Abstract:
A medical connector for use with one or more medical implements. In some embodiments, the connector minimizes or eliminates the retrograde flow of fluid into the connector from one end or port upon the disconnection of a medical implement from the other end or port. In some embodiments, the connector generates a positive flow of fluid out of the connector from one end or port when a medical implement is disconnected from the other end or port.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 11/924,494, filed Oct. 25, 2007 (entitled “MEDICAL CONNECTOR”), now U.S. Pat. No. 8,105,314, which claims the benefit of U.S. Provisional Patent Application No. 60/854,524, filed Oct. 25, 2006 (entitled “MEDICAL CONNECTOR”), the entire disclosure of each being hereby incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The inventions relate generally to medical connectors. In particular, certain embodiments of the inventions relate to medical connectors for use with standard luer connectors. In certain embodiments, the medical connectors generate a positive flow of fluid away from a medical implement as the implement is removed from an end or port of the medical connector. 
     2. Description of the Related Art 
     Medical connectors are often used to selectively open and close fluid pathways for use in treating patients. In some connectors, a small amount of retrograde fluid flow occurs when the connector is closed, drawing fluid away from the patient and toward the connector. This retrograde flow can lead to clotting or obstructions in the fluid line, effectively shortening the time period during which a particular injection point is useable. In many applications, it is advantageous to minimize or eliminate such retrograde flow or to produce a positive flow of fluid toward the patient as the valve closes. 
     U.S. Pat. No. 6,599,273 (incorporated herein in its entirety) includes a general description of some examples of medical connectors in which retrograde fluid flow may occur. U.S. Pat. Nos. 6,245,048, 6,428,520, 6,695,817, and U.S. Patent Application Publication No. 2006-0161115A1 (incorporated herein in their entireties) include general descriptions of some examples of medical valves in which a positive flow of fluid is produced away from the medical connector and toward the patient as the connector closes. There are many different types of medical connectors, and the foregoing patents are cited merely to illustrate some ways in which fluid can be transferred through connectors. The methods, structures, and principles disclosed herein can be used in or adapted to function with the connectors (and components thereof) disclosed in the foregoing patents as well as in many different types of medical connectors known or used in this field. 
     SUMMARY OF THE INVENTION 
     In some embodiments, a medical connector for use with a first and second medical implement is described including a housing having a first proximal end and a second distal end, each configured for attachment to standard luer connectors. In some embodiments, the connector further includes an inner rigid element extending within the housing having at least one opening on a side thereof. The inner rigid element may be substantially hollow in its interior with the said opening extending from an outer surface of the inner rigid element to the hollow interior. A substantially hollow flexible element may be positioned within the housing substantially surrounding the inner rigid element. The flexible element may include at least one inward projection on an inner wall thereof, wherein at least a portion of the inward projection may be shaped to cooperate with the opening in the inner rigid element such that when the connector is in a substantially closed position, wherein fluid is not permitted to flow through the connector, the portion of the inward projection is within the opening and when the connector is in a substantially open position, the portion of the inward projection is outside of the opening to permit a reduction in the inner volume of the flexible element and/or the interior of the inner rigid element when the connector is in the substantially closed position. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Having thus summarized the general nature of the invention and some of its features and advantages, certain preferred embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein having reference to the figures that follow, of which: 
         FIG. 1  is a side view of a medical connector in a first position and a medical implement according to some embodiments of these inventions. 
         FIG. 2  is a top perspective view of the medical connector of  FIG. 1 . 
         FIG. 3  is a bottom perspective view of the medical connector of  FIG. 1 . 
         FIG. 4  is an exploded perspective view of the medical connector of  FIG. 1 . 
         FIG. 5  is a bottom perspective view of a component of a medical connector according to some embodiments of these inventions. 
         FIG. 6A  is a cross-sectional view of the medical connector component of  FIG. 5 . 
         FIG. 6B  is a cross-sectional view of the medical connector component of  FIG. 6A  rotated 90 degrees. 
         FIG. 7A  is a cross-sectional view of a component for a medical connector according to some embodiments of these inventions. 
