Abstract:
The present invention relates to medical treatment devices. In particular, according to one embodiment, the present invention a medical treatment device that includes, for example, a tube member, a treatment member by way of which energy can be transmitted in connection with performance of a medical procedure, a sleeve, and a hub member. In this example, the treatment member is positioned within the tube member and the tube member thus affords a degree or protection to the treatment member. The combination of the treatment member and the tube member is configured to be partially received within, and secured by, the hub member. In particular, the hub member includes a securement portion and a delivery portion which are releasably attached to each other.

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates to medical treatment devices. In particular, the present invention relates to an introducer sheath and hub for use with medical treatment devices that emit energy in connection with the performance of medical procedures. The present invention also relates to an introducer sheath and hub that may be used with other devices, such as those used in medical procedures. 
     One such medical device using energy is for vein ablation. Vein ablation is a procedure that may be used to treat varicose veins. Varicose veins exist because valves in the blood veins fail, allowing blood to stagnate. This stagnation causes pain and noticeable purple or red traces of the vein visible from the outside of the skin. During a normal vein ablation procedure for varicose veins, a practitioner first identifies a vein or veins for the procedure. The veins are then mapped as a guide for the practitioner in order for him to perform the procedure. Once the veins are mapped, the practitioner prepares the vein for ablation by introducing a sheath into a far end of the vein, in preparation for introduction of a treatment device, such as a laser or radio frequency device. 
     The treatment device is introduced into the vein at the distal end and extended in the vein to a junction with a healthy branch of a larger vein to ensure that the entire damaged vein is treated. In a laser treatment procedure, a fiber-optic member is covered by a sheath for introduction and for the treatment procedure. As fiber-optic members are usually very slender fibers of glass, it is not desirable to introduce the fiber-optic member without a covering because the fiber can break off in the patient, or can puncture the vein walls, damaging surrounding tissues. 
     Thus, the fiber-optic member is introduced in a sheath or catheter and advanced to the beginning of the treatment area. The practitioner can determine the location of the tip of the fiber-optic member in the patient by ultrasound imaging, transillumination of the anatomy using an aiming or targeting beam, by feel, and/or by estimating the location based on a calculated position inside of the vein targeted for treatment. Once the fiber-optic member reaches the beginning of the treatment area, the practitioner exposes a terminal portion of the fiber-optic member by extending the fiber-optic member out of the end of the sheath, exposing about 2 cm of fiber. To expose the end of the fiber, a practitioner looks at marks positioned on the fiber near a hub, indicating to the practitioner a position where the end of the fiber is inside of the sheath, and where the fiber is extended out of the sheath about 2 cm. The laser is then activated and transmits energy through the fiber, thereby heating the tissue and fluid around the end of the treatment fiber, effectively destroying the vein and preventing further filling of the vein with stagnant blood. The ablation procedure removes the appearance of the varicose vein, alleviates the pain caused by the varicose vein, and prevents further complications. 
     Additionally, in a traditional ablation procedure, a practitioner needs to monitor the energy expended by the laser to ensure sufficient treatment of the target veins. One way to see where the end of the treatment catheter is located inside of the patient is by seeing light through the patient&#39;s skin before or during the laser treatment of the target area. Light in the visible spectrum, which may be a targeting light, may be used. Thus, practitioners often dim the lights, allowing better viewing of the monitors and of the treatment location in the patient. However, the low-light conditions make seeing the marks on the fiber difficult, creating the possibility of errors because of misreading the marks. Thus, in placing a fiber for treatment into a patient in a traditional ablation procedure, a practitioner needs to identify markings on the fiber in very low light, simultaneously monitoring treatment, location of treatment, and patient comfort. 
