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  • 专利说明
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    • 专利摘要:
    SYSTEMS AND METHODS TO INCREASE THE RIGIDITY AND RESISTANCE TO CATHETER TIP GRASP. A venous catheter having a catheter tip comprising diffusion holes to increase the resistance to grip of the venous catheter. The invention further provides systems and methods for providing axial protrusions placed between diffusion holes to increase the rigidity of the vented tip of the catheter.
    公开号:BR112014004842B1
    申请号:R112014004842-8
    申请日:2012-08-07
    公开日:2021-05-04
    发明作者:Siddarth K. Shevgoor
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    BACKGROUND OF THE INVENTION
    [001] The present invention relates generally to vascular infusion systems and components, including catheter assemblies and devices used with catheter assemblies. In particular, the present invention relates to systems and methods for increasing the rigidity and grip resistance of a vascular infusion system having catheter port arrangements to provide better infusion flow rates, lower system pressures, and speeds. reduced jet outflow from the catheter. Furthermore, the present invention relates to a general improvement in the rigidity of a thin wall structure.
    [002] Vascular access devices are used to communicate fluid with a patient's anatomy. For example, vascular access devices, such as catheters, are commonly used to administer fluid, such as saline, various medications, and/or total parenteral nutrition, to a patient, draw blood from a patient, and/or monitor several parameters of the patient's vascular system.
    [003] A variety of clinical circumstances, including severe trauma, major surgical procedures, severe burns, and certain morbid conditions such as pancreatitis and diabetic ketoacidosis, can produce profound circulatory volume depletion. This depletion can be caused either by an actual loss of blood or by an imbalance of internal fluid. In these clinical situations, it is often necessary to administer blood and/or other fluid quickly to a patient to rule out serious consequences.
    [004] In addition, the ability to rapidly inject large amounts of fluid may be desirable for some other medical and diagnostic procedures. For example, some diagnostic imaging procedures use contrast enhancement to increase the conspicuity of the lesion in an attempt to increase the number of rapid diagnoses. These procedures require that viscous contrast media be injected by a specialized "boostered" injection pump intravenously at very high flow rates, which causes a bolus of contrast or a small buffer of contrast media into the patient's bloodstream, resulting in a better image quality.
    [005] Outgoing injection procedures generate high pressures within the infusion system, thus requiring specialized vascular access devices, extension sets, media transfer sets, pumping syringes, and syringes for bulk contrast media or syringes already filled out. As the concentration (and thus viscosity) and infusion rate of contrast media are increased, the bolus density also increases which results in better image quality via computed tomography (CT) attenuation. Therefore, a current trend in health care is to increase the density of the contrast media pool by increasing the concentration of contrast media and the rate at which media are administered to the patient, and all of this ends up increasing demands. relating to system pressure.
    [006] Intravenous infusion rates can be set either as routine, typically up to 999 cubic centimeters per hour (cc/hr), or rapid, typically between 999 cc/h and 90,000 cc/hr (1.5 liter per hour) minute) or higher. For some diagnostic procedures using viscous contrast media, an injection rate of about 1 to 10 ml/second is required to ensure a sufficient bolus concentration. Heavy injections of viscous media at this injection rate produce significant back pressure within the infusion system which commonly results in failure of infusion system components.
    [007] Traditionally, rapid infusion therapy entails the use of an intravenous catheter attached to a peristaltic pump and a fluid source. Infusion to the patient is performed while a tip portion of the catheter is inserted into a patient's vasculature and the pump forces a fluid through the catheter and into the patient's vein. Current rapid infusion therapies utilize a catheter and catheter tip with geometries identical to those used with traditional, routine infusion rates. These geometries include a tapered catheter tip such that fluid is accelerated as fluid moves through the catheter tip and exits into a patient's vasculature. This acceleration of the administered fluid is undesirable for several reasons.
    [008] For example, the tapered catheter leads to greater back pressure for the remainder of the catheter assembly. This effect is undesirable due to limitations on the pumpability of the infusion pump as well as the limited structural integrity of the components and subcomponents of the infusion system. For example, if the back pressure becomes too great, pump efficiency may decrease and certain seals or connections within the infusion system may not work. In addition, fluid acceleration at the catheter tip results in a recoil force that can cause the catheter tip to shift within the patient's vein, thus displacing the catheter and/or damaging the patient's vein and/or the site. of the injection. Fluid acceleration also increases the velocity of the infusion jet delivered through the catheter tip. In some procedures, the fluid jet can puncture the patient's vein, thus leading to leakage or infiltration. Not only does this cause discomfort and pain for the patient, but infiltration can also prevent the patient from receiving needed therapy.
