JP5185597B2 - Blood purification circuit - Google Patents

Description

  The present invention relates to a blood purification circuit used across both clean and unclean areas in a treatment room where PCI and preoperative examinations are performed.

  PCI (Percutaneous Coronary Intervention) is a technique for stenosis or occlusion of a blood vessel when stenosis or occlusion occurs in a blood vessel such as a blood vessel or when a blood vessel is occluded by a thrombus. Widely used as a safe and effective treatment method for expanding and improving blood flow on the peripheral side of blood vessels.

  PCI is known as a minimally invasive treatment method because it does not require laparotomy or thoracotomy unlike a general surgical operation, and thus places little burden on the patient.

  In general surgery, in order to prevent infection from surgical wounds, parts that touch or may touch a patient's surgical wound, such as an operator's hand or surgical instrument, are subjected to aseptic operation and a high degree of cleanliness. Is maintained. Such a clean area is called a clean field.

  On the other hand, PCI requires only a small incision site, so it is not necessary to perform thorough hygiene management unlike an operating room. Therefore, PCI is usually performed in a treatment room where no special hygiene management is performed. It is common. In such a treatment room, PCI is operated as a clean field only on the patient's bed (operating table).

  Contrast media are widely used as an indispensable drug in PCI and preoperative examinations, but in recent years, it is known that the side effects of contrast media become a problem for patients with impaired renal function. . For this reason, efforts have been made to minimize the use of contrast media as much as possible, but imaging for difficult lesions such as left main coronary artery (LMT) lesions and chronic total occlusion (CTO) lesions, and metals that require detailed confirmation A large amount of contrast medium is required for confirmation of placement of a stent or a drug release stent (DES).

  The side effects of contrast agents include renal dysfunction, skin disorders, cardiovascular disorders, respiratory disorders, urinary disorders, etc., but in recent years, the number of patients who have diabetes combined with patients undergoing PCI is increasing. Among the side effects, renal dysfunction (contrast-induced nephropathy) is particularly problematic. The use of contrast media in patients with impaired renal function such as renal failure is particularly serious because it is not rapidly excreted from the body. In order to solve such problems, it is necessary to use a blood purification circuit in the treatment room when blood purification is performed for the purpose of removing the administered contrast medium from the body during PCI and preoperative examination. is there.

  In general, the treatment room is not specially hygienically managed, and the actual situation is that the spaces other than the limited clean field are unclean fields that are not specially hygienically managed. The catheter operation itself in PCI is performed in a clean field by an operator such as a cardiologist, but the operation of a radiation monitoring apparatus using a contrast agent is generally performed in an unclean field by a professional engineer. It is.

  Further, in the blood purification apparatus for the purpose of removing the contrast agent, the blood purification circuit is connected to the patient for blood removal from the patient and blood return to the patient, and the patient's bed (operating table), that is, It is necessary to get on the clean field. The other side of the circuit is connected to the blood purification apparatus, but it is considered unclean because it is impossible to keep the area around the blood purification apparatus clean. The blood purification apparatus is operated by an operator other than an operator such as a cardiologist. The blood purification circuit must be cleaned and primed before use in the clean field after the outer sterilization package is removed, and these operations are also performed by operators other than the clean operator who performs the clean operation. Will be implemented. However, in a dedicated circuit corresponding to a normal blood purification device, the dedicated circuit is installed in the blood purification device and removed from a sterilization bag for cleaning and priming, thereby connecting to the patient (for blood removal) Circuit and blood return circuit), that is, the portion operated in the clean field is exposed to the unclean field. In addition, a clean operator who performs a clean operation or another clean operator cleans and primes the circuit consisting only of the part connected to the patient in the clean field, and then creates a dedicated circuit corresponding to the blood purification device. It is possible to connect from the other side, but it is not realistic because of time and effort. To date, there has been no blood purification circuit that can be used across both clean and dirty areas in the treatment room, and blood purification has been performed to remove administered contrast media from the body during PCI and preoperative examinations. It was difficult to do. Although PCI does not require any special hygiene management, it is necessary to clarify the boundary between the clean field and the unclean field, but the blood purification circuit that can be used across the clean field and unclean field therapy in the treatment room Since there is a risk that the boundary between the clean field and the unclean field will be ambiguous, the entire device should be installed in a highly controlled treatment room such as an operating room, or exposed to the unclean field The only way was to sterilize by wiping with a disinfecting cloth.

  Another approach is to dock the clean and unclean parts before the PCI operation. However, when a circulatory physician in the clean field operates, there is a concern that the level of sterilization of the circulatory physician itself may decrease, while infectious pathogens contained in the blood are scattered in the unclean field. There is a danger that it will end up. In addition, it took time to integrate the parts and there was concern about the airtightness between the parts.

