Patent Publication Number: US-2021187250-A1

Title: Inhibiting fluid leakage and splatter in catheter devices and systems

Description:
RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 62/949,939, filed Dec. 18, 2019, and entitled INHIBITING FLUID LEAKAGE AND SPLATTER IN CATHETER DEVICES AND SYSTEMS, which is incorporated herein in its entirety. 
    
    
     BACKGROUND 
     Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used for infusing fluids into a patient such as saline solution, medication, total parenteral nutrition, etc. Catheters may also be used for withdrawing blood from the patient. 
     A common type of catheter is an over-the-needle peripheral intravenous catheter (“PIVC”). Other common types of catheters include, but are not limited to, peripherally inserted central catheters (“PICC”), central venous catheters (“CVC”), etc. 
     As its name implies, the over-the-needle PIVC 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 away from skin of the patient. The PIVC and the introducer needle are typically inserted at a shallow angle through the skin and into a blood vessel of the patient, such as an artery, a vein, or other vasculature of the patient. Once the PIVC has been properly placed within the blood vessel, the introducer needle may be withdrawn and the PIVC may be secured within the blood vessel by securing a catheter adapter (coupled with the PIVC) to the skin of the patient with dressing. 
     However, fluid leakage (e.g., blood, medications, saline solutions, etc.) can occur during insertion of a catheter, such as a PIVC. For example, blood leakage may occur during insertion of a Cathena™ catheter while the introducer needle is parked within the septum of the catheter adapter. In this configuration, blood may be able to leak out of the catheter adapter through a small space or gap formed between the septum and the introducer needle when the introducer needle is parked within the septum. This leaked blood may then flow into the needle tip shield through the needle passageway of the needle tip shield. Once blood has entered into the needle tip shield, the blood may then proceed to leak out of the needle tip shield through an opening on the needle tip shield that receives a V-Clip safety mechanism. Moreover, blood may splatter out of the opening when the V-Clip fires to trap the needle tip within the needle tip. Accordingly, improved devices, systems, and methods for restricting fluid splatter and leakage into and/or out of the needle tip shield would be desirable. 
     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. 
     SUMMARY 
     The present disclosure generally relates to catheter devices and systems. The various catheter devices and systems of the present disclosure have been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available catheter devices and systems for inhibiting fluid leakage and splatter during catheter insertion. 
     In some embodiments, a needle tip shield may include a needle passageway, a tip shield interior space, and a fluid restriction member. The needle passageway may be formed through the needle tip shield and may receive a needle therethrough. The tip shield interior space may receive a needle block therein and the tip shield interior space may include an opening for inserting the needle block into the tip shield interior space. The fluid restriction member may be configured to restrict fluid leakage into and/or out of the needle tip shield. The fluid restriction member may be selected from the group consisting of: (1) a fluid impedance member located adjacent the needle passageway that may impede fluid from entering into the needle tip shield through the needle passageway; (2) a fluid retention member that may retain fluid within the tip shield interior space; and (3) an anti-splatter member that may inhibit fluid splatter when the needle block moves from an open position to a closed position within the tip shield interior space. 
     In some embodiments of the needle tip shield, the selection may include the fluid impedance member. In some embodiments, the fluid impedance member may include at least one of: a sponge, an absorbent plug, a foam, a wicking material, a hydrogel, a high viscosity silicone lube, an O-ring, a compliant septum, a membrane, and a tip shield nose that is shaped to impede fluid from entering into the needle tip shield through the needle passageway. 
     In some embodiments of the needle tip shield, the selection may include the fluid retention member. In some embodiments, the fluid retention member may include at least one of a cover placed over the opening to retain fluid within the tip shield interior space, and an absorbent material placed within the tip shield interior space to retain fluid within the tip shield interior space. 
     In some embodiments of the needle tip shield, the selection may include the anti-splatter member. In some embodiments, the anti-splatter member may include at least one of a damping member and a shock absorbing material. In some embodiments, the needle block may include a V-Clip that is movable between the open position and the closed position, such that: (1) in the open position, the V-Clip allows a needle to advance distally through the needle passageway; (2) in the closed position, the V-Clip prevents the needle from advancing distally through the needle passageway; (3) the damping member may be coupled to the V-Clip to slow movement of the V-Clip as it moves from the open position to the closed position; and (4) the shock absorbing material may be placed within the tip shield interior space adjacent the V-Clip to slow movement of the V-Clip as it moves from the open position to the closed position. 
