JP4903603B2 - Catheter fixture - Google Patents

Description

  The present invention relates to a catheter fixture used in the medical field, and more particularly to a catheter fixture used to fix a catheter to the skin.

  As a means for fixing the catheter to the patient's skin, (1) a method for fixing the outside of the catheter to the skin with an adhesive tape, (2) a method for fixing the outside of the catheter directly to the skin with a suture, (3) (4) Create a subcutaneous tunnel, insert a catheter with a cuff on the outer surface, and adhere the cuff and the subcutaneous tissue to the skin through a suture fixing part provided outside the catheter body. There is a method to make it. this house,

  The method (1) can easily fix the catheter, but the fixing force is inherently weak, and if the patient's sweat, body fluid, or disinfectant adheres to the skin, catheter, adhesive tape, etc., the fixing force is greatly reduced. There is a risk.

  In the method (2), since the catheter is directly bound with a suture thread, the catheter is easily damaged, kinks and leaks are likely to occur, and in the worst case, cutting may occur.

  The method (3) is an improvement of the method (2) and is most popular. By the way, in the case of troubles such as a decrease in flow rate, there is a case where it is desired to adjust the catheter by moving it to some extent in the rotational direction or in the forward / backward direction. Furthermore, in extracorporeal circulation catheters such as dialysis, blood flow is likely to be insufficient depending on the position of the indwelling blood vessel, and thus frequent movement of the catheter position is often required. However, once the catheter is indwelling and fixed as in the method (3), if it is desired to move the catheter as described above, or if it is forced to move, the suture fixed to the skin is in each case. In addition, it has to be cut again and must be re-sewn after movement, which may impose a burden on the doctor and patient.

  In order to solve these problems, as an application method of (3), it is possible to release the fixed state by fixing it with a catheter fixing tool that can only rotate the catheter, or with a clip or the like. A fixture that can rotate and advance and retract has been developed (Patent Document 1). In this patent document 1, a cylindrical soft resin holder having a slit formed in the axial direction on the bottom surface is clamped by a clamping member which is a metal Ω-shaped spring, whereby the catheter is It is to be fixed.

  However, when the clip is made of metal, it is necessary to remove it when using an image diagnostic method such as MRI (Nuclear Magnetic Resonance Diagnosis Apparatus) that measures in a magnetic field region, which causes a problem in clinical use. As a countermeasure, if an Ω-shaped spring is to be formed of resin, it will be necessary to increase the size to obtain a clamping force equivalent to that of metal with the strength of general resin. There is a problem that causes trouble.

As a countermeasure against this, resin-made fixing tools in which a catheter holding tool and a cover of the holding tool are integrated have been developed (Patent Documents 2 and 3). However, because the holder is compressed and pressed with a cover or the like that is slightly smaller than the outer diameter of the holder, once the catheter is placed and fixed, the position of the catheter tip in the blood vessel can be easily adjusted by moving in the rotational direction or the forward and backward directions. There is no problem.
Japanese Patent Laid-Open No. 9-75463 JP 2002-360705 A Japanese Patent Laid-Open No. 2003-154012

  The present invention is a fixture for fixing the catheter to the skin, and can be easily adjusted in the body tip position by moving the catheter in the rotational direction or forward and backward direction after the catheter is once placed, In addition, it is an object of the present invention to provide a catheter fixture that does not need to be removed at the time of measurement in a strong magnetic field region such as MRI.

  A fixing tool for fixing a tubular indwelling catheter according to the present invention includes a cylindrical holding tool formed of a resin having a lower hardness than the catheter and having a slit in the longitudinal direction, and pressing the holding tool from the outer periphery. And a resin-made clip that fixes the catheter inserted through the lumen of the holder, and the inner holder and the outer housing can be fitted and released from each other. When the fitting is released, the inner diameter is large enough to cover the holder with the inner holder, and the fixing tool covers the inner holder and the outer housing by covering the holder with the clip. The holder can be clamped by reducing the inner diameter of the inner holder with the outer housing when fitted. It is an feature.

