Abstract:
A delivery system extends from a laser radiation source for connecting to a medical device that utilizes the laser radiation for medical treatment. The delivery system comprises an optical fiber connecting to a male launch connecter. The male launch connector having a body portion with the optical fiber fixed or constrained therein and the optical fiber terminating at a male ferrule with a forward directed fiber facet, the male ferrule may be cantilevered within the body portion by the optical fiber line providing freedom of movement of the male ferrule. The launch connector engages a receiving connector on the medical device first with mechanical connection portions and then more finely aligning optical connection portions by the male ferrule self aligning in a female ferrule with cooperating tapered surfaces. The male portion may fully seat in the female portion with cooperating cylindrical surfaces.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application Nos. 62/317,296 filed Apr. 1, 2016, and 62/428,269, filed Nov. 30, 2016, the disclosures of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    Laser-based medical devices use laser radiation for medical treatments. The laser radiation type, power, and parameters vary depending upon the treatment. A laser source connects to a medical device using a delivery system having an optical fiber and an optical connector that couples to an interface of a medical device. The delivery system could be single use or reusable depending on the medical treatment and regulations. 
         [0003]    The optical connector is a critical component the delivery system. Generally the size of optical fiber connectors have decreased over time due to the desirability of a higher density of connectors on telecommunications equipment; that is, more connectors per square inch of equipment space. Typical connectors for medical purposes comprise slightly modified optical connectors developed for telecommunication devices use, such as SMA-905 or SMA-906 modified connectors with a forward projecting ferrule with an exposed fiber facet. Such connectors are of small size and the mating components are also small, specifically, the ferrule securing the optical fiber and the cooperating female component. The small size of the graspable portion requires delicate manipulations to make the optical fiber connection to the medical device. The small sized connectors are not conducive to handling with gloves, nor making a quick connection. Also, it is easy to contaminate or damage the input fiber facet during mating with medical device as the facet is exposed and defines the furthermost portion of the connector. Any issue associated with the integrity of the connection between the laser source and medical device can impact the performance of the medical device and potentially the medical procedure. 
         [0004]    Thus, improvements in connector design (both parts, at laser device output and at the input of delivery system) that are ergonomically advanced (including handling with gloves), safer, easier to mate, more robust, and less prone to damage or contamination of the fiber facet, more economical to manufacture and use, would be well received by the medical industry. Moreover, a means for confirming the integrity of the connection would be advantageous. Additionally, improvements in affordability would be well received. 
       SUMMARY 
       [0005]    A delivery system extending from a laser radiation source for connecting to a medical device that utilizes the laser radiation for medical treatment. The delivery system comprises an optical cable with an optical fiber extending from the laser source with a male launch connecter having a male ferrule on the optical cable. The launch connector couples to a receiving connector having a female ferrule that interfaces with the male ferrule on the medical device. The male launch connector having a body portion with an outer tubular portion projecting forward with an outermost or forwardmost edge and having a central axial recess defined therein. The optical fiber terminating at the male ferrule positioned in the central recess rearward of the forwardmost edge and presenting a forward facing fiber facet. In embodiments, the optical fiber fixed with respect to the body portion of the connector at an anchor point on the optical fiber rearwardly of the ferrule such that a dangling or cantilevered portion of the optical cable or fiber supports the ferrule. In embodiments the optical cable or fiber is the exclusive support of the male ferrule before the launch connector is connected to the receiving connector. The ferrule having freedom of movement provided by the flexibility of the optical cable forward of the anchor position. The ferrule may be constrained laterally by structure within or part of the body portion such as a tubular portion of the body portion thereby limiting the lateral freedom of movement. Such structure providing a circumferential gap around the ferrule for the entire length of the ferrule when the ferrule is axially centered within the tubular portion. In embodiments a resilient material may be attached to the rearward end portion of the male ferrule for controlling the radial or lateral freedom of movement that does provide some resistance to lateral movement beyond that provided by the optical fiber or cable. 
