• 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:
    septum, catheter assembly and method for sealing a catheter. it is a septum that can be used in a catheter assembly to selectively seal an opening in the catheter assembly. the septum has a tubular part and a buffer part. the plug part has a slit through it. the septum is able to transition from a non-collapsed state to a collapsed state. when the septum is in the non-collapsed state, the plug part is displaced from the tubular part such that part of the length of the slit extends outwardly from the distal end of the tubular part. when the septum enters the collapsed state, the plug part moves into the internal cavity such that part of the length of the slit extends or not extends out of the distal end of the tubular part.
    公开号:BR112014020750B1
    申请号:R112014020750-0
    申请日:2013-02-20
    公开日:2021-03-30
    发明作者:Daniel Kirk Hyer；Corey Christensen；Carl Ellis
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    Fundamentals of the Invention
    [001] The present invention relates to septa used in catheter and introducer needle assemblies. In medicine, these catheter and introducer needle assemblies are used to correctly insert a catheter into the patient's vascular system. Once in place, catheters, such as intravenous (or "IV") catheters, are used to infuse fluids, including normal saline, medical compounds and / or nutritional compositions (including total parenteral nutrition, or "TPN"), into a patient in need of such treatment. The catheters also allow you to remove fluids from the circulatory system and monitor conditions within the patient's vascular system.
    [002] A type of catheter commonly used is the "over needle" catheter, which is mounted on an introducer needle with a pointed distal tip. The introducer needle cuts through the patient's skin and serves as a structural support for the catheter as it advances through the skin. The distal edge of the catheter clings to the outside of the introducer needle to facilitate its introduction through the skin along with the introducer needle. When a part of the introducing needle is introduced into the target vessel, the catheter is slid over the introducing needle to its place inside it. After confirming the placement of the catheter, the introducer needle is removed from the catheter assembly, leaving the catheter in place.
    [003] As blood begins to flow to the catheter adapter, several seals or septa may be positioned on the catheter adapter to prevent fluid from escaping from the catheter assembly. This septum may have an interference fit between the catheter assembly and the introducing needle system to create radial compression forces against the introducing needle designed to prevent unwanted blood leakage between the septum and the introducing needle. The compressive forces that act against the introducing needle also act to close the septum and keep it closed after removing the introducing needle. The interference fit that closes the septum after removing the needle introduces frictional forces against the needle-septum interface. These frictional forces create drag forces that resist needle extraction, thus making it difficult for medical staff to remove the needle from the catheter assembly, especially by hand. Turn and a half, the frictional force required to remove the needle results in an uncomfortable or painful vibration or movement of the catheter inside the patient. It would be a breakthrough in the technique to provide a septum with a lower frictional force, resisting the extraction of the needle and, at the same time, maintaining the proper sealing functionality. SUMMARY OF THE INVENTION
    [004] In this context, the present invention proposes a septum for use in catheter and introducer needle assemblies. The septum provides a seal around the introducer needle before and during needle removal, as well as providing a seal around the proximal opening of the catheter assembly after needle withdrawal. The septum is configured to exercise minimized drag during needle extraction and, at the same time, still provide an effective seal against high pressures within the catheter assembly, such as those involved in high pressure fluid injections. These characteristics are obtained, at least in part, by displacing the septum slit in such a way that the radial compression forces from the catheter adapter applied to the slit are primarily indirect forces. In this displacement configuration, the frictional forces against the needle at the needle-septum interface are minimized, which facilitates the withdrawal of the needle.
    [005] To provide an improved sealing function during the injection of high pressure fluid, the septum can be further configured to assume a collapsed state, usually after removing the introducing needle, when a relatively high pressure is applied to the distal face of the septum. In these cases, the part of the septum that contains the slit, a part of the plug, is collapsed at least partly into a tubular part of the septum, which increases the compressive force against the slit, thus keeping the slit closed despite pressure high. In this collapsed state, the septum resists high pressures within the catheter assembly without compromising the seal provided by the septum. Thus, the septum can act as a low-drag, high-pressure septum.
    [006] Therefore, in some aspects of the invention, a septum is proposed that can be used in a catheter assembly to selectively seal an opening in the catheter assembly. The septum has a tubular part and a buffer part. The plug part has a slit through it. The septum can go from a non-collapsed state to a collapsed state. When the septum is in the non-collapsed state, the plug part is displaced from the tubular part in such a way that part of the length of the slit extends outwardly from the distal end of the tubular part. When the septum is in a collapsed state, the plug part penetrates an internal cavity in the tubular part in order to decrease the length of the slit that extends outwardly from the distal end of the tubular part.