  According to the present invention, in the above, the inner holder and the outer housing are slidable in the axial direction in a state where the outer housing is covered with the inner holder, and the sliding state is the fitted state and the fitted state. It is preferable that the inner diameter of the inner holder is reduced by a wedge action between the inner holder and the outer housing in the fitted state.

Moreover, according to this invention, it is suitable to have a holding means for holding an inner holder and an outer housing in a fitting state.
Moreover, according to this invention, it is suitable to have a connection means for connecting these inner holders and outer housings while preventing the inner holders and outer housings from being detached.

  According to the present invention, by using a holder made of a resin having a hardness lower than that of the catheter, the catheter is extremely deformed by fitting the inner holder of the clip and the outer housing together while preventing deformation of the catheter. It can be easily and reliably fixed to the patient's body surface. Furthermore, the fixing can be temporarily released by a simple method of simply releasing the fitting between the inner holder and the outer housing of the clip, and then it can be re-fixed thereafter. Further, since the clip is made of resin, it is not necessary to remove the clip in the case of measurement in a strong magnetic field region such as MRI, and it can be inspected as it is.

  FIG. 12 shows an example of a double lumen catheter to which the fixture of the present invention is applied. Here, 1 is a main body portion of the catheter, which is formed in a tube shape having two lumens, and a certain range is inserted from the distal end portion 2 into the body.

  A holder 11 is fitted on a portion of the main body 1 of the catheter that is located outside the body. The holder 11 is made of a material having a hardness lower than that of the main body 1 of the catheter. As shown in FIGS. 12 and 13, the holder 11 has a cylindrical holder 12 and both sides from the holder 12. And a pair of flat plate-like wing-like portions 13 formed toward the direction. The wing 13 is formed with a hole 14 for binding the holder 11 to the human skin with a thread. A slit 15 is formed in the holder portion 12 in the length direction at a portion that becomes the bottom when the wing-shaped portion 13 is brought into contact with the human skin. For this reason, the holder 11 is configured to be able to cover the main body 1 from the side of the main body 1 of the catheter by widening the slit 15. The size of the inner diameter of the holder 11 is easily attached to the main body 1 of the catheter, and can easily move the main body 1 of the catheter in the rotational direction and the forward / backward direction as necessary, and a clip described later is attached. The size of the main body 1 of the catheter is not limited as long as it does not move freely. Specifically, it is preferable that the size is substantially the same as or smaller than the outer diameter of the main body 1 of the catheter to be mounted. Although the position of the slit 15 is not particularly defined, it is preferable that the slit 15 is formed on the skin side of the patient in the holder 11 for ease of attachment to the patient. On the outer periphery of the holder 11, a protrusion 19 is formed for positioning a clip to be described later attached to the holder 11.

  The material of the holder 11 is preferably a soft polymer elastomer having rubber elasticity near room temperature, which is a material that is in close contact with the catheter body 1 and has little resistance to contact with the skin. For example, soft polyvinyl chloride, silicone rubber, polyurethane, styrene-butadiene rubber, polyisoprene rubber, styrene-ethylene-butylene-styrene copolymer, styrene-ethylene-propylene-styrene copolymer, ethylene-vinyl acetate copolymer Examples thereof include synthetic polymer materials such as polymers and nylon-polyether copolymers, and natural polymer materials such as natural rubber.

  FIG. 1 shows a state in which a clip 16 made of a resin that is harder than the holder 11 is attached to a holder 11 that covers the main body 1 of the catheter. The clip 16 is formed to have a U-shaped or C-shaped cross section so as to be covered with the cylindrical holder 11, and has an inner holder 17 and an outer housing 18. The inner holder 17 and the outer housing 18 are slidable in the axial direction with the outer housing 18 being put on the inner holder 17. Here, when the positions of the inner holder 17 and the outer housing 18 along the axial direction are aligned as shown in FIG. 1, they are referred to as being “fitted” to each other. Also, as shown in FIGS. 2 and 3, when the inner holder 17 and the outer housing 18 are displaced in the axial direction, both are referred to as being “fitted”. The outer housing 18 is configured to have higher rigidity than the inner holder 17 by increasing the thickness, for example.

