JP2014068739A - Connector with pressure sensor - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a connector with a pressure sensor capable of sufficiently securing responsiveness with respect to a pressure change of an extracorporeal circulation circuit and measurement precision.SOLUTION: A connector with a pressure sensor 1A includes: a pressure sensor 3 having a pressure sensor substrate 10 to which pressure from the blood flowing in an extracorporeal circulation circuit is transmitted and a covering part 11 composed of soft resin for covering the pressure sensor substrate 10; and a housing 2 for holding the pressure sensor 3 at a position where the covering part 11 comes in contact with the blood flowing in the extracorporeal circulation circuit.

Description

  The present invention relates to a connector with a pressure sensor that can be connected to an extracorporeal circuit.

  In the extracorporeal circuit constituting the heart-lung machine, it is indispensable to always monitor the internal pressure according to the safety device installation standard for the heart-lung machine defined by the Japanese Society of Extracorporeal Circulation Technology.

  As a method for measuring the pressure of the extracorporeal circuit, a method using a pressure measuring circuit including a chamber provided with a diaphragm is known. In this method, a branch pipe is provided at a pressure measurement site of the extracorporeal circuit, and one end of the pressure measurement circuit is connected to the branch pipe, and the other end is connected to a pneumatic pressure measurement device. Then, the air from the branch pipe to the diaphragm is removed and the blood is filled in the pressure measurement circuit. Since the diaphragm of the pressure measurement circuit is deformed according to the pressure of the pressure measurement part of the extracorporeal circuit, the pressure measurement part of the extracorporeal circuit is detected by detecting the change in air pressure downstream of the diaphragm accompanying the deformation by the pressure measurement device. Measure the pressure. As another pressure measurement method, there is known a method in which a pressure sensor is brought into close contact with a diaphragm that is in direct contact with the extracorporeal circuit, and the pressure at the pressure measurement portion of the extracorporeal circuit is measured based on a signal output from the pressure sensor. ing.

Japanese Patent No. 5007410 JP 2008-51663 A JP 2008-259553 A

  Among the pressure measurement methods described above, the method of connecting a pressure measurement circuit to a branch pipe cannot deny the possibility of damaging thrombus formation or blood compatibility because blood guided into the pressure measurement circuit hardly flows. In addition, this method requires a complicated operation for venting air to the diaphragm before measurement. Furthermore, since pressure measurement is performed via a diaphragm, the response and measurement accuracy of pressure change may not be sufficient. On the other hand, the method of bringing the pressure sensor into close contact with the diaphragm is a pressure measurement through the diaphragm, although there is no possibility that the blood will remain, so the pressure change responsiveness and measurement accuracy are not sufficient as in the above method There is.

  Therefore, an object of the present invention is to provide a connector with a pressure sensor that can sufficiently ensure the responsiveness and measurement accuracy to a pressure change of the extracorporeal circuit.

  The connector with a pressure sensor of the present invention is a connector with pressure sensor (1A, 1B, 1C) that can be connected to an extracorporeal circulation circuit and can output a signal corresponding to the pressure at the connection site. A pressure sensor (3, 31) having a pressure receiving part (10) to which a pressure from blood flowing therein is transmitted and a covering part (11, 35) made of a soft resin and covering the pressure receiving part; A housing (2, 30) for holding the pressure sensor at a position where the covering portion contacts blood flowing in the extracorporeal circuit.

  According to this connector, the pressure at the connection part connected to the extracorporeal circuit is transmitted to the pressure receiving part via the covering part made of the soft resin. For this reason, since the pressure of a connection site | part is directly transmitted to a pressure receiving part compared with the pressure measurement using a diaphragm, the responsiveness with respect to the pressure change of an extracorporeal circuit, and a measurement precision are fully securable. Further, since the pressure receiving portion of the pressure sensor is covered with the covering portion and does not directly touch the blood, deterioration of the pressure sensor due to blood can be suppressed and blood damage can be reduced.

