US20040181191A1 - Anti-occlusion catheter - Google Patents

Abstract

A catheter for the administration of fluid or pharmaceutical agents, or for hemodialysis comprising a proximal control end comprising a housing with a proximal end and a distal end, a distal delivery end, an elongated intermediate portion between the proximal control end and a distal delivery end, one or more than one delivery lumen within the intermediate portion extending from the proximal control end to the distal delivery end; one or more than one inflation balloon in each delivery lumen, and one or more than one inflation lumen in the intermediate portion extending from the proximal control end to the one or more than one inflation balloon in the one or more than one delivery lumen, and connected to the one or more than one inflation balloon through one or more than one fenestration, where the proximal control end further comprises a mechanism for aspiration and injection of fluids through the distal delivery end, and where the proximal control end further comprises a mechanism for controlling inflation of the one or more than one inflation balloon.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This application is a divisional of U.S. patent application Ser. No. 09/880,310, titled “Anti-Occlusion Catheter,” filed Jun. 13, 2001, now U.S. Pat. No. 6,692,459, issued Feb. 17, 2004, that claims the benefit of U.S. Patent Application 60/219,041, titled “Carotid Filter Device,” filed Jul. 18, 2000; the contents of which are incorporated by reference herein in their entirety.[0001]
BACKGROUND
• Catheters, such as central venous catheters, are used for a variety of diagnostic and therapeutic purposes, including the administration of fluid and pharmaceutical agents, and for hemodialysis in patients with renal failure. Unfortunately, central venous catheters lumens are prone to occlusion due to thrombosis from retrograde blood flow. In some cases, the thrombosis can be cleared from the catheter. In other cases, the catheter must be removed and a new catheter placed. Each new catheter placement is associated with a risk of complications, including infection, hemorrhage, pneumothorax and embolus.[0002]
• Some central venous catheters have a unidirectional valve at the distal catheter tip to prevent retrograde blood flow. However, catheters with such valves still occlude due to thrombosis from retrograde blood flow and the valves tend to disadvantageously impede antegrade fluid flow.[0003]
• Therefore, it would be useful to have a catheter that was less prone to thrombosis from retrograde blood flow. Additionally, it would be useful to have a method of delivering fluid and pharmaceutical agents, or for performing hemodialysis, that is associated where a lower incidence of catheter replacement due to thrombosis of the catheter from retrograde blood flow.[0004]
SUMMARY
• According to one embodiment of the present invention, there is provided a catheter for the administration of fluid or pharmaceutical agents, or for hemodialysis. The catheter comprises a proximal control end comprising a housing with a proximal end and a distal end; a distal delivery end; an elongated intermediate portion between the proximal control end and a distal delivery end; one or more than one delivery lumen within the intermediate portion extending from the proximal control end to the distal delivery end; one or more than one inflation balloon in each delivery lumen; and one or more than one inflation lumen in the intermediate portion extending from the proximal control end to the one or more than one inflation balloon in the one or more than one delivery lumen, and connected to the one or more than one inflation balloon through one or more than one fenestration. The proximal control end further comprises a mechanism for aspiration and injection of fluids through the distal delivery end, and the proximal control end further comprises a mechanism for controlling inflation of the one or more than one inflation balloon.[0005]
• In a preferred embodiment, the one or more than one delivery lumen is two delivery lumens. In another preferred embodiment, the intermediate portion comprises an external surface and the one or more than one delivery lumen comprises an intraluminal surface, and the external surface or the intraluminal surface or both comprise at least one hydrophilic coating or comprise heparin molecules bound to the external surface or to the intraluminal surface, or both, to reduce the accumulation of thrombus and fibrin on these surfaces. In another preferred embodiment, the housing comprises one or more than one anchoring device.[0006]
