Patent Application
20090306606
The present invention pertains to the field of medical devices. More particularly, the present invention relates to a catheter hub and a vascular access catheter with a catheter hub assembly and a method of using such vascular access catheter.
Vascular access procedures may be used when a patient needs intravenous antibiotic treatment chemotherapy or anticancer drugs, pheresis, drug infusion, blood sampling, long-term intravenous (IV) feeding for nutritional support, bolus injections, or hemodialysis, for example. Such procedures may involve the insertion of a catheter into a patients blood vessel to provide a method of drawing blood or delivering drugs and nutrients into a patients bloodstream over a period of weeks, months or even years.
Devices used during vascular access procedures may include catheters or subcutaneously implantable ports. Catheters used during vascular access procedures may include peripherally inserted central catheters (PICCs) or hemodialysis catheters, among others. Peripherally inserted central catheter (PICC) lines are inserted into a large vein in the arm and extend into the largest vein (superior vena cava) near the heart and typically provide central IV access for several weeks, but may remain in place for several months. Hemodialysis catheters are used to remove waste products such as potassium and urea from the blood, such as in the case of renal failure. During hemodialysis, waste products that have accumulated in the blood because of kidney failure are transferred via mass transfer from the blood across a semi permeable dialysis membrane to a balanced salt solution. One type of hemodialysis catheter that is well-known in the art is a triple-lumen hemodialysis catheter.
Triple lumen hemodialysis catheters are designed to provide long-term access to the venous system for dialysis and typically have an inflow lumen for withdrawing blood to be treated from a blood vessel and an outflow lumen for returning cleansed blood to the vessel. The distal segment of the catheter is preferably positioned at the junction of the superior vena cava and right atrium to obtain a blood flow of sufficient volume to accommodate dialysis treatment requirements. This allows blood to be simultaneously withdrawn from one lumen, to flow into the dialysis circuit, and be returned via the other lumen. Triple lumen hemodialysis catheters have an additional third lumen that may be used for guidewire insertion, administration and withdrawal of fluids such as antibiotics, chemotherapeutics or other drugs, blood sampling, hydration, or parenteral nutrition, to name a few.
While triple lumen dialysis catheters have many advantages, such catheters may also have disadvantages, such as drug or other fluid leakage from such catheters or the extension tubes when such catheters are used for chemotherapy or high pressure CT injections. If chemotherapy drugs are leaked into the surrounding tissues, this can cause damage, which may be very dangerous and difficult to treat. Further, if certain drugs are administered into a vein in the arm of patients who need frequent injections and intravenous treatments, it is possible to run out of usable veins in which to inject the drugs.
Typically, in triple lumen catheters, three extension tubes extend out of the catheter bifurcate while being in fluid communication with three catheter lumens. This design causes the proximal end of such catheters to be bulky at the insertion site, which can be cumbersome for medical personnel to use. This can also cause the proximal end of the catheter to be heavier compared to typical dual lumen catheters. The extra weight can bear down on the patient during prolonged treatment times and can cause discomfort to the patient, kinking, and an increased risk of infection. The crowding and/or abrasion of the extension tubes and/or clamps may also potentially damage the catheter. The third lumen in such triple lumen catheters is typically infrequently used. This lack of use can cause potential leaking if the extension tube that is connected to the third lumen is left unclamped. The unclamped extension tube may also be prone to infection and may be subject to failure over a long period of time.
As an alternative to vascular access catheters, implantable vascular access ports are also frequently used to overcome problems associated with limited peripheral access and to address the need for frequent venipuncture in patients receiving long-term, intensive therapy. Unlike catheters, which exit from the skin, implantable ports are placed completely below the skin. Ports may be implanted for short or long terms in a patient. Ports are used mostly to treat hematology and oncology patients, but have also been adapted for hemodialysis patients. Ports may also be connected to and used in conjunction with catheters.