    [007] In some implementations of the septum, the internal cavity extends from the proximal end of the tubular part to the plug part. The inner cavity may have a smaller cross-sectional area (perpendicular to the central axis of the tubular part) than the plug part, such that the plug part closes the inner cavity when inserted into it. Furthermore, as the tampon part penetrates the internal cavity, it increases the compressive force at least against that part of the septum, which improves the septum sealing capabilities. The septum plug portion may extend outwardly from a central region at the distal end of the tubular portion and be surrounded by a distal end portion of the tubular portion that forms an annular surface around the tampon portion.
    [008] In some implementations of the septum, a first compressive force is applied to the cleft surfaces when the septum is in the non-collapsed state, but a second, larger compressive force is applied to the cleft surfaces in the collapsed state, thus enabling greater sealing capabilities around the slit, which strengthens the septum seal against high pressures. The septum changes from the non-collapsed state to the collapsed state in response to a limit pressure against the distal face of the septum. As a result, a seal against high pressures is created which, in other contexts, would compromise the seal of the septum. This limit pressure is greater than the pressure produced to withdraw the needle through the slit in the buffer part so that the septum is not contracted during the withdrawal of the needle.
    [009] In some implementations of catheter assembly, one or more holes are formed through the side walls of the catheter adapter, which extend between the internal channel and the external environment. The one or more orifices are located along the internal channel at one or more locations covered by the septum, when the septum is in the non-collapsed state, and discovered by the septum, when the septum is in the collapsed state. In this configuration, when the internal pressure in the catheter adapter is sufficient to compress the septum backwards, in such a way that one or more orifices are exposed, that internal pressure decreases as fluids escape through one or more orifices.
    [010] These and other features and advantages of the present invention can be incorporated into certain embodiments of the invention and will be seen more fully by reading the description below and the appended claims, or will be learned by practicing the invention as defined hereinafter. The present invention does not require that all of the advantageous features and advantages described herein be incorporated into all embodiments of the invention. Brief Description of the Various Views of the Drawings
    [011] In order for the way in which the above mentioned features and advantages of the invention are obtained, in addition to other features and advantages, to be easily understood, a more specific description of the invention summarized above will be presented with reference to specific embodiments of the invention, which are illustrated in the accompanying drawings. These drawings illustrate only typical embodiments of the invention and, therefore, should not be considered limitations on the scope of the invention.
    [012] Figure 1 is a partially exploded perspective view of a representative integrated catheter and introducer needle assembly incorporating a septum.
    [013] Figure 2 is a partially exploded perspective view of the catheter assembly of Figure 1 with the septum shown separately from the catheter assembly.
    [014] Figure 3 is an isolated perspective view of a representative septum.
    [015] Figure 4 is an isolated side view of the septum in Figure 3.
    [016] Figure 5 is an isolated cross-sectional view of the septum of Figures 3 and 4 along line 5-5 in Figure 4.
    [017] Figure 6 is a cross-sectional view of a catheter assembly with an introducing needle positioned.
    [018] Figure 7 is a cross-sectional view of the catheter assembly of Figure 6 with the introducer needle partially removed and the septum in a non-collapsed state.
    [019] Figure 8 is a cross-sectional view of the catheter assembly of Figure 6 with the introducing needle removed and the septum in a collapsed state.
    [020] Figure 9 is a cross-sectional view isolated from another embodiment of a septum.
    [021] Figure 10 is a cross-sectional view isolated from yet another embodiment of a septum.
    [022] Figure 11 is a flow chart of a method for sealing a catheter assembly. Detailed Description of the Invention
    [023] Some embodiments of the present invention will be better understood with reference to the drawings, in which like reference numbers indicate like or similarly functional elements. It will be readily apparent that the components of the present invention, as described and illustrated in general in the accompanying figures, can be organized and designed in a wide variety of different configurations. Therefore, the following more detailed description, as represented in the figures, should not be interpreted as limiting the scope of the invention as claimed, being merely representative of the currently preferred embodiments of the invention.
    [024] As used in this document, the term “proximal” indicates a part of a device that, during normal use, is closer to the user handling the device and further away from the patient. As used in this document, the term “distal” indicates a part of a device that, during normal use, is further away from the user handling the device and closer to the patient.
    [025] In addition, the terms "inside" or "inside" refer to a location in relation to the device which, during normal use, is towards the interior of the device. Conversely, the terms "out" or "out" refer to a location in relation to the device that, during normal use, is towards the outside of the device.
    [026] In some parts of the Detailed Description below, the invention is described with reference to a peripheral IV catheter with an integrated extension tube. It should be borne in mind, however, that the septum of the present invention can be used with several other catheter systems. For example, the invention is applicable to standard peripheral IV catheters, extended permanent catheters that require the needle to be connected to the needle tube by a stylus, and other medical devices in which it is desirable to introduce a septum to regulate the flow of fluid inward or outside of a space.