    [009] To overcome undesirable back pressures and increased acceleration of delivered fluids, some intravascular systems include arrays of diffusion holes provided in and around the tip portion of the intravenous catheter. Examples of diffusion hole arrangements and diffusion hole geometries are provided in US Patent Applications 12/427,633 and 13/022,501, each of which is incorporated herein by reference.
    [010] In general, diffusion holes increase the surface area of the opening at the tip of the catheter, thus decreasing the fluid pressure at the opening at the tip of the catheter. However, adding diffusion holes at or near the tip of a catheter also reduces the resistance to warping of the catheter, thus making the catheter tip more susceptible to breakage during insertion. The result is that the addition of diffusion holes can lead to cauterization failure and physical pain for the patient. In addition, the addition of diffusion holes provides the catheter with a non-continuous outer surface that can grip or grip the opening of the patient's skin and/or vein through which the catheter is inserted. This can also lead to cauterization failure, physical pain and/or physical harm to the patient.
    [011] Thus, although methods and systems currently exist to reduce the output speed of an infusion during rapid infusion processes, challenges still exist. Consequently, it would be an advance in the art to extend or even replace current techniques with other techniques. BRIEF SUMMARY OF THE INVENTION
    [012] The systems and methods of the present disclosure have been developed in response to problems and needs in the art that have not yet been fully resolved by currently available infusion systems and methods. Thus, those systems and methods of the present disclosure were developed to provide safer and more efficient procedures for rapid infusion.
    [013] One aspect of the present invention is to provide an improved vascular access device for use in combination with a vascular infusion system capable of rapidly delivering an infusion to a patient's vascular system. The vascular access device typically includes an intravenous catheter configured to access a patient's vascular system. The intravenous catheter is attached to the vascular infusion system by a section of intravenous tubing. The intravenous catheter material can include a polymer or metallic material compatible with infusion procedures.
    [014] In some embodiments, a tip portion of the intravenous catheter is modified to include a plurality of diffusion holes. The tip portion generally comprises a tapered profile, wherein the outer and inner surface of the tip tapers towards the distal end of the catheter. The tapered outer surface provides a smooth transition between the narrow diameter of the catheter tip and the larger diameter of the catheter tubing. Thus, while the catheter tip is inserted into a patient's vein, the tapered outer surface facilitates comfortable insertion of the catheter through the access port. The tapered inner surface is generally provided to firmly contact the outer surface of an introducer needle housed within the lumen of the catheter. The introducer needle is provided to create an opening in the patient's vein through which the tip of the catheter is inserted. The tapered inner surface ensures a tight seal between the inner surface of the catheter and the outer surface of the needle. Following placement of the catheter, the introducer needle is removed.
    [015] In some implementations, a peripheral catheter is provided comprising a catheter body having an outer surface, a proximal end, a distal end, a lumen extending between the distal and proximal ends, and a distal lumen opening, the catheter further including a recess formed in the outer surface of the catheter body. In some implementations, a diffusion orifice is positioned further into the recess through the wall of the catheter body. This prevents the diffusion hole recess site from coming into direct contact with the patient's skin or other tissues during catheter insertion. Consequently, the diffusion orifice is prevented from sticking to the patient's skin or tissues.
    [016] In some implementations, a method of manufacturing a vented, grip-resistant catheter is provided, wherein the method includes the steps of providing a catheter body having an outer surface, a proximal end, a distal end, a lumen and extending between the proximal and distal ends, and a lumen opening. The method further includes the steps of providing a recess in the outer surface of the catheter body, and further providing a diffusion orifice in the recess through the wall of the catheter body. This prevents the diffusion hole recess site from coming into direct contact with the patient's skin or other tissues during catheter insertion. Consequently, the diffusion orifice is prevented from sticking to the patient's skin or tissues.
