• 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:
    The present invention relates to a vascular access device which can include a housing, which can include a proximal end, a distal end and a slit. The distal end of the housing can be configured to be coupled to a catheter assembly. The vascular access device may also include an instrument arranged within the housing. The instrument can include a catheter or a probe. The instrument may include a proximal end and a distal tip. The proximal end of the instrument can extend through the slot and can be configured to move along the slot to move the instrument from a proximal position to a distal position. In response to movement from the proximal end of the instrument from the proximal to the distal position, the catheter can be advanced beyond the distal end of the housing to a patient's catheter and / or vasculature assembly.
    公开号:BR112020001073A2
    申请号:R112020001073-1
    申请日:2018-07-18
    公开日:2020-07-14
    发明作者:Jonathan Karl Burkholz；Bryan Bihlmaier；Joseph Spataro
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    [001] [001] Catheters are commonly used for a variety of infusion therapies. For example, catheters can be used to infuse fluids, such as normal saline, various medications and total parenteral nutrition, into a patient. Catheters can also be used to draw blood from the patient.
    [002] [002] A common type of catheter is a peripheral intravenous (“IV”) catheter over a needle. As the name implies, the needle catheter can be mounted on an introducer needle with a sharp distal tip. The catheter and the introducing needle can be mounted so that the distal tip of the introducing needle extends beyond the distal tip of the catheter with the chamfer of the needle facing upwards on the patient's skin. The catheter and introducer needle are usually inserted at a shallow angle through the skin into the patient's vasculature.
    [003] [003] To check the proper placement of the introducing needle and / or the catheter in the blood vessel, a doctor usually confirms that there is "return" of blood in a return chamber of the catheter assembly. After confirming the placement of the needle, the doctor can temporarily hide the flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.
    [004] [004] Blood withdrawal using a peripheral IV catheter can be difficult for several reasons, particularly when the catheter remains longer than one day. For example, when the catheter is left inserted in the patient for an extended period of time, it may be more susceptible to narrowing, collapse, twisting, debris blocking (for example, fibrin clots or platelets) and adherence to a tip of the catheter to the vasculature. Because of this, catheters can often be used to acquire a blood sample at the time of placement of the catheter, but are much less frequently used to acquire a blood sample during the catheter's period of stay. Therefore, when a blood sample is required, an additional needle stick is needed to provide access to the vein for blood collection, which can be painful for the patient and result in higher material costs. Therefore, there is a need for catheter systems and methods that facilitate the placement of blood sample instruments, such as, for example, catheters and probe instruments in the patient's vasculature, without additional needle sticks. SUMMARY OF THE INVENTION
    [005] [005] The present application generally relates to an extension or introducer that can accommodate an instrument, such as, for example, an intravenous catheter or probe, as well as related systems and methods. In some embodiments, the extension may include a vascular access device that allows the instrument to access a patient's vasculature through another vascular access device, such as, for example, a catheter set, which can be inserted into the patient's vasculature . In some modalities, when the instrument is introduced into the catheter set via the extension, the instrument can access a fluid path from the catheter set and / or the instrument can extend through the catheter set and access the patient's vasculature.
    [006] [006] In some modalities, the extension may include a blood collection device, which can be used to obtain a blood sample. In some embodiments, a catheter in the catheter assembly with significant residence time may be susceptible to narrowing, collapse, twisting, blockage by debris (for example, fibrin clots or platelets) and adhesion of a catheter tip to the vasculature. Thus, drawing blood using the catheter can be difficult. In some embodiments, the instrument may include another catheter that can be disposed within the extension, and the other catheter can provide access to the patient's vasculature without any additional needle sticks. Thus, in some modalities, the extension can be used for needle-free blood collection and / or fluid infusion. Advantageously, in some modalities, the extension can also allow the maintenance of a closed system and aseptic technique, while reducing the disturbance or displacement of the catheter and / or catheter fixation dressing.
    [007] [007] In some modalities, the instrument may include a probe, which can be arranged inside the extension. In some embodiments, the probe may include one or more openings and / or one or more sensors. In some embodiments, the openings and / or the sensors can be arranged towards a distal tip of the probe. In some embodiments, the openings can serve as fluid inlets and / or outlets. In some embodiments, sensors can measure one or more parameters and / or detect one or more elements related, for example, to diagnostic information, blood chemistry, pressure, flow rate, drug identification, microbes, stent placement implantable, catheter tip stabilization feature in the vein, or other device, etc. In some embodiments, the extension may facilitate the placement of a portion of the probe that includes the sensors within the fluid path of the catheter assembly and / or the patient's vasculature. In some embodiments, the instrument can function as both the probe and the other catheter, including elements from both the probe and the other catheter.
    [008] [008] In some embodiments, the catheter assembly may include one or more of the following items: the catheter, a catheter adapter, a septum housing, and a septum. In some embodiments, the catheter can be fixed inside and extend distally from the catheter adapter. In some embodiments, the catheter assembly may include a peripheral IV catheter assembly. In some embodiments, the catheter adapter may include a distal end, a proximal end, and a lumen that extends between them. In some embodiments, the septum may be disposed within the lumen of the catheter adapter. In some embodiments, the septum may be at least partially disposed within the septum housing and configured to at least substantially seal the lumen of the catheter adapter. In some embodiments, the septum housing can prevent the septum from moving or destabilizing, thus preventing fluid leakage from the lumen of the catheter adapter.