         FIG. 7B  is a cross-sectional view of the medical connector component of  FIG. 7A  rotated 90 degrees. 
         FIG. 8A  is a cross-sectional view of a medical connector in a first position and a medical implement according to some embodiments of these inventions. 
         FIG. 8B  is a cross-sectional view of the medical connector and medical implement of  FIG. 8A  rotated 90 degrees. 
         FIG. 9A  is a cross-sectional view of a medical connector engaged with a medical implement according to some embodiments of these inventions. 
         FIG. 9B  is a cross-sectional view of the medical connector and medical implement of  FIG. 9A  rotated 90 degrees. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     While the description sets forth various embodiment specific details, it will be appreciated that the description is illustrative only and should not be construed in any way as limiting the invention. Furthermore, various applications of the invention, and modifications thereto, which may be apparent to those who are skilled in the art, are also encompassed by the general concepts described herein. For example, any of the structures in the devices illustrated or described in the patent documents incorporated herein by reference may be combined with or used instead of the structures disclosed herein. 
       FIG. 1  illustrates a male luer connector  10  with a luer end  12  and a luer lock  14  approaching a female connector  16 . The female connector  16  has a proximal end  18 , a distal end  20 , with a male luer  22  on its distal end. The distal end  20  may further include a luer lock. The female connector  16  includes a housing  24 .  FIG. 2  illustrates a perspective view of the female connector  16 . The proximal end  48  of a flexible element  26  is illustrated. The flexible element  26  may include an orifice  27  that is normally closed until a distally directed force is applied to flexible element  26 .  FIG. 3  illustrates a perspective view of the connector  16  in which the male luer  22  on the distal end  20  of the connector is visible. 
       FIG. 4  is an exploded perspective view of the connector  16  of  FIG. 2 . Some of the internal components of connector  16  are illustrated, such as flexible element  26  and rigid element  28 . In some embodiments of the assembled configuration, an inner rigid element  30  is provided and can fit within a cavity  32  inside of flexible element  26 . Orifice  27  is shown closed in this exploded perspective view. In some embodiments, orifice  27  is open when flexible element  26  is separate from housing  24 . In some embodiments, contact between the inner cavity of the housing  24  and portions of the proximal end  48  of flexible element  26  upon insertion of flexible element  26  into housing  24  may cooperate to substantially close orifice  27  such that the fluid flow path through connector  16  is impeded. 
       FIG. 5  illustrates a perspective view of rigid element  28  having a proximal end  31  and a distal end  33 . Distal end  33  may include radially projecting elements  35 . Radial elements  35  interact with corresponding features in the internal wall of housing  24  to secure rigid element  28  within housing  24  upon assembly of the connector  16 . Radial elements  35  extending along the longitudinal axis of connector  16  may interact with housing  24  to inhibit rotation of rigid element  28  inside of housing  24  when connector  16  is manipulated, for example when a female connector is attached to the distal end  20  of connector  16 . 
     In some embodiments, inner rigid element  30  has multiple openings. For example, openings  34  can be used to permit fluid to flow into an internal passage or fluid-flow path  36  inside of inner rigid element  30 . In some embodiments, two openings  34  are disposed on opposite sides of inner rigid element  30 . Additional openings similar to opening  34  can also be provided. In some embodiments, an opening can be provided at the proximal end  31  of inner rigid element  30 . In some embodiments, one or more of openings  34  and  38  are combined (i.e., the same openings(s) are configured to receive fluid and to receive one or more protrusions  52  (see  FIG. 7A ). Inner rigid element  30  may be blunt, pointed, opened-ended, closed-ended, or shorter or longer, or wider or narrower than shown here. Inner rigid element  30  may have many different shapes. For example, it may be configured as a tube-like structure as shown, configured as a sleeve with one or more longitudinal openings or slits extending partially along the length of the sleeve or along the entire length of the sleeve, or the inner rigid element  30  may be eliminated entirely. Inner rigid element  30  may be in a fixed position inside of the housing  24  or it may be moveable or floating inside of the housing  24 . In the absence of inner rigid element  30 , one or more fluid openings may be provided at or near a distal region of the cavity inside the housing to convey fluid within the housing cavity to the male end of the connector. 
