• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    catheter with a pressure-activated divisible feature. a catheter (114, 214, 314, 414) is shown having a catheter body (220, 320, 420) with a lumen (322, 422) and a distal opening of the lumen (242, 342,442). the lumen of the catheter extends through the body of the catheter along a longitudinal axis of the body of the catheter. a divisible feature (250, 350, 450) is formed within a wall of the catheter body.
    公开号:BR112014004322B1
    申请号:R112014004322-1
    申请日:2012-08-07
    公开日:2021-02-23
    发明作者:William G. Moulton；Justin G. Hortin；Jeffrey R. Mcmurray
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    Background
    [001] Vascular access devices are used for fluid communication with a patient's anatomy. For example, vascular access devices, such as catheters, are typically used for infusing fluid, such as saline, various medications, and / or total parenteral nutrition, to a patient, drawing blood from a patient, and / or control of various parameters of the patient's vascular system.
    [002] A number of clinical circumstances, including extensive trauma, major surgical procedures, massive burns, and some disease states, such as pancreatitis and diabetic ketoacidosis, can produce a profound depletion of the circulatory volume. This depletion can be caused by loss of real blood or an imbalance of internal fluids. In these clinical settings, it may be necessary to infuse blood and / or other fluids quickly to a patient to avoid serious consequences.
    [003] In addition, the ability to inject large amounts of fluid quickly may be desirable for some other medical and diagnostic procedures. For example, some diagnostic imaging procedures use improved contrast media to improve the perceptibility of the lesion in an effort to increase the early diagnostic procedure. These procedures require viscous contrast media to be injected by a specialized "energy injector" pump intravenously at very high flow rates, which establish a contrast bolus or small contrast media buffer in the patient's bloodstream, which results in the best image quality.
    [004] Energy injection procedures generate high pressures within the infusion system, thus requiring some specialized vascular access devices, extension sets, media transfer sets, pump syringes and bulk syringes or contrast media filled. As the concentration (and therefore the viscosity) and infusion rate of the contrast medium are increased, the bolus density also increases, resulting in better image quality through attenuation computed tomography (CT). Therefore, a current trend in healthcare is to increase the density of the contrast medium bolus, increasing both the concentration of the contrast medium and the rate at which the medium is infused into the patient, all of which, ultimately, drive the highest system pressure requirements.
    [005] Intravenous infusion rates can be set, either as a routine, usually up to 999 cubic centimeters per hour (cm3 / h), or quickly, usually between about 999 cm3 / hour and 90,000 cm3 / hour (1.5 liters per minute) or a higher rate. For some diagnostic procedures that use viscous contrast media, an injection rate of about 1 to 10 mL / second is necessary in order to guarantee a sufficient bolus concentration. Injections of viscous medium energy at this injection rate produce significant back pressure within the infusion system, which generally results in a failure of the components of the infusion system.
    [006] Traditionally, rapid infusion therapy involves the use of an intravenous catheter connected to a pump, such as a peristaltic pump, and a fluid source. A patient is administered with an infusion as a tip portion of the catheter is inserted into the patient's vasculature and the pump forces fluid through the catheter into the patient's vein. Current rapid infusion therapies use a catheter and catheter tip with geometries identical to those used with traditional routine infusion rates. These geometries can include a tapered catheter tip, so that the fluid is accelerated when the fluid travels through the catheter tip, entering a patient's vasculature. This acceleration of the infusion fluid is undesirable for several reasons.
    [007] For example, the tapered catheter results in greater back pressure for the rest of the catheter set. This effect is undesirable due to the limitations of the pumping capacity of the infusion pump, as well as the limited structural integrity of components and subcomponents of the infusion system. For example, if the back pressure becomes too large, the efficiency of the pump may decrease and certain seals or connections inside the infusion system may fail. In addition, the acceleration of the fluid at the tip of the catheter results in a repulsion force that can cause the tip of the catheter to move within the patient's vein, thereby displacing the catheter and / or damaging the patient's vein and / or the location of the catheter. injection. The acceleration of the fluid also increases the jet speed of the infusion solution at the tip of the catheter. In some procedures, the jet of fluid can pierce the patient's vein wall, thereby leading to leakage or infiltration. This fact is not only uncomfortable and painful for the patient, but infiltration can prevent the patient from receiving the necessary therapy.