  In view of such problems, the present invention provides a blood circuit that can be used across both the clean field and the unclean field in a treatment room, and more specifically, a blood purification circuit.

  As a result of intensive studies by the present inventors in order to solve the above problems, the present inventors have invented the blood purification circuit of the present invention.

That is, the present invention is a blood purification circuit used across a clean field and an unclean field in a treatment room where PCI and preoperative examination are performed, and an outer surface of a portion operated in the clean field is internally sterilized. The circuit covered by packaging, wherein the part operated in the unclean field and the part operated in the clean field are covered and sterilized as a continuous circuit by the outer sterilization package The outer surface of the portion operated in the clean field relates to a blood purification circuit that can be maintained in a clean state even in the operation in the unclean field.

  The present invention also provides a blood purification circuit comprising a part operated in a clean field and a part operated in an unclean field, wherein the outer surface of the part operated in the clean field is covered with an inner sterilization package. In particular, the present invention relates to a blood purification circuit characterized in that a portion operated in an unclean field and a portion operated in a clean field are covered with an external sterilization package and sterilized as a continuous circuit.

  The present invention also relates to a blood purification circuit used across a clean field and an unclean field in a treatment room where PCI and preoperative examinations are performed. The circuit is operated in the clean field and the unclean field. The part to be operated is connected by the boundary mark member, the part operated by the boundary mark member and the clean field is covered by the inner sterilization packaging, and the part operated by the clean field and the part operated by the unclean field It is related with the circuit for blood purification characterized by being covered with outer sterilization packaging.

  The present invention also relates to a blood purification circuit characterized in that the inner sterilization package can be removed without touching the outer surface of a portion operated in a clean field.

  By means for solving the above problems, the blood purification circuit of the present invention is used across the clean field and the unclean field in the treatment room where PCI and preoperative examination are performed, and is operated in the clean field of the circuit. Operation in the clean field before use in the clean field after the outside sterilization package is removed by the operator of the blood purification device other than the clean operator who performs the clean operation without the outer surface of the part to be cleaned That is, cleaning and priming can be performed.

  Also, an operator other than the clean operator who performs the clean operation removes the inner sterilization package without touching the outer surface of the part operated in the clean field in the circuit, and cleans the clean operator in the clean field. The part operated in the field can be handed over, and a clean state can be maintained in the connection operation to the patient in the clean field.

  And a blood purification circuit that can be used across both the clean field and the unclean field in a treatment room, and in the treatment room, during the implementation of PCI and preoperative examination, an imaging that may cause an impaired renal function. Blood purification can be easily performed for the purpose of removing the agent from the body.

  A schematic diagram of one embodiment of a blood purification circuit according to the present invention is shown in FIG. A blood purification circuit 01 shown in FIG. 1 is operated in a clean field, a member 02 having a shape that can be connected to a dedicated circuit corresponding to a blood purification device operated in an unclean field, and a circuit part 03 for blood removal or return. A member 04 having a shape connectable to a blood removal member or a blood return member of the patient, a blood removal or blood return circuit portion 05, and a blood removal or blood return circuit portion operated in the clean field, respectively. It is comprised from the connection member 06 which has a shape which can be connected, and has the liquid passing property which has the both ends. The inner sterilization packaging 09 includes a boundary mark member 07 that serves as a mark of the boundary between the parts 04 to 06 operated in the clean field and the parts 02 to 03 operated in the unclean field, and the part 04 operated in the clean field. A gap 08 having a minimum size for opening the portions 02 to 03, which cover the boundary marking member 07 and the boundary marking member 07 and are operated in the unclean field, is provided. Further, the outer sterilization package 10 covers the whole of these 02 to 09.

  The blood removal or blood return circuit portion 03 operated in the unclean field has a member 02 having a shape that can be connected to a dedicated circuit corresponding to the blood purification device. Of the dedicated circuits prepared so as to be installed in the blood purification apparatus, they are used in a state where they are connected to the blood removal circuit and the blood return circuit, respectively.

  The blood removal or blood return circuit portion 05 operated in the clean field has a member 04 shaped to be connectable to the blood removal member or blood return member of the patient. These are used in a state where they are connected to a member for blood removal or blood return of a patient, for example, an indwelling needle, a catheter for blood collection, a connector or the like.

  The fluid-permeable connecting member 06 has at each end a member that has a shape that can be connected to the member 04 included in the circuit part 05 for blood removal or blood return operated in the clean field. Until the package is removed, for example, when cleaning and priming the inside of the circuit using sterilized liquid, it is included in the circuit part 05 for blood removal or blood return operated in the clean field. It is used in a state where both ends are connected to the member 04.