     In some embodiments of the needle tip shield, the damping member may include a visco-elastic material. 
     In some embodiments of the needle tip shield, the damping member may further include a stiffening member coupled to the visco-elastic material. 
     In some embodiments, a needle tip shield may impede fluid from entering into the needle tip shield, and may include a needle passageway and a fluid impedance member. The needle passageway may be formed through the needle tip shield and may receive a needle therethrough. The fluid impedance member may be located adjacent the needle passageway and may impede fluid from entering into the needle tip shield through the needle passageway. 
     In some embodiments of the needle tip shield, the fluid impedance member may include an absorbent material including at least one of: a sponge, an absorbent plug, a foam, and a wicking material. 
     In some embodiments of the needle tip shield, the fluid impedance member may include a viscous material including at least one of a hydrogel and a high viscosity silicone lube. 
     In some embodiments of the needle tip shield, the fluid impedance member may include a compliant material including at least one of an O-ring and a compliant septum. 
     In some embodiments of the needle tip shield, the fluid impedance member may include a tip shield nose that is shaped to impede fluid from entering into the needle tip shield. 
     In some embodiments, the needle tip shield may further include a recess adjacent the needle passageway that receives the fluid impedance member therein. 
     In some embodiments, the needle tip shield may further include a membrane coupled to the needle tip shield adjacent the needle passageway that impedes fluid from entering into the needle tip shield. 
     In some embodiments, a needle tip shield that may retain fluid within the needle tip shield, and may include a needle passageway, a tip shield interior space, and a fluid retention member. The needle passageway may be formed through the needle tip shield and may receive a needle therethrough. The tip shield interior space may receive a needle block therein, and the tip shield interior space may include an opening for inserting the needle block into the tip shield interior space. The fluid retention member may retain fluid within the tip shield interior space. 
     In some embodiments of the needle tip shield, the fluid retention member may include a cover placed over the opening to retain fluid within the tip shield interior space. 
     In some embodiments of the needle tip shield, the cover may include at least one of: a tape, a heat seal material, a thin film, and a plastic cover. 
     In some embodiments of the needle tip shield, the cover may be coupled to the needle tip shield with at least one of: an adhesive, a snap feature, an interference feature, a heat seal material, a glue, and sonic welding. 
     In some embodiments of the needle tip shield, the fluid retention member may include at least one of: a sponge, a foam, an absorbent material, a wicking material, and a clotting material. 
     In some embodiments of the needle tip shield, the fluid retention member may be placed within the tip shield interior space. 
     In some embodiments of the needle tip shield, the fluid retention member may be coupled to the needle block. 
     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 embodiments of the present disclosure, as claimed. It should be understood that the various embodiments of the present disclosure are not limited to the arrangements and instrumentality shown in the drawings. It should also be understood that the embodiments of the present disclosure may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the spirit or scope of the various embodiments of the present disclosure. The following detailed description is, therefore, not to be taken in a limiting sense. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1  is an exploded view of an example catheter system that utilizes a needle tip shield, according to some embodiments; 
         FIG. 2A  is a front perspective view of the needle tip shield of  FIG. 1 ; 
         FIG. 2B  shows the needle tip shield of  FIG. 2A  coupled with a fluid impedance member; 
         FIG. 2C  shows the needle tip shield of  FIG. 2A  coupled with a membrane; 
         FIG. 3A  is a bottom perspective view of the needle tip shield of  FIG. 1 ; 
         FIG. 3B  shows the needle tip shield of  FIG. 3A  coupled with a cover; 
         FIG. 4  is a bottom perspective view of the needle tip shield of  FIG. 1  with an absorbent material placed therein; 
         FIG. 5A  is a perspective view of a V-Clip with a damping member coupled thereto; 
         FIG. 5B  shows the V-Clip of  FIG. 5A  with a stiffening member coupled over the damping member; and 
         FIG. 6  is a cross-sectional view of the needle tip shield of  FIG. 1  with a shock absorbing material placed therein. 
     
    
    
     It is to be understood that the Figures are for purposes of illustrating the concepts of the present disclosure and may not be drawn to scale. Furthermore, the Figures illustrate exemplary embodiments and do not represent limitations to the scope of the present disclosure. 
