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    • 专利摘要:
    CATHETER SET AND PERFORATED SEPTUM VALVE A perforated septum valve is described here. The perforated septum valve includes a septum (50) that is located within a lumen of a body (14). A septum activator (80) is positioned proximal to the septum within the body's lumen. A seal (98) is disposed between an external surface of the septum activator and the body to seal the distal septum activator part with respect to the lumen of the septum activator part proximal to the lumen. One or more vents (100) are arranged between the seal and the body lumen to allow air to pass through, but not blood beyond the seal.
    公开号:BR112013001044B1
    申请号:R112013001044-4
    申请日:2011-03-16
    公开日:2020-11-03
    发明作者:Marty L. Stout
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    Foundations
    [001] Catheters are commonly used for a variety of infusion therapies. For example, catheters are used to infuse fluids, such as a normal saline solution, various medications, and total parenteral nutrition to a patient; drawing blood from a patient or monitoring various parameters of the patient's vascular system. The catheters are typically attached to a catheter adapter that supports the catheter and provides attachment to the IV tube. Generally, after placing the catheter in the patient's vascular system, the catheter adapter can be attached to a fluid source through a section of IV tubing to infuse fluids into the patient.
    [002] In order to check the proper placement of the catheter in the blood vessel, the doctor usually confirms that there is a "return" of blood from the patient's vascular system into a catheter return chamber or catheter adapter. Once the proper placement of the catheter is confirmed, the physician must attach the catheter adapter to a section of the IV tubing, or continue to manually block the vein to prevent unwanted blood exposure. The process of coupling the catheter adapter to the IV tubing section requires the physician to maintain odd pressure in the patient's vein while simultaneously coupling the catheter adapter and the IV tubing. A common, but undesirable, practice is to allow blood to flow temporarily and freely from the catheter adapter while the doctor locates and couples the adapter to the IV tubing before placing the catheter into the patient's vein. While this method can prevent undesirable blood exposure, positive pressure from the IV tubing inside the catheter may not allow for a desirable return and thus reduce the physician's ability to confirm proper catheter placement.
    [003] Accordingly, there is a need in the art for a catheter set that allows controlled and desirable return without the risk of encountering undesirable blood exposure. Such a catheter set is described here. summary
    [004] In order to overcome the limitations discussed above, the present invention relates to a perforated septum valve that provides selective activation of fluid flow through the catheter assembly while minimizing or eliminating blood exposure. Additionally, the catheter placement configuration can be improved with an additional flash chamber that is created by including a seal around the outside of the septum activator. The combination of the perforated septum valve and the seal around the septum activator can provide a longer return period in which the physician can assume that a catheter has been properly placed in a patient's blood vessel.
    [005] In one aspect, a perforated septum valve includes a septum, a septum activator, a seal and one or more ventilations. The septum is arranged within a lumen of a body. A septum activator is disposed near the septum within the body's lumen. A seal is disposed between an external surface of the septum activator and the body. The seal seals the septum activator part away from the seal from the septum activator part near the seal. One or more breaths are arranged between the seal and the body lumen, and one or more breaths, each having a transverse area that allows air to pass, but not blood.
    [006] Some implementations include one or more of the following aspects. The cross-sectional area of each ventilation can be between 6.45 x 10'4 and 1.94 x 10'3 cm2. One or more breaths may include six or more breaths. The seal can surround the septum activator. One or more vents can be formed outside the seal. One or more ventilation can be formed through the seal. One or more breaths can be channels formed in the body. The body can be a catheter adapter and the body lumen can extend through the catheter adapter. The seal may have an outer diameter greater than or equal to an inner diameter of the lumen. The seal may include an elastomeric material. The seal can be arranged around a proximal part of the septum activator.
    [007] In another aspect, a catheter assembly includes a catheter adapter, a septum and a septum activator, a seal, one or more flow restrictors, and one or more ventilations. The catheter adapter has a lumen extending through it. The septum is disposed within the lumen. One or more flow restrictors are disposed between the septum and the catheter adapter. A septum activator is disposed within the lumen close to the septum. A seal is disposed between an external surface of the septum activator and the catheter adapter. The seal seals the septum activator part away from the septum activator part near the seal. One or more vents are arranged on the seal.
