Catheters are commonly used for a variety of infusion therapies. Catheters may be used for infusing normal saline solution, various medicaments, total parenteral nutrition, or other fluids into a patient. Catheters may also be used to withdraw blood from the patient for diagnostic or other purposes.
A common type of catheter is a peripheral intravenous catheter (“PIVC”) that is “over-the-needle.” As its name implies, the PIVC that is over-the-needle may be mounted over an introducer needle having a sharp distal tip. The PIVC and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle facing up away from skin of the patient. The PIVC and introducer needle are generally inserted at a shallow angle through the skin into the vasculature of the patient.
In order to verify proper placement of the introducer needle and/or the PIVC in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the clinician may remove the introducer needle, leaving the PIVC in place for future fluid infusion.
The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced.
The present disclosure relates generally to vascular access devices and related systems and methods. More specifically, the present disclosure relates to retainer elements to secure a valve within a catheter adapter, as well as related devices, systems, and methods. In some embodiments, a catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter adapter may include a side port disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter.
In some embodiments, the catheter assembly may include a catheter secured within the catheter adapter and extending distally from the distal end of the catheter adapter. In some embodiments, the catheter assembly may include an annular valve disposed within the lumen and configured to seal the side port from the lumen. In some embodiments, the catheter assembly may include a retainer element configured to secure the annular valve within the lumen. In some embodiments, the retainer element may be disposed within the lumen proximal to a proximal end of the annular valve or within the proximal end of the annular valve. In some embodiments, the retainer element may contact the annular valve.
In some embodiments, the retainer element may include a ring, and the ring may be disposed proximal to the annular valve. In some embodiments, the retainer element may include a C-shape, and the retainer element may pinch the annular valve between the C-shape and the catheter adapter. In some embodiments, a portion of the annular valve within an open portion of the C-shape may be unclamped, which may facilitate opening of the annular valve in response to infusion of fluid from the side port into the lumen. In some embodiments, the portion of the annular valve may be on a same side of the catheter assembly as the side port. In some embodiments, the catheter assembly may include an antimicrobial coating disposed on an outer surface of the retainer element.
In some embodiments, the catheter assembly may include a valve disposed within the lumen, and a C-shaped retainer element secured within the lumen proximal to the valve. In some embodiments, an inner surface of the catheter adapter may form the lumen and may include a narrowed diameter portion proximal to the valve. In some embodiments, the C-shaped retainer element may be configured to compress to move distally through the narrowed diameter portion. In some embodiments, the C-shaped retainer element may be proximate the valve.
In some embodiments, after moving distally through the narrowed diameter portion, the C-shaped retainer element may be configured to expand within the lumen proximate the valve. In some embodiments, the lumen may include a first inner diameter distal to the narrowed diameter portion and proximal to the valve and a second inner diameter at the narrowed diameter portion. In some embodiments, the second inner diameter may be less than the first inner diameter. In some embodiments, the lumen may include a third inner diameter proximal to the narrowed diameter portion. In some embodiments, the second inner diameter may be less than the third inner diameter.
In some embodiments, a width of the C-shaped retainer element may be greater than a distance from the narrowed diameter portion to the proximal end of the catheter adapter. In some embodiments, the first inner diameter may be equal to the second inner diameter. In some embodiments, an outer diameter of the C-shaped retainer element in a natural state may be greater than the first inner diameter.
In some embodiments, in the natural state, a distal end of the C-shaped retainer element may include a first outer diameter and a proximal end of the C-shaped retainer element may include a second outer diameter, and the second outer diameter may be greater than the first outer diameter. In some embodiments, an inner surface of the catheter adapter forms the lumen, wherein the first outer diameter and the second outer diameter contacts the inner surface.
In some embodiments, the catheter assembly may include the retainer element, which may be configured to secure the annular valve within the lumen, and the retainer element is disposed within the lumen proximal to a proximal end of the annular valve. In some embodiments, the retainer element may include a spring or a metal disc. In some embodiments, the spring may be tapered inwardly in a proximal direction. In some embodiments, the metal disc may include a central opening. In some embodiments, an outer edge of the metal disc may include multiple proximally-extending protrusions configured to press into the inner surface. In some embodiments, an edge of the opening may include multiple distally-extending teeth.
It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality illustrated in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.
Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
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In some embodiments, the catheter assembly 30 may include a catheter 40 secured within the catheter adapter 32 and extending distally from the distal end 34 of the catheter adapter 32. In some embodiments, the catheter 40 may include a peripheral intravenous catheter, a midline catheter, or a peripherally-inserted central catheter. In some embodiments, the catheter assembly 30 may include an annular valve 41 disposed within the lumen 38 and configured to seal the side port 33 from the lumen 38.