    [009] [009] In some embodiments, the extension can be coupled to a closed IV catheter assembly or to a catheter assembly with an integrated extension tube, such as, for example, the Becton Dickinson NEXIVATY closed IV catheter system or the Becton Dickinson NEXIVA'y DIFFUSICSTY closed IV catheter, In these and other embodiments, a proximal end of the catheter adapter may include a first port and a second port. In these and other embodiments, the lumen of the catheter adapter may include a first lumen and / or a second lumen. In some embodiments, the first port can form the first lumen and / or the second port can form the second lumen. In some embodiments, the first and second lumens can be joined in a common lumen. In some embodiments, the first lumen can generally be aligned with the common lumen and / or the second door can include a side door. In some embodiments, the septum and / or the septum housing may be arranged in the first lumen.
    [010] [010] In some embodiments, the second lumen of the catheter adapter can be attached to the extension via an extension tube that can extend from the second port of the catheter adapter, as will be explained in more detail later. In some embodiments, a needle introducing the catheter assembly can be removed through the catheter adapter after insertion of the catheter into the patient's vasculature. In the closed IV catheter system, when the introducer needle is removed through the catheter adapter, the first lumen, which may correspond to a “needle channel”, can be closed by the septum from an external environment around the adapter. catheter. Thus, the septum can at least substantially seal the first port and prevent fluid from escaping from the catheter adapter through the first port. In some embodiments, a fluid path from the catheter assembly during fluid infusion and / or blood withdrawal may extend through the second port and not the first port. In some embodiments, the septum and / or the septum housing may be arranged proximal to the second port of the catheter adapter.
    [011] [011] In some embodiments, the catheter assembly may include another type of catheter assembly, such as, for example, a non-integrated catheter assembly or a catheter assembly without the integrated extension tube. In some embodiments, the extension can be attached to the non-integrated catheter set.
    [012] [012] In some embodiments, the extension may include a barrel or housing, which may include a proximal end and a distal end. In some embodiments, the distal end of the housing may include a coupling mechanism, which can couple the extension to the catheter assembly. In some embodiments, the coupling mechanism can be coupled directly to the catheter adapter. In some embodiments, a proximal end of the catheter assembly extension tube can be attached to an adapter or coupler element, which can be attached to the extension. In some embodiments, the coupling element may include a y-adapter, a single port, or double ports. In some embodiments, the coupling element may include a luer fitting and / or a blood control valve. In some embodiments, the coupling element may include a luer accessory and a removable or non-removable needle-free connector.
    [013] [013] In some embodiments, the instrument may be at least partially arranged or housed within the housing. In some embodiments, the housing can at least partially surround the instrument, which can protect the instrument from the external environment around the extension. In some embodiments, the housing may include a slit, which may extend parallel to a longitudinal axis of the housing. In these and other modalities, the housing can be rigid or semi-rigid.
    [014] [014] In some embodiments, the extension may include an adapter, which can be attached to a proximal end of the instrument. In some embodiments, the adapter can be configured to move along the slot from a proximal position to a distal position and / or from a distal position to a proximal position. In some embodiments, in response to the adapter's movement along the slit from the proximal to the distal position, the instrument is advanced beyond the distal end of the housing. In some embodiments, in response to the adapter's movement along the slit from the distal to the proximal position, the instrument can be removed into the housing. In some embodiments, the distal end of the housing may include an elastomer or other suitable sealing material to provide a fluid seal between the distal end of the extension housing and the instrument.
    [015] [015] In some embodiments, the adapter may include a cavity configured to receive, for example, a syringe and / or blood collection tube. In some embodiments, the adapter may include a cannula disposed within the cavity and configured to pierce a syringe septum in response to the syringe being advanced into the adapter cavity. Additionally or alternatively, in some embodiments, the cannula can be configured to pierce a septum in the blood collection tube in response to the blood collection tube being advanced into the adapter cavity.
    [016] [016] In some modalities, the adapter can be attached to the proximal end of the instrument in several ways. In some embodiments, the adapter can be formed integrally with the proximal end of the instrument. In some embodiments, the adapter can be permanently attached to the proximal end of the instrument or monolithically formed as a single piece with the proximal end of the instrument. In some embodiments, the adapter can be selectively attached to the proximal end of the instrument. For example, the proximal end of the instrument may include a luer accessory, which can be attached to a corresponding adapter luer accessory. In some embodiments, the luer accessory on the proximal end of the instrument can correspond to a luer accessory on any number of devices. In some embodiments, the proximal end of the instrument may include or be coupled to an instrumentation interface, an electrical connection and / or an optical connection.
    [017] [017] In some modalities, the instrument may include the proximal end and a distal tip. In some embodiments, the proximal end of the instrument, which may include an instrument hub, may extend through the slot, which may allow the physician to move the proximal end of the instrument along the slot to move the instrument from a proximal position. to a distal position and / or from a distal position to a proximal position. In some embodiments, the proximal end of the instrument may include an instrument hub, as will be explained in more detail later. In some modalities, the distal or extraction position of the instrument and / or adapter may correspond to a position to probe or collect blood. In some modalities, when the instrument is placed in the proximal position, the proximal end of the instrument can be arranged at or near a proximal end of the slot. In some embodiments, when the instrument is disposed in the distal position, the proximal end of the instrument can be disposed at or near a distal end of the slot.