    [008] In order to overcome undesirable backpressures and increased acceleration of infused fluids, some intravenous systems include arrays of diffusion orifices provided around the tip portion of the intravenous catheter. In general, the diffusion holes increase the surface area of the opening of the catheter tip, thereby decreasing the pressure of the fluid in the opening of the catheter tip. However, the addition of diffusion holes at or near the tip of a catheter also reduces the resistance to deformation of the catheter, making the tip of the catheter more susceptible to crushing during insertion. As a result, adding holes in the diffuser can result in catheterization failure and physical pain for the patient. In addition, the addition of holes in the diffuser provides the catheter with a discontinuous external surface that can hinder or trap the opening of the patient's skin and / or vein through which the catheter is inserted. This can also result in catheterization failure, physical pain and / or physical damage to the patient.
    [009] Thus, although currently existing methods and systems for reducing the rate of outflow of an infusion liquid during rapid infusion procedures, the challenges still persist. Therefore, it would be an improvement in the art to increase or even replace current techniques with other techniques. Summary of the invention
    [010] The systems and methods of this 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, these systems, components and methods are developed to provide safer and more efficient procedures for rapid infusion.
    [011] One aspect of the invention provides an improved vascular access device for use in combination with a vascular perfusion system capable of rapidly providing an infusion solution to a patient's vascular system. Some embodiments of the invention can be configured as follows. The vascular access device may include an intravenous catheter configured to access a patient's vascular system. The intravenous catheter may have a lumen that extends through it along a longitudinal axis, for an opening of the distal lumen. The tip portion may include a tapered portion, where the outer and inner surface of the tip tapers towards the distal end of the catheter. The tapered part of the intravenous catheter can be modified to include a separable feature formed through a wall of the catheter body, in that because the lumen of the catheter is subjected to an increase in fluid pressure, the separable feature is activated, thereby increasing , the effective area of the distal opening of the catheter.
    [012] In another aspect of the invention, a catheter has a catheter body, which has a lumen and a distal opening of the lumen. The lumen can extend through the catheter body along a longitudinal axis of the catheter body to the distal opening of the lumen. The catheter may also have a separable function formed through a distal tapered portion of the catheter body. In some implementations, the separable feature is a line of drill holes. In other implementations, the divisible feature is a dividing line.
    [013] In yet another aspect of the invention, a peripheral catheter includes a catheter body that has a lumen and a distal opening of the lumen. The lumen extends through the catheter body along a longitudinal axis of the catheter body. In some implementations of the present invention, the catheter body is sufficiently truncated to access a patient's peripheral vein, and the catheter body is less than or equal to a fourteen gauge catheter. A separable feature is formed through a distal tapered part of the catheter body.
    [014] In addition, in some implementations of the present invention, a method is provided for manufacturing a catheter that has a divisible characteristic. The steps of the method include providing a catheter body provided with an outer surface, an inner surface, a proximal end, a distal end, a lumen that extends between the proximal and distal ends along a longitudinal axis of the catheter body , and a distal opening of the lumen; providing a tip of the catheter, forming a part of the distal end of the tip of the catheter, including the opening of the distal lumen and providing a separable feature formed within a wall of the tip of the catheter. Brief description of the visualization of the drawings
    [015] In order that the manner in which the characteristics described above and other aspects and advantages of the invention are obtained, a more particular description of the invention will be readily briefly described above, with reference to specific embodiments thereof, being illustrated in the drawings attachments. These drawings describe only typical embodiments of the invention and are therefore not considered to limit the scope of the invention.
    [016] Figure 1 is a perspective view of an infusion system according to a representative embodiment of the present invention.
    [017] Figure 2 is a detailed perspective view of a catheter, with slits at its distal end, according to a representative embodiment of the present invention.
    [018] Figure 3 is a perspective view of a slotted catheter tip and an introducing needle that extends through it, according to a representative embodiment of the present invention.
    [019] Figure 4 is an extreme cross-sectional view of a catheter cannula before infusing fluids, according to a representative embodiment of the present invention.
