Abstract:
An example medical device system includes a reusable connector cable having a female adaptor and a first fiber optic cable disposed within the reusable connector cable. A single use device is capable of connecting to the reusable connector cable and includes a male adaptor capable of mating with the female adaptor. A second fiber optic cable extends through the single use device such that the second fiber optic cable optically connects to the first fiber optic cable when the male adaptor of the single use device is disposed within the female adaptor of the reusable connector cable. A cleaning assembly is disposed within the single use device and is capable of cleaning an end of the first fiber optic cable when the male adaptor of the single use device is mated with the female adaptor of the reusable connector cable.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority under 35 U.S.C. §119 to U.S. Provisional Application Ser. No. 61/981,075, filed Apr. 17, 2014, the entirety of which is incorporated herein by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    The present disclosure pertains to medical devices, and methods for using and manufacturing medical devices. More particularly, the present disclosure pertains to medical devices and methods that include self-cleaning optical connectors. 
       BACKGROUND 
       [0003]    A wide variety of intracorporeal medical devices have been developed for medical use, for example, intravascular use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices. 
       SUMMARY 
       [0004]    This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example medical device system is disclosed. The medical device comprises: 
         [0005]    a reusable connector cable including a female adaptor; 
         [0006]    a first fiber optic cable disposed within the reusable connector cable; 
         [0007]    a single use device capable of connecting to the reusable connector cable, the single use device including a male adaptor capable of mating with the female adaptor of the reusable connector cable; 
         [0008]    a second fiber optic cable extending through the single use device such that the second fiber optic cable optically connects to the first fiber optic cable when the male adaptor of the single use device is disposed within the female adaptor of the reusable connector cable; and 
         [0009]    a cleaning assembly disposed within the single use device, capable of cleaning an end of the first fiber optic cable when the male adaptor of the single use device is mated with the female adaptor of the reusable connector cable. 
         [0010]    Alternatively or additionally to any of the embodiments above, the single use device comprises a single use connector cable including the male adaptor at a first end and capable of connecting at a second end to a pressure sensing guidewire. 
         [0011]    Alternatively or additionally to any of the embodiments above, the single use device comprises a pressure sensing guidewire including the male adaptor at a first end thereof. 
         [0012]    Alternatively or additionally to any of the embodiments above, the reusable connector cable is operably connected to a signal processing module. 
         [0013]    Alternatively or additionally to any of the embodiments above, the cleaning assembly is secured to the male adaptor of the single use device. 
         [0014]    Alternatively or additionally to any of the embodiments above, the cleaning assembly comprises a wiping surface that is capable of wiping the end of the first fiber optic cable. 
         [0015]    Alternatively or additionally to any of the embodiments above, the cleaning assembly is biased to hold the wiping surface against the end of the first fiber optic cable 
         [0016]    Alternatively or additionally to any of the embodiments above, the second fiber optic cable is recessed within the male adaptor of the single use device. 
         [0017]    Alternatively or additionally to any of the embodiments above, the male adaptor includes a pocket to accommodate the cleaning assembly when the cleaning assembly is moved into a collapsed configuration when the male adaptor of the single use device mates with the female adaptor of the reusable connector cable. 
         [0018]    Alternatively or additionally to any of the embodiments above, the female adaptor of the reusable connector cable includes a vent that is positioned to correspond to the pocket when the male adaptor of the single use device mates with the female adaptor of the reusable connector cable. 
         [0019]    A medical device system is disclosed. The medical device system comprises: 
         [0020]    a signal processing module; 
         [0021]    a reusable connector cable operably connectable to the signal processing module, the connector cable including a female adaptor; 
         [0022]    a first fiber optic cable disposed within the reusable connector cable; 
         [0023]    a single use connector cable including a male adaptor capable of mating with the female adaptor of the reusable connector cable; 
         [0024]    a second fiber optic cable extending through the single use connector cable such that the second fiber optic cable optically connects to the first fiber optic cable when the male adaptor of the single use connector cable is mated with the female adaptor of the reusable connector cable; and 
         [0025]    a cleaning assembly disposed within the single use device, capable of cleaning an end of the first fiber optic cable when the male adaptor of the single use connector is mated with the female adaptor of the reusable connector cable. 