• In another preferred embodiment, the mechanism for aspiration and injection of fluids comprises one or more than one combined aspiration and injection port. In a particularly preferred embodiment, the combined aspiration and injection port is concave toward the distal end of the housing.[0007]
• In another preferred embodiment, the one or more than one combined aspiration and injection port has a distal end and where the mechanism for aspiration and injection of fluids further comprises one or more than one aspiration and injection conduit connecting the distal end of each port to the one or more than one delivery lumen. In a particularly preferred embodiment, the mechanism for aspiration and injection of fluids further comprises constricting means for constricting the aspiration and injection conduit.[0008]
• In another preferred embodiment, the mechanism for controlling inflation of the one or more than one inflation balloon comprises inflation means and deflation means. In a particularly preferred embodiment, the inflation means comprises a reservoir and an inflation actuator. The housing comprises a superior surface, and the inflation actuator can comprise a tactile recognizable surface that projects from the superior surface of the housing.[0009]
• In one embodiment, the inflation means comprises an elastic bulb. In a preferred embodiment, the inflation means comprises a rigid upper unit slidably fitting into a rigid lower reservoir and separated by a reservoir spring coil within the reservoir.[0010]
• In a preferred embodiment, the reservoir connects to the one or more than one inflation lumen through an antegrade flow conduit, and the inflation means further comprises a one-way, antegrade flow valve between the inflation lumen and the antegrade flow conduit. In another preferred embodiment, the reservoir connects to the one or more than one inflation lumen through one or more than one retrograde flow conduit, and where the inflation means further comprises a one-way, retrograde flow valve between the one or more than one inflation lumen and each retrograde flow conduit.[0011]
• In another embodiment of the present invention, there is provided a diagnostic or therapeutic procedure in a human or animal. The method comprises the steps of providing a catheter according to the present invention, placing the catheter subcutaneously into the human or animal with the distal end inserted into a target vessel, injecting fluid into or aspirating fluid from the proximal control end of the catheter, and allowing the fluid to flow through the distal delivery end. The method can further comprise anchoring the catheter to subcutaneous tissues of the human or animal. The method can also comprise preventing flow through the distal delivery end by inflating the one or more than one inflation balloon in the distal delivery end. Inflating the one or more than one inflation balloon in the distal delivery end can be achieved by depressing a portion of the proximal control end through skin overlying the placed catheter.[0012]
• The method can further comprise allowing flow through the distal delivery end to resume by deflating the one or more than one inflation balloon in the distal delivery end. Deflating the one or more than one inflation balloon in the distal delivery end is achieved by depressing a portion of the proximal control end through skin overlying the placed catheter.[0013]
FIGURES
• These and other features, aspects and advantages of the present invention will become better understood with regard to the following description, appended claims, and accompanying figures where:[0014]
• FIG. 1 is a lateral perspective view of a catheter according to one embodiment of the present invention;[0015]
• FIG. 2 is a lateral perspective view of another catheter according to another embodiment of the present invention;[0016]
• FIG. 3 is a cross-sectional view of the intermediate portion of a catheter shown in FIG. 1 having one delivery lumen taken along[0017]3-3.
• FIG. 4 is a cross-sectional view of the intermediate portion of a catheter shown in FIG. 2 having two delivery lumens taken along[0018]4-4;
• FIG. 5 is a lateral perspective view of the distal portion of a catheter shown in FIG. 2;[0019]
• FIG. 6 is a cross-sectional view of the distal delivery end of a catheter shown in FIG. 1 having one delivery lumen, with the single inflation balloon uninflated;[0020]
• FIG. 7 is a cross-sectional view of the distal delivery end of a catheter shown in FIG. 1 having one delivery lumen, with the single inflation balloon inflated;[0021]
• FIG. 8 is a cross-sectional view of the distal delivery end of a catheter shown in FIG. 2 having two delivery lumens, with both inflation balloons uninflated;[0022]