         [0006]    In embodiments, the ferrule having registration surfaces such as an outer cylindrical surface that registers with a cooperating inwardly facing cylindrical surface on the female ferrule of the receiving connector without the female ferrule having an axial stop for the male ferrule in the optical registration receiver. The inventors have recognized that the criticality of the axial placement, that is, the forward rearwardly axial position of the male ferrule with respect to the female ferrule is substantially less that the criticality of the centration alignment, that is, the radial and axial alignment of the ferrule. Conventional optical fiber connector art rely upon axial stop surfaces that are part of the ferrule or rigidly and directly connected to the ferrule. Embodiments herein provide suspension of the ferrule in the male connector only by the optical cable or fiber rearward of the ferrule and a seating interface with the optical registration component, such as a female ferrule, in a cylindrical interface with no axial stop surfaces on the ferrule or directly fixed with respect to the ferrule. The forward-backward axial position of the ferrule is controlled by the optical cable or fiber extending rearward from the ferrule that is attached directly or indirectly to the connector body. Such an arrangement provides an economical, simple, and reliable connection configuration with the needed centration, that is, precise radial and axial alignment, and sufficient axial forward-rearward positional placement. 
         [0007]    In embodiments of the invention, the optical fiber rearwardly of the ferrule is fixed to an elastomeric support member providing axial cushioning and or resilience when the ferrule engages with a portion of the connector of the medical device. In embodiments, the forward face of the male ferrule, for example a chamfer surface has a tapered to cooperate with a like shaped concave recess in the female ferrule of the receiving connector of the medical device. The fixation of the optical fiber with respect to the launch connector body may be in resilient elastomeric disks defining diaphragms. 
         [0008]    In embodiments of the invention, the ferrule is slidingly received in a bore of an optical registration receiver, the optical registration receiver may have a tapered concave lead-in registration surface and a cylindrical registration surface, the male ferrule having a cooperating convex outer tapered surface and a cylindrical registration surface to closely engage the cylindrical registration surface of the optical registration receiver. 
         [0009]    In embodiments of the invention, the outer tubular portion of the launch connector engages with a mechanical registration receiver of the receiving coupling attached to, for example, the medical device. Or, the leading edge of the tubular outer portion and/or the outermost edge of the mechanical registration receiver may be tapered to provide an insertion tolerance. 
         [0010]    A feature and advantage of embodiments of the invention is an optical fiber connector with graspable body portion and having a single fiber that has an internal floating ferrule and a graspable handle of an enlarged sized, in embodiments the diameter of a central lengthwise portion of the graspable portion is from 5 to 20 mm. In embodiments the diameter of a central lengthwise portion of the graspable portion is from 8 to 16 mm. 
         [0011]    A feature and advantage of embodiments of the invention is an optical fiber launch connector with a single fiber that has an internal movable ferrule fixed only to the single optical fiber and optionally to sheaths on the fiber. The ferrule positionally constrained by but not positionally fixed by being partially positioned in the bore of an inner tubular portion of the launch connector. 
         [0012]    A feature and advantage of embodiments of the invention is a optical fiber coupling with cooperating connectors, one connector being a launch connector with a ferrule supporting an optical fiber with a fiber facet, the other connector receiving the one connector and having an optical registration receiver that receives the ferrule. Each connector having the optical connecting portion of the connector recessed from the exterior of the connector. 
         [0013]    In embodiments, a cooperating pair of optical fiber connectors for connecting a laser source to a medical device for delivery of laser energy, each connector having an outer mechanical coupling portion and an inner optical coupling portion, each of the outer mechanical coupling portions configured as an outer tubular portion with a forward edge, each outer tubular portion having a tubular wall and defining respective axial recesses, the optical coupling portions concentrically positioned within the axial recesses and spaced from the tubular walls, the optical coupling portions inset from the respective forward edges. In embodiments, one connector provides an optical cable with a optical fiber connecting to a ferrule and presenting a fiber facet. The ferrule having a central position, the ferrule received within a female portion of an optical registration receiver. In embodiments, one of the tubular mechanical coupling portions interlaced between the tubular mechanical coupling portion of the other coupling and the optical coupling portion of the other coupling. The tubular mechanical coupling portions slidingly engaged with one another. In embodiments the connector supplying the laser energy to the medical device, a launch connector, has its outer tubular portion extending within the outer tubular portion of the connector associated with the medical device. In embodiments, as the connectors are manually manipulated, the outer mechanical couplings engage first and bring the connectors into an axial alignment as the outer mechanical couplings are slidingly engaged and brought together, the connectors become axially aligned before the optical coupling portions engage each other. The optical coupling portions then are prealigned and as the optical coupling portions engage with tapered surfaces on one or both optical coupling portion, the optical couplings are brought into final operational alignment. In embodiments one optical coupling portion is laterally movable with respect to its respective mechanical coupling portion. 
