Patent Publication Number: US-2023140352-A1

Title: Sheath valve housing

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of priority under 35 U.S.C. § 119 to prior filed U.S. Provisional Patent Application No. 63/272,849 filed on Oct. 28, 2021, the entire contents of which is hereby incorporated by reference as if set forth in full herein. 
    
    
     FIELD 
     The present application relates generally to catheters, and specifically to sheath valve housings. 
     BACKGROUND 
     Catheters are used in various medical and surgical procedures, including ablation, such as arrhythmia ablation, mapping, such as cardiac mapping, and drug delivery, such as intracardial drug delivery. One danger of catheters is the potential for an air embolism caused by the unintentional introduction of air into a patient&#39;s circulatory system at an insertion site. In the related art, either extremely slow and careful insertion of the catheter or jetting (e.g., over-pressurization of a valve housing) are used to mitigate this risk. However, these mitigation efforts require active effort on the part of an operation team. 
     Thus, structural mechanisms of reducing the risk of air embolisms are desired in the art. 
     SUMMARY 
     A sheath valve housing is included herein, which includes: an input port disposed on a proximal side of the sheath valve housing; an output port disposed on a distal side of the sheath valve housing, the input port and output port defining a longitudinal axis extending therethrough; a chamber disposed within the sheath valve housing between the input port and the output port and centered on the longitudinal axis, a catheter pathway being defined within the sheath valve housing through the chamber between the input port and the output port; and a plurality of ribs disposed about the chamber so that a member is aligned with the longitudinal axis upon insertion into the chamber. 
     In any of the examples disclosed herein, at least one rib of the plurality of ribs may have at least one cutout. 
     In any of the examples disclosed herein, at least one of the at least one cutout may be between about one-fourth and one-half of a length of the at least one rib. 
     In any of the examples disclosed herein, at least one of the at least one cutout may be about one-third the length of the rib. 
     In any of the examples disclosed herein, at least one cutout being between about one-half and three-fourths of a length of the rib. 
     In any of the examples disclosed herein, at least one of the at least one cutout may be about two-thirds the length of the rib. 
     In any of the examples disclosed herein, at least one of the at least one cutout may be on an edge of the catheter pathway. 
     In any of the examples disclosed herein, at least one of the at least one cutout may be an internal hole through the at least one rib. 
     In any of the examples disclosed herein, at least one of the at least one cutout may be on an edge of the at least one rib closest to a body of the chamber. 
     In any of the examples disclosed herein, the sheath valve housing may further include an aspiration port connected to the chamber. 
     In any of the examples disclosed herein, at least one of the plurality of ribs may have a cutout creating a fluid pathway on a perimeter of the chamber to the aspiration port. 
     In any of the examples disclosed herein, the plurality of ribs may be positioned substantially parallel to the catheter pathway. 
     In any of the examples disclosed herein, the plurality of ribs may be slanted inwardly along the catheter pathway. 
     In any of the examples disclosed herein, the chamber may be slanted inwardly along the catheter pathway. 
     In any of the examples disclosed herein, the sheath valve housing may further include a secondary wall formed about a distal end of the plurality of ribs. 
     In any of the examples disclosed herein, the sheath valve housing may further include a valve body and a cap, the cap forming the input port. 
     In any of the examples disclosed herein, the plurality of ribs may provide a guidance mechanism to a catheter through the catheter pathway. 
     According to aspects of the present disclosure, there is provided a method of using a using a sheath valve housing, the method including providing a sheath valve housing according to any of the foregoing, attaching the sheath valve housing to a sheath; inserting a catheter through the catheter pathway via the input port such that the catheter is centered on the longitudinal axis by the plurality of ribs in the chamber; and aspirating the catheter through the aspiration port. 
