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Publication numberWO2013079961 A1
Publication typeApplication
Application numberPCT/GB2012/052966
Publication date6 Jun 2013
Filing date30 Nov 2012
Priority date2 Dec 2011
Also published asEP2785403A1
Publication numberPCT/2012/52966, PCT/GB/12/052966, PCT/GB/12/52966, PCT/GB/2012/052966, PCT/GB/2012/52966, PCT/GB12/052966, PCT/GB12/52966, PCT/GB12052966, PCT/GB1252966, PCT/GB2012/052966, PCT/GB2012/52966, PCT/GB2012052966, PCT/GB201252966, WO 2013/079961 A1, WO 2013079961 A1, WO 2013079961A1, WO-A1-2013079961, WO2013/079961A1, WO2013079961 A1, WO2013079961A1
InventorsSamy Ahmed HAMBOLY
ApplicantPROBERT, Rhyan
Export CitationBiBTeX, EndNote, RefMan
External Links: Patentscope, Espacenet
Multitube catheter and method for making the same
WO 2013079961 A1
Abstract
Multitube catheter and method for making the same are provided. The assembly includes two (T1,T3) tube fused together to form one catheter tube shaft. Each tube has (112,113) one lumen extending longitudinally through the catheter from its distal end to its proximal end. The tubes are fused together by use of heat & pressure. Heat and pressure can be generated by heat Shrinkable tube slides over a segment of catheter tubes while metallic mandrels are passed through each tube lumen to protect the lumens during fusion. The heat Shrinkable tube will shrink once heat is applied. The heat Shrinkable tube will shrink and apply the required pressure over the catheter tubes. Continual heating will melt and re -shape the catheter tubes inside the heat Shrinkable tube while the letter will not be affected due to its high melting temperature. After cooling, the heat Shrinkable tube is to be removed, the metallic mandrels are pulled back and the tubes forming the united catheter tube. One or more of the tubes can be of different hardness, material and/or color. The difference will provide pressure resistant lumen (s), overall catheter elasticity and/or identification. Distal end of the united catheter tube can be split free floating, stepped or tapered tipped. The proximal segment (none fused) will form catheter extension legs.
Claims  (OCR text may contain errors)
CLAIMS:
1 . A multitube catheter assembly comprising:
a plurality of tube catheters, each having a proximal opening, a distal opening and outer surface defining a lumen extending longitudinally therethrough between the respective distal and proximal openings, the tube catheters being non-concentric with at least one of said lumens being circular throughout the length between said respective distal and proximal openings, and each lumen being independent from each other;
wherein the multitube catheter assembly has a generally circular outside configuration when viewed in transverse cross section, and
wherein at least one of the tube catheters is formed of a material having a different material property to other tube catheters in the multitube catheter assembly.
2. A multitube catheter assembly according to claim 1 , wherein the material having a different material property is a pressure resistant material having a hardness or rigidity that is greater than the hardness or rigidity of the material comprising other tube catheters comprising the plurality of tube catheters.
3. A multitube catheter assembly according to claim 1 or 2, wherein a portion of the outer surface of one tube catheter is fused to at least a portion of the outer surface of at least one other tube catheter to form a fused bundle.
4. A multitube catheter assembly according to claim 1 , 2 or 3, wherein the lumens are substantially the same in transverse cross section.
5. A multitube catheter assembly according to claim 1 , 2, 3 or 4, wherein the plurality of tube catheters is comprised of a shorter tube and a longer tube, the distal opening of said shorter tube being proximal to the distal opening of said longer tube, said distal openings having a distance between them, said distance being sufficient to prevent recirculation of a first fluid passing through the distal opening of the shorter tube in a first flow direction and second fluid passing through the distal opening of the longer tube in a second flow direction, the first and second flow directions being different.
6. A multitube catheter assembly according to claim 5, wherein a portion of said longer tube has a greater circular cross section than a circular cross section of said shorter tube.
7. A multitube catheter assembly according to claim 6, wherein said shorter tube is dedicated to receive a withdraw fluid, and wherein said longer tube is dedicated to an infuse fluid.
8. A multitube catheter assembly according to any preceding claim, wherein the assembly is adapted to be fixable to a patient's skin.
9. A multitube catheter assembly according to any preceding claim, further comprising a cuff.
10. A multitube catheter assembly according to any preceding claim, wherein the tube catheters are releasably joined.
1 1 . A multitube catheter assembly according to any one of claims 1 to 9, wherein the tube catheters are unreleasably joined.
12. A multitube catheter assembly according to any preceding claim, wherein the lumens and fused bundle each have a diameter, an outer surface of said lumens being formed from fused material, said fused material being located inside a region corresponding to the fused bundle diameter and a region outside the lumen diameter.
13. A multitube catheter assembly according to any preceding claim, wherein the catheter tubes are non- conjoined at the distal opening.
14. A multitube catheter assembly according to any preceding claim, wherein said assembly is comprised of an assembly distal end and an assembly proximal end, wherein the assembly distal end is tapered so as to form a tapered tip and wherein the assembly proximal end is comprised of catheter extension legs.
15. A multitube catheter assembly according to claim 14, wherein said tapered tip is comprised of an opening for at least one of the tubes.
16. A multitube catheter assembly of claim 14 or 15 wherein the extension legs are further comprised of a fixed or removable luer end.
17. A multitube catheter assembly according to claim 14, 15 or 16, wherein one or more of the tubes have side openings adjacent the assembly distal end.
18. A multitube catheter assembly according to any preceding claim, wherein the material having a different material property is a material having a colour.
19. A method of manufacturing a multitube catheter comprising the steps of:
providing a plurality of heat fusible catheter tubes each having a lumen, at least one of said tube catheter comprising a material having a different material property to other tube catheters comprising the multitube catheter;
providing a plurality of mandrels and a heat shrinkable tube slide;
for each lumen, inserting a respective mandrel into a respective one of the lumens;
gathering said catheter tubes so as to form a bundle;
placing the heat shrinkable tube slide over a segment of said bundle;
heating said slide and said bundle such that the catheter tubes fuse together and form a united catheter with a plurality of lumens;
removing the shrinkable tube slide from said bundle; and
removing the mandrels from the lumens.
20. A method according to claim 19, wherein the material having a different material property is a pressure resistant material having a hardness or rigidity that is greater than the hardness or rigidity of the other tube catheters comprising the plurality of tube catheters.
21 . A method according to claim 19 or 20 wherein the step of heating said slide and said bundle such that the catheter tubes fuse further comprises adjusting the heat to the slide and the bundle such that the catheter tubes are non-releasable after the slide is removed.
22. A method according to claim 21 wherein the catheter tubes have ends capable of being processed into different shapes.
23. A method according to claim 19, 20, 21 or 22, wherein the shrinkable tube slide shrinks when heated to apply pressure to said bundle.
24. A method according to any one of claims 19 to 23, wherein the multitube catheter's outside cross-section is circular.
25. A method according to any one of claims 19 to 24, wherein the catheter tubes are of different lengths.
26. A method according to any one of claims 19 to 25, wherein the heating of the slide and bundle melts and fuses the catheter tubes around the mandrels and inside the heat shrinkable tube.
27. A method according to any one of claims 19 to 26, wherein the catheter tubes have end and wherein a portion of the catheter tubes are separated at one end.
28. A method according to claim 27 wherein the separated tubes form catheter extension legs that have ends processable into different shapes.
29. A method according to any one of claims 19 to 28, wherein the multitube catheter inner lumen has a substantially circular cross-section.
30. A method according to any one of claims 19 to 29, wherein the multitube catheter has different inner diameters
31 . A method according to any one of claims 19 to 30, wherein the multitube catheter has a proximal and distal end and said multitube catheter lumens are continuous.
32. A method according to any one of claims 19 to 31 , wherein the material having a different material property is a material having a colour.
Description  (OCR text may contain errors)