    [020] Figure 5 is a side perspective view of a catheter tip after infusing liquids, according to a representative embodiment of the present invention.
    [021] Figure 6 is an end view of the cross section of the tip of the catheter of Figure 5, according to a representative embodiment of the present invention.
    [022] Figure 7 is a side perspective view of a cannula and catheter before infusing fluids, according to a representative embodiment of the present invention.
    [023] Figure 8 is a cross-sectional view of the tip of the catheter of Figure 7, according to a representative embodiment of the present invention.
    [024] Figure 9 is an end view in cross section of the tip of the catheter of Figure 8, after removal of the cannula and after infusion of fluid according to a representative embodiment of the present invention. Detailed description of the invention
    [025] Embodiments of the present invention will be better understood by reference to the drawings, where equal reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the present figures, can be provided and designed in a wide range of different configurations. Thus, the following more detailed description, as represented by the figures, is not intended to limit the scope of the invention as claimed, on the contrary it is merely representative of the presently preferred embodiments of the invention.
    [026] The systems and methods of the present invention are generally designed for use in combination with a vascular perfusion system capable of rapidly delivering an infusion solution to a patient's vascular system. Referring now to Figure 1, a vascular perfusion system 100 is shown, in accordance with a representative embodiment of the present invention. Infusion systems of this type are generally configured to operate at internal pressures up to (2000 psi) = 13,790 x 103 Pa. Many systems operate in the range (75 to 2000 psi), = 517,125 x 103 Pa at 13,790 x 103 Pa, while specific devices of this type operate at (100, 200 and 300 psi), respectively, 689.5 x103 Pa, 1379 x 103 Pa and 2068.5 x 103 Pa. The vascular perfusion system 100 comprises a vascular access device 112 coupled to an injection pump 120 via a coiled extension 130. In some embodiments, the infusion system 100 further comprises a safety device 140 placed between the vascular access device 112 and the injection pump 120. In some forms of In this embodiment, a safety device 140 is provided to automatically block the fluid path of the infusion system 100, thereby preventing the accumulation of excessive pressure in the components downstream of the infusion.
    [027] An injection pump 120 generally comprises a fluid pumping apparatus configured to rapidly deliver an infusion solution, such as blood, medications, CT scan contrast agents to a patient's vascular system. Desirable infusion solutions may also include various fluids, often of high viscosity as required for medical and diagnostic procedures. In some embodiments, the injection pump 120 comprises a power injector capable of delivering an infusion solution to a patient, with flow rates from about 10 ml / hour to more than 1500 ml / minute. In some embodiments, a high infusion flow rate is desirable for medical procedures, which require bolus density enhancement of an infusion solution in a patient's vascular system. For example, a trend in diagnostic imaging procedures is the use of enhanced contrast media, which requires more viscous contrast media pressed to a patient at a higher flow rate, thus resulting in an increase in image quality. . Thus, in some embodiments, an injection pump 120 and a vascular access device 112 are selected to achieve the compatibility of a desired infusion flow rate.
    [028] The coiled extension set 130 generally comprises a flexible or semi-flexible polymer tubing configured to release an infusion solution from the injection pump 120 to the vascular access device 112. The extension set 130 includes a first coupler to connect the set extension 130 for a downstream device 112 or 140. Extension set 130 also includes a second coupler 134 for connecting extension set 130 to the injection pump 120. The rolled-up configuration of extension set 130 generally prevents unwanted folding or occlusion of the set 130 during the infusion procedures. However, one skilled in the art will appreciate that extension set 130 can include any configuration capable of efficiently delivering an infusion solution from an injection pump 120 to the patient via a vascular access device 112. In some In embodiments, extension set 130 is coupled between a syringe and a vascular access device, whereby an infusion solution is injected manually into a patient. In other embodiments, the infusion system comprises only a syringe and a vascular access device, in accordance with the present invention.