         [0026]    Alternatively or additionally to any of the embodiments above, the single use connector cable includes the male adaptor at a first end and is capable of connecting at a second end to a pressure sensing guidewire. 
         [0027]    Alternatively or additionally to any of the embodiments above, the cleaning assembly is secured to the male adaptor of the single use device. 
         [0028]    Alternatively or additionally to any of the embodiments above, the cleaning assembly comprises a wiping surface that is capable of wiping the end of the first fiber optic cable and the cleaning assembly is biased to hold the wiping surface against the end of the first fiber optic cable 
         [0029]    Alternatively or additionally to any of the embodiments above, the male adaptor of the single use connector cable protects an end of the second fiber optic cable. 
         [0030]    Alternatively or additionally to any of the embodiments above, the male adaptor includes a pocket to accommodate the cleaning assembly when the cleaning assembly is moved into a collapsed configuration when the male adaptor of the single use device mates with the female adaptor of the reusable connector cable. 
         [0031]    Alternatively or additionally to any of the embodiments above, the female adaptor of the reusable connector cable includes a vent that is positioned to correspond to the pocket when the male adaptor of the single use device mates with the female adaptor of the reusable connector cable. 
         [0032]    A method of connecting a pressure sensing guidewire to a signal processing module is disclosed. The method comprises: 
         [0033]    providing a connector cable operably connectable to the signal processing module, the connector cable including a female adaptor and a first fiber optic cable extending within the female adaptor; 
         [0034]    providing a disposable cable including a male adaptor and a second fiber optic cable extending within the male adaptor; 
         [0035]    providing a cleaning assembly disposed within the male adaptor; 
         [0036]    advancing the male adaptor of the disposable cable into the female adaptor of the connector cable such that an end of the second fiber optic cable contacts the cleaning assembly; and 
         [0037]    further advancing the male adaptor of the disposable cable within the female adaptor of the connector cable such that the cleaning assembly cleans the end of the second fiber optic cable and is bent out of the way so that the first fiber optic cable can optically connect with the second fiber optic cable. 
         [0038]    Alternatively or additionally to any of the embodiments above, the method further comprises connecting a pressure sensing guidewire to the disposable cable. 
         [0039]    Alternatively or additionally to any of the embodiments above, the method further comprises obtaining a pressure measurement using the pressure sensing guidewire. 
         [0040]    The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0041]    The present disclosure may be more completely understood in consideration of the following detailed description of various embodiments of the present disclosure in connection with the accompanying drawings, in which: 
           [0042]      FIG. 1  is a schematic illustration of a medical device system including a pressure sensing guidewire; 
           [0043]      FIG. 2  is a perspective view of a cable connector useful in the medical device system of  FIG. 1 ; 
           [0044]      FIG. 3  is a top plan view of a portion of a cable connector useful in the medical device system of  FIG. 1 ; 
           [0045]      FIG. 4  is a cross-sectional view of the cable connector of  FIG. 2 ; 
           [0046]      FIG. 5  is a cross-sectional view of the cable connector of  FIG. 2 , with a first part of the connector partially inserted into a second part of the connector; 
           [0047]      FIG. 6  is a cross-sectional view of the cable connector of  FIG. 2 , with the first part of the connector fully inserted into the second part of the connector; 
           [0048]      FIG. 7  is a schematic illustration of a cleaning assembly useful in the cable connector of  FIG. 2 ; and 
           [0049]      FIG. 8  is a schematic illustration of another cleaning assembly useful in the cable connector of  FIG. 2 . 
       
    
    
       [0050]    While the present disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the present disclosure to particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. 
