Catheter assembly plug device, system, and method
A plug device with a body and vent channels addresses the challenge of confirming catheter placement and preventing blood leakage in intravenous catheters by facilitating air venting, improving procedural efficiency and safety.
Patent Information
- Application Number
- JP2023528352
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-11-12
- Filing Date
- 2021-10-27
- Publication Date
- 2025-12-16
- Estimated Expiration
- 2041-10-27
AI Technical Summary
Existing intravenous catheter systems face challenges in effectively confirming proper placement and preventing blood leakage while allowing air venting, which can lead to inefficiencies and complications during infusion or withdrawal procedures.
The introduction of a plug device with a body, neck portion, and vent channels that block the proximal end of the flashback chamber, providing air venting while minimizing blood leakage by using annular grooves and air vent channels to control airflow without allowing blood passage.
The plug device ensures proper catheter placement confirmation and reduces blood leakage, enhancing the efficiency and safety of infusion and withdrawal procedures by maintaining a controlled air pathway.
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Abstract
Description
[Technical Field]
[0001] The present invention relates to catheter assembly plug devices, systems, and methods. [Background technology]
[0002] Intravenous catheters are commonly used for various infusion therapies. For example, intravenous catheters may be used to infuse fluids, such as saline, various medications, and total parenteral nutrition, into a patient. Intravenous catheters may also be used to withdraw blood from a patient.
[0003] Common types of intravenous catheters are peripheral IV catheters ("PIVCs"), peripherally inserted central catheters ("PICCs"), and midline catheters. Intravenous catheters can include "over-the-needle" catheters, which can be mounted on a needle with a sharp distal tip. The sharp distal tip can be used to puncture the patient's skin and vasculature. Insertion of an intravenous catheter into the vascular system can occur following puncture of the vascular system with the needle. Generally, needles and intravenous catheters are inserted through the skin at a shallow angle into the patient's vascular system, with the bevel of the needle facing up and away from the patient's skin.
[0004] To confirm proper placement of the introducer needle and / or intravenous catheter within the vasculature, a user will typically confirm the presence of a flashback of blood that may be visible to the user. In some cases, the introducer needle may include a notch disposed toward the distal end of the introducer needle, and in response to the distal tip of the introducer needle being placed within the vasculature, blood may flow proximally through the needle lumen, exit the needle lumen through the notch, and then travel proximally between the outer surface of the introducer needle and the inner surface of the intravenous catheter.
[0005] Thus, if the intravenous catheter is at least partially transparent, the user may visualize a small amount of blood "flashback," thereby confirming placement of the intravenous catheter within the vasculature. The presence of a vasculature entry indicator, such as flashback, may facilitate successful placement of the intravenous catheter. Once placement of the introducer needle within the vasculature is confirmed, the user may temporarily block flow within the vasculature and withdraw the introducer needle, leaving the intravenous catheter in place for future blood withdrawals and / or infusions. Summary of the Invention [Problem to be solved by the invention]
[0006] The subject matter claimed herein is not limited to embodiments that solve any drawbacks or that operate only in environments such as those described above. Rather, this background is provided only to illustrate one example technology area in which some implementations described herein may be practiced. [Means for solving the problem]
[0007] The present disclosure generally relates to plug devices, systems, and methods for facilitating venting. In some embodiments, the plug may be utilized to block the proximal end of a flashback chamber in an intravenous catheter assembly. In some embodiments, the plug may provide an air vent for the flashback chamber. In some embodiments, the plug may include a body that may include a cavity and a vent hole extending distally from the cavity.
[0008] In some embodiments, the plug may include a neck portion extending from the distal end of the body. In some embodiments, the neck portion may include one or more annular grooves spaced apart by one or more disc-shaped portions. In some embodiments, the proximal-most of the disc-shaped portions may be positioned proximal to the body. In some embodiments, the outer edge of each of the disc-shaped portions may include an air vent channel that may be generally aligned with the longitudinal axis of the plug. In some embodiments, the air vent channel of the proximal-most disc-shaped portion may be aligned with the vent hole.
[0009] In some embodiments, the distal-most one of the disc-shaped portions may form the distal end of the neck portion. In some embodiments, the proximal-most disc-shaped portion and the distal end of the body may form a stepped surface. In some embodiments, the proximal end of the body may include an opening to the cavity. In some embodiments, the surface of the cavity may include a plurality of annular protrusions.
[0010] In some embodiments, the neck portion may include one or more holes extending therethrough. In some embodiments, the holes may be generally perpendicular to the longitudinal axis of the plug. In some embodiments, the air pathway through the plug may include holes, air vent channels, vent holes, and cavities. In some embodiments, the holes may be spaced apart in a distal-proximal direction along the neck portion.