    [008] Some implementations include one or more of the following aspects. The one or more vents arranged in the seal can each have a cross-sectional area between 6.45 x 10'4 and 1.94 x 10'3 cm2. One or more flow restrictors include one or more openings, each having a cross-sectional area greater than 1.94 x 10'3 cm2. The volume external to the septum activator between the septum and the seal can form a return chamber. The septum activator may have a substantially tubular shape body with a lumen extending through it. The seal may have an outer diameter greater than or equal to an inner diameter of the lumen at the locations. The seal can be arranged around a proximal part of the septum activator. The seal may include an elastomeric material.
    [009] In another aspect, a catheter assembly includes a catheter adapter, a septum, a septum activator, an annular seal, and one or more ventilations. The catheter adapter has a lumen extending through it. The septum is disposed within the lumen. One or more flow restriction channels are arranged between the septum and the catheter adapter. The cross-sectional area of each of the flow restriction channels is greater than 1.94 x 10-3 cm2. The septum activator is disposed within the lumen close to the septum, the septum activator has a substantially tubular shaped body. An annular seal is disposed between an external surface of the septum activator and an internal surface of the lumen. The seal surrounds a proximal part of the septum activator. One or more vents are arranged between the seal and the body lumen 6.45 x 10'4 and 1.94 x 10'3 cm2. Brief Description of the Various Views of the Drawings
    [010] In order that the form in which the characteristics and advantages recited above and others of the invention are obtained will be readily understood, and a more particular description of the invention described briefly above will be created by reference to the specific modalities of it that are illustrated in the attached drawings. These drawings present only the typical modalities of the invention and, therefore, are not considered to limit the scope of the invention. Figure 1 is a perspective view of a catheter set, according to some modalities; Figure 2 is a perspective view of a catheter assembly following the removal of an introducer needle, according to some modalities; Figure 3 is an exploded sectional view of a catheter assembly, according to some modalities; Figure 4 is a cross-sectional perspective view of another set of catheters before activation of the septum, according to some modalities; Figure 5 is a sectional perspective view of the catheter assembly in Figure 4 after septum activation, according to some modalities; Figure 6 is a cross-sectional perspective view of another set of catheter prior to septum activation, according to some modalities; Figure 7 is a partial perspective view of a seal on a septum activator, according to some modalities; Figure 8 is a perspective view of another septum activator, according to some modalities;
    [011] Figure 9 is a perspective view of a septum, according to some modalities. Detailed Description of the Invention
    [012] The embodiment of the present invention will be better understood by reference to the drawings, where the reference numbers indicate identical elements or similar functionality. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures here, can be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, should not limit the scope of the invention as claimed, but is merely representative of the currently preferred embodiments of the invention.
    [013] With reference now to figure 1, a catheter assembly 10 is illustrated. Catheter assembly 10 generally includes a catheter 12 attached to a distal end 16 of catheter adapter 14. Catheter 12 and catheter adapter 14 are integrally coupled so that an internal lumen of catheter adapter 14 is in fluid communication. with an internal lumen of catheter 12. Catheter 12 generally comprises a biocompatible material having sufficient stiffness to withstand the pressures associated with inserting the catheter into a patient.
    [014] In some embodiments, as shown, catheter 12 is a needle catheter that is made of a flexible or semi-flexible polymeric material and that can be used in combination with a rigid insertion needle 22. The rigid insertion needle 22 allows the insertion of the catheter over a non-rigid needle in a patient. The introducing needle 22 can be coupled to a needle hub 26 which is selectively attached to the proximal end 18 of the catheter adapter 14. The introducing needle 22 is typically inserted through the catheter 12 so that a tip of the needle 22 extends in addition to the tapered tip 20 of catheter 12. Inserting the introducing needle 22 into the patient's vein creates an opening in the vein through which the tapered tip 20 of catheter 12 is inserted. The outer surface of the tapered tip 20 allows for the gradual insertion of catheter 12 into the opening.
    [015] In other embodiments, catheter 12 is not a needle catheter, but comprises a rigid polymeric material such as vinyl. Rigid catheters can include a beveled cut surface that is used to provide an opening in a patient to allow insertion of catheter 12 into the patient's vascular system. Accordingly, in some embodiments, catheter 12 comprises a metallic material such as titanium, stainless steel, nickel, molybdenum, surgical steel, and alloys thereof. In addition, in other embodiments, surgically implanted catheters can also be used in combination with the present invention.
