JPS5817627B2 - Medical set for diffuser - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION Blood processing devices are used in the medical field for dialysis, ultrafiltration, oxygenation of blood, and for experimental enzymatic or adsorbent treatments of blood, etc.

All of these operations require numerous operations to direct blood into the diffuser during one operation and to remove it from the diffuser for return to the patient.

For example, in hemodialysis, conventional arterial and venous sets are currently used to remove blood from a patient, transport the blood to a dialyzer, and return the blood back to the patient.

The set generally includes a foam trap, a sterile access site for the injection needle, a filter, and a pressure monitor access site.

The set is otherwise constructed primarily of flexible, blood-compatible plastic tubing.

In current conventional usage, two different and separate long tubular sets are used for dialysis, one being an arterial set and the other being a venous set.

Therefore, to prepare for a dialysis operation, a dialyzer must be selected and the technician must obtain arterial and venous sets separately.

The packaging of all these instruments must be opened;
The instruments must also be assembled together and other accessories must be attached to the system.

This requires the work of a highly skilled technician, who must make a considerable number of connections between the set and the dialyzer, completely error-free.

It has also been suggested to use monolithic hydraulic circuits made from a single molded block of plastic or similar materials to replace many functions of arterial and venous sets and auxiliary devices.

According to the invention, many of the rigid parts of the set are manufactured from a single bracket member which is a molded piece in the mortar type,
The flexible tubing of the set, on the other hand, can be attached to and supported by the bracket member, thus providing a complete, single combined arterial and venous set, optionally containing a dialyzer or other diffusion device during fabrication. An improved single medical set is provided.

Thus, a complete diffusion device, including, for example, a flow path and a dialyzer, can be packaged as a single unit.

This greatly simplifies the preparation of the system prior to use, eliminates many of the connections that must be made by technicians at the point of use, and reduces the possibility of errors and contamination of the system during assembly and connection operations. .

Furthermore, the system of the present invention is compact and simple, saving considerable space around the bed during dialysis or other operations.

The medical set of the present invention forms a flexible flow line for fluids and is adapted for communication with a blood processing device, such as a blood dialyzer or oxygenator.

In accordance with the present invention, a monolithic, typically molded, bracket member is provided in which a flexible flow line is supported on the bracket member.

Rigid internal access members or other shaped elements are typically inserted into the flow line to provide a sterile, resealable needle entry into the flow line for sampling or other purposes, and to provide a connecting junction for branch flow lines. mounted on top.

The generally rigid access member described above is removably attached to the bracket member.

This can be accomplished by fabricating the bracket in a conventional mass molding operation.

In that case, the various rigid access elements are molded simultaneously in the same operation as the molding of the integral bracket element, and the access elements are then formed into thin, frangible webs that can be torn away by hand later when it is desired to use the device of the invention. Connect to the bracket member with.

After the assembly is fabricated, the various flexible parts of the set, such as tubes and foam traps, are assembled.

To complete the medical set of the present invention, it may be connected to the set by conventional heat or solvent sealing techniques as desired.

Alternatively, the access member may be removably attached by a clip member integral with the bracket member.

In this case, the access member can be molded separately and mounted on the bracket for convenient assembly, storage and use.

It may also be desirable to provide attachment means on the bracket member to allow the bracket member and diffuser to be connected into a single unit.

Therefore, if desired, the bracket member with all attached flexible parts and one diffusion unit can be packaged in a single sterile container, which the technician then has to open. , you will see a diffusion device that can be prepared in less time and with less skill than previous devices.

The preferred medical set of the invention also preferably includes a pair of flow lines each formed from flexible chamber-defining wall means supported by and suspended therefrom. It has a flexible foam trap.

The upper portion of the wall means adjacent the bracket member defines a chamber having a larger lateral dimension than the lower portion of the wall means remote from the bracket member.

Intermediate wall means, which are generally integral with the remaining portions of the room-limiting wall means, extend laterally between the upper and lower portions.

A first access means is provided in communication between the exterior and a location in the chamber adjacent the intermediate wall means.

A second access means is provided in communication between the exterior and a location adjacent the chamber end remote from the bracket member.

This type of foam trap offers a number of advantages.

Its flexibility allows the foam trap to be deflated as in a conventional drip chamber to prime the set.

Also preferably the first entry through the intermediate wall means enters below the liquid level so that the section has an upward velocity component to aid in the separation of bubbles from the blood (normally the liquid level is upwardly ), which is particularly advantageous for removing bubbles.

However, foaming is reduced when the inlet is substantially below the liquid level.