    [027] Figure 1 illustrates, in general terms, an integrated catheter and introducer needle assembly 20 that incorporates a septum 10 (disposed within the catheter adapter 24). The catheter and introducer needle assembly 20 includes a catheter assembly 18, with a catheter 22 attached to a catheter adapter 24, as well as a needle system 16, with an introducer needle 30. Introducer needle 30 is inserted into the catheter assembly catheter 18 along an axis 12, such as a longitudinal axis of the catheter assembly 18.
    [028] The catheter adapter 24 shown in Figure 1 includes wings 26 that extend radially outwardly from both sides of the catheter adapter 24. The wings 26 facilitate handling of the catheter and introducer needle assembly 20 and offer a larger surface area for fixing catheter 22 to the patient. The wings 26 may optionally include suture holes 28. The catheter adapter 24 also includes a septum 10, disposed within it, capable of preventing, at least in part, the escape of fluid from the proximal end of the adapter. catheter 24. The introducer needle system 16 includes an introducer needle 30. The proximal end of the introducer needle 30 is housed in a needle tube 32, while the distal end of the introducer needle 30 has a pointed tip 34 to pierce the skin of the patient. In use, the introducing needle 30 and the catheter 22 are inserted into the patient's blood vessel, the correct introduction is confirmed, and the introducing needle 30 is removed, leaving the catheter 22 back in place.
    [029] Figure 2 is a partially exploded perspective view of the catheter assembly 18 with the septum 10 shown apart from the catheter assembly 18. When assembled, the septum 10 is positioned within the proximal region of an internal channel 36 of the adapter catheter 24 to prevent fluid leakage from the proximal end of catheter adapter 24. In some embodiments, the septum 10 is a one-piece device adapted to fit securely within catheter adapter 24. For example, the outside diameter of the septum 10 can be approximately equal to or greater than the inner diameter of a region of the inner channel 36 of catheter adapter 24 or part thereof.
    [030] As illustrated, septum 10 may include surface features that help keep it in place. For example, a proximal region of the body 46 of the septum may have a reduced external diameter compared to the distal region of the body 44, whose dimensions and shape are suitable to fit into a sleeve (not shown) that helps maintain the septum 10 at the place. The reduced outer diameter of the proximal region of the body 46 can also be fitted in a compatible manner around an inwardly-facing ring (not shown) on the inner surface of the inner channel 36 of the catheter adapter 24. Other representative structures of the type used to maintain the septum 10 in place are illustrated in Figures 6 to 10 and described below.
    [031] Figures 3 to 7 illustrate isolated views of embodiments of the septum 10. Reference will be made, in the first place, to Figure 3, which illustrates a perspective view of the septum 10. The septum 10 is configured to provide a seal around the introducer needle 30 before and during removal of the needle from catheter assembly 18. The septum 10 is configured to exert a low drag force during needle withdrawal and, at the same time, still provide a seal effective against high pressures within the catheter assembly, such as those involved in high pressure fluid injections. These characteristics can be obtained, at least in part, by displacing slit 60 of the septum 10 distally in such a way that a radially compressive force that is primarily indirect is applied against most of the slit 60 from the catheter adapter 24. In this displacement configuration , the drag forces against the needle at the needle-septum interface are minimized during the withdrawal of the introducing needle 30.
    [032] In order to provide an improved sealing function during high pressure fluid injection, septum 10 is also configured to move from a non-collapsed state (as shown in Figures 3 to 7) to a collapsed state (as illustrated) Figure 8) after removing the introducer needle 30 and when a relatively high pressure is applied against the distal face 54 of the septum 10. In such cases, the part of the septum 10 that contains the slit 60, a part of buffer 42, penetrates, at least in part, in a tubular part 40 of the septum 10, which increases the compressive force against the slot 60, thus keeping the slot 60 closed. In this collapsed state, the septum 10 is configured to withstand high pressures within the catheter assembly 18 without compromising the seal formed by the septum 10.
    [033] The septum 10 in a non-collapsed state will now be taken as a reference, as shown in Figure 3. As illustrated, in some configurations, the septum 10 is a one-piece septum 10 which, in general, includes a portion tube part 40 and a plug part 42. The plug part 42 has a slit 60 that runs through it along the central axis 12 of the septum 10. In this non-collapsed state, the plug part 42 is displaced from the tubular part 40 so that part of the length, or all of it (indicated by 70 in Figure 5), of the slot 60 extends distally from the distal end 50 of the tubular part 40. The part of the length 70 that extends distally may include about 15% about 100% of slot 60, including about 15%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90% or about 100% of the length 70 of the slit 60. As used in this document, the term “slit length” refers to the length of the slit 60 that extends between the distal and proximal ends of the plug part 42. In some configurations, as shown, the plug part 42 extends from a central region at the distal end 50 of the tubular part 40, and the distal end 50 of the tubular part 40 forms an annular surface around the plug part 42.