Multitube Catheter and Method for Making the Same

FIELD OF THE INVENTION The present invention relates generally to multitube catheter assemblies, and more particularly to multitube catheter assemblies having distal tapered tip end for positioning within an area to be catheterized

The lumens of the multitube catheter are full circular where they extend all through the distal end, the catheter main stem and the proximal end of the extension part.

The presented multitube catheter are to be used in any medical field where an access to the central venous system is required like, infusion, transfusion, haemodialysis, haemofiltration, plasma exchange, chemotherapy, etc.

The tube with higher hardness can be used for powerful infusion.

BACKGROUND OF THE INVENTION (A) Technical Background

Catheters for the introduction or removal of fluids may be located in various venous locations and cavities throughout the body for the introduction or removal of fluids. Such catheterization may be performed by using a single catheter having multiple lumens.

Generally, to insert any catheter in a blood vessel, the vessel is identified by aspiration with a long hollow needle in accordance with the Seldinger technique. When blood enters a syringe attached to the needle, indicating that the vessel has been found, a thin guide wire is then introduced, typically through a syringe needle or other introducer device, into the interior of the vessel. The introducer device is then removed leaving the guide wire within the vessel. The guide wire projects beyond the surface of the skin.

At this point, several options are available to a physician for catheter placement. The simplest is to pass a catheter into the vessel directly over the guide wire. The guide wire is then removed leaving the catheter in position within the vessel. However, this technique is only possible in cases where the catheter is of a relatively small diameter, made of a stiff material and not significantly larger than the guide wire, for example, for insertion of small diameter dual lumen catheters. If the catheter to be inserted is significantly larger than the guide wire, a dilator device is first passed over the guide wire to enlarge the hole. The catheter is then passed over the guide wire, and the guide wire and dilator are removed.

U.S. Pat. No. 6,524,302 which issued to Kelley (February, 2003), describes a multi- lumen catheter and method of manufacturing such a multi-lumen catheter having a plurality of individual catheter tubes. Each catheter tube has an outer surface, an inner surface and a lumen. The catheter tubes can be made of different thermoplastic materials. A mandrel is first inserted into the lumen of each catheter tube to provide support. The catheter tubes are then juxtaposed to each other in an arrangement. Importantly, the outer surface of one catheter tube is in contact with the outer surface of at least one other catheter tube in the arrangement. The arrangement of catheter tubes is then held in a sleeve and is advanced through the sleeve, and through a heating cylinder to fuse the outer surfaces of the catheter tubes. A cooling means is placed in the lumen of each catheter tube to prevent the inner surface of each catheter tube from melting.

Nearly 20 percent of central line recipients will need a CT scan. Patients have central venous catheters placed to administer chemotherapeutic agents or other IV medications. The overall safety and use of central venous catheters for these indications is well known. However, although these patients frequently undergo IV contrast-enhanced CT as part of their clinical examination and follow-up, the feasibility and safety of using central venous catheters to administer IV contrast material using a power injector need to be established. This is also because many patients requiring central venous catheters have poor peripheral IV access, it is both practical and possibly necessary to administer IV contrast material through the central venous catheter, as well as more convenient for the patient.

The viscosities of the contrast media are high and an amount of up to 200 ml needed to be injected over the shorted possible time In general, consistent vascular enhancement and high levels of hepatic enhancement can be achieved when rapid infusion rates and appropriate delay times are used.

As such, there is a need in the art for a multiple catheter assembly and a need for making such a catheter assembly which can provide the advantages of the above- mentioned multi-lumen catheters with respect to easy insertion and which can prevent the potential risk of leakage at the site of vessel entry, but which can still provide the advantage of multiple catheter assemblies with respect to independent movement within a vessel and good flow properties while being able to handle the increased pressures required of catheters used in the administering of viscous liquids such as contrast, or when a liquid is required to be administered under a higher pressure.

