Bio-Compatible Catheter

Abstract

A bio-compatible lumen bearing device such as a catheter formed of a polymeric material having a titanium surface bonded to the underlying exposed catheter surface. The titanium surface is employed in patients to improve bio-compatibility and enhance lubricity during insertion and removal.

Claims

1. A lumen bearing component comprising: a lumen defined by an interior surface of a surrounding wall having an exterior surface and additionally having end wall surfaces communicating between said interior surface and said exterior surface, said lumen formed of polymeric material which is operatively flexible for intravenous insertion and navigation; and a titaniumized surface formed upon substantially all of said exterior surface of said surrounding wall; said titaniumized surface imparting increased lubricity and bio-compatibility to said polymeric material during a contact thereof with a body of a patient in which said catheter is positioned; and said titaniumized surface being comprised exclusively of titanium.

2. The lumen bearing component of claim 1 further comprising: said titaniumized surface being the only surface formed upon substantially all of said exterior surface.

3. The lumen bearing component of claim 1 further comprising: said titaniumized surface covering substantially all of said end wall surfaces.

4. The lumen bearing component of claim 2 further comprising: said titaniumized surface covering substantially all of said end wall surfaces.

5. The lumen bearing component of claim 1 further comprising: a second layer of said titaniumized surface also covering a portion of said interior surface.

6. The lumen bearing component of claim 2 further comprising: a second layer of said titaniumized surface also covering a portion of said interior surface.

7. The lumen bearing component of claim 3 further comprising: a second layer of said titaniumized surface also covering a portion of said interior surface.

8. The lumen bearing component of claim 4 further comprising: a second layer of said titaniumized surface also covering a portion of said interior surface.

9. The lumen bearing component of claim 1 further comprising: a second layer of said titaniumized surface also completely covering substantially all of said interior surface.

10. The lumen bearing component of claim 2 further comprising: a second layer of said titaniumized surface also completely covering substantially all of said interior surface.

11. The lumen bearing component of claim 3 further comprising: a second layer of said titaniumized surface also completely covering an entire area of said interior surface.

12. The lumen bearing component of claim 4 further comprising: a second layer of said titaniumized surface also completely covering an entire area of said interior surface.

13. The lumen bearing component of claim 1 wherein: said titaniumized surface covering said exterior surface is formed in said first layer having a thickness substantially being in a range between 20-60 nm; and forming said thickness of said first layer within said range thereby defining a flexible said first layer of said titaniumized surface which maintains a flexibility of the underlying polymeric material.

14. The lumen bearing component of claim 2 wherein: said titaniumized surface covering said exterior surface is formed in said first layer having a thickness substantially being in a range between 20-60 nm; and forming said thickness of said first layer within said range thereby defining a flexible said first layer of said titaniumized surface which maintains a flexibility of the underlying polymeric material.

15. The lumen bearing component of claim 3 wherein: said titaniumized surface covering said exterior surface is formed in said first layer having a thickness substantially being in a range between 20-60 nm; and forming said thickness of said first layer within said range thereby defining a flexible said first layer of said titaniumized surface which maintains a flexibility of the underlying polymeric material.

16. The lumen bearing component of claim 7 wherein: said titaniumized surface covering said exterior surface is formed in said first layer having a thickness substantially being in a range between 20-60 nm; and forming said thickness of said first layer within said range thereby defining a flexible said first layer of said titaniumized surface which maintains a flexibility of the underlying polymeric material.

17. The lumen bearing component of claim 8 wherein: said titaniumized surface covering said exterior surface is formed in said first layer having a thickness substantially being in a range between 20-60 nm; and forming said thickness of said first layer within said range defining a flexible said first layer of said titaniumized surface which maintains a flexibility of the underlying polymeric material.

18. The lumen bearing component of claim 1 wherein: said titaniumized surface defining a complete barrier to a communication between said body of said patient and said polymeric material, and wherein said barrier prevents blood clot formation, infection, and allergic reactions in said patient caused by such a said communication.

19. The lumen bearing component of claim 16 wherein: said titaniumized surface defining a complete barrier to a communication between said body of said patient and said polymeric material, and wherein said barrier prevents blood clot formation, infection, and allergic reactions in said patient caused by such a said communication.