Thus, the upwardly moving bubbles are immediately pushed up to the top of the chamber and merge with the bubbles normally present at the inner top of the chamber while the operation is being carried out in the core.

Similarly, the relatively wider upper portion of the foam trap provides extra space and results in less changes in the main fluid level due to small changes in blood volume in the foam trap.

Also, the upper part of the foam trap has become larger. The blood velocity at the top of the trap is slowed down to allow removal of microbubbles to the last drop.

Preferably, the second entry point of the foam trap for one of the traps is a tube that passes through the bracket member and terminates adjacent the distal end of the chamber, and for the other trap, is a tube that passes through the bracket member and terminates adjacent the distal end of the chamber. Preferably, the conduit passes through adjacent chamber-forming walls.

In both cases, these entry points are intended to be used as exits from the foam trap and are therefore located at its lowest level, far from any foam that may remain in the system. It is provided.

In the drawings, FIG. 1 is a perspective view of an embodiment of a medical set according to the present invention adapted for use in a hollow fiber blood dialyzer, in which a rigid internal access member is integrally connected to a bracket member. It has been separated from its original position, and other parts have also been removed from its original form to a usable form.

FIG. 2 is a plan view of the bracket member and associated components of the present invention, with the dialyzer and some other components not shown for clarity; FIG.

is shown as molded integrally connected to the bracket member.

FIG. 3 is a front view of the bracket member of the present invention showing some parts in cross-section, with the internal access member being attached to the bracket member in its first integral structure as shown in FIG. It is shown in the following relationship.

FIG. 4 is a partial plan view of another embodiment of a medical set according to the invention in which the access member is removably mounted to the bracket member by means of a clip.

It is a diagram.

FIG. 5 is a front view showing a part of the specific example shown in FIG. 4, with a part thereof being made into a longitudinal section.

FIG. 6 shows an individual rigid inner tube adapted to be supported in the clip of the embodiment of FIGS. 4 and 5. FIG.

FIG. 3 is a perspective view showing how the partial parts are all integrally molded in collective molding.

Referring to FIGS. 1-3, the medical set shown therein supports a pair of bubble traps 12, 14 and other flexible channels for fluids described below in a sealed suspended relationship. A bracket member 10 suitable for this purpose is constructed.

In this embodiment, the bracket 10 defines a clamping member 16 that is part of a cylinder with an arc of 180 degrees or more and that maintains a snap-fit relationship with a conventional hollow fiber dialyzer 18. Can be installed.

Typically, the dialyzer 18 has a dialysate port 20 and a blood supply port 22.
and a blood outlet 24 so that blood enters into dialysis exchange relationship with dialysate across the barrier membrane provided by the hollow fiber dialyzer 18 .

A support arm 26 is provided having fingers 28 that fit around the cylindrical portion 16 to support both the set of the present invention and the dialyzer 18 as shown in FIG.

The finger 28 fits around the locking projection 29.

As previously mentioned, the various internal access members are typically molded in the same process as the bracket 10, which is typically fabricated from a thermoplastic material, and are initially integrally attached to the bracket member 10.

As shown in FIGS. 2 and 3, a fitting 30 serves to connect to a cannula that connects to the patient's blood system.
．． 32 initially forms an integral part with the bracket member 10 by means of a shaped web 34, and the web 34 is connected to the fitting 3 when desired for use as in FIG.
Can be broken by hand to separate 0.32.

Similarly, T-shaped connectors 36 and 38 are located intermediately along the length of the flow path, as will be described later.

As shown in FIGS. 2 and 3, a frangible web 40 can be integrally formed and connected to the bracket member 10.

These T-shaped connectors can also be separated by manually breaking the web 40 as shown in FIG.

The structure described above greatly simplifies the fabrication of the parts of the set.

For example, in this particular example. Five separate parts are molded simultaneously during molding of the bracket member.

If desired, more parts can be molded simultaneously in a similar manner.

After the molding process, flexible tubes and similar parts can be attached to various rigid, co-molded parts as desired.

To further explain the set of the present invention, the arterial line 42 is made of polyvinyl chloride or other flexible blood-compatible material and typically has an inner diameter of 0.475 F and a 0.0
It consists of a flexible tube with a thickness of 14 cfrL.

As shown in FIG. 1, the arterial line 42 terminates in connection with a fitting 30 that is used to make a connection to a cannula that communicates with the patient's arterial system in a conventional manner.

The flexible attachment cap 44 seals the fitting 30 until it is desired to open the fitting 30.

An on/off clamp 46 is provided to shut off flow through the arterial line 42 when necessary.

An injection site 48 located midway through the arterial line 42 is provided.