    [017] Furthermore, in some implementations, a peripheral catheter is provided comprising a catheter body having a predetermined wall thickness, the catheter body member having a proximal end, a distal end, a lumen extending between the ends. distal and proximal, and a distal lumen opening, the catheter body further having a shortened length to access a patient's peripheral vein. In some implementations, the peripheral catheter further comprises a recess formed in the outer surface of the catheter body, wherein a hole is provided within the recess through the predetermined wall and in communication with the lumen. This prevents the diffusion hole recess site from coming into direct contact with the patient's skin or other tissues during catheter insertion. Consequently, the diffusion orifice is prevented from sticking to the patient's skin or tissues.
    [018] The present invention further includes methods for fabricating an intravenous catheter for administering an infusion. Some methods include the steps of providing an IV catheter and forming a plurality of staggered holes throughout the wall of the IV catheter. Some methods of the present invention further include using a laser probe to provide the various staggered holes. Furthermore, some methods of the present invention include extrusion and co-extrusion processes to provide the catheter body and various other features discussed in detail below. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
    [019] In order that the manner in which the above stated features and other features and advantages of the invention are obtained will be readily understood, a more particular description of the invention briefly described above will be presented with reference to specific embodiments thereof which are illustrated in the accompanying drawings . These drawings represent only typical embodiments of the invention and are therefore not to be considered as limiting the scope of the invention.
    [020] Figure 1 is a perspective view of an infusion system according to a representative embodiment of the present invention.
    [021] Figure 2 is a detailed perspective view of a catheter according to a representative embodiment of the present invention.
    [022] Figure 3 is a perspective view of a catheter tip according to a representative embodiment of the present invention.
    [023] Figure 4 is a side sectional view of the catheter tip according to a representative embodiment of the present invention.
    [024] Figure 5 is a side sectional view of the catheter tip during catheterization according to a representative embodiment of the present invention.
    [025] Figure 6A is an end sectional view of a catheter tip during catheterization according to a representative embodiment of the present invention.
    [026] Figure 6B is an end sectional view of a catheter tip during catheterization, the catheter tip incorporating a hardening material according to a representative embodiment of the present invention.
    [027] Figure 7 is a detailed sectional end view of a catheter tip having a flow interruption feature according to a representative embodiment of the present invention.
    [028] Figure 8 is a perspective view of a catheter tip according to a representative embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION
    [029] Embodiments of the present invention will be better understood with reference to the drawings, in which like reference numerals indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generically described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the more detailed description below, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of currently preferred embodiments of the invention.
    [030] The systems and methods of the present invention are generally designed for use in combination with a vascular infusion system capable of rapidly delivering an infusion to a patient's vascular system. Referring now to Figure 1, a vascular infusion system 100 is shown, in accordance with a representative embodiment of the present invention. Infusion systems of this type are commonly configured to operate at internal pressures up to 2000 psi. Many systems operate in the 75 to 2000 psi range, while specific devices of this type operate at 100, 200, and 300 psi. Vascular infusion system 100 comprises a vascular access device 112 coupled to an injection pump 120 by a spiral extension assembly 130. In some embodiments, infusion system 100 further comprises a safety device 140 positioned between the device. access port 112 and injection pump 120. In some embodiments, a safety device 140 is provided to close the fluid path of infusion system 100, thereby preventing excessive pressure buildup in the downstream infusion components.
    [031] An injection pump 120 generally comprises an apparatus for pumping fluid configured to rapidly deliver an infusion, such as blood, medications, and agents for CT scanning contrast into a patient's vascular system. Desirable infusions may also include various fluids often with high viscosity as required for medical and diagnostic procedures. In some embodiments, the injection pump 120 comprises a reinforced injector capable of delivering an infusion to a patient at flow rates from about 10 ml/hour to about 1200 ml/minute. In some embodiments, a high infusion flow rate is desirable for medical procedures that require increased bolus density of an infusion into a patient's vascular system. For example, a trend in diagnostic imaging procedures is to use contrast media enhancement, which requires more viscous contrast media to be inserted into a patient at a higher flow rate, thus resulting in higher image quality. Thus, in some embodiments an injection pump 120 and a vascular access device 112 are selected to matchably achieve a desired infusion flow rate.
