OCCLUSION RESISTANT CATHETER AND METHOD OF USE

Abstract

An implantable occlusion and tissue ingrowth resistant fluid interface is provided with a housing, an orifice and a catheter port. The housing is formed from at least one biocompatible material and is configured without sharp edges or corners. The housing at least partially defines an internal housing cavity. The orifice member at least partially defines an orifice between the internal housing cavity and an exterior of the housing. The orifice has an elongated transverse cross-section configured with a length that is at least four times its maximum width. The catheter port is located on the housing and is configured to couple with a catheter such that the internal housing cavity is in fluid communication with a lumen of the catheter when the catheter is coupled to the catheter port. Embodiments having a moving cylinder, a rotor, and non-chemical surface modifications, as well as methods of use are also disclosed.

Claims

1. An implantable occlusion resistant fluid interface comprising: a housing formed from at least one biocompatible material and configured without sharp edges or corners, the housing at least partially defining an internal housing cavity; an agitator formed from at least one biocompatible material and at least partially defining an orifice between the internal housing cavity and an exterior of the housing, the agitator configured to passively move longitudinally between a first position and a second position, thereby changing fluid flow patterns within the internal housing cavity; and a catheter port located on the housing and configured to couple with a catheter such that the internal housing cavity is in fluid communication with a lumen of the catheter when coupled to the catheter port.

2. The fluid interface of claim 1, wherein the agitator is cylindrically shaped.

3. The fluid interface of claim 1, wherein the housing comprises a transverse cross-section that is generally triangular in shape.

4. The fluid interface of claim 3, wherein the transverse cross-section comprises three rounded apexes and three inwardly curving side faces spanning between the three apexes.

5. The fluid interface of claim 4, wherein each of the three apexes comprises a longitudinally extending internal channel that overlaps with and is in fluid communication with the internal housing cavity.

6. The fluid interface of claim 4, wherein each of the three side faces comprises an elongated slot in fluid communication with the internal housing cavity and with the exterior of the housing.

7. An implantable occlusion resistant fluid interface comprising: a housing formed from at least one biocompatible material and configured without sharp edges or corners, the housing at least partially defining an internal housing cavity; a rotor formed from at least one biocompatible material rotatably mounted within the internal housing cavity such that a fluid flow in the cavity will cause the rotor to passively rotate; and a catheter port located on the housing and configured to couple with a catheter such that the internal housing cavity is in fluid communication with a lumen of the catheter when coupled to the catheter port.

8. The fluid interface of claim 7, wherein the rotor comprises a plurality of turbine blades.

9. The fluid interface of claim 7, wherein the rotor is elongated and has two ends, and wherein the fluid interface further comprises a ball bearing located at each of the two rotor ends configured to allow the rotor to passively rotate relative to the housing.

10. The fluid interface of claim 9, wherein the ball bearings are made of sapphire.

11. The fluid interface of claim 8, wherein the housing comprises an end cap having at least one vent hole therethrough, the vent hole being configured to allow fluid to flow from the internal housing cavity, past the turbine blades and out through the vent hole to an exterior of the housing.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0022] FIG. 1 is a side perspective view showing a first exemplary embodiment of an implantable fluid interface;

[0023] FIG. 2 is an exploded perspective view showing the components of the fluid interface of FIG. 1;

[0024] FIG. 3 is a cross-sectional view taken along Line 3-3 of FIG. 1;

[0025] FIG. 4 is an enlarged cross-sectional view showing a portion of FIG. 3;

[0026] FIG. 5 is a top plan view showing an exemplary fluid interface coupled with a catheter;

[0027] FIG. 6 is a perspective view showing a second exemplary embodiment of an implantable fluid interface;

[0028] FIG. 7 is an exploded perspective view showing the components of the fluid interface of FIG. 6;

[0029] FIG. 8 is a cross-sectional view taken along Line 8-8 of FIG. 6;

[0030] FIG. 9 is a cross-sectional view taken along Line 9-9 of FIG. 6;

[0031] FIG. 10 is a perspective view showing a third exemplary embodiment of an implantable fluid interface;

[0032] FIG. 11 is an exploded perspective view showing the components of the fluid interface of FIG. 10;

[0033] FIG. 12 is another exploded perspective view taken from an opposite direction from that of FIG. 11;

[0034] FIG. 13 is an enlarged perspective view of the middle housing portion of the fluid interface of FIG. 10;

[0035] FIG. 14 is a proximally-looking end elevation view of the middle housing portion of the fluid interface of FIG. 10; and

[0036] FIG. 15 is a cross-sectional view taken along Line 15-15 of FIG. 10.