The injection site is not initially integrally attached to bracket member 10 in this particular embodiment.

However, such an integral connection is also possible in other embodiments.

Injection site 48 is similar to that currently found in conventional arterial and venous sets sold by Travenol Laboratories, Inc., Deerfield, Illinois, USA.

Alternatively, an injection site similar to that of US Pat. No. 3,850,202 may be used if desired.

Connector 30 and injection site 48 from the patient's arterial system.
As blood flows through the step, it passes through a step that provides a connection to a further length of arterial line 42 and to a fluid addition line 52 that is specifically used for adding priming saline to the set or as desired. Branched connector 3 with
flows through 6.

The fitting 36 is initially attached to the bracket member 10 as seen in FIG. 2 and later removed for use as described above.

Downstream of fitting 36, typically about 45.72 cIrL
a roller pump tube 50 of length, which tube has a larger diameter than the arterial tube 40.

This requires the use of stepped fittings 36.

The hollow portion 54 of the stepped fitting 36 has a tapered portion as seen in FIG. 1 and has various length dimensions.

Tube 50 has an inner diameter of 0.635 CffL and 0.152
It can have a wall thickness of 4CrrL.

The other end of the roller pump tube 50 is a second stepped bifurcated fitting 38, which is also initially attached to the bracket member 10.

Fitting 38 is for a branch connection for a heparin line 56, which is initially coiled and
Ends with cap 58.

The cap fits into a perforated flap 60 which is normally an integral part of the stepped fitting 38.

The cap 58 is thus retained within the perforated flap or ear 60 to keep the line 56 in place.

The pull string 62 on the cap 58 can be connected to a conventional heparin dispenser for blood when the heparin line 56 is desired to be used.
To facilitate removal of the cap from the flap 60.

Downstream of the fitting 38 is the last section of the arterial tube 42, which communicates at its distal end with the intermediate wall 64 of the flexible foam trap 12 and serves to seal the upper enlarged chamber 66 section. However, the tube extends below the foam trap 12 and beyond the narrow chamber 68.

Any bubbles present are therefore forced up through the intermediate wall 64 into the upwardly expanding chamber 66.

This facilitates bubble separation without foaming when the blood surface level 69 is located within the enlarged chamber 66.

Blood then flows from the bottom of the narrow chamber 68 into the suspension tube 7.
0 and flows upwardly through bracket member 10 into inlet line 12, which is also a flexible tube made of polyvinyl chloride or similar material.

Line 72 communicates with blood supply 22 of dialyzer 18 .

Another sterile injection site 74 is provided through the bracket member 10 for needle communication with the enlarged chamber 66 for taking samples, removing air bubbles, etc.

Injection site 74 is of conventional design.

Arterial monitor line 76 also has an end 78 that communicates with foam trap 12 through bracket member 10 to permit measurement of foam trap pressure.

The opposite end of the line T6 is connected to the hole 8 of the bracket member 10.
2, terminating in a conventional connecting member 80 which fits into the connector 2.

Bracket member 10 such that slot 84 functions as an on/off clamp for arterial pressure monitor line 76.
established in

Jaws 85 function to accommodate and support the coils of line 16 during storage to reduce twisting.

Dialyzed blood exiting outlet 24 is routed through flexible conduit 86.
The conduit communicates at its other end with a conduit passing through the intermediate wall 88 of the foam trap 14, which corresponds to the intermediate wall 64 of the foam trap 12.

In a similar manner, the upward flow of blood forces the bubbles upwardly, and foaming is minimized by maintaining the level of blood in the enlarged chamber 90 of the foam trap 14, which corresponds to the enlarged chamber 66 of the foam trap 12. be done.

Blood is withdrawn from a narrow chamber 92 in foam trap 14 corresponding to chamber 68 in foam trap 12, passes through a sock-shaped filter 94, and enters an intravenous line 96 attached to a conduit passing through the bottom of foam trap 14. .

Intravenous line 96 may also be constructed from the same conventional flexible blood-compatible plastic.

Another injection site 98, similar to site 74, extends through bracket member 10 to permit sample collection and, among other things, aseptic removal of gas bubbles from bubble trap 14.

The venous bubble trap pressure monitor line 100 has one end 1
02 through the bracket member 10 to communicate with the interior of the foam trap 14, and at the other end a conventional fitting 10.
It ended with 6.

The connecting member 106 is connected to the hole 108 in the bracket member until it is used.
(Fig. 2).

Also provided is a throat 110 which functions as an on/off clamp for the venous pressure line.

Jaws 111 function similarly to jaws 85 to retain the coils of tube 100.