    [032] A spiral extension assembly 130 generally comprises flexible or semi-flexible polymer tubing configured to deliver an infusion from the injection pump 120 to the vascular access device 112. The extension assembly 130 includes a first coupler 132 for connecting the extension assembly 130 to a downstream device 112 or 140. Extension assembly 130 also includes a second coupler 134 for connecting extension assembly 130 to an injection pump 120. A spiral configuration of extension assembly 130 generally prevents entanglement or undesirable closure of assembly 130 during infusion procedures. However, one skilled in the art will appreciate that the extension assembly 130 can include any configuration capable of efficiently delivering an infusion from an injection pump 120 to the patient through a vascular access device 112. extension 130 is coupled between a syringe and a vascular access device and thus an infusion is manually injected into a patient. In other embodiments, the infusion system comprises only a syringe and a device for vascular access, in accordance with the present invention.
    [033] The vascular access device 112 generally comprises a peripheral intravenous catheter 114. A peripheral intravenous catheter 114 according to the present invention generally comprises a short or shortened catheter (usually from 13mm to 52mm) that is inserted into a small peripheral vein. These catheters generally comprise a diameter approximately equal to that of a 14 gauge or smaller catheter. Peripheral intravenous catheters 114 are typically designed for temporary placement. The short length of catheter 114 facilitates convenient placement of the catheter, but makes them prone to premature dislodgement of the vein due to patient movement and/or recoil forces experienced during infusion procedures. Furthermore, unlike midline or central peripheral catheters, peripheral intravenous catheters 114 in accordance with the present invention comprise a tapered catheter tip 146 to accommodate use with an introducer needle (not shown) designed to aid insertion of the catheter 114.
    [034] An introducer needle is typically inserted through the catheter 114 so that one tip of the needle extends beyond the tapered tip 146. The tapered geometry of the tapered tip 146 conforms tightly to the outer surface of the introducer needle. Both the outer surface and inner surface of tip 146 are tapered toward the distal end of catheter 114. The outer surface of tip 146 is tapered to provide a smooth transition from the smaller profile of the introducer needle to the larger profile of the outer diameter of the catheter . Insertion of the introducer needle into the patient's vein provides an opening into the vein through which the tapered tip 146 of catheter 114 is inserted. The tapered outer surface of tip 146 allows easy insertion of catheter 114 into the opening. Once the peripheral intravenous catheter 114 is inserted into the patient's vein, the introducer needle (not shown) is removed from the lumen of the catheter 114 to allow infusion through the catheter 114.
    [035] The desired infusion is typically sent to catheter 114 by a section of intravenous tubing 116 coupled to catheter 114. In some embodiments, a Y-adapter 118 is coupled to an end of tubing 116 opposite catheter 114, enabling the device of vascular access 112 be coupled to the remainder of the vascular infusion system 100. The skilled person will notice the possible variations and specific characteristics of the devices available for vascular access 112, as they are commonly used in the medical and research professions. For example, in some embodiments a catheter 114 in accordance with the present invention may include additional access sites, clamps, parallel intravenous lines, valves, couplers, introducer needles, coatings and/or materials as desired to fit a specific application.
    [036] Referring now to Figure 2, a catheter 214 is shown in accordance with a representative embodiment of the present invention. Catheter 214 generally comprises a catheter adapter 218 configured to accommodate a tubular body member 220. Catheter adapter 218 further includes an inlet passage 230 that is coupled to an intravenous tubing section 216. The intravenous tubing section 216 it is further coupled to upstream-administered components as shown and described with respect to Figure 1 above.
    [037] Catheter adapter 218 facilitates sending an infusion within intravenous tubing 216 to a patient through tubular body member 220. An inner lumen of catheter adapter 218 is in fluid communication with an inner lumen of intravenous tubing 216 and with an inner lumen of tubular body member 220. In some embodiments, catheter adapter 218 further comprises an access passage 222. Access passage 222 is generally provided to allow direct access to the inner lumen of catheter adapter 218. In some embodiments, access passage 222 is accessed by a needle and syringe to deliver an infusion to a patient via tubular body member 220. In other embodiments, an introducer needle or lead wire is inserted into the access passage. 222 and advances through the inner lumen 222 of the tubular body member 220. In some embodiments, a tip portion of the introducer needle or lead wire (not shown) extends beyond a tip portion 240 of the tubular body member 220. As such, the tip portion of the introducer needle or lead wire may provide an opening into a patient's vascular system into which the tubular body member 220 is inserted. Following placement of the tubular body member 220 into the patient's vein, the introducer needle or lead wire is removed from the access passage 222 thereby establishing fluid communication between the tubular body member 220, the catheter adapter 218. and the intravenous tubing 216.