       DETAILED DESCRIPTION 
       [0051]    Definitions of certain term are provided below, and these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. 
         [0052]    All numeric values used herein are assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same or substantially the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure. 
         [0053]    The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). 
         [0054]    As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents, unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or”, unless the content clearly dictates otherwise. 
         [0055]    The following detailed description should be read with reference to the drawings in which similar elements in different drawings are identified with the same reference numbers. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. 
         [0056]    It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless cleared stated to the contrary. 
         [0057]    During some medical interventions, it may be desirable to measure and/or monitor the blood pressure within a blood vessel. For example, some medical devices may include pressure sensors that allow a clinician to monitor blood pressure. Such devices may be useful in determining fractional flow reserve (FFR), which may be understood as the pressure after a stenosis relative to the pressure before the stenosis. A number of pressure sensing devices, however, may pose technical challenges for steering, tracking, torqueing or otherwise navigating the device within the vasculature. For example, medical devices may include a relatively stiff pressure sensor located at or near the distal tip of the device and/or a sensor housing (in which the sensor is mounted) that may also be relatively stiff. Disclosed herein are a number of medical device that include pressure sensing capabilities and may be more easily steered, tracked, torqued, and/or otherwise navigated through the anatomy. 
         [0058]      FIG. 1  is a schematic view of an example system  10  for obtaining pressure measurements within a patient&#39;s anatomy. In some embodiments, the system  10  may be considered as including a reusable portion  12  and a disposable or one-time use portion  14 . It will be appreciated that in some instances, one or more elements of the reusable portion  12  may instead be disposable or replaceable, and in some instances, one or more elements of the disposable portion  14  may be used more than once. 
         [0059]    The reusable portion  12  includes some of the supporting devices that enable use of the disposable portion  14 . In some embodiments, the reusable portion  12  includes a signal processing module  16 . The signal processing module  16  may, for example, include a light source and may be configured to process optical signals that are received by the signal processing module  16 . In some embodiments, as illustrated, the signal processing module  16  may communicate with a display  18  via a cable  20 . The display  18  may represent data textually, graphically, or pictorially for diagnosing a medical condition within the body lumen. A clinician may utilize the readings from the display  18  to tailor the intervention to the needs of the patient or otherwise advance the goals of the intervention. The signal processing module  16  may be operably connectable to an optical cable  22  that enables communication between the signal processing module  16  and the disposable portion  14 . 
         [0060]    In some embodiments, the disposable portion  14  includes a pressure sensing guidewire  24  extending from a distal region  26  to a proximal region  28 . At the distal region  26 , the pressure sensing guidewire  24  may include a pressure sensor  30  that may be configured to obtain pressure measurements within the environment immediately outside of pressure sensing guidewire  24 . Accordingly, the distal region  26  may include one or more apertures (not illustrated) to provide fluid communication between the environment and the pressure sensor  30 . 
         [0061]    While the pressure sensor  30  is shown schematically in  FIG. 1 , it can be appreciated that the structural form and/or type of the pressure sensor  30  may vary. For example, the pressure sensor  30  may include a semiconductor (e.g., silicon wafer) pressure sensor, piezoelectric pressure sensor, a fiber optic or optical pressure sensor, a Fabry-Perot type pressure sensor, an ultrasound transducer and/or ultrasound pressure sensor, a magnetic pressure sensor, a solid-state pressure sensor, or the like, or any other suitable pressure sensor. 
         [0062]    A fiber optic cable  32  is operably connected to the pressure sensor  30  and extends proximally therefrom. In some embodiments, the fiber optic cable  32  is a polymer fiber optic cable. In some embodiments, at least part or all of the fiber optic cable  32  may instead be a glass fiber optic cable. The fiber optic cable  32  permits optical signals to be communicated to and from the pressure sensor  30 . 