[0011] In some embodiments, a first hole of the plurality of holes may be adjacent to a second hole of the plurality of holes. In some embodiments, the second hole may be adjacent to a third hole of the plurality of holes. In some embodiments, the first air vent channel may extend between the first hole and the second hole. In some embodiments, the second air vent channel may extend between the second hole and the third hole. In some embodiments, the first air vent channel may be located on an opposite side of the neck portion from the second air vent channel.
[0012] In some embodiments, the third hole may be adjacent to a fourth hole of the plurality of holes. In some embodiments, a third air vent channel may extend between the third hole and the fourth hole. In some embodiments, the third air vent channel may be located on the same side of the neck portion as the first air vent channel. In some embodiments, the holes may include a proximal-most hole. In some embodiments, the vent hole may intersect with the proximal-most hole. In some embodiments, the proximal end of the neck portion and the distal end of the body may form a stepped surface.
[0013] In some embodiments, a plug may be utilized to block a port of an adapter in an intravenous catheter assembly. In some embodiments, the plug may provide an air vent for the port. In some embodiments, the neck portion may extend from the body. In some embodiments, one or more longitudinal air vent channels may be generally aligned with a longitudinal axis of the plug. In some embodiments, one or more transverse air vent channels may connect to the longitudinal air vent channels to provide an air passageway from the distal end of the neck portion.
[0014] In some embodiments, longitudinal air vent channels and lateral air vent channels Towards The vent channel may not allow blood to pass through but may allow air to pass through. In some embodiments, the body may include an end wall and a skirt extending from the end wall, defining an annular receiving channel between the skirt and the neck portion. In some embodiments, the inner surface of the skirt may include threads. In some embodiments, the end wall may include one or more vent holes extending therethrough. In some embodiments, the inner surface of the skirt may include a plurality of snap mechanisms.
[0015] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention as claimed. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that embodiments may be combined or other embodiments may be utilized, and that structural changes may be made, unless otherwise claimed, without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]
[0016] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings.
[0017] [Figure 1A] FIG. 1 is a top perspective view of an exemplary catheter assembly, according to some embodiments. [Figure 1B] FIG. 1 is a top perspective view of an exemplary plug, according to some embodiments. [Figure 1C] FIG. 1B is a cross-sectional view of a portion of the catheter assembly of FIG. 1A, according to some embodiments. [Figure 1D] FIG. 1B is an enlarged cross-sectional view of a portion of the catheter assembly of FIG. 1A, according to some embodiments. [Figure 1E] FIG. 1C is an enlarged top perspective view of a portion of the plug of FIG. 1B showing a plurality of exemplary air vent channels and a portion of an exemplary annular groove, according to some embodiments. [Figure 1F] 1F-1F is a cross-sectional view of the catheter assembly of FIG. 1A taken along line 1F-1F in FIG. 1A, according to some embodiments. [Figure 1G] 1G is a cross-sectional view of the catheter assembly of FIG. 1A taken along line 1G-1G in FIG. 1A, according to some embodiments. [Figure 1H] 1H-1H is a cross-sectional view of the catheter assembly of FIG. 1A taken along line 1H-1H in FIG. 1A, according to some embodiments. [Figure 2A]FIG. 1 is a top perspective view of a catheter assembly, according to some embodiments. [Figure 2B] FIG. 10 is a top perspective view of another exemplary plug, according to some embodiments. [Figure 2C] FIG. 2B is a cross-sectional view of a portion of the catheter assembly of FIG. 2A, according to some embodiments. [Figure 2D] FIG. 2B is an enlarged cross-sectional view of a portion of the catheter assembly of FIG. 2A, according to some embodiments. [Figure 2E] 2E is a cross-sectional view of the catheter assembly of FIG. 2A taken along line 2E-2E in FIG. 2A, according to some embodiments. [Figure 2F] 2F-2F is a cross-sectional view of the catheter assembly of FIG. 2A taken along line 2F-2F in FIG. 2A, according to some embodiments. [Figure 2G] 2G is a cross-sectional view of the catheter assembly of FIG. 2A taken along line 2G-2G in FIG. 2A, according to some embodiments. [Figure 3A] FIG. 10 is a top perspective view of another exemplary plug, according to some embodiments. [Figure 3B] FIG. 3B is a top perspective view of the plug of FIG. 3A according to some embodiments. [Figure 3C] FIG. 3B is a top perspective view of the plug of FIG. 3A according