     Some previous efforts to solve some of the problems associated with vein ablation procedures include, for example, a device and method disclosed in U.S. Patent Publication No. US 2006/0142747. In the disclosed device, a split straw is used to maintain a fiber inside of a sheath during insertion and prior to using the laser. The split straw includes a portion over the fiber, preventing the fiber from advancing in the sheath past a point where the terminal end of the fiber would be exposed outside of the sheath. The split straw also includes a second handle portion to aid in removing the split straw from the fiber, allowing a terminal end of the fiber to be advanced outside of the sheath. 
     However, the split straw can easily disconnect from the fiber during manipulation, such as during insertion of the sheath into the patient. For example, the handle portion can easily catch on other objects, removing the split sheath, or by pushing the fiber and sheath together, the angle of the split straw can cause the split straw to pop off of the fiber. If the split straw comes off prematurely, the split straw may become unusable by touching a non-sterile surface. Additionally, having the small split straw become disengaged from the fiber would cause problems for the practitioner in positioning the fiber correctly and completing the procedure. 
     Thus what is needed is a device that aids the practitioner by providing a fiber positioning system that is easy to use in low-light conditions and that can be employed without requiring the used of a removable piece that is easily lost or tends to premature deployment. 
     BRIEF SUMMARY OF AN EMBODIMENT OF THE INVENTION 
     The present invention relates to medical treatment devices. In particular, according to one embodiment, the present invention a medical treatment device that includes, for example, a tube member, a treatment member by way of which energy can be transmitted in connection with performance of a medical procedure, a sleeve, and a hub member. In this example, the treatment member is positioned within the tube member and the tube member thus affords a degree of protection to the treatment member. The combination of the treatment member and the tube member is configured to be partially received within, and secured by, the hub member. In particular, the hub member includes a securement portion, which may be used to secure the treatment member to the hub member, and a delivery portion, for use in delivering treatment to an individual. The securement portion and the delivery portion may be releasably attached to each other. 
     The securement portion may include a compression fitting that selectively secures and releases the treatment member. The securement portion may also be permanently affixed to the treatment member. Similarly, the sleeve member may be releasably coupled or permanently affixed to the treatment member, such that the sleeve member covers a portion of the treatment member. 
     The tube member may be permanently coupled to the delivery portion. In some embodiments, the tube member may be placed inside of an individual during a medical procedure, such as during a laser vein ablation procedure, with a fiber-optic member as the treatment member. 
     The delivery portion may also include a side port configured to allow passage of fluids between the side port and a distal end of the tube member. The delivery portion may also include a seal configured to reduce passage of fluids from the delivery portion to the securement portion. The delivery portion and the securement portion may be removably coupled with a snap or pressure fit such that the securement portion and delivery portion each include complementary features, such that a complementary feature of one of the securement or delivery portion deforms to fit into the complementary feature of the other portion. 
     In some embodiments, the sleeve member may have a length of between 1 and 3 cm, and may cover a portion of the treatment member. The treatment member may be configured to slide into the tube member through the delivery portion. The sleeve member may also be configured to slide into the delivery portion along with the treatment member. With the treatment member partially inserted into the delivery portion and the tube member, the sleeve member may releasably hold the securement portion apart from the delivery portion by resisting entry of the sleeve member into the delivery portion by requiring deformation by the seal for entry of the sleeve member into the delivery portion. The sleeve member may be permanently affixed to the securement portion. 
     The delivery portion and the securement portion may be removably coupled together with a snap or pressure fit, such that the securement portion and delivery portion each include complementary features, wherein one of the complementary features deforms to fit into the other complementary feature. 
     Some embodiments may include a kit containing a dilator, a guide wire, a treatment member, a hub, a tube member coupled to a portion of the hub, and a sleeve member permanently coupled to a different portion of the hub. 