DETAILED DESCRIPTION

[0037] Referring to FIGS. 1-3, a first exemplary embodiment of an implantable occlusion resistant fluid interface 10 is shown. In this embodiment, fluid interface 10 includes three components: a top housing shell 12, a bottom housing shell 14, and a movable orifice member plate 16. In its assembled configuration, as shown in FIG. 1, plate 16 is sandwiched between top shell 12 and bottom shell 14, and is movably captivated therebetween. In this embodiment, top shell 12 and bottom shell 14 are manufactured to be identical pieces differing only in name.

[0038] Referring to FIG. 2, the main portion of bottom shell 14 is provided with an oval shaped inner wall 18, a U-shaped outer wall 20, and a recessed portion 22 located therebetween. The right side of bottom shell 14 is provided with a trough 24 that communicates with recessed portion 22. Thickened wall sections 26 are provided on either side of trough 24. Top shell 12 includes the same features as bottom shell 14. During the assembly of device 10, the outer wall 20 of bottom shell 14 is joined with outer wall 20 of top shell 12, and the thickened wall sections 26 of bottom shell 14 are joined with the thickened wall sections 26 of top shell 12. The joining process may include laser welding, ultrasonic welding, adhesive, or other suitable joining processes. Once top shell 12 is joined with bottom shelf 14, a catheter port 28 is formed at one end of device 10 by troughs 24, as shown in FIG. 1.

[0039] Referring to FIG. 3, a cross-section of device 10 taken along line 3-3 of FIG. 1 is shown. Once the top housing shell 12 and bottom housing shell 14 are joined together as previously described, their respective recessed portions 22 together form an internal housing cavity defined by the toroidal housing of assembled device 10. As can be seen in FIG. 3, the inner walls 18 of top shell 12 and bottom shell 14 do not extend as far towards the opposing shell as do outer walls 20. This arrangement leaves room for plate 16 to be movably received between top shell 12 and bottom shell 14 with additional space remaining above and/or below plate 16 between it and inner walls 18 of top shell 12 and bottom shell 14. This additional space not only allows plate 16 to move relative to the housing of device 10, but provides at least one oval shaped orifice 30 (also shown in FIG. 1) between the internal housing cavity and the exterior of the housing (in the center portion of the toroidal housing). It can be seen from FIG. 3 that plate 16 is sized such that when it moves laterally in either direction to contact the inside of outer walls 20, the opposite side of plate 16 still remains within the space between inner walls 18. This is also true when plate 16 moves in either direction longitudinally relative to top shell 12 and bottom shell 14.

[0040] Referring to FIG. 4, an enlarged portion of the cross-sectional view of FIG. 3 showing plate 16 is provided. In this exemplary embodiment, plate 16 is captivated between inner walls 18 of top housing shell 12 and bottom housing shell 14, and is allowed to float therebetween, as shown in FIGS. 3 and 4. As depicted in these figures, orifice 30 can exist above and/or below plate 30. It can be appreciated that a maximum orifice width W can be defined as the distance between the upper inner walls 18 and lower inner walls 18 minus the thickness of plate 16. This maximum orifice width W would occur on the opposite side of plate 16 when it rests against either the upper inner walls 18 or the lower inner walls 18. In FIG. 4, plate 16 is depicted as being in a central position with an orifice width W/2 above the plate and another orifice having width W/2 below the plate. Orifice or orifices 30 can also be defined as having a length of at least L, as shown in FIG. 4. The length L of orifice 30 can alternatively be defined in the longitudinal direction of device 10, or even as the length of the inside circumference of inner wall 18 of either the top housing shell 12 or bottom housing shell 14.