to some embodiments. [Figure 3D] FIG. 3B is a top perspective view of the plug of FIG. 3A according to some embodiments. [Figure 3E] FIG. 3B is a top perspective view of the plug of FIG. 3A according to some embodiments. [Figure 3F] FIG. 3B is a top perspective view of the plug of FIG. 3A according to some embodiments. [Figure 3G] FIG. 3B is a top perspective view of the plug of FIG. 3A according to some embodiments. [Figure 3H] FIG. 3B is a top perspective view of the plug of FIG. 3A according to some embodiments. [Figure 3I] 1 is a graph of hydrodynamic resistance. [Figure 4A]FIG. 10 is a top perspective view of another exemplary plug including a luer slip connector, according to some embodiments. [Figure 4B] 4B is a top perspective view of the plug of FIG. 4A showing an exemplary proximal end of the plug, according to some embodiments. [Figure 4C] 4B is a cross-sectional view of an exemplary Y-adapter coupled to the plug of FIG. 4A according to some embodiments. [Figure 5A] FIG. 10 is a top perspective view of another exemplary plug including a luer screw connector, according to some embodiments. [Figure 5B] 5B is a top perspective view of the Y-adapter of FIG. 4C coupled to the plug of FIG. 5A according to some embodiments. [Figure 5C] FIG. 5C is a cross-sectional view of a portion of the Y-adapter and plug of FIG. 5B according to some embodiments. [Figure 6A] FIG. 10 is a top perspective view of another exemplary plug including a luer snap connector, according to some embodiments. [Figure 6B] 6B is a top perspective view of the Y-adapter of FIG. 4C coupled to the plug of FIG. 6A according to some embodiments. [Figure 6C] 6C is a cross-sectional view of a portion of the Y-adapter and plug of FIG. 6B according to some embodiments. [Figure 7] FIG. 10 is a top perspective view of another catheter assembly, according to some embodiments. [Figure 8A] FIG. 10 is a cross-sectional view of another catheter assembly showing another exemplary plug, according to some embodiments. [Figure 8B] 8B is a top perspective view of the plug of FIG. 8A according to some embodiments. [Figure 8C] 8B is a bottom perspective view of the plug of FIG. 8A according to some embodiments. [Figure 8D] 8B is a top perspective view of the plug of FIG. 8A according to some embodiments. [Figure 8E] 8B is a bottom perspective view of the plug of FIG. 8A according to some embodiments. [Figure 9A]FIG. 4D is a cross-sectional view of a portion of the Y-adapter of FIG. 4C coupled to another plug, showing the plug in a first position, according to some embodiments. [Figure 9B] 9B is a cross-sectional view of a portion of the Y-adapter and plug of FIG. 9A showing the plug in a second or venting position, according to some embodiments. [Figure 9C] FIG. 9B is a top perspective view of the Y-adapter and plug of FIG. 9A according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION
[0018] All examples and conditional language recited herein are intended for educational purposes to help the reader understand the concepts contributed by the inventor to the development of the present invention and the art, and should be construed as not being limited to such specifically recited examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made thereto without departing from the spirit and scope of the present invention.
[0019] 1A, a catheter assembly 10 is shown according to some embodiments. In some embodiments, the catheter assembly 10 may include a catheter adapter 12, which may include a distal end 14, a proximal end 16, and a lumen extending through the distal end 14 and the proximal end 16. In some embodiments, the catheter assembly 10 may include a catheter 18 extending distally from the distal end 14 of the catheter adapter 12. In some embodiments, the catheter assembly 10 may include a needle hub 20, which may include a distal end 22 and a proximal end 24. The distal end 22 of the needle hub 20 may be coupled to the proximal end 16 of the catheter adapter 12.
[0020] In some embodiments, the catheter assembly 10 may comprise a peripherally inserted central catheter ("PICC") assembly or a midline catheter assembly, such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BD NEXIVA™ DIFFUSICS™ Closed IV Catheter System, the BD SAF-T-INTIMA™ Closed IV Catheter System, the BD INSYTE™ AUTOGUARD™ BC Shielded Catheter, the BD ANGIOCATH™ AUTOGUARD™ Shielded IV Catheter, or another suitable intravenous catheter assembly. In some embodiments, the catheter assembly 10 may comprise a peripherally inserted central catheter ("PICC") assembly or a midline catheter assembly.
[0021] In some embodiments, the catheter assembly 10 may include a needle 26, which may include a distal end 28, a proximal end 30, and a lumen extending therebetween. In some embodiments, the needle 26 may include an introducer needle, which may include a sharp distal tip 32. In some embodiments, the needle 26 may be secured within the needle hub 20. In some embodiments, the needle 26 may be constructed of metal or another suitable material.