    [038] In some embodiments, the tubular body member 220 comprises an intravenous catheter. Intravenous catheter 220 generally comprises a flexible or semi-flexible biocompatible material as commonly used in the art. In some embodiments, intravenous catheter 220 comprises a polymer material, such as polypropylene, polystyrene, polyvinyl chloride, polytetrafluoroethylene, and the like. In other embodiments, intravenous catheter 220 comprises a metallic material, such as surgical steel, titanium, cobalt steel, and the like.
    [039] The tubular body member 220 can comprise any length, where the length is selected based on the application for which the catheter 214 is intended. In some applications, the tubular body member 220 is inserted into a peripheral vein of the patient . In other applications, tubular body member 220 is inserted into a central vein of the patient. In some embodiments, the tip portion 240 of the tubular body member 220 is modified to include a recess 248 formed in the wall of the tubular body member 220, as shown in Figures 2 and 3.
    [040] Still referring to Figures 2 and 3, recess 248 generally comprises a small concavity defined by adjacent side walls or chamfered surfaces 249. In some embodiments recess 248 further comprises a diffusion orifice 250 to facilitate rapid infusion applications . Diffusion port 250 is generally provided to divert fluid from the main flow channel through the inner lumen of tubular body member 220. As such, diffusion port 250 effectively slows the jet of infusion exiting the catheter tip. 240 during rapid infusion procedures. In addition, diffusion port 250 enlarges the accumulation area of catheter tip opening 242 to relieve pressure as a whole in vascular infusion system 100. In some embodiments, diffusion port 250 comprises one or more lateral ports that meet the requirements of International Standard ISO 10555-2, section 4.4.3.
    [041] In some embodiments, tubular body member 220 further comprises a plurality of recesses as shown in Figure 4. For example, in some embodiments tubular body member 220 comprises a second recess 258 positioned opposite recess 248. second recess 258 further comprises a second diffusion orifice 251 positioned opposite diffusion orifice 250. In some embodiments, a plurality of recesses and diffusion orifices are provided in adjacent annular circles along the length of the tubular body member 220. In other embodiments, the plurality of recesses and diffusion holes are provided in a staggered pattern of adjacent annular circles along the length of the tubular body member 220. Thus, a recess and an upstream diffusion hole are not aligned with relationship to an adjacent recess and diffusion hole downstream.
    [042] Recesses 248 and 258 are generally provided by fabrication methods known in the art. For example, in some embodiments recesses 248 and 258 are provided through an extrusion process. In other embodiments, recesses 248 and 258 are provided through an engraving process, such as laser engraving. Furthermore, diffusion holes 250 and 251 are generally provided by methods known in the art. For example, in some embodiments the plurality of diffusion holes 250 and 251 are provided with a laser probe.
    [043] In some embodiments, the recesses 248 and 258 are symmetrically positioned in the tubular body member 220 so as to prevent the tip of the catheter 240 from being displaced due to lateral forces caused by an infusion that is exiting the diffusion holes 250 and 251. For example, in some embodiments, a tubular body member 220 is provided having three recesses, each recess comprising a diffusion hole radially spaced approximately 120° from an adjacent diffusion hole. In another example, some embodiments comprise a tubular body member 220 having more than three recesses and more than three diffusion holes.
    [044] Alternatively, in some embodiments the tubular body member 220 is modified to include a plurality of axial protrusions 266 formed on the outer surface of the tubular body member 220 by extrusion or some other heat forming method. Diffusion holes 250 and 251 can be placed between axial bosses 266 as shown. During catheterization (i.e., insertion of the tubular body 220 into a patient's vascular system), axial ridges 266 lift the skin and other tissue above the diffusion holes 250 and 251 thereby preventing tissue from gripping the diffusion holes, as discussed Next.
    [045] In some embodiments, diffusion holes 250 and 251 are formed through the catheter wall 260 so that an inner surface 252 of each hole is oriented at an angle 262 that is oblique to an inner surface 272 of the catheter lumen 270 In some embodiments, the angle 262 is between about 15° and about 75°. In other embodiments, the angle 262 is approximately 45°. Also, in some embodiments the angle 262 is approximately 90° with respect to the inner surface 252.
