JP6018935B2 - Body fluid treatment device - Google Patents

Description

The present invention relates to a bodily fluid treatment apparatus used for hemodialysis, blood filtration, hemodiafiltration, plasma separation, and the like, and relates to an improvement of the invention in which a port and a housing are laser welded.
More specifically, the present invention relates to an improvement of a body fluid treatment device in which a nonwoven fabric is disposed (sandwiched) between a port and a housing and irradiated with laser light to weld the transparent materials of the port and the housing together.

In the past, many modules of body fluid treatment devices were welded by ultrasonic welding.
However, ultrasonic welding has the following problems (a), (b), and (c).
(A) Welding debris is generated depending on the material and is mixed into the port or the hollow fiber. (B) If the welding horn does not contact the welding surface evenly, a sufficient welding force cannot be expected, and the shape of the welding part is often limited.
(C) A material having high crystallinity such as polypropylene is difficult to be uniformly welded by ultrasonic waves.

Therefore, recently, a product in which a port and a housing are welded using a laser has been put on the market. The product uses an opaque port material to absorb the laser.
In addition, the applicant disclosed in Patent Document 1 (Japanese Patent No. 4421827) an invention of a body fluid treatment apparatus in which a port and a housing are laser-welded.

The invention described in Patent Document 1
(A) As the first invention, (Claim 1) (A-1) At least one of the port and the housing is made of a material that generates heat by absorbing a laser, and (A-2) the slope of the end of the port The slopes of the protrusions at the end of the housing are welded together. (See Figure 2)
(B) As a second invention, (Claim 3) (B-1) A weld space is provided between the port end and the housing end, and (B-2) a laser absorbing member in the weld space. Is arranged. (See Figs. 3 and 4)
(C) As a third invention, (Claim 4) (C-1) At least one of the port and the housing is made of a material that generates heat by absorbing the laser, and (C-2) a step portion of the port and the housing The end flange is welded. (See Figure 5)
The invention is disclosed.

Patent Document 2 (Japanese Patent Laid-Open No. 2006-15405) discloses a method of irradiating a laser using a material such as a nonwoven fabric on one surface layer of a welding member itself.
(D) In the present invention, laser absorption is obtained between transparent materials by roughening the surface of the welding surface by sandpaper or blasting to give fine irregularities.

Japanese Patent No. 4421827 (Claims, FIGS. 1 to 5) JP 2006-15405 A (summary column, paragraph [0006], FIG. 1)

The commercially available body fluid treatment device and Patent Document 1 The points (A-1) and (C-1) of the (A) first invention and the (C) third invention are for absorbing the laser. The material itself is opaque.
(D) For this reason, since the inside of the port or the housing cannot be seen, there is a problem that it is impossible to check the air remaining in the port at the time of priming or the degree of residual blood.

The points (A-1), (B-2), and (C-1)
(E) (e-1) If a colored material or the like is used to improve laser absorption and heat generation, an unintended color is applied to the module. (E-2) Further, the application of the absorbent is expensive, and the production cost is increased including the technique of applying the absorbent uniformly. (E-3) The material for absorbing the laser itself is an unnecessary material for the treatment itself, and considering the risk of elution in contact with blood, it is necessary to verify sufficient safety.
The points (A-2), (B-1), and (C-2)
(F) A high degree of molding is required, leading to an increase in production costs including molds.

The invention described in Patent Document 2 has the following problems (g), (h), and (i).
(G) When processing scraps are generated during surface processing and mixed into the port or hollow fiber, there is a serious risk of entering the patient's body when blood is circulated.
(H) In addition, if washing and drying are performed to remove processing waste, it is impossible online, and additional processing steps and costs are required.
(I) Although a method of providing irregularities with a mold is also provided, it is difficult to provide sufficient irregularities sufficient to obtain an anchor effect in terms of extraction during molding.