    [034] Figure 4 illustrates a side view of the septum 10 of Figure 3, including the distal region of the body 44, with its widest external dimensions, and the proximal region of the body 46, with its reduced external dimensions. This figure also illustrates how the plug portion 42 extends distally outwardly from the central region at the distal end 50 of the tubular portion 40 of the septum 10. As also illustrated, one or more edges of the septum 10 can be rounded or tapered.
    [035] Figure 5 will now be taken as a reference, which illustrates a cross-sectional view of the septum 10 along line 5-5 in Figure 4. As illustrated, in some configurations, the septum 10 includes a cavity inner 62, which extends from an opening 56 at the proximal end 52 of the tubular part 40 to the plug part 42. In turn, the proximal side of the plug part 42 defines the distal end 66 of the inner cavity 62. The inner cavity 62 forms the interior of at least part (or most) of the tubular part 40 of the septum 10. In some embodiments, the internal cavity 62 serves to provide a region where little or no pressure is applied against the parts of the introducing needle 30 located inside it. The internal cavity 62 also serves to provide a region into which the plug portion 42 of the septum 10 contracts under high pressures, as shown in Figure 8 and described below.
    [036] Figure 5 also illustrates the plug part 42, which is substantially indicated by an oval for clarity. The plug part 42 is displaced from the tubular part 40 in such a way that part (for example, at least about a half) of the length 70 of the slot 60 extends distally from the distal end 50 of the tubular part 40. For example , the fraction 74 of the length 70 of the slot 60 that extends distally from the distal end 50 of the tubular part 40 (referred to in this document as deviation length 74 or displaced fraction 74) may be (but need not necessarily be) greater than the fraction 72 of the length of the slit 60 located proximally from the distal end 50 (referred to in this document as overlying length 72 or overlying fraction 72). This deviation causes the forces applied against the septum 10 from a catheter adapter 24 to be primarily indirect radial compression forces. The primarily indirect radial compression forces are not as strong as direct compression forces would be and therefore result in less contact force at the needle-septum interface and less drag forces against the introducing needle 30 during needle extraction. This makes it easier for the medical team to remove the introducing needle 30 from the catheter assembly 24, mainly by hand. The lower contact force at the needle-septum interface also decreases or eliminates any vibration or uncomfortable movement caused by the removal of the patient's introducing needle 30 through the septum 10.
    [037] Reference will now be made to Figure 6, which illustrates a septum 10 installed within a catheter assembly 18. The septum 10 is positioned along the longitudinal axis 12 within an internal channel 36 on the adapter. catheter 24. Inner channel 36 extends along the longitudinal axis 12 of catheter assembly 18 between the proximal and distal ends of catheter adapter 24 and in and through catheter 22. Inner channel 36 has one or more recesses 84 formed on its inner surface 82, whose dimensions and shape are suitable to retain at least part of the outer surface of the septum 10 and prevent, at least in part, that the septum 10 is forced out of the proximal opening 88 of the inner channel 36 when the internal pressure in the internal channel 36 increases. In some configurations, one or more holes 86 are formed in the side wall of the catheter adapter 24, as will be described below.
    [038] In some embodiments, the inner channel 36 of the catheter adapter 24, along with the tubular part 40 of the septum 10, has dimensions and shape such that an inward compressive force is applied against the tubular part 40 of the septum 10 from of the catheter adapter 24. This compressive force inward, as described above, acts on the slot 60, keeping it closed against the introducer needle 30 and later closed without the introducer needle 30. As noted above, since the slit 60 is partially displaced from the tubular part 40, the compression forces acting on part of the slit 60 are indirect, following an indirect compression path 78.
    [039] With reference also to Figure 6, during storage and use of catheter adapter 24, the plug portion 42 of the septum 10 conforms to the shape of the introducing needle 30. Thus, as the catheter 22 and the needle introducer 30 are inserted into a patient, the septum 10 prevents leakage of fluid entering the catheter adapter 24. After removing the introducer needle 30, however, as shown in Figure 7, the septum slit 60 closes to seal the catheter adapter 24. In Figure 7, the slot 60 is shown to close as the distal tip 34 of the introducing needle 30 is removed into the internal cavity 62 of the septum 10. During any subsequent fluid infusion through the catheter assembly 18, the plug portion 42 of the septum 10, which protrudes slightly into the flow path of the infuser, creates a disturbance in the flow that results in better discharge capacity within the catheter adapter 24.
    [040] Reference will now be made to Figure 8, which illustrates the transition from septum 10 from a non-collapsed state to a collapsed state in response to hydrostatic pressures 90 against the distal face 54 of the septum 10. The shape external septum 10 in the non-collapsed state is illustrated using dashed lines, whereas the shape of septum 10 in the collapsed state is illustrated using solid lines. As illustrated, in response to pressure against the distal face 54 of the septum 10, like the pressure created during the infusion of a high pressure fluid, the septum 10 assumes a collapsed state. To ensure that the septum 10 does not contract during the withdrawal of the needle, it is configured to contract at pressures that exceed a limit value, which is greater than the pressure value caused during withdrawal of the needle through the slot 60.