    [016] Catheter 12 can be a peripheral type intravenous catheter that generally comprises a short or truncated catheter for insertion into a small peripheral vein. Such catheters generally comprise a diameter of about a catheter 14 or smaller (on a Stubs scale) and are between about 13 mm to 52 mm in length. Peripheral intravenous catheters are typically designed for temporary placement. The short length of the catheter facilitates convenient placement of the catheter. In other modalities, catheter 12 is an intermediate line or central catheter, which can be longer and used for longer periods of time.
    [017] Referring now to figure 2, once catheter 12 is inserted into the patient's vein, the introduction needle 22 is removed proximally from catheter 12 to supply a fluid conduit through the internal lumen 36 of catheter 12 , which can be connected to a fluid source. In some embodiments, a portion of catheter 12 and / or catheter adapter 14 can be connected to a section of intravenous tubing 40 to further facilitate delivery of a fluid to or removal of a fluid from a patient. In some embodiments, a proximal end 18 of the catheter adapter 14 includes a flange 32. The flange 32 provides a positive surface that can be configured to allow the attachment of an intravenous tubing 40 or patient conduit to the catheter assembly 10. In some embodiments, the flange 32 includes a set of threads 30. The threads 30 are generally provided and configured to receive in a compatible manner a complementary set of threads 44 comprising a part of a male luer or conduit coupler 42. The conduit coupler 42 is generally coupled to a patient end portion 40 of fluid impermeable. In some embodiments, an inner part of the conduit coupler 42 is extended outwardly to provide a probe element 46.
    [018] The probe element 46 can be inserted in a compatible manner within a proximal end 18 of the catheter adapter 14 to activate the septum, thereby opening a fluid path within the catheter adapter 14. In some configurations, afterwards from the insertion of the probe element 46 at the proximal end 22 of the catheter adapter 14, the conduit coupler 42 is interlocked with the coupler 42 and the flange 28 (through the screw sets 30 and 44), such as by rotation. During the interlocking process of the coupler 42 and the flange 28, the probe element 46 is advanced into the lumen 36 of the catheter adapter 14 to an inserted position (as illustrated in figure 6). As shown in figure 5, intravenous tubing 40 is connected to catheter adapter 14, probe element 46 advances into lumen 36 of catheter adapter 14, forcing a septum activator 80 to pierce through septum 50. Perforation septum 50 opens the septum and provides a fluid path through which fluids from intravenous tubing 40 flow through perforated septum 50 and catheter 12 into the patient. The septum perforation process 50 is described in detail below. As will be understood, prior to insertion of the probe element 46, the inner lumen 36 of the catheter adapter 14 is sealed to prevent exposure of the blood through the return.
    [019] Reference will be made to figures 3 and 4. Figure 3 shows an exploded cross-sectional view of a catheter set 10. Figure 4 shows a cross-sectional view of an assembled catheter set 10. The septum activator 80 in figure 4 has an alternative structure to that of figure 3 as explained below. These figures, together with figure 6, present the modalities of the perforated septum valves, which include a septum having a cut that is opened and closed by the advance and retraction of a probe-type septum activator.
    [020] As illustrated, in some embodiments, a septum 50 is positioned within the internal lumen 36 of catheter adapter 14 to control fluid flow. The septum 50 generally comprises a flexible or semi-flexible polymeric plug having an outside diameter that is configured to fit in a compatible manner within a groove or channel 60 formed on an inner surface 66 of catheter adapter 14. In some embodiments, the septum 50 has plunger-shaped and has a protective element 52 at its distal end and a cavity 54 within its proximal end. When positioned within channel 60, the protective element 52 of the septum 50 divides the inner lumen 36 of the catheter adapter 14 into a front fluid chamber 62 and a rear fluid chamber 64. Thus, the presence of septum 50 can limit the passage of fluid between the front and rear fluid chambers 62 and 64.
    [021] In some embodiments, the protective element 52 of the septum 50 includes a cut 56. The cut 56 can provide selective access or flow of a fluid through the protective surface 52 as it opens (activates) and closes (disables) in response to septum activator 80. In some embodiments, cut 56 is configured to remain in a closed impermeable position until it is activated or opened by advancing a septum activator 80 through cut 56 in a distal 72 direction. In some cases, the protective element 52 comprises a single cut 56. In other cases, the protective element 52 is modified to include multiple cuts 56, such as two cuts 56 forming a cross or x shape. In other cases, the protective element 52 is modified to include three cuts 56 forming a Y shape.
