Multi-lumen catheter
10220184 ยท 2019-03-05
Assignee
Inventors
Cpc classification
A61M2025/0037
HUMAN NECESSITIES
A61M2025/0031
HUMAN NECESSITIES
A61M25/007
HUMAN NECESSITIES
A61M2025/0034
HUMAN NECESSITIES
International classification
A61M1/36
HUMAN NECESSITIES
Abstract
The invention provides a catheter for placement within a vessel of a patient. The catheter comprises an elongated catheter body, a septum extending longitudinally through the interior of the catheter body from the dividing the interior of the catheter body into a first lumen and a second lumen. Each lumen has curved or angled internal walls at the distal end of the catheter that terminate at ports located on opposing sides of the catheter body. The invention also provides a method for exchanging fluids in a patient comprising the step of positioning the catheter of the present invention in communication with a fluid-containing vessel of a patient. The method is particularly well-suited for hemodialysis, plasmapheresis, and other therapies which require removal and return of blood.
Claims
1. A catheter for placement within a vessel of a patient comprising: an elongated catheter body haying a proximal end and a distal end; and a septum extending longitudinally through at least a portion of the interior of the catheter body, thereby dividing the interior of the catheter body into a first lumen and a second lumen; wherein each of the first lumen and the second lumen comprise curved internal walls at the distal end of the catheter that terminate at ports located on opposing sides of the catheter body such that fluid flowing through the ports is deflected within a single plane.
2. The catheter of claim 1, wherein a distal end of the first lumen extends beyond a distal end of the second lumen.
3. The catheter of claim 2, wherein the distal end of the first lumen extends from about 2 cm to about 3 cm beyond the distal end of the second lumen.
4. The catheter of claim 1, wherein the first lumen and the second lumen are split apart.
5. The catheter of claim 1, wherein the first lumen and the second lumen are the same length such that the ports are adjacent to one another.
6. The catheter of claim 1, wherein at least one of the first lumen and the second lumen comprises at least one aperture.
7. The catheter of claim 6, wherein the at least one aperture is a side hole.
8. The catheter of claim 1, wherein at least a portion of the catheter is spirally twisted, thereby further deflecting fluid flowing through the catheter.
9. A catheter for placement within a vessel of a patient comprising: an elongated catheter body having a proximal end and a distal end; a first lumen comprising a first internal wall at the distal end of the catheter that forms an input port, wherein the first internal wall is curved such that fluid flowing through the input port is deflected within a single plane; a second lumen comprising a second internal wall at the distal end of the catheter that forms an out port, wherein the second internal wall is curved such that fluid flowing through the out port is deflected within a single plane; and a septum extending longitudinally through at least a portion of the interior of the catheter body, thereby dividing the interior of the catheter body into the first lumen and the second lumen.
10. The catheter of claim 9, wherein a distal end of the first lumen extends beyond a distal end of the second lumen.
11. The catheter of claim 10, wherein the distal end of the first lumen extends from about 2 cm to about 3 cm beyond the distal end of the second lumen.
12. The catheter of claim 9, wherein the first lumen and the second lumen are split apart.
13. The catheter of claim 9, wherein the first lumen and the second lumen are the same length such the input port and the out port are adjacent to one another.
14. The catheter of claim 9, wherein at least one of the first lumen and the second lumen comprises at least one aperture.
15. The catheter of claim 14, wherein the at least one aperture is a side hole.
16. The catheter of claim 9, wherein at least a portion of the catheter is spirally twisted, thereby further deflecting fluid flowing through the catheter.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
(10) In accordance with the apparatus of the present invention, there is provided a catheter body that is adapted for insertion into a vessel of a patient such as, for example, a vein. The catheter body comprises an external wall and a septum extending longitudinally along the internal length of the catheter body to define two substantially parallel lumina each having an internal wall and a port located at the side of the distal end thereof.
(11) At the distal end of each lumen, at least a portion of the internal walls of the lumina are curved or angled to define a transition zone terminating at the port. So configured, the transition zone permits the flow of fluids traveling the length of the lumen to be gradually deflected from the longitudinal direction of the lumen to the transverse direction of the side-facing port at the distal end thereof.