As the dialyzed blood passes through the venous line 96, it encounters an injection site 112 that is similar in construction to the injection site 48 of the arterial line.

A clamp 114 is provided to shut off flow through the system when desired.

Finally, the intravenous line terminates in a fitting 32 having a sealing cap 114, which fitting is adapted to be connected to a cannula for communication with the patient's venous system in a conventional manner.

Connector 32 is the fourth access member in this embodiment that is initially attached to bracket member 10 .

If desired, flow line sections, such as lines 42 and 96, may be co-extruded.

The tubes can be connected by just a thin web of the same material, allowing the tubes to be pulled apart by hand when needed, if desired.

This simplifies the construction of the system and also reduces the possibility of tubing becoming confused and tangled during use.

Therefore, the medical set shown in FIGS. 1-3.

Various tubes 42, 50, 42, 72°86.96, which are flexible blood flow lines, are provided in advance to complete the blood circuit between the dialyzer 18, which is a medical diffusion device, and the patient.

The various tubes constituting these blood lines are attached to the dialyzer 18 by being removably supported on a bracket member 10 provided with a clamp member 16 (in this case, the bracket member 10 is supported by tearable webs 34, 40). 10), tube 42.96,5
It is supported by fittings 32, 34, 36.degree. 38, which are tubular rigid members connected in communication with the tube.

Therefore, in order to complete the blood circuit using this medical set, the webs 34, 40 must be separated from the bracket member 10.

removing the caps 44, 114 of the fittings 30, 32 and connecting them to cannulas in communication with the patient's arteries and veins;
Furthermore, it is only necessary to connect the free ends of tubes 72 and 86 to blood supply 22 and outlet 24 of dialyzer 18, respectively.

Referring to FIGS. 4 and 5, there is shown another unitary medical set according to the present invention which is identical in structure, purpose and function to the embodiment of FIGS. 1-3 except as noted. Can be seen.

Bracket member 10a is integrally molded and includes a clamp member 16a for attachment in a snap-fit relationship to a conventional hollow fiber dialyzer, as in the previous embodiment.

The main difference from the previous embodiments is that the bracket member 10a has a series of integrally molded gripping means or clamping members 1
20, 122, 124, and 126, these members have fittings 30a, 32a and T-shaped fittings 36a, 38a, which correspond in function to like-numbered parts in the previous embodiment. It includes a cylindrical portion integrally connected to and forming a part of the bracket member 10a for removably holding various internal access members therein by spring gripping action.

Another difference from the previous embodiment is that the clamping member 120.1
22, 124 and 126 have been changed from the corresponding positions found in the previous embodiment to the front face of bracket member 10a, with members 36a and 38a being on opposite sides of the corresponding parts in the previous embodiment.

Internal entry members 30a, 32a, 36a, 3
Although 8a is not integral with bracket member 10a, it can still be removably attached thereto.

Each part is made by a single, separate assembly operation forming the product as shown in FIG.

There, the integral access members are all connected together by a conventional mass-formed web 128.

After molding, each component is cut from web 128, attached to its respective connected tube member as in the previous embodiment, and clamped to clamp members 120, 122, 1.
24,126.

The caps 129° 130 of members 30a and 32a are
They may be connected by a thin flexible web 132 and integrally molded as shown, or alternatively the cap may be separately molded and attached by a loop to the periphery of the integral access member.

The remaining parts in the embodiment of FIGS. 4 and 5 are identical in structure and function to the previously described parts with the same numbers in the previous embodiment of FIGS. 1-3.

In particular, to provide the functions previously described with respect to tubes 52 and 56, tube 56a can be attached to fitting 38a and tube 52a can be attached to fitting 36a after the fitting is formed.

Tubes 42a and 50a can be attached in the same manner to provide the same functionality as previously described.

One particular advantage of the embodiments of FIGS. 4 and 5 is that the bracket of the invention can be attached to a separately manufactured blood tubing set, such as an arterial and venous set for an artificial kidney or a corresponding set for oxygenation. 10a can be used.

In this way, storage sets of different types can be attached to separate brackets NOa, if desired, prior to use, and the entire system later sterilized and ready for use, for example in an emergency.

Bracket member 10a serves to hold this structure in place and to support the foam trap and other items so that final preparation is completed in less time and with less chance of error or disruption of sterility. achieved.

These sets are convenient to use because they are preassembled and sterilized at the factory under tightly controlled conditions, rather than being assembled from component parts by overworked or unskilled personnel at various locations. This results in substantial improvements in performance and reliability.

Substantial cost savings are also realized by co-molding the various parts for the set of the present invention, and the same construction allows convenient and compact storage of the set in an orderly and normal form.