• FIG. 9 is a cross-sectional view of the distal delivery end of a catheter shown in FIG. 2 having two delivery lumens, with both inflation balloons inflated;[0023]
• FIG. 10 is a top perspective view of the proximal control end of the catheter shown in FIG. 1;[0024]
• FIG. 11 is a top perspective view of the proximal control end of the catheter shown in FIG. 2;[0025]
• FIG. 12 is a cutaway top perspective view of the housing as shown in FIG. 1;[0026]
• FIG. 13 is a cutaway top perspective view of the housing as shown in FIG. 2;[0027]
• FIG. 14 and FIG. 15 are sequential close-up, cutaway, partial views of the port and means for constricting of a catheter according to the present invention in use;[0028]
• FIG. 16 is a partial side perspective view of the inflation means and the deflation means of a catheter according to the present invention;[0029]
• FIG. 17 is a partial cutaway, side perspective view of the inflation means and the deflation means according to the present invention;[0030]
• FIG. 18 is a top perspective, cutaway view of a one-way, antegrade flow valve according to the present invention in the inflation balloon deflated position; and[0031]
• FIG. 19 is a top perspective, cutaway view of a one-way, retrograde flow valve according to the present invention in the inflation balloon inflated position.[0032]
DESCRIPTION
• In one embodiment, the present invention is a catheter suitable for a variety of diagnostic and therapeutic procedures, including the administration of fluid and pharmaceutical agents, and for hemodialysis in patients with renal failure, and suitable for implantation into a human or animal. In another embodiment, the present invention is a method of performing a diagnostic and therapeutic procedure in a human or animal, comprising providing a catheter according to the present invention. These inventions will now be discussed in detail.[0033]
• Referring now to FIG. 1 and FIG. 2, there are shown lateral perspective views of two[0034]catheters100 and200 according to the present invention. As can be seen, eachcatheter100 and200 generally comprises aproximal control end102 and202, adistal delivery end104 and204, and an elongatedintermediate portion106 and206 between theproximal control end102 and202 and thedistal delivery end104 and204. Each catheter also comprises one or more than onedelivery lumen108 and208 within theintermediate portion106 and206. Referring now to FIG. 3 and FIG. 4, there are shown cross-sectional views of theintermediate portion106 and206 of the catheters shown in FIG. 1 taken along3-3 having onedelivery lumen108, and shown in FIG. 2 taken along4-4 having twodelivery lumens208, respectively. Eachdelivery lumen108 and208 extends generally from theproximal control end102 and202 to thedistal delivery end104 and204, respectively.
• In a preferred embodiment, as shown in FIG. 1, the[0035]catheter100 has anintermediate portion106 comprising onedelivery lumen108 and theintermediate portion106 has an outer diameter of about 8 Fr. (2.7 mm) to about 10 Fr. (3.3 mm). Thiscatheter100 is suitable for the administration of fluid or pharmaceutical agents to a human or animal.
• In another preferred embodiment, as shown in FIG. 2, the[0036]catheter200 has anintermediate portion206 comprising twodelivery lumens208 and210 and theintermediate portion206 has an outer diameter of about 14 Fr. (4.7 mm) to about 15 Fr. (5.0 mm). Thiscatheter200 is suitable for the administration of fluid or pharmaceutical agents to a human or animal, or for performing hemodialysis in patients with renal failure.
• The proximal to distal length of[0037]intermediate portion106 and206 depends upon the intended use of thecatheter100 and200 having theintermediate portion106 and206. Generally, the proximal to distal length of theintermediate portion106 and206 is between about 10 cm and about 50 cm. In a particularly preferred embodiment, the proximal to distal length of the intermediate portion is between about 20 cm and about 50 cm.
• The cross-sectional area of[0038]intermediate portion106 and206 also depends upon the intended use of thecatheter100 and200 having the intermediate portion. Generally, the radius ofintermediate portion106 is between about 1 mm and about 1.7 mm for the embodiment shown in FIG. 1, 100, and the radius ofintermediate portion206 is between about 2 mm and about 2.5 mm for the embodiment shown in FIG. 2, 200.