A port typically has a reservoir and a self-sealing silicone septum that overlays the reservoir and can be punctured many times with a needle before the need to be replaced. Drugs can be injected into the needle, or blood samples can be withdrawn. The port device is surgically inserted under the skin in the upper chest or in the arm and appears as a bump under the skin. Implanting a subcutaneous port generally requires multiple incisions. In addition to a first incision to place the port, the patient must undergo a second surgical procedure to have the port removed after treatment is completed. To implant a port underneath the skin, a port implantation site is selected and a small subcutaneous pocket is created. A catheter is tunneled from the port site to the blood vessel which is to be catheterized, and the catheter is placed into the blood vessel of interest. The port reservoir is placed under the skin following a small skin incision, connected to the catheter, and then sutured to the surrounding underlying tissue. To administer treatment or to withdraw blood, a medical practitioner must locate the septum underneath the skin and disinfect the area. The port is then accessed by puncturing the overlying skin with a 90° non-coring Huber point needle into the reservoir of the port, although other types of needles may also be used.
As with triple lumen catheters, implantable vascular access ports have many advantages, but they also have several disadvantages. For instance, pneumothorax, or collapse of the lung because of injury to the lung from an inserted needle could occur. Other complications could include hemothorax, or bleeding into the chest because of injury to the blood vessels from the needle at insertion, cellulitis, infection of the skin around the port, and pain or discomfort to the patient when using a needle to inject into the port through the patient's skin, swelling, fever, sepsis, tachycardia, tachypnoea, hypotension, occlusions, thrombus formation, or increased procedure time due to having to replace the port if the port malfunctions or is damaged. The longer the port is left implanted in the patent, the greater the chance the port may become infected. The port may also be prone to rotation or flipping within the patient, which may make it difficult to locate the port and may require the port to be removed and re-positioned within the patient's body.
If used in conjunction, or in addition to, a catheter, implantable ports can also cause an increase in procedure time, due to the extra steps required to implant the port and connect the port to a catheter. These connection steps can also increase procedure costs, the chance of infection, and patient discomfort. The additional need for consideration by medical personnel and patients regarding what device to use, i.e., whether to use a port or a catheter, in cases where the devices are used separately, can also cause an increase in overall procedure time, which can adversely affect the quality of patient care.
A vascular access catheter has not yet been proposed that solves all of the above-mentioned problems. A catheter hub or bifurcate assembly that incorporates a vascular access port within the hub, for use with a vascular access catheter, such as those described above, is provided. The hub assembly has one or two extension tubes, instead of three, for use with a dual or triple lumen vascular access catheter, thereby minimizing the proximal end bulk of the catheter and decreasing the chance of infection and patient discomfort.
A catheter hub for use with a vascular access catheter, such as dual lumen or triple lumen catheter, is provided. The catheter hub assembly incorporates a vascular access port that is fluidly connected to a third lumen of the catheter that is capable of being used for injections or infusion of drug treatments, such as in chemotherapy or for high pressure CT injections, or urokinase, to effectively break up fibrin sheath buildup or other occlusive material along the catheter shaft.
A vascular access catheter with a catheter hub assembly is also provided. This catheter hub assembly incorporates a vascular access port that is fluidly connected to third lumen of the vascular access catheter shaft and can be used for injections or infusion of drugs or high pressure CT injections.
A further purpose is to provide a vascular access catheter, such as a hemodialysis catheter or a peripherally inserted central catheter (PICC), with a catheter hub assembly having a vascular access port positioned partially within the catheter hub, thereby combining two products into one, providing multiple functionalities, eliminating the need for multiple incisions, thereby shortening procedure time, and decreasing costs and patient discomfort.
Various other purposes and embodiments of the present invention will become apparent to those skilled in the art as more detailed description is set forth below. Without limiting the scope of the invention, a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description.
A catheter hub is provided for use with a vascular access catheter. The catheter hub has a body that has a proximal end, a distal end, an exterior surface, and defining an interior cavity having a bottom surface. The exterior surface of the body has a plurality of openings. At least one opening of the plurality of openings is defined in the proximal end, and at least one opening of the plurality of openings is defined in the distal end. The catheter hub also has a vascular access port that is positioned at least partially therein the interior cavity. The vascular access port has a housing that has a base and a wall extending therefrom the base, and at least one self-sealing septum having an outer surface that is configured for a leak-proof connection to an upper portion of the wall of the housing. A portion of a bottom surface of the at least one septum and portions of the wall and base of the housing define at least one reservoir. A portion of the housing is in fluid communication with the at least one reservoir, and at least a portion of the outer surface of the at least one septum is defined within a port opening of the plurality of openings of the body.