[0022] In some embodiments, the needle hub 20 may include a flashback chamber 34. In some embodiments, in response to placement of the sharp distal tip 32 within the patient's vasculature, blood may flow proximally through the lumen of the needle 26, out the proximal end 30 of the needle 26, and into the flashback chamber 34. In some embodiments, the needle hub 20 may be transparent, which may facilitate a user's observation of the blood within the flashback chamber 34. Thus, in some embodiments, the user may visualize a small amount of blood "flashback," thereby confirming placement of the catheter 18 within the vasculature.
[0023] In some embodiments, the catheter assembly 10 may include a plug 36, which may be coupled to the proximal end 24 of the needle hub 20. In some embodiments, the plug 36 may be utilized to block or seal the proximal end of the flashback chamber 34 within the catheter assembly 10. In some embodiments, the plug 36 may provide an air vent for the flashback chamber 34. In some embodiments, as will be described in further detail, the plug 36 may be coupled to the proximal end 24 of the needle hub 20. 24 This may prevent or reduce leakage of blood from the
[0024] 1B-1H , in some embodiments, plug 36 may include a body 38, which may include a cavity 40. In some embodiments, body 38 may include one or more vent holes 42, which may extend distally from cavity 40. In some embodiments, plug 36 may include a neck portion 44, which may extend from a distal end 46 of body 38. In some embodiments, neck portion 44 may include one or more annular grooves 48 spaced apart by one or more disk-shaped portions 50. In some embodiments, annular grooves 48 may correspond to transverse channels.
[0025] In some embodiments, the proximal-most of the disc-shaped portions 50 may be disposed proximate to the body 38. In some embodiments, the outer edge of each of the disc-shaped portions 50 may include one or more air vent channels 54, which may be generally aligned with the longitudinal axis 56 of the plug 36. In some embodiments, the proximal-most air vent channel 54 of the disc-shaped portion 50 may be aligned with and / or disposed proximate to the vent hole 42.
[0026] In some embodiments, the air path through plug 36 may include annular groove 48, air vent channel 54, vent hole 42, and cavity 40. More specifically, in some embodiments, in response to a flashback entering flashback chamber 34, air may flow proximally through air vent channel 54 and annular groove 48 until it reaches vent hole 42. In some embodiments, air may then flow proximally through vent hole 42 into cavity 40, which may come into contact with the external environment.
[0027] In some embodiments, the air vent channel 54 may be configured to allow air to pass through but not blood. However, in other embodiments, blood may leak through the air vent channel 54 and the air pathway, which may also be a fluid pathway containing blood. In some embodiments, the plug 36 may incorporate abrupt contraction, abrupt expansion, and bending loss, which may control and reduce blood flow and leakage. In some embodiments, the annular groove 48 may provide abrupt expansion and bending loss, while the air vent channel 54 may provide abrupt contraction. In some embodiments, the annular groove 48 and the air vent channel 54 may slow blood leakage through the plug 36. In some embodiments, the annular groove 48 may retain a substantial amount of blood, allowing the plug 36 to be relatively short while slowing blood leakage. In some embodiments, the annular groove 48 may be deeper than the air vent channel 54.
[0028] In some embodiments, unlike vent plugs known in the art, plug 36 may not include a membrane to slow blood leakage due to the presence of annular groove 48 and air vent channels 54. In some embodiments, plug 36 may include a membrane in addition to annular groove 48 and / or air vent channels 54. In some embodiments, neck portion 44 may include a first line of air vent channels 54 opposite a second line of air vent channels 54, as shown in FIG. 1D, for example, which may slow blood leakage. In some embodiments, neck portion 44 may include various other patterns of air vent channels 54.
[0029] In some embodiments, the distal-most one of the disk-shaped portions 50 may form the distal end 58 of the neck portion 44. In some embodiments, the disk-shaped portions 50 may span the lumen of the needle hub 20, and the outer edge of each of the disk-shaped portions 50 may contact the inner wall of the needle hub 20. In some embodiments, the outer edge of each of the disk-shaped portions 50 may be generally circular. In some embodiments, the neck portion 44 may be tapered to match the shape of the lumen of the needle hub 20 and fit securely within the needle hub 20. In some embodiments, the proximal-most one of the disk-shaped portions 50 and the distal end 46 of the body 38 may form a stepped surface 60, and the stepped surface 60 may be annular. In some embodiments, the stepped surface 60 may extend beyond the proximal end of the needle hub 20. 24 It may be in contact with the
[0030] In some embodiments, the proximal end 62 of the body 38 may include an opening 64 for the cavity 40. In some embodiments, the plug 36 may prevent or reduce blood leakage outside of or proximal to the needle hub 20. For example, the surface of the cavity 40 may include one or more annular protrusions 66, which may slow blood leakage within the body 38. As shown in FIGS. 1F-1G, in some embodiments, the inner surface of the needle hub 20 may include one or more channels 68 that align with the air vent channels 54.