     
    
     
       DESCRIPTION OF THE FIGURES 
         [0014]      FIG. 1  is a perspective view of a delivery system with a launch connector disconnected from a connector on a medical device in accord with inventions herein. 
           [0015]      FIG. 2  is a perspective view of a coupling for a laser radiation delivery system connected to a medical device in accord with embodiments of the invention. 
           [0016]      FIG. 3  is a cross sectional view of the coupling of  FIG. 2  in a partial mechanical coupling in accord with embodiments of the invention. 
           [0017]      FIG. 4  is a detailed cross sectional view of  FIG. 3  showing the mechanical coupling and optical coupling with a frustoconical registration of the ferrule and optical registration receiver optical coupling in accord with embodiments of the invention. 
           [0018]      FIG. 5A  is a cross sectional view of an embodiment of a coupling illustrating mechanical connection portions and optical connection in a pre-connection condition. 
           [0019]      FIG. 5B  is a cross sectional view of the coupling of  FIG. 5A  with a cylindrical registration of a male ferrule and the female ferrule in accord with embodiments of the invention. 
           [0020]      FIG. 6  is a cross sectional view of a coupling with cylindrical registration and a conical registration of a male ferrule and with a stop surface in the optical registration receiver. 
           [0021]      FIG. 7  illustrates an embodiment with the outer mechanical connection portion of the launch connector exterior to the mechanical connection portion of the medical device mechanical connection portion. 
           [0022]      FIG. 8  is a cross sectional view of coupling according to embodiments. 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    Referring to  FIGS. 1 and 2 , a delivery system  20  comprises a optical fiber cable  22  and a launch connector  24 . The launch connector  24  and a connector  28  on a medical device  30  defining an optical fiber coupling  32  for providing laser radiation to the medical device  30  from the laser radiation source  34 . 
         [0024]    Referring to  FIGS. 1-4 , each of the connectors  24 ,  28  have a mechanical connection portion  36 ,  38  and respective optical connection portion  40 ,  42  configures as a male ferrule and a female ferrule respectively. The launch connector  24  has a body portion  48  that extends from a forward or proximal end  52  to a rearward or distal end  54  of the connector  24 . A strain relief tail portion  56  provides transitional support to the optical fiber cable as it exits the connector. The optical fiber cable extends axially along a central axis  58  in apertures  60  of the body portion such that the cable may be spaced from inward surfaces  62  of the body portion. In the embodiment of  FIGS. 3 and 4 , the optical fiber cable is supported by a compliant fiber supports  64 ,  66 . The compliant fiber supports may be disc shaped with the fiber fixed to the center  70  of the discs  64 ,  66 , such as by adhesive and with the disc supported at its peripheral portion  72  by the body portion  48 . The compliant fiber supports  64 ,  66  may provide axial displacement capability and cushioning of the optical connection portion  40  with respect to the body portion of the launch connector  24 . 
         [0025]    The mechanical connection portion of the launch connector is a mechanical registration guide configured as a tubular end portion  36 . 
         [0026]    The optical connection portion  40  of the launch connector  24  comprises a ferrule  78  with an optical fiber  80  fixed in a axial bore  81  therein such as by adhesive  82 . The optical fiber may have two or more sheathings  86 ,  88  covering the fiber rearward of the ferrule  78 . The ferrule  78  may have a frustoconical portion  90  with a tapered surface  92  at its forward end  94  and rearward of the tapered surface have a cylindrical surface  96 . The ferrule may be formed of conventional materials such as glass, bronze, other metals, and ceramic materials. 