    [018] [018] In some embodiments, the proximal end of the instrument may include a curved or angled part, which may extend through the slot and / or may be attached to the adapter or other device. In some embodiments, the adapter can be angled in relation to the housing. In some embodiments, the adapter can be oriented parallel to the longitudinal axis of the housing. In some embodiments, the extension may include an advance guide, which can be attached to the proximal end of the instrument and / or the adapter. In some modalities, the doctor may pinch or hold the advancement guide to move the instrument to the proximal and / or distal position. In some embodiments, the instrument is advanced beyond the distal end of the housing and / or the catheter when the adapter is disposed in the distal position. In some embodiments, the feed guide can be moved from the slot, which can facilitate easy movement of the instrument and / or the adapter in relation to the slot. In some embodiments, the adapter can be used as the feed guide.
    [019] [019] In some embodiments, at least part of the housing may be axially compressible or axially collapsible. In some embodiments, the extension may include a hem or sleeve. In some embodiments, the sleeve may at least partially surround the instrument. In these and other modalities, the sleeve can protect the instrument from contaminants and / or isolate any blood or other fluids that may remain in the instrument after accessing the catheter assembly fluid path. In these and other modalities, the sleeve can protect the instrument from the external environment around the extension.
    [020] [020] In some embodiments, the instrument may be at least partially arranged inside the sleeve. In some embodiments, the sleeve may be axially collapsible or axially compressible. In more detail, in some embodiments, the instrument can be advanced to the distal position beyond a distal end of the sleeve when the sleeve is compressed or retracted in the distal direction.
    [021] [021] In some embodiments, a kit may include one or more of the following items: the catheter set, the extension, the syringe, the blood collection tube, an alcohol pad, one or more disinfection caps, a antimicrobial skin preparation solution, and catheter fixation dressing. In some embodiments, the dressing may include a crack in the extension tube and / or one or more antimicrobial agents. In some embodiments, disinfection caps may include one or more antimicrobial agents and / or may be configured to close the coupling element and / or one or more catheter adapter ports. Specifically, in some embodiments, the kit may include a blood collection kit, and the instrument may include the other catheter. BRIEF DESCRIPTION OF THE DRAWINGS
    [022] [022] In order that the manner in which the above and other features and advantages of the invention are obtained is readily understood, a more particular description of the invention described briefly above will be made by reference to specific embodiments thereof which are illustrated in the drawings attached. These drawings represent only typical embodiments of the invention and, therefore, should not be considered as limiting the scope of the invention.
    [023] [023] Figure 1A is a perspective view from above of an exemplary extension coupled to an exemplary catheter set, illustrating an exemplary instrument in a proximal position, according to some modalities.
    [024] [024] Figure 1B is a perspective view from above of the extension of Figure 1A coupled to the catheter assembly, illustrating the instrument in a distal position, according to some modalities.
    [025] [025] Figure 1C is a perspective view from above of an exemplary instrument with a variable external diameter, according to some modalities.
    [026] [026] Figure 2A is a perspective view from above of the extension of Figure 1A, illustrating an exemplary adapter angled in relation to an exemplary housing, according to some modalities.
    [027] [027] Figure 2B is a perspective view from above of another exemplary extension, illustrating the adapter oriented parallel to a longitudinal axis of the housing, according to some modalities.
    [028] [028] Figure 2C is a perspective view from above of an exemplary luer accessory arranged on a proximal end of the instrument, according to some modalities.
    [029] [029] Figure 2D is a perspective view from above of the extension of Figure 1A, illustrating an exemplary blood collection tube coupled to the adapter, according to some modalities.
    [030] [030] Figure 2E is a perspective view from above of an exemplary extension tube attached to the proximal end of the instrument, according to some modalities.
    [031] [031] Figure 2F is a perspective view from above of another exemplary extension tube attached to the proximal end of the instrument, according to some modalities.
    [032] [032] Figure 2G is a perspective view from above of exemplary markings arranged in an exemplary housing, according to some modalities.
    [033] [033] Figure 2H is a perspective view from above of an exemplary sleeve when the instrument is placed in the proximal position.
    [034] [034] Figure 2! it is a perspective view from above of the sleeve of Figure 2H when the instrument is disposed in the distal position.
    [035] [035] Figure 3 is a perspective view from above of another catheter system, illustrating another exemplary housing, according to some modalities.
    [036] [036] Figure 4 is a perspective view from above of an example kit,
    [037] [037] The currently preferred embodiments of the present invention can be understood by reference to the drawings, in which similar 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 figures contained herein, can be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of the currently preferred embodiments of the invention. In addition, the Figures may show simplified or partial views, and the dimensions of the elements in the Figures may be exaggerated or not in proportion for clarity.
    [038] [038] As used in the present description, the terms "proximal" and "distal" can refer to the nearest and distant direction, respectively, of a doctor who would put the catheter system in contact with a patient. Thus, for example, the end of the catheter system first touching the patient's body would be the distal end, while the opposite end of the catheter system (for example, the end of the device being manipulated by the physician) would be the proximal end of the delivery system. catheter.