  As one aspect of the connector with a pressure sensor of the present invention, the soft resin may be a material that meets a biological safety evaluation standard defined in ISO10993. According to this aspect, since the material of the covering portion that is in direct contact with blood conforms to the above evaluation criteria, the biological safety of the extracorporeal circuit is reliably ensured.

  As one aspect of the connector with a pressure sensor of the present invention, the extracorporeal circuit includes a tube (T) for guiding blood, and the housing has a first connection portion (5) connected to one end of the tube. 21) and a second connecting portion (6, 22) connected to the other end of the tube, and a passage portion (7, 23) connecting the first connecting portion and the second connecting portion. The covering portion of the pressure sensor may be exposed inside the passage portion. According to this aspect, since the covering portion is exposed inside the passage portion, the pressure of blood flowing through the passage portion can be reliably transmitted to the pressure receiving portion.

  In this aspect, the passage portion may be formed with a slope (15) for smoothly connecting the covering portion exposed inside and each of the first connection portion and the second connection portion. In this case, since each of the first connection portion and the second connection portion and the covering portion are smoothly connected by the slope, the retention of the blood guided to the passage portion is suppressed, and the bubbles It is hard to adhere and the bubble removal is more reliable. As a result, thrombus formation in the passage portion can be prevented.

  The slope may be inclined in a direction in which a passage area of the passage portion decreases toward the covering portion. In this case, as a result of the slope inclining in the direction in which the passage area of the passage portion decreases toward the covering portion, the passage area of the passage portion is reduced at and around the covering portion. Therefore, there is an advantage that blood does not stagnate in the vicinity of the covering portion as compared with a form in which the passage area of the passage portion expands in the covering portion and the vicinity thereof.

  Further, each of the first connection portion and the second connection portion may hold the outer peripheral surface of the tube so that the inner peripheral surface of the tube and the inner surface of the passage portion are smoothly connected. . In this case, since no step is formed between the inner peripheral surface of the tube and the passage portion, the blood retention suppressing effect is further improved.

  As an aspect of the connector with a pressure sensor of the present invention, the extracorporeal circuit is provided with a luer port (LP), and the housing has the luer in a state where the covering portion is exposed inside the luer port. It may be configured to be able to fit into the port. According to this aspect, the connector can be easily connected to the extracorporeal circuit because it can be fitted into the luer port provided in the extracorporeal circuit. Moreover, the connector of this aspect can be connected to a luer port provided in an extracorporeal circuit, for example, a luer port provided in an artificial heart-lung machine or the like.

  In addition, in the above description, in order to make an understanding of this invention easy, the reference sign of the accompanying drawing was attached in parenthesis, but this invention is not limited to the form of illustration by it.

  As described above, according to the connector with the pressure sensor of the present invention, the pressure at the connection portion connected to the extracorporeal circuit is transmitted to the pressure receiving portion through the covering portion made of soft resin. Sufficient response and measurement accuracy to the pressure change of the circulation circuit can be secured.

The perspective view which showed the connector with a pressure sensor which concerns on the 1st form of this invention. Sectional drawing regarding the II-II line of FIG. Sectional drawing regarding the III-III line of FIG. The perspective view which showed the connector with a pressure sensor which concerns on the 2nd form of this invention. Sectional drawing regarding the VV line of FIG. The figure which showed the connector with a pressure sensor which concerns on the 3rd form of this invention.

(First form)
The connector with pressure sensor (hereinafter simply referred to as a connector) 1A shown in FIGS. The extracorporeal circuit is a known circuit that circulates blood outside the body. For example, various devices such as an oxygenator for exchanging gas and a blood pump for pumping blood are connected to the circuit. The connector 1A includes a housing 2 that is connected to a tube T that is included in the extracorporeal circuit and that guides blood, a pressure sensor 3 that is configured as a pressure transducer and is held by the housing 2, and a signal output from the pressure sensor 3 to the outside. And a cable insertion portion 4 for connecting an electric cable (not shown) for taking out. The cable insertion portion 4 is provided integrally with the housing 2. The illustrated connector 1A is subjected to a sterilization process (EOG sterilization) using ethylene oxide gas, and is shipped after the process. Similarly, EOG sterilization is performed on the connectors of the second and third embodiments described later before shipment.