(B) Manufacturing Background The SchonCath (U.S. Pat. Publication No. 2003/0153898) invention includes methods for making the multilumen catheter. The method includes forming a unitary catheter tube having a proximal portion, a distal portion, and a distal end portion terminating in a distal end tip. The unitary catheter tube may be formed using any suitable heat molding process, including injection molding, expansion/compression molding, and extrusion. The unitary catheter tube is formed by extrusion through a die to form internal lumens, the lumens are substantially the same and substantially identical in size and configuration. The unitary catheter tube, with internal longitudinally extending lumens, may also be formed by injection molding the tube around metal rods which have the shape of the internal lumens. The unitary catheter tube is then split longitudinally along the distal portion of the tube using a sharp edge such as a hot knife or razor blade for a pre-determined distance, depending upon the particular size desired for the catheter. The tube is preferably split as evenly as possible between the two lumens along an internal septum. Splitting the unitary catheter tube forms a first distal end tube and a second distal end tube The second distal end tube can then cut to size relative to the first distal end tube, if it is desired that one distal end tube be greater in length than the other. Separate lengths for the distal end tubes helps avoid recirculation of fluids entering and leaving the tubes within the area to be catheterized. After the unitary catheter tube and the distal end tubes are formed, the exterior surface of the unitary catheter tube and the exterior surfaces of the distal end tubes are then ground and polished to a smooth surface. Radio frequency (RF) tipping can be used to provide the smooth surface. Radio frequency (RF) tipping uses RF energy to re-heat an outer surface until there is some melting and then to polish the surface. Further, the unitary catheter tube and the distal end tubes could undergo radio frequency (RF) tipping on a mandrel, so that the tubes may be re-shaped to have a generally circular transverse cross section both in the interior passageways (lumens) and on the exterior surfaces, if desired. Once the surfaces are shaped and smoothed, holes can then be formed in the distal end tubes, if desired, using techniques well known in the art. The number, size, shape, and spacing of the holes are as individually preferred, but some general and specific aspects have been described above. Portions of the split catheter can then be releasably attached, if desired, by bonding portions of exterior surfaces of the distal end tubes with a weak adhesive. As an alternative to splitting the unitary catheter tube, after forming that tube, individual distal end tubes, which may be previously extruded or heat molded, may be fused onto the unitary catheter tube. The distal end tubes are formed such that they each have a respective longitudinal passageway (lumen) extending longitudinally therethrough, and may also be formed to include a plurality of holes either prior to attachment to the distal end of the unitary catheter tube. Each formed distal end tube is then attached to the distal end of the unitary catheter tube by a suitable heat molding process, or by another form of attachment, such as adhesive, ultrasonic welding or other methods known in the art, such that the first passageway in the first distal end tube is in fluid communication with the first lumen of the unitary catheter tube and the second passageway in the second distal end tube is in fluid communication with the second lumen in the unitary catheter tube. In one aspect of the invention, heat fusing is used to attach the distal end tubes, and the fusing may be carried out using heat applied to the unitary catheter tube and to the distal end tubing lengths in a female cavity mold to create a smooth fused portion where the tube and end tube lengths meet. Extension tubes may be provided either by extruding or molding the extension tubes initially when forming the unitary catheter tube using techniques similar to those used to form the distal end tubes as described above. However, it is preferred to attach the extension tubes to a proximal end of the unitary catheter tube using a hub. A hub is then molded around the proximal end of the unitary tube and the distal end of the proximally extending catheter tubes. Preferably, to maintain the unitary catheter and extension tubes in place, the hub mold either has cavities to receive the tubes, or metal rods inserted through the extension tubes and lumens within the formed unitary catheter portion, to retain the shape of the lumens and hold the tubes in place. A plurality of holes may also be provided to the distal end portions of the catheter tubes.

The Split Ash catheter (U.S. Pat. No. 6,190,349) invention, the multiple catheter assembly includes extrusion of a first catheter has an outer surface defining a first lumen. The second catheter has an outer surface defining a second lumen extend through the full length of their respective catheters. Te lumens each have a generally semi-circular cross section. Accordingly, the first catheter has an outer surface defined by a rounded wall portion and a generally flat side surface, and the second catheter also has an outer surface defined by a rounded wall portion and a generally flat side surface, as viewed in cross section. The flat side surfaces face each other. The generally flat side surfaces do not touch each other, but are very close. Also, the lumens and respective rounded wall portions and generally flat side surfaces are identical to each other so that the cannulating portion of the catheter assembly has a generally circular cross section. The catheter assembly includes a splitable membrane which extends longitudinally between and joins the opposite generally flat side surfaces of the first and second catheters. It is preferred that the membrane extends between the central line of the flat side surfaces for dimensional stability. However, the membrane could extend between edges of the side surfaces or between other regions of the flat side surfaces or rounded wall portions. The membrane performs multiple functions. First, the membrane joins the first and second catheters so that the catheters can be easily manipulated, particularly along the section of the catheters where the membrane is unbroken. If the membrane is completely intact, the catheters can be manipulated as a single catheter. Second, the membrane allows the first and second catheters to be at least partially longitudinally split apart from each other without damaging the outer surfaces of either of the first or second catheters thereby allowing independent movement of the split end regions in the vessel or other area to be catheterized. The membrane is constructed to split easily when the first and second catheters are forcibly separated from each other. The membrane has a cross-sectional width at its thinnest portion is a very small fraction of the outer diameter of the catheter assembly to facilitate easy tearing. The membrane is constructed of a material which will tear before the forces exerted on the outer surfaces of either of the first or second catheters reach a level sufficient to cause damage thereto. However, the membrane material should be sufficiently strong to resist tearing during normal handling of the assembly. The membrane has a cross-sectional length which is also a small fraction of the outer diameter of catheter assembly. The cross-sectional length also defines the distance between the generally flat side surfaces. The cross-sectional distance is preferably small to maintain an overall generally circular cross section for the un- separated section of the catheter assembly and to facilitate handling of the un- separated section of the catheter assembly in the cannulation portion. The cannulation portion is joined to the extension tube portion by a hub.

Kelly catheter (U.S. Pat. No. 6,524,302) and method for manufacturing can't control the surface or the size of the end result fused tube as the cross-section of the multi-lumen catheter has an outer periphery with at least three distinct lobes, with each distinct lobe corresponding to one of said fused tubes and not round outer surface area. Also an additional lumen is created from the outer surfaces of the three fused catheter tubes.

SUMMARY OF THE INVENTION

In brief, the present invention relates generally to multitube catheter assemblies includes two or more tube fused together to form one catheter tube shaft. Each tube has at least one lumen extending longitudinally through the catheter from its distal end to its proximal end. The tubes are fused together by use of heat & pressure. At least one of the tubes is formed from a material having a different material property to other catheter tubes forming the multitube catheter. The different material property may be, for example, a pressure resistant material, or a color.