     According to aspects of the present disclosure, there is provided a method of using a using a sheath valve housing, the method including providing a sheath valve housing including an input port disposed on a proximal side of the sheath valve housing, an output port disposed on a distal side of the sheath valve housing, the output port and input port defining a longitudinal axis extending therethrough; a chamber disposed within the sheath valve housing between the input port and the output port, a catheter pathway being aligned with the longitudinal axis and defined within the sheath valve housing through the chamber between the input port and the output port; a plurality of ribs disposed about the chamber; and an aspiration port connected to the chamber; attaching the sheath valve housing to a sheath; inserting a catheter through the catheter pathway via the input port such that the catheter is centered on the longitudinal axis by the plurality of ribs in the chamber; and aspirating the catheter through the aspiration port. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       While the specification concludes with claims, which particularly point out and distinctly claim the subject matter described herein, it is believed the subject matter will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: 
         FIG.  1 A  illustrates a side cross-sectional view of a sheath valve housing connected to a sheath according to aspects of the present disclosure; 
         FIG.  1 B  is an exploded view of a sheath valve housing according to aspects of the present disclosure; 
         FIG.  1 C  is a perspective view of a sheath valve housing according to aspects of the present disclosure; 
         FIG.  1 D  is a planar view of a sheath valve housing facing according to aspects of the present disclosure 
         FIG.  2 A  is a side cross-sectional view of a sheath valve housing according to aspects of the present disclosure; 
         FIG.  2 B  is an interior view of a sheath valve housing according to aspects of the present disclosure; 
         FIG.  3 A  is a side cross-sectional view of a sheath valve housing according to aspects of the present disclosure; 
         FIG.  3 B  is an interior view of a sheath valve housing according to aspects of the present disclosure; 
         FIG.  4 A  is a side cross-sectional view of a sheath valve housing according to aspects of the present disclosure; 
         FIG.  4 B  is an interior view of a sheath valve housing according to aspects of the present disclosure; 
         FIG.  5 A  is a side cross-sectional view of a sheath valve housing according to aspects of the present disclosure; 
         FIGS.  5 B and  5 C  are interior views of a sheath valve housing according to aspects of the present disclosure; 
         FIGS.  6 - 8    illustrates airflows in sheath valve housings according to aspects of the present disclosure; 
         FIGS.  9 A- 9 H  illustrate example rib designs according to aspects of the present disclosure; 
         FIG.  10    is a flowchart of a method of creating a sheath valve housing according to aspects of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The following description of certain examples of the disclosure should not be used to limit the scope of the present disclosure. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the disclosure. The detailed description illustrates by way of example, not by way of limitation, the principles of the disclosure. Other examples, features, aspects, embodiments, and advantages of the disclosure will become apparent to those skilled in the pertinent art from the following description, which includes, by way of illustration, one of the best modes contemplated for carrying out the disclosure. As will be realized, the disclosure is capable of other different or equivalent aspects, all without departing from the disclosure. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive. 
     The following-described teachings, expressions, versions, examples, etc., should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined are apparent to those skilled in the pertinent art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims. 
     As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ±20% of the recited value, e.g., “about 90%” may refer to the range of values from 71% to 99%. 
     As used herein, the terms “comprising” or “containing” or “including” are interpreted to mean that at least the named compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named. 
     As used herein, the use of terms such as “having,” “has,” “including,” or “includes” are open-ended and are intended to have the same meaning as terms such as “comprising” or “comprises” and not preclude the presence of other structure, material, or acts. Similarly, though the use of terms such as “can” or “may” are intended to be open-ended and to reflect that structure, material, or acts are not necessary, the failure to use such terms is not intended to reflect that structure, material, or acts are essential. To the extent that structure, material, or acts are presently considered to be essential, they are identified as such. 
     Ranges described as being between a first value and a second value are inclusive of the first and second values, as well as all values therebetween. Likewise, ranges described as being from a first value and to a second value are inclusive of the first and second values, as well as all values therebetween. 
     It is also to be understood that the mention of one or more method steps does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. 
     The components described hereinafter as making up various elements of the disclosure are intended to be illustrative and not restrictive. Many suitable components that would perform the same or similar functions as the components described herein are intended to be embraced within the scope of the disclosure. Such other components not described herein can include, but are not limited to, for example, similar components that are developed after the development of the presently disclosed subject matter. 
     Reference will now be made in detail to examples of the disclosed technology, such as those illustrated in the accompanying drawings. Wherever convenient, the same references numbers will be used throughout the drawings to refer to the same or like parts. 
       FIG.  1 A  illustrates an example sheath valve housing  100 , attached to a sheath  1 . Sheath valve housing  100  has a valve body  110  with proximal end  102  and a distal end  104 . Valve body  110  includes an input port  120  (e.g., a catheter input port  120 ) and an output port  140  (e.g., catheter output port  140 ) defining a catheter pathway  130  extending therethrough. The catheter pathway  130  may be a longitudinal axis  130  of the sheath valve housing  100 . A cap  150  may be on a proximal end of the valve body  110 . Input port  120  may be formed within cap  150 . Cap  150  may be removably connectable to the proximal end of valve body  110  by, for example, press-fit and/or a screw fit. Cap  150  may be configured to form a sealed connection with valve body  110 . 