  The housing 2 is made of a hard resin such as PVC, PC, PMMA, ABS or the like. The housing 2 has a first connection portion 5 connected to one end of the tube T and a second connection portion 6 connected to the other end. As shown in FIG. 2, the housing 2 is formed with a passage portion 7 that connects these connecting portions 5 and 6. The housing 2 holds the outer peripheral surface Tb of the tube T so that the inner peripheral surface Ta of the tube T and the passage inner surface 7a of the passage portion 7 are smoothly connected without any step. In this form, tube T and each connection part 5 and 6 are connected by adhere | attaching the outer peripheral surface Tb of the tube T, and the inner peripheral surfaces 5a and 6a of each connection part 5 and 6 with a predetermined adhesive agent. The Their bonding width Bw is set to 1 to 1.5 times the outer diameter of the tube T.

  As shown in FIGS. 2 and 3, the pressure sensor 3 includes a pressure sensor substrate 10 serving as a pressure receiving portion to which pressure from blood is transmitted, and a coating that covers the pressure sensor substrate 10 and is made of a soft resin. Part 11. A known electric circuit capable of outputting an electric signal having a magnitude corresponding to the amount of strain due to the transmitted pressure is formed on the pressure sensor substrate 10, and the electric signal is transmitted to the electric cable insertion portion 4 through the wiring 10 a. Is done. The electric cable insertion portion 4 is provided with a drip-proof connector 4a that is electrically connected to the wiring 10a and that can be inserted and removed from the electric cable side. In addition, it is also possible to change to the form which connects the wiring 10a and an electric cable directly, without providing the drip-proof connector 4a (refer FIG. 6). The soft resin constituting the covering portion 11 is a material that conforms to the biological safety evaluation standard defined in ISO10993. Therefore, not only the improvement of hygiene by covering the pressure sensor substrate 10 with the covering part 11 but also the biological safety of the extracorporeal circuit is ensured by ensuring that the material that directly contacts the blood meets the above evaluation criteria. The

  The pressure sensor 3 is held by the housing 2 at a position where the covering portion 11 comes into contact with the blood guided to the passage portion 7. In other words, the covering portion 11 is exposed inside the passage portion 7. The connecting portions 5 and 6 and the covering portion 11 are smoothly connected by the slope 15 so that no step is generated in the passage portion 7 as the covering portion 11 is exposed inside the passage portion 7. Each slope 15 is inclined in a direction in which the passage area of the passage portion 7 gradually decreases toward the covering portion 11. Since the connecting portions 5 and 6 and the covering portion 11 are smoothly connected by the slope 15, the retention of the blood guided to the passage portion 7 is suppressed, and the bubbles are less likely to adhere and the removal of the bubbles is more reliable. . As a result, thrombus formation in the passage portion 7 can be prevented. Moreover, as a result of each slope 15 being inclined toward the covering portion 11 in a direction in which the passage area of the passage portion 7 decreases, the passage area of the passage portion 7 is narrowed around the covering portion 11. Therefore, the connector 1 </ b> A has an advantage that blood does not stagnate around the covering portion 11 as compared with a form in which the passage area of the passage portion 7 is enlarged around the covering portion 11. Further, in the present embodiment, since the inner peripheral surface Ta of the tube T and the passage inner surface 7a of the passage portion 7 are smoothly connected as described above, the inner peripheral surface Ta of the tube T and the passage inner surface 7a of the passage portion 7 are provided. Compared with the case where there is a step between the blood retention, the blood retention suppression effect is further improved.

