Patent Publication Number: US-2020281575-A1

Title: Needle stabilization system and methods of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application Ser. No. 62/813,227, filed Mar. 4, 2019, entitled “NEEDLE STABILIZATION SYSTEM 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 needle stabilizers for use in medical settings. More particularly the present disclosure relates to temporary needle stabilizers for use during biopsies and other interventional procedures. 
     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 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. 
     Because the tissue to be sampled may be hard to reach, and in locations that are not outwardly visible, the use of imaging systems is helpful in safely guiding the biopsy needle. These imaging systems may include computed tomography (CT), real-time X-ray (fluoroscopy), ultrasound, or other similar technologies, or combinations thereof. 
     Problems may occur during these procedures as the physician attempts to navigate the needle to the proper location for sampling. For example, biopsy needles may become displaced during the procedure, especially at times when the physician is reviewing the imaging systems, when the patient is entering the CT scanner, or if the patient inadvertently moves. In such cases, the physician may need to reintroduce/reposition the needle and/or relocate the position of the target tissue. This lengthens the procedure time and may increase the risk of procedural complications (e.g., bleeding, infection, damaging surrounding structures, etc.) and causes discomfort to the patient. Additionally, the physician is typically limited by having to hold the biopsy needle throughout the procedure. 
     SUMMARY OF THE DISCLOSURE 
     In some embodiments, a needle stabilizing device includes a first body having a substantially cylindrical portion and a spherical portion and defining a central lumen therethrough, a base having a concave seat to accept the spherical body of the first body, and a lateral extension, the base defining a secondary lumen in communication with the central lumen of the first body, the spherical portion and the seat of the base being movable with respect to one another with respect to at least two axes, and an adhesive layer coupled to the base and having an adhesive surface on an end opposite the base. 
     In some embodiments, a needle stabilizing device includes a pad at least partially formed of a hydrogel having a density of between 0.9 g/mL and 0.9 g/mL and a height of at least 2 centimeters, and an adhesive material coupled to the pad. 
     In some embodiments, a method of stabilizing a biopsy needle includes providing a stabilizing device having a pad at least partially formed of a hydrogel having a density of between 0.9 g/mL and 2 g/mL and a height of at least 2 centimeters, and an adhesive material coupled to the pad, adhering the adhesive material to the patient&#39;s tissue to secure the pad to the patient&#39;s tissue, piercing the pad with the biopsy needle, and reviewing an imaging device to determine a position of the biopsy needle with respect to adjacent body tissue. 
     In some embodiments, a needle stabilizing device includes a hollow frustoconical body having a first circumference adjacent a first end of between 0.5 mm and 4 mm, and a second circumference adjacent a second end of between 6 cm and 16 cm, and defining a central opening centered around a longitudinal axis, and a ring-shaped adhesive material coupled to the frustoconical body on an end opposite the central opening, the adhesive material being ring shaped and having an opening to allow a needle to pass from the central opening to a patient&#39;s body tissue. 
     In some embodiments, a method of stabilizing a biopsy needle includes providing a stabilizing device comprising a hollow frustoconical body having a first circumference adjacent a first end of between 0.5 mm and 4 mm, and a second circumference adjacent a second end of between 6 cm and 16 cm, and defining a central opening centered around a longitudinal axis, and a ring-shaped adhesive material coupled to the frustoconical body on an end opposite the central opening, the adhesive material being ring shaped and having an opening to allow a needle to pass from the central opening to a patient&#39;s body tissue, adhering the adhesive material to the patient&#39;s tissue to secure the frustoconical body to the patient&#39;s tissue, passing a biopsy needle through the central opening, through the hollow frustoconical body along the longitudinal axis, and piercing the patient&#39;s body tissue, and reviewing an imaging device to determine a position of the biopsy needle with respect to adjacent body tissue. 