• The[0039]intermediate portion106 and206 can comprise any biocompatible material suitable for implantation as will be understood by those with skill in the art with reference to this disclosure. In a preferred embodiment, theintermediate portion106 and206 comprises a biocompatible, braided, kink-resistant polyurethane. In a particularly preferred embodiment, theintermediate portion106 and206 further comprises at least one hydrophilic coating on the external surface or on each intraluminal surface, or both, to reduce the accumulation of materials leading to occlusion of the lumen, such as thrombus and fibrin. In another particularly preferred embodiment, theintermediate portion106 and206 comprises heparin molecules bound to the external surface or to each intraluminal surface, or both, to reduce the accumulation of thrombus and fibrin on these surfaces.
• Referring now to FIG. 5, there is shown a lateral perspective view of the[0040]distal delivery end204 of acatheter200 shown in FIG. 2. As can be seen in FIG. 4 and FIG. 5, theintermediate portion206 of thecatheter200 comprises two lumens, afirst lumen208 and asecond lumen210, and thefirst lumen208 ends proximally to thesecond lumen210 at thedistal delivery end204 of thecatheter200. In a preferred embodiment, thefirst lumen208 ends between about 3 cm and about 4 cm proximally to thesecond lumen210 at thedistal delivery end204 of thecatheter200. As will be understood by those with skill in the art with reference to this disclosure, this embodiment is particularly suitable for use in performing hemodialysis in patients with renal failure, because the first lumen can be used to aspirate venous blood during hemodialysis and the second lumen can be used to return dialyzed blood, decreasing the admixture of undialyzed and dialyzed blood and, thereby, increasing dialysis efficiency.
• As can be further seen in FIG. 3 and FIG. 4, each[0041]catheter100 and200 of the present invention further includes at least oneinflation lumen112 and212 extending generally from theproximal control end102 and202 to thedistal delivery end104 and204. The inflation lumen can be placed within the wall of theintermediate portion106 and206 of thecatheter100 and200 as shown in FIG. 3, or can be placed within the wall separating twolumens208 and210 as shown in FIG. 4, when more than one delivery lumen is present. Theinflation lumen112 and212 has a sufficient cross-sectional area throughout its length to serve as a conduit for gas or fluid, such as sterile saline, sterile water or sterile contrast material, to flow from the proximal control end of the catheter to one or more than one inflation balloon at the distal delivery end of the catheter. In another preferred embodiment, theinflation lumen112 and212 is round in cross-section and has an internal diameter of between about 0.4 mm to about 0.7 mm. In a particularly preferred embodiment, theinflation lumen112 and212 is round in cross-section and has an internal diameter of about 0.55 mm.
• Referring now to FIG. 6 and FIG. 7, there are shown cross-sectional views of the[0042]distal delivery end104 of the catheter shown in FIG. 1. Referring now to FIG. 8 and FIG. 9, there are shown cross-sectional views of thedistal delivery end204 of the catheter shown in FIG. 2. As can be seen, eachinflation lumen112 and212 ends in thedistal delivery end104 and204 at one or more than onefenestration114 and214 interconnecting theinflation lumen112 and212 with one or more than oneinflation balloon116 and216. In a preferred embodiment, the one or more than onefenestration114 and214 is present in about the distal 3 cm of the distal end of theinflation lumen112 and212.
• Each[0043]inflation balloon116 and216 is preferably made of biocompatible, low pressure and high compliance latex, C-Flex, silicone rubber or other suitable material as will be understood by those with skill in the art with reference to this disclosure. Techniques for producing inflation balloons suitable to the present invention are well known to those with skill in the art. Briefly, a thin layer of balloon material is bonded around the one or more than onefenestration114 and214 in thedelivery lumen108 and208,210 atdistal delivery end104 and204 of thecatheter100 and200, leaving a small linear section of the material directly over the one or more than onefenestration114 and214 unbonded.
• As shown in FIG. 6 and FIG. 8, each[0044]inflation balloon116 and216 is configured to have a minimum profile when deflated such that it does not significantly impede flow through the delivery lumen. As shown in FIG. 7 and FIG. 9, eachinflation balloon116 and216 is configured to have a profile sufficient to occlude the delivery lumen at the distal delivery end of the catheter when inflated. Inflation of theinflation balloon116 and216, with its resultant occlusion of thedelivery lumen108 and208,210, prevents back flow of blood into thedelivery lumen108 and208,210. As can be seen in the preferred embodiment shown in FIG. 8 and FIG. 9, asingle inflation lumen212 is used to simultaneously inflate the inflation balloons216 present in eachdelivery lumen208 and210 at thedistal delivery end204 when more than one delivery lumen is present in the catheter. However, the present invention also includes providing more than oneinflation lumen212 to inflate more than oneinflation balloon216, not shown, such that eachinflation balloon216 can be inflated independently.