[0031] In some embodiments, the plug 36 may be used to plug a port of an adapter of a particular catheter assembly, such as the adapter described with respect to FIG. 5B. In some embodiments, the plug 36 may be coupled to the port of the adapter and may provide an air vent for the adapter. In some embodiments, the plug 36 may prevent or reduce blood leakage from the port. In some embodiments, the disk-shaped portions 50 may extend into the lumen of the adapter, and the outer edges of each of the disk-shaped portions 50 may contact the inner wall of the adapter. In some embodiments, the stepped surface 60 may abut the port of the adapter.
[0032] 2A-2G, a catheter assembly 10 is shown according to some embodiments. In some embodiments, the catheter assembly 10 may include a plug 70. In some embodiments, the plug 70 may be similar or identical in one or more included components and / or operation to the plug 36 described with respect to FIGS. 1A-1H.
[0033] In some embodiments, the neck portion 44 of the plug 70 may include one or more holes 72 extending therethrough. In some embodiments, the holes 72 may be generally perpendicular to the longitudinal axis 56 of the plug 70. In some embodiments, the holes 72 may be spaced apart in a distal-proximal direction along the neck portion 44, as shown in FIG. 2B , for example. In some embodiments, the holes 72 may be axially aligned. In some embodiments, the neck portion 44 may include a frustum or cylinder, which may allow the neck portion 44 to fit snugly within the needle hub 20 or adapter. In some embodiments, the holes 72 may be aligned with the longitudinal axis 56, which may increase the length and volume of the holes 72.
[0034] In some embodiments, neck portion 44 may include any suitable number of holes 72, such as, for example, 1 to 10 holes 72. In some embodiments, neck portion 44 may include five holes 72. Similarly, in some embodiments, neck portion 44 may include any suitable number of air vent channels 54, and any suitable number of air vent channels 54 may connect holes 72. In some embodiments, neck portion 44 may include one or more of a first hole 72a, a second hole 72b, a third hole 72c, a fourth hole 72d, and a fifth hole 72e (which may be collectively referred to as "holes 72" in this disclosure). In some embodiments, the neck portion 44 may include one or more of a first air vent channel 54a, a second air vent channel 54b, a third air vent channel 54c, a fourth air vent channel 54d, and a fifth air vent channel 54e (which may be collectively referred to as "air vent channels 54" in this disclosure).
[0035] In some embodiments, the air vent channels 54 may be alternately positioned between a first side of the neck portion 44 and a second side opposite the first side of the neck portion 44, which may slow blood leaking through the plug 70. In some embodiments, the first hole 72a may be adjacent to the second hole 72b. In some embodiments, the second hole 72b may be adjacent to the third hole 72c. In some embodiments, the first air vent channel 54a may extend between the first hole 72a and the second hole 72b. In some embodiments, the second air vent channel 54b may extend between the second hole 72b and the third hole 72c. In some embodiments, the first air vent channel 54a may be positioned on the opposite side of the neck portion 44 from the second air vent channel 54b.
[0036] In some embodiments, the third hole 72c may be adjacent to the fourth hole 72d. In some embodiments, the third air vent channel 54c may extend between the third hole 72c and the fourth hole 72d. In some embodiments, the third air vent channel 54c may be located on the same side of the neck portion 44 as the first air vent channel 54a. In some embodiments, the fourth hole 72d may be adjacent to the fifth hole 72e. In some embodiments, the fifth air vent channel 54e may extend from the flashback chamber 34 to the first hole 72a.
[0037] In some embodiments, the hole 72 is, for example, the fifth hole 7 2 In some embodiments, the plug 70 may include a most proximal hole, such as hole 72. In some embodiments, the vent hole 42 may intersect with the most proximal hole. In some embodiments, the air pathway through the plug 70 may include hole 72, air vent channel 54, vent hole 42, and cavity 40. In some embodiments, the air vent channel 54 may be configured to allow air to pass without allowing blood to pass through. However, in other embodiments, blood may leak through the air vent channel 54 and the air pathway such that the air pathway is also a fluid pathway containing blood. In some embodiments, the plug 70 may incorporate sudden contraction and sudden expansion, which may control and reduce blood flow and leakage. In some embodiments, the hole 72 may provide sudden expansion, while the air vent channel 54 may provide sudden contraction. In some embodiments, the hole 72 may hold a larger volume than the air vent channel 54, which may provide sudden expansion. In some embodiments, the proximal end 74 of the neck portion 44 and the distal end 46 of the body 38 may form a stepped surface 60, which may abut the needle hub 20 or the adapter.
[0038] 3A-3G, there is shown a plug 76 according to some embodiments. In some embodiments, the plug 76 may be similar or identical in one or more included components and / or operation to the plug 36 described with respect to FIGS. 1A-1H and / or the plug 70 described with respect to FIGS. 2A-2G.