  According to the connector 1A, the pressure at the connection site of the extracorporeal circuit is transmitted to the pressure sensor substrate 10 via the covering portion 11 made of a soft resin. For this reason, since the pressure of a connection site | part is directly transmitted to the pressure sensor board | substrate 10 compared with the pressure measurement using a diaphragm, the response with respect to the pressure change of an extracorporeal circuit, and a measurement precision are fully securable. Further, the housing 2 of the connector 1A is made of a hard resin, and necessary rigidity is ensured. Therefore, even when external stress is applied to the connector 1A due to the shaking of the tube T of the extracorporeal circuit or the shaking of the cable when the electric cable is connected, the influence on the pressure measurement value can be suppressed as much as possible.

(Second form)
Next, a 2nd form is demonstrated, referring FIG.4 and FIG.5. As is apparent from these drawings, the connector 1B is the connector 1A of the first embodiment except for the respective configurations of the connecting portions 21 and 22 connected to the tube T and the passage portion 23 connecting these connecting portions 21 and 22. And in common. Therefore, in the following description, the same reference numerals are shown for the components common to the connector 1A, and the description is omitted.

  The first connection portion 21 and the second connection portion 22 provided in the connector 1B are connected to the tube T by being inserted into the tube T so as to enlarge the inner diameter thereof. A plurality (two in FIG. 5) of bamboo shoot-shaped anti-skids 25 that make it difficult to remove the connected tubes T are arranged in each connection portion 21, 22 in the longitudinal direction of each connection portion 21, 22. Each of the connection portions 21 and 22 is formed with tapered portions 21a and 22a whose thickness gradually decreases toward the tip portion. The tapered portions 21a and 22a facilitate the insertion of the connecting portions 21 and 22 into the tube T. Also in this embodiment, the covering portion 11 is exposed inside the passage portion 23 that connects the first connecting portion 21 and the second connecting portion 22. And the coating | coated part 11 and each connection part 21 and 22 are smoothly connected by the slope 15, and the level | step difference has not arisen in the channel | path inner surface 23a of the channel | path part 23. FIG.

  According to the connector 1B of the present embodiment, the responsiveness and measurement accuracy with respect to the pressure change of the extracorporeal circuit can be sufficiently secured as in the case of the connector 1A of the first embodiment, and each connection portion 21, when compared with the connector 1A, There is an advantage that no adhesive is required when connecting the tube T to the tube 22. Therefore, if a sterilized connector 1B is prepared in advance, the connector 1B can be connected to the extracorporeal circuit in the operating room immediately before use, for example.

(Third form)
Next, a third embodiment will be described with reference to FIG. In the following description, the same reference numerals are assigned to the same components as those in the first or second embodiment, and description thereof is omitted. The connector 1 </ b> C includes a housing 30 and a pressure sensor 31 configured as a pressure transducer and held in the housing 30. A connecting portion 32 for connecting to the extracorporeal circuit is formed in the housing 30 adjacent to the pressure sensor substrate 10 as a pressure receiving portion. The connecting portion 32 is formed in a hollow shape, and the hollow portion 32 a is open to the pressure sensor substrate 10. The hollow portion 32a formed in the connecting portion 32 is filled with a soft resin made of the same material as the constituent material of the covering portion 11 used in the first or second form. Thereby, the coating | coated part 35 which coat | covers the pressure sensor board | substrate 10 is formed. The wiring 10a of the pressure sensor substrate 10 is electrically connected directly to an electric cable C that can be connected to a pressure measurement display.

  The connecting portion 32 can be fitted into the luer port LP with the covering portion 35 exposed inside the luer port LP provided in the extracorporeal circuit. The luer port LP and the connection portion 32 are each formed in a well-known luer taper shape so as to be connectable. That is, the connecting portion 32 is formed in a male luer shape, and the luer port LP is formed in a female luer shape. Therefore, when the male luer connection portion 32 is fitted into the luer port LP, they are in close contact with each other and are connected in a liquid-tight manner. Furthermore, in this embodiment, a cap portion 36 in which a female screw 36 a that can be screwed into a male screw X formed in the luer port LP is provided so as to surround the connecting portion 32. Therefore, when the connector 1C is connected to the luer port LP, the connection strength between the luer port LP and the connecting portion 32 can be increased by screwing the cap portion 36 into the male screw X of the luer port LP.