    [022] The septum activator 80 comprises a probe-like structure that serves to activate and deactivate the septum 50 in response to insertion and removal of the probe element 46. The septum activator 80 can basically be housed in the rear chamber 64 of the adapter catheter 14, near the septum 50. In some embodiments, the septum activator 80 is a tubular body 82 having a distal end 84 and a proximal end 86. The tubular body 82 can be made of a rigid or semi-rigid material, such as as a plastic or metallic material. The tubular body 82 may have an internal lumen 88 which facilitates the flow of a fluid and / or liquid through the septum activator 80 when the septum activator 80 punctures through the cut 56 of the septum 50.
    [023] The distal end 84 of the tubular body 82 can be configured to be inserted in a compatible manner into the cavity 54 within the proximal side of the septum 50 so that it is positioned where it can pierce through the cut 56 of the protective element 52 to form a fluid path through it. The distal end 84 additionally includes a front surface 90 that can be inserted through opening 54 of the septum 50 to a position close to the protective element 52 of the septum 50, as shown in figure 6. When distally forced, the front surface 90 advances through cut 56 as septum activator 80 is moved from a disabled position, as shown in figure 4, to an activated position, as shown in figure 5.
    [024] To properly align the septum activator 80 within the inner lumen 36 of the catheter adapter 14, one or more alignment structures can be included between the outer surface of the septum activator 80 and the inner surface 66 of the catheter adapter 14. For example, as shown in figure 4, one or more alignment fins 110 can project from the outer surface of the septum activator 80 and inserted into one or more alignment grooves 112 formed within the inner surface 66 of the adapter catheter 14. As the septum activator travels longitudinally into the catheter adapter, the one or more alignment fins 110 each track within one or more alignment grooves 112 to keep septum activator 80 properly aligned inside the catheter adapter 14. In some configurations there are three, four, five or six alignment fins 110, each inserted into one of the alignment grooves 112 of the same amount.
    [025] In addition to septum activation 50, septum activator 80 may form part of a return chamber 116 that provides an extended return indication to clinicians. The return usually occurs when the introducing needle 22 and / or the catheter 12 enters a patient's blood vessel, piercing the blood vessel, and opening a fluid path through catheter 12. The patient's blood pressure forces the blood to stop. outside the blood vessel and into the catheter assembly 10. When the catheter adapter 14 or part of it is transparent or semitransparent, as in some embodiments, blood flow through its internal lumen 36 is observed and may indicate for a doctor that catheter 12 is currently located inside the patient's blood vessel. If the blood flow stops, the doctor may understand that catheter 12 is no longer located within the blood vessel or that some other factor is restricting blood flow through catheter 12. Thus, a return that may last long enough to that a doctor properly place a catheter is desirable.
    [026] Referring to figure 4, in some embodiments, blood generally enters catheter assembly 10 and follows a return path 114 through catheter assembly 10. Fluid path 114 enters front chamber 62, which can be a first return chamber as it includes the volume that can be observed to be filled with blood. The blood then flows through flow restrictors 70 arranged around the septum 50 and enters the return chamber 116, which can be a second return chamber. In cases in which the catheter adapter 14 or a part of it is transparent or semi-transparent, a doctor can observe this blood flow filling these chambers, which indicates the proper placement of the catheter 12.
    [027] As mentioned, during the return, blood enters the return chamber 116 through one or more flow restrictors 70 interspersed between the septum 50 and the inner surface 66 of the catheter adapter 14 to provide a flow path for the return. Generally, the septum 50 rests within a groove or channel 60 that comprises a recessed part of the inner surface 66 of the catheter adapter 14. The outer diameter of the septum 50 can rest in a compatible and secure manner within the channel 60. For example, in some embodiments, the outer diameter of septum 50 is selected to be slightly smaller than the diameter of channel 60 and slightly larger than the diameter of inner lumen 16. As such, septum 50 is retained within channel 60 during use of the set of catheter 10. Flow restrictor 70 can allow air and fluid to pass through it, while generally regulating flow rates. The cross-sectional size of each flow restrictor can at least partially control the rate of fluid flowing through it. For example, as the cross-sectional area of flow restrictors 70 increases, the potential rate of fluid flow through flow restrictors 70 increases. Likewise, flow restrictors 70 having smaller cross-sectional areas will reduce the flow of fluid through them. The sizes and configurations of flow restrictors 70 and other components are described in detail below.