         [0063]    The system  10  includes one or more optical cables that are external to the pressure sensing guidewire  24  in order to carry optical signals between the pressure sensing guidewire  24  and the signal processing module  16 . At the proximal region  28 , the pressure sensing guidewire  24  may be configured to be attached to a connector or handle member  34 . The handle  34  may include a suitable connector for an optical cable  36  to be attached to the handle  34 . These are just examples. It will be appreciated that other devices and/or arrangements may be utilized with the pressure sensing guidewire  24 . 
         [0064]    In some embodiments, for example, a clinician may use the pressure sensing guidewire  24  to measure or calculate FFR (e.g., the pressure after an intravascular lesion relative to the pressure before the lesion). This may include taking an initial pressure reading before or upstream of the lesion and then a comparative reading after or downstream of the lesion. This may also include monitoring the pressure while advancing the pressure sensing guidewire  24  through a blood vessel until a pressure differential or drop in pressure is observed, indicating that the pressure sensing guidewire  24  has reached and/or partially past the lesion as well as monitoring increases in pressure during and/or following a treatment intervention. In some embodiments, a second pressure measuring device may be used to measure pressure at another intravascular location and this pressure may be utilized in the calculation of FFR or otherwise used as part of the intervention. 
         [0065]    As illustrated, the system  10  may be considered as including a connector assembly  38  and a connector assembly  40 . The connector assembly  38  may be considered as providing an optical connection between the optical cable  22  and an optical cable  42 . Similarly, the connector assembly  40  may be considered as providing an optical connection between the optical cable  42  and the optical cable  36 . In some embodiments, it is contemplated that the optical cable  42  may be optional, and thus the connector assembly  38  may provide an optical connection directly between the optical cable  22  and the optical cable  36 . The optical cable  42 , if present, may be considered as being a connector cable. 
         [0066]    While the connector assembly  38  and the connector assembly  40  are described and illustrated herein as pertaining to medical devices, it will be appreciated that the features and elements of the connector assembly  38  and the connector assembly  40  may have application in other, non-medical, fields of endeavor. 
         [0067]    As will be discussed, the connector assembly  38  may be considered as including a female adaptor  44  at an end of the optical cable  22  and a corresponding male adaptor  46  at an end of the optical cable  42 . The male adaptor  46  may be configured to fit within the female adaptor  44 . In this, it will be appreciated that the terms male and female are used for convenience and generally an element labeled as male fits within an element labeled as female. These elements could just as easily be referred to as a first element and a second element. The connector assembly  40 , if present, may be considered as including a female adaptor  48  at an end of the optical cable  42  and a corresponding male adaptor  50  at an end of the optical cable  36 . The male adaptor  50  may be configured to fit within the female adaptor  48 . If the optical cable  42  is absent, the connector assembly  38  would include the female adaptor  44  and the male adaptor  50 . 
         [0068]      FIG. 2  is a perspective view and  FIG. 4  is a cross-sectional view of a connector assembly  52  that may be considered as representing either the connector assembly  38  or the connector assembly  40 . The connector assembly  52  may be considered as including a first portion  54  and a second portion  56 . The first portion  54  includes a cable  58  and a female adaptor  60  at an end thereof. The second portion  56  includes a cable  62  and a male adaptor  64  at an end thereof. It will be appreciated that in some embodiments, and with reference to the system  10  described in  FIG. 1 , the first portion  54  may represent a reusable portion while the second portion  56  may represent a disposable portion, but this is not required. 
         [0069]    It will be appreciated that the female adaptor  60  shown in  FIGS. 2 and 4  is illustrative only, as this element may take other shapes as well. Turning briefly to  FIG. 3 , another embodiment of the first portion  54  is illustrated. In  FIG. 3 , a first portion  154  includes a female adaptor or sheath  160  and a cable  158  extending from the female adaptor  160 . In some embodiments, as illustrated, the female adaptor  160  may include features that enable a user to better grip the first portion  154 . For example, the female adaptor  160  may include one or more features such as a reduced diameter portion  162  that may be sized to accommodate a user&#39;s thumb and/or knurling  164  that may help to provide a better grip. A fin  166 , if present, may be of assistance in orienting the first portion  154 . 