• Referring now to FIG. 10 and FIG. 11, there are shown a top perspective view of the[0045]proximal control end102 of thecatheter100 shown in FIG. 1 and a top perspective view of theproximal control end202 of thecatheter200 shown in FIG. 2, respectively. As can be seen in FIG. 1, FIG. 2, FIG. 10 and FIG. 11, theproximal control end102 and202 comprises ahousing118 and218 with adistal end120 and220 connected to the proximal end of theintermediate portion122 and222.
• The[0046]housing118 and218 can comprise any biocompatible material suitable for implantation as will be understood by those with skill in the art with reference to this disclosure. In a preferred embodiment, the outer casing of thehousing118 and218 comprises titanium. Further, as will be understood by those with skill in the art with reference to this disclosure, thehousing118 and218 has a size suitable for the intended use. By way of example, thehousing118 and218 can be approximately 2 cm in height, 4 cm in width and 6 cm in proximal to distal length.
• The[0047]housing118 and218 is configured to be inserted subcutaneously in a human or animal into a pouch created by blunt dissection or by the action of a high-pressure balloon dilatation instrument, according to techniques known to those with skill in the art. In a preferred embodiment, thehousing118 and218 is configured to be anchored to the tissues forming the pouch by attaching one or more than oneanchoring device124 and224 to the tissue forming the pouch. In a preferred embodiment, the one or more than oneanchoring device124 and224 is a plurality of anchoring devices. In a particularly preferred embodiment, theanchoring device124 and224 is a semi-circular metal ring attached to the lower portion of thehousing118 and218, and nonresorbable sutures or surgical stapes are used to attach the one more than oneanchoring device124 and224 to the tissue forming the pouch according to techniques known to those with skill in the art.
• The[0048]housing118 and218 further comprises a mechanism for aspiration and injection offluids126 and226 through the one or more than onedelivery lumen108 and208,210 of theintermediate portion106 and206 of thecatheter100 and200. Referring now to FIG. 12 and FIG. 13, there are shown a cutaway top perspective view of thehousing118 and218 as shown in FIG. 1 and FIG. 10, and in FIG. 2 and FIG. 11, respectively. As can be seen, the mechanism for aspiration and injection offluids126 and226 comprises one combined aspiration andinjection port128 for the embodiment shown in FIG. 12, and two combined aspiration andinjection ports228 for the embodiment shown in FIG. 13, at the proximal end of thehousing118 and218. In a preferred embodiment, as shown, eachport128 and228 is configured to be concave toward the distal end of thehousing118 and218. This configuration advantageously assists in guiding a needle used to aspirate or inject into theport128 and228.
• The mechanism for aspiration and injection of[0049]fluids126 and226 further comprises an aspiration andinjection conduit130 and230 connecting the distal end of eachport128 and228 to the proximal end of thedelivery lumen108 and208,210 of theintermediate portion106 and206 of thecatheter100 and200. In a preferred embodiment, the mechanism for aspiration and injection offluids126 and226 further comprises constricting means132 and232 for constricting the proximal end of the aspiration andinjection conduit130 and230 so as to create a water-tight seal between theport128 and228 and the proximal end of thedelivery lumen108 and208,210. In a preferred embodiment, the constricting means132 and232 for constricting comprises a puncture resistant, fabric sleeve surrounding the aspiration andinjection conduit130 and230 and attached to a plurality of elastic bands that compress the sleeve radially. In a particularly preferred embodiment, the sleeve comprises poly-paraphenylene terephthalamide fibers, such as those sold under the name KEVLAR® by DuPont, with an inner rubberized surface. In another particularly preferred embodiment, the elastic bands comprise a plurality of axially oriented thin metal strips that are concave toward the center of the sleeve. The thin metal bands provide tension against the center of the sleeve radially and, thereby, the aspiration andinjection conduit130 and230 radially, thus creating the water-tight seal in the aspiration andinjection conduit130 and230. Other means are also suitable as will be understood by those with skill in the art with reference to this disclosure.