    [028] The septum activator 80 in combination with the catheter adapter 14 and the septum 50 defines the return chamber 116, illustrated in figure 4. In some configurations, the outer surface 92 of the septum activator 80 provides fluid protection that prevents fluid from flowing between the inner lumen 88 of the septum activator 80 and the volume of space around the outer surface 92 of the septum activator 80. Accordingly, as illustrated, in some cases, the septum activator 80 is a solid tube having only two openings: one proximal and one distal.
    [029] As the fluid enters the return chamber 116, a seal 98 disposed between the septum 50 and the inner surface 66 of the catheter adapter 14 can prevent the fluid from flowing out of the proximal end of the catheter adapter 14. In some embodiments, seal 98 surrounds septum activator 80, as illustrated. In some embodiments, the seal 98 is coupled to the outer surface 92 of the septum activator 80 to prevent the proximal flow of fluids from passing through the seal 98. In other embodiments, the seal 98 can be coupled to the inner surface 66 of the catheter adapter 14 By adjusting the seal location 98, the return chamber volume 116 increases or decreases. In this way, seal 98 can be positioned at various locations between the proximal and distal ends of the septum activator 80. For example, seal 98 can be arranged in a proximal part of the septum activator 80, such as the proximal half. septum activator 80, as illustrated. More specifically, in a non-limiting example, seal 98 is arranged at the proximal end 86 of the septum activator 80, as illustrated in figure 8, which is described below. In addition, the seal 98 can circumscribe a part of the outer surface 92 of the septum activator 80 in the form of a ring, as illustrated, to seal the area around a part of the septum activator 80.
    [030] In some embodiments, the seal 98 can provide fluid impermeable protection around the septum activator 80 that prevents blood from leaking through the proximal end of the return chamber 116 and out through the catheter assembly 10. For example, seal 98 may have an outside diameter greater than or equal to the lumen inner diameter 36 of catheter adapter 14 to block fluid flow through the entire area between septum activator 80 and catheter adapter 14. seal 98 can also be made of flexible material so that it can properly conform to the inner surface 66 of the catheter adapter 13 to form a seal. Accordingly, seal 98 may comprise a non-rigid material, such as an elastomeric material. In other cases, the seal 98 is made of other flexible, semi-flexible or semi-rigid materials, which can provide an impermeable seal between the catheter adapter 14 and the septum activator 80.
    [031] Initially during return, blood flowing into catheter 12 forces air to flow through flow restrictors 70. This initial blood infusion can be very fast as blood flows through catheter 12 into front chamber 62. Front chamber 62 can serve as a return chamber that provides a first indication to doctors that blood is flowing into the catheter assembly 10. By observing this blood flow, a doctor can verify that catheter 12 entered a blood vessel. However, in some cases, the time at which this initial return occurs is very fast and is not long enough for a doctor to check the proper placement of the catheter. Accordingly, in some configurations, a second return chamber 116 is provided on the proximal side of the septum 50 which provides extended return indications. Accordingly, air and blood from inside the advancement chamber 62 can flow through the flow restrictors 70 disposed between the septum 50 and the catheter adapter 14 within the second flash chamber 116. Since the size of the flow restrictors flow 70 controls blood flow therethrough, the rate of return into the second return chamber 116 can be regulated to provide longer average return periods.
    [032] When blood begins to flow into the catheter assembly, positive pressure is developed within the front chamber 62, the first return chamber, and the second return chamber 116. This pressure can reduce or impede the flow of blood into the catheter assembly 10, thereby preventing a desired return of the patient's blood into the catheter adapter 14. Thus, some embodiments include accessories or elements to allow air to flow through or around the seal 98 to relieve positive pressure by allowing air, but not blood, to escape through it. As such, some embodiments of the present invention provide complete observable feedback, as generally desired for infusion procedures.
    [033] In some embodiments, the septum 98 of the septum activator 80 is modified to include one or more ventilations 100. In other embodiments, one or more ventilations 120 (illustrated in figure 6) in the form of channels, are interspersed between the seal 98 and the internal surface 66 of the catheter adapter 14. These vents 100 relieve positive pressure within the return chambers 62, 116 by providing an access for air to pass the seal 98 into the external environment. In some embodiments, the vents 100 are constructed by removing parts of the seal surface 98, resulting in a plurality of generally parallel grooves. An enlarged perspective view of a seal 98 having multiple vents 100 is shown in figure 7. In other embodiments, the vents 100 are formed as channels through the seal 98 instead of on the surface of the seal 98.