    [039] [039] The present application relates generically to an extension that can accommodate an instrument, such as, for example, an intravenous catheter or probe, as well as related systems and methods. Referring now to Figures 1A-1B, in some embodiments, extension 10 or introducer can be configured to introduce instrument 12 into a catheter set 14. In some embodiments, when instrument 12 is inserted into catheter set 14, the instrument 12 can access a fluid path from catheter assembly 14 and / or the instrument can extend through catheter assembly 14 and access a patient's vasculature.
    [040] [040] In some embodiments, extension 10 may include a blood collection device, which can be used to obtain a blood sample. In some embodiments, a catheter 16 of the catheter assembly 14 with significant residence time may be susceptible to narrowing, collapse, twisting, blockage by debris (for example, fibrin clots or platelets) and adhesion of a tip 18 of catheter 16 to the vasculature. Thus, drawing blood using catheter 16 can be difficult. In some embodiments, instrument 12 may include another catheter that can be disposed within the extension, and the other catheter can provide access to the patient's vasculature without any additional needle sticks, as illustrated, for example, in Figure 1B. Thus, in some modalities, extension 10 can be used for needle-free blood collection and / or fluid infusion.
    [041] [041] In some embodiments, the instrument 12 may include a probe, which may be at least partially arranged within the extension 10. In some embodiments, the probe may include one or more openings and / or one or more sensors. In some embodiments, the openings and / or the sensors can be arranged towards a distal tip of the probe. In some embodiments, the openings can serve as fluid inlets and / or outlets. In some modalities, sensors can measure one or more parameters and / or detect one or more elements related to, for example, diagnostic information, blood chemistry, pressure, flow rate, drug identification, microbes, stent placement implantable, catheter tip stabilization feature in the vein, or other device, etc. In some embodiments, extension 10 may facilitate the placement of a portion of the probe that includes the sensors within the fluid path of the catheter assembly 14 and / or the patient's vasculature. In some embodiments, the instrument 12 can function as the probe and the other catheter, including probe and other catheter elements.
    [042] [042] In some embodiments, catheter assembly 14 may include one or more of the following items: catheter 16, catheter adapter 20, septum housing, and septum. In some embodiments, catheter 16 can be fixed in and extend distally from catheter adapter 20. In some embodiments, catheter set 14 may include a peripheral IV catheter set. In some embodiments, the catheter adapter 20 may include a distal end, a proximal end, and a lumen that extends between them. In some embodiments, the septum may be disposed within the lumen of the catheter adapter 20. In some embodiments, the septum may be at least partially disposed within the septum housing and configured to at least substantially seal the lumen of the catheter adapter. In some embodiments, the septum housing can prevent the septum from moving or destabilizing, thereby preventing fluid leakage from the lumen of the catheter adapter.
    [043] [043] In some embodiments, extension 10 can be attached to a closed IV catheter set or a catheter set with an integrated extension tube 22, such as, for example, the Becton Dickinson NEXIVA'Y closed IV catheter system or the Becton Dickinson NEXIVATY DIFFUSICSTY closed IV catheter system. In these and other embodiments, a proximal end of the catheter adapter 20 may include a first port 24 and a second port 26. In these and other embodiments, the lumen of the catheter adapter 20 may include a first lumen and / or a second lumen. . In some embodiments, the first port 24 can form the first lumen and / or the second port 26 can form the second lumen. In some embodiments, the first and second lumens can be joined in a common lumen. In some embodiments, the first lumen can generally be aligned with the common lumen and / or the second port 26 can include a side port. In some modalities, the septum and / or the septum housing may be arranged in the first lumen 24.
    [044] [044] In some embodiments, the second lumen of catheter adapter 20 can be attached to extension 10 through extension tube 22 which can extend from second port 26 of catheter adapter 20, as will be explained later in more Details. In some embodiments, an introducer needle (not shown) from catheter assembly 14 can be removed via catheter adapter 20 after insertion of catheter 16 into the patient's vasculature. In the closed IV catheter system, when the introducer needle is removed through adapter 20, the first lumen 24, which may correspond to a “needle channel”, can be closed by the septum from an external environment around the adapter. catheter 20. Thus, the septum can at least substantially seal the first port 24 and prevent fluid from leaving catheter adapter 20 through first port 24. In some embodiments, a fluid path from catheter assembly 14 during infusion of fluid and / or blood withdrawal may extend through the second port 26 and not the first port 24. In some embodiments, the septum and / or the septum housing may be arranged proximal to the second port 26 of the catheter adapter 20.
    [045] [045] In some embodiments, the catheter set 14 may include another type of catheter set, such as, for example, a non-integrated catheter set or a catheter set without the integrated extension tube 22. In some embodiments, extension 10 can be coupled to the non-integrated catheter assembly. In some embodiments, extension 10 can be coupled directly to a non-integrated catheter assembly port. In some embodiments, accessing the fluid path and / or the vasculature through a particular septum and / or the first port 24, the insertion of the instrument 12 through a longer path of the extension tube 22 or an integrated extension set can be avoided.