In particular, the present invention relates to a multitube catheter assembly comprising: a plurality of tube catheters, each having a proximal opening, a distal opening and outer surface defining a lumen extending longitudinally therethrough between the respective distal and proximal openings, the tube catheters being non-concentric with at least one of said lumens being circular throughout the length between said respective distal and proximal openings, and each lumen being independent from each other; wherein the multitube catheter assembly has a generally circular outside configuration when viewed in transverse cross section, and wherein at least one of the tube catheters is formed of a material having a different material property to other catheter tubes in the mutlitube catheter assembly. Advantageously, a multitube catheter assembly having at least one of the tube catheters formed of a material having a different material property to other catheter tubes in the mutlitube catheter assembly enables a multitube catheter assembly to be provided where different cathether tubes within the assembly can be used for different purposes. For example, one catheter tube within the assembly could be used for high pressure fluids (in which case the catheter tube would be constructed from a pressure resistant material). A catheter tube could also be coloured to enable the tube to be identifiable to the user to avoid misconnection of the catheter tube end. In embodiments, the material having a different material property is a pressure resistant material having a hardness or rigidity that is greater than the hardness or rigidity of the material comprising other tube catheters comprising the plurality of tube catheters. Advantageously, by providing at least one tube catheter formed of a pressure resistant material, this enables a multitube catheter, which is able to receive fluids at an increased pressure (for example viscous fluids such as contrast), to be provided.

In some embodiments, a portion of the outer surface of one tube catheter is fused to at least a portion of the outer surface of at least one other tube catheter to form a fused bundle.

In further embodiments, the lumens are substantially the same in transverse cross section.

In some embodiments, the plurality of tube catheters is comprised of a shorter tube and a longer tube, the distal opening of said shorter tube being proximal to the distal opening of said longer tube, said distal openings having a distance between them, said distance being sufficient to prevent recirculation of a first fluid passing through the distal opening of the shorter tube in a first flow direction and second fluid passing through the distal opening of the longer tube in a second flow direction, the first and second flow directions being different. Preferably, a portion of said longer tube has a greater circular cross section than a circular cross section of said shorter tube. More preferably, the shorter tube is dedicated to receive a withdraw fluid, and wherein said longer tube is dedicated to an infuse fluid. In some embodiments, the assembly is adapted to be fixable to a patient's skin. In further embodiments, the multitube assembly further comprising a cuff. In some embodiments, the tube catheters are releasably joined. Alternatively, the tube catheters are unreleasably joined.

In further embodiments, the lumens and fused bundle each have a diameter, an outer surface of said lumens being formed from fused material, said fused material being located inside a region corresponding to the fused bundle diameter and a region outside the lumen diameter.

In embodiments, the catheter tubes are non- conjoined at the distal opening. In further embodiments, the assembly is comprised of an assembly distal end and an assembly proximal end, wherein the assembly distal end is tapered so as to form a tapered tip and wherein the assembly proximal end is comprised of catheter extension legs. Preferably, the tapered tip is comprised of an opening for at least one of the tubes. In some embodiments, the extension legs are further comprised of a fixed or removable luer end.

In further embodiments, one or more of the tubes have side openings adjacent the assembly distal end. One or more of the catheter tubes in the multitube catheter assembly may also comprise a material having a colour. Such an arrangement advantageously enables the prevention of misconnection of the catheter ends to equipment, as they may be colour-coded accordingly to match with an appropriate piece of equipment. Furthermore, instead of just having a colour-coded end to the catheter tube, having the colour running the length of the catheter tubes enables that catheter tube to be identifiable along the length of the catheter assembly (if, for example the catheter assembly is surrounded by a transparent or translucent material).

The present invention also provides a method of manufacturing a multitube catheter comprising the steps of: providing a plurality of heat fusible catheter tubes each having a lumen, at least one of said tube catheter comprising a material having a different material property to other catheter tubes; providing a plurality of mandrels and a heat shrinkable tube slide; for each lumen, inserting a respective mandrel into a respective one of the lumens; gathering said catheter tubes so as to form a bundle; placing the heat shrinkable tube slide over a segment of said bundle; heating said slide and said bundle such that the catheter tubes fuse together and form a united catheter with a plurality of lumens; removing the shrinkable tube slide from said bundle; and removing the mandrels from the lumens. The material property may, for example, comprise a pressure resistant material for use with high pressure fluids. The material may also comprise colour.

Advantageously, a multitube catheter assembly having at least one of the tube catheters formed of a material having a different material property to other catheter tubes in the mutlitube catheter assembly enables a multitube catheter assembly to be provided where different cathether tubes within the assembly can be used for different purposes. For example, one catheter tube within the assembly could be used for high pressure fluids (in which case the catheter tube would be constructed from a pressure resistant material). A catheter tube could also be coloured to enable the tube to be identifiable to the user to avoid misconnection of the catheter tube end.

In embodiments of the method, the material of the catheter tube is a pressure resistant material having a hardness or rigidity that is greater than the hardness or rigidity of the other tube catheters comprising the plurality of tube catheters.

Advantageously, by providing at least one tube catheter formed of a pressure resistant material, this enables a multitube catheter, which is able to receive fluids at an increased pressure (for example viscous fluids such as contrast), to be provided.

In some embodiments of the method, the step of heating said slide and said bundle such that the catheter tubes fuse further comprises adjusting the heat to the slide and the bundle such that the catheter tubes are non-releasable after the slide is removed. Preferably, the catheter tubes have ends capable of being processed into different shapes.

In embodiments of the method, the shrinkable tube slide shrinks when heated to apply pressure to said bundle. In some embodiments of the method, the multitube catheter's outside cross-section is circular. In further embodiments, the catheter tubes are of different lengths. In embodiments of the method, the heating of the slide and bundle melts and fuses the catheter tubes around the mandrels and inside the heat shrinkable tube.

In further embodiments, the catheter tubes have end and wherein a portion of the catheter tubes are separated at one end. Preferably, the separated tubes form catheter extension legs that have ends processable into different shapes.

In some embodiments, the multitube catheter inner lumen has a substantially circular cross-section. In embodiments, the multitube catheter has different inner diameters. Furthermore, the multitube catheter may have a proximal and distal end and said multitube catheter lumens are continuous.

One or more of the catheter tubes in the multitube catheter assembly may also comprise a material having a colour. Such an arrangement advantageously enables the prevention of misconnection of the catheter ends to equipment, as they may be colour-coded accordingly to match with an appropriate piece of equipment. Furthermore, instead of just having a colour-coded end to the catheter tube, having the colour running the length of the catheter tubes enables that catheter tube to be identifiable along the length of the catheter assembly (if, for example the catheter assembly is surrounded by a transparent or translucent material).

