the space in the bag is from the opening to the constricted portion A residual contaminants extraction bag for a medical device that has a shape that shrinks toward the bottom and expands from the constricted portion toward the bottom of the bag.   The bag of Claim 1 which consists of a thermoplastic resin provided with the crimping | compression-bonding zipper in the opening part.   The medical device residual contamination extraction bag according to claim 1 or 2, wherein the extraction liquid is sealed in the bag.   The opening of the residual contaminant extraction bag according to any one of claims 1 to 3 containing the extraction liquid is opened upward, and the blade pair can be freely opened and closed at the intermediate portion from the opening into the extraction bag. Insert the pivoted saddle-shaped medical surgical instrument from the working part on one end side, and hold the pivot part of the medical surgical instrument on the extraction bag with the handle on the other end coming out of the extraction bag. A method for extracting residual contaminants of a medical instrument, wherein the operating part is opened and closed by operating the handle part. The method for extracting residual contaminants of a medical instrument according to claim 4, wherein the medical instrument is a forceps or / and a needle holder.

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