[0041] In some embodiments, the maximum orifice width is maintained at about 0.010 inches or less. In some embodiments, the maximum orifice width is maintained at about 0.003 inches or less. In other embodiments, a mixture of orifice sizes is used. Initial testing suggests that by keeping the maximum orifice width W to these small dimensions, tissue ingrowth and/or protein buildup that would otherwise clog orifice 30 can be impeded or eliminated. To increase the flow rate through orifice 30, it is desirable for the orifice to have a larger cross-section. The orifice cross-section is defined as being transverse to the fluid flow through the orifice. This can be accomplished by maintaining the orifice width W at 0.010 inches, 0.003 inches or less and increasing the length L to create an elongated orifice. In some embodiments of the inventiveness fluid interface, the orifice has an elongated transverse cross-section configured with a length that is at least four times the maximum width. In some embodiments, the orifice length is at least 10 times the maximum width. In some embodiments the orifice length is at least 100 times the maximum width. In the exemplary embodiment shown, the device is about 0.5 inches long, has an orifice length L of about 0.7 inches (taken along the inside circumference of inner walls 18) and a maximum width W of 0.003 inches. This yields an orifice 30 having an elongated transverse cross-section configured with a length L that is more than 200 times the maximum width W.

[0042] In addition to the elongated transverse cross-section of orifice 30, the movement of plate 16 relative to orifice or orifices 30 that it partially defines contributes to impeding or eliminating tissue ingrowth and/or protein buildup that would otherwise clog the orifice(s). In some cases when device 10 is implanted within a patient, plate 16 is continuously or at least periodically moving relative to inner walls 18. Such movement can cause the orifice to be self-cleaning. The movement can also create a varying orifice size, and therefore create variable regional fluid flow near the orifice. It is believed that such variable regional fluid flow, or flow instability, contributes to impeding or eliminating tissue and/or protein buildup in and around the orifice. Conversely, it is believed that a constant, non-varying fluid flow contributes to tissue and/or protein buildup.

[0043] In some embodiments, top housing shell 12, bottom housing shell 14 and orifice member plate 16 are formed from titanium. The outside of device 10 can be ultra-electropolished. To further inhibit orifice clogging, plate 16 can be nano-etched (roughened) to help prevent tissue and proteins from forming on plate 16. This can be accomplished with ion blasting, such as with a xenon ion gun, to form nano channels or ripples on plate 16. There will be less adsorbed proteins on the modified surfaces due to a decrease of the surface energy caused by the surface modification. In some embodiments, the nano-ripples are less than about 50 nm high. In some embodiments, the nano-ripples are about 10 nm high. Initial testing indicates that if the nano-ripples are created with a spacing of about 52 nm or less, adhesion of tissue and protein to plate 16 can be prevented. Some embodiments include varied nano sized surface curvatures. These surface treatments can be applied to other surfaces of device 10 and to surfaces of other devices disclosed herein.

[0044] In some embodiments, surface treatment(s) of plate 16 are purely mechanical, as described above, without any chemical treatments or changes to the stoichiometry of the device surfaces. Advantages of purely mechanical treatments include avoidance of degradation of the material of plate 16, and also the avoidance of additional regulatory issues, such as with the U.S. Food and Drug Administration (FDA).

[0045] As shown in FIG. 5, device 10 can be attached to one end of a catheter 32. In one embodiment, this is accomplished by welding a titanium mesh onto the neck or catheter port 28 of device 10, and then over molding the mesh with silicone to bond to catheter 32. Alternatively, a solid neck having one or more grooves 34, barbs or other recessed features may be used as the core in an over molding process. A silicon material having a higher durometer than the rest of the catheter 32 may be overmolded in the region of catheter port 28 as depicted in FIG. 5. An essentially seamless transition 36 between the catheter 32 and catheter port 28 can be created by matching the outer diameter of catheter port 28 with the outer diameter of catheter 32. This inhibits tissue ingrowth after implantation and also enables device 10 to be removed from a patient without tissue damage.