In some embodiments, the annular valve 41 may include a distal end 42 and a proximal end 44. In some embodiments, the catheter assembly 30 may include a retainer element 46 configured to secure the annular valve 41 within the lumen 38. In some embodiments, the retainer element 46 may be disposed within the lumen 38 proximal to the proximal end 44 of the annular valve 41. In some embodiments, the retainer element 46 may be in contact the annular valve 41. In some embodiments, the retainer element 46 may contact the annular valve 41 in response to infusion of fluid through the side port 33.
In some embodiments, the retainer element 46 may include a ring, and the ring may be disposed proximal to the annular valve 41. In some embodiments, the ring may be press-fit within the lumen 38 of the catheter adapter 32 or secured in another suitable manner. In some embodiments, the ring may prevent the annular valve 41 from moving proximally in response to injection of fluid through the side port 33, which may include a high-pressure injection equal to or greater than 300 psi. In some embodiments, a width of the retainer element 46 may be about 0.5 mm or another suitable width to reduce movement of the annular valve 41.
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In some embodiments, an inner surface of the catheter adapter 61 may form the lumen 66 and may include a narrowed diameter portion 70 proximal to the valve 68. In some embodiments, the lumen 66 may include a first inner diameter 71 distal to the narrowed diameter portion 70 and proximal to the valve 68 and a second inner diameter 72 at the narrowed diameter portion 70. In some embodiments, the second inner diameter 72 may be less than the first inner diameter 71. In some embodiments, the lumen 66 may include a third inner diameter 73 proximal to the narrowed diameter portion 70. In some embodiments, the second inner diameter 72 may be less than or equal to the third inner diameter 73.
In some embodiments, the valve 68 within the lumen 66 may be configured to seal the proximal end 62 of the catheter adapter. In some embodiments, the catheter assembly 60 may include a C-shaped retainer element 74 configured to secure the valve 68 within the lumen 66. For example, the C-shaped retainer element 74 may secure the valve 68 in response to injection of fluid through the side port, which may include a high-pressure injection equal to or greater than 300 psi.
In some embodiments, the C-shaped retainer element 74 may be disposed within the lumen 66 proximal to the valve 68. In some embodiments, the C-shaped retainer element 74 may be proximate the valve 68. In some embodiments, the C-shaped retainer element 74 may be in contact the valve 68. In some embodiments, the C-shaped retainer element 74 may contact the valve in response to infusion of fluid through the side port distal to the valve 68.
It should be understood that the embodiments may be combined. For example, the catheter assembly 60 may be similar or identical to the catheter assembly 30 of
In some embodiments, the C-shaped retainer element 74 may be secured within the lumen 66 proximal to the valve 68. In some embodiments, the C-shaped retainer element 74 may be configured to compress to move distally through the narrowed diameter portion 70, as illustrated, for example, in
In some embodiments, after moving distally through the narrowed diameter portion 70, the C-shaped retainer element 74 may be configured to expand within the lumen 66 distal to the narrowed diameter portion 70 and/or proximate the valve 68, as illustrated, for example, in
In some embodiments, the first inner diameter 71 may be equal to the second inner diameter 72. In some embodiments, an outer diameter 80 of the C-shaped retainer element 74 in a natural state, illustrated, for example, in
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In some embodiments, the catheter assembly 90 may be similar or identical in terms of one or more features and/or operation to one or more of the following: the catheter assembly 60 of
In some embodiments, the retainer element 100 may be configured to secure the valve 102 within the lumen 104, and the retainer element 100 may be disposed within the lumen 104 proximal to a proximal end of the valve 102. In some embodiments, the retainer element 100 may include a spring, as illustrated, for example, in
In some embodiments, the proximal end of the spring may contact a flange 103 of the catheter adapter 92. In some embodiments, the proximal end of the spring may be engaged in an interference fit with the catheter adapter 92. In some embodiments, the proximal end of the spring may be engaged in an interference fit with at the flange 103 and/or proximal to the flange 103. In some embodiments, movement of the valve 102 into the spring may cause a diameter of an end coil of the spring in contact with the catheter adapter 92 to expand, further increasing interference of the spring with the catheter adapter 92. In some embodiments, the retainer element 100 may prevent dislodgement of the valve 102 during infusion of fluid into the side port at high pressures, such as, for example, 300 psi.
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In some embodiments, the metal disc may include a central opening 112. In some embodiments, the central opening 112 may be just large enough for an introducer needle 108 to pass through. In some embodiments, an edge of the central opening 112 may include multiple distally-extending teeth 114, which may grip onto the valve 102, which may be elastomeric. Thus, in some embodiments, the distally-extending teeth 114 may reduce a likelihood of the valve 102 squeezing through the central opening 112 when high pressure is applied.
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All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.
This application claims the benefit of U.S. Provisional Patent Application No. 63/194,060, filed on May 27, 2021, entitled RETAINER ELEMENT TO SECURE A CATHETER ADAPTER VALVE, which is incorporated herein in its entirety.
Number | Date | Country | |
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63194060 | May 2021 | US |