    [041] As illustrated, when the septum 10 is in the collapsed state, the plug portion 42 moves proximally towards the internal cavity 62 of the septum 10, such that the length 70 of the slit 60 moves proximally from the distal end 50 of tubular part 40. Therefore, in this condition, the offset length 74 of the slot 60 decreases and the overlying length 72 of the slot 60 increases. In some cases, in this collapsed state, the fraction of length 70 that extends distally includes about 0% to about 75% of slot 60, including about 5%, about 10%, about 20%, about 30 %, about 40%, about 50%, about 60% or about 70%. In some configurations, about 50% of the slot 60 extends distally in the non-collapsed state, while 20% of the slot extends distally in the collapsed state. Furthermore, since a smaller fraction of the length of the slot 70 is displaced from the tubular part 40, the compressive forces against the surfaces of the slot 60 are greater in this condition because they act directly, rather than indirectly, against the surfaces of the slot 60. In addition , when the plug part 42 is wider than the inner cavity 62, the plug part 42 is compressed into the inner cavity 62, thus creating additional compressive forces that act against the gap 60. In some cases, as the hydrostatic pressures 90 increase, the plug part 42 is pressed even deeper into the internal cavity 62, thereby increasing the compressive forces against the gap 60 and thus strengthening the seal against the increased pressure.
    [042] In some embodiments, the septum 10 is configured in such a way that, in both collapsed and non-collapsed states, without something being inserted through slot 60, the surfaces of slot 60 remain in contact. In other words, the slot 60 remains closed. Therefore, the plug part 42 can be of such size and shape that it is large enough to resist being blown into the internal cavity 62 by means of hydrostatic pressure, which would open the gap 60. Therefore, the plug part 42 it can be wider than the inner cavity 62, such that the plug part 42 does not fully engage as it is forced into the inner cavity 62, during which the tubular part 40 folds around the inner part buffer 42. This strengthens the general sealing capacity of the septum 10. Therefore, in some configurations, the transverse area of the internal cavity 62 (perpendicular to the central axis 12 of the tubular part 40) is smaller than the transverse area of the tubular part 42 (also perpendicular to the central axis 12 of the tubular part 40) at a distal location from the distal end 50 of the tubular part 40. This difference in size causes the plug part 42 to close the internal cavity 62 when the septum 10 I have been r in the collapsed state, thus allowing the slot 60 to remain closed.
    [043] As Figures 6 to 8 illustrate, in some embodiments, one or more holes 86 are strategically formed through the side wall of catheter adapter 24 to provide pressure relief to catheter adapter 24 when septum 10 is in the collapsed state and is compressed proximally to the point of exposing one or more orifices 86. These orifices 86 decrease the potential for pressure spikes, which, in other contexts, would jeopardize the integrity of the catheter assembly components 18 or damage the veins of the patient. In some embodiments, after relieving some of the pressure, the septum 10 will recover from its collapsed state and plug the orifices 86 again. Therefore, the one or more orifices 86 can be located between the septum 10 and the inner surface 82 of the internal channel 36, when the septum 10 is in the non-collapsed state, but can be discovered when the septum 10 recedes proximally due to a pressure level that exceeds a limit pressure. In some embodiments, two or more holes 86 are formed in the catheter adapter 24 at different distances along the longitudinal axis 12 of the catheter assembly 18, such that the more the septum 10 is forced proximally, the more holes 86 are formed. exposed, intensifying pressure relief. In some embodiments, several orifices 86 are formed along each location along the longitudinal axis 12 of the catheter assembly 18 such that, as the fluid escapes through the orifices 86, the lateral forces generated by the escaping fluid neutralized, thus preventing unwanted movement of the catheter adapter.
    [044] Figures 9 and 10 illustrate embodiments of septa 10 with alternative configurations for the external surface. Turning first to Figure 9, in some embodiments, the outer surface 100 of the tubular part 40 of the septum 10 is substantially cylindrical, with no recess or protuberance, along substantially the entire length of the body 40. Turning now to Figure 10, in some embodiments of the septum 10, the outer surface 100 of the tubular part 40 of the septum 10 is substantially cylindrical and includes one or more recesses 102 that can receive one or more ring rings on the inner surface 82 of the inner channel 36 of the catheter adapter 24. In other configurations, the outer surface 100 of the tubular part 40 of the septum 10 includes one or more annular rings that can be received in one or more recesses on the inner surface 82 of the inner channel 36 on the catheter adapter 24. It is also contemplated that several other features and surface configurations are formed on the external surfaces of the septum 10.