In another aspect, a vascular access catheter that has a catheter hub assembly is provided. The catheter hub assembly of the catheter has a body having a proximal end, a distal end, an exterior surface, and an interior cavity having a bottom surface. The exterior surface of the body further defines at least one proximal opening defined in the proximal end of the body. The exterior surface of the body further defines at least one distal opening defined in the distal end of the body that is configured to receive at least a portion of a proximal portion of the catheter shaft. The body further defines at least one channel that is integral to the at least one distal opening. The hub assembly has a plurality of extension tubes, each extension tube having a proximal end and a distal end. Each of the proximal openings is configured to receive the distal end of one extension tube, which tubes are fluidly connected to a proximal portion of one channel of the body. The hub assembly also has a vascular access port that is positioned at least partially in the interior cavity of the hub. The vascular access port has a housing having a base and a wall extending therefrom the base and at least one self-sealing septum having an outer surface. The septum is mounted in an upper portion of the wall of the housing. A portion of a bottom surface of the septum and portions of the wall and base of the housing define the reservoir. A portion of the housing is in fluid communication with the at least one reservoir. At least a portion of the outer surface of the septum is defined in a port opening that is defined in the body.
In a further aspect, a method of infusing an infusate into patient body through the vascular access catheter with catheter hub assembly is also provided.
The foregoing purposes and features, as well as other purposes and features, will become apparent with reference to the description and accompanying figures below, which are included to provide an understanding of the invention and constitute a part of the specification, in which like numerals represent like elements, and in which:
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected preferred embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention.
The skilled artisan will readily appreciate that the devices and methods described herein are merely exemplary and that variations can be made without departing from the spirit and scope of the invention. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.
Ranges may be expressed herein as from “about” to one particular value, and/or to “about” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independents of the other endpoint. As used herein, the term “proximal” means closer to the operator while the term “distal” means further away from the operator than proximal.
Referring now in detail to the drawings, in which like reference numerals indicate like parts or elements throughout the several views, in various embodiments, and referring to
In one exemplary aspect,
In one exemplary aspect, the catheter hub 49 may be made of any suitable polymeric material, such as, but not limited to, polyurethane, polypropylene, Carbothane, Tecoflex®, Isoplast, polyamide, nylon, polyether block material (PEBA), polyethethersulfone (PES), PP, PE, PCV, ABS resin, or mixtures and copolymers thereof, to name a few. One skilled in the art will recognize that other suitable materials may be used for the hub body 11. In one aspect, the entire hub assembly 57 may be either insert molded, as illustrated in
In the assembled state, as illustrated in
In one aspect, in the assembled state, extension tubes 50, 51 extend out of the proximal end 1 of the catheter hub 49 through openings 32 for connection to a dialysis machine. It is contemplated that any of extension tubes 50 or 51 may have an identification (ID) tag denoting the flow rate and/or volume of fluid to be injected into the catheter shaft 7 through the extension tubes 50, 51. Extension tubes 50, 51 may be comprised of polyurethane, as well as other materials, such as, but not limited to Carbothane or Tecoflex®. In one aspect, the extension tubes 50, 51 are composed of Carbothane. The proximal portion of the catheter shaft 7 extends distally from the hub 49 through opening 36 toward the distal end of the catheter (partially illustrated).
In one exemplary aspect, opening 36 may be sized to receive a catheter shaft 7 with an outer wall 16 having an outer diameter of approximately 0.203 inches, although, as one skilled in the art will appreciate, other diameter catheters are within the scope of this invention. Catheters for use with this catheter hub assembly 57 may also be, but are not limited to, a 15.5 Fr catheter, although, as one skilled in the art will appreciate, any suitable size catheter may be used. In one aspect, the catheter hub assembly 57 may be used with catheters that have a unitary catheter shaft 7. In one aspect, the catheter shaft 7 may be composed of, but is not limited to, carbothane, Tecoflex®, silicone, polyurethane, polyethylene, and teflon, or any suitable polymeric material. In another aspect, the catheter shaft 7 may also contain a radiopaque material to enhance visibility under fluoroscopy. The catheter shaft 7 may optionally be comprised of materials of different durometers to produce a shaft 7 with enhanced flexibility.