     DESCRIPTION OF EMBODIMENTS 
     Exemplary embodiments of the present disclosure will be best understood by reference to the Figures, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the Figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus and systems, as represented in the Figures, is not intended to limit the scope of the present disclosure, as claimed in this or any other application claiming priority to this application, but is merely representative of exemplary embodiments of the present disclosure. 
       FIG. 1  illustrates an exploded view of a catheter system  100  that may be utilized with the teachings of the present disclosure, according to some embodiments. However, it will be understood that the teachings of the present disclosure can be utilized with any catheter system known in the art. The catheter system  100  may include a needle assembly  110  including a needle  150  coupled to a needle hub  160 , a needle tip shield  200 , a catheter adapter body  130 , and a catheter  140  coupled to a distal end of the catheter adapter body  130 . 
       FIGS. 2A-2C  illustrate various views of the needle tip shield  200  of  FIG. 1 . Specifically,  FIG. 2A  is a front perspective view of the needle tip shield  200  of  FIG. 1 ;  FIG. 2B  shows the needle tip shield  200  of  FIG. 2A  coupled with a fluid impedance member  400 ; and  FIG. 2C  shows the needle tip shield  200  of  FIG. 2A  coupled with a membrane  500 . 
     The needle tip shield  200  may include a needle passageway  210  formed through the needle tip shield  200 . The needle passageway  210  may be configured to slidably receive the needle  150  therethrough. In some embodiments, a diameter of the needle  150  may be slightly smaller than a diameter of the needle passageway  210  such that a small gap may exist between the needle  150  and the needle passageway  210  that may allow fluid to flow therethrough. In some embodiments, the needle tip shield  200  may also include a tip shield nose  240 . In some embodiments, the tip shield nose  240  may encircle (or otherwise surround) the needle passageway  210  and/or project distally away from the needle passageway  210 . In some embodiments, a recess  250  may be formed in the tip shield nose  240 . 
     In some embodiments, a fluid impedance member  400  may be located adjacent the needle passageway  210 . The fluid impedance member  400  may impede/prevent fluid from entering into the needle tip shield  200  through the needle passageway  210  by creating a seal around the needle  150 . Preventing and/or decreasing blood flow into the needle tip shield  200  can eliminate subsequent blood leakage out of the needle tip shield  200  and/or increase the length of time before blood leakage occurs from the needle tip shield  200 . 
     In some embodiments, the fluid impedance member  400  may be placed within the recess  250  that is formed in the tip shield nose  240 , as shown in  FIG. 2B . 
     In some embodiments, the fluid impedance member  400  may include an absorbent material. 
     In some embodiments, the absorbent material may, but not be limited to, a sponge, an absorbent plug, a foam, a wicking material (e.g., a cellulous, gelatin, micro spun mesh, PEG material, etc.), a clotting material, etc. 
     In some embodiments, the fluid impedance member  400  may include a viscous material. 
     In some embodiments, the viscous material may include, but not be limited to, a hydrogel, a high viscosity silicone lube, etc. 
     In some embodiments, the fluid impedance member  400  may include a compliant material. 
     In some embodiments, the compliant material may include an O-ring, a compliant septum, etc. 
     In some embodiments, the fluid impedance member  400  may include a membrane  500  located distal the needle passageway  210 . The membrane  500  may impede/prevent fluid from entering into the needle tip shield  200 . 
     In some embodiments, the membrane  500  may be coupled to the needle tip shield  200  adjacent the needle passageway. 
     In some embodiments, the membrane  500  may be coupled to the tip shield nose  240 . 
     In some embodiments, the membrane  500  may be coupled to a distal end of the tip shield nose  240 , as is shown in  FIG. 2C . 
     In some embodiments, the membrane  500  may include a needle aperture (not shown) for receiving the needle  150  therethrough. 
     In some embodiments, the membrane  500  may include a penetrable membrane. In these embodiments the needle  150  may penetrate the membrane  500  as the needle  150  is inserted through the needle tip shield  200 . 
     In some embodiments, the membrane  500  (and/or the fluid impedance member  400 ) may be coupled to the needle tip shield  200  (and/or coupled to the tip shield nose  240 ) by any suitable means including, but not limited to, an adhesive, a glue, a snap feature, an interference feature, a heat seal material, sonic welding, etc. 