     These and other aspects of the present invention will become more fully apparent from the following description and appended claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1  is a perspective view of an example embodiment of an introducer sheath and hub assembly; 
         FIG. 2  is a cross-sectional view of a portion of the assembly of  FIG. 1 ; and 
         FIG. 3  is a cross-sectional view of a portion of the assembly of  FIG. 1 ; 
         FIG. 4  is a cross sectional view of a portion of the assembly of  FIG. 1 ; 
         FIG. 5  is a perspective view of the assembly of  FIG. 1 ; 
         FIG. 6  is a perspective view of the assembly of  FIG. 1  in a configuration ready for placement; and 
         FIG. 7  is a perspective view of the assembly in a placed configuration. 
     
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
     In the illustrated embodiments, aspects of an introducer sheath assembly are disclosed and described below. 
       FIGS. 1-7  illustrate device  100 , including hub  150 , introducer sheath  350 , and treatment member  400 . Hub  150  includes securement portion  200  and delivery portion  300 .  FIG. 1  illustrates hub  150  in an assembled state, with securement portion  200  coupled with delivery portion  300 . Treatment member  400  traverses hub  150 , passing through securement portion  200  and delivery portion  300 , and extending from a distal end of introducer sheath  350 . Delivery portion  300  is coupled to tube  338 . Tube  338  is coupled to stopcock  339  which may be used to evacuate or provide fluids or materials through introducer sheath  350 . 
     Treatment member  400  may be a fiber-optic member, an electrical conductor, or other suitable material configured to convey energy to a treatment site. Some energy sources that may be used with treatment member  400  may include RF, microwave, ultrasound, heated fluid, radiant light, lasers, electrical conduction, or other energy sources used in medical procedures. 
       FIGS. 2 and 3  illustrate cross-sectional views of securement portion  200  and delivery portion  300 , respectively. Securement portion  200  may be configured to hold treatment member  400  in a fixed position, allowing manipulation of treatment member  400 . For example, in a vein ablation procedure, securement portion  200  may be used to manipulate treatment member  400  through delivery portion  300  and into introducer sheath  350  in preparation for a vein ablation procedure. Similarly, securement portion  200  may be coupled to sleeve member  250 , which may be configured to provide a guide to how far treatment member  400  is inserted into introducer sheath, as described below with particularity in connection with  FIGS. 5 and 6 . In  FIG. 2 , securement portion  200  includes collar  210  and barrel  240 . Collar  210  includes tabs  212 , flange  214 , collar passageway  220 , collar threads  226 , and engagement surface  228 . Barrel  240  includes barrel passageway  242 , barrel threads  246 , and compression tabs  248 . Barrel  240  may be releasably coupled to collar  210  by engaging barrel and collar threads  246 ,  226 , respectively, which cooperate to hold collar  210  and barrel  240  together. 
     Treatment member  400  is shown in  FIG. 2  as passing through collar passageway  220  and barrel passageway  242 . When treatment member  400  is located in barrel passageway  242 , securement portion  200  may hold treatment member  400  by way of tightening of the threaded connection of collar  210  and barrel  240 . The threaded connection may be a conventional threaded interface such that by turning barrel  240  with respect to collar  210 , barrel  240  and collar  210  are coupled together or uncoupled, depending on the turning direction. 
     In some embodiments, when coupling collar  210  and barrel  240 , engagement surface  228  presses against compression tabs  248 , causing compression tabs  248  to move inwardly, toward the center of barrel  240 , constricting barrel passageway  242 . In such embodiments, when treatment member is  400  is located in barrel passageway  242 , this constriction causes compression tabs  248  to press against and frictionally hold treatment member  400  axially with respect to securement portion  200 . Selective loosening and tightening of securement portion  200  can enable adjustment of a length of treatment member  400  extending from securement member  200 . For example, in a vein ablation procedure, the length of treatment member extending from securement member  400  will correlate to the length of introducer sheath  350  ( FIGS. 3-6 ) and sleeve member  250 , as described in more detail below. 