The multitube catheter assemblies has distal split independent free floating tip ends, stepped tip end or tapered tip end for positioning within an area to be catheterized.

The lumens of the multitube catheter may be full circular where they extend all through the distal end, the catheter main stem and the proximal end of the extension part. The presented multitube catheter may to be used in any medical field where an access to the central venous system is required like infusion, transfusion, haemodialysis, haemofiltration, plasma exchange, chemotherapy infusion, etc. A lumen with higher hardness material can be used also for powerful injection.

The assembly includes fusion between two or more tube fused together to form one catheter tube shaft. Each tube has at least one lumen extending longitudinally through the catheter from its distal end to its proximal end. The way of fusion and the degree of heat and pressure applied, allow the catheter tubes to be un-releasable joined. The tubes are fused together by use of heat Shrinkable tube slides over the tubes while metallic mandrels are passed through each tube lumen to protect the lumens during fusion. The heat Shrinkable tube will generate pressure once heat is applied. Continual heating will melt/re-shape the catheter tubes inside the heat Shrinkable tube. After cooling the heat Shrinkable tube is to be removed around the catheter tube. The metallic mandrels then pulled back. The distal end of fused united tube is tapered tipped. The end result is a multitube tube catheter has a distal tapered tip end.

In aspect of the present invention, the catheter tube stem, the distal end tubes, and the lumens, can also have a different shape or configuration at different points along a respective longitudinal length of each. In aspect of the present invention, through using the art of heat shrink tube, the outer wall of the catheter stem tube, the outer wall of the distal end tubes, and the lumens, can have various shapes in cross section, such as but not limited to a circular, semicircular, or oval shape. We also describe a method for making a multitube catheter assembly, by fusing two or more tubes together by use of heat Shrinkable tube slides over the tubes while metallic mandrels are passed through each tube lumen to protect the lumens during fusion. The heat Shrinkable tube will generate pressure once heat is applied. Continual heating will melt/re-shape the catheter tubes inside the heat Shrinkable tube while the letter will not be affected due to its high melting temperature. After cooling the heat shrink tube is removed around the fused catheter tubes, the metallic mandrels pulled back and the tubes, forming the one catheter tube.

In aspects of the method for making a multitube catheter assembly, by fusing two or more tubes together by use of a elastic tube stretched & slides over the tubes while metallic mandrels are passed through each tube lumen to protect the lumens during fusion. The elastic tube will compress the catheter tubes. Continual heating will melt/reshape the catheter tubes inside the silicon tube while the letter will not be affected due to its high temperature resistance. The elastic tube will compress over the melted catheter tubes. After cooling the elastic tube is slide back the fused catheter tubes, the metallic mandrels pulled back and the tubes, forming the one catheter tube. The elastic tube can be silicon, rubber or equivalents material.

In other aspects of the invention, the absence of a connector or a hub between catheter shaft and extension line allows the catheter to be advanced and positioned to any desirable length then fixed with any fixation devices.

BRIEF DESCRIPTION OF THE DRAWINGS & PICTURES The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention in the drawings: FIG. 1 is an enlarged view of catheter tube cross sectional changes during different steps of the fusion process.

FIG. 2 is an enlarged view of catheter tube cross sectional changes during different steps of the fusion process illustrating tubes with different hardness, material or color.. FIG. 3 is a top plan view of a catheter assembly formed as result of fusion between proximal parts of two tubes according to the the present invention.

FIG. 4 is a top plan view of a catheter assembly formed as result of fusion between proximal parts of two tubes with different hardness, material or color according to the present invention.

FIG. 5 is a top plan view of a preferred impediment of catheter assembly according to fusion between proximal parts of two tubes with different hardness and color according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

In describing the embodiments of the invention illustrated in the drawings, specific terminology will be used for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, it being understood that each specific term includes all technical equivalents operating in similar manner to accomplish similar purpose. It is understood that the drawings are not drawn exactly to scale. In the drawings, similar reference numbers are used for designating similar elements throughout the several drawings.

The following describes particular embodiments of the invention. However, it should be understood, based on this disclosure, that the invention is not limited to the embodiments detailed herein. Generally, the following disclosure refers to dual or multiple lumen catheter assemblies, although catheter assemblies having more lumens and/or distal end tubes are within the scope of the invention. Further, the methods described below for making the catheter assemblies of the present invention are also applicable to making catheter assemblies having more than two lumens and/or distal end tubes. It is only for reasons of convenience that the following description refers to two or three lumen embodiments of the present invention.

The multitube catheter assemblies of the present invention are inserted into an area of a body of a patient to be catheterized for removing and introducing fluids to the body. The catheter assemblies of the present invention are secured to a fixed location in or on the patient body, such as a subcutaneous area, before the catheter assembly is properly inserted and positioned in the area to be catheterized. This method is particularly preferred for long term catheterization. Alternatively, in short term catheterization, the catheter assemblies of the present invention may be secured to an external surface of the body before or after the catheter assembly is properly inserted and positioned in the area to be catheterized.

The multitube catheter assemblies of the present invention can be adapted for use in various applications in which bodily fluids, medicaments, or other solutions are introduced into and removed from the body, such as infusion, transfusion, plasmapheresis, hemodialysis, chemotherapy, and the like. The area to be catheterized is preferably a blood vessel, such as an internal jugular vein, but may be any suitable area within the body. Other areas in which the catheter assemblies may be used include other blood vessels, including the femoral and subclavian veins, any cavity, and other areas of the body including intra-abdominal, sub-diaphragmatic and sub hepatic areas. It is understood that the above-referenced areas are exemplary, and that the catheter assemblies of the present invention may be used to remove or introduce fluids to various areas to be catheterized.

The preferred embodiment of the present invention shown in the drawings are particularly useful for infusion and transfusion, of fluid into a blood vessel, such as the internal jugular vein and powerful injection of viscid fluid like contrast media..

The embodiments of the present invention shown in the drawings are also useful for intake, or removal, of blood to be purified from a blood vessel, such as the internal jugular vein, and introduction of purified blood into the same vessel. The blood can be purified by any suitable hemodialysis apparatus attached in communication with lumens of the disclosed catheter assemblies.