         [0070]    Returning to  FIG. 4 , the first portion  54  includes a fiber optic cable  66  having a contact portion  68  while the second portion  56  includes a fiber optic cable  70  having a contact portion  72 . It will be appreciated that in some embodiments, the contact portion  68  is at least partially protected by the female adaptor  60  and the contact portion  72  is at least partially protected by the male adaptor  64  while the first portion  54  and the second portion  56  are separated from each other, before they are connected. 
         [0071]    In some embodiments, as illustrated, the contact portion  68  is biased via a spring  74  and the contact portion  72  is biased via a spring  76 . The springs  74 ,  76 , if present, help to hold the contact portion  68  against the contact portion  72  when the first portion  54  is fully inserted into the second portion  56 , as will be demonstrated with respect to  FIGS. 5 and 6 . By helping to ensure good contact between the contact portion  68  and the contact portion  72 , good optical transmission can occur through the connector assembly  52 . 
         [0072]    The connector assembly  52  includes a cleaning assembly  78 . As best illustrated in  FIG. 7 , the cleaning assembly  78  includes a wiping surface  80  that is configured to contact and wipe a front surface  82  of the contact portion  68  and a support structure  84  that is configured to support the wiping surface  80  and to secure the cleaning assembly  78  to the male adaptor  64 . In some embodiments, the support structure  84  may be formed of a resilient material such as stainless steel or spring steel in order to provide a biasing force to the wiping surface  80 . 
         [0073]    In the illustrated embodiment, the support structure  84  includes a U-shaped portion  86  that frictionally engages a wall portion  88  of the male adaptor  64 . It will be appreciated that in some embodiments, the cleaning assembly  78  may instead be adhesively secured to the male adaptor  64 . The wiping surface  80  may be formed from or otherwise includes an absorbent pad that includes a cleaning solution such as alcohol or any other suitable cleaner. 
         [0074]    While the wiping surface  80  is illustrated as being largely planar in shape, it will be appreciated that in some embodiments, the wiping surface  80  may instead be non-planar.  FIG. 8  illustrates a cleaning assembly  90  having a curved wiping surface  92 . The curved wiping surface  92  may be either concave or convex in nature, in order to improve the cleaning action when the wiping surface  92  (or  80 , in  FIG. 7 ) moves across the front surface  82  of the contact portion  68 . 
         [0075]      FIGS. 5 and 6  provide an illustration of how the cleaning assembly  78  (or  88 ) cleans the front surface  82  of the contact portion  68 . In  FIG. 5 , the male adaptor  64  has been partially inserted into the female adaptor  60  such that the wiping surface  80  (or  92 ) has just contacted the front surface  82  of the contact portion  68 . In  FIG. 6 , the male adaptor  64  has been fully inserted into the female adaptor  60  such that the contact portion  68  and the contact portion  72  are in contact with each other such that optical communication through the connector assembly  52  can occur. It can be seen that the springs  72  and  74  have been partially compressed, and thus provide a biasing force to hold the contact portion  68  and the contact portion  72  in good contact with each other. 
         [0076]    It can be seen, in comparing  FIG. 6  to  FIG. 5 , that the cleaning assembly  78  (or  88 ) has been pushed out of the way. In some embodiments, the male adaptor  64  includes a pocket  94  that is positioned and sized to accommodate the cleaning assembly  78  (or  88 ) as the cleaning assembly  78  (or  88 ) is pushed out of the way. In some embodiments, the female adaptor  60  includes a corresponding vent  96 , but this is not required. 
         [0077]    Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as exemplary only, and departure in form and detail may be made without departing from the scope and spirit of the present disclosure as described in the following claims.