Therefore, as a result of intensive studies to solve the above problems, the present inventors have reached the following invention.
[1] The present invention includes a port (2), a housing (3), and a nonwoven fabric (5),
The port (2) is made of a transparent synthetic resin that transmits a laser, and has a substantially cylindrical shape.
The housing (3) is made of a synthetic resin not containing a reinforcing material and has a substantially tubular form,
The nonwoven fabric (5) is colorless, does not contain additives, has a substantially annular shape, has a thickness (5T) of 0.2 mm to 0.5 mm, and a laser transmittance (RPM) of 30. % Or less,
The port (2) has a laser transmittance (2RIFPM) to the welding interface (WIF) between the port (2) and the housing (3) of 70% or more,
The port (2) and the housing (3) are formed so that a welding width (WW) of a welding surface (WP) is 1.5 mm or more and 4 mm or less,
Place a nonwoven fabric (5) between the end (DE) side and the proximal end of the housing (3) (PE) side of the port (2),
It said port (2), by irradiating a laser welding portion of the housing (3) and the non-woven fabric (5), by melting the nonwoven fabric (5),
Provided is a method for producing a body fluid treatment device (1) in which a terminal (DE) side of the port (2) and a base end side (PE) of the housing (3) are welded.

[2] In the present invention, the port (2), the housing (3) and the nonwoven fabric (5) are formed of the same material,
The nonwoven fabric (5) that is melted by absorbing laser manufacturing method of a body fluid treatment device (1) according to the port (2) and welded by melting the constituent material of the housing (3) [1] I will provide a.

[3] The humor treatment device according to [1] or [2], wherein the port (2), the housing (3), and the nonwoven fabric (5) are any one of polypropylene, polycarbonate, polyethylene, polystyrene, and polyethylene terephthalate. The manufacturing method of (1) is provided.

[4] In the present invention, the port (2), the housing (3) and the nonwoven fabric (5) are made of polypropylene,
A base material ( PE ) side and a terminal ( DE ) side of the nonwoven fabric (5) are attached with a coating material having a melting temperature lower than that of polypropylene,
Placing the nonwoven fabric (5) between the port (2) and the housing (3);
Said port (2), by irradiating a laser welding portion of the housing (3) and the non-woven fabric (5), by melting the coating material of the non-woven fabric (5),
Provided is a method for manufacturing a body fluid treatment device (1) in which a terminal (DE) side of the port (2) and a base end (PE) side of the housing (3) are welded.

[5] The body fluid treatment according to [4], wherein the coating material of the nonwoven fabric (5) absorbs the laser and melts, thereby melting and welding the constituent materials of the port (2) and the housing (3). A method for manufacturing the device (1) is provided.

The present invention is
(1) A transparent material can be laser-welded without coloring. A laser absorber is also unnecessary.
(2) Since it can weld with the nonwoven fabric of the same raw material as the material to weld, the safety | security of material can be ensured.
(3) Unlike ultrasonic welding, a so-called “O-ring” that is liquid-tight is not used between the port and the housing, so there is no generation of welding debris or the like. In addition, there is no worry of elution because no laser absorber is used.
(4) As in (1) to (3). By allowing laser welding without coloring one of the materials itself or applying a laser absorbing drug, the risk of contamination of toxic substances in the body can be avoided.

(5) Surface processing of the welded portion between the port and the housing is unnecessary.
(6) Since the nonwoven fabric has a shape buffering action, a pretreatment such as annealing of the port (a heat treatment that removes internal strain generated in the process of cooling the resin by heating) is unnecessary.
(7) Since the price of the nonwoven fabric itself is low, it can be manufactured at a lower cost than using a special surface treatment or absorbent.
It is possible to achieve the advantageous effects.

It is the schematic of the place which laser-welds the port and housing of the bodily fluid processing apparatus of this invention. Partial enlargement of the vicinity of the weld between the port and housing (A) It is the schematic of the place which laser-welds the port and housing of the bodily fluid processing apparatus of this invention. (B) It is the schematic of the place which produces the test piece after the laser welding of the bodily fluid processing apparatus of this invention. (C) It is the schematic of the tensile test of the test piece of (B).