[0039] In some embodiments, the neck portion 44 may include one or more longitudinal air vent channels 78, which may be generally aligned with the longitudinal axis 56 of the plug 76. In some embodiments, the neck portion 44 may include one or more lateral air vent channels 80, which may connect to the longitudinal air vent channels 78 to provide an air passageway from the distal end 58 of the neck portion 44. In some embodiments, the longitudinal air vent channels 78 and the lateral air vent channels 80 may be air permeable but not blood permeable. In some embodiments, the longitudinal air vent channels 78 and the lateral air vent channels 80 may be disposed on an outer surface of the neck portion 44. In some embodiments, the longitudinal air vent channels 78 may be generally straight. In some embodiments, the lateral air vent channels 80 may be arc-shaped.
[0040] In some embodiments, the longitudinal air vent channels 78 and / or the lateral air vent channels 80 may be arranged in various patterns, which may enhance pressure drop compared to prior art plugs. As shown in FIG. 3A , in some embodiments, one or more of the lateral air vent channels 80 may be circular or semi-circular. In some embodiments, the lateral air vent channels 80 may be shallower and / or wider than the longitudinal air vent channels 78. As shown in FIG. 3B , in some embodiments, the longitudinal air vent channels 78 may extend along the entire length of the neck portion 44 from the distal end 58 of the neck portion 44. In some embodiments, the neck portion 44 may include two or more longitudinal air vent channels 78, which may be equally spaced around the outer surface of the neck portion 44. For example, the neck portion 44 may include three longitudinal air vent channels 78, e.g., as shown in FIG. 3 B may be evenly spaced around the neck portion 44.
[0041] As shown in FIGS. 3C and 3F , in some embodiments, a first group of one or more longitudinal air vent channels 78 may extend from the distal end 58 of the neck portion 44 along a portion of the length of the neck portion 44. In some embodiments, each of the first group of longitudinal air vent channels 78 may have a distal end located at the distal end 58 of the neck portion 44 and a proximal end located at a particular lateral air vent channel 80. In some embodiments, a second group of one or more longitudinal air vent channels 78 may have a distal end located at a particular lateral air vent channel 80 and a proximal end of the neck portion 44 or near the proximal end 74 of the neck portion 44. In some embodiments, the first group of longitudinal air vent channels 78 and the second group of longitudinal air vent channels 78 may alternate around the outer surface of the neck portion 44.
[0042] In some embodiments, the pattern of longitudinal air vent channels 78 may be symmetrical. As shown in FIG. 3C , in some embodiments, a first group of longitudinal air vent channels 78 may include three longitudinal air vent channels 78, which may be evenly spaced around the neck portion 44. In some embodiments, a second group of longitudinal air vent channels 78 may include three longitudinal air vent channels 78, which may be evenly spaced around the neck portion 44. As shown in FIG. 3H , in some embodiments, a first group of longitudinal air vent channels 78 may include two longitudinal air vent channels 78, which may be evenly spaced around the neck portion 44. In some embodiments, a second group of longitudinal air vent channels 78 may include two longitudinal air vent channels 78, which may be evenly spaced around the neck portion 44.
[0043] As shown in FIG. 3D , in some embodiments, the neck portion 44 may not include a lateral air vent channel 80. As shown in FIGS. 3D and 3G , in some embodiments, the neck portion 44 may include between 1 and 20 longitudinal air vent channels 78. For example, the neck portion 44 may include 10 longitudinal air vent channels 78. In some embodiments, the neck portion 44 may include any suitable number of longitudinal air vent channels 78 and / or lateral air vent channels 80. As shown in FIG. 3E , in some embodiments, the neck portion 44 may include a combination of longitudinal air vent channels 78 extending along the entire length of the neck portion 44 and longitudinal air vent channels 78 extending along a portion of the length of the neck portion 44.
[0044] Referring now to FIG. 3I, a graph of hydrodynamic resistance is shown, but the values are not limited to those shown. According to some embodiments, the graph shows hydraulic pressures corresponding to the use of the plug 76 embodiments shown in FIGS. 3B-3E and 3H. Prior art plugs may include a membrane to slow blood leakage. As shown in FIG. 3I, at certain flow rates, plug 76 embodiments utilizing various channels in the neck portion instead of a membrane may reduce pressure within a particular catheter assembly.
[0045] In some embodiments, unlike vent plugs known in the art, plug 36 may not include a membrane to retard blood leakage due to the presence of annular groove 48 and air vent channel 54. In some embodiments, plug 36 may include a membrane in addition to annular groove 48 and / or air vent channel 54.