     In some embodiments, a needle stabilizing device includes a first body having a substantially cylindrical portion and a spherical portion and defining a central lumen therethrough, a base having a concave seat to accept the spherical body of the first body, and a lateral extension, the base defining a secondary lumen in communication with the central lumen of the first body, the spherical portion and the seat of the base being movable with respect to one another with respect to at least two axes, and an adhesive layer coupled to the base and having an adhesive surface on an end opposite the base. 
     In some embodiments, a method of stabilizing a biopsy needle includes providing a stabilizing device including a first body having a substantially cylindrical portion and a spherical portion and defining a central lumen therethrough, a base having a concave seat to accept the spherical body of the first body, and a lateral extension, the base defining a secondary lumen in communication with the central lumen of the first body, the spherical portion and the seat of the base being movable with respect to one another with respect to at least two axes, and an adhesive layer coupled to the base and having an adhesive surface on an end opposite the base, adhering the adhesive layer to the patient&#39;s tissue to secure the base to the patient&#39;s tissue, passing a biopsy needle through the central lumen of the first body, and the secondary lumen of the base, and piercing the patient&#39;s body tissue with the biopsy needle, reviewing an imaging device to determine a position of the biopsy needle with respect to adjacent body tissue, and adjusting the orientation of the cylindrical portion with respect to the base. 
    
    
     
       BRIEF DESCRIPTION OF THE DISCLOSURE 
       Various embodiments of the presently disclosed needle stabilizers are shown herein with reference to the drawings, wherein: 
         FIG. 1A  is a schematic perspective view of a biopsy needle being inserted through a pad-like needle stabilizer according to one embodiment of the present disclosure; 
         FIG. 1B  is a schematic perspective view of the biopsy needle and needle stabilizer of  FIG. 1A  after the location of the needle has been adjusted; 
         FIG. 2A  is a schematic perspective view of a biopsy needle being inserted through a frustoconical needle stabilizer according to another embodiment of the present disclosure; 
         FIG. 2B  is schematic top view of the frustoconical needle stabilizer of  FIG. 2A ; 
         FIG. 3A  is a schematic cross-sectional view of a ball-and-socket needle stabilizer according to a third embodiment of the present disclosure; 
         FIG. 3B  is a schematic perspective view of the biopsy needle and needle stabilizer of  FIG. 3A  after the location of the needle has been adjusted; and 
         FIG. 3C  is schematic top view of a biopsy needle disposed within the needle stabilizer of  FIG. 3A . 
     
    
    
     Various embodiments of the present invention will now be described with reference to the appended drawings. 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 needles 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 securing and stabilizing needles, such as biopsy needles. Among other advantages, the present disclosure may address one or more of these needs. 
     As used herein, the term “proximal,” when used in connection with a component of a needle, refers to the end of the component closest to the physician when the needle is inserted in a patient, whereas the term “distal,” when used in connection with a component of a needle assembly, refers to the end of the component farthest from the physician when the needle is inserted in a patient. 
     Likewise, the terms “trailing” and “leading” are to be taken as relative to the operator (e.g., physician) of the needle or biopsy assembly. “Trailing” is to be understood as relatively close to the operator, and “leading” is to be understood as relatively farther away from the operator. 
     The present disclosure relates to a needle stabilization system that lowers the possibility of displacement or accidental movement of a biopsy needle during a procedure. The needle stabilization system may also shorten procedure time, and improve patient comfort and safety by assisting the physician to accurately and quickly reach the target area of the biopsy, and maintaining the biopsy needle in place without the physician&#39;s hands. 
       FIG. 1A  shows a conventional biopsy device  10  having a handle  12 , a body  14  and a needle  16  having a compartment for obtaining a tissue sample. Several variations of biopsy devices are available but almost all include a needle with an opening capable of collecting a sample. As used herein, the terms “biopsy device,” and “biopsy needle” are used to refer to any such device having a needle for piercing the skin. Additionally, it will be understood that others needles, catheters, tubes, introducers, rods, shafts, screws and similar devices may be used in connection with some of these embodiments to increase stability. As shown, biopsy device  10  is being used in connection with one embodiment of the stabilizer according to the present disclosure. Specifically, needle stabilizer  100  includes a pad  110  having an adhesive layer  120  coupled thereto, the adhesive layer  120  being coupleable to a patient&#39;s skin “S” near the target tissue “T” disposed below the skin and having suspicious regions “R 1 ” and “R 2 ,” which are to be examined. 