Hereinafter, the present invention will be described in detail with reference to the drawings.
Hereinafter, in order to clearly describe the present invention, the following definitions are provided.
(Definition 1) In the present invention, “base end PE (side or direction)” means an end portion on the port inlet 2I side as shown in FIG.
(Definition 2) “Terminal DE (side or direction)” means an end opposite to “base end PE (side or direction)” as shown in FIG. More specifically, it means the end opposite to the port inlet 2I side.
(Definition 3) “Center axis or center CL (side or direction)” means the center in the longitudinal L direction of the housing 3 (see the broken line in the figure), as shown in FIG.

(Definition 4) “Longitudinal L (side or direction)” means the long direction of the housing 2 as shown in FIG.
The “side portion S (side or direction)” means a direction (360 ° direction) that intersects the longitudinal L direction substantially perpendicularly as shown in FIG.
(Definition 5) “First side S1 (side or direction)” means “side S (side or direction)”, referring to FIG. Means.
(Definition 6) “Second side portion S2 (side or direction)” means a direction opposite to “first side portion S1 (side or direction)” as shown in FIG. Of the “side part S (side or direction)”, referring to FIG.

(Regarding the description of the signs indicating the direction of the position and arrangement of the names of each part)
In the drawings of the present invention and the description of the invention, the reference numerals indicating the direction of the position / arrangement, etc., are within the scope that allows understanding of the invention and recognized as necessary, and only a part of the drawings and the description of the invention. Described.

[Body fluid treatment device]
In the body fluid treatment device 1 of the present invention, a hollow fiber membrane is arranged inside the housing 3 along the longitudinal L direction of the housing 3 although not shown. The proximal end side and the distal end side of the hollow fiber membrane are fixed in the housing 3 by a fixing material.
Although not shown, a port inlet for dialysate (a treatment liquid for body fluid such as blood) is mounted on the terminal DE side of the housing 3 in the direction of the first side S1, and the first inlet PE side of the housing 3 A port outlet such as dialysate (treatment fluid for body fluid such as blood) is attached to the side S1. )
The port 2 has a so-called “substantially cylindrical” shape and is attached to the base end PE side of the housing 3.
The port 2 has a so-called “substantially tubular” port inlet 2 </ b> I projecting from the terminal DE side toward the base end PE side along the central axis CL at the approximate center.
The housing 3 has a so-called “substantially tubular” shape and is mounted on the terminal DE side of the port 2.
The housing 3 forms a flange 3F on the base end PE side.

(Nonwoven fabric 5)
The nonwoven fabric 5 is processed into a so-called “substantially annular” form, and is disposed between the terminal DE side of the port 2 and the base end PE side of the housing 3, and by laser irradiation,
It plays the role of welding the port 2 and the housing 3 together.
The nonwoven fabric 5 preferably has a thickness (5T): 0.2 to 0.5 mm. If the thickness is too small (less than 0.2 mm), the laser beam is likely to be transmitted and is difficult to absorb.
On the contrary, if the thickness is too large (over 0.5 mm), the nonwoven fabric 5 cannot be melted uniformly. For this reason, the weldability of the welding member (port 2 and housing 3) is deteriorated.

The “laser transmittance (RPM)” of the nonwoven fabric 5 is 0 to 30%, preferably 0 to 20%.
The nonwoven fabric 5 that does not transmit laser at all (laser transmittance (RPM) 0%) is the best because it can absorb the laser most.
If the nonwoven fabric 5 transmits too much laser (laser transmittance (RPM) exceeds 30%), the heat generation effect due to laser absorption is reduced, which is not preferable.

(Port 2 and housing 3)
As for the dimension of the welding surface (WP) of the port 2 and the housing 3, the welding width (WW) is preferably 1.5 to 4 mm.
If the welding width (WW) is too small (less than 1.5 mm), the welding area becomes small, and further laser beam misalignment tends to occur, so that sufficient strength cannot be expected.
On the other hand, if the welding width (WW) is too large (exceeding 4 mm), the adhesion of the welding surface is deteriorated and uniform welding is difficult.