    [045] Reference will now be made to Figure 11, which illustrates a flow chart of a method 110 for using the needle and catheter assemblies 20. In step 112, a catheter 18 assembly is provided. Catheter 18 includes a catheter adapter 24, with an inner channel 36 that runs through it, and an introducer needle 30, which extends through inner channel 36. A septum 10 is included within inner channel 36 of catheter adapter 24 around of the introducing needle 30. The septum 10 has a tubular part 40 and a buffer part 42, which is coupled to the distal end of the tubular part. A slit 60 passes through the septum 10. The septum 10 transits from a non-collapsed state, in which part of the length 70 of the slit 60 extends distally from the distal end of the tubular part 40, to a collapsed state, in which a the shortest length 70 of the slit 60 or no length extends distally from the distal end 50 of the tubular part 40. Furthermore, the septum 10 can transition from the non-collapsed state to the collapsed state in response to pressure against the distal face 54 of the septum 10 that exceeds a limit value, the pressure limit value being greater than that produced by the withdrawal of the introducing needle 30 through the slot 60 in the plug part 42.
    [046] In step 114, catheter 22 of catheter assembly 18 is positioned in the patient's blood vessel. At this stage, the correct introduction of the catheter can be confirmed. Then, in step 116, the introducing needle 30 is removed from inside the catheter assembly 18, while the septum 10 remains in the non-collapsed state. The septum 10 remains in this condition during the extraction of the needle because it is configured to contract at a pressure against its distal face 54 greater than the pressure created during the withdrawal of the needle. In addition, in some configurations, the introducer needle 30 and the slot 60 include a lubricant, as is known in the art, capable of decreasing the drag of the needle.
    [047] In step 118, after positioning catheter 22, fluid is infused into the patient via catheter adapter 24 and catheter 22. The fluid can include normal saline, medical compounds and / or nutritional compositions (including TPN) . During fluid infusion, if the pressure inside the catheter adapter 24 exceeds a limit value, the septum 10 will transition from the non-collapsed state to the collapsed state in response to pressure within the catheter adapter 24. Therefore, the septum 10 it acts both as a low-drag septum and as a high-pressure septum 10.
    [048] In view of the above, it will be realized that the use of catheter assemblies 18, septa 10 and methods of the present invention can bring several advantages and benefits. For example, a septum 10 provides a seal around the introducer needle 30 before and during removal. The septum 10 also provides a seal around the proximal opening 88 of the catheter assembly 18 when using the catheter assembly 18. The septum 10 is further configured to exert low drag force against the introducing needle 30 during extraction. Furthermore, the septum 10 responds to a hydrostatic pressure 90 against its distal face 54 which, in other contexts, would compromise the seal by deforming itself in order to self-seal and strengthen its own sealing capabilities. When deformed, or collapsed, the geometry of the septum 10 is such that the plug portion 42 acts as a plug, which, when pressure is applied, is forced into a constricted region of the internal cavity 62 of the septum 10, thereby strengthening the seal of the crack in proportion to the pressure level. This buffering action also increases the contact force at the septum-catheter adapter interface, which also improves this sealing surface in proportion to the pressure level.
    [049] The present invention can be realized in other specific forms without deviating from its structures, methods or other essential characteristics as described in general terms in the present document and in the claims hereinafter. The described embodiments should be considered, for all purposes, as merely illustrative and not restrictive. Therefore, the scope of the invention is indicated by the appended claims, rather than by the preceding description. All changes that fit the meaning and the equivalence range of the claims must be considered within its scope.
    权利要求:
    Claims (8)
    [0001]
    1. Septum (10) comprising: a tubular part (40) having an internal cavity (62) within it; and a plug part (42) coupled to a distal end of the tubular part having a non-collapsed state and a collapsed state, the plug part having a slot (60) extending through it, the slot having a slot length extending between a distal end of the tampon part (42) and a proximal end of the tampon part (42), the tampon part (42) being displaced from the tubular part (40) so that, when the septum is in the non-collapsed state, part of the slit length extends distally from the distal end (50) of the tubular part (40), when the septum goes into the collapsed state, the plug part is moved proximally into the internal cavity (62) in such a way that a smaller part of the length of the slot extends distally from the distal end (50) of the tubular part (40), CHARACTERIZED by the fact that the plug part (42) is displaced from the tubular part (40) so that, when in the collapsed state, the part tubular (40) applies an internal radial force against the plug part (42) to thereby seal the slit (60) to prevent fluid from passing through the slit.
    [0002]
    2. Septum, according to claim 1, CHARACTERIZED by the fact that the septum changes from the non-collapsed state to the collapsed state in response to a pressure on a distal face of the septum that exceeds a limit pressure.
    [0003]
    3. Septum, according to claim 2, CHARACTERIZED by the fact that the limit pressure is greater than a pressure produced by the withdrawal of an introducing needle (30) through the slit in the plug part.
