All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
The present disclosure relates to implantable occlusion resistant fluid interfaces, such as catheter tips used in the treatment of hydrocephalus.
One application of the occlusion resistant catheters disclosed herein is in shunting systems for cerebral-spinal fluid for use in treating hydrocephalus. Conventional shunting systems used for this purpose typically include three components: a ventricular catheter portion; a peritoneal catheter portion; and a valve located between the two catheter portions. The catheter portions typically are formed from a flexible synthetic polymer such as silicone rubber. A proximal end of the ventricular catheter portion is configured for insertion in a cerebral ventricle. A distal end of the peritoneal catheter portion is configured for insertion in a body cavity, or in some cases configured to drain fluid outside of the body. In many cases it would be preferable that all three components be implanted subcutaneously and left in place for many years.
The purpose of the shunting systems when treating hydrocephalus is to affect periodic drainage of excess cerebral-spinal fluid from the cerebral ventricle. The cerebral ventricle that is typically drained is ventricle III. The cerebral-spinal fluid is drained from the cerebral ventricle in order to maintain proper endro-cranial tension or pressure at normal physiological values.
Conventional shunting systems for treating hydrocephalus suffer from occlusion of the fluid path through the shunt, typically at the inlet in the proximal end of the ventricular catheter portion and/or at the outlet in the distal end of the peritoneal catheter portion. Many attempts have been made to design clog resistant tips and orifices, however most have not met with much success. Blockage in the fluid path typically occurs as a result of tissue ingrowth and/or protein buildup in and around these orifices, often the result of the deposition of filaments of fibrin. Such blockage will often render the shunting systems useless in less than two years after implantation, requiring frequent replacement of the shunt. Such replacement procedures can be expensive, uncomfortable for the patient, and expose the patient to unnecessary complications associated with the procedures.
Further information relating to the treatment of hydrocephalus with conventional shunting systems may be found in U.S. Pat. No. 4,375,816 to Labianca and U.S. Pat. No. 7,582,068 to Koullick et al.
What is needed and is not provided by the prior art are implantable shunting systems that can be used in the treatment of hydrocephalus, and in other medical applications such as hemodialysis, without occlusion and tissue ingrowth.
According to some aspects of the present disclosure, an implantable occlusion resistant fluid interface may be configured to prevent inflammatory cells from binding to its surface(s), as the inflammatory process and associated tissue can greatly reduce the necessary fluid flow of the implantable. In some embodiments, the occlusion resistant interface is provided with a housing, an orifice and a catheter port. The housing is formed from at least one biocompatible material and may be configured without sharp edges or corners. The housing may at least partially define an internal housing cavity. The orifice member is formed from at least one biocompatible material and may at least partially define an orifice between the internal housing cavity and an exterior of the housing. In some embodiments, 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.
In some embodiments, the maximum width of the transverse cross-section of the orifice does not exceed 0.003 inches. The orifice member may be configured to be movable with respect to the housing. In some embodiments, the movable orifice member includes a plate. The housing may be formed from at least two separate pieces that are joined together to captivate the plate therebetween. In some embodiments, each of the at least two separate pieces is an elongated hemispherical toroidal shell that form a completed elongated toroidal shell when joined together. The plate is located across a central aperture of the toroid in these embodiments.
According to other aspects of the present disclosure, an implantable occlusion resistant shunt is provided with a fluid interface as described above. The shunt is also provided with a flexible catheter formed from a biocompatible material. The catheter has a first end and a second end, with the first end coupled with the catheter port of the fluid interface. In some embodiments, the shunt further comprises a second fluid interface as described above. In these embodiments, the second end of the catheter is coupled with the catheter port of the second fluid interface.
According to other aspects of the present disclosure, a method of treating hydrocephalus is disclosed. In some embodiments, the method comprises providing a shunt as described above, and implanting the fluid interface and the first end of the shunt catheter within a patient adjacent to brain tissue. The method may also include implanting a remainder of the catheter within the patient, and locating the second end of the catheter in a region of the patient away from the brain tissue.
In some embodiments, an implantable occlusion resistant fluid interface comprises a housing, an orifice member and a catheter port. In these embodiments, 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 is also formed from at least one biocompatible material and it 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 maximum width and configured with a length that is at least four times the 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 coupled to the catheter port.
In some embodiments of the above fluid interface, the maximum width of the transverse cross-section of the orifice does not exceed 0.003 inches. The orifice member may be movable with respect to the housing and may comprise a plate. The housing may be formed from at least two separate pieces that are joined together to captivate the plate therebetween. The at least two separate pieces may each be an elongated hemispherical toroidal shell that form a completed elongated toroidal shell when joined together, and the plate may be located across a central aperture of the toroid. In some embodiments, the orifice member comprises nano-ripples formed by ion blasting on one or more surfaces. The nano-ripples may have a height of about 50 nm or less and a spacing of about 52 nm or less.
In some embodiments, an implantable occlusion resistant shunt comprises a fluid interface as described above, and a flexible catheter formed from a biocompatible material. In these embodiments, the flexible catheter has a first end and a second end, and the first end is coupled with the catheter port of the fluid interface. The shunt may further comprise a second fluid interface as described above, wherein the second end of the catheter is coupled with the catheter port of the second fluid interface.
In some embodiments, a method of treating hydrocephalus comprises providing a shunt as described above and implanting the fluid interface and the first end of the catheter within a patient adjacent to brain tissue. These methods further comprise implanting a remainder of the catheter within the patient and locating the second end of the catheter in a region of the patient away from the brain tissue.
In some embodiments, an implantable occlusion resistant fluid interface comprises a housing, an agitator and a catheter. In these embodiments, the housing is formed from at least one biocompatible material and configured without sharp edges or corners. The housing at least partially defines an internal housing cavity. The agitator is formed from at least one biocompatible material and at least partially defines an orifice between the internal housing cavity and an exterior of the housing. The agitator is configured to passively move longitudinally between a first position and a second position, thereby changing fluid flow patterns within the internal housing cavity. 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 coupled to the catheter port.
In some embodiments of the above fluid interface, the agitator is cylindrically shaped. The housing may comprise a transverse cross-section that is generally triangular in shape. The transverse cross-section may comprise three rounded apexes and three inwardly curving side faces spanning between the three apexes. Each of the three apexes may comprise a longitudinally extending internal channel that overlaps with and is in fluid communication with the internal housing cavity. Each of the three side faces may comprise an elongated slot in fluid communication with the internal housing cavity and with the exterior of the housing.
In some embodiments, an implantable occlusion resistant fluid interface comprises a housing, a rotor and a catheter port. In these embodiments, 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 rotor is formed from at least one biocompatible material and is rotatably mounted within the internal housing cavity such that a fluid flow in the cavity will cause the rotor to passively rotate. 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 coupled to the catheter port.
In some embodiments of the above fluid interface, the rotor comprises a plurality of turbine blades. The rotor may be elongated and have two ends, and the fluid interface may further comprise a ball bearing located at each of the two rotor ends configured to allow the rotor to passively rotate relative to the housing. The ball bearings may be made of sapphire. The housing may comprise an end cap having at least one vent hole therethrough. The vent hole may be 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.
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:
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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.
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.
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.
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).
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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.
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.
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.
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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.
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.
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.
This application claims the benefit under 35 U.S.C. 119 of U.S. Provisional Patent Application 61/801,232 filed Mar. 15, 2013, and entitled “Occlusion Resistant Catheter and Method of Use.”
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