         [0027]    The launch connector  24  has a graspable portion  100  for manual manipulation of the connector. The graspable portion may have a bulbous portion  102 , a recessed portion  104 , and a forward lip  106 , all facilitating handling of the connector, particularly in a medical setting where users may be wearing gloves and ready and quick access and control of the connector is advantageous. The diameter d of the graspable portion may be from 5 to 20 mm in embodiments. In other embodiments the diameter of the graspable portion may be from 8 to 16 mm. The graspable portion  100  may be unitary or integral with the body portion  48  of the launch connector  24  and may be formed of polymers including, for example, thermoplastic elastomers. 
         [0028]    The medical device connector  28  has the optical coupling portion  42  which couples with the optical connection portion  40  of the launch connector. The optical connection portion comprises an optical registration receiver configured as a female ferrule  112  formed of ceramic material, glass, metal, or other conventional materials. A recess  118  is defined by a reverse frustoconical surface  120  that conforms to the tapered surface  92  of the launch connector optical coupling portion configured as a male ferrule  40 . The female ferrule is fixed to a body portion  122  of the medical device connector and the medical device connector is attached to a wall  126  or other structure of the medical device. The body portion, or other structure of the connector  28  provides a mechanical registration receiver  130  configured as a tubular portion  38  that conforms to and snugly receives the tubular portion  36  of the launch connector. 
         [0029]    Referring to  FIGS. 3 and 4 , the coupling is made by the tubular portion  36  of the launch connector  24  initially being partially inserted into the mechanical connection portion  38  of the medical device connector  28 , as shown in  FIG. 3 . The connectors are in an axial alignment, this provides a gross or prealignment of the optical connection portions before they make contact or are engaged, that is, the connectors can only move axially and rotationally with respect to one another. As shown in  FIG. 4 , when the optical coupling portions make contact the ferrule and optical registration receiver self-align by way of the conforming cooperating surfaces  92 ,  120  and the ferrule  78  and optical fiber  80  are slightly displaced rearwardly facilitated by the compliant members  64 ,  66 . When the launch connector is fully seated the optical connection portions are fully engaged. 
         [0030]    Referring to  FIGS. 5A and 5B , another embodiment is illustrated with launch connector  224  and a medical device connector  228 . The medical device optical coupling portion, configured as a female ferrule  242 , has a tapered lead-in surface  220  and a cylindrical seating surface  222 . The optical coupling portion  240  of the launch connector  224  comprises a ferrule  278  with a cylindrical outer surface  296  and chamfered guide-in surface  300 . The optical coupling portion further comprising an optical fiber line  280  that is fixed to the body portion  248  such as by adhesive  249 . The optical fiber line  280  and ferrule may cantilever outwardly from the body portion providing lateral movement capability of the ferrule such that the optical connection portions may self-align when they initially engage. The optical fiber line includes an optical fiber and may include sheathing or other layers on the optical fiber. When the ferrule  278  is finally seated in the female ferrule, the coupling is complete, there is no axially loading on the optical connection portion of the launch connector  224 . There are no stop surfaces on the female ferrule to axially position, forward-rearwardly, the male ferrule. The female ferrule may have a throughhole  279  that and internal surface  280  with a diameter D 1  that converges from a first side  281  to a mid portion  282  with a cylindrical surface  222 , and then diverges to the second side  284  resulting in an hour glass shape. The male ferrule  278  is separated from an anchored position  288  by a distance D. In embodiments this distance is 4-15 mm, or thereabout. In embodiment distance D is 6 to 11 mm. The male ferrule cantilevers forwardly by the optical fiber line and has a gap  292 , that is, space, between the outer surface of the male ferrule and the body portion of the connector. 
         [0031]    Similar to the embodiment of  FIGS. 3 and 4 , the tubular portions of the mechanical connection portion of the embodiments of  FIGS. 5A and 5B  first engage to provide a gross alignment of the optical connection portions, then the optical portions engage, self align by movement of the male ferrule, and then fully engage with cylindrical surface seating on cylindrical surface. The forward-rearward placement is not as critical to coupling performance as the radial and axial alignment. 