20. The lumen bearing component of claim 17 wherein: said titaniumized surface defining a complete barrier to a communication between said body of said patient and said polymeric material, and wherein said barrier prevents blood clot formation, infection, and allergic reactions in said patient caused by such a said communication.

Description

BRIEF DESCRIPTION OF DRAWING FIGURES

[0033] FIG. 1 shows an elevated view of the device depicting a multi lumen bearing component such as a catheter tube having a titanium surface.

[0034] FIG. 2 is a cross section view of one mode of the device of FIG. 1, showing a catheter having two lumens, along cut line AA.

[0035] FIG. 3 shows an elevated view of the device depicting a single lumen catheter tube with the exterior surface, interior surface, and ends coated in titanium providing increased bio-compatibility.

[0036] FIG. 4 is a cross section view of one mode of the device of FIG. 3, showing a single lumen catheter, along cut line BB of FIG. 3.

[0037] FIG. 5 shows an elevated view of another preferred mode of the device showing a catheter cuff coated in titanium.

[0038] FIG. 6 is a view depicting a preferred method for applying a titanium coating to a lumen bearing device such as a catheter, plasma-activated chemical vapor deposition at a temperature lower than the melting point of the polymeric material of the catheter, showing the catheter disengaged from the mounting component.

[0039] FIG. 7 shows a view of the method of FIG. 6 with the interior wall of the axial passage of the catheter is engaged to a mount and held vertical during the plasma-activated chemical vapor deposition process and a fan or air movement is employed to communicate the vapor through the axial chamber.

[0040] FIG. 7a depicts a slice through a plurality of catheters undergoing plasma-activated vapor deposition and showing the vapor induced to communicate through the lumen bearing device such as a catheter at temperatures below the melting point of the material forming the lumen, to impart titanium to the axial passage of the lumen or lumens.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

[0041] Now referring to drawings in FIGS. 1-7a, wherein similar components are identified by like reference numerals, there is seen in FIG. 1 and FIG. 2 elevated and cross sectional views respectively of the device 10 comprising a catheter 12 having a layer of titanium 16 thereon which is coated or otherwise formed on the exterior surface area 14 of the catheter 12. The catheter 12 may be polyurethane or silicone or any other material known in the art for catheters and similar type tubing suited for receiving a titanium layer as is the intended scope of the device 10. Further, while shown as a double lumen catheter, those skilled in the art will realize that catheters come with varying numbers of internal lumens from one to multiples and the depicted dual lumen catheter 12 is for illustration purposes only since the invention herein is applicable to all catheters and tubes which may be employed in medical uses for insertion into a patient.

[0042] It is preferred that the catheter 12 maintains its flexibility as needed for intravenous insertion insofar as the titanium layer 16 is substantially thin and since titanium by nature is more ductile than other metals. In a particularly preferred mode the layer 16 on the exterior surface 14 of the catheter 12 is in the order of magnitude of 20-60 nm will perform well with titanium in a thickness depending on the flexibility of the formed polymeric catheter material, other thicknesses may be employed. In this manner, the catheter 12 employs the benefits of bio-compatibility and other benefits associated with the titanium layer 16 without compromising the flexibility of the structure needed for advancing the device 10 through the often serpentine like blood vessels to place the distal end in the desired location. Further, when wet, the titanium surface provides a means to overcome friction against the exterior of the catheter 12.

[0043] The titanium layer 16 is preferably formed by conventional methods such as coating, spraying, thermoforming, film engaging or other means known in the art. Further, it must be noted that in order to adhere or otherwise form the titanium layer 16 on some types of catheters 12 those skilled in the art may employ various other alloys of titanium better suited for varying types of tubing material and such is anticipated within the scope of this patent. Further, the polymeric material extruded as the catheter may be impregnated with titanium to a percentage allowing extrusion and yielding an exterior surface with a high percentage of titanium contacting body tissues.

[0044] FIG. 3 and FIG. 4 show elevated and cross sectional views respectively of another preferred mode of the device 10 providing still increased bio-compatibility. Shown is a single lumen catheter 13 having a layer of titanium 17 on the interior surface 18 and a layer of titanium 19 on the end walls 21 in combination with a layer of titanium 16 on the exterior surface area 14 of the catheter 13. Again, the catheter 13 may be a polymeric material adapted to form a flexible conduit such as polyurethane or silicone or any other material known in the art for catheters and similar type tubing suited for receiving a titanium layer as is the intended scope of the device 10. By employing a surface of titanium on all surfaces, bio-compatibility, anti-pathogenic qualities, and increased lubricity are provided in all modes of employment of the device. Further, while shown as a single lumen catheter 13, the invention in this mode herein is applicable to all catheters and tubes which may be employed in medical uses for insertion into a patient and is not to be considered limited by the depiction.