(12) For fluids entering the side-facing port of the lumen, the transition zone permits the flow to be gradually deflected from the direction of travel through the vessel through the lateral direction of entry to the longitudinal direction of travel in the lumen. In this fashion, the transition zone provides a gradual change in the direction of flow into and out of the lumina. This smoother and more physiologic change of direction of the fluids traveling through the lumina decreases firehosing of the catheter tip during high rates of fluid exchange, reduces stresses experienced by the fluid, and permits a more efficient and higher rate of flow into and out from the catheter. This more gradual change in direction of blood flow also results in less prolongation of blood residence time within the catheter tips which can decrease the likelihood of thrombus formation within the catheter. In the context of hemodialysis, plasmapheresis, and other therapies which require the transport of blood, decrease in stress provided by the transition zones at the distal end of the lumina decreases the incidence of platelet activation, hemolysis and trauma to the vessel lining.
(13) In one embodiment, a first lumen of the catheter terminates in a first bolus cavity, which is formed into one side of a bolus tip at a position between the interfacing section of the lumen and a nose section of the bolus tip. The nose section of the terminal portion of the first lumen may be formed through an injection molding process to create a helical shape of the nose section and first bolus cavity so that fluids such as blood traveling through the lumen have a smooth transition of its direction of flow as it enters the first lumen. The second lumen of the catheter terminates in a second bolus cavity oriented 180 from the first bolus cavity, and possesses a nose section which has a similar injection molded-configuration as the nose tip of the first lumen. The nose sections of the first and second lumina direct blood flow in directions opposite to each other thereby reducing the admixture of treated blood with non-treated blood. Preferably, the second lumen in this embodiment extends beyond the first lumen by about 2 to about 3 centimeters so that the nose section of the terminal portion of the second lumen is longitudinally spaced from the nose section of the terminal portion of the first lumen.
(14) In another embodiment, the terminations of the first and second lumina within the nose section are partly recessed, to enable the overhanging aspect of the nose section to serve as a barrier with the vessel wall. This design is intended to reduce the phenomenon of partial or total occlusion of the lumina of the catheter.
(15) In yet another embodiment, an additional lumen is provided within the catheter body to allow introduction of a guide wire. The guide wire inserted into this additional lumen and used to assist in the introduction and proper placement of the catheter tip into a vessel of a patient. The additional lumen for the guide wire may terminate at the same position as the first and/or second lumina, or may terminate distally beyond the distal ends of the lumina to provide additional stability to the catheter body. In such a configuration, the substantially helical transition zones of the first and second lumina may be created through mechanically or thermally (e.g., with a laser) skiving the apertures within the terminal shafts of the catheter.
(16) In still another embodiment, the first and second lumina may be split apart along the distal portion of the septum by, for example, a splittable membrane in the septum. In this manner, the lumina may be partially longitudinally separated from each other.
(17) As used herein, reference to curvature or angularity with regard to the internal walls of the lumina includes a wide range of configurations in which at least a portion of the internal walls of the lumen at the distal ends thereof undergoes a transition in direction from the longitudinal direction of the lumen to a direction angled from such longitudinal direction. In this fashion, fluids traveling in either direction through the lumen will bear against the curved or angled wall in the transition zone in changing direction from or to a longitudinal orientation.
(18) This change in the direction of the internal wall of the lumen in the transition zone may be constant or may vary along some or all of the transition zone, and may extend along two dimensions in which the flow path changes direction substantially within a single plane, or through three dimensions. Preferably, the curvature or angularity of the internal walls of the lumina extends in three dimensions and is substantially helical. As used herein, helical patterns includes patterns that are regular and irregular and with constant or varying diameters along their length. So configured, the movement of fluids through the transition zone imparts a helical flow pattern to such fluids. This helical flow pattern reduces the incidence of in-plane recirculation. In the context of hemodialysis, plasmapheresis, and other therapies which require the transport of blood, this helical flow pattern reduces the incidence of treated blood that is delivered to the patient through the catheter to re-enter the catheter at the intake port. The reduction of this type of recirculation allows for more efficient blood exchange and, consequently, reduced treatment time.