[0046] 4A-4C, in some embodiments, plug 76 may include a Luer slip connector. In some embodiments, body 38 may include an end wall 82 and a skirt 84 extending from end wall 82 to define an annular receiving channel 86 between skirt 84 and neck portion 44. In some embodiments, the inner surface of skirt 84 may be smooth. In some embodiments, neck portion 44 may form a slip tip, which may conform to the dimensions of a needle hub (such as needle hub 20 shown in FIGS. 1A and 2A) or adapter 88. In some embodiments, the slip tip and needle hub or adapter 88 may be pressed together and held by friction.
[0047] In some embodiments, longitudinal air vent channels 7 8 may extend proximal to the distal end of the needle hub or port 90 of the adapter 88. In some embodiments, the inner surface of the skirt 84 may be spaced from the outer surface of the needle hub 20 or adapter 88, allowing air to pass through the longitudinal air vent channel. 78 to the external environment. In some embodiments, the adapter 88 may include port 90 and / or other ports 92. In some embodiments, a needleless connector 93 or another suitable device may be coupled to the other port 92. In some embodiments, the adapter 88 may include a Y-adapter or another suitable adapter. In some embodiments, a medical device may be coupled to the Y-adapter for fluid administration or blood withdrawal. In some embodiments, an extension tube may extend from the adapter 88 to a side port of the catheter assembly.
[0048] 5A-5C, in some embodiments, plug 76 may include a luer lock connector. In some embodiments, the inner surface of skirt 84 may include threads 94. In some embodiments, end wall 82 may include one or more vent holes 42 extending therethrough.
[0049] 6A-6C, in some embodiments, the inner surface of the skirt may include one or more snap features 96, which may include protrusions configured to lock the plug 76 to the needle hub or adapter 88 in response to movement of a flange 97 over the snap feature 96. In some embodiments, the flange 97 may be annular. In some embodiments, the adapter 88 may include the flange 97, or the needle hub 20 (see, e.g., FIG. 2C) may include the flange 97.
[0050] 7, a catheter assembly 98 according to some embodiments is shown. In some embodiments, the catheter assembly 98 may be similar or identical in one or more included components and / or operation to the catheter assembly 10 described with respect to FIGS. 1A-2G. As shown in FIG. 7, the adapter 88 may be coupled to the proximal end of an extension tube 100 that may extend from a side port 101 of the catheter adapter 12.
[0051] 8A-8E, portions of a catheter system 102 are shown according to some embodiments. In some embodiments, the catheter system 102 may be similar to or identical in one or more included components and / or operation to the catheter assembly 10 described with reference to FIGS. 1A-2G and / or the catheter assembly 98 described with reference to FIG. 7. In some embodiments, the catheter system 102 may include a plug 104, which may be similar to or identical in one or more included components and / or operation to one or more of the following: plug 36 described with reference to FIGS. 1A-1H, plug 70 described with reference to FIGS. 2A-2G, and plug 76 described with reference to FIGS. 3A-6C.
[0052] In some embodiments, the plug 104 may include the neck portion 44 but not the body 38. Thus, in some embodiments, the proximal end 74 of the neck portion 44 may correspond to the proximal end of the plug 104. In some embodiments, the plug 104 may be made of polyisoprene, polyimide, latex, polyurethane, nylon, polyethylene, plastic, or another suitable material. In some embodiments, the plug may include a longitudinal air vent channel 78 and / or a lateral air vent channel 80. In some embodiments, the longitudinal air vent channel 78 may be wider and / or deeper than the lateral air vent channel 80. In some embodiments, the plug 104 may be generally cylindrical. In some embodiments, the distal-proximal length 106 of the plug 104 may be less than the height 108 of the plug 104, which may reduce material and manufacturing costs.
[0053] 9A-9C, a plug 110 is shown according to some embodiments. In some embodiments, plug 110 may be similar to or identical in terms of one or more included components and / or operation to one or more of the following. For example, plug 36 is described with reference to FIGS. 1A-1H, plug 70 is described with reference to FIGS. 2A-2G, plug 76 is described with reference to FIGS. 3A-6C, and plug 104 is described with reference to FIGS. 8A-8E. In some embodiments, plug 110 may be used to plug the proximal end of a flashback chamber, such as, for example, flashback chamber 34 shown in FIG. 1C.
[0054] In some embodiments, the inner surface of the skirt 84 may include one or more first snap features 112, which may include a protrusion configured to lock the plug 110 to the needle hub or adapter 88 in response to movement of the flange 97 proximally beyond the first snap feature 112. In some embodiments, the flange 97 and / or a particular first snap feature 112 may be annular. In some embodiments, the adapter 88 may include the flange 97, or the needle hub 20 (see, e.g., FIG. 2C ) may include the flange 97.