     In some embodiments, the tip shield nose  240  may be shaped to impede fluid from entering into the needle tip shield  200 . For example, the tip shield nose  240  may include a shape similar to a tip shield nose of a Venflon™ catheter (not shown), which has a revolver-shaped nose design. 
       FIGS. 3A-4  illustrate various views of the needle tip shield  200  of  FIG. 1  in combination with a fluid retention member that may retain fluid within the needle tip shield  200 . Specifically,  FIG. 3A  is a bottom perspective view of the needle tip shield  200  of  FIG. 1 ;  FIG. 3B  shows the needle tip shield  200  of  FIG. 3A  coupled with a fluid retention member including a cover  600 ; and  FIG. 4  shows a bottom perspective view of the needle tip shield  200  of  FIG. 1  with one or more fluid retention members including absorbent material placed within the needle tip shield  200 . 
     The needle tip shield  200  may include a tip shield interior space  220  configured to receive a needle block therein, such as a V-Clip  300  (as one non-limiting example). The tip shield interior space  220  may also include an opening  230  for inserting the V-Clip  300  into the tip shield interior space  220 . 
     In some embodiments, the fluid retention member includes the cover  600 . The cover  600  may be placed over the opening  230  to retain fluid within the tip shield interior space  220 , as shown in  FIG. 3B . 
     In some embodiments, the cover  600  may include any suitable material including, but not limited to, a tape, a heat seal material, a thin film, a plastic cover, etc. 
     In some embodiments, the cover  600  may be coupled to the needle tip shield  200  over the opening  230  by any suitable means including, but not limited to, an adhesive, a glue, a snap feature, an interference feature, a heat seal material, sonic welding, etc. 
     In some embodiments, the fluid retention member may include an absorbent material. 
     In some embodiments, a first absorbent material  710  may be coupled to the V-Clip  300 , or other needle block, as shown in  FIG. 4 . 
     In some embodiments, the first absorbent material  710  may be coupled to a surface  310  of the V-Clip  300  adjacent the needle  150 . In this manner, the first absorbent material  710  may absorb fluid from the needle  150  as the needle  150  slides past the first absorbent material  710 . 
     In some embodiments, a second absorbent material  720  may be placed within the tip shield interior space  220  and/or coupled to the needle tip shield  200 , as shown in  FIG. 4 . In this manner, the second absorbent material  720  may absorb fluid within the tip shield interior space  220  that may come into contact with the second absorbent material  720 . However, it will also be understood that any number of absorbent materials may be placed within the tip shield interior space  220  and/or coupled to any part of the needle tip shield  200  and/or V-Clip  300  to help retain fluid within the needle tip shield  200 . 
     In some embodiments, the first absorbent material  710  and/or the second absorbent material  720  may each include any suitable material including, but not limited to, a sponge, a foam, a wicking material (e.g., a cellulous, gelatin, micro spun mesh, PEG material, etc.), a clotting material, etc. 
       FIGS. 5A and 5B  illustrate various views of the V-Clip  300  coupled with an anti-splatter member and removed from the needle tip shield  200  of  FIG. 1 . Specifically,  FIG. 5A  is a perspective view of the V-Clip  300  with an anti-splatter member including a damping member  800 , and  FIG. 5B  shows the V-Clip  300  of  FIG. 5A  with an anti-splatter member including the damping member  800  and a stiffening member  900  coupled over the damping member  800  to form a constrained-layer damping member. 
     Each of these V-Clip  300  designs may inhibit fluid splatter when the V-Clip  300  “fires” or “snaps closed” within the tip shield interior space  220  by slowing down the V-Clip  300  when it fires. For example, the V-Clip  300  may be movable between an open position and a closed position. In the open position, the V-Clip  300  may allow the needle  150  to advance distally through the needle passageway  210 . In the closed position, the V-Clip  300  may prevent the needle  150  from advancing distally through the needle passageway  210 . Thus, in the closed position, the V-Clip  300  may trap the tip of the needle  150  within the needle tip shield  200  as a safety mechanism. The V-Clip  300  may fire into the closed position when the needle  150  is pulled far enough proximally to allow the V-Clip  300  (which may be resilient) to fire and move toward the closed position. 