    [046] [046] In some embodiments, instrument 12 may be guided by one or more resources, such as, for example, one or more conical surfaces, to allow instrument 12 to access a fluid path from the catheter assembly and / or the vasculature of the patient. The orientation of instrument 12 through catheter assembly 14 is described in more detail in US Patent Application No. 62 / 534,557, filed July 19, 2017, entitled “Systems and Methods to Improve Instrument Guidance Within an Intravenous Catheter Assembly, which is hereby incorporated by reference in its entirety.
    [047] [047] In some embodiments, extension 10 may include a barrel or housing 28, which may include a proximal end and a distal end. In some embodiments, the distal end of the housing 28 may include a coupling mechanism 30, which may attach the extension 10 to the catheter assembly 14. In some embodiments, the coupling mechanism 30 may be a luer fitting, such as, for example , a male luer accessory or a luer lock threaded collar. In some embodiments, the coupling mechanism 30 may include a non-luer coupling mechanism. In some embodiments, the coupling mechanism 30 may be part of an introducer element, as described in more detail in US Patent Application No. 62 / 534,557, filed July 19, 2017, entitled “Systems and Methods to Improve Instrument Guidance Within an Intravenous Catheter Assembly ”.
    [048] [048] In some embodiments, the coupling mechanism 30 can be coupled directly to the catheter adapter 20. In some embodiments, a proximal end of the extension tube 22 of the catheter assembly 14 may include an adapter or coupler element 32, which can be coupled to the corresponding coupling mechanism 30 of extension 10. In some embodiments, the extension tube 22 may provide conformity and / or flexibility in the system, which may allow a length of extension 10 to be shortened and / or prevent the use of another extension tube, as will be explained in more detail later. In some embodiments, the coupling element 32 may include a y-adapter, a single port or double ports. In some embodiments, the coupling element 32 may include a luer fitting and / or a blood control valve. In some embodiments, the blood control valve can facilitate the maintenance of the closed system and prevent blood leakage.
    [049] [049] In some embodiments, the coupling mechanism 30 may include at least one valve, which can provide a fluid seal that is penetrated by the instrument. The valve of the coupling mechanism 30 can be arranged in any number of locations to prevent fluid from the catheter assembly 14 from entering all or part of one or more of the following items: the coupling mechanism 30, a sleeve 55 (illustrated in Figures 2H -2l)) and housing 28. In some embodiments, the valve may include a septum and / or a slit. In some embodiments, the valve may cover a distal opening of the coupling mechanism 30. In some embodiments, the valve may be arranged within an inner lumen of the coupling mechanism 30 and / or extend across a diameter of the inner lumen.
    [050] [050] In some embodiments, instrument 12 may be at least partially arranged or housed within housing 28. In some embodiments, housing 28 may at least partially surround the instrument, which may protect instrument 12 from the surrounding external environment extension 10 and / or microbes. In some embodiments, the housing 28 may include a slot 34, which may extend parallel to a longitudinal axis of the housing 28. In these and other embodiments, the housing 28 may be rigid or semi-rigid. In some embodiments, housing 28 may be clear or opaque.
    [051] [051] In some embodiments, at least part of the housing 28 may be axially compressible or axially collapsible. For example, housing 28 may include one or more folding and / or telescopic barrels. Additionally or alternatively, housing 28 may include slot 34. In some embodiments, a first concentric barrel may be advanced to a second concentric barrel. In some embodiments, at least part of the first concentric barrel and / or the second concentric barrel may be collapsible.
    [052] [052] In some embodiments, extension 10 may include an adapter 36, which can be attached to a proximal end of the instrument 12. In some embodiments, adapter 36 can be configured to move along slot 34 from a proximal position to a distal position and / or from the distal position to the proximal position. In some embodiments, in response to the movement of the adapter 36 along the slit 34 from the proximal to the distal position, the instrument 12 is advanced beyond the distal end of the housing 28. In some embodiments, in response to the movement of the adapter 36 along from the slit 34 from the distal to the proximal position, the instrument 12 can be removed to the housing 28.
    [053] [053] In some embodiments, adapter 36 may include a cavity configured to receive, for example, a syringe and / or blood collection tube. In some embodiments, adapter 36 may include a cannula 38 disposed within the cavity and configured to puncture a septum of the syringe in response to the syringe being advanced into the cavity of adapter 36. Additionally or alternatively, in some embodiments, cannula 38 may be configured to perforate a septum of the blood collection tube in response to the blood collection tube being advanced into the adapter cavity 36. In some embodiments, adapter 36 may correspond to the Becton Dickinson VACUTAINERO single use holder or a similar holder.
    [054] [054] In some embodiments, the instrument 12 may include the proximal end and the distal tip 42. In some embodiments, the distal tip 42 may include one or more holes 44, which may be inlet and / or outlet holes. In some embodiments, the distal tip 42 may be constructed of a softer and / or less rigid material than the proximal end of the instrument 12 for resistance to bending. In some modalities, the distal tip 42 can be blind, straight or tapered. In some embodiments, the proximal end of the instrument 12 may extend through the slit 34, which may allow the physician to move the proximal end of the instrument 12 along the slit 34 to move the instrument from the proximal position to the distal position and / or from the distal to the proximal position.