[0046] A fluid interface device 10 constructed according to aspects of the present disclosure can be located at the inlet end of a catheter, at the outlet end, or both, when the catheter is used to move fluid from one region of a patient to another.

[0047] The exterior surfaces of device 10 can be roughened to reduce surface tension. This in turn can alleviate air bubbles from adhering to device 10 during insertion of the device into the patient, which would otherwise cause adverse effects.

[0048] In an alternative embodiment (not shown), the principles of the present disclosure can be used to construct a device having a movable ball instead of a movable plate. In such an embodiment, the ball can partially define one or more orifices, such as round holes located on opposite sides of a housing.

[0049] Referring to FIGS. 6-9, a second exemplary embodiment of an implantable occlusion resistant fluid interface 100 is shown. In this embodiment, fluid interface 100 includes an elongated housing 102 and a cylindrical agitator 104 captivated within a central void 105 inside housing 102. As best seen in FIGS. 6 and 7, housing 102 comprises a proximal portion 106, a middle portion 108, and a distal portion 110. Housing portions 106, 108 and 110 may be separate components that are joined together during assembly, or one or more of the components may be integrally formed. Proximal housing portion 106 comprises a fitting configured to couple to a catheter. A central lumen through proximal portion 106 is in fluid communication with central void 105 inside middle portion 108. Middle portion 108 is provided with three elongated slot 112 that provide fluid communication between central void 105 inside middle portion 108 and the exterior of device 100.

[0050] Referring to FIG. 8, middle housing portion 108 as a transverse cross-section that is generally triangular in shape, but has rounded apexes and inwardly curving side faces. Each apex or lobe is provided with a longitudinally extending channel 114 that overlaps with and is in fluid communication with central void 105. In some embodiments, agitator 104 has a diameter of 0.059 inches and central void 105 has a diameter of 0.062 inches, leaving an even gap of about 0.0015 inches between agitator 104 and central void 105 on all sides, or a maximum gap of about 0.003 inches on one side. In some embodiments, channels 114 have a diameter of 0.032 inches.

[0051] As best seen in FIGS. 6 and 9, distal housing portion 110 is generally hemispherical in shape and is contoured to mate smoothly with the apexes and inwardly curving side faces of middle housing portion 108. Similarly, proximal housing portion 106 has a larger cylindrical portion that is also contoured to mate smoothly with the apexes and inwardly curving side faces of middle housing portion 108. The outer diameter of the larger cylindrical portion of proximal housing portion 106 may be identical to the outer diameter of the catheter it mates with. With the above described contours and dimensions, device 100 may be more easily implanted and/or removed, and may reside within a patient without causing trauma to adjacent tissue.

[0052] Referring to FIG. 9, a longitudinal cross-section of device 100 is shown. As can be seen, the length of agitator 104 is shorter than the length of central void 105 so that agitator 104 may slide longitudinally within central void 105. With this arrangement, agitator 104 may passively move within central void 105 when the orientation of device 100 changes and or the direction of fluid flow through central void 105 changes. For example, when the distal end 110 of device 100 is lowered and or fluid is flowing in a distal direction, agitator 104 may move distally. Conversely, when the distal end 110 of device 100 is raised and or fluid is flowing in a proximal direction, agitator 104 may move proximally. Such changes in fluid direction may be caused by the use of a fluid bulb in fluid communication with the catheter (not shown) to back flush the catheter system. Longitudinal movement of agitator 104 may serve to disrupt any tissue ingrowth and or protein build up that may be starting to occur within device 100, and or may serve to change the fluid flow paths when the fluid flow changes direction, thereby inhibiting tissue ingrowth and or protein build up.

[0053] In the exemplary embodiment shown in FIGS. 6-9, device 100 has an overall length of about 0.65 inches and has a maximum diameter of about 0.135 inches.