    [046] In some embodiments, the 262 hole angle further affects the placement of the catheter within the patient's vein. For example, when inserted into a vein, the venous catheter usually extends through the skin and into the vein at approximately 30°. Therefore, the tip of the venous catheter commonly contacts or rests on the inner wall of the vein opposite the catheter insertion site. As fluid flow increases, a high jet velocity from the tip of the catheter is exerted directly on the inner wall of the vein. However, when the venous catheter tip is modified to include diffusion holes, the deflected infusion exiting the diffusion holes pushes the catheter tip away from the vein wall resulting in a centered position of the catheter tip within the vein . Thus, the jet velocity from the tip is directed into the vein fluid stream and not into the vein wall. Consequently, in some embodiments the hole angle 262 of the diffusion holes 250 and 251 is selected to achieve optimal centered positioning of the catheter tip 240 within the patient's vasculature during infusion procedures.
    [047] Referring now to Figure 5, a distal end portion 242 of venous catheter 214 is shown, in accordance with a representative embodiment of the present invention. As discussed above, in some embodiments an outer surface of catheter tip 240 is tapered to provide a gradual transition from catheter opening 242 of tip 240 to the diameter of tubular body 220. Also, in some embodiments, the outer surface of the catheter tip 240 is tapered to provide a gradual transition from the outside diameter of an introducer needle 300 to the diameter of the tubular body 220, as shown.
    [048] In some embodiments, the venous catheter 214 comprises an over-the-needle catheter. Thus, in some embodiments an opening 320 is provided within the patient's skin 302 or other tissue by an introducer needle 300 housed within catheter lumen 270. In some embodiments, a tip 310 of introducer needle 300 is positioned externally to the catheter lumen. 270 to provide an exposed cutting surface through which an opening 320 into the patient's vasculature is provided. Upon advancement of the venous catheter within the patient, the tapered configuration of the tubular body 220 allows for easy passage of the tip of the catheter 240 into the opening 320.
    [049] As shown, the axial protrusions 266 lift the patient's skin 302 or other tissues away from the diffusion holes 250 and 251 during catheterization. Alternatively, recesses 248 and 258 position diffusion holes 250 and 251 away from opening 320 thereby avoiding unwanted contact or grip between diffusion holes and opening 320. Thus, in some embodiments axial bosses 266 and/or recesses 248 and 258 increase the grip resistance of the tip of the catheter 240, as shown in Figure 6A.
    [050] In some modalities, the inclusion of diffusion holes at or near the tip of a short catheter can result in a reduction in the resistance to warping for the catheter, thus making the catheter more susceptible to breakage during catheterization. Consequently, in some embodiments the axial protrusions 266 further increase the stiffness with respect to bending and warping of the catheter tip 240, thereby minimizing the risk of the catheter tip breaking or buckling during insertion. Someone of average skill in the art will therefore realize and recognize that the hardening effect of the axial protrusions 266 can be achieved by any number of structural modifications in which the thickness and/or stiffness of the catheter wall 260 between the diffusion holes 250 and 251 is augmented to resist compression and/or shear forces during insertion.
    [051] For example, in some embodiments the stiffness of the wall of catheter 260 positioned between diffusion holes 250 and 251 is increased by adding a stiffening material 290, as shown in Figure 6B. In some embodiments, the hardening material comprises a rigid or semi-rigid radiopaque material, such as a wire or an extruded filler material that can include a chemical salt of bismuth or barium, or an element such as platinum or tungsten. In some embodiments the hardening material 290 comprises barium sulfate. In other embodiments, the stiffening material 290 comprises a polymer material having an increased density compared to the polymer material remaining from the venous catheter 214. In some embodiments, the venous catheter 214 and the stiffening material 290 are co-extruded, in that the stiffening material 290 is embedded within the wall of the tubular body member 220. In other embodiments, the stiffening material 290 is applied directly to the outer surface of the tubular body member 220, thereby forming axial protrusions 266.
    [052] Referring now to Figure 7, in some embodiments sidewalls 249 further comprise a flow breaking feature 280. A "flow breaking feature" refers to a diffusion orifice feature 250 and/or a physical feature adjacent to the diffusion orifice 250 which substantially breaks, thins, or slows down an infusion jet exiting the diffusion orifice 250 so that the jet will lose velocity more rapidly within the vein.