    [029] The vascular access device 112 generally comprises a peripheral intravenous catheter 114. A peripheral intravenous catheter 114 in accordance with the present invention generally comprises a short or truncated catheter (generally 13 mm to 52 mm) that is inserted into a small vein peripheral. Such catheters generally comprise a diameter of about 14 gauge or less. Peripheral intravenous catheters 114 are usually designed for temporary placement. The short duration of the catheter 114 facilitates the convenient placement of the catheter, but makes it prone to premature dislodging from the vein, due to the patient's movement and / or the recoil forces experienced during the infusion procedures. In addition, unlike midline catheters 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 introducing needle (not shown) intended to aid in catheter insertion 114.
    [030] The tapered outer surface of the catheter tip 146 can provide a smooth transition between the narrow diameter of the catheter tip opening and the largest diameter of the catheter tubing. Thus, as the tip 146 of catheter 114 is introduced into a patient's vein, the tapered outer surface 146 facilitates easy insertion of catheter 114 through the access orifice. The tapered inner surface is usually provided for firm contact with the outer surface of an introducing needle, housed within the catheter lumen. The introducing needle is provided in order to create an opening in the patient's vein, through which the tip of the catheter should be inserted. The tapered inner surface ensures a secure seal between the inner surface of the catheter and the outer surface of the needle. After placing the catheter, the introducer needle is removed.
    [031] An introducer needle is typically inserted through catheter 114 such that one end of the needle extends beyond the tapered tip 146. The tapered geometry of the tapered tip 146 conforms firmly to the outer surface of the introducer needle. Both the outer surface and the inner surface of tip 146 are tapered towards the distal end of catheter 114. The outer surface of tip 146 is tapered to provide a smooth transition from the lower profile of the introducer needle to the larger profile of the outer diameter of the catheter. Inserting the introducing needle into the patient's vein provides an opening in the vein through which the tapered tip 146 of catheter 114 is inserted. The tapered outer surface of tip 146 facilitates 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 catheter 114 to allow infusion through catheter 114.
    [032] In some embodiments, an inner surface of tip 146 is tapered to provide a perfect seal between the inner surface of catheter tip 146 and the outer surface of the introducer needle (not shown). In addition, the tapered inner surface of tip 146 causes an acceleration of the infusion solution within the lumen of the catheter, when the infusion solution approaches and flows through the tip of catheter 146. Following an infusion process, the catheter peripheral intravenous 114 is simply removed from the vein and discarded.
    [033] A desired infusion solution is typically delivered to catheter 114 via a segment of intravenous tube 116 attached to catheter 114. In some embodiments, a Y-shaped adapter 118 is attached to one end of tubing 116 as opposed to catheter 114, allowing the vascular access device 112 to be coupled to the remaining part of the vascular perfusion system 100. A person skilled in the art will appreciate the possible variations and specific characteristics of the available vascular access devices 112, which are normally used in the professions medical and research. For example, in some embodiments of a catheter 114 in accordance with the present invention, additional access locations, cuffs, parallel intravenous lines, valves, couplers, introducing needles, linings and / or materials may be included, as desired for adjustment for a specific application.
    [034] Referring now to Figure 2, a catheter 214 is shown according to a representative embodiment of the present invention. Catheter 214 generally comprises a catheter adapter 218 configured to house a tubular body member 220. Catheter adapter 218 further includes an inlet port 230, which is coupled to a segment of intravenous tubing 216. The segment of intravenous tubing 216 it is further linked to the upstream infusion components, as shown and described in connection with Figure 1, above.
    [035] The catheter adapter 218 facilitates the delivery of an infusion solution inside the intravenous tubing 216 to a patient, through the tubular body member 220. An internal lumen of the catheter adapter 218 is in fluid communication with both, a internal lumen of the intravenous tubing 216 and an internal lumen of the tubular body member 220. In some embodiments, the catheter adapter 218 further comprises an access adapter 222. Access adapter 222 is generally provided to allow direct access to the internal lumen of catheter adapter 218. In some embodiments, access adapter 222 can be accessed via a needle and syringe to provide an infusion solution to a patient, through the tubular body member 220. In other forms of embodiment, an introducer needle thread or guide thread is inserted into access adapter 222 and inserted into the inner lumen of the tubular body member 220. In some embodiments, a pa the tip of the introducer needle or guide 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 guide wire can provide an inward opening of the vascular system of a patient in which the tubular body member 220 is inserted. After placing the tubular body member 220 in the patient's vein, the introducer needle or guidewire is removed (o) from the access adapter 222, which thus establishes fluid communication between the tubular body member 220, the catheter adapter 218 and the intravenous tubing 216.