In one aspect, as illustrated in
In one aspect, as illustrated in
In one aspect, the vascular access port housing 18 may be composed of materials, such as titanium or plastic, silicone rubber, polyurethane, polysulfone, or any suitable combination of these materials. In one aspect, the housing 18 of the port 20 may be of any suitable shape or size, provided that it is configured to fit inside of the catheter hub 49. The vascular access port 20 of the present invention may be MRI-compatible. The base 12 of the housing 18 is positioned therein the interior cavity 61 of the body 11 substantially parallel relative to a horizontal plane bisecting the catheter body 11. In one exemplary aspect, in the assembled state, the base 12 of the housing 18 is mounted therein a portion of the interior cavity 61 of the body 11, as described below. In one aspect, the septum 2 is mounted in an upper portion of the wall of the housing 18. The base 12 is sealingly engaged to a portion of the bottom surface 3 of the interior cavity 61 of the body 11. The catheter hub 49 further comprises a means for securing the base 12 to the bottom surface 3 of the interior cavity 61 of the body 11. Means for securing the base 12 to the bottom surface 3 of the interior cavity 61 of the body 11 may include one or more of a plurality of securement tabs 24, 26 (described below), adhesives, and the like. The size and shape of the port 20 may be adjusted, based on the type of port 20 and catheter that will be used. In one aspect, the port 20 may be a low profile port.
In one aspect, at least a portion of the septum 2 is defined therein the housing 18, such that it forms an interference fit with the housing 18. At least a portion of the outer surface 6 of the septum 2 is thus defined therein a port opening 22 (
In one aspect, the vascular access port 20 may have at least one reservoir 10, as illustrated in
In one aspect, as illustrated in
In one aspect, in the assembled state, a vascular access catheter comprising the catheter hub assembly 57 may have a catheter shaft 7 that comprises a plurality of lumens. The plurality of lumens may comprise a first lumen 9 and a second lumen 19, illustrated in
In one aspect, as illustrated in
In one aspect, outer wall 16 and inner wall 13 define the inflow lumen 19. In another aspect, the outflow lumen 9 is defined by outer wall 16 and inner wall 25. The effective cross-sectional area of each lumen 19 and 9 may be substantially equalized, which aids in providing substantially equalized flow rates in both the inflow and outflow directions. In one non-limiting example, the resulting cross-sectional area of each respective lumen 19 and 9 is approximately 0.0065 inches2. The inflow lumen 19 can be exemplarily used for withdrawal of blood from the patient during dialysis or other procedures. In another aspect, the outflow lumen 9 can be exemplarily used for delivering cleansed blood back into the patient's circulatory system. One skilled in the art will appreciate that, although designated herein as inflow and outflow lumens, dialysis may be performed by reversing the blood flow through the lumens. Hence, the terms first lumen and second lumen may also be used herein to designate the interchangeability of the outflow and inflow lumens, respectively. In one exemplary aspect, blood can be withdrawn from the vessel of the patent into lumen 19 where it is passed through the extension tube 51 and into the dialysis machine. Blood can be returned to the patient through extension tube 50 into lumen 9, into the vessel of a patient.
In one aspect, the distal portion of at least one channel 42, 52 is fluidly connected to the proximal portion of the plurality of lumens of the catheter shaft 7 at the distal end of the body 4. In one aspect, channel 42 is in sealed fluid communication with at least a portion of lumen 19 of the catheter shaft 7 and is fluidly connected to lumen 19 of the catheter shaft 7 at transition point 58. Channel 52 is fluidly connected to at least a portion of lumen 9 of the catheter shaft 7 at transition point 58 and is in sealed fluid communication with lumen 9. Alternatively, in one aspect, lumens 19, 9 may be in sealed fluid communication with transition tubing (not illustrated), which in turn, may be fluidly sealed to channels 42, 52. At transition point 58 in the insert-molded hub 49, channels 42, 52 form a seamless transition with the lumens of the catheter shaft 7, while in the snap-fit hub 49, the channels 42, 52 are sealingly engaged or welded together with lumens 9, 19 of the catheter shaft 7 at transition point 58.