    [053] Figures 2-7 generally represent circular diffusion holes. However, in some embodiments one or more diffusion holes may not be circular. For example, in some embodiments the flux breaking feature 280 may include a flux disruptor, elongated diffusion orifice geometries, and diffusion orifice orientations such that the geometric axis of flow of two or more diffusion orifices collide. In some embodiments, flux breaking feature 280 is a flux disruptor comprising an inward projection that contacts the infusion jet exiting diffusion orifice 250. In other embodiments, flux breaking feature 280 is a disruptor that includes a pointed extension. Also, in some embodiments, feature 280 comprises a plurality of inward projections. An "inward projection" refers to a portion of a diffusion hole periphery that projects toward the inner portion of the diffusion hole.
    [054] In some embodiments, a single diffusion orifice includes more than one flow-break feature. Examples of flow-breaking features are described here, including at least inward projections, wedge-shaped extensions, an elongated diffusion hole geometry, and diffusion hole geometry axis orientations that result in collisions with other jets of fluid . For example, in some embodiments, a diffusion orifice includes an inward projection and has a geometric axis orientation that collides with that of another orifice. Furthermore, in some embodiments the diffusion orifice further includes a wedge-shaped extension. In other embodiments, other combinations of flow-breaking features are combined to provide a more effective, less harmful, catheter diffusion port configuration and diffusion port arrangement.
    [055] From what has been seen, it will be noted that one or more flow-breaking features may be included in one or more catheter diffusion holes in a catheter tip. Flow breaking features can virtually break, thin, or slow down a jet of fluid exiting a diffusion orifice so that the jet will lose speed more quickly within the shaft and cause less damage to the vessel walls. . In particular, the flow-breaking features are particularly advantageous when used in rapid infusion therapy that uses high infusion speeds to rapidly introduce a bolus of fluid into a patient through the tip of the catheter. During these procedures, one or more flow-breaking features of a diffusion orifice can increase patient comfort during infusion, decrease patient pain, allow for greater infusion rates, and prevent damage to the vessel.
    [056] Referring now to Figure 8, in some embodiments the recess 288 and the axial protrusions 296 extend along the length of the tubular body 220, thus accommodating a plurality of recessed diffusion holes 298. The infusion coming out of the diffusion holes in recesses 298 will produce an infusion of fluid with less impact energy and which poses less risk to the patient's vessel walls. In some embodiments, recess 288 comprises a non-linear recess thus providing a non-linear alignment of recessed diffusion holes 298. For example, in some embodiments recess 288 comprises a helical recess, wherein recess 288 circumscribes the outer surface of the tubular member 220 helically. In other embodiments, recess 288 comprises a plurality of longitudinal recesses, wherein a portion of each longitudinal recess is surrounded with a protrusion thereby dividing each longitudinal recess into two or more sections.
    [057] The present invention can be incorporated into other specific forms without departing from its structures, methods or other essential features as broadly described herein and claimed below. The modalities described are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims and not by the description given. Any changes that may be inserted in the meaning and equivalence range of the claims must be accepted as being within its scope.
    权利要求:
    Claims (15)
    [0001]
    1. A vascular infusion system (100), comprising: a vascular access device (112) configured to be coupled to an injection pump (120), the vascular access device (112) comprising a catheter (214), the catheter ( 214) comprising a catheter adapter (218) that couples to the injection pump (120) and a tubular body member (220) extending from the catheter adapter (218), the tubular body member (220) having an outer surface, a proximal end, a distal end, a lumen (270) extending between the proximal and distal ends, a tapered tip (240) at the distal end, and a distal lumen opening (242), the adapter a catheter (218) further comprising an introducer needle (300) that is contained within the lumen (270) and extends distally from the distal lumen opening (242) of the tubular body member (220); CHARACTERIZED in that the tubular body member (220) comprises: a recess (248, 258, 288) formed in the outer surface, the recess (248, 258, 288) comprising opposing side walls (249) and a surface, the recess (248, 258, 288) extending along the tapered tip (240) of the tubular body member (220) in a direction parallel to the length of the tubular body member (220); and a hole (250, 251, 298) positioned in the recess (248, 258, 288), the hole (250, 251, 298) being formed in the surface through a wall thickness (260) of the tubular body member (220). ) and in fluid communication with the lumen (270).