  As a specific material of the clip 16, it is necessary to have a strength capable of fixing the catheter main body 1 by pressing from the outer periphery so as to cover the holder 11, so that it is harder than at least the holder 11 as described above. It is preferable that Examples of the polymer compound include polyethylene, polypropylene, rigid polyvinyl chloride, polyester, polyamide, polyetherimide, polyacetal, rigid polyurethane, polycarbonate, polymethyl methacrylate, etc., and a mixture or copolymer of these substances. Further, in order to further increase the strength, another resin may be mixed.

  2 and 3, when the fitting between the inner holder 17 and the outer housing 18 is released, the clip 16 is held so that the inner diameter of the inner holder 17 covers, for example, the main body 1 of the catheter. It is larger than the outer diameter of the tool 11. Thereby, the inner holder 17 can be further covered on the holder 11 in a state of covering the main body 1 of the catheter. Further, the clip 16 in a state where the inner holder 17 covers the holder 11 can be removed from the holder 11.

Further, as shown in FIG. 1, the clip 16 can reduce the diameter of the inner holder 17 by the outer housing 18 by fitting the inner holder 17 and the outer housing 18 to each other. The clip 11 can hold the holder 11 together with the catheter body 1.
Next, the details of the clip 16 acting in this way will be described.

  5 to 7 show details of the inner holder 17. Here, 21 is the front end, and 22 is the rear end. The inner holder 17 is formed from the front end portion 21 to the rear end portion 22 so as to have a C-shaped cross section. The diameter of the inner peripheral portion of the inner holder 17 is set to be equal to or larger than the outer diameter of the holder 11 in the state where the main body portion 1 of the catheter is passed as shown in FIGS. A flange 23 is integrally formed on one half of the front end portion 21, and a hook 24 is integrally formed on the flange 23.

  Convex portions 25 and 26 are integrally formed on the side portion where the flange 23 is not formed on the outer surface of the inner holder 17 and the side portion where the flange 23 is formed. The convex portion 25 on the side where the flange 23 is not formed is formed from the front end portion 21 toward the rear end portion 22. The convex portion 26 on the side portion on which the flange 23 is formed is formed continuously toward the flange 23 and then toward the rear end portion 22. And the convex parts 25 and 26 are formed so that the width dimension may become constant toward the rear end part 22 side from the front end part 21 side. On the other hand, the heights of the convex portions 25 and 26 are formed so as to gradually decrease from the front end portion 21 side toward the rear end portion 22 side. That is, the convex portions 25 and 26 are formed as inclined surfaces such that the front end surface 27 gradually decreases from the front end portion 21 side toward the rear end portion 22 side.

  On the outer periphery of the rear end 22, a protrusion 28 is integrally formed at a position spaced in the circumferential direction from a position corresponding to the protrusion 25 to a position corresponding to the protrusion 26. The protrusion 28 is formed so that the height gradually decreases toward the rising surface 29 formed in the radial direction of the inner holder 17 so as to face the front end portion 21 and the rear end portion 22 side. And an inclined surface 30.

  8 and 9 show details of the outer housing 18. Here, 33 is a front end portion thereof, and 34 is a rear end portion thereof. The outer housing 18 is formed from the front end portion 33 to the rear end portion 34 so that the cross section is U-shaped. A flange 35 is formed integrally with the front end portion 33 at a half circumferential portion opposite to the portion where the flange 23 of the inner holder 17 is located when the outer housing 18 is covered with the inner holder 17. The flange 35 is integrally formed with a hook 36 that engages with the hook 24 of the flange 23 of the inner holder 17 when the outer housing 18 is put on the inner holder 17.

  On the inner surface of the outer housing 18, groove portions in which these convex portions 25, 26 can be fitted respectively at positions corresponding to the convex portions 25, 26 of the inner holder 17 when the outer housing 18 is covered with the inner holder 17. 37 and 38 are formed, respectively. As shown in the drawing, the groove portions 37 and 38 are opened at the end surface 39 of the front end portion 33 and are formed from the end surface 39 toward the rear end portion 34. The groove portions 37 and 38 are formed so that the width dimension thereof is constant from the front end portion 33 side toward the rear end portion 34 side, and the groove depth is changed from the front end portion 33 side to the rear end portion 33 side. It forms so that it may become shallow gradually toward the edge part 34 side. That is, the groove portions 37 and 38 are formed as inclined surfaces such that the groove bottom surface 40 gradually becomes shallower from the front end portion 33 side toward the rear end portion 34 side.