In one aspect, the vascular access catheter shaft 7 described herein further comprises a third lumen 27 or infusion lumen 27, as illustrated in
In one exemplary aspect, as illustrated in
In one exemplary aspect, and not meant to be limiting, the inner diameter of third lumen 27 may be approximately 0.037 inches. In one aspect, the third lumen 27 is in selective fluid communication with an infusate. Thus, third infusion lumen 27 may be used for the injection and delivery of drugs, such as, for example and without limitation, urokinase or other anti-thrombotic agents, fluids, such as contrast media, or blood sampling, perfusion, infusion, plasmapheresis, chemotherapy, high pressure CT injections, and the like. Infusates, such as drugs, may be injected through a needle 23 (
In one exemplary alternative embodiment, and as illustrated in
In various aspects, the liner 64 can protect the inner wall 43 of the lumen 27 from erosion due to drug and chemical use, thereby allowing the catheter hub assembly 57 and the catheter shaft 7 to be more resistant to drug therapy, and also supports high pressures for the purpose of CT injection, thereby allowing the catheter hub assembly 57 and catheter to be effectively used for high pressure CT injection, and eliminating the need for port placement. As noted above, the liner 64 may be made of any suitable material that may increase the burst pressure of the lumen 27, such as, but not limited to, nylon, polyamide, and the like. The liner 64 can also function to reduce friction over a guidewire. In one example, the liner 64 may have a wall thickness of between approximately 0.002 and 0.005 inches. Optionally, the liner 64 can comprise a higher strength material than the catheter shaft 7.
In one aspect, the reservoir 10 of the access port 20 is fluidly connected to the third lumen 27 of the catheter shaft 7 of the catheter hub assembly 57 via the extension tube 70. In one aspect, the third lumen 27 extends proximally into the catheter hub cavity 61. In one exemplary embodiment, at least a portion of the third lumen 27 of the catheter shaft 7 is positioned therein the interior cavity 61 of the hub body 11 between the first lumen 9 and the second lumen 19 of the catheter shaft 7. In one aspect, the third lumen 27 extends substantially the entire length of the catheter shaft 7, and the transverse cross-sectional area of the third lumen 27 is substantially less than the cross-sectional area of the lumens 19 and 9 of the catheter. Third lumen 27 is in selective communication with an infusate and can be used for the injection of infusates such as medication or fluids, including glucose or saline solutions through septum 2 of the port 20, into the patient's body. In one aspect, the third lumen 27 is also configured to selectively receive at least a portion of a guidewire.
In one aspect, a dual lumen catheter shaft 7, as illustrated in
In this aspect, at least a portion of the distal portion of the lumen 66 of extension tube 50 is in sealed, fluid communication with channel 52 in the interior cavity 61 of the hub body 11, being connected to channel 52 at transition point 55. Channel 52 is in sealed fluid communication with lumen 9 of the catheter shaft 7 and is fluidly connected with lumen 9 at transition point 58 at the distal end 4 of the hub body 11. The catheter shaft 7 with outer wall 16 extends distally from opening 36 at the distal end 4 of the hub 49.
In one aspect, the infusion lumen 27, which extends substantially the entire length of the catheter shaft 7 is fluidly connected with connection tube 70 at transition point 58, allowing lumen 72 of connection tube 70 to be in sealed, fluid communication with lumen 27 of the catheter shaft 7. As described above, the proximal end of connection tube 70 is in sealed, fluid communication with the at least one reservoir 10 of the port 20 after the port is secured to the bottom surface of the interior cavity 61, prior to completion of the hub assembly 57. The plurality of extension tubes 50, 51, at least a portion of channels 42, 52 and at least a portion of the proximal portion of the catheter shaft 7 extend substantially longitudinally in the interior cavity 61 of the hub relative to a longitudinal axis of the hub body 11.
In one exemplary aspect, as illustrated in
The catheter hub 49 of this invention is beneficial because it provides an automatic third lumen 27 that is available to be used for such purposes as, but is not limited to, drug infusion, CT injections, and blood sampling, to name a few. In another aspect, the third lumen 27 may be heparin-locked in the same manner that other catheter lumens of the catheter may be heparin-locked. This is critical because the third lumen 27 is small in diameter, so it is important to decrease the chance that the third lumen 27 will become occluded.