    [034] In some embodiments, the rate at which air and / or fluids flow through the vents 100 in the seal 98 is adjusted by manufacturing catheter adapter 14 to include a greater or lesser number of vents 100 or by changing the cross-sectional area of the ventilations 100. Thus, in some embodiments, the rate at which air and / or fluid flows out of the second return channel 116 is increased by the manufacture of a catheter adapter 14 to have an increased number of ventilations 100 or ventilations 100 with a larger cross-sectional area. Conversely, in other embodiments, the rate at which air and / or fluid flows from the second return chamber 116 is reduced by manufacturing a catheter adapter 14 with a reduced number of ventilations 100 or ventilations 100 having a smaller cross-sectional area .
    [035] Those skilled in the art will appreciate that the patient's blood pressure is highly responsible for the rate at which blood and air flow through the septum 50 and the ventilations 100 at or around seal 98. As such, the rate of flow through of the system is affected by the combined effective hydraulic diameter of all flow paths. Thus, in some embodiments, the hydraulic diameter of the ventilations 100 is modified to increase or reduce the flow rate through the catheter assembly 10. In other embodiments, the hydraulic diameter of the ventilations 100 is reduced, thus resulting in a substantially flow reduced or interrupted by the ventilation device. The equation for controlling the flow rate through the ventilation device is provided in equation 1, where BP is the blood pressure, A is the surface area of the ventilation device, σ is the blood surface tension, and P is the perimeter of the ventilation device. Equation 1: BP (A) = σ (P)
    [036] Thus, according to equation 1, when the perimeter of a ventilation is small, the ventilations 100 will allow air ventilation, but will prevent blood from flowing due to a relatively high surface tension (σ) of the blood . However, when the ventilation perimeter is increased, the surface tension between the blood and the ventilation 100 is reduced, thus allowing blood to leak slowly through the ventilations and around the septum to provide a desirable but controlled return. Therefore, by adjusting the variable in equation 1, a desired flow will be achieved. Thus, based on the size and / or number of breaths around the septum, the catheter set design will provide a personalized, predictable controlled blood flow through seal 100.
    [037] In some embodiments, one or more breaths 100 are designed to allow air flow and interrupt blood flow. In some embodiments, the number of breaths 100 is between 1 and 40. In other embodiments, the number of breaths 100 is between 1 and 20. In some embodiments, six or more breaths 100 are included. While in other modalities, five or less 100 ventilations are included. Accordingly, in some embodiments, the ventilations 100 have a cross-sectional area between 4.52 x 10'5 cm2 and 2.58 x 10'4 cm2. In other embodiments, the vents 100 have a cross-sectional area between about 6.45 x 10'5 and 1.94 x 10'4 cm2. In other embodiments, the vents 100 have a cross-sectional area of about 1.29 x 10'4 cm2. For example, in some embodiments, the vents 100 have a height of about 0.002 cm and 0.007 cm and a width of about 0.02 cm. In other embodiments, the vents have a height of about 0.005 cm to 0.007 cm and a width of about 0.01 cm.
    [038] Similarly, one or more flow restrictors 70 between the septum 50 and the inner surface 66 of the catheter adapter 14 can be specifically configured to allow blood and air to pass through it in an estimated range of rates flow. For example, one or more flow restrictors 70 may allow blood to flow through them at a rate between about 10 to 200 ml / hr. In other cases, the one or more flow restrictors 70 may allow blood to flow through them at a rate between about 15 and 150 ml / hr. In other cases, one or more flow restrictors 70 may allow blood to flow through them at a rate between about 50 and 100 ml / hr. At these rates, the rate of blood flow within the return chamber 166 can be measured to provide the physician with adequate time to correctly locate the catheter within the patient's blood vessel. Accordingly, in some embodiments, flow restrictors 70 have a cross-sectional area greater than 1.94 x 10'4 cm2. In other embodiments, flow restrictors 70 have a cross-sectional area greater than 2.58 x 10'4 cm2. In other embodiments, the ventilations 100 have a cross-sectional area of about 6.45 x 10'4 cm2. In other embodiments, the ventilations 100 have a cross-sectional area of about 0.01 cm2.
    [039] Referring now to figure 5, a cross-sectional view of the catheter assembly 10 is illustrated following the activation of the septum 50 through the frequency activator 80. By inserting the coupler 42 in the proximal opening 26 of the catheter adapter 14, the probe element 46 of the coupler 42 contacts the contact surface 96 of the septum activator 80. The septum activator 80 is advanced in a distal direction 72 as the coupler 42 is further inserted into lumen 36 of the catheter adapter 14. To As the coupler 42 is advanced further into the lumen 36, the probe surface 92 of the septum activator 80 passes through the protective elements 52 of the septum 50. As such, the probe surface 92 of the septum activator 80 is positioned inside the front chamber 62 providing a fluid path through the open cut 56 of the septum 50.