    [0004]
    4. Septum according to claim 1, CHARACTERIZED by the fact that the plug part (42) extends from a central part of the distal end (50) of the tubular part.
    [0005]
    5. Septum according to claim 4, CHARACTERIZED by the fact that the distal end (50) of the tubular part forms an annular surface around the plug part (42).
    [0006]
    6. Septum according to claim 1, CHARACTERIZED by the fact that the internal cavity (62) extends from a proximal end of the tubular part (40) to the plug part (42).
    [0007]
    7. Septum, according to claim 1, CHARACTERIZED by the fact that the internal cavity (62) has a first cross-sectional area, perpendicular to a central axis of the tubular part (40), which is smaller than a second cross sectional area of the plug part (42), perpendicular to the central axis of the tubular part at a distal location from the distal end of the tubular part.
    [0008]
    8. Septum, according to claim 1, CHARACTERIZED by the fact that the septum is a one-piece elastomeric septum.
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    US9108021B2|2015-08-18|
    JP2015508010A|2015-03-16|
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    MX2014010019A|2014-09-12|
    CN104411358B|2017-11-17|
    CN104411358A|2015-03-11|
    US20130218082A1|2013-08-22|
    JP6181671B2|2017-08-16|
    CA2865175A1|2013-08-29|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US4781693A|1983-09-02|1988-11-01|Minntech Corporation|Insulin dispenser for peritoneal cavity|
    US5085645A|1990-08-15|1992-02-04|Becton, Dickinson And Company|Apparatus and method for a catheter adapter with valve|
    US5211634A|1991-08-06|1993-05-18|Vaillancourt Vincent L|Composite seal structure and a coupling arrangement for a cannula|
    US5330435A|1993-04-08|1994-07-19|Vaillancourt Vincent L|Valve for a catheter assembly|
    US5697914A|1995-03-16|1997-12-16|Becton Dickinson And Company|Control forward/flashback forward one hand introducer needle and catheter assembly|
    JPH0947512A|1995-08-10|1997-02-18|Nippon Zeon Co Ltd|Medical valve and auxiliary inserting equipment for medical use|
    US5810780A|1996-05-10|1998-09-22|Becton Dickinson And Company|Multiple cross section needle and elastic plug assembly for a medical device|
    US6273869B1|1996-06-13|2001-08-14|Vincent L. Vaillancourt|Valve connector|
    US5807348A|1996-11-27|1998-09-15|Elcam Plastics|Needleless valve|
    US5843046A|1997-05-29|1998-12-01|Paul J. Motisi|Catheter apparatus|
    US20030120214A1|2001-03-28|2003-06-26|Howell Glade H.|Blood seal having a spring-biased septum|
    US6228060B1|1998-09-02|2001-05-08|Becton, Dickinson And Company|Blood seal having a spring-biased septum|
    US6224569B1|1999-09-24|2001-05-01|Becton, Dickinson And Company|Compact needle point shield|
    US6699221B2|2000-06-15|2004-03-02|Vincent L. Vaillancourt|Bloodless catheter|
    US6506181B2|2001-05-25|2003-01-14|Becton, Dickinson And Company|Catheter having a low drag septum|
    US7270649B2|2004-07-14|2007-09-18|P. Rowan Smith, Jr.|Intravenous catheter device|
    CA2625471C|2005-10-11|2014-06-17|Covidien Ag|Iv catheter with in-line valve and methods related thereto|
    US7670317B2|2005-10-25|2010-03-02|Becton, Dickinson And Company|One piece low drag septum|
    US7798994B2|2005-11-15|2010-09-21|Becton, Dickinson And Company|Needle shield to septum interconnect|
    US8679063B2|2009-02-11|2014-03-25|Becton, Dickinson And Company|Systems and methods for providing a catheter assembly|
    US8721627B2|2010-07-22|2014-05-13|Carefusion 303, Inc.|Needleless valve infection prevention and pre-opening device|AT424879T|2005-07-06|2009-03-15|Vascular Pathways Inc|DEVICE FOR INTRAVENOUS CATHETER INTRODUCTION AND USE METHOD|
    AT548972T|2007-05-07|2012-03-15|Vascular Pathways Inc|INTRAVENOUS CATHETER INTRODUCTION AND BLOOD SPECIMENS|
    USD903100S1|2015-05-01|2020-11-24|C. R. Bard, Inc.|Catheter placement device|
    US8932258B2|2010-05-14|2015-01-13|C. R. Bard, Inc.|Catheter placement device and method|
    US10384039B2|2010-05-14|2019-08-20|C. R. Bard, Inc.|Catheter insertion device including top-mounted advancement components|
    USD903101S1|2011-05-13|2020-11-24|C. R. Bard, Inc.|Catheter|
    US9872971B2|2010-05-14|2018-01-23|C. R. Bard, Inc.|Guidewire extension system for a catheter placement device|