    [055] [055] Referring now to Figure 1C, in some embodiments, instrument 12 may include a variable outside diameter. In some embodiments, a distal part 41 of the instrument may have a smaller outside diameter than a proximal portion 43 of the instrument 12. Additionally or alternatively, the instrument 12 may have variable stiffness over the length of the instrument 12. In some embodiments, the distal part 41 can be configured to flex in a transition from the second lumen of the catheter adapter 20 to the common lumen, as illustrated in Figure 1C. In these and other modalities, the proximal part 43 may be more rigid than the distal part 41. In some modalities, the distal part 41 may be more rigid than the proximal part 43.
    [056] [056] Referring now to Figures 2A-2F, in some embodiments, adapter 36 can be attached to the proximal end of instrument 12 in several ways. In some embodiments, adapter 36 may be removably or non-removably attached to the proximal end of the instrument 12. In some embodiments, the other extension tube may extend from the proximal end of the instrument 12 to adapter 36. In some embodiments , adapter 36 can be formed integrally with the proximal end of the instrument 12. In some embodiments, adapter 36 can be permanently attached to the proximal end of the instrument 12 or monolithically formed as a single piece with the proximal end of the instrument 12. In some cases modalities, the adapter 36 can be selectively coupled to the proximal end of the instrument 12. For example, the proximal end of the instrument can include a luer accessory 40, as illustrated, for example, in Figure 2C, which can be coupled to a corresponding luer accessory adapter 36. In some embodiments, the luer attachment 40 on the proximal end of the instrument 12 respond and be attached to a luer accessory of any number of devices. In some embodiments, the proximal end of the instrument 12 may include an instrumentation interface, an electrical connection, and / or an optical connection.
    [057] [057] In some embodiments, the proximal end of the instrument 12 can include a curved or angled part, which can extend through the slot 34 and / or can be coupled to the adapter 36 or other device. In some embodiments, the other extension tube may extend through slot 34. In some embodiments, the proximal end of the instrument may include an instrument hub, which can facilitate coupling with the adapter. In some embodiments, the instrument hub may include the curved or angled part and / or may extend through the slot 34. In some embodiments, the instrument hub may be attached to a distal part of the instrument 12 via mechanical, adhesive, solvent, ultrasonic, or other suitable type of bond. For clarity, in some embodiments, the proximal end of the instrument 12 may extend through the slot 34 via or the hub of the instrument which extends through the slot 34 or another part of the instrument 12 which extends through the slot 34.
    [058] [058] In some embodiments, the adapter 36 can be angled in relation to the housing, as illustrated, for example, in Figure 2A. In some embodiments, the adapter 36 can be oriented parallel to the longitudinal axis of the housing 28, as illustrated, for example, in Figure 2B.
    [059] [059] In some embodiments, the extension may include an advance guide 46, which can be attached to the proximal end of the instrument 12 and / or adapter
    [060] [060] Figure 2E illustrates a distal end of an extension tube 49 coupled to the proximal end of the instrument 12, according to some modalities. In some embodiments, the proximal end of the extension tube 49 can be attached to adapter 36 or another device. In some embodiments, the proximal end of the extension tube 49 may include a coupling mechanism, such as, for example, a luer fitting which may be compatible with an adapter luer fitting 36 and / or other device. In some embodiments, the extension tube 49 can be constructed of a flexible material. In some embodiments, extension tube 49 can facilitate greater adherence and / or flexibility during blood collection, which can reduce disturbance of catheter 16 and / or catheter fixation dressing.
    [061] [061] Referring now to Figure 2F, in some embodiments, the extension tube 49 may extend through the proximal end of the housing 28. In some embodiments, the extension tube 49 may include an extended length.
    [062] [062] With reference now to Figure 2G, in some modalities, the housing 28 may include one or more markings 53 or measurements, which can visually indicate to the doctor a depth of insertion of the instrument 12. In some modalities, markings 53 may indicate the extent to which one or more different instruments are inserted and / or removed 12, which may include different types of catheters, for example. In some embodiments, the extension 10 may include a locking mechanism, which may allow the instrument 12 to be locked in the distal position, in the proximal position or in one or more positions between the distal position and the proximal position. In some embodiments, instrument 12 can be selectively locked. In some modalities, the markings may include holders or other resources that can permanently or selectively maintain the instrument 12. In some modalities, the markings 53 may indicate one or more of the following items: the distal position of the instrument, the proximal position of the instrument, and the positions between the distal position and the proximal position of the instrument.
    [063] [063] Referring now to Figures 2H-21, in some embodiments, the extension 10 may include the sheath or sleeve 55. In some embodiments, the sleeve 55 may at least partially surround the instrument 12. In these and other embodiments, the sleeve 55 can protect instrument 12 from contaminants and / or isolate any blood or other fluids that may remain in instrument 12 after accessing the fluid path of catheter assembly 14. In these and other embodiments, sleeve 55 can protect instrument 12 from the external environment around the extension.