     In some embodiments, the anti-splatter member includes the damping member  800  coupled to the V-Clip  300 , as shown in  FIG. 5A , in order to slow movement of the V-Clip  300  as it moves from the open position to the closed position. 
     In some embodiments, the damping member  800  includes a visco-elastic material that may act to slow movement of the V-Clip  300  as it moves from the open position to the closed position. 
     In some embodiments, the anti-splatter member includes the damping member  800  in combination with the stiffening member  900 , which may be coupled over the damping member  800  in order to form a constrained-layer damping member. 
     In some embodiments, the stiffening member  900  may act to increase visco-elastic forces that may be associated with the visco-elastic material in order to further slow movement of the V-Clip  300  as it moves from the open position to the closed position. 
     In some embodiments, the stiffening member  900  may include any suitable material including, but not limited to, metal, plastic, tape, fabric, etc. 
     In some embodiments, the damping member  800  and/or the stiffening member  900  may be coupled to the V-Clip  300  and/or to each other via any suitable means including, but not limited to, an adhesive, a glue, a snap feature, an interference feature, a heat seal material, sonic welding, etc. 
       FIG. 6  shows a cross-sectional view of the needle tip shield  200  of  FIG. 1  with an anti-splatter member placed within the tip shield interior space  220 . 
     In some embodiments, the anti-splatter member may include a shock absorbing material  1000  placed adjacent the V-Clip  300 . The shock absorbing material  1000  may act to slow movement of the V-Clip  300  as it moves from the open position to the closed position and prevent/reduce fluid splatter. 
     In some embodiments, the shock absorbing material  1000  may include any suitable material including, but not limited to, a foam, a sponge, an absorbent material, a wicking material (e.g., a cellulous, gelatin, micro spun mesh, PEG material, etc.), a clotting material, etc. 
     It will be understood that any/all of the fluid restriction members described herein may be utilized alone and/or in combination with any/all of the other fluid restriction members that are described herein. For example, in some embodiments the needle tip shield  200  may generally include one or more of the fluid restriction members described herein, each of which may be configured to restrict fluid splatter and/or fluid leakage into and/or out of the needle tip shield  200 . In some embodiments, the fluid restriction member may be selected from the group consisting of: (1) a fluid impedance member located adjacent the needle passageway  210  that impedes fluid from entering into the needle tip shield  200  through the needle passageway  210  (e.g., see  FIGS. 2A-2C ); (2) a fluid retention member that retains fluid within the tip shield interior space  220  (e.g., see  FIGS. 3A-4 ); and (3) an anti-splatter member that inhibits fluid splatter when the V-Clip  300  or needle block moves from the open position to the closed position within the tip shield interior space  220  (e.g., see  FIGS. 5A-6 ). 
     Reference throughout this specification to “an embodiment” or “the embodiment” means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment. It is to be understood that any of the embodiments of the present disclosure, or any portion(s) of any of the embodiments of the present disclosure, may be combined together in any number of different ways. 
     Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure. This disclosure format, however, is not to be interpreted as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Description Of Embodiments are hereby expressly incorporated into this Description Of Embodiments, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. 
     Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Elements recited in means-plus-function format are intended to be construed in accordance with 35 U.S.C. § 112 Para.  6 . It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles set forth herein. 
     Standard medical directions, planes of reference, and descriptive terminology are employed in this specification. For example, anterior means toward the front of the body. Posterior means toward the back of the body. Superior means toward the head. Inferior means toward the feet. Medial means toward the midline of the body. Lateral means away from the midline of the body. Axial means toward a central axis of the body. Abaxial means away from a central axis of the body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. A sagittal plane divides a body into right and left portions. A midsagittal plane divides the body into bilaterally symmetric right and left halves. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions. These descriptive terms may be applied to an animate or inanimate body. 
     The phrases “connected to,” “coupled to,” “engaged with,” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term “abutting” refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together. The phrase “fluid communication” refers to two features that are connected such that a fluid within one feature is able to pass into the other feature. 
     As defined herein, “substantially equal to” means “equal to,” or within about a + or −10% relative variance from one another. 
     The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments. While the various aspects of the embodiments are presented in the Figures, the Figures are not necessarily drawn to scale unless specifically indicated. 
     While specific embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that the scope of the appended claims is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the apparatus and systems disclosed herein. 
     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 disclosure 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 present disclosure.