     Pad  110  may be substantially cube-shaped as shown having a length, width and height of between 2 centimeters and 10 centimeters. Alternatively, pad  110  may be formed as a cylinder or disk having a diameter of between 2 centimeters and 10 centimeters, and a height of between 1 centimeter and 5 centimeters, or in other suitable shapes. Pad  110  may be formed of an aqueous material or suitable hydrogel such as those used in standoff pads common in ultrasonic imaging. Alternatively, pad  110  may be formed of a foam. In at least some examples, the pad  110  is translucent, bacteriostatic and/or hypoallergenic. In at least some example, pad  110  has a sufficient density that enables it to stabilize the biopsy device. For example, pad  110  may have a density of between 0.9 g/mL and 2 g/mL. It will be understood that a relationship exists between the density of the material and the height of the pad, and that a less dense pad may require a greater height to provide the requisite stability. 
     Adhesive layer  120  may be coupled to the bottom portion of pad  110  (i.e., the portion of the pad that is closest to the skin), and may have a lower surface opposite the pad to secure and adhere the pad  110  to a predetermined location on the patient&#39;s skin. Suitable materials for adhesive layer  120  may include acrylate, including methacrylates and/or epoxy diacrylates, rosin, copal and/or silica, and suitable combinations thereof. 
     With the pad  110  and adhesive layer  120  coupled over the target tissue, the user may introduce biopsy device  10  through pad  110  at entrance point  112 . As shown, biopsy device  10 , and specifically needle  16  of the device may be inserted through pad  110  and may begin to puncture the patient&#39;s skin “S”. With the biopsy device  10  inserted through the entire height of the pad  110 , the physician may step away and examine the imaging system to determine if the needle approach is correct. In some embodiments, the needle may be stabilized within the biopsy device and secured by the device before puncturing the skin. 
     Specifically, once the device  10  has passed through pad  110 , the pad may support biopsy device  10  and maintain its location and orientation, enabling the physician to leave the device  10  and turn his attention to the guidance system. After reviewing the position and orientation of biopsy device  10  and specifically the needle, the physician may (1) determine that the location of the needle is proper and that the target tissue is adjacent to needle  16 , and begin to collect a sample; (2) continue to advance the biopsy device  10  along the same trajectory to reach the target tissue, (3) adjust the orientation and/or trajectory of the needle  16 ; or (4) completely remove the biopsy device  10  and begin the procedure at a new location  113  as shown in  FIG. 1B . Thus, the process of inserting and adjusting the location of the needle, and comparing the location to the imaging system can be done and the physician may remove his hands from the biopsy needle when he is reviewing the imaging system, speaking to the patient or performing a different function without being concerned with the biopsy needle falling out, or losing the current position of the needle. 
     In another embodiment, a frustoconical stabilizing device  200  is used to secure the biopsy device  10 . As shown in  FIG. 2A , stabilizing device  200  includes a frustoconical body  210  having a general cone shape, and a central aperture  220  sized to receive a portion of biopsy device  10 . Body  210  may be formed partially or entirely from a polymeric material, such as silicone, thermoplastic polyurethanes (TPU), rubber, metal, 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. First body  305  may also be formed at least partially or entirely of a metal such a stainless steel, titanium, or other biocompatible metal, or of wood or cardboard. 