    [064] [064] In some embodiments, sleeve 55 can be axially collapsible or axially compressible. In more detail, in some embodiments, the instrument 12 can be advanced to the distal position in addition to a distal end of the sleeve 55 and / or catheter 16 when the sleeve 55 is retracted or compressed in the distal direction, as illustrated, for example, in Figure 2l. In some embodiments, a proximal end of the sleeve 55 can be attached to the instrument. For example, a proximal end of the sleeve 55 can be attached to the proximal end of the instrument 12. In some embodiments, the distal end of the sleeve 55 can be attached to the coupling mechanism 30 or the other part of the housing 28. In some embodiments, the sleeve 55 may or may not extend through slot 34.
    [065] [065] With reference now to Figure 3, in some embodiments, at least part of the sleeve 55 can be axially compressible or axially collapsible. In more detail, in some embodiments, the instrument 12 can be advanced to a position beyond the distal end of the sleeve 55 when the sleeve 55 is compressed or collapsible in the distal direction. In some embodiments, extension 10 may include a hub or claw 50, which may be attached to a proximal end of the sleeve 55. In some embodiments, a physician may move the claw 50 distally to compress or retract the sleeve 55 in the distal direction and advance the instrument 12 to the position beyond the distal end of the sleeve 55. In some embodiments, a physician may move the claw 50 proximally to expand the sleeve 55 in a proximal direction and withdraw the instrument 12 to the sleeve 55, where the instrument 12 can be locked. In some embodiments, the claw 50 and / or the instrument 12 can be coupled, for example, to the adapter 36, another device, an instrumentation interface, an electrical connection and / or an optical connection. In some embodiments, as shown in Figure 3, extension 10 may not include housing 28.
    [066] [066] Referring now to Figure 4, in some embodiments, a kit 52 may include one or more of the following items: catheter assembly 14, extension 10, syringe 54, blood collection tube 48, a compress soaked in alcohol 56, one or more disinfection caps 58, and a catheter fixation dressing (not shown). In some embodiments, the dressing may include a crack in the extension tube and / or one or more antimicrobial agents. In some embodiments, the disinfection caps 58 may include one or more antimicrobial agents and / or may be configured to close coupler element 32 and / or one or more catheter adapter ports. Specifically, in some embodiments, Kit 52 may include a blood collection kit or line removal kit, and instrument 12 may include the other catheter.
    [067] [067] In some embodiments, a method of using extension 10 and / or kit 52 may include disinfecting the coupling element 32 with the alcohol pad 56. In some embodiments, after disinfecting the coupling element 32, the extension 10 it can be coupled to the catheter assembly 14 through the coupling element 32. In some embodiments, the catheter assembly 14 may have been previously inserted into the patient's vasculature. In some embodiments, the instrument 12 can then be advanced through the fluid path of the catheter assembly 14 and / or the distal tip 42 of the instrument can be placed in the vasculature distal to the tip 18 of catheter 16. In some embodiments, after advancement of the instrument, syringe 54, which can be pre-filled, can be used to wash the catheter assembly 14 to remove stagnant blood and / or medication. In some embodiments, a plunger of syringe 54 can be pulled out to withdraw a sample for disposal. In some embodiments, blood collection tube 48 can be attached to adapter 36 to obtain a blood sample. In some embodiments, after blood collection and / or probing, extension 10 can be decoupled from catheter assembly 14 and disinfection cap 58, which may include one or more antimicrobial agents, can be placed on coupling element 32 for disinfection . In some embodiments, one or more steps of the method may be optional, such as, for example, washing the catheter assembly 14 and / or removing the disposal sample. In some embodiments, extension 10 can be discarded after use.
    [068] [068] The present invention can be incorporated in other specific forms, without abandoning its structures, methods or other essential characteristics, as here described and widely claimed below. 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, and not by the previous description. All changes that fall within the meaning and equivalence range of the claims must be covered within its scope.
    权利要求:
    Claims (20)
    [1]
    1. Vascular access device, CHARACTERIZED by the fact that it comprises: a housing, comprising a proximal end, a distal end, and a slit; and an instrument disposed within the housing, in which the instrument comprises a proximal end and a distal tip, in which the instrument comprises a catheter or probe, in which the proximal end of the instrument extends through the slot and is configured to move along the slit from a proximal to a distal position, in response to the movement of the proximal end of the instrument from the proximal to the distal position, the instrument is advanced beyond the distal end of the housing.
    [2]
    2. Vascular access device according to claim 1, CHARACTERIZED by the fact that the instrument comprises the catheter, in which the proximal end of the instrument is coupled to an adapter, in which the adapter comprises a cavity configured to receive a syringe or blood collection tube, where the adapter additionally comprises a cannula disposed within the cavity and configured to pierce a septum of the syringe or blood collection tube in response to the syringe or blood collection tube being advanced into the cavity adapter.
    [3]
    3. Vascular access device, according to claim 1, CHARACTERIZED by the fact that the housing is rigid or semi-rigid.
    [4]
    4. Vascular access device according to claim 1, CHARACTERIZED by the fact that the proximal end of the instrument comprises a luer accessory.
    [5]
    5. Vascular access device, according to claim 1, CHARACTERIZED by the fact that the adapter is angled in relation to the housing.
    [6]
    6. Vascular access device according to claim 1, CHARACTERIZED by the fact that the adapter is oriented parallel to a longitudinal axis of the housing.
    [7]
    7. Vascular access device, according to claim 1, CHARACTERIZED by the fact that it additionally comprises an advance guide coupled to the instrument.