  The boundary marking member 07 is located at the boundary between the parts 04 to 06 operated in the clean field and the parts 02 to 03 operated in the unclean field, and has a shape that serves as a mark for the boundary, and is an internal sterilization package. When 09 is removed, it is desirable to know at a glance how far the part operated in the clean field, that is, the part where the outer surface of the circuit is kept clean. Furthermore, as shown in the enlarged view (A) in the vicinity of the gap 08 opened in the inner sterilization package 09 shown in FIG. This shape makes it difficult for the portions 04 to 06 operated in the clean field to slip out or be pulled out from the gap 08, and therefore before use in the clean field after the outer sterilization package 10 is removed. In the operation in the unclean field, for example, the installation in the apparatus, the cleaning and priming of the inside of the circuit using the sterilized liquid, the outer surface of the portion operated in the clean field can be kept clean. Alternatively, as another form, as shown in FIG. 2B, the boundary marking member 07 may be one, and the blood removal and blood return circuits may be integrated into one, and the boundary from the gap 08 may be combined. Any shape that prevents the mark member 07 from slipping out may be used.

  The inner sterilization package 09 covers the parts 04 to 06 operated in the clean field and the boundary marking member 07, and is the minimum for taking out the parts 02 to 03 operated in the unclean field from the package. The sterilized package 09 is removed at least when connected to a patient in a clean field.

  Preferably, in the clean field before use in the clean field after the outer sterilization package 10 is removed, for example, installation in the apparatus, cleaning and priming the inside of the circuit using the sterilized liquid, in the clean field It is desirable to have a shape that can maintain the outer surface of the part to be operated in a clean state.

  Further, preferably, in the clean field before use in the clean field after the outer sterilization package 10 is removed, for example, installation in the apparatus, cleaning of the inside of the circuit using the sterilized liquid and priming, internal sterilization A shape that prevents the parts 02 to 03 operated in the unclean field opened in the package from slipping out or pulling out from the gap 08 having a minimum size for taking out the package, that is, It is better that the size of the gap 08 is smaller than a state in which two members 07 that can pass liquid are collected.

  More preferably, in the clean field before use in the clean field after the outer sterilization package 10 is removed, for example, installation in the apparatus, cleaning and priming the inside of the circuit using the sterilized liquid, from the gap 08 Affix with adhesive tape or the like near the boundary member 07 of the parts 02 to 03 operated in the unclean field so that it is difficult to slip out or be pulled out and to prevent unclean liquid from entering. It is preferable that the gap 08 is minimized, for example, by being stopped.

  In addition, preferably, an operator of the blood purification apparatus other than the clean operator who performs the clean operation does not touch the outer surfaces of the parts 04 to 06 operated in the clean field of the circuit without touching the outer surface. The inner sterilization package 09 may be of a shape and material that can be easily removed so that it can be handed to a clean surgeon in the clean field and can maintain a clean state in connection operation to a patient in the clean field. preferable. For example, it is desirable that part or all of the packaging is paper or non-woven fabric, thin vinyl, and that there is a notch on the edge of the packaging so that it is easy to tear, and there are adhesive parts that are easy to peel off. It is not limited.

  The outer sterilization package 10 covers the whole of 02 to 09, and is sterilized in a state where the blood purification circuit 01 is packaged, and then packed, shipped and stored. After that, it is not removed until just before use.

  Hereinafter, the present invention will be described in more detail with reference to examples. However, the present invention is not limited to the following examples.

Example 1
A blood purification circuit shown in FIG. 1 was produced. Each of the circuit lengths is 30 cm for the blood removal / return circuit portion 03 operated in the unclean field, 220 cm for the blood removal / return circuit portion 05 operated in the clean field, and the connection member 06 is 10 cm. did. All circuits used tubes made of polyvinyl chloride having an inner diameter of 4 mm and an outer diameter of 6 mm. As the connection members 02 and 04, luer lock type connectors were used so that they could be connected to devices such as commercially available blood purification circuits and indwelling needles. The boundary marking member 07 was covered with a polyvinyl chloride tube having a large diameter so as to be larger than the gap 08 of the inner sterilization packaging. Blood purification circuits 02 to 06 are put in the inner sterilization package 09, sealed with the portions 02 to 03 operated in the unclean field from the gap 08 opened in the inner sterilization package 09, and all of them are removed. Sealed in sterile packaging. Commercially available sterilization bags of 40 cm × 20 cm were used for the inner sterilization package 09 and the outer sterilization package 10. The produced blood purification circuit 01 was sterilized with ethylene oxide gas.