    US9950139B2|2010-05-14|2018-04-24|C. R. Bard, Inc.|Catheter placement device including guidewire and catheter control elements|
    US8690833B2|2011-01-31|2014-04-08|Vascular Pathways, Inc.|Intravenous catheter and insertion device with reduced blood spatter|
    ES2750035T3|2011-02-25|2020-03-24|Bard Inc C R|Medical component insertion device including a retractable needle|
    CN108607150B|2013-01-30|2021-01-12|血管通路股份有限公司|Systems and methods for venipuncture and catheter placement|
    US10154904B2|2014-04-28|2018-12-18|Edwards Lifesciences Corporation|Intravascular introducer devices|
    SG10201503314VA|2014-04-29|2015-11-27|Braun Melsungen Ag|Valved catheter assemblies and related methods|
    US10232146B2|2014-09-05|2019-03-19|C. R. Bard, Inc.|Catheter insertion device including retractable needle|
    US20160287794A1|2015-04-02|2016-10-06|Xend Medical Systems, Llc|Hypodermic needle system activation mechanism|
    CN113350614A|2015-05-15|2021-09-07|C·R·巴德股份有限公司|Catheter placement device including extendable needle safety feature|
    ES2805302T3|2015-08-18|2021-02-11|Braun Melsungen Ag|Catheter Devices with Valves and Related Methods|
    US10639455B2|2015-10-28|2020-05-05|Becton, Dickinson And Company|Closed IV access device with paddle grip needle hub and flash chamber|
    US10245416B2|2015-10-28|2019-04-02|Becton, Dickinson And Company|Intravenous catheter device with integrated extension tube|
    US10814106B2|2015-10-28|2020-10-27|Becton, Dickinson And Company|Soft push tabs for catheter adapter|
    US10525237B2|2015-10-28|2020-01-07|Becton, Dickinson And Company|Ergonomic IV systems and methods|
    US10744305B2|2015-10-28|2020-08-18|Becton, Dickinson And Company|Ergonomic IV systems and methods|
    US10357636B2|2015-10-28|2019-07-23|Becton, Dickinson And Company|IV access device having an angled paddle grip|
    US10463840B2|2015-10-28|2019-11-05|Becton, Dickinson And Company|Compliant catheter adapter having self-slitting needle|
    US10549072B2|2015-10-28|2020-02-04|Becton, Dickinson And Company|Integrated catheter with independent fluid paths|
    US10729889B2|2015-11-13|2020-08-04|B. Braun Melsungen Ag|Needle devices with dual diameter cannula and related methods|
    WO2017143176A1|2016-02-18|2017-08-24|Smiths Medical Asd, Inc.|Closed system catheter|
    EP3463158A4|2016-05-26|2020-01-22|Covidien LP|Cannula assemblies for use with robotic surgical systems|
    US10493262B2|2016-09-12|2019-12-03|C. R. Bard, Inc.|Blood control for a catheter insertion device|
    USD835262S1|2016-10-05|2018-12-04|Becton, Dickinson And Company|Intravenous catheter assembly|
    USD837368S1|2016-10-05|2019-01-01|Becton, Dickinson And Company|Catheter adapter grip|
    US10238852B2|2016-10-05|2019-03-26|Becton, Dickinson And Company|Septum housing|
    USD819802S1|2016-10-05|2018-06-05|Becton, Dickinson And Company|Catheter adapter|
    USD844781S1|2016-10-05|2019-04-02|Becton, Dickinson And Company|Needle hub|
    USD808013S1|2016-10-27|2018-01-16|Smiths Medical Asd, Inc.|Catheter|
    US10569069B2|2016-12-14|2020-02-25|Combat Comb, Llc|Applicator for treatments applied to animal skin|
    USD828653S1|2016-12-14|2018-09-11|Brandon Penland|Treatment applicator|
    EP3576829B1|2018-03-05|2021-01-06|Poly Medicure Limited|Intravenous catheter assembly|
    USD921884S1|2018-07-27|2021-06-08|Bard Access Systems, Inc.|Catheter insertion device|
    US20200046938A1|2018-08-09|2020-02-13|Becton, Dickinson And Company|Blood control septum and related systems|
    US20200061343A1|2018-08-23|2020-02-27|Becton, Dickinson And Company|Low-drag septum for a catheter system|
    US20210068731A1|2019-09-10|2021-03-11|Becton, Dickinson And Company|Catheter system to facilitate blood collection and related methods|
    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2020-01-07| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-02-23| B09A| Decision: intention to grant|
    2021-03-30| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 20/02/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/402,133|2012-02-22|
    US13/402,133|US9108021B2|2012-02-22|2012-02-22|Low drag, high pressure septum|
    PCT/US2013/026935|WO2013126446A1|2012-02-22|2013-02-20|A low drag, high pressure septum|
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