(19) The cross-sectional area and geometry of the lumina may be similar to or different from each other. Preferably, the cross-sectional area of each lumen is similarly sized in order to accommodate similar flow volumes and rates into and out from the catheter. In preferred from, the cross-sectional area of each lumen is from about 3.5 mm to about 5 ram, and more preferably from about 4.5 mm to about 5 mm. The cross-section geometry of the lumina may assume a variety of shapes including circular, semi-circular (D-shaped), elliptical, semi-elliptical, teardrop-shaped, or curved teardrop-shaped resembling a yin-yang symbol.
(20) The ports provided in the side walls of the distal ends of the lumina may accommodate a range of sizes and shapes including circular, semi-circular (D-shaped), elliptical, semi-elliptical, teardrop-shaped. Preferably, the ports are semi-elliptical and are from about 3 to about 6 mm in maximal diameter. The terminating cavities of the first and second channels have a greater surface area than prior designs, such us that shown in U.S. Pat. No. 4,808,155 by Mahurkar. This results in more efficient exchange of fluids and blood.
(21) The catheter of the present invention may be constructed from materials that are commonly used for multi-lumen catheters such as silicone or polyurethanes including polyurethanes sold under the trademark Carbothane by Carboline Company of St. Louis, Mo.
(22) In another aspect of the present invention, there is provided a method for exchanging fluids in a patient comprising the step of positioning a catheter of the present invention in communication with a fluid-containing vessel of a patient. In preferred embodiments, the exchanged fluid comprises blood and the fluid-containing vessel of the patient is a vein. The method of the present invention is particularly well-suited to the performance of hemodialysis, plasmapheresis, and other therapies which require removal and return of blood from a patient. The method of the present invention may further comprise the steps of ultrafiltration and/or venous sampling.
(23) Turning now to the embodiment that is shown in the drawings and referring to
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(25) In operation, the lumina 61 and 62 of the catheter 60 may be attached with a weak adhesive to maintain structural integrity of the catheter during operation. The adhesive may be water-soluble such that blood flow around the catheter 60 causes the adhesive to dissolve, thereby causing at least a portion of the lumina 61 and 62 to split. For example, the catheter 60 may be manufactured such that the last 5 cm of the catheter have the water-soluble adhesive and thus split when the adhesive dissolves.
(26) Based upon the intended fluid flow and acceptable disruption of the fluid, one or more side holes 69 may be included in the catheter 60. The side holes 69 may assist in providing additional means of blood or other fluid exchange as well as serve as a mounting point for attaching the catheter 60 on a guide wire during insertion/removal/exchange from a patient.
(27) The side holes 69 may be sized and positioned such that fluid flow is optimized about the lumen tips. For example, the side holes 69 may be approximately 1 mm in diameter, and be positioned approximately 1 cm from the ports 65 and 66. Alternatively, the side holes may be smaller (e.g., 0.5 mm), larger (e.g., 1.5 mm), or positioned in another location (e.g., 1.5 cm from the ports). The size and location of the side holes 69 may produce changes in shear stress and blood cell residence time at the catheter tips, and thus the optimal balance may incorporate side holes being approximately 0.75 mm to 1.2 mm in diameter.
(28) Using properly spaced and sized side holes, such as side holes 69, may result in a highly optimized catheter. For example, by using a similar catheter to the catheter 60 as shown in
(29) It should be noted that side holes 69 as shown in
(30) As shown in
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(32) At the distal end of the catheter 70, the lumina 71 and 72 may have with curved walls 73 and 74 which terminate at ports 75 and 76 disposed on opposite sides of catheter 70. As shown by way of example only, the lumen 71 extends beyond the end of lumen 72, thereby forming a stepped tip design and further separating the intake port 75 from outflow port 76. As before, in operation, fluid, such as blood, enters intake port 75, changes direction as the flow of fluid passes curved wall 73 through lumen 71 to tube 77 which conveys the fluid for treatment to a device such as a dialysis machine (not shown). After treatment, the treated fluid is returned to a patient through tube 78 to lumen 72. At the end of lumen 72, the fluid is deflected by curved wall 74 and out port 76 into the vessel of the patient.