  A further groove 41 is formed on the inner surface of the outer housing 18 in the same direction as the grooves 37 and 38. The protrusions 28 of the inner holder 17 can enter the groove 41 when the outer housing 18 is put on the inner holder 17. Similarly, the groove portion 41 opens at the end surface 39 of the front end portion 33 and is formed from the end surface 39 toward the rear end portion 34. The groove width and depth are constant. A protrusion 42 is formed integrally with the outer housing 18 at a predetermined distance from the end surface 39 inside the groove portion 41. The protrusions 42 are formed so that the height gradually decreases toward the rising surface 43 formed in the radial direction of the outer housing 18 so as to face the rear end portion 34 and the front end portion 33 side. And an inclined surface 44.

  A short flange 45 is integrally formed on the inner periphery of the rear end portion 34 of the outer housing 18.

  The clip 16 is operated by a worker by hand when the clip 16 is attached to the holder 11 or when the inner holder 17 and the outer housing 18 described later are slid. A protrusion 46 that functions as a slip stopper is formed integrally. In the outer housing 18 shown in FIG. 1 to FIG. 3 and FIG. 8 to FIG. 9, a pair of protrusions 46 arranged in the vertical direction when the same direction as the direction of the main body 1 of the catheter is taken as the horizontal direction are spaced apart from each other. It is formed in a state where it is covered.

  10 and 11 show a modification of the protrusion 46. FIG. That is, FIG. 10 shows the protrusion 46 formed in the lateral direction at the upper part of the side wall of the outer housing 18. In FIG. 11, as the protrusion 46, the pair of vertical ones shown in FIGS. 1 to 3 and FIGS. 8 to 9 and the horizontal one shown in FIG. 10 are integrated. What is formed into a U-shape is shown.

  Since the groove portions 37, 38, 41 of the outer housing 18 are all open at the end surface 39 of the front end portion 33, the inner holder 17 inserts the convex portions 25, 26 into the groove portions 37, 38 from the end surface 39, and projects 28 can be inserted into the groove portion 41 from the end face 39 while being slid in the direction of the groove portions 37, 38, 41 inside the outer housing 18. When this fitting is performed, the inclined surface 30 of the protrusion 28 of the inner holder 17 fitted into the groove 41 of the outer housing 18 abuts the inclined surface 44 of the protrusion 42 of the outer housing 18. When a large fitting force is applied in this state, the projections 28 and 42 are pushed against each other. Finally, the resin inner holder 17 and the outer housing 18 are elastically deformed, and the inner holder 17 projections 28 pass the position of the projection 42 of the outer housing 18 toward the back side of the outer housing 18.

  Thereafter, as shown in FIG. 4A, the inner holder 17 and the outer housing 18 are positioned so that the protrusion 28 of the inner holder 17 hits the protrusion of the outer housing 18 from the rear end portion 34 side of the outer housing 18. As shown in FIG. 4B, the inner holder 17 is slidable with respect to a position where the inner holder 17 enters the inside of the outer housing 18. As shown in FIG. 4A, the rising surface 29 of the protrusion 28 of the inner holder 17 hits the rising surface 43 of the protrusion 42 of the outer housing 18 from the rear end portion 34 side of the outer housing 18. The holder 17 and the outer housing 18 are prevented from separating from each other. In other words, the projections 28 and 42 constitute a connecting means for connecting the inner holder 17 and the outer housing 18 in a state of preventing separation. FIG. 4A shows a state where the disengaged state shown in FIGS. 2 and 3 is viewed from the opening side of the inner holder 17 and the outer housing 18 having a U-shaped or C-shaped cross section. FIG. 4B shows a state where the fitted state shown in FIG. 1 is viewed from the opening side.

  In FIG. 4A, the inner holder 17 is in a natural state without being deformed. From this state, the inner holder 17 and the outer housing 18 are slid relative to each other so that the inner holder 17 enters the outer housing 18 and the outer housing 18 sufficiently covers the inner holder 17 as shown in FIG. State.