         [0032]    Means  63 , schematically shown, for confirming complete coupling is provided on the medical device and connecting to the laser source to prevent the laser for operating if the coupling is not fully coupled. Such can be by way of micro switches,  63 . 2 , and other means known in the art. Such means may provide a lock-out of the laser radiation source. That is, unless the complete connection of the coupling is verified, the laser light source is not allowed to generate the laser radiation. 
         [0033]    Referring to  FIG. 6 , another embodiment is illustrated with launch connector  324  and a medical device connector  328 . The medical device optical coupling portion  342  has a tapered lead-in surface  320  and a cylindrical seating surface  322  and a stop surface  324 . The optical coupling portion  340  of the launch connector  324  comprises a ferrule  378  with a cylindrical outer surface  396  and a tapered forward surface  400 . The optical coupling portion further comprising an optical fiber  380  that is compliantly attached to the body portion  348  through compliant members  364 ,  366 . The optical fiber  380  and ferrule may cantilever outwardly from the body portion providing lateral movement capability of the ferrule such that the optical connection portions may self-align when they initially engage. Upon final seating of the ferrule in the optical registration receiver the ferrule and optical fiber may be slightly displaced rearward facilitated by the compliant members. 
         [0034]    Referring to  FIG. 7 , another embodiment is illustrated with launch connector  424  and a medical device connector  428 . The medical device optical coupling portion  442  has a tapered lead-in surface  420  and a cylindrical seating surface  422 . The optical coupling portion  440  of the launch connector  424  comprises a ferrule  478  with a cylindrical outer surface  496 . The optical coupling portion further comprising an optical fiber  480  that is fixed to the body portion  448 . The optical fiber  480  and ferrule may cantilever outwardly from the body portion providing lateral movement capability of the ferrule such that the optical connection portions may self-align when they initially engage. The bore  490  of the body portion constrains laterally the ferrule allowing some lateral movement of the ferrule. Upon final seating of the ferrule in the optical registration receiver  491  the ferrule and optical fiber are not under axial loading. The mechanical connection portion  436  of the launch connector envelops the mechanical connection portion  438  of the medical device mechanical connection portion which is different than the embodiments illustrated in  FIGS. 1-6 . 
         [0035]    Referring to  FIG. 8 , another embodiment is illustrated with a launch connector  502  and a receiving connector  504 . In this embodiment the optical fiber line  510  has a optical fiber with multiple layers of sheathing  512  removed in the connector. The male ferrule is a high precision glass male ferrule  520  connecting to sleeve  538  that connects to compliant material, such as a thermoplastic elastomer, configured as a ring  542 , provides slight compliance along all axis. The launch connector has a strain relief boot  550  for the optical fiber line  510 . The female ferrule  556  has a precision bore  558  that engages and aligns the male ferrule  520  in centration and axial position. A ball detent mechanism  568  including a circumferential spring  571  engages with a exterior groove  569  in the tubular portion  570  of the body portion  572  of the launch connector. A latch arm  580  pivots about the body portion of the receiving connector  504  to push out the launch connector. 
         [0036]    The mechanical connection portions may be configured as bayonet connections, screw on connections, press fit connections, or detent connections. 
         [0037]    The following U.S. patents are incorporated by reference for all purposes: U.S. Pat. Nos. 5,329,541; 5,907,650; 5,943,460; 6,238,103; 7,503,701; 8,419,293; 8,888,378; 9,329,350; 9,393,081; 9,395,496; and 9,429,713. 
         [0038]    The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any incorporated by reference references, any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed The above references in all sections of this application are herein incorporated by references in their entirety for all purposes. 
         [0039]    Although specific examples have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement calculated to achieve the same purpose could be substituted for the specific examples shown. This application is intended to cover adaptations or variations of the present subject matter. Therefore, it is intended that the invention be defined by the attached claims and their legal equivalents, as well as the following illustrative aspects. The above described aspects embodiments of the invention are merely descriptive of its principles and are not to be considered limiting. Further modifications of the invention herein disclosed will occur to those skilled in the respective arts and all such modifications are deemed to be within the scope of the invention.