Patent Publication Number: US-2020281640-A1

Title: Percutaneous biopsy cauterization device and methods of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application Ser. No. 62/813,234, filed Mar. 4, 2019, entitled “PERCUTANEOUS BIOPSY CAUTERIZATION DEVICE AND METHODS OF USE,” the contents of which are fully incorporated as if fully set forth herein. 
    
    
     FIELD OF THE DISCLOSURE 
     The present disclosure relates to biopsies in medical settings. More particularly the present disclosure relates to devices and methods to aid in cauterizing vessels after performing a percutaneous biopsy procedure. 
     BACKGROUND OF THE DISCLOSURE 
     Certain medical procedures employ the use of needles to puncture a patient&#39;s skin. The use of such needles is typically temporary. One example of such a procedure is a percutaneous biopsy, in which a needle is passed to a target location within the body to sample tissue. After extraction, the sampled tissue is analyzed to determine if the tissue is benign, malignant or infectious. For example, biopsies may be used to diagnose lymphoma, kidney cancer, liver cancer, lung cancer, and other soft tissue cancer. A biopsy might also be needed to diagnose a variety of other conditions and/or diseases. 
     After a biopsy procedure is performed and the instruments are removed, there is a risk of bleeding at the site of the biopsy. This is especially true for biopsies where the target is an organ with dense vasculature. 
     SUMMARY OF THE DISCLOSURE 
     In some embodiments, a cautery device having a proximal end and a distal end includes a housing, a battery encased within the housing, a trigger disposed on the housing, a metallic rod in electrical communication with the battery, and an insulating jacket disposed over a portion of the metallic rod. 
    
    
     
       BRIEF DESCRIPTION OF THE DISCLOSURE 
       Various embodiments of the presently disclosed biopsy devices are shown herein with reference to the drawings, wherein: 
         FIG. 1  is a schematic side view of a biopsy kit including an introducer, a stylet and a biopsy needle; 
         FIGS. 2A-B  are schematic top and side views of one embodiment of a cautery device; 
         FIG. 2C  is a schematic cross-sectional view of a base for coupling a metallic rod to the housing; and 
         FIGS. 3A-B  are schematic side and rear end views of another embodiment of a cautery device. 
     
    
    