    [8]
    8. Vascular access device, according to claim 7, CHARACTERIZED by the fact that the feed guide is displaced from the slot.
    [9]
    9. Vascular access device, CHARACTERIZED by the fact that it comprises: a sleeve, comprising a proximal end and a distal end, in which the distal end is configured to be coupled to a catheter assembly, in which the sleeve is compressible in one distal direction; and an instrument arranged inside the sleeve, in which the instrument comprises a proximal end and a distal tip, in which the instrument comprises a catheter or probe, in which the instrument is configured to move from a proximal position to a distal position, wherein the instrument is advanced beyond the distal end of the sleeve when the adapter is disposed in the distal position.
    [10]
    Vascular access device according to claim 9, CHARACTERIZED by the fact that it additionally comprises a housing comprising a proximal end and a distal end, wherein the distal end is configured to be coupled to the catheter assembly, wherein the catheter is advanced to a position beyond the distal end of the housing when the sleeve is compressed in the distal direction.
    [11]
    11. Vascular access device, according to claim 9, CHARACTERIZED by the fact that the instrument comprises the catheter,
    further comprising an adapter coupled to the proximal end of the instrument, the adapter comprising a cavity configured to receive a syringe or blood collection tube, the adapter further comprising a cannula disposed within the cavity and configured to pierce a septum of the syringe or from the blood collection tube in response to the syringe or blood collection tube being advanced into the adapter cavity.
    [12]
    12. Vascular access system, CHARACTERIZED by the fact that it comprises: a set of peripheral intravenous catheters, comprising: a catheter adapter, comprising a distal end, a proximal end and a lumen that extends between them, the catheter adapter having an integrated extension tube; and a first catheter, wherein the first catheter extends distally from the catheter adapter; and an extension, comprising: a housing, comprising a proximal end and a distal end; and an instrument disposed within the housing, in which the instrument comprises a second catheter or probe, in which the instrument comprises a proximal end and a distal tip, in which the instrument is configured to move relative to the housing from a proximal position to a distal position, in which the instrument is advanced beyond the distal tip of the first catheter when the instrument is placed in the distal position.
    [13]
    13. Vascular access system, according to claim 12, CHARACTERIZED by the fact that the housing additionally comprises a slot, in which the proximal end of the instrument extends through the slot, in which the second catheter is advanced beyond the distal tip of the first catheter in response to the movement of the proximal end of the instrument along the slit.
    [14]
    14. Vascular access system, according to claim 13, CHARACTERIZED by the fact that the housing is rigid or semi-rigid.
    [15]
    15. Vascular access system, according to claim 13, CHARACTERIZED by the fact that the instrument comprises the second catheter, additionally comprising an adapter coupled to the proximal end of the instrument, in which the adapter comprises a cavity configured to receive a syringe or blood collection tube, where the adapter additionally comprises a cannula disposed within the cavity and configured to pierce a septum of the syringe or blood collection tube in response to the syringe or the blood collection tube being advanced into the adapter cavity , where the adapter is angled in relation to the housing.
    [16]
    16. Vascular access system according to claim 13, CHARACTERIZED by the fact that the instrument comprises the second catheter, additionally comprising an adapter coupled to the proximal end of the instrument, in which the adapter comprises a cavity configured to receive a syringe or blood collection tube, where the adapter additionally comprises a cannula disposed within the cavity and configured to pierce a septum of the syringe or blood collection tube in response to the syringe or the blood collection tube being advanced into the adapter cavity , in which the adapter is oriented parallel to a longitudinal axis of the housing.
    [17]
    17. Vascular access system, according to claim 13, CHARACTERIZED by the fact that it additionally comprises an advancement cap coupled to the second catheter.
    [18]
    18. Vascular access system, according to claim 12, CHARACTERIZED by the fact that it additionally comprises a sleeve arranged inside the housing, in which the instrument is arranged inside the sleeve,
    where the sleeve is compressible in a distal direction, where the second catheter is advanced beyond the distal tip of the first catheter when the instrument is disposed in the distal position and the sleeve is compressed in the distal direction.
    [19]
    19. Vascular access system according to claim 12, CHARACTERIZED by the fact that it additionally comprises an extension tube, in which the extension tube comprises a proximal end and a distal end, in which the proximal end of the instrument is coupled to the distal end of the extension tube.
    [20]
    20. Vascular access system according to claim 19, CHARACTERIZED by the fact that it additionally comprises an adapter, in which the proximal end of the extension tube is coupled to the adapter, in which the adapter comprises a cavity configured to receive a syringe or blood collection tube, where the adapter additionally comprises a cannula disposed within the cavity and configured to pierce a septum of the syringe or blood collection tube in response to the syringe or blood collection tube being advanced into the cavity adapter.
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    US20190021640A1|2019-01-24|
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    法律状态:
    2021-11-03| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    US201762534552P| true| 2017-07-19|2017-07-19|
    US62/534.552|2017-07-19|
    US16/037,246|US20190021640A1|2017-07-19|2018-07-17|Extension housing a probe or intravenous catheter|
    US16/037.246|2018-07-17|
    PCT/US2018/042608|WO2019018473A2|2017-07-19|2018-07-18|Extension housing a probe or intravenous catheter|
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