     In other embodiments, other ways of holding treatment member  400  with securement portion  200  may be employed. For example, securement portion  200  may include a lever that causes a compression hold with treatment member  400 , or treatment member  400  may be permanently affixed to securement portion  200  by adhesives, welding, monolithic construction, or any other way of securing treatment member  400  with securement portion  200 . 
     As shown in  FIG. 2 , securement portion  200  also includes tabs  212 . Tabs  212  may function with corresponding features of delivery portion  300  to removably couple securement portion  200  and delivery portion  300  together, as described in more detail below with regard to  FIG. 4 . Tabs  212  may also hold sleeve member  250 . Sleeve member  250  may be permanently affixed, by adhesives, welding, or other suitable attachment, or may be selectively removable from securement member  200 . As shown in  FIG. 2 , sleeve member  250  may be of tubular construction and sized such that treatment member  400  passes through sleeve member  250 . The diameter of sleeve member  250  may be such that the inner diameter of sleeve member  250  is slightly larger than the outer diameter of treatment member  400 , such that a close fit between sleeve member  250  and treatment member  400  is achieved. 
     The length of sleeve member  250  may correlate with a desired exposed at treatment length of distal end  410  of treatment member  400 . In a vein ablation procedure, treatment lengths may range from about 1-4 cm. Thus, sleeve member  250  may be from about 1-4 cm long, or any other length as desired by the practitioner. One particular use of device  100  with sleeve member  250  is described in further detail below. 
     As shown in the exemplary embodiment of  FIG. 3 , delivery portion  300  of device  100  includes cap  310 , body  330 , and cover  320 . As illustrated, cap  310  includes top opening  314  which may be located in the center of cap  310  and positioned such that opening  314  is part of channel  370  when cap  310  is located over body  330 . Cap  310  may also function to hold seal  312  in place between body  330  and cap  310 . Cap  310  may be permanently affixed or removably coupled to body  330 . In some embodiments, cap  310  may be integrally formed with body  330 . 
     Seal  312  may be arranged to prevent materials, such as blood and fluids, from exiting channel  370  through opening  314  while allowing introduction of tools, instruments, and other devices, such as treatment member  400  and sleeve member  250 , through opening  314 . Seal  312  may be made from a pliable material such as rubber, plastic, or other suitable material. Seal  312  may have a slit or a plurality of slits such that seal  312  may be penetrated by an introduced object, such as treatment member  400  or sleeve member  250 , but retain a substantially closed configuration when not being penetrated. Seal  312  may also continue to form a seal around an introduced object, allowing the introduced object to slidably move along channel  370  while maintaining a seal preventing materials from exiting channel  370  around an introduced object. 
     Body  330  includes port  334  and side-channel  336  passing through port  334  to allow introduction or removal of materials from a distal end of introducer sheath  350  through channel  370 . For example, a vacuum may be applied to side-channel  336  through tube  338  and stopcock  339  (shown in  FIGS. 1 ,  7 ) to evacuate blood or other fluids during a medical procedure. Tube  338  may be attached to port  334 , and may be held to port  334  by features configured to aid in the retention of tube  338  to port  334 . 
     Similarly, body  330  may be permanently affixed or removably coupled to introducer sheath  350  such that movement of delivery portion  300  may also move introducer sheath  350 . For example, during a vein ablation procedure, introducer sheath  350 , treatment member  400 , and hub  350  may be simultaneously withdrawn. 
     Cover  320  may be rotatably coupled to body  330 . Cover  320  may include portion  322 , which may be used to secure device  100  in a particular location, for example by tape or suture, while allowing rotational movement of body  330  and, by extension, all other portions of device  100 , within cover  320 , allowing a practitioner to rotate introducer sheath, treatment member  400 , or other portion as required by a particular procedure. 