For purposes of describing the embodiments of the present invention shown in the drawings, the catheter assemblies will be described with respect to an application of channeling to the venous system. However, it is understood that the catheter assemblies of the present invention can be configured and adapted, by increasing or decreasing a size (diameter or length) and/or number of distal end tubes and/or lumens in the respective catheter assembly, so that the catheter assembly can be beneficially used for other medical applications in which fluids are introduced into and/or removed from the body.

Figure 1 illustrates the catheter tube T1 , T2 cross sectional changes during the fusion process. According to C1 , the first tube T1 and the second tube T2 of same material hardness and color have a general round outer surface and circular lumen 1 12, 1 13 and a wall 1 15, 1 16. C2 illustrates the presence of the heat Shrinkable tube 1 17 slides over the first and second tube T1 , T2. Catheter lumens 1 12, 1 13 are protected during fusion process by the presence of a round mandrel M1 & M2 with definite size inside each of them. When applying heat, the heat shrinkable tube 1 17 contract and hence generates pressure over catheter tubes T1 & T2. Continual heating will melt/re-shape the catheter tubes T1 , T2 inside the heat shrinkable tube 1 17 while the latter will not be affected due to its high melting temperature. At C3& C4 continual heating melt the wall 1 15, 1 16 of the first and second tube T1 , T2. At C5, The wall 1 15, 1 16 fuse together forming one wall 1 1 1 defining the catheter tube TC around the catheter lumen 1 12, 1 13. After cooling, the heat Shrinkable tube 1 17 is removed around the formed TC. The metallic mandrels are to be pulled back. At C6 catheter shaft tube TC is formed with the wall 1 1 1 around the catheter lumens 1 12, 1 13.

Figure 2 illustrates the catheter tube T1 , T3 cross sectional changes during the fusion process. According to C1 1 , the first tube T1 and the second tube T3 of different material hardness or color have a general round outer surface and circular lumen 1 12, 1 13 and a wall 1 15, 1 18. C12 illustrates the presence of the heat Shrinkable tube 1 17 slides over the first and second tube T3, T2. Catheter lumens 1 12, 1 13 are protected during fusion process by the presence of a round mandrel M1 & M2 with definite size inside each of them. When applying heat, the heat shrinkable tube 1 17 contract and hence generates pressure over catheter tubes T1 & T3. Continual heating will melt/reshape the catheter tubes T3, T2 inside the heat shrinkable tube 1 17 while the latter will not be affected due to its high melting temperature. At C13 & C14 continual heating melt the wall 1 18, 1 15 of the first and second tube T1 , T3. At C15, The wall 1 18, 1 15 fuse together forming one wall defining the catheter tube TC2 around the catheter lumen 1 12, 1 13. After cooling, the heat Shrinkable tube 1 17 is removed around the formed TC2. The metallic mandrels are to be pulled back. At C16 catheter shaft tube TC2 is formed with the wall made of different material, hardness or color around the catheter lumens 1 12, 1 13. Figure 3 illustrates a catheter assembly has at least two lumens. The illustration of two lumens is exemplary, and the scope of the invention encompasses catheters having more than two lumens.

The catheter assembly includes first tube T1 which has a distal end 101 and a proximal end 103. The catheter assembly includes a second tube T2 which has a distal end 104 and a proximal end 106. C7 & C8 illustrate cross sections at tube T1 & T2 . Tube T1 has a lumen 1 12 and a wall 1 15. Tube T2 has a lumen 1 13 and wall 1 16. The fist tube T1 and the second tube T2 united (fused) at point 107 forming catheter shaft TC as a result of fusion of a portion wall 1 15 of first tube T1 and the 1 16 of second tube T2. The catheter assembly can be provided (manufactured) so that the first tube T1 and the second tube T2 is fused along a portion extending to the end of both tube 103, 106 so as to have a common proximal end.

The assembly according to the embodiment includes tipping of the distal end of the catheter shaft TC to form a proximal catheter tip.

The multilumen catheter assembly includes a first lumen 1 12 and a second lumen 1 13 extending longitudinally there through as illustrated at figure (1 ). The first and second lumen 1 12, 1 13 are continuous with and through the first and second tube T1 , T2 from the proximal end 103, 106, the catheter shaft TC and extension tube EC1 , EC2. The first and the second extension tubes EC1 and EC2 lead to a disyall end of the catheter assembly, through which the materials entering and or exiting the patient enter and/or exit the catheter assembly. The words "proximal" and "distal" refer to directions away from and closer to, respectively, the inserted end of the catheter assembly.

The exterior of the catheter shaft TC includes a smooth, rounded without ridges or grooves.

As shown in the cross-section C6 of the catheter shaft TC, the outer surface of the catheter shaft TC is generally rounded in shape (outer configuration), C6 illustrating in cross-section a generally round shaped outer wall, with the first and the second lumens 1 12, 1 13 having a circular cross-section. Catheter shaft TC can have various shapes, such as but not limited to circular, semi-circular or oval. Also lumen cross section can have various shapes, such as but not limited to circular, semi-circular or oval

In the above mentioned embodiments, it is noted that the distal ends 101 , 104 may occur at different locations in various catheters. It is within the scope of the present invention to incorporate, in the dimensional aspects of length disclosed above, all locations where the distall ends 101 , 104 could be said to occur in catheters known in the art, disclosed herein, or to be developed. The assembly according to the embodiment includes incorporating different connectors to the distal ends 101 , 104 to form distal catheter hubs.

The smooth generally round exterior surface of the catheter shaft TC passes through and remains positioned at a vessel wall insertion site during insertion of the catheter assembly into a patient. A vessel wall seals quite well around the smooth, round exterior surface of the catheter shaft TC, as shown in cross-section C6. Since the exterior of the catheter shaft TC provides a good seal at the insertion site, the risk of blood loss around the catheter assembly at the insertion site is minimized.

The first and the second lumens 1 12, 1 13 are always circular since circular cross sections are most conducive to fluid flow properties. However, other shapes such as D- shaped passageways and/or lumens, oval, triangular, square, elliptical, kidney-bean shaped passageways and/or lumens, or other configurations are also within the scope of the invention. Further, while the catheter tubes T1 , T2, the lumens 1 12, 1 13 and the distal end tubes EC1 , EC2 are preferably identical in cross section, it is within the scope of the invention to vary the size, shape and/or configuration such that smaller distal end tubes and/or lumens, or varying types of lumens and distal end tubes may be used for other applications, such as an addition of a third, smaller lumen and corresponding distal end tube for introduction of medication.