[0045] Shown in FIG. 5 is a particularly preferred catheter cuff 20 shown having titanium coatings on the exterior surface 22, interior surface 24, and end walls 26. Such a cuff may be a tissue ingrowth stabilizing cuff or other cuff known in the art. As such, when the employment of such a cuff 20 is desired, the titanium coating assures bio-compatibility. It must be noted that it is also an object of the invention that other types of connectors, and ports, and other components employed in combination with a catheter, may similarly employ titanium on exposed exterior surfaces which may contact body tissue as needed for improved bio-compatibility, lubricity, and pathogen inhibitance. As such, all connectors and components which those skilled in the art would anticipate as being employed with the titanium surfaced catheter herein, are considered to be capable of surfacing with the same titanium layer on exposed surfaces and considered within the scope of this disclosure.

[0046] FIG. 6 and FIG. 7 show views of one preferred method for the plasma-activated chemical vapor deposition process employed for bonding titanium to the exterior surface 16, interior surface 18, and end walls 21 of a catheter 13 to form a titanium surface thereon bonded with the underlying polymeric surface such as silicone, polyethylene, or polyurethane. It must be noted that although a single lumen catheter 13 is depicted, the following method may be employed with any and all single and multi-lumen catheters employed in the medical and veterinary medical fields.

[0047] In all modes of the device herein, the titanium bonded surface is anticipated to be imparted at temperatures below the melting point of the underlying lumen bearing device such as any type of catheter, to increase lubricity and biocompatibility thereof. The configuration of the titanium bonded into and on the exterior surface or surfaces of a catheter, to form a unitary structure layer, can be employed on any one or a plurality of such lumen bearing structures from a group including but not limited to Peritoneal Dialysis Catheters, Hemodialysis Catheters, Pleural and Peritoneal Drainage Catheters, Biliary Catheters, Ureteral Catheters, CV Catheters, Ventricular-Peritoneal Shunts, Ventricular Drainage Catheters, Ascites Shunts, Urinary Catheters, PICC lines, and any lumen bearing line which is inserted or implanted in a human or animal patient where the benefits of increased lubricity, anti-pathogenic qualities, and bio-compatibility are desirable.

[0048] As can be seen, in FIGS. 7 and 7a, a mount 30 having a plurality of engagement points such as prongs 32 at distal ends or steps in FIG. 7a, such that the catheter may be frictionally engaged with a passageway communicating into the axial passage at one end of a lumen in a catheter 13. The prongs 32 or steps are preferably shaped or otherwise formed to impart a slight outward biasing force on the interior surface 18 forming the lumen or lumens of the catheter 13 such as to frictionally and securely engage the catheter 13 as shown in FIGS. 7 and 7a.

[0049] During formation, with a lumen bearing device such as the depicted catheter 13 in this vertically disposed position, the gas 34 containing the titanium material is induced to flow through the axial passage by a fan or pump or other means to create the flow within the deposit chamber. The gas 34 is passed over the end of the catheter, the outside surface, and through the axial passage and inner surface, such that titanium material will be deposited on and bonded with the end walls 21, exterior surface 16, as well as pass through the interior surface 18 of the catheter 13, providing a coating thereon.

[0050] The present invention provides an improved bio-compatible catheter having a layer of titanium positioned on one or a combination of the interior surface, exterior surface, and endwalls.

[0051] While it is an object of the invention to provide a bio-compatible catheter tubing, with enhanced resistance to friction, and which need not be removed during an MRI and all of the fundamental characteristics and features of the invention have been shown and described herein, with reference to particular embodiments thereof, a latitude of modification, various changes and substitutions are intended in the foregoing disclosure and it will be apparent that in some instances, some features of the invention may be employed without a corresponding use of other features without departing from the scope of the invention as set forth. It should also be understood that various substitutions, modifications, and variations may be made by those skilled in the art without departing from the spirit or scope of the invention. Consequently, all such modifications and variations and substitutions are included within the scope of the invention as defined by the following claims.