[0054] Referring to FIGS. 10-15, a third exemplary embodiment of an implantable occlusion resistant fluid interface 200 is shown. In this embodiment, fluid interface 200 includes a housing 202 and a rotor 204 (shown in FIG. 11) rotatably disposed within a central cavity 205 inside housing 202. As best seen in FIGS. 11 and 12, housing 202 comprises a proximal portion 206, a middle portion 208, and a distal end cap 210. Housing portions 206, 208 and 210 may be separate components that are joined together during assembly, or one or more of the components may be integrally formed. Proximal housing portion 206 comprises a double-barbed fitting configured to couple to a catheter. A central lumen 212 through proximal portion 206 is in fluid communication through apertures 214 with central void 205 inside middle portion 208.

[0055] Referring to FIG. 11, rotor 204 comprises a series of radially extending turbine blades 216 disposed around its distal end. Rotor 204 is received within central cavity 205 inside middle housing portion 208 and captivated therein when distal cap 210 is attached to the distal end of middle housing portion 208 during assembly. Rotor 204 is allowed to freely rotate about a longitudinal axis by virtue of its being mounted between two ball bearings 218, which in some embodiments are made of sapphire. The distal most ball 218 is located between a circular recess 220 in the distal end of rotor 204 and a circular recess 222 on the proximal side of distal end cap 210 (shown in FIG. 12.) The proximal most ball 218 is located between a circular recess 224 on the proximal end of rotor 204 (shown in FIG. 12) and a circular recess 226 located within middle housing portion 208 (shown in FIGS. 13 and 14.) The vent holes 228 are provided through distal end cap 210 to allow fluid to flow from central cavity 205 past turbine blades 216 and out through vent holes 228 to the exterior of device 200, and or along the same path in the opposite direction. The flow of fluid past turbine blades 216 causes rotor 204 to rotate about its longitudinal axis. The distal most edges of turbine blades 216 may be located very close to vent holes 228 (such as within about 0.005 inches or less) such that the movement of turbine blades 216 disrupts tissue, protein and other matter from adhering to end cap 210.

[0056] Referring to FIG. 14, a longitudinal cross-section of device 200 is shown. Representative fluid flow is depicted with arrows between point A and point B. Fluid flow may also be in the opposite direction.

[0057] In the exemplary embodiment shown in FIGS. 10-15, device 200 has an overall length of about 0.54 inches and has a maximum diameter of about 0.125 inches.

[0058] According to aspects of the invention, clog-resistant fluid orifices may be formed between a passively movable component and a device housing, wherein the movable component is not part of a valve or other structure. In some embodiments, components forming an orifice, such as a movable component and a housing, may comprise dissimilar metals. The dissimilar metals can create an electrical potential between the components that changes the hydrophobicity of the surface(s). This in turn can repel proteins and or inhibit tissue ingrowth. In some embodiments, the electrical potential is tuned to attract particular biomarkers that the device is configured to sample.

[0059] According to aspects of the invention, the exemplary fluid interface devices disclosed herein can be used in various applications. For example, the devices may be used in hydrocephalus drainage systems (such as for brain injuries), in hemodialysis systems, in fluid sampling systems, in wound care (such as for Extremity Compartment Syndrome, reconstructive flaps, burns, surgical incisions, etc.) The devices may also be used for drug delivery, such as long-term chemotherapeutics, localized drug delivery to tumor sites, delivery of antibiotics, pain medications, regenerative growth factors, etc. In some applications such as hydrocephalus drainage systems, typical fluid flow rates can be around 2 milliliters per minute or less. In other applications, fluid flow rates may be about 40 ml/min. unassisted and 400 ml/min. under assistance, such as suction or pressure.

[0060] As for additional details pertinent to the present invention, materials and manufacturing techniques may be employed as within the level of those with skill in the relevant art. The same may hold true with respect to method-based aspects of the invention in terms of additional acts commonly or logically employed. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Likewise, reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms a, and, said, and the include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as solely, only and the like in connection with the recitation of claim elements, or use of a negative limitation. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The breadth of the present invention is not to be limited by the subject specification, but rather only by the plain meaning of the claim terms employed.