The catheter assembly according to the various embodiments may incorporate a fixation wing secured or over molded over point 107.

The present invention further includes methods for making the multilumen catheter assemblies described above. The fusion parameter settings allow the catheter tube to be non-releasable joined.

The present invention also provides a method for making a multitube catheter assembly, by fusing two or more tubes together by use of heat shrinkable tube slides over the tubes while metallic mandrels are passed through each tube lumen to protect the lumens during fusion. The heat shrinkable tube will generate pressure once heat is applied. Continual heating will melt/re-shape the catheter tubes inside the heat Shrinkable tube while the letter will not be affected due to its high melting temperature. After cooling the heat shrink tube is removed around the fused catheter tubes, the metallic mandrels pulled back and the tubes, forming the one catheter tube.

Figure 4 illustrates a second catheter assembly has at least two lumens. The illustration of two lumens is exemplary, and the scope of the invention encompasses catheters having more than two lumens. The catheter assembly includes first tube T1 which has a distal end 101 and a proximal end 103. The catheter assembly includes a second tube T3 of different material, hardness or color and has a proximal end 108 and a distal end 109. C7 & C9 illustrate cross sections at tube T1 & T3 . Tube T1 has a lumen 1 12 and a wall 1 15. Tube T3 has a lumen 1 16 and wall 18

In multitube design, due to its rounded inner lumen, the resistance effect to flow of fluids and especially viscid fluids are lower and hence higher flow rate is obtained. Since at least one of the fused tubes is made from a material that has a higher grade that will resist higher internal pressure resulting in pressure resistant lumen. The higher laminar flow rate and resistance to pressure make the catheter suitable for the powerful injection of contrast media where flow needed is up to 10 ml/sec.

Furthermore, constructing the catheter using two tubes of different low and high hardness lower the overall catheter rigidity compared to a catheter assembly where all tubes comprising the catheter assembly are made from a hard material. A catheter assembly having low and high hardness tubes is much safer for the patients.

The fist tube T1 and the second tube T3 united (fused) at point 107 forming catheter shaft TC2 as a result of fusion of a portion of wall 1 12 of first tube T1 and portion of the wall 1 18 of second tube T3.

The assembly according to the embodiment includes tipping of the proximal end of the catheter shaft TC2 to form a proximal catheter tip. The multilumen catheter assembly includes a first lumen 1 12 and a second lumen 1 13 extending longitudinally there through as illustrated at figure (2).

The first and second lumen 1 12, 1 13 are continuous with and through the first and second tube T1 , T3 from the proximal end 103, 109, the catheter shaft TC2 and extension tube EC1 , EC2. The first and the second extension tubes EC1 and EC2 lead to a distal end of the catheter assembly, through which the materials entering and or exiting the patient enter and/or exit the catheter assembly. The words "proximal" and "distal" refer to directions away from and closer to, respectively, the inserted end of the catheter assembly.

The exterior of the catheter shaft TC includes a smooth, rounded without ridges or grooves. As shown in the cross-section C16 of the catheter shaft TC2, the outer surface of the catheter shaft TC2 is generally rounded in shape (outer configuration), C16 illustrating in cross-section a generally round shaped outer wall, with the first and the second lumens 1 12, 1 13 having a circular cross-section. Catheter shaft TC2 can have various shapes, such as but not limited to circular, semi-circular or oval. Also lumen cross section can have various shapes, such as but not limited to circular, semi-circular or oval

In the above mentioned embodiments, it is noted that the distal ends 101 , 108 may occur at different locations in various catheters. It is within the scope of the present invention to incorporate, in the dimensional aspects of length disclosed above, all locations where the proximal ends 101 , 108 could be said to occur in catheters known in the art, disclosed herein, or to be developed. The assembly according to the embodiment includes incorporating different connectors to the proximal ends 101 , 108 to form distal catheter hubs.

The smooth generally round exterior surface of the catheter shaft TC passes through and remains positioned at a vessel wall insertion site during insertion of the catheter assembly into a patient. A vessel wall seals quite well around the smooth, round exterior surface of the catheter shaft TC2, as shown in cross-section C16. Since the exterior of the catheter shaft TC2 provides a good seal at the insertion site, the risk of blood loss around the catheter assembly at the insertion site is minimized.

The first and the second lumens 1 12, 1 13 are always circular since circular cross sections are most conducive to fluid flow properties. However, other shapes such as D- shaped passageways and/or lumens, oval, triangular, square, elliptical, kidney-bean shaped passageways and/or lumens, or other configurations are also within the scope of the invention. Further, while the catheter tubes T1 , T3, the lumens 1 12, 1 13 and the proximal end tubes EC1 , EC2 are preferably identical in cross section, it is within the scope of the invention to vary the size, shape and/or configuration such that smaller distal end tubes and/or lumens, or varying types of lumens and distal end tubes may be used for other applications, such as an addition of a third, smaller lumen and corresponding distal end tube for introduction of medication. The catheter assembly according to the various embodiments may incorporate a suture wing secured or over molded over point 107.

The present invention further includes methods for making the multilumen catheter assemblies described above.

The fusion parameter settings allow the catheter tube to be non-releasable joined.

The present invention also provides a method for making a multitube catheter assembly, by fusing two or more tubes of different material, hardness or color together by use of heat shrinkable tube slides over the tubes while metallic mandrels are passed through each tube lumen to protect the lumens during fusion. The heat shrinkable tube will generate pressure once heat is applied. Continual heating will melt/re-shape the catheter tubes inside the heat Shrinkable tube while the letter will not be affected due to its high melting temperature. After cooling the heat shrink tube is removed around the fused catheter tubes, the metallic mandrels pulled back and the tubes, forming the one catheter tube.

The materials used for each of the lumens should be thermoplastics preferably with close glass transition temperature or melting points. Fusion can be typically done between polyether based and polyester based polyurethane. For example, the pressure resistant and other tubes may be formed of polyether block amide ("PEBA") material, thermoplastic polyurethane ("TPU"), or other suitable conventional catheter material. PEBA, for example, is a high performance thermoplastic elastomer known for its flexibility and favourable mechanical properties at low and high temperatures. TPU has many useful properties, including elasticity, transparency, and resistance to oil, grease and abrasion. Fusion can occur between PEBA and TPU.

