Patent Publication Number: US-2020297330-A1

Title: Hysteroscopic tissue biopsy devices, systems, and methods

Description:
BACKGROUND 
     Technical Field 
     The present disclosure relates generally to medical devices, systems, and methods. More particularly, the present disclosure relates to tissue biopsy devices and systems used in hysteroscopic surgical procedures, and methods of hysteroscopic tissue biopsy. 
     Background of Related Art 
     Tissue biopsy is a medical procedure used to obtain a tissue sample from an area of the body. The obtained tissue sample is usually tested to assist in diagnosing a medical condition or to assess the effectiveness of a particular treatment. Endometrial biopsies are procedures employed for evaluating uterine tissue for the presence of cancerous or pre-cancerous cells. Endometrial biopsies typically include the insertion of a catheter through the cervix and into the uterus of the patient. Following insertion of the catheter, a biopsy needle is inserted into the uterus via the catheter, whereupon a small amount of endometrial lining is aspirated with the biopsy needle. 
     SUMMARY 
     In an aspect of the present disclosure, a tissue biopsy system is provided and includes an elongate guide member and a biopsy needle. The elongate guide member includes a proximal end portion, and a distal end portion. The distal end portion has a distal tip extending distally therefrom. The distal tip has a helical configuration and is configured to pierce tissue during a rotation of the elongate guide member about a longitudinal axis defined by the elongate guide member. The biopsy needle has a distal tip configured to pierce and capture a sample of tissue. The distal tip of the elongate guide member is configured to guide the distal tip of the biopsy needle toward the sample of the tissue. 
     In aspects, the distal tip of the elongate guide member may define a channel. 
     In aspects, the distal tip of the biopsy needle may be configured to pass through the channel defined by the distal tip of the elongate guide member to pierce and capture the sample of the tissue. 
     In aspects, the channel of the distal tip of the elongate guide member may have a diameter that is greater than a diameter of the distal tip of the biopsy needle. 
     In aspects, the elongate guide member may have a hollow shaft, and the distal tip of the elongate guide member may extend distally from the hollow shaft. 
     In aspects, the biopsy needle may have an elongate body portion configured to pass through the hollow shaft. The distal tip of the biopsy needle may extend distally from the elongate body portion. 
     In aspects, the biopsy needle may define a longitudinally-extending passageway. The distal tip of the elongate guide member may be configured for receipt in the passageway. 
     In aspects, the biopsy needle may be configured to slide distally relative to and over the distal tip of the elongate guide member while the distal tip of the elongate guide member is disposed in the passageway. 
     In accordance with another aspect of the disclosure, an elongate guide member is provided and includes a shaft, a handle portion, and a distal tip. The shaft has a proximal end portion and a distal end portion and defines a longitudinal axis. The handle portion is coupled to the proximal end portion of the shaft and the distal tip extends distally from the distal end portion of the shaft. The distal tip has a helical configuration and is configured to pierce tissue during a rotation of the shaft about the longitudinal axis. 
     In aspects, the distal tip may define a longitudinally-extending channel. 
     In aspects, the shaft may define a longitudinally-extending channel coextensive with the channel of the distal tip. 
     In aspects, the distal tip may have a further-most end that is tapered for piercing tissue. 
     In accordance with yet another aspect of the disclosure, a method of performing a needle biopsy of uterine tissue is provided. A distal tip of an elongate guide member is positioned relative to uterine tissue; the elongate guide member is rotated, thereby fixing the distal tip of the elongate guide member in the uterine tissue; and a distal tip of a biopsy needle is guided along the elongate guide member and into the uterine tissue to take a sample of the uterine tissue. The distal tip of the elongate guide member has a helical configuration. 
     In aspects, guiding the distal tip of the biopsy needle may include moving the distal tip of the biopsy needle through a channel defined by the distal tip of the elongate guide member. 
     In aspects, guiding the distal tip of the biopsy needle may include distally sliding the distal tip of the biopsy needle over the distal tip of the elongate guide member. 
     In aspects, the biopsy needle may define a longitudinally-extending passageway. The distal tip of the elongate guide member may be disposed in the passageway while the distal tip of the biopsy needle distally slides over the distal tip of the elongate guide member. 