  In the state shown in FIG. 4B, the convex portions 25 and 26 of the inner holder 17 enter to the back side of the groove portions 37 and 38 of the outer housing 18. And when it will be in this state, the dimension of each part so that the height of the inclined convex parts 25 and 26 of the inner holder 17 may become larger than the depth of the groove parts 37 and 38 of the outer housing 18 corresponding to this. Is set. Then, since the outer housing 18 has higher rigidity than the inner holder 17 as described above, the groove bottom surfaces 40 and 40 of the groove portions 37 and 38 push the front end surfaces 27 and 27 of the convex portions 25 and 26 by the wedge action, As shown in FIGS. 4B and 4C, the inner holder 17 is elastically deformed so as to be reduced in diameter.

  That is, as shown in FIGS. 2 and 3, the clip 16 is put on the holder 11 in the state shown in FIG. 4A, that is, in the disengaged state, and then the inner holder 17 and the outer housing 18 are slid together. If it does, it will be in the state shown by the virtual line of FIG.4 (b) and FIG.4 (c), ie, the state fitted. Thereby, the holder 11 is clamped and elastically reduced in diameter, whereby the main body 1 of the catheter can be reliably clamped and fixed in place.

  From this state, the inner holder 17 and the outer housing 18 can be slid to each other to be in the state shown in FIGS. 4A, 2 and 3 again, and the operation for that is easy. For this reason, the fixed state of the main body 1 of the catheter by the holder 11 can be released as necessary, and the rotation and advancement / retraction thereof can be easily performed.

  In addition, it is sufficient that one or more of the convex portions 25 and 26 of the inner holder 17 and the groove portions 37 and 38 of the outer housing 18 are provided. However, if two are provided as described above, a stable clamping force can be generated. Alternatively, the entire outer peripheral surface of the inner holder 17 and the entire inner peripheral surface of the outer housing 18 are respectively tapered surfaces, and a wedge action can be exerted between the tapered surfaces.

  As a holding means, the hook 24 of the flange 23 of the inner holder 17 and the hook 36 of the flange 35 of the outer housing 18 are configured as follows. That is, an inclined surface 47 is formed at the end of the hook 24, and an inclined surface 48 is formed at the end of the hook 36. These inclined surfaces 47 and 48 are in contact with or close to each other in the fitted state shown in FIG. 1, and are pressed against each other when trying to change from the fitted state to the fitted released state shown in FIGS. It is formed in the direction that can act. That is, the inclined surface 48 of the outer housing 18 is formed so as to be inclined toward the rear end portion 34, and the inclined surface 47 of the inner holder 17 is directed in the opposite direction, that is, toward the end surface of the front end portion 21. It is formed so as to be inclined.

  For this reason, in the fitting state shown in FIG. 1, the inner holder 17 and the outer housing 18 are prevented from sliding freely with each other, and can be held in this fitting state.

  When the inner holder 17 and the outer housing 18 are slid from each other by applying a large force from the fitted state, the hook 24 having the inclined surface 47, that is, the flange 23, and the hook 36 having the inclined surface 48, that is, the flange 35. Are elastically deformed, and the engagement state between the hooks 24 and 36 due to the contact between the inclined surfaces 47 and 48 is released, thereby changing the engagement state shown in FIGS. 2 and 3. Is possible.

  On the contrary, when the inner holder 17 and the outer housing 18 are slid from each other and the hooks 24 and 36 are brought close to each other from the disengaged state shown in FIGS. 2 and 3, the hooks 24 and 36 come into contact with each other. However, by applying a large force, the same elastic deformation occurs, and the fitting state shown in FIG. 1 can be achieved.

  In addition, since the clip 16 presses the holder 11 from the outer periphery, nonuniform deformation hardly occurs in the main body 1 of the catheter inserted through the inside of the holder 11. In addition, since the holder 11 is made of a relatively soft organic polymer elastomer, even if the holder 16 is excessively tightened by the clip 16, the holder 11 is deformed to exert an interference action. An excessive force is not applied to the catheter main body 1 inserted into the catheter, it is possible to prevent unexpected deformation of the catheter main body 1, and a predetermined cross-sectional shape of the catheter main body 1 can always be maintained. Therefore, it is possible to prevent a decrease in flow rate due to holding and fixing the catheter. Further, the clip 16 can easily release the tightening force to the holder 11 as described above, and can be reapplied with one hand, so that the advancing and retreating direction with respect to the main body 1 of the catheter as described above. -The fixed position in the rotation direction can be easily adjusted.