    [040] During the activation of the septum, the volume of the return chamber 116 decreases as the septum activator 80 advances in the distal direction 72. The reduction in volume can create a positive pressure inside the return chamber 116 that can cause that fluids inside the return chamber 116 flow back through the flow restrictors 70 into the advance chamber 62, along the fluid flow path 115. That fluid can then be rinsed out of the catheter assembly 10 with infusion of fluids from the intravenous line 40.
    [041] In some embodiments, the catheter assembly 10 is configured to allow the septum activator 80 to return to a fully disabled position within the rear chamber 64 following the removal of coupler 42 from catheter adapter 14. Thus, when the coupler 46 is removed or detached from the catheter assembly 10, the fluid path through the septum 50 is closed again.
    [042] Reference will now be made to figure 6, which presents a set of catheter 10 similar to that of figurei 4. However, as illustrated in some embodiments, seal 98 does not include ventilations 100. Instead, as illustrated in figure 6 , one or more vents 120 are formed within the inner surface 66 of the catheter adapter 14. In some configurations, the one or more vents 120 extend along the length of the inner surface 66 of the catheter adapter 14 at least at each location where seal 98 contacts catheter adapter 14 as it is moved from a disabled position to an activated position. This configuration can allow air ventilation through one or more ventilations 120 regardless of the location of the septum activator 80. In other configurations, the one or more ventilation 120 extends only through the place where seal 98 contacts the inner surface 66 of the catheter adapter 14 in a disabled position, the position shown in figure 6.
    [043] As mentioned, the dimensions of the ventilations 120 can be selected to allow air, but not blood, to flow through them. These dimensions can be substantially similar to those mentioned above for the ventilations 100 within the seal 98.
    [044] Reference will now be made to figure 8, which features a septum activator 80 that has an alternative seal configuration. As illustrated, the septum activator 80 includes a tubular body 82 with a distal end 84 and a proximal end 86. A seal 130 is arranged at the distal end 86 of the septum activator 80, which will provide the longest possible length of the return chamber 116 Ventilations 132 are formed in the seal similarly to those previously mentioned. In some embodiments, seal 130 is integrated with the septum activator, so that the two form a one-piece structure. In some embodiments, septum activator 80 and seal 130 are made of different materials that are impermeably connected.
    [045] With reference now to figure 9, a one-septum 104 embodiment is illustrated. In some embodiments, an outer surface 108 of the septum 104 is modified to include a plurality of recessed grooves 106. The recessed grooves 106 provide paths between the front and rear chambers 62 and 64 through which air and / or fluid can flow . Thus, in some embodiments, channel 60 does not include airflow restriction channels 70, but instead, the outer surface 108 of the septum 104 is modified to provide the desired flow between the front and rear chambers 62 and 64 The shape and size of these grooves can be selected, as mentioned, to provide the desired flow rate through them. For example, one or more flow restrictors 132 may allow blood to flow through them at a rate between about 10 and 200 ml / hr. In other cases, one or more breaths 132 may allow blood to flow through them at a rate between about 15 and 150 ml / hr. In other cases, one or more breaths 132 may allow blood to flow through them at a rate between about 50 and 100 ml / hr.
    [046] From the above, it can be seen that a perforated septum valve can provide selective activation of fluid flow through the catheter assembly while minimizing or eliminating blood exposure. In addition, the perforated septum valve can improve the physician's ability to confirm the placement of the catheter by providing an additional flash chamber between a seal around the outside of the septum activator and the septum.
    [047] The present invention can be embodied in other specific forms without distancing itself from its structures, methods, or other essential characteristics, as widely described here and claimed later. The described modalities should be considered in all aspects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the description above. All changes that come within the meaning and equivalence range of the claims must be encompassed within its scope.
    权利要求:
    Claims (15)
    [0001]
    1. Perforated septum valve comprising: a septum (50, 104) disposed within a lumen (36) of a body (14); a septum activator (80) disposed proximal to the septum (50, 104) within the lumen (36) of the body (14); a seal (98) disposed between an external surface of the septum activator (80, 82) and the body, the seal sealing a part of the septum activator (80, 82) distal to the seal from a part of the septum activator ( 80, 82) proximal to the seal (98); CHARACTERIZED by the fact that one or more ventilations (100) is / are formed in the seal (98) and arranged between the seal (98) and the lumen (36) of the body (14), the one or more ventilations (100, 120 ) each having a cross-sectional area that allows air to pass through, but not blood.