Heating above glass transition temperature or even above melting points is required depending on the similarity or dissimilarity between materials.

When fusion pressure is applied at the designated temperature and force, the molecules from each tube surface end mix. As the joint cools, the molecules return to their crystalline form, due to interdiffusion of polymer chains across the interface, the original interfaces have been removed, and the two tubes have become one continuous length. The end result is a fusion joint is as strong as the tube itself. The wall between lumens is composed of a layer of one material irreversibly joined to a layer of the other.

Preferred Embodiment

Figure 5 illustrates a preferred Embodiment of catheter assembly where a catheter assembly has at least two lumens. The illustration of two lumens is exemplary, and the scope of the invention encompasses catheters having more than two lumens.

The catheter assembly includes first tube T1 which has a distal end 101 and a proximal end 103. The catheter assembly includes a second tube T3 of a material having a different hardness and/or color and has a proximal end 108 and a distal end 109. C7 & C9 illustrate cross sections at tube T1 & T3. Tube T1 has a lumen 1 12 and a wall 1 15. Tube T3 has a lumen 1 16 and wall 18 The fist tube T1 and the second tube T3 united (fused) at point 107 forming catheter shaft TC2 as a result of fusion of a portion of wall 1 12 of first tube T1 and portion of the wall 1 18 of second tube T3. The catheter assembly can be provided (manufactured) so that the first tube T1 and the second tube T3 is fused along a portion extending from the point 107 to the end of both tube 103, 109 so as to have a common distal end. The assembly according to the embodiment includes tipping of the distal end of the catheter shaft TC2 to form a distal catheter tip 120.

The multilumen catheter assembly includes a first lumen 1 12 and a second lumen 1 13 extending longitudinally there through as illustrated at C7, C9 & C16.

The first and second lumen 1 12, 1 13 are continuous with and through the first and second tube T1 , T3 from the distal end 103, 109, the catheter shaft TC2 and first and second extension tube EC1 , EC3. The first and the second extension tubes EC1 and EC3 lead to a distal end of the catheter assembly, through which the materials entering and or exiting the patient enter and/or exit the catheter assembly. The words "proximal" and "distal" refer to directions closer to and away from, respectively, the inserted end of the catheter assembly.

The exterior of the catheter shaft TC2 includes a smooth, rounded without ridges or grooves.

As shown in the cross-section C16 of the catheter shaft TC2, the outer surface of the catheter shaft TC2 is generally rounded in shape (outer configuration), C16 illustrating in cross-section a generally round shaped outer wall, with the first and the second lumens 1 12, 1 13 having a circular cross-section. Catheter shaft TC2 can have various shapes, such as but not limited to circular, semi-circular or oval. Also lumen cross section can have various shapes, such as but not limited to circular, semi-circular or oval In the above mentioned embodiments, it is noted that the distal ends 101 , 108 may occur at different locations in various catheters. It is within the scope of the present invention to incorporate, in the dimensional aspects of length disclosed above, all locations where the distall ends 101 , 104 could be said to occur in catheters known in the art, disclosed herein, or to be developed. The smooth generally round exterior surface of the catheter shaft TC2 passes through and remains positioned at a vessel wall insertion site during insertion of the catheter assembly into a patient. A vessel wall seals quite well around the smooth, round exterior surface of the catheter shaft TC, as shown in cross-section C16. Since the exterior of the catheter shaft TC2 provides a good seal at the insertion site, the risk of blood loss around the catheter assembly at the insertion site is minimized.

The first and the second lumens 1 12, 1 13 are always circular since circular cross sections are most conducive to fluid flow properties. However, other shapes such as D- shaped passageways and/or lumens, oval, triangular, square, elliptical, kidney-bean shaped passageways and/or lumens, or other configurations are also within the scope of the invention. Further, while the catheter tubes T1 , T3, the lumens 1 12, 1 13 and the distall end tubes EC1 , EC3 are preferably identical in cross section, it is within the scope of the invention to vary the size, shape and/or configuration such that smaller distal end tubes and/or lumens, or varying types of lumens and distal end tubes may be used for other applications, such as an addition of a third, smaller lumen and corresponding distal end tube for introduction of medication.

A plurality of side holes 121 , 122 extending through exterior surfaces of tubes TC2, to the first and second lumens 1 12, 1 13. The side holes 121 , 1222 provide additional or alternative flow paths. The side holes 121 , 1 122 can be of various shape, but are typically circular or oval, or of some combination.

The catheter assembly according to the embodiment may be secured to patient skin by a fixation device.

The catheter assembly according to the embodiment may incorporate a suture wing secured or over molded over point 107. The catheter assembly according the preferred embodiment has one or more tube of higher hardness. Material of higher hardness known to exhibit high resistance to internal pressure.

The preferred embodiment of the present invention shown in the drawings are particularly useful for infusion and transfusion, of fluid into a blood vessel, such as the internal jugular vein and powerful injection of viscid fluid like contrast media in the lumen with the different hardness identified with the different color.

The present invention further includes methods for making the multilumen catheter assemblies described above.

The fusion parameter settings allow the catheter tube r to be non-releasable joined.

The present invention also provides a method for making a multitube catheter assembly, by fusing two or more tubes of different material, hardness or color together by use of heat shrinkable tube slides over the tubes while metallic mandrels are passed through each tube lumen to protect the lumens during fusion. The heat shrinkable tube will generate pressure once heat is applied. Continual heating will melt/re-shape the catheter tubes inside the heat Shrinkable tube while the letter will not be affected due to its high melting temperature. After cooling the heat shrink tube is removed around the fused catheter tubes, the metallic mandrels pulled back and the tubes, forming the one catheter tube.

Although the present invention has been described hereinabove with reference to specific embodiments, the present invention is not limited to the specific embodiments and modifications will be apparent to a skilled person in the art which lie within the scope of the present invention. Any of the embodiments described hereinabove can be used in any combination.

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Referenced by
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WO2016094576A1 *9 Dec 201516 Jun 2016Tephratech LLCPartially shrinkable tubing with multiple lumens and associated methods
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