    [0002]
    2. Vascular infusion system (100), according to claim 1, CHARACTERIZED by the fact that the orifice (250, 251, 298) comprises a plurality of orifices.
    [0003]
    3. Vascular infusion system (100), according to claim 1, CHARACTERIZED by the fact that it further comprises a plurality of recesses, in which each of the recesses comprises at least one orifice.
    [0004]
    4. Vascular infusion system (100) according to claim 1, CHARACTERIZED in that the tapered tip (240) is tapered from an outer diameter of the introducer needle (300) to an outer diameter of the tubular body member (220).
    [0005]
    5. Vascular infusion system (100), according to claim 4, CHARACTERIZED by the fact that it further comprises a flow-break feature (280) positioned on one or both side walls (249).
    [0006]
    6. Vascular infusion system (100), according to claim 5, CHARACTERIZED by the fact that the flow break feature (280) includes a flow disruptor.
    [0007]
    7. Vascular infusion system (100), according to claim 6, CHARACTERIZED by the fact that the flow disruptor is an inward projection.
    [0008]
    8. Vascular infusion system (100) according to claim 1, CHARACTERIZED by the fact that a hole angle (262) of the orifice (250, 251, 298) is oblique to an inner wall surface of the lumen (270 ).
    [0009]
    9. Vascular infusion system (100) according to claim 1, CHARACTERIZED by the fact that the tubular body member (220) further comprises a stiffening material (290) embedded within the wall thickness (260) of the member of tubular body (220).
    [0010]
    10. Vascular infusion system (100) according to claim 9, CHARACTERIZED by the fact that the hardening material (290) comprises a plurality of strips of hardening material (290) that are spaced within and extend along the length of the tapered tip (240).
    [0011]
    11. Vascular infusion system (100), according to claim 10, CHARACTERIZED by the fact that the hardening material (290) comprises a radiopaque material.
    [0012]
    12. Vascular infusion system (100), according to claim 1, CHARACTERIZED by the fact that it further comprises a flow-break feature (280) that is positioned adjacent to the orifice (250, 251, 298).
    [0013]
    13. Vascular infusion system (100) according to claim 12, CHARACTERIZED by the fact that the flow breaking feature (280) comprises a circular protrusion that extends around the orifice (250, 251, 298).
    [0014]
    14. Vascular infusion system (100) according to claim 3, CHARACTERIZED by the fact that the plurality of recesses comprises two recesses positioned on opposite sides of the tubular body member (220), and the at least one hole in one The recess and the at least one hole in the other recess are symmetrically positioned so that when the infusion is injected through the holes, the forces generated by the infusion leaving each hole are balanced.
    [0015]
    15. Vascular infusion system (100) according to claim 1, CHARACTERIZED by the fact that the catheter adapter (218) includes an access passage (222) through which the lumen (270) of the tubular body member (220) is accessible.
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    同族专利:
    公开号 | 公开日
    MX2014002354A|2014-04-14|
    MX345309B|2017-01-25|
    IN2014DN02041A|2015-05-15|
    US9402975B2|2016-08-02|
    CA2846081A1|2013-03-07|
    CN103857435B|2017-11-17|
    EP2750750A1|2014-07-09|
    CN103857435A|2014-06-11|
    AU2012301509A1|2014-03-13|
    WO2013032647A1|2013-03-07|
    BR112014004842A2|2017-04-04|
    US10478592B2|2019-11-19|
    JP2014525319A|2014-09-29|
    JP6581775B2|2019-09-25|
    ES2872274T3|2021-11-02|
    EP2750750B1|2021-03-24|
    CA2846081C|2019-02-19|
    CN202822420U|2013-03-27|
    US20130053826A1|2013-02-28|
    US20160354577A1|2016-12-08|
    NZ621752A|2016-07-29|
    AU2012301509B2|2016-09-08|
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-09-15| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2021-02-17| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-05-04| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/08/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/233,178|2011-08-31|
    US13/223,178|US9402975B2|2011-08-31|2011-08-31|Systems and methods to increase rigidity and snag-resistance of catheter tip|
    PCT/US2012/049859|WO2013032647A1|2011-08-31|2012-08-07|Systems and methods to increase rigidity and snag-resistance of catheter tip|
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