    [036] In some embodiments, the tubular body member 220 is an intravenous catheter (or catheter body). The intravenous catheter 214 generally comprises a biocompatible, flexible or semi-flexible material, as is generally used in the art. In some embodiments, the intravenous catheter 214 comprises a polymeric material, such as polypropylene, polystyrene, polyvinyl chloride, polytetrafluoroethylene, and the like. In other embodiments, the intravenous catheter 214 comprises a metallic material, such as surgical steel, titanium, cobalt steel, and the like.
    [037] The tubular body member 220 can comprise any length, where that length is selected based on the desired application of catheter 214. In some applications, the tubular body member 220 is inserted into a peripheral vein of the patient. In other applications, the tubular body member 220 is inserted into a central patient vein.
    [038] For rapid infusion applications, the tip portion 240 of the tubular body member 220 is modified to include a divisible characteristic 250. The divisible characteristic 250 generally allows the tip of catheter 240 to open or detach when a solution of infusion is injected through catheter 214 at high pressure. As such, the inner and outer tapered surface geometries of the tip of the catheter 240 are expanded, thereby eliminating any geometric constraint that would otherwise increase the speed of the flow out of the distal opening 242 of the lumen of the tubular body member. Thus, for some embodiments, the force required to open the separable feature 250 is less than the force exerted on the tip of catheter 240 by the infusion solution during high pressure infusion procedures.
    [039] In some embodiments, the separable function 250 comprises a closed position, before being inserted into a patient's vascular system, as shown in Figure 2. The closed position of the separable feature 250 allows for the effective insertion of a venous catheter 214, as discussed above. In particular, the closed position ensures a close tolerance maintained between the distal opening 342 and an outer surface of the introducer needle 304, as shown in Figure 3. In this way, the tip of the catheter 340 is able to be easily inserted into the patient's vascular system through an opening provided by the introducing needle. In addition, the absence of large diffusion holes provides a continuous outer surface of the tubular body 320, thereby preventing any obstruction or capture of the tubular body 320 on the patient's skin or other tissues during catheterization. In addition, the absence of large diffusion holes maintains the structural rigidity of the catheter tip 340, thereby preventing any undesirable crushing or rupture of the tip of the catheter 340 during the catheterization procedure.
    [040] With continued reference to figures 3 and 4, in some embodiments, the divisible feature 350 divides the tip of catheter 340 into a plurality of fingers or adjacent segments 343. When shown in the closed position, the plurality of adjacent fingers 343 they are connected via the separable feature 350, thus forming the tip of the closed catheter 340. In some embodiments, the separable function 350 comprises a line of perforating openings or holes interposed between adjacent fingers 343. A space 352 is selected between the proximal and distal openings, in order to facilitate rupture or separation of material from the catheter tip between adjacent proximal and distal openings. Therefore, when subjected to increased pressure within the lumen of the catheter body 322, the divisible resources 350 separate, thus assuming an open position, which forms a plurality of separate, adjacent fingers 343, as shown in the Figures 5 and 6.
    [041] In some embodiments, the divisible features 350 are axially oriented and therefore approximately parallel to a longitudinal axis 305 of the catheter 314. In the open position, the plurality of separate fingers 343 increases the effective area of the distal opening of the catheter 342 by providing a plurality of narrow tapered slits or openings, through which an infusion solution 324 leaves the lumen 322. Once the divisible characteristics 350 have been separated, any geometric or structural compression of the tip 340 is eliminated. As such, the pressures of the internal lumen caused by the infusion solution 324 are reduced and / or eliminated, thus producing a low, laminar flow of the infusion solution 324 through the tubular body 320 and the tip of the catheter 340.