The foregoing description has been presented by way of example only and is not intended to limit the invention as claimed.

[Brief explanation of the drawing]

FIG. 1 is a perspective view of a specific example of a medical set according to the present invention;
FIG. 2 is a plan view of the bracket member and related parts of the present invention;
FIG. 3 is a front view showing some parts of the bracket member in cross section, FIG. 4 is a plan view of another specific example of the medical set according to the present invention, and FIG. 5 is one of the specific examples of FIG. FIG. 6 is a perspective view showing a state in which the internal access member of the specific example of FIGS. 4 and 5 is integrally molded. 10.10a...Bracket member-12, 14
...Bubble trap, 16,114.16a...
... Clamp member, 18 ... Dialyzer + 3
0, 32, 36° 38 degrees 30a, 32a, 36a, 38
a... Connector, 42... Arterial line,
46...On/Off. Clamp, 112, 48... Injection site, 50.
...Roller pump tube, 56...
Heparin line, 76... Arterial monitor line, 96... Venous line, 100... Venous bubble trap pressure monitor line.

Claims (1)

[Claims] 1. A flexible blood flow line to be incorporated into a blood circuit between a medical diffusion device and a patient is provided in advance, and the flow line is communicated with the diffusion device to complete the blood circuit. a medical set adapted for use with the diffuser, the medical set having a bracket member attachable to the diffuser, the bracket member supporting the flow line; The medical set further comprising a tubular rigid member mounted in communication with the flow line and removably supporting a tubular rigid member for connecting it to the blood circuit. 2. What are the bracket member and the tubular rigid member? The medical set of claim 1 comprising a single piece of integrally molded plastic connected together by a unitary frangible web portion. 3. The medical set of claim 1, wherein said bracket member supports a pair of flexible foam traps as part of said flow line. 4. The unitary bracket member includes gripping means integrally formed with the bracket member for removably receiving and retaining the tubular rigid member, thereby retaining the tubular rigid member relative to the bracket member. A medical set according to claim 1, which can be detachably attached. 5. Each flexible foam trap has a flexible chamber-defining wall means suspended from said bracket member. Defining a chamber having a larger lateral dimension than a lower portion of the wall means remote from the bracket member. An upper portion of the wall means adjacent the bracket member, intermediate wall means extending laterally between the upper and lower portions, and communication between an exterior and a first volume of the interior adjacent the intermediate wall means. and a second access means communicating between an exterior and a first volume adjacent an end of the chamber distal from the bracket member. A medical set according to claim 3. 6. The medical set of claim 5, wherein one of said foam traps present has second access means comprising a tube passing through said bracket member and terminating adjacent said distal chamber end. 7. The medical set of claim 6, wherein the other of said bubble traps present has a second access means comprising a conduit passing through said chamber-limiting wall means adjacent said distal chamber end. 8. Claim 7, wherein said other foam trap includes a filter located adjacent said distal chamber end.
Medical set of items. 9. The medical set of claim 7, wherein said foam trap first entry means includes a conduit passing through said intermediate wall means. 10. The medical set of claim 5, wherein said bracket member includes a sealed injection site passing therethrough and communicating with said flexible foam trap. 11 said flow line has a tubing section suitable for mounting a roller pump, said roller pump tubing section being of a larger diameter than the remainder of said flow line, and said roller pump tubing section being of a larger diameter than the remainder of said flow line and being connected thereto by means of a stepped fitting; The medical set of claim 1 connected to the remainder of the flow line at both ends. 12. The medical set of claim 1, wherein the bracket member includes means for attaching the bracket member to a diffuser. 13 separate hole means provided through said bracket member in communication with each of said flexible foam traps, and a pressure monitor tube communicating with said hole means and extending outwardly from each foam trap; each of said pressure monitor tubes terminating in a connecting member, and further apertures in said bracket member for removably receiving and retaining said pressure monitor tube connecting members. Medical set in scope 5. 14. One of the stepped connecting means is provided with a side hole communicating with the interior of the connecting means. A heparin dosing line communicates with the interior through the side hole, the other end of the heparin dosing line terminating in another connection means extending outwardly from the stepped connection means and connecting the heparin dosing line to the interior. 12. A medical set according to claim 11, further comprising perforated flap means adapted to accommodate and retain a line fitting. 15. One of said stepped connection means is provided with a flap member extending outwardly therefrom, said flap member further being provided with a fitting at the end of a flexible tube which is attached to said medical set with a branch connection. 12. A medical set according to claim 11, wherein a hole is provided for freely storing and holding the medical set.