  Using the manufactured blood purification circuit 01, cleaning and priming the inside of the circuit using a sterilized liquid among the operations in the unclean field before use in the clean field after removing the outer sterilization package A schematic diagram is shown in FIG. First, an operator other than a clean operator who performs a clean operation removed the outer sterilization package of the blood purification circuit 01 in FIG. 3 and took out the contents. The blood purification device is formed with a member 02 having a shape that can be connected to one of the blood purification device-compatible dedicated circuits out of the two blood removal or blood return circuit portions 03 operated in the unclean field with the inner sterilization package 09 attached. 11 was connected to one of two circuits, a blood removal circuit and a blood return circuit 12, among the blood purification device-compatible dedicated circuits installed in 11. The remaining one of the blood removal or blood return circuit portion 03 operated in the unclean area of the blood purification circuit 01 is placed in the waste liquid container 14 and the blood purification device installed in the blood purification device 11. Of the two dedicated circuits, the remaining one of the blood removal circuit and the blood return circuit 12 was connected to a sterilization liquid bag 13 containing a sterilized liquid.

  The blood pump of the blood purification device 11 was operated, and 1000 mL of sterilized physiological saline was poured from the sterilization solution bag 13 to wash the blood purification device-compatible circuit 12 and the blood purification circuit 01. Next, 500 mL of a sterilized physiological saline solution to which heparin was added was poured from the sterilizing solution bag 13 to prime the blood purification device compatible circuit 12 and the blood purification circuit 01. The waste liquid was collected in a waste liquid container.

  Although the above operation is performed by an operator other than a clean operator in the unclean field, it was possible to maintain that the outer surface of the portion operated in the clean field was in a clean state.

(Example 2)
FIG. 4 is a schematic diagram showing the connection operation to the patient in the clean field after removing the inner sterilization package 09 using the blood purification circuit 01 produced in the first embodiment. First, a clean operation in which an operator other than a clean operator breaks the sterilization package 09 of the blood purification circuit 01 shown in FIG. The parts 04 to 06 operated by the person in the clean field inside were taken out. A boundary mark member 07 serving as a mark of a boundary between the portion 03 operated in the unclean field and the portion 05 operated in the clean field was installed at the boundary 17 between the clean field and the unclean field. After tearing the inner sterilization package 09, the parts 04 to 06 located in the clean field were touched only in a clean state. Next, the clean operator who performs the clean operation removes the connecting member 06 that can be passed through from the member 04 having a shape connectable to the blood removal member or the blood return member of the patient, and operates in the clean field. The blood removal or blood return circuit portion 05 was connected to a blood removal member (Y connector connected to a blood collection catheter) and a blood return member (16G indwelling needle) of a patient in a clean field. Thereafter, an operator other than a clean operator who performs a clean operation operates the blood pump of the blood purification device 11 to perform blood purification. During the above operations, it was possible to maintain that the outer surface of the portion operated in the clean field was in a clean state.

It is the schematic of one Embodiment of the circuit for blood purification | cleaning in this invention. FIG. 2 is an enlarged view of the vicinity of a gap 08 opened in the inner sterilization package 09 in FIG. 1. It is a schematic diagram of cleaning and priming inside the circuit using one embodiment of the blood purification circuit in the present invention. It is a schematic diagram of the connection operation to the patient using one Embodiment of the circuit for blood purification in this invention.

Explanation of symbols

01 Blood purification circuit 02 A member with a shape that can be connected to a dedicated circuit for blood purification devices 03 A circuit part for blood removal or blood return operated in an unclean area 04 Connectable to a member for blood removal or blood return of a patient 05 A circuit part for blood removal or blood return operated in a clean field 06 Connecting member 07 Boundary mark member 08 Gap 09 Internal sterilization packaging 10 External sterilization packaging 11 Blood purification device 12 Blood purification device dedicated circuit 13 Sterilization Liquid bag 14 Waste liquid container 15 Unclean field 16 Clean field 17 Boundary between clean field and unclean field

Claims (3)

A blood purification circuit used across the clean and unclean areas in the treatment room where PCI and preoperative examinations are performed, and the outer surface of the part operated in the clean field is covered with an internal sterilization package A part operated in the unclean field and a part operated in the clean field are covered with an outer sterilization package as a continuous circuit and sterilized. The outer surface of the part to be operated is a circuit for blood purification that can be kept clean even when operating in an unclean field.   A circuit for blood purification used across the clean and unclean areas in the treatment room where PCI and preoperative examinations are performed, and the part operated in the clean field and the part operated in the unclean field The boundary mark member is connected to the boundary mark member and the part operated in the clean field is covered by the inner sterilization packaging, and the part operated in the clean field and the part operated in the unclean field are covered by the outer sterilization packaging. A blood purification circuit, characterized in that it is covered. 3. The blood purification circuit according to claim 1, wherein the blood purification circuit has a packaging form in which the inner sterilization packaging can be removed without touching the outer surface of the portion operated in the clean field.

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