    [042] In some embodiments, the separable feature 450 comprises a plurality of cut lines formed on an internal surface of the tip portion 440 of the tubular body 420 of catheter 414, as shown in Figures 7-9. In some embodiments, the separable feature 450 is provided so as to divide the tip of catheter 440 into a plurality of fingers or adjacent segments 443. When locating the divisible feature 450, on the inner surface of the catheter tip 440, the tip 440 maintains a continuous external surface thus preventing any blocking or locking of the tip of catheter 440 on the patient's skin or tissues, during the insertion of the catheter in the vasculature of the patient. However, in some embodiments, the divisible feature 450 comprises a plurality of cut lines formed on an outer surface of the tip portion 440. In addition, in some embodiments, the separable feature 450 comprises one or more cut lines or lines formed, either on the outer surface, on the inner surface, or on both the outer and inner surfaces of the tip portion 440.
    [043] When in the closed position, as shown in Figures 7 and 8, the plurality of adjacent fingers 443 are connected via a separable feature 450, thus forming the closed catheter tip 440. As such, the separable feature 450 forms a plurality of axially oriented grooves 452, and therefore approximately parallel to a longitudinal axis 405 of catheter 414. In some embodiments, the axial orientation of grooves 452 provides a plurality of axially oriented ribs or splines 454, which facilitate greater flow of laminar fluid from the infusion solution through the lumen of catheter 422. In addition, in some embodiments, grooves 452 provide an increase in the effective inner diameter of catheter tip 440. Each of these characteristics, alone or in combination, reduces the turbulent flow of the infusion solution, thus encouraging laminar flow and increasing the effective flow rate for the infusion solution.
    [044] One end of each groove 452 comprises a thin web of catheter material that has a selected thickness such that the thin web is overcome in response to increased pressure within the lumen of the 422 catheter body during discharge procedures pressure and / or high-speed infusion procedures. When expired, the divisible feature 450 divides the tip of catheter 440 into a plurality of separate, adjacent fingers 443 thereby expanding the effective surface area of distal opening of catheter 442, providing a plurality of tapered slits or extended openings 446, through the which an infusion solution 424 leaves the lumen 422, as shown in Figure 9.
    [045] The separable characteristics of the present invention may include any structure, geometry, mechanical function or other mechanism by which the elimination of a constrictive structure from a tip of the catheter occurs, by expanding the effective area of the opening of the distal end, when exposed to an increase in the internal pressure of the lumen. For example, the divisible characteristics in accordance with the present invention may include non-linear configurations, as described in US patent application Serial No.: 13/053. 495, now incorporated by reference.
    [046] The separable characteristics according to the present invention may include projected points of weakness within the catheter body and / or the catheter tip, which are intended to be nullified in response to the increased pressure of the internal lumen during infusion procedures. In some embodiments, a catheter comprises a single separable feature. In other embodiments, a catheter comprises two or more divisible characteristics. Therefore, when subjected to an increase in the internal pressure of the lumen, some catheters of the present invention provide a single finger, in which a single separable characteristic is overcome, thus forming a single enlarged slit or tapered opening, through which an infusion solution leaves the lumen of the catheter. In other embodiments, when subjected to an increase in the internal lumen pressure, some catheters of the present invention provide two or more adjacent fingers, in which two or more divisible characteristics are overcome, thus forming two or more tapered slits or enlarged openings, through of which an infusion solution leaves the lumen of the catheter.
    [047] In general, the divisible characteristics of the present invention are intended to include sufficient structural integrity to maintain the closed position of the catheter tip during insertion of the catheter into the patient's vasculature. In particular, the divisible characteristics of the present invention are provided, being able to withstand compression forces exerted on the tip of the catheter during insertion into the patient. However, the divisible characteristics of the present invention are additionally designed to be overcome, when exposed to greater internal pressures in the lumen within the tip part of the catheter, under the application of high pressure.
    [048] Catheters comprising divisible characteristics in accordance with the present invention can be provided by any methods known in the art. In some embodiments, the divisible features of the present invention are provided by molding the separable feature into a catheter tube during the tip formation process. For example, divisible characteristics of the present invention can be provided by an injection molding process, using mechanical processes and / or by using a laser. In particular, the desired geometry to make the functionality separable, can be included in a tilt mandrel, an inclined die, or both, as well as inside the central pin, in the mold cavity, or both, used to produce and / or manufacture the catheter device.
    [049] The present invention can be realized in other specific forms without departing from its structures, methods, or other essential characteristics as here described and claimed hereinafter. The described embodiments 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, instead of the preceding description. All changes that fall within the meaning and equivalence range of the claims must fall within its scope.