(33) Similar to the discussion above in reference to
(34) As shown in
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(36) At the distal end of the catheter 80, the lumina 81 and 82 may have with curved walls 83 and 84 which terminate at ports 85 and 86 disposed on opposite sides of catheter 80. In this symmetrical tip embodiment, the lumen 81 extends to same point as the lumen 82, thereby forming a symmetrical tip design. As before, in operation, fluid, such as blood, enters intake port 85, changes direction as the flow of fluid passes curved wall 83 through lumen 81 to tube 87 which conveys the fluid for treatment to a device such as a dialysis machine (not shown). After treatment, the treated fluid is returned to a patient through tube 88 to lumen 82. At the end of lumen 82, the fluid is deflected by curved wall 84 and out port 86 into the vessel of the patient. By providing the curved walls 83 and 84 to deflect the fluid, the design eliminates the septum extending beyond the ports while still maintaining a low level of fluid from the out port 86 mixing with fluid entering the intake port 85.
(37) Similar to the discussion above in reference to
(38) The side holes 89 may be sized and positioned such that fluid flow is optimized about the lumen tips. For example, the side holes 89 may be approximately 1 mm in diameter, and be positioned approximately 1 cm from the ports 85 and 86. Alternatively, the side holes may be smaller (e.g., 0.5 mm), larger (e.g., 1.5 mm), or positioned in another location (e.g., 1.5 cm from the ports). The size and location of the side holes 89 may produce changes in shear stress and blood cell residence time at the catheter tips, and thus the optimal balance may incorporate side holes being approximately 0.75 mm to 1.2 mm in diameter.
(39) Using properly spaced and sized side holes, such as side holes 89, may result in a highly optimized catheter. For example, by using a similar catheter to the catheter 80 as shown in
(40) It should be noted that side holes 89 as shown in
(41) As shown in
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(43) Unlike the catheter 80 as shown in
(44) At the distal end of the catheter 90, the lumina 91 and 92 may have with curved walls 93 and 94 which terminate at ports 95 and 96 disposed on opposite sides of catheter 90. In this symmetrical tip embodiment, the lumen 91 extends to same point as the lumen 92, thereby forming a symmetrical tip design. As before, in operation, fluid, such as blood, enters intake port 95, changes direction as the flow of fluid passes curved wall 93 and through the twisted portion 100 of lumen 91 to tube 97 which conveys the fluid for treatment to a device such as a dialysis machine (not shown). After treatment, the treated fluid is returned to a patient through tube 98 to lumen 92. At the end of lumen 92, the fluid is deflected by the twisted portion 100 and the curved wall 94, and passes through out port 96 into the vessel of the patient. By providing the curved walls 93 and 94 and the twisted portion 100 to deflect the fluid, this design eliminates the septum extending beyond the ports while still maintaining a low level of fluid from the out port 96 mixing with fluid entering the intake port 95.
(45) Similar to the discussion above in reference to
(46) The side holes 99 may be sized and positioned such that fluid flow is increased about the lumen tips. For example, the side holes 99 may be approximately 1 mm in diameter, and be positioned approximately 1 cm from the ports 95 and 96. Alternatively, the side holes may be smaller (e.g., 0.5 mm), larger (e.g., 1.5 mm), or positioned in another location (e.g., 1.5 cm from the ports). The size and location of the side holes 99 may produce changes in shear stress and blood cell residence time at the catheter tips, and thus the optimal balance may incorporate side holes being approximately 0.75 mm to 1.2 mm in diameter.
(47) Using properly spaced and sized side holes, such as side holes 99, may result in a highly optimized catheter. For example, by using a similar catheter to the catheter 90 as shown in
(48) It should be noted that side holes 99 as shown in
(49) As shown in
(50) Although the invention has been described in language specific to structural features and/or methodological acts, it is to be understood that the invention defined in the appended claims is not necessarily limited to the specific features or acts described. Rather, the specific features and acts are disclosed as exemplary forms of implementing the claimed invention.
(51) Various of the above-disclosed and other features and functions, or alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art, each of which is also intended to be encompassed by the disclosed embodiments.