[0055] In some embodiments, the inner surface of the skirt 84 may include one or more second snap features 114, which may include a protrusion configured to lock the plug 110 in the venting position in response to proximal movement of the flange 97 beyond the second snap feature 114. In some embodiments, the particular second snap feature 114 may be annular. In some embodiments, the plug 110 may vent the catheter assembly in response to the plug 110 being in the venting position. In some embodiments, a spring 116 may exert a distal force against the port 90 of the adapter 88, which may actuate the plug 110 and reduce the risk of it being accidentally moved to the venting position. In some embodiments, a user may actuate the plug 110 by moving it to the venting position before inserting the catheter assembly into the patient's vasculature.
[0056] The present invention may be embodied in other specific forms without departing from its structure, methods, or other essential characteristics as broadly described herein and claimed below. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are intended to be embraced within their scope.
Claims
1. 1. A plug for use in blocking a proximal end of a flashback chamber of an intravenous catheter assembly, said plug providing an air vent for said flashback chamber; a body having a cavity and a vent hole extending distally from the cavity; a neck portion extending from a distal end of the body, the neck portion comprising a plurality of annular grooves spaced apart by a plurality of disc-shaped portions, the most proximal of the disc-shaped portions being disposed proximate the body, an outer edge of each of the disc-shaped portions comprising an air vent channel generally aligned with a longitudinal axis of the plug, the air vent channel of the most proximal disc-shaped portion being aligned with the vent hole; A plug equipped with
2. The plug of claim 1 , wherein a distal-most disc-shaped portion of the plurality of disc-shaped portions forms a distal end of the neck portion.
3. The plug of claim 1 , wherein the proximal-most disk-shaped portion and the distal end of the body form a stepped surface.
4. The plug of claim 1 , wherein the proximal end of the body includes an opening to the cavity.
5. The plug of claim 1 , wherein a surface of the cavity comprises a plurality of annular projections.
6. 1. A plug for use in blocking a proximal end of a flashback chamber of an intravenous catheter assembly, said plug providing an air vent for said flashback chamber; a body having a cavity and a vent hole extending distally from the cavity; a neck portion extending from the distal end of the body, a plurality of holes extending through the neck portion generally perpendicular to the longitudinal axis of the plug; a neck portion, wherein a plurality of air vent channels are disposed on an outer edge of the neck portion and connect the plurality of holes, and an air passage through the plug includes the plurality of holes, the plurality of air vent channels, the vent hole, and the cavity; A plug equipped with
7. The plug of claim 6, wherein the plurality of holes are spaced apart in a distal-proximal direction along the neck portion.
8. 8. The plug of claim 7, wherein a first hole of the plurality of holes is adjacent to a second hole of the plurality of holes, the second hole being adjacent to a third hole of the plurality of holes, a first air vent channel extending between the first hole and the second hole, a second air vent channel extending between the second hole and the third hole, the first air vent channel being positioned on an opposite side of the neck portion from the second air vent channel.
9. 9. The plug of claim 8, wherein the third hole is adjacent to a fourth hole of the plurality of holes, a third air vent channel extends between the third hole and the fourth hole, and the third air vent channel is disposed on the same side of the neck portion as the first air vent channel.
10. The plug of claim 6 , wherein the proximal end of the body includes an opening to the cavity.
11. The plug of claim 6 , wherein the surface of the cavity comprises a plurality of annular projections.
12. The plug of claim 6 , wherein the plurality of holes includes a proximal-most hole, and the vent hole intersects with the proximal-most hole.
13. The plug of claim 6 , wherein the proximal end of the neck portion and the distal end of the body form a stepped surface.
14. 1. A plug for use in blocking a port of an adapter of an intravenous catheter assembly, said plug providing an air vent for said port; The main body and a neck portion extending from the body; a plurality of longitudinal air vent channels generally aligned with a longitudinal axis of the plug, wherein a plurality of lateral air vent channels connect the plurality of longitudinal air vent channels to provide an air passageway from a distal end of the neck portion; A plug equipped with
15. 15. The plug of claim 14, wherein the longitudinal air vent channel and the lateral air vent channel are air permeable but not blood permeable.
16. The plug of claim 14 , wherein the proximal end of the neck portion and the distal end of the body form a stepped surface.
17. 15. The plug of claim 14, wherein the body includes an end wall and a skirt extending from the end wall, the skirt defining an annular receiving channel between the skirt and the neck portion.
18. The plug of claim 17 , wherein the inner surface of the skirt comprises threads.
19. 20. The plug of claim 18, wherein the end wall includes a vent hole extending therethrough.
20. 18. The plug of claim 17, wherein the inner surface of the skirt comprises a plurality of snap features.
Citation Information
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