    权利要求:
    Claims (13)
    [0001]
    1. A vascular access device comprising: a catheter adapter (218) having an access adapter (222), an inlet port (230), and an intravenous tube segment (116) having a first end which is coupled to the port inlet (230) and a second end that is coupled to an adapter, the adapter being configured to connect the catheter adapter (218) to an injection pump (120); a catheter (214) extending from a distal end of the catheter adapter (218), the catheter (214) comprising: a catheter body (320, 420) having an outer surface, an inner surface, a proximal end, a distal end, a lumen extending between the proximal and distal ends, along a longitudinal axis of the catheter body, and an opening of the distal lumen (342, 442), the lumen of the catheter body being in fluid communication with the access adapter (222) and the inlet port of the catheter adapter (218), a catheter tip (340, 440) forming a part of the distal end, the catheter tip including the distal opening of the lumen; CHARACTERIZED by the fact that a divisible feature (350, 450) is formed within a wall of the tip of the catheter, the divisible feature (350, 450) comprising a plurality of cut lines formed along an internal surface of the wall, each one of the plurality of cut lines extending sufficiently on the inner surface of the wall so that when fluid is injected by the pump (120) through the lumen while the catheter tip (340, 440) is inserted into a patient's vasculature, the pressure applied on the internal surface by the fluid causes the cut lines to split in order to transform the catheter tip (340, 440) into a plurality of separate fingers (343, 443), and an introducer needle that extends through of the access adapter (222) of the catheter adapter (218) and through the lumen of the catheter, such that a tip of the introducer needle extends through the opening of the distal lumen of the catheter tip (340, 440), an internal diameter d the catheter tip firmly shaped to an outer surface (304) of the introducing needle.
    [0002]
    2. Vascular access device, according to claim 1, CHARACTERIZED by the fact that the divisible characteristic comprises three or more cut lines (450), such that the tip of the catheter is transformed into three or more fingers separated by the pressure applied in the internal surface of the wall by the fluid.
    [0003]
    Vascular access device according to claim 1, CHARACTERIZED by the fact that the divisible feature further comprises one or more cut lines formed along an external wall surface.
    [0004]
    Vascular access device according to claim 1, CHARACTERIZED by the fact that the catheter further comprises one or more axial ribs or grooves (454) formed along the internal surface of the wall.
    [0005]
    5. Vascular access device comprising: a catheter adapter (218) having an access adapter (222), an inlet port (230), and an intravenous tube segment (116) having a first end which is coupled to the port inlet (230) and a second end that is coupled to an adapter, the adapter being configured to connect the catheter adapter (218) to an injection pump (120); a catheter (214) extending from a distal end of the catheter adapter (218), the catheter (214) comprising: a catheter body (320, 420) having an outer surface, an inner surface, a proximal end, a distal end, a lumen extending between the proximal and distal ends, along a longitudinal axis of the catheter body, and an opening of the distal lumen (342, 442), the lumen of the catheter body being in fluid communication with the access adapter (222) and the inlet port of the catheter adapter (218), a catheter tip (340, 440) forming a part of the distal end, the catheter tip including the distal opening of the lumen; CHARACTERIZED by the fact that a divisible characteristic (350, 450) is formed within a wall of the tip of the catheter, the divisible characteristic (350, 450) comprising a plurality of lines of drilling holes, each drilling hole in a line being separated by another drilling hole positioned proximally or distally in the line by a space (352) of material from the catheter tip, the space (352) being configured to separate due to increased pressure applied against an internal surface of the wall by the fluid when the fluid is injected by the pump through the catheter tip while the catheter tip is inserted into a patient's vasculature in order to transform the catheter tip into a plurality of separate fingers, and an introducer needle that extends through the access adapter ( 222) of the catheter adapter (218) and through the lumen of the catheter, such that a tip of the introducer needle extends through the opening of the distal lumen of the tip ateter (340, 440), an internal diameter of the catheter tip firmly shaped to an external surface (304) of the introducer needle.