     As used herein, the term distal refers to that portion of the device which is farthest from the user, while the term proximal refers to that portion of the device which is closest to the user. Further, to the extent consistent, any of the aspects detailed herein may be utilized with any or all of the other aspects detailed herein. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiment(s) given below, serve to explain the principles of the disclosure, wherein: 
         FIG. 1  is a cross-sectional view illustrating an exemplary embodiment of a tissue biopsy system including an elongate guide member inserted hysteroscopically into the uterus and engaged with uterine tissue and a biopsy needle disposed within the elongate guide member; 
         FIG. 2  is a side view illustrating the biopsy needle shown in  FIG. 1 ; 
         FIG. 3  is a side view illustrating a distal tip of the biopsy needle shown in  FIG. 2  extending through a helical distal tip of the elongate guide member shown in  FIG. 1 ; and 
         FIG. 4  is a side view illustrating another embodiment of a tissue biopsy system including a biopsy needle extending over a helical distal tip of an elongate guide member. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments of the present disclosure will now be described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. 
     The devices, systems, and methods of the present disclosure may be used for retrieving tissue during any minimally invasive procedure. That is, although the systems and methods of the present disclosure are described below with reference to a hysteroscopic biopsy procedure, the systems and methods of the present disclosure may also be used for other minimally invasive tissue-retrieving procedures. 
     With reference to  FIGS. 1-3 , a tissue biopsy system  10  is configured for insertion into a tissue opening, for example, a cervix “C,” and to take a sample of tissue, for example, uterine tissue “T,” for biopsy. The tissue biopsy system  10  generally includes a biopsy needle  12  and an elongate guide member  30  for guiding the biopsy needle  12  to a target tissue site. 
     The biopsy needle  12  has an elongate body portion  14 , a handle portion  16  coupled to a proximal end portion  14   a  of the elongate body portion  14 , and a distal tip  18  coupled to a distal end portion  14   b  of the elongate body portion  14 . The elongate body portion  14  may be a catheter, a cannula, a tube, or the like, and defines a longitudinally-extending passageway  20 . The elongate body portion  14  may be fabricated from any suitable material including a metal or plastic, such as, for example, silicone rubber, polyurethane, PET, thermoplastic polymers, and/or nylon. The handle portion  16  is configured to be grasped by a clinician to manipulate the biopsy needle  12  to a selected position within a surgical site. In some aspects, the handle portion  14  of the biopsy needle  12  may be configured to be attached to a robotic arm assembly (not shown) for controlling movement of the biopsy needle  12 . 
     The distal tip  18  of the biopsy needle  12  extends distally from the distal end portion  14   b  of the elongate body portion  14 . In aspects, the distal tip  18  may be monolithically formed with the distal end portion  14   b  of the elongate body portion  14  or be connected thereto in any other suitable manner, e.g., via mechanical engagement, welding, adhesion, etc. The distal tip  18  is configured to pierce tissue and capture a sample of the tissue therein. The distal tip  18  may be fabricated from metal (e.g., stainless steel) and defines a hollow interior  22  configured for receipt of tissue. A distal-most end  24  of the distal tip  18  may have a lancet point configuration. It is contemplated that the distal-most end  24  of the distal tip  18  may be any suitable needle tip type of any suitable geometry and any suitable gauge (e.g., 18 gauge) to facilitate piercing tissue. 
     With reference to  FIGS. 1 and 3 , the elongate guide member  30  of the tissue biopsy system  10  includes a shaft  32 , a handle portion  34  ( FIG. 1 ), and a distal tip  36 . The shaft  32  is hollow, and therefore defines a longitudinally-extending channel  38  configured for passage of the elongate body portion  14  and the distal tip  18  of the biopsy needle  12  therethrough. In some aspects, the shaft  32  may be configured as a flexible (and, in embodiments, resilient) wire. In other aspects, the shaft  32  may be a rigid linear wire or a wire having a rigid or biased helical configuration along at least a portion of its length. The shaft  32  has a proximal end portion  32   a  and a distal end portion  32   b  and defines a longitudinal axis “X” ( FIG. 3 ). 
     The handle portion  34  of the elongate guide member  30  is coupled to the proximal end portion  32   a  of the shaft  32  and is configured to be grasped by a clinician to manipulate the elongate guide member  30  to the target tissue site. In some aspects, the handle portion  34  of the elongate guide member  30  may be configured to be attached to the robotic arm assembly for controlling movement of the elongate guide member  30 . 
     The distal tip  36  of the elongate guide member  30  extends distally from the distal end portion  32   b  of the shaft  32 . In aspects, the distal tip  36  of the elongate guide member  30  may be monolithically formed with or otherwise connected to the distal end portion  32   b  of the shaft  32 , e.g., via welding, mechanical engagement, etc. The distal tip  36  of the elongate guide member  30  is an open coil helical wire, such that adjacent coils  36   a,    36   b  of the distal tip  36  have a space  40  defined therebetween to allow for tissue to be disposed therebetween. The distal tip  36  may be configured to resist compression or may be configured to compress under a threshold force to narrow the distance