The catheter hub assembly 57 described herein is also beneficial because it only requires one or two extension tubes 50, 51, rather than three, as in typical triple lumen hemodialysis catheters, and thereby eliminates at least one extension tube that would otherwise be connected to a third infrequently used lumen. The elimination of the third extension tube is beneficial because it allows a user to perform fewer procedural steps when opening or closing the extension tubes. The elimination of the third extension tube also decreases the possibility of a user confusing or mixing up the extension tubes.
The catheter hub design described herein is also beneficial because it prevents leaks or malfunctions from occurring in the catheter extension tubes or the catheter. This helps to prevent potential leaking of the extension tube if the extension tube that is connected to the third lumen is left unclamped and helps to prevent the catheter shaft from breaking. The chance of infection and of catheter failure over a long period of time is also decreased with the catheter hub design disclosed herein, thereby reducing the need for a catheter repair kit.
Removing the third leg of a typical triple lumen dialysis catheter and replacing it with a self-healing port in the bifurcate removes proximal end bulk and excess extension tubes extending from the bifurcate and decreases treatment and procedure time. The catheter hub 49 provided herein also allows for a lower profile of the hub 49, decreases excess weight and lessens the chance of infection, thereby increasing patient comfort and the quality of medical care.
The catheter hub assembly 57 described herein is beneficial because it combines several vascular access products into one, i.e., a vascular access port and a hemodialysis catheter, such as that illustrated in
The catheter hub assembly 57 may be assembled using several different techniques. In one aspect, the entire hub assembly 57 may be insert molded. Before the catheter hub assembly 57 is insert molded, the port 20 is assembled with septum 2. The proximal end of the connection tube 70 is fluidly connected to the assembled port 20 and is attached or molded to the port body 11 at reservoir outlet stem 28 in the interior cavity 61 of the hub 49, described, for example, in
In several exemplary aspects, the stem 28 may comprise a means for securing the third lumen 27 of the catheter shaft 7 to the outlet stem 28. The inner wall 91 of the connection tube 70 can be attached to the stem 28 by placing the connection tube 70 over a barbed fitting, by using a press-fit design, or a solvent bond or molded-on connection, a standard male/female connection, or an adhesive material or a sealant, such as an epoxy, or any other type of suitable connection means. The barbed fitting of the stem 28 may encircle the outlet stem 28 and flare radially outwardly. In one aspect, illustrated in
In one exemplary aspect, as illustrated in
In another exemplary embodiment (not illustrated), the base 12 of the port 20 may have at least one protrusion that extends from the bottom surface of the base 12 to contact the bottom surface 3 of the interior cavity 61 when the port 20 is placed in the interior cavity 61 of the hub body 49. This enables the port 20 to have an enhanced sealing engagement with the bottom surface 3 of the interior cavity 61 of the hub 49 and to be better stabilized within the interior cavity 61 upon compression of the port 20 within the cavity 61. As the port 20 is compressed within the hub body 11, the protrusion allows the port 20 to be suspended within the interior cavity 61 of the port 20 between the extension tubes 50, 51 and clamps (not illustrated) on either side of the hub body 11 during the insert molding procedure. The space created between the bottom surface of the port 20 and the bottom surface 3 of the interior cavity 61 also allows for a sealing means, such as an adhesive or epoxy, to securely contact the bottom surface of the base 12 of the port 20 and the bottom surface 3 of the interior cavity 61 of the port 20. This feature may be used in either an insert-molded hub or a snap-fit hub. In another exemplary aspect, the port 20 and extension tubes 50, 51 may be pre-molded, and the resulting assembly may be placed inside of the interior cavity 61 of the hub body 11 before the entire catheter hub assembly 57 is insert molded.