    [0006]
    6. Vascular access device, according to claim 5, CHARACTERIZED by the fact that the divisible characteristic (350, 450) comprises three or more lines of perforation holes, such that the tip of the catheter is transformed into three or more separate fingers by the pressure applied to the internal surface of the wall by the fluid.
    [0007]
    7. Vascular access device according to claim 5, CHARACTERIZED by the fact that the divisible characteristic (350, 450) comprises six or more lines of perforation holes such that the catheter tip is transformed into six or more fingers separated by pressure applied to the internal surface of the wall by the fluid.
    [0008]
    Vascular access device according to claim 5, CHARACTERIZED by the fact that the catheter further comprises one or more axial ribs or grooves (454) formed along the internal surface of the wall.
    [0009]
    Vascular access device according to claim 5, CHARACTERIZED by the fact that at least some of the drilling holes extend completely through the wall of the catheter bridge.
    [0010]
    10. A vascular access device comprising: a catheter adapter (218) having an access adapter (222), an inlet port (230), and an intravenous tube segment (116) having a first end which is coupled to the port inlet (230) and a second end that is coupled to an adapter, the adapter being configured to connect the catheter adapter (218) to an injection pump (120); a catheter (214) extending from a distal end of the catheter adapter (218), the catheter (214) comprising: a catheter body (320, 420) having a proximal end, a distal end, a lumen extending from the distal end to the proximal end, and an opening of the distal lumen (342, 442), the catheter body (320, 420) still having a truncated length sufficient to access a patient's peripheral vein, the catheter body having a dimension less than or equal to a fourteen gauge catheter, the lumen of the catheter body being in fluid communication with the access adapter and the inlet port of the catheter adapter, FEATURED by the fact that a divisible feature (350, 450) is formed through a distal tapered portion of the catheter body, the divisible feature (350, 450) comprising a plurality of cut lines extending sufficiently on an inner surface of the distal tapered portion of m Since, when the fluid is injected by the pump (120) through the distal tapered portion while the distal tapered portion is inserted into a patient's vasculature, the pressure applied to the internal surface by the fluid causes the cut lines to split in a way transform the distal tapered portion into a plurality of separate fingers (343, 443), and an introducer needle that extends through the access adapter (222) of the catheter adapter (218) and through the lumen of the catheter, such that a tip of the introducer needle extends through the opening of the distal lumen of the catheter tip (340, 440), an inner diameter of the catheter tip firmly shaped to an outer surface (304) of the introducer needle.
    [0011]
    11. Vascular access device, according to claim 10, CHARACTERIZED by the fact that the divisible characteristic comprises three or more cut lines (450), such that the distal tapered portion is transformed into three or more fingers separated by the pressure applied in the internal surface of the wall by the fluid.
    [0012]
    Vascular access device according to claim 10, CHARACTERIZED by the fact that the divisible feature further comprises one or more cut lines formed along an external surface of the distal tapered portion.
    [0013]
    Vascular access device according to claim 10, CHARACTERIZED by the fact that the catheter further comprises one or more axial ribs or grooves (454) formed along the inner surface of the distal tapered portion.
    类似技术:
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    同族专利:
    公开号 | 公开日
    EP2747828B1|2021-10-06|
    US9056182B2|2015-06-16|
    CA2846079C|2019-04-02|
    CN103842018B|2016-09-14|
    JP2014524333A|2014-09-22|
    AU2012299355B2|2016-09-22|
    CA2846079A1|2013-02-28|
    JP6194311B2|2017-09-06|
    CN202844307U|2013-04-03|
    MX353425B|2018-01-12|
    US20130053825A1|2013-02-28|
    WO2013028348A1|2013-02-28|
    EP2747828A1|2014-07-02|
    NZ621749A|2015-09-25|
    BR112014004322A2|2017-03-28|
    MX2014002139A|2014-03-27|
    AU2012299355A1|2014-03-13|
    CN103842018A|2014-06-04|
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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| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|
    2021-02-02| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-02-23| 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
    US13/216,029|2011-08-23|
    US13/216,029|US9056182B2|2011-08-23|2011-08-23|Catheter having a pressure activated splittable feature|
    PCT/US2012/049858|WO2013028348A1|2011-08-23|2012-08-07|A catheter having a pressure activated splittable feature|
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