Further, the preferred size of the thickness (2H) of the port 2 that transmits the laser [in other words, the height to the welding interface (WIF) between the port 2 and the housing 3) depends on the material of the port 2.
The laser transmittance (2RIFPM) to the welding interface (WIF) of the port 2 is 70 to 100%, preferably 80 to 100%.
Laser transmittance (2RIFPM)
Port 2 is best because it can transmit 100% laser (laser transmittance (2RIFPM) is 100%) because it can transmit the most laser.
If the port 2 does not transmit much laser (laser transmittance (2RIFPM) is less than 70%), the laser does not reach the welding interface (WIF), and the heat generation effect due to laser absorption of the nonwoven fabric 5 decreases, which is not preferable.

If the thickness (2H) of the port 2 is too large, the laser absorbs the laser inside the material of the port 2 and the welding strength at the welding interface (WIF) becomes low.
In the case of polypropylene, sufficient strength can be realized with a welding width (WW) of 1.5 to 3 mm, a thickness (2H) of 1 to 4 mm, and a laser transmittance (2RIFPM) of 71 to 86%.
The laser transmittance (2RIFPM) of 71% corresponds to the case where the thickness (2H) is 4 mm (actual measurement value).
The laser transmittance (2RIFPM) of 86% corresponds to the thickness (2H) of 1 mm (actual measurement value).
As shown in FIG. 1, the thickness (3H) of the housing 3 is the thickness [height in the longitudinal direction] of the housing flange 3 </ b> F, and a suitable size depends on the material of the housing 3.

(Example)
As shown in FIGS. 1, 2, and 3 (A), the nonwoven fabric 5 is disposed between the distal end side of the port 2 and the proximal end side of the housing 3. The welding part of the port 2, the housing 3, and the nonwoven fabric 5 was irradiated with a laser to melt the nonwoven fabric 5, and the distal end side of the port 2 and the proximal end side of the housing 3 were welded.
[Welding interface (WIF): Dimensions]
(Thickness of housing 3) (3H): 2.5 mm
(Outer diameter of port 2 and housing 3: OD): 54.8 mm
(Thickness of port 2) (2H): 2.5 mm
[(Note) The outer diameter of the housing 3 is the outer diameter of the housing flange 3F. ]

(Welding conditions): A laser irradiation device manufactured by Laser Line, Germany was used, and laser light was irradiated at 1 to 6 m / min along the welded portion WB.
The distance of the laser beam was adjusted so as to be focused on the welding interface WIF.
(Maximum output): 100W
(Fiber core diameter (condensed beam)): 0.9 mm [(Note) Possible between 0.6 and 1.2 mm]
(Wavelength): 940 nm
(Irradiation speed): 4 m / min
(Presser foot pressure): 1 MPa

In order to compare the welding strength between the example of the present invention and the comparative example, weak irradiation conditions were set so that the welding interface (WIF) (of this example) was broken, and blasting (of the comparative example) The difference with the welding method in was confirmed.
[Weld strength evaluation conditions]
(Equipment): Shimadzu Autograph AG-X
(Used cell): 500N
(Tensile speed): 10 mm / min
Table 1 shows the results of Examples and Comparative Examples.

From the results shown in Table 1, in the present welding conditions, in the present invention (Example), the welding strength was 19.33 ± 6.56N, and the welding in the surface blasting process as a comparative example was 17.07 ± 7.21N. In other words, it was confirmed that the present invention (Example) has effects of strength and uniformity equal to or higher than those of the comparative example.

(Material of port 2, housing 3 and nonwoven fabric 5)
The material of the port 2 and the housing 3 of the present invention may be anything as long as it is a transparent and hard synthetic resin, such as polypropylene, polycarbonate, polyethylene,
Any one of polystyrene, polyethylene terephthalate and the like is used.
By sandwiching a non-woven fabric of the same material as the material of the port 2 and the housing 3 between the port 2 and the housing 3, the non-woven fabric absorbs the laser and melts so that the ports 2 and the housing 3 on both sides of the non-woven fabric 5 are transparent. The material (transparent resin) can also be melted and welded.