     The valve body  110  may further include a chamber  170  disposed along the catheter pathway  130 . Chamber  170  may be centered on the longitudinal axis  130 . An aspiration port  160  may extend from chamber  170  to an exterior of sheath valve housing  100 . Aspiration port  160  may be used to withdraw air from chamber  170  introduced, for example, through input port  120 . A plurality of ribs  180  may be disposed about chamber  170 . The ribs  180  may be substantially aligned with the catheter pathway  130 . The ribs  180  provide an irrigation pathway to allow air to naturally coalesce within chamber  170  and move out of an irrigation pathway through aspiration port  160 . In some cases, an inner wall of ribs  180  may be slanted inwardly along the catheter pathway  130 , which may help guide a catheter from the input port  120  to the output port  140  along the catheter pathway  130 . As non-limiting examples, the angle of the slant may be between about 10 and 40 degrees from parallel and, more particularly, between about 10 and 30, 10 and 20, 20 and 30, 20 and 40, 30 and 40, 10 and 15, 15 and 20, 20 and 25, 25 and 30, 30 and 35, or 35 and 40 degrees from parallel. In some cases, the slant may be about 30 degrees from parallel. Ribs  180  may sit substantially perpendicular to a radial direction of catheter pathway  130 , or may be slanted outward such that bottom edges of ribs  180  are longitudinally closer to outlet port  140  than inward bottom edges of ribs  180 . 
       FIG.  1 B  illustrates a perspective view of sheath valve housing  100  with output port  140  pointing roughly down, aspiration port  160  pointing roughly leftward, and with cap  150  floating above valve body  110 .  FIG.  1 C  illustrates a perspective view of valve housing  100  looking towards output port  140 .  FIG.  1 D  illustrates a perspective view of valve housing  100  looking towards input port  120  and cap  150 . 
       FIG.  2 A  illustrates a cutaway view of valve housing  100 .  FIG.  2 B  illustrates a top-down view of valve housing  100  with cap  150  removed. As can be seen in  FIGS.  2 A and  2 B , six ribs  180   a  are substantially monolithic and evenly spaced around chamber  170 . However, this is merely an example, and various changes to a number, distribution, or constitution of the ribs  180  may be made without departing from the scope of the present disclosure. 
       FIG.  3 A  illustrates a cutaway view of valve housing  100 .  FIG.  3 B  illustrates a top-down view of valve housing  100  with cap  150  removed. As can be seen in  FIGS.  3 A and  3 B , six ribs  180   b  include cutouts  384  between about one-fourth and one-half a length of ribs  180   b,  for example, about one-third a length of ribs  180   b.  Cutouts  384  may help form a channel for air to move from chamber  170  to aspiration port  160 . In  FIGS.  3 A and  3 B , six ribs with substantially similar sizes and cutouts are spaced substantially evenly around chamber  170 . However, this is merely an example, and various changes to a number, distribution, or constitution of the ribs  180  may be made without departing from the scope of the present disclosure. 
       FIG.  4 A  illustrates a cutaway view of valve housing  100 .  FIG.  4 B  illustrates a top-down view of valve housing  100  with cap  150  removed. As can be seen in  FIGS.  4 A and  4 B , six ribs  180   c  include cutouts  484  between about one-half and three-fourths a length of ribs  180   c,  for example, about two-thirds a length of ribs  180   c.  Cutouts  484  may help form a channel for air to move from chamber  170  to aspiration port  160 . In  FIGS.  4 A and  4 B , six ribs with substantially similar sizes and cutouts are spaced substantially evenly around chamber  170 . However, this is merely an example, and various changes to a number, distribution, or constitution of the ribs  180  may be made without departing from the scope of the present disclosure. 
       FIG.  5 A  illustrates a cutaway view of valve housing  100 .  FIG.  5 B  illustrates a top-down view of valve housing  100  with cap  150  removed.  FIG.  5 C  illustrates a perspective view of valve housing  100  with cap  150  removed. As can be seen in  FIGS.  5 A- 5 C , six ribs  180   d  include cutouts  584  about one-third a height of ribs  180   d.  Cutouts  584  may be substantially similar to cutouts  384 . Additionally, a secondary wall  590  is formed at a base of ribs  180   d  around and an outlet from chamber  170  to outlet port  140 . Secondary wall  590  may further assist in retaining air bubbles within chamber  170  are they are directed to aspiration port  160 . In some cases, the secondary wall  590  may be about 60 percent or less of the height of ribs  180   d,  and, more particularly, less than about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, or 55 percent or less of the height of ribs  180   d.  In some cases, the secondary wall  590  may be between about 5 and 60 percent of the height of ribs  180 , and, more particularly, between about 5 and 10, 10 and 15, 15 and 20, 20 and 25, 25 and 30, 35 and 40, 45 and 50, 50 and 55, and 55 and 60 of the height of ribs  180   d.  In some cases, the secondary wall may be about 50 degrees of the height of ribs  180   d.  In some cases, secondary wall  590  may be flanged outwardly at a portion nearer the inlet port. As non-limiting examples, the angle of the flange may be between about 5 and 50 degrees from parallel and, more particularly, between about 10 and 30, 10 and 20, 20 and 30, 20 and 40, 30 and 40, 40 and 50, 5 and 10, 10 and 15, 15 and 20, 20 and 25, 25 and 30, 30 and 35, 35 and 40, 40 and 45, or 45 and 50 degrees from parallel. In some cases, the flange may be about 30 degrees from parallel. 