• The constricting means[0050]132 and232 is used by inserting an access needle, such as a 14 or 15 gauge needle, into theport128 and228. The concave surface of theport128 and228 assists in guiding the needle into the aspiration andinjection conduit130 and230.
• Referring now to FIG. 14 and FIG. 15, there are shown close-up, cutaway, partial views of the[0051]port128 and one embodiment of the constricting means132 while in use. The constricting means232 can be configured in a corresponding manner to the constricting means132. As can be seen in these Figures, as theneedle134 enters theport128 and constricting means132, it separateselastic bands136 and opens a passage into theconduit130. Asleeve138 assists in preventing perforation of theconduit130 by the tip of theneedle134. Withdrawal of theneedle134 allow the tension provided by theelastic bands136 to again seal the conduit.
• The[0052]housing118 and218 further comprises a mechanism for controllinginflation140 and240 of the one or more than oneinflation balloon116 and216. Themechanism140 and240 comprises an inflation means142 and242 and comprises a deflation means144 and244. Though the inflation means142 and242 and deflation means144 and244 are disclosed with reference to particular preferred embodiments, it will be understood by those with skill in the art with reference to this disclosure that other embodiments are possible and are within the contemplated scope of this invention.
• Referring again to FIG. 1, FIG. 2, FIG. 12 and FIG. 13, and referring now to FIG. 16 and FIG. 17, there are shown in FIG. 16 and FIG. 17, respectively, a partial side perspective view of the inflation means[0053]142 and the deflation means144 and a partial cutaway, side perspective view of the inflation means142 and the deflation means144 of thecatheter100 shown in FIG. 1. The inflation means242 and the deflation means244 of thecatheter200 can be configured in a corresponding manner to the inflation means142 and the deflation means144 of thecatheter100. As can be seen, the inflation means142 and242 comprises areservoir146 and246 and aninflation actuator148 and248. As shown in the Figures, theinflation actuator148 and248 preferably comprises a tactile recognizable surface that projects from the superior surface of thehousing118 and218 and is passively maintained in the balloon deflated position. The inflation means142 and242 can comprise an elastic bulb, as shown in FIG. 1, FIG. 2, FIG. 12 and FIG. 13, where part of the bulb serves as thereservoir146 and246 and part serves as theinflation actuator148 and248 and projects from the superior surface of thehousing118 and218. Alternately, as shown in FIG. 16 and FIG. 17, the inflation means142 can comprise a collapsible unit such as a rigidupper unit150 slidably fitting into a rigidlower reservoir146 and held apart in the balloon deflated position by areservoir spring coil152 within thereservoir146. Other inflation means are also suitable, as will be understood by those with skill in the art with reference to this disclosure.
• At the distal end, the[0054]reservoir146 and246 connects to anantegrade flow conduit154 and254 and, thereby, to the proximal end of theinflation lumen112 and212. Theantegrade flow conduit154 is interrupted by a one-way,antegrade flow valve156. Referring now to FIG. 18, there is shown a top perspective, cutaway view of a one-way,antegrade flow valve156 according to the present invention. The one-way,antegrade flow valve156 comprises a antegradeflow conduit sealer158 generally held in the inflation balloon deflated position by a antegradevalve spring coil160 as shown.
• At the proximal end, the[0055]reservoir146 and246 connects to one or more than oneretrograde flow conduit162 and262 and, thereby from eachretrograde flow conduit162 and262, to the proximal end of theinflation lumen112 and212. Eachretrograde flow conduit162 and262 is interrupted by a one-way,retrograde flow valve164 and264. Each one-way,retrograde flow valve164 and264 is connected to adeflation actuator166 and266. Eachdeflation actuator166 and266 preferably comprises a tactile recognizable surface that projects from the lateral surface of thehousing118 and218 and is passively maintained in that balloon inflated position by a retrogradevalve spring coil168 and268 within theretrograde flow valve164 and264. Referring now to FIG. 19, there is shown a top perspective, cutaway view of a one-way,retrograde flow valve164 according to the present invention. The one-way,retrograde flow valve264 of thecatheter200 can be configured in a corresponding manner to the one-way,retrograde flow valve164 of thecatheter100. As can be seen, the one-way,retrograde flow valve164 comprises aretrograde flow conduit162 and retrogradeflow conduit sealer170 generally held in the inflation balloon inflated position by a retrogradevalve spring coil168.