    [0002]
    2. Perforated septum valve, according to claim 1, CHARACTERIZED by the fact that the cross-sectional area of each ventilation (100) is between 6.45 x 10'4 to 1.94 x 10'3 cm2 and / or in that one or more ventilations (100) are channels formed in the body (14).
    [0003]
    3. Perforated septum valve, according to claim 2, CHARACTERIZED by the fact that one or more breaths (100) includes six or more breaths.
    [0004]
    4. Perforated septum valve, according to claim 3, CHARACTERIZED by the fact that the seal (98) surrounds the septum activator (80, 82).
    [0005]
    5. Perforated septum valve, according to claim 1, CHARACTERIZED by the fact that one or more ventilations (100) are formed outside the seal (98) or through the seal (98).
    [0006]
    6. Perforated septum valve, according to claim 1, CHARACTERIZED by the fact that the body (14) is a catheter adapter (14) and the lumen (36) of the body (14) extends through the catheter adapter ( 14).
    [0007]
    7. Perforated septum valve, according to claim 1, CHARACTERIZED by the fact that the seal (98) has an outer diameter greater than or equal to an inner diameter of the lumen (36) and / or in which the seal (98 ) includes an elastomeric material.
    [0008]
    8. Perforated septum valve according to claim 1, CHARACTERIZED in that the seal (98) is arranged around a proximal part of the septum activator (80, 82).
    [0009]
    9. Catheter assembly (10), CHARACTERIZED by the fact that it comprises: the perforated septum valve as defined in claim 1, in which the body (14) is a catheter adapter (14) having a lumen (36) extending through the same; further comprising one or more flow restrictors (70) disposed between the septum (50, 104) and the catheter adapter (14).
    [0010]
    10. Catheter set (10), according to claim 9, CHARACTERIZED by the fact that one or more ventilations (100) arranged between the seal (98) and the lumen (36) of the body (14) each have a cross-sectional area between 6.45 x 10-4 and 1.94 x 10'3 cm2.
    [0011]
    11. Catheter set (10), according to claim 9, CHARACTERIZED by the fact that one or more flow restrictors (70) include one or more openings, each having a transversal area of more than 1.94 x 10 '3 cm2.
    [0012]
    12. Catheter assembly (10), according to claim 9, CHARACTERIZED by the fact that the external volume of the septum activator (80) between the septum (50, 104) and the seal (98) forms a return chamber ( 116).
    [0013]
    13. Catheter assembly (10) according to claim 9, CHARACTERIZED by the fact that the septum activator (80) has a substantially tubular body (82) with a lumen (36) extending through it.
    [0014]
    14. Catheter assembly (10) according to claim 13, CHARACTERIZED by the fact that the seal (98) has an outer diameter greater than or equal to an inner diameter of the lumen (36) and in which the seal (98 ) preferably be arranged around a proximal part of the septum activator (80).
    [0015]
    15. Catheter assembly (10) according to claim 14, CHARACTERIZED by the fact that the seal (98) includes an elastomeric material.
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    同族专利:
    公开号 | 公开日
    CN105879196B|2019-07-12|
    CN103079630B|2016-04-27|
    EP2593166A1|2013-05-22|
    EP2593166B1|2018-12-19|
    CN103079630A|2013-05-01|
    US20120016301A1|2012-01-19|
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    JP5813764B2|2015-11-17|
    BR112013001044A2|2016-05-24|
    AU2011279748B2|2014-03-13|
    AU2011279748A1|2013-02-28|
    WO2012009027A1|2012-01-19|
    US8361020B2|2013-01-29|
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    法律状态:
    2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-08-27| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-04-07| B09A| Decision: intention to grant|
    2020-11-03| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/03/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US36457610P| true| 2010-07-15|2010-07-15|
    US61/364,576|2010-07-15|
    US13/042,073|US8361020B2|2010-07-15|2011-03-07|Catheter assembly and pierced septum valve|
    US13/042,073|2011-03-07|
    PCT/US2011/028712|WO2012009027A1|2010-07-15|2011-03-16|A catheter assembly and pierced septum valve|
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