  In the above description, the protrusions 25 and 26 are formed on the inner holder 17 and the grooves 37 and 38 are formed on the outer housing 18. However, the grooves are formed on the inner holder 17 and the protrusions are formed on the outer housing 18. The formed configuration can also function in the same manner. Even so, there is no effect on the fitting and pressing. For the combination of the groove 41 having the protrusion 42 and the protrusion 28 to prevent the inner holder 17 and the outer housing 18 from being separated, the configuration of the inner holder 17 and the outer housing 18 can be reversed. is there.

  As described above, the inner holder 17 and the outer housing 18 are prevented from detaching when the protrusions 28 and 42 as the connecting means come into contact with each other. Thus, one connected device is obtained. This is preferable in terms of use because the number of parts is reduced and complexity is eliminated. For this purpose, any means may be used as long as it is slidable and difficult to separate once connected as in the above-described specific structure.

  In the above, the catheter fixture provided with the holding tool 11 and the clip 16 through which the main body 1 of the double lumen catheter having two lumens of the catheter and the outside of the body shown in FIG. did. However, the type of catheter is not limited to this. In addition to a single lumen catheter, a triple lumen catheter having three lumens of the catheter body and three branch tubes outside the body, there are four lumens and branches of the catheter body. There may be more than one. The catheter may be any medical tube as long as it is inserted into the body for body fluid drainage, body fluid circulation, infusion or perfusion fluid infusion or drainage, or examination.

1 is an overall perspective view of a catheter fixture according to an embodiment of the present invention. It is a perspective view which shows the fitting cancellation | release state of the catheter fixture of FIG. It is another perspective view which shows the fitting cancellation | release state of the catheter fixture of FIG. It is a figure which shows the fitting state and fitting release state of the catheter fixture of FIG. It is a perspective view of the inner holder in the catheter fixture of FIG. It is another perspective view of the inner holder. It is another figure which shows the inner holder. It is a perspective view of the outer housing in the catheter fixture of FIG. It is another perspective view of the same outer housing. It is a figure which shows the modification of the protrusion of the outer housing in the fixing tool of this invention. It is a figure which shows the other modification of the protrusion of the outer housing in the fixing tool of this invention. It is a figure which shows an example of the catheter which can use the fixing tool of this invention. It is a perspective view of the principal part in the catheter of FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Main part of catheter 11 Holding tool 16 Clip 17 Inner holder 18 Outer housing 24 Hook 25 Convex part 26 Convex part 28 Protrusion 36 Hook 37 Groove part 38 Groove part 42 Protrusion

Claims (4)

  A fixing tool for fixing a tubular indwelling catheter, a cylindrical holding tool formed of a resin having a hardness lower than that of the catheter and having a slit in the longitudinal direction, and the holding tool by pressing the holding tool from the outer periphery And a clip made of resin for fixing the catheter inserted through the lumen of the inner holder, the inner holder and the outer housing being able to be fitted and released from each other, and the inner holder is connected to the outer housing. When the fitting is released, the inner diameter is large enough to cover the holder with the inner holder, and the fixing member covers the holder with the inner holder and the outer housing. The holder can be clamped by reducing the inner diameter of the inner holder with the outer housing. Catheter fixture to.   The inner holder and the outer housing are slidable in the axial direction with the outer housing covered on the inner holder, and can be switched between a mating state and a mating release state by this sliding. 2. The catheter fixture according to claim 1, wherein in the state, the inner diameter of the inner holder is reduced by a wedge action between the inner holder and the outer housing.   The catheter fixture according to claim 1 or 2, further comprising holding means for holding the inner holder and the outer housing in a fitted state.   The catheter fixture according to any one of claims 1 to 3, further comprising connecting means for connecting the inner holder and the outer housing in a state in which the inner holder and the outer housing are prevented from being detached. .

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