     In at least some examples, central aperture  220  has a diameter of between 0.5 millimeters and 4 millimeters and may be sized to accept a biopsy needle having sizes of 10-25 gauge. An adhesive ring  230  is coupled to the other side of frustoconical body  210 , opposite central aperture  220 . Adhesive ring  230  may have a circumference of between 6 centimeters and 16 centimeters, and may include a glue or adhesive material such as those described above with respect to the embodiment of  FIGS. 1A and 1B . Body  210  may include a scored region or line  240  extending from the central aperture along the body  210  to the adhesive ring  230  ( FIG. 2B ). A physician may split the body along scored line  240  after the procedure for easy removal of the stabilizing device. 
     Biopsy device  10  may be inserted through central aperture  220  into the interior of body  210 , and down to the patient&#39;s skin. Biopsy device  10  may then puncture the skin at location  112  toward the target tissue. If the physician wishes to temporarily release the device  10 , they may do so and the device will stay upright and/or in place as a portion of the biopsy device rests on a portion of the circumference of central aperture  220 . As shown, central aperture  220  provides enough spacing so that the physician is capable of finely adjusting the approach angle of the needle with respect to target tissue without having to reposition the stabilizing device. 
     A third embodiment of a stabilizing device  300  is shown in  FIGS. 3A-C . Stabilizing device  300  includes a first body  305  having a substantially cylindrical portion  310  terminating in a substantially spherical portion  320 . Stabilizing device  300  may further include a second body in the form of a base  330  having a cup-like concavity  332  capable of accepting spherical portion  320  so that the spherical portion is securely seated therein. Base  330  further includes a lateral portion  335  that extends radially outward away from concavity  332 . In at least some examples, spherical portion and concavity  332  are configured to have substantially smooth surfaces so that they can be moved relative to each other without much friction. In at least some examples, spherical portion and concavity  332  have a coefficient of static friction of between 0.1 and 0.9. 
     First body  305  may formed of any of the materials described above with respect to device  200 , and base  330  may be formed of the same material or a different material as first body  305 , and may be selected from any of the materials disclosed with respect to the first body  305 . 
     First body  305  may be moveable relative to base  330 . Specifically, spherical portion  320  and concavity  332  function as a ball-and-socket joint having three degrees of freedom, so that the spherical portion  320  and with it the cylindrical portion  310  can be oriented as desired. In at least some examples, the joint between the first body and the base is capable of only two degrees of freedom (e.g., the cylindrical portion is not capable of rotation about its central axis). 
     A central lumen  325  is defined through cylindrical portion  310  and spherical portion  320 , and a secondary lumen  326  is defined within base  330 . Central lumen  325  may have a diameter of between 0.5 millimeters and 4 millimeters, and secondary lumen  326  may have a diameter of between 2 centimeters and 16 centimeters. Central lumen  325  and secondary lumen  326  may be in communication so that a needle that is passed through central lumen may continue through secondary lumen  326  to reach the patient&#39;s skin “S”. In at least some examples, secondary lumen  326  has a larger diameter than central lumen  325  so that when the angle a 1  of the cylindrical portion is changed ( FIG. 3B ), the needle is capable of easily passing through the secondary lumen  326 . 
     Base  330  is secured to adhesive layer  340 , which is configured to adhere to the skin in similar ways and using any of the materials described above with respect to the previous two embodiments. 
     In use, the physician may secure the adhesive layer  340  to the patient&#39;s skin over the target area and introduce the needle of the biopsy device into the central lumen of the cylindrical portion, through the spherical portion  320  and the secondary lumen of the base to pierce the patient&#39;s skin. If the physician desires to step away from the procedure, for example, to review the imaging system, he may leave the biopsy device to be supported by the cylindrical portion and return to it at a later point in time. If, after review of the imaging system, the physician decides to further advance the needle, he may do so. If, instead, the physician decides to change the trajectory of the needle, the spherical portion may be moved within the cup-like concavity of the base to adjust the angle of the cylindrical portion with respect to the skin. This adjustment may be made with respect to axis x or axis y as shown in  FIG. 3C . 
     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.