       FIG. 4  shows a cross-sectional view of securement portion  200  and delivery portion  300  in a coupled configuration.  FIGS. 5 and 6  show sequential steps that may be used to couple securement portion  200  and delivery portion  300  for use in a medical procedure such as vein ablation. In a vein ablation procedure, a practitioner may want to insert distal end  410  of treatment member  400  into a patient to access a treatment area. A practitioner may create an initial opening into the patient and the desired vein by using conventional procedures such as by using a trocar. Once an opening is created, a dilator and/or guide wire may be used to create the desired pathway into the vein targeted for treatment. 
     Prior to use in a vein ablation procedure, device  100  may be prepared for use in the procedure. To prepare device  100  for use in the procedure, treatment member  400  may be secured to securement portion  200 . The location of securement portion  200  on treatment member  400  may be predetermined such that the length of treatment member extending between distal end  410  of treatment member  400  and securement portion  200  is about the same length as introducer sheath  350  plus about 1-4 cm, which corresponds to the length of sheath member  250 . 
     Distal end  410  of treatment member  400  may then be inserted into channel  370  of delivery portion  300  through seal  312 , (shown in  FIGS. 4-5 ), and advanced until distal end  252  of sleeve member  250  contacts seal  312 , as shown in  FIG. 6 . Because the diameter of sleeve member  250  is larger than the diameter of treatment member  400 , a practitioner may feel resistance as distal end  252  of sleeve member  250  contacts seal  312 . In this configuration, distal end  410  of treatment member  400  may be located at distal end  352  of introducer sheath  350 , such that distal end  410  of treatment member  400  may be somewhat inside, even with, or somewhat extending from distal end  352  of introducer sheath  350 , as desired by the practitioner. 
     With distal end  410  of treatment member  400  positioned about at distal end  352  of introducer sheath  350 , distal end  410  of treatment member  400  may be protected by introducer sheath  350  from being damaged and from damaging tissues when being placed in a desired location in a patient. 
     In a vein ablation procedure, for example, once the pathway into the targeted vein is established, and device  100  prepared for use in the procedure, introducer sheath  350  and treatment member  400  may be introduced into the patient. Introducer sheath  350  may be used to assist in placing treatment member  400  in the desired location in a patient, as shown in  FIG. 7 . Once the desired location is reached, a practitioner may then push sleeve member  250  through seal  312  until tabs  212  push through opening  314  of cap  310 , thereby coupling securement portion  200  to delivery portion  300 , as shown in  FIG. 4 . 
     In the coupled position, as shown in  FIG. 4 , distal end  410  of treatment member  400  may extend from distal end  352  of introducer sheath  350  a distance that is about the same as the length of the sleeve member  250 , assuring the practitioner that the device  100  is properly positioned and ready for use. If the practitioner determines that more or less of distal end  410  of treatment member  400  should be exposed, securement portion  200  may be loosened and repositioned on treatment member  400 , as described above, for adjustmenting the positioning of distal end  410  with respect to distal end  352  of introducer sheath  350 . Such adjustments may be made at any time before or during a procedure, as desired by a practitioner. 
     In some embodiments, sleeve member  250  may be color coded such that a particular color corresponds to a particular length. In other embodiments, sleeve member  250  may be cut to a desired length by a practitioner, or several different sleeve members  250  having distinct lengths may be provided. 
     In some embodiments, device  100  may be packaged in a kit, which may include items that may be used in conjunction with device  100 . For example, a kit may include a trocar, a dilator, a guide wire, at least one introducer sheath  350  coupled to delivery portion  300 , and treatment member  400 , having a length corresponding to the length of introducer sheath  350 , coupled to securement portion  300 . Thus, a practitioner may then prepare the patient using the supplementary items in the kit for use with device  100 , and use device  100  as described above. In some embodiments, the kit may include a plurality of sleeve members  250  having different lengths. 
     Each portion of device  100  may be manufactured of materials suitable for use in medical procedures, and may be sterilized with an appropriate sterilization method. Although device  100  has been described above in conjunction with a vein ablation procedure, device  100  may also be used in other medical procedures and practices when such an assembly might be useful or desirable. 
     The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.