• The present invention further comprises a method of performing a diagnostic and therapeutic procedure in a human or animal. The method comprises providing a catheter according to the present invention. The catheter is then placed subcutaneously into the human or animal using standard techniques with the distal end inserted intravenously and advanced into the appropriate position for performing the diagnostic or therapeutic procedure. Briefly, under sterile conditions and, preferably, local anesthesia, an entry needle is used to percutaneously puncture the target vessel. Next, a guidewire is coaxially inserted into the target vessel and the entry needle is withdrawn over the guidewire while maintaining access to the target vessel.[0056]
• Then, the subcutaneous tissues adjacent the entry site are incised and a subcutaneous pouch is created sufficient to hold the proximal control end of a catheter according to the present invention using a tunneling device. The tunneling device is then used to advance the catheter through the subcutaneous pouch and advance the distal end of the catheter exteriorly through the incision at the guidewire entry site. The housing is preferably secured within the pouch as disclosed above, and the entry incision used to create the pouch is closed, such as by suturing.[0057]
• Next, a peel-away sheath is then inserted into the target vessel over the guide wire and is advanced to the appropriate location with the target vessel, such as into the superior vena cava or the inferior vena cava. The guidewire is then removed from the sheath and the distal end of the catheter is inserted into the target vessel through the sheath. The sheath is then removed and the catheter seated into its final position subcutaneously. Finally, the entry site incision is closed and the incisions are dressed in a standard manner.[0058]
• Once, the catheter is placed subcutaneously, it is used as follows. Fluid is administered or withdrawn by needle access through the port. The needle access opens the means for constricting, when present.[0059]
• To stop retrograde flow through the lumen of the intermediate portion, the inflation means is actuated, such as by depression of the inflation actuator through the overlying skin. This action sends fluid from the reservoir into the antegrade flow conduit, opening the antegrade flow valve and inflating the one or more than one inflation balloon. Inflating the one or more than one inflation balloon stops retrograde flow into the one or more than one lumen in the distal end of the catheter. Fluid can be injected into the lumen through a port simultaneously to assist in stopping retrograde flow. Additionally, fluid can be injected into the lumen through a port simultaneously to confirm occlusion of the lumen by one or more than one inflation balloon using tactile feedback. Once actuation of the inflation means stops, fluid pressure distal to the antegrade flow valve closes the antegrade flow valve and prevents retrograde flow into the reservoir, thus maintaining inflation of the one or more than one inflation balloon and occlusion of the distal catheter.[0060]
• When patency of the lumen of the intermediate portion is again needed, the deflation means is actuated, such as by depression of the deflation actuator through the overlying skin. This action sends fluid from the one or more than one inflation balloon into the retrograde flow conduit, opening the retrograde flow valve and into the reservoir. Once actuation of the deflation means stops, the retrograde flow valve closes preventing antegrade flow from the reservoir, thus maintaining deflation of the one or more than one inflation balloon and patency of the distal catheter.[0061]
• Although the present invention has been discussed in considerable detail with reference to certain preferred embodiments, other embodiments are possible. For example, the catheter of the present invention can be used as a gastric or enteral feeding tube to prevent retrograde flow of gastric or enteral contents. Therefore, the scope of the appended claims should not be limited to the description of preferred embodiments contained in this disclosure.[0062]