     In  FIGS.  5 A- 5 C , six ribs with substantially similar sizes and cutouts are spaced substantially evenly around chamber  170 . However, this is merely an example, and various changes to a number, distribution, or constitution of the ribs  180  may be made without departing from the scope of the present disclosure. For example, substantially monolithic ribs  180   a  or ribs with an increased cutout (e.g.,  180   b ) may be used with secondary wall  590 . Additionally, various changes can be made to secondary wall  590 , as illustrated without departing from the scope of the present disclosure. 
       FIG.  6    illustrates an example airflow  699  in a sheath valve housing  100  according to aspects of the present disclosure. As can be seen, the flow trajectories show that the ribs  180   a    384  allow for liquid and air bubbles to flow when aspirating through aspiration port  160 . 
       FIG.  7    illustrates an example airflow  799  in a sheath valve housing  100  according to aspects of the present disclosure. As can be seen, the flow trajectories show that the ribs  180   b  with cutouts  384  allow for liquid and air bubbles to flow thru when aspirating through aspiration port  160 . 
       FIG.  8    illustrates an example of airflow  899  in a sheath valve housing  100  according to aspects of the present disclosure. As can be seen, the flow trajectories show that the ribs  180   c  with cutouts  484  allow for liquid and air bubbles to flow thru when aspirating through aspiration port  160 . In some cases, openings within ribs (e.g., cutouts  384  or  484 ) may improve the flow trajectories. 
       FIGS.  9 A- 9 H  illustrate different rib designs  180   a - 180   h  according to example embodiments. Referring to  FIG.  9 A , rib  180   a  is substantially monolithic and solid. Referring to  FIG.  9 B , rib  180   b  includes a cutout  384  about one-third of the way down rib  180   b.  Referring to  FIG.  9 C , rib  180   c  includes a cutout  484  about two-thirds of the way down rib  180   c.  Referring to  FIG.  9 D , rib  180   d  includes a cutout  984   d  halfway down a side of  180   d,  but is substantially monolithic and solid at top and bottom edges. Referring to  FIG.  9 E , rib  180   e  includes a cutout  984   e  through an interior portion go rib  180   e  (e.g., an internal hole). Cutout  984   e  may be substantially ovular, but this is merely an example. Referring to  FIG.  9 F , rib  180   f  includes a plurality of cutouts  984   f  through an interior portion go rib  180   f.  Cutouts  984   f  may be substantially circular, and of a substantially similar size and shape. However, this is merely an example. Referring to  FIG.  9 G , rib  180   g  includes a plurality of slots  984   g  through an interior portion go rib  180   g.  Slots  984   g  may be substantially rectangular with substantially even heights and varying lengths. However, this is merely an example. Referring to  FIG.  9 H , rib  180   h  includes a cutouts  984   h  on an edge of the rib  180   h  closest to catheter pathway  130  (e.g., on an interior edge of rib  180   h ). 
     One of ordinary skill will recognize in light of the present disclosure that various alternative rib designs may be used. Additionally, example features of multiple ribs  180   a - 180   h  may be combined. For example, a rib  180  may include an exterior-edge cutout  384 , an interior cutout  984   e,  and an interior-edge cutout  984   h.  Furthermore, various rib designs may be used within a same sheath valve housing  100 . For example, ribs  180  farther from aspiration port  160  may have more and/or larger cutouts than ribs  180  closest to aspiration port  160 , but this is merely an example. 
       FIG.  10    is a flowchart of a method  1000  of using a sheathe valve housing  100  according to aspects of the present disclosure. The method may be performed, for example, by a medical professional. The method may include attaching  1010  sheath valve housing  100  to a sheath  1 . The method could include inserting  1010  an end of a sheath  1  into output port  140 . Sheath  1  may already be inserted within a patient, e.g., within a patient&#39;s arteries. 
     Once sheath  1  is connected to sheath valve housing  100 , a catheter may be fed through catheter insertion path  130  via input port  120  of sheath valve housing  100 . That is, a distal end of the catheter may move from exterior to a patient, through input port  120 , through chamber  170 , and through outlet port  140  into sheath  1 . Sheath  1  may be used to guide the catheter to a destination site within the patient. 
     Finally, when the catheter is being inserted  1020  and/or after the catheter has been inserted, sheath valve housing  100  is aspirated through aspiration port  160  at  1030 . For example, a suction machine may be connected to aspiration port  160  to draw air and/or other fluids from chamber  170  to prevent them from entering a patient. 
     The descriptions contained herein are examples of embodiments and are not intended in any way to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of system components, including alternative combinations of components illustrated in separate figures, alternative materials, alternative component geometries, and alternative component placement. Modifications and variations apparent to those having skill in the pertinent art according to the teachings of this disclosure are intended to be within the scope of the claims which follow.