     In some embodiments, one or more openings  38  are provided in inner rigid element  30 , and may be located in a direction distal from opening  34 . As will be described below, in some embodiments, opening  38  is intended to receive a protrusion on an internal surface of flexible element  26  when the connector  16  is in the closed configuration (see  FIG. 8A ). In some embodiments, opening  38  is adapted to receive fluid flow. Where opening  38  is used to facilitate fluid flow through inner rigid element  30 , opening  34  may or may not be included. 
       FIGS. 6A and 6B  illustrate orthogonal cross-sections of rigid element  28  taken in a vertical plane. In some embodiments, as illustrated, the proximal edges  40 ,  42  of openings  34 ,  38  can be flat and substantially horizontal, and the distal edges  44 ,  46  of openings  34 ,  38  can be slanted or beveled. 
     As illustrated, the fluid-flow path  36  may extend from the proximal end of the inner rigid element  30  along a generally axially-oriented linear path to the male end  22 . In some embodiments, as illustrated, the fluid-flow path  36  in the distal region of the inner rigid element  30  is generally non-tortuous; for example, the fluid-flow path  36  may not turn in a direction that is perpendicular to or substantially non-parallel with the axis of the inner rigid element  30 , and/or it may not include fluid-exiting side openings in the distal region of the inner rigid element  30 . Such a fluid-flow path may provide a higher fluid flow rate and create less turbulence in the fluid flow (which can be especially advantageous when the fluid includes blood cells). 
       FIGS. 7A and 7B  illustrate orthogonal cross-sections of flexible element  26  taken in a vertical plane. Flexible element  26  can be longitudinally compressed and/or moved by a force applied to the proximal end  48  toward the distal end  50 . A plurality of inwardly projecting elements  52  are provided in an internal cavity  32  of flexible element  26 . In some embodiments, there is one such protrusion  52 . In the illustrated embodiment, there are two protrusions  52 . In some embodiments, there can be multiple openings  38 , some of which can be positioned along different regions of inner rigid element  30 , and there can be additional corresponding protrusions  52  that can be designed to selectively fit within or be withdrawn from one or more openings  38 . In some embodiments, as shown, the internal edges or faces  53  of the opposing protrusions  52  can be positioned and oriented to contact each other and/or be close to each other when the connector  16  is in a substantially closed position. The protrusions  52  can extend into the inner rigid element  30  at an intermediate position within the fluid-flow path  36  of the inner rigid element  30 . In some embodiments, the wall of the inner rigid element  30  is not positioned between the opposing edges or faces  53  of the protrusions  52  in the substantially opened position. Openings  38  can have a variety of different shapes and sizes. For example, one or more of openings  38  can be round, square, rectangular, trapezoidal, elliptical, etc. Opening  38  can be larger than opening  34 . In some embodiments, opening  38  can be approximately at least one-fifth, one-quarter, one-third, one-half, or more of the length of inner rigid element  30 . Protrusions  52  can also have a variety of different shapes and sizes, which may correspond to or be different from the shapes and/or sizes of openings  38 . As shown, the protrusions  52  can be substantially planar. In some embodiments, the volume of the one or more protrusions  52  can be approximately equivalent to or greater than the volume in the proximal region of the connector adapted to receive the luer  12 . 
     In some embodiments, upper or proximal edges  54  of protrusions  52  can be slanted and/or beveled. Similarly, lower or distal edges  56  of protrusions  52  can be also slanted and/or beveled. Slanting or beveling these surfaces may facilitate fluid flow through the connector  16  and may minimize turbulence in the fluid flow. In general, the shape, materials, and structure of rigid element  28  and flexible element  26  can be selected to allow protrusions  52  to be positioned within openings  38  when the connector is closed, and protrusions  52  can be completely or partially withdrawn from openings  38  when the connector is opened. When the connector  16  is in the substantially closed position, the inward protrusions  52  function so as to reduce the fluid space within the connector  16  and the fluid flow path as compared to when the connector  16  is in the substantially open position. 