  According to the connector 1 </ b> C of this embodiment, the pressure at the connection site is transmitted to the pressure sensor substrate 10 through the covering portion 35 while being connected to the luer port LP. Therefore, the responsiveness and measurement accuracy with respect to the pressure change of the extracorporeal circuit can be sufficiently secured as in the first or second embodiment described above. Further, the connector 1C does not need to be connected to the extracorporeal circuit using a bonding means such as an adhesive, and therefore has the same advantages as the second embodiment when compared with the first embodiment. Furthermore, since the connector 1C completes the connection to the extracorporeal circuit by fitting the connecting portion 32 formed in the housing 30 into the existing luer port LP, the extracorporeal circulation is compared with the connector 1B of the second embodiment. There is an advantage that connection to a circuit becomes easy. The connector 1 </ b> C can be changed to a form in which the cap portion 36 surrounding the connection portion 32 is omitted. Further, the shapes of the connecting portion 32 and the luer port LP may be interchanged, and the connecting portion 32 may be formed into a female luer shape, and the luer port LP may be formed into a male luer shape.

  The present invention is not limited to the above embodiments, and can be implemented in various forms within the scope of the gist of the present invention. In the 1st or 2nd form, although the channel | path part which connects each connection part is formed linearly, this channel | path part can also be implemented with the form curved to some extent. In the connector of the first or second form, the cable insertion part for connecting the electric cable is integrally formed with the housing. However, as in the third form, the wiring of the pressure sensor board is used as the electric cable. It can also be changed to be directly connected.

1A, 1B, 1C Connector with pressure sensor 2, 30 Housing 3, 31 Pressure sensor 5, 21 First connection portion 6, 22 Second connection portion 7, 23 Passage portion 10 Pressure sensor substrate (pressure receiving portion)
11, 35 Cover 15 Slope T Tube LP Luer port

Claims (7)

A connector with a pressure sensor that can be connected to an extracorporeal circuit and that can output a signal corresponding to the pressure at the connection part,
A pressure sensor having a pressure receiving portion to which pressure from blood flowing in the extracorporeal circulation circuit is transmitted; a pressure sensor configured by a soft resin and covering the pressure receiving portion; and blood flowing in the extracorporeal circulation circuit And a housing for holding the pressure sensor at a position where the covering portion contacts.   The connector with a pressure sensor according to claim 1, wherein the soft resin is a material that conforms to a biological safety evaluation standard defined in ISO10993. The extracorporeal circuit includes a tube that guides blood,
The housing has a first connection portion connected to one end of the tube and a second connection portion connected to the other end of the tube, and the first connection portion and the second connection portion are provided. A connecting passage is formed,
The connector with a pressure sensor according to claim 1 or 2, wherein the covering portion of the pressure sensor is exposed inside the passage portion.   The pressure sensor connector according to claim 3, wherein the passage portion is formed with a slope that smoothly connects the covering portion exposed inside and each of the first connection portion and the second connection portion. .   The connector with a pressure sensor according to claim 4, wherein the slope is inclined in a direction in which a passage area of the passage portion decreases toward the covering portion.   Each of the said 1st connection part and the said 2nd connection part hold | maintains the outer peripheral surface of the said tube so that the inner peripheral surface of the said tube and the channel | path inner surface of the said channel | path part may be connected smoothly. The connector with a pressure sensor according to any one of 5. The extracorporeal circuit is provided with a luer port,
The connector with a pressure sensor according to claim 1 or 2, wherein the housing is configured to be fitted into the luer port in a state where the covering portion is exposed to the luer port.

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