The non-woven fabric itself is preferably colorless, and is preferably one in which the welded portion WB after laser welding is not colored.
The nonwoven fabric becomes a certain amount of cushioning material, and even if there is some unevenness in the tightness of the mating surfaces of the hard resins, it can be welded evenly, so there is no need to require complete flatness of the weld interface as in the prior art.

Furthermore, laser welding is possible if the port 2 and the housing 3 are materials whose melting temperature is lower than that of the nonwoven fabric. For example, different materials can be welded together by attaching a polyethylene terephthalate member to a polypropylene nonwoven fabric. An example will be described in detail below.

The port 2, the housing 3 and the nonwoven fabric 5 are made of polypropylene.
A coating material (for example, polyethylene terephthalate) having a melting temperature lower than that of polypropylene is attached to the base end PE side and the terminal DE side of the nonwoven fabric 5.
A non-woven fabric 5 is disposed between the port 2 and the housing 3.
By irradiating the welded portion of the port 2, the housing 3, and the nonwoven fabric 5 with a laser, the coating material (polyethylene terephthalate) of the nonwoven fabric 5 is melted to weld the distal end side of the port 2 and the proximal end side of the housing 3. To do.
When the coating material of the nonwoven fabric 5 absorbs and melts the laser, the constituent materials of the port 2 and the housing 3 can also be melted and welded.

1 Body fluid treatment device 2 Port 2I (Port) Inlet 2H (Port) Thickness (Height)
3 Housing 3F (Housing) Flange 3H (Housing) Thickness (Height)
5 Unemployed cloth 5T (unemployed cloth) thickness

Claims (5)

A port (2), a housing (3) and a non-woven fabric (5);
The port (2) is made of a transparent synthetic resin that transmits a laser, and has a substantially cylindrical shape.
The housing (3) is made of a synthetic resin not containing a reinforcing material and has a substantially tubular form,
The nonwoven fabric (5) is colorless, does not contain additives, has a substantially annular shape, has a thickness (5T) of 0.2 mm to 0.5 mm, and a laser transmittance (RPM) of 30. % Or less,
The port (2) has a laser transmittance (2RIFPM) to the welding interface (WIF) between the port (2) and the housing (3) of 70% or more,
The port (2) and the housing (3) are formed so that a welding width (WW) of a welding surface (WP) is 1.5 mm or more and 4 mm or less,
Place a nonwoven fabric (5) between the end (DE) side and the proximal end of the housing (3) (PE) side of the port (2),
It said port (2), by irradiating a laser welding portion of the housing (3) and the non-woven fabric (5), by melting the nonwoven fabric (5),
A method for manufacturing a body fluid treatment device (1) , wherein a distal end (DE) side of the port (2) and a proximal end side (PE) of the housing (3) are welded.
The port (2), the housing (3) and the nonwoven fabric (5) are formed of the same material,
The nonwoven fabric (5) that is melted by absorbing laser welded by melting the constituent material of the port (2) and the housing (3), that the body fluid treatment device according to claim 1, wherein The manufacturing method of (1).
The body fluid treatment device (1) according to claim 1 or 2, wherein the port (2), the housing (3), and the nonwoven fabric (5) are any one of polypropylene, polycarbonate, polyethylene, polystyrene, and polyethylene terephthalate. ) Manufacturing method .
The port (2), the housing (3) and the nonwoven fabric (5) are made of polypropylene,
A base material ( PE ) side and a terminal ( DE ) side of the nonwoven fabric (5) are attached with a coating material having a melting temperature lower than that of polypropylene,
Placing the nonwoven fabric (5) between the port (2) and the housing (3);
Said port (2), by irradiating a laser welding portion of the housing (3) and the non-woven fabric (5), by melting the coating material of the non-woven fabric (5),
A method of manufacturing a body fluid treatment device (1) , wherein a terminal (DE) side of the port (2) and a base end (PE) side of the housing (3) are welded.
The body fluid treatment device according to claim 4 , wherein the coating material of the nonwoven fabric (5) absorbs the laser and melts, thereby melting and welding the constituent materials of the port (2) and the housing (3). The manufacturing method of (1).