     In some embodiments, flexible element  26  can be made of silicon, and the remaining components of connector  16  can be made of a polymer material such as polycarbonate. A proximal region  58  of flexible element  26  can include a portion with an increased wall thickness or a structure (or materials of composition) that contribute to the proximal region  58  being stiffer or harder than the portion of the flexible element  26  that flexes during compression. By providing increased stiffness or hardness for the proximal region  58 , there is a lower likelihood that fluid within the valve will be forced back into the fluid path  32  inside of flexible element  26  as flexible element  26  expands to its original height when the valve is closed. Moreover, in some embodiments, a proximal portion  60  of fluid pathway  32  inside the flexible element  26  has a horizontal cross-sectional area that is substantially less than the horizontal cross-sectional area of a region in the fluid path  36  of element  28 , so that fluid flow out of the distal end of the connector is encouraged and retrograde fluid flow toward the proximal end of the connector is discouraged. 
     In some embodiments, orifice  27  extends along an axis substantially perpendicular to inward projections  52 , as shown in  FIG. 7A . In other embodiments, orifice  27  extends along substantially the same plane as projections  52 . 
     As shown in  FIGS. 7A  and B, proximal portion  60  may include a non-rotationally symmetrical cross-sectional diameter. In some embodiments, the proximal portion  60  has smaller cross-sectional diameter in the plane perpendicular to orifice  27  and a larger cross-sectional diameter in the plane of orifice  27 . In some embodiments, portions of proximal portion  60  have a substantially rectangular cross-sectional area. 
       FIG. 8A  illustrates a vertical cross-section of the male luer  10  and female connector  16  illustrated in  FIG. 1 . In  FIGS. 8A and 8B , a portion of rigid element  28  is positioned within the internal cavity  32  of flexible element  26 . Inward protrusions  52  are positioned within openings  38 , and more particularly, in the fluid flow path through connector  16 . Fluid flow within connector  16  is substantially occluded. The proximal end  48  of flexible element  26  may be swabbable with antiseptic in a sweeping motion across the proximal end  18  of the connector  16 , and the proximal end  48  may extend above the housing, may be substantially flush with the housing, or may be recessed within the housing. 
       FIGS. 9A and 9B  illustrate an embodiment of the female connector  16  after it is connected to the male luer connector  10  in orthogonal vertical cross-sections. In some embodiments, flexible element  26  can be compressed and/or moved by a distally directed force applied by the male luer  12 . As shown, a portion of inner rigid element  30  can extend in a proximal direction beyond orifice  27  during compression. In some embodiments, inner rigid element  30  does not extend further in a proximal direction than the proximal end  48  of the flexible element  26  when compressed. In some embodiments, orifice  27  may automatically open to allow fluid flow through the connector  16  upon insertion of the male luer connector  10  into connector  16 . 
     In  FIGS. 9A and 9B , the medical connector  16  is substantially open to fluid flow between the male luer  10  and the distal end  20  of the female connector  16 . As shown in  FIG. 9A , the protrusions  52  can be partially or completely withdrawn from the openings  38  so that the volume inside of the fluid path  36  during the open stage of the connector  16  is substantially larger than the fluid volume inside of the fluid path  36  when the connector  16  is closed (see, e.g.,  FIG. 8A ). This can diminish, or eliminate, retrograde fluid flow from the patient toward the proximal end  18  of the connector  16 , or even produce a positive flow of fluid upon closure in the direction of the distal end  20  of the connector  16  and toward the patient. In some embodiments, proximal region  58  resists compression to a greater extent than a region on flexible element  26  positioned distal from the region  58  during the insertion of the mail luer connector  10  into the female connector  16 . Proximal region  58  can substantially maintain its height, before and after compression and/or movement, as fluid flow is enabled through the connector  16 , which may reduce any vacuum effect in this portion of flexible element  26 . 
     The foregoing description is provided to illustrate certain examples. The inventive concepts, principles, structures, steps, and methods disclosed herein can be applied to the devices and methods disclosed in the attached patents and in many other types of medical connectors.