After the port 20 and the hub body 11 are assembled, and the connection tube 70 is assembled to the port 20, the base 12 of port 20 is then secured to the bottom surface 3 of the bottom portion 34 of the interior cavity 61 of the hub 49. In one exemplary aspect, the base 12 of the port housing 18 is secured to the bottom surface 3 of the interior cavity 61 using various means such as, but not limited to, one or more of an adhesive, such as an expoxy, and/or a plurality of securement tabs 24, for example, those illustrated in
The catheter shaft 7 is positioned within the opening 36 of the hub 49 to extend along the internal cavity 61 of the hub, and the extension tubes 50, 51 are placed within openings 32. The diameter of the openings 32, 36 which are defined in the hub body 11, and are configured to receive the extension tubes 50, 51 and the catheter shaft 7, may be varied to allow the finished hub 49 to accommodate different sized extension tubes 50, 51 and catheter shaft 7. As described above, and also illustrated in
The distal portion of at least one of extension tubes 50, 51 becomes fluidly sealed to at least a portion of the proximal ends of channels 42, 52 in the interior cavity 61 of the hub body 11 at transition point 55, such that the finished hub assembly 57 is fused to a distal portion of the extension tubes 50, 51 and a proximal portion of the catheter shaft 7, and it forms a single, unified structure. Extension tubes 50, 51 and the channels 42, 52 are fluidly joined and defined in surrounding relationship to vascular access port 20, as illustrated in
The catheter hub assembly 57 may also be assembled using a snap-fit technique, followed by a potting technique, known in the art, as illustrated in
Before the bottom portion 34 and top portion 30 are snap-fit together, the base of the assembled port 20, with septum 2, is secured to the bottom surface 3 of the interior cavity 61 using various means such as, but not limited to, one or more of an adhesive and/or a plurality of securement tabs 24, illustrated in
In one aspect, the base of the port 20 may comprise a plurality of protrusions extending from the base 12 and defined therein the base 12 of the port 20. In one exemplary aspect, the base 12 may comprise four protrusions that are defined therein the base and extend from the base 12 of the port 20, spaced equidistantly from one another along the base 12 of the port 20, such as illustrated in
In one aspect, the bottom surface of the tabs 24 may contact the bottom surface 3 of the interior cavity 61 and are secured to the bottom surface 3 of the interior cavity 61 using an adhesive, such as an epoxy. In one aspect, the top surface of tabs 24 may have a lip (not illustrated) which extends from the tab 24 inside the pre-formed opening, extends outwardly, and overhangs the surrounding base 12 of the port 20, so as to further enhance the engagement between the tab 24, the bottom surface 3 of the interior cavity 61, and the base of the port 20. In one aspect, as illustrated in
As illustrated in
In one aspect, the bottom portion 34 of the hub body 11 is illustrated in
In one aspect,
In one aspect, any suitable needle 23 may be used with the vascular access port 20, such as, but not limited to, a non-coring Huber style needle. The Huber needle has a deflected point with an opening facing to the side of the needle shaft (i.e., a “beveled” needle design) which prevents the needle from coring out material from the silicone septum. This type of needle also helps to prevent permanent leaks or the infusion of cored silicone emboli into the patient. The needle 23 may be removably inserted into at least a portion of the surface 6 of septum 2 which is located exterior to the exterior surface 11 of the catheter hub body 11, and into the reservoir 10 to deliver drugs and other therapies and for blood sampling, as described below. The self-sealing septum 2 may be punctured up to several thousand times with needle 23 and still be able to be resealed into the port reservoir 10.
The method further comprises providing an infusate; and injecting the infusate through the needle 23, into the port 20, into the reservoir 10, into the connection tube 70, and into the third lumen 27 of the catheter, and into the body. In one aspect, the infusate may be selected from the group consisting of anti-restenosis agents, anti-thrombogenic agents, anti-inflammatory agents, anti-thrombotic agents, saline, contrast agents, urokinase, streptokinase, tissue plasminogen activator (t-PA), fibrinolytic agents, anti-proliferative agents, chemotherapeutics, and anti-coagulants.
In another aspect, a method for injecting infusates, including under high pressure for CT injection, is also provided. This method involves providing a vascular access catheter with catheter hub assembly 57, as described herein for use with a catheter, providing a contrast agent, and injecting the contrast agent under high pressure through the surface 6 of the septum 2 of the catheter hub assembly 57 into the third lumen 27 of the catheter and the port 20 and into the body for computed tomography.
The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. All these alternatives and variations are intended to be included within the scope of the claims where the term “comprising” means “including, but not limited to”. The words “including” and “having,” as used herein including the claims, shall have the same meaning as the word “comprising.” Those familiar with the art may recognize other equivalents to the specific embodiments described herein, which equivalents are also intended to be encompassed by the claims.
Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g., each claim depending directly from claim 1 should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below.
This completes the description of the selected embodiments of the invention. Those skilled in the art may recognize other equivalents to the specific embodiments described herein which equivalents are intended to be encompassed by the claims attached hereto.