     Various embodiments of the present invention will now be described with reference to the appended drawing. It is to be appreciated that these drawings depict only some embodiments of the invention and are therefore not to be considered limiting of its scope. 
     DETAILED DESCRIPTION 
     Despite the various improvements that have been made to biopsy devices and their methods of use, conventional devices suffer from some shortcomings as described above. 
     There therefore is a need for further improvements to the devices, systems, and methods of closing and sealing spaces after biopsy procedures. Among other advantages, the present disclosure may address one or more of these needs. 
       FIG. 1  illustrates a biopsy kit that generally includes an introducer  100 , a stylet  130  and a biopsy needle  160 . Each of these components will be described generally in order to appreciate the functionality of the cauterization device. Introducer  100  includes a hub  102  having an entrance port  104 , and a hollow cannula  106  having a lumen  108  in communication with the entrance port. Entrance port  104  and hollow cannula  106  may be sized to accept either one of stylet  130  or biopsy needle  160 . In at least some examples, introducer  100  may be 13 to 19 gauge and may be 8 cm to 23 cm in length. Optionally, introducer  100  may include depth markings  110  on cannula  106 , spaced apart to allow a physician to determine the depth to which the cannula has been inserted into a patient&#39;s body. The kit may also include stylet  130 , which includes hub  132  connected to metallic needle  134 , the metallic needle  134  terminating in a sharp tip  136 . Optionally, metallic needle  134  terminates in a blunt tip (not shown). Stylet  134  is sized to be inserted within introducer  100 . 
     The kit also includes a biopsy needle  160 . Biopsy needle  160  generally includes a handle  102 , a main body  164 , and a metallic inner core (not shown) and an outer sheath  166 . Handle  162  is configured to be grasped by the physician and may include a pair of rings as shown, or a pair of perpendicularly extending arms. Inner core and outer sheath  166  may include a compartment  168  for collecting a specimen during a biopsy. In one example, the inner core and the outer sheath are movable relative to one another, and firing the device causes a movement of one of the components with respect to the other adjacent body tissue, the movement causing a sample of the tissue to be collected within compartment  168 . 
     Outer sheath  166  may also include a plurality of spaced indicator markings  170  as shown. Typical biopsy needles also include a plunger  172  or other trigger mechanism configured to allow collection of the specimen. In the example shown, biopsy needle  160  includes a plunger  172  that may be retracted and pushed to cock and fire the outer sheath to rapidly move over the inner core to collect a sample. 
     A typical biopsy procedure will now be briefly described to better understand the functionality of each of these components. First, the site is prepared and adequate anesthesia is provided to the patient. A scalpel may be used to puncture the skin. The introducer and stylet may be inserted into the patient to a position proximal to the lesion to be biopsied. Imaging guidance may be useful at this step. The stylet may then be removed, leaving the introducer in place as a guide for the biopsy needle. The biopsy needle may then be cocked, for example, using a plunger and an appropriate penetration depth may be chosen. After the biopsy needle is advanced to the appropriate site, it may be fired to capture a specimen. The biopsy needle may be removed and the specimen removed. This process may be repeated if additional biopsies are required. 
     At this juncture, it may be possible to use a cautery device as illustrated in  FIGS. 2A-3B . Cautery device  200  generally extends between a proximal end  202  and a distal end  204 , and includes a housing  210  having a trigger  212 , and an insulating jacket  214  extending over a portion of a metallic rod (or wire)  216 . Insulating jacket  214  may cover most of metallic rod  216  except for an exposed portion at the distal end. In at least some examples, exposed portion of the metallic rod  216  is in the range of 0.5 to 3.0 mm. Both insulating jacket and metallic rod  216  may be formed of a diameter that is small enough fit within the cannula of introducer  100 . Introducers  100  may range from 11 gauge to 19 gauge, and biopsy needles may range from 12 to 22 gauge. In at least some examples, insulating jacket has an outer diameter of between 12 gauge and 22 gauge. In other embodiments, a cautery device  200  may be formed without the insulating jacket. In those cases, the metallic rod may be formed slightly larger than embodiments with the insulating jacket, and the metallic rod may have an outer diameter of 12 gauge to 22 gauge. In at least some examples, the largest diameter on the metallic rod and/or insulating jacket may be one gauge higher than the accompanying introducer. 
     Suitable materials for the housing and the insulating jacket may include a polymeric material, such as silicone, thermoplastic polyurethanes (TPU), rubber, plastic, polypropylene, polyethylene, acrylonitrile butadiene styrene (ABS), high impact polystyrene (HIPS), polyvinyl chloride (PVC) polycarbonate, thermoplastic elastomers, polybutylene terephthalate, ethylene vinyl acetate, nylon a low-density polyethylene, linear low-density polyethylene, and suitable combinations thereof. Suitable materials for the metallic rod may include copper, stainless steel or other conductive metals. 
     In some examples, insulating jacket  214  may be translatable relative to the metallic rod  216  so that the length of the exposed portion of the wire (i.e., the portion of the distal tip of the wire not covered by the insulating jacket) may be varied. In at least some other embodiments, the insulating jacket may be formed of two or more concentric segments that telescope relative to one another so that the length of the insulating jacket may be varied, and with it the length of the exposed portion of the metallic rod. 
     As shown in  FIG. 2B , the generally cylindrical housing  210  encases a battery  222  coupled to trigger  212  via wire  220   a , the trigger  212  being in turn coupled to metallic rod  216  via wire  220   b . In one example, trigger  212  may be in the form of a button, that when pressed, electrically connects the metallic rod  216  to battery  222  and causes the metallic rod to heat up to a temperature of between 500 and 1500 degrees Fahrenheit. 
     In some example, the cautery device  200  is disposable and made in a cost-effective manner so that it used for a single procedure and then discarded. Alternatively, the housing and the components therein may be used. For example, battery  222  may hold sufficient charge for multiple procedures. Additionally, battery  222  may be rechargeable. In such applications, the metallic rod  216  may be connected to the housing (and the wire  220   a ) via a base ( FIG. 2C ). As shown in this example, metallic rod  216  and/or insulating jacket  214  may be releasably coupleable to the housing via, for example, a base  230  having a threaded mechanism  232 . In such instances, housing and base  230  may be reused for multiple procedures while the metallic rod and/or insulating jacket may be discarded after use and replaced. Base  230  may also serve to electrically connect the metallic rod to the battery. 
       FIG. 3A-B  illustrates another embodiment of a cautery device, the device having some additional features and/or modifications. Cautery  300  extends between a proximal end  302  and a distal end  304 , and includes a housing  310  having a circumferential depression  311  for improved ergonomics. A trigger  312  is disposed on the proximal end of the device in line with the metallic  316  and the insulating jacket  314 . Housing  310  may encase a battery coupled to the trigger as previously described. In one other variation, metallic rod  316  may be retractable within jacket  314  so that it is exposed during use, and capable of being totally pulled within the jacket when not in use. 
     In use, the physician may remove the biopsy needle after obtaining the required sample(s). With the introducer still in place, the physician may advance the cautery device within the cannula of the introducer into the site of the biopsy. When cautery device is in the proper position, the physician may actuate the trigger which causes the metallic rod to be in electrical communication with the battery, heating up the metallic rod to 200 degrees Fahrenheit. The heated wire will cauterize the surrounding tissue, sealing the area of the biopsy and preventing any excess bleeding. Insulating jacket may surround portions of the metallic rod so that only the wire&#39;s distal tip is exposed. This may prevent the remaining portions of the wire from heating up the inside of the introducer or from other tissue such as muscle tissue. The cautery device may then be removed and discarded. While a simple mechanism has been described, in some examples, the cautery device utilizes radiofrequency ablation, cryoablation, or laser ablation. 
     Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims. 
     It will be appreciated that the various dependent claims and the features set forth therein can be combined in different ways than presented in the initial claims. It will also be appreciated that the features described in connection with individual embodiments may be shared with others of the described embodiments.