Claims (19)

I claim:

1. A catheter for the administration of fluid or pharmaceutical agents, or for hemodialysis comprising:

a) a proximal control end comprising a housing with a proximal end and a distal end;

b) a distal delivery end;

c) an elongated intermediate portion between the proximal control end and a distal delivery end;

d) one or more than one delivery lumen within the intermediate portion extending from the proximal control end to the distal delivery end;

e) one or more than one inflation balloon in each delivery lumen; and

f) one or more than one inflation lumen in the intermediate portion extending from the proximal control end to the one or more than one inflation balloon in the one or more than one delivery lumen, and connected to the one or more than one inflation balloon through one or more than one fenestration;

where the proximal control end further comprises a mechanism for aspiration and injection of fluids through the distal delivery end; and

where the proximal control end further comprises a mechanism for controlling inflation of the one or more than one inflation balloon.

2. The catheter ofclaim 1, where the one or more than one delivery lumen is two delivery lumens.

3. The catheter ofclaim 1, where the one or more than one delivery lumen has an axial length of between about 10 cm and about 50 cm.

4. The catheter ofclaim 1, where the intermediate portion has a cross-sectional area and where the cross-sectional area is between about 1 cm and about 3 cm.

5. The catheter ofclaim 1, where the intermediate portion comprises an external surface and the one or more than one delivery lumen comprises an intraluminal surface; and

where the external surface or the intraluminal surface or both comprise at least one hydrophilic coating.

6. The catheter ofclaim 1, where the intermediate portion comprises an external surface and the one or more than one delivery lumen comprises an intraluminal surface; and

where the external surface or the intraluminal surface or both comprise heparin molecules bound to the external surface or to the intraluminal surface, or both, to reduce the accumulation of thrombus and fibrin on these surfaces.

7. The catheter ofclaim 1, where the inflation lumen has an internal diameter of between about 0.4 and about 0.7 mm.

8. The catheter ofclaim 1, where the housing comprises one or more than one anchoring device.

9. The catheter ofclaim 1, where the mechanism for aspiration and injection of fluids comprises one or more than one combined aspiration and injection port.

10. The catheter ofclaim 9, where the combined aspiration and injection port is concave toward the distal end of the housing.

11. The catheter ofclaim 9, where each of the one or more than one combined aspiration and injection port has a distal end and where the mechanism for aspiration and injection of fluids further comprises one or more than one aspiration and injection conduit connecting the distal end of each port to the one or more than one delivery lumen.

12. The catheter ofclaim 11, where the mechanism for aspiration and injection of fluids further comprises constricting means for constricting the aspiration and injection conduit.

13. The catheter ofclaim 1, where the mechanism for controlling inflation of the one or more than one inflation balloon comprises inflation means and deflation means.

14. The catheter ofclaim 13, where the inflation means comprises a reservoir and an inflation actuator.

15. The catheter ofclaim 14, where the housing has a superior surface, and where the inflation actuator comprises a tactile recognizable surface that projects from the superior surface of the housing.

16. The catheter ofclaim 13, where the inflation means comprises an elastic bulb.

17. The catheter ofclaim 13, where the inflation means comprises a rigid upper unit slidably fitting into a rigid lower reservoir and separated by a reservoir spring coil within the reservoir.

18. The catheter ofclaim 14, where the reservoir connects to the one or more than one inflation lumen through an antegrade flow conduit, and where the inflation means further comprises a one-way, antegrade flow valve between the inflation lumen and the antegrade flow conduit.

19. The catheter ofclaim 14, where the reservoir connects to the one or more than one inflation lumen through one or more than one retrograde flow conduit, and where the inflation means further comprises a one-way, retrograde flow valve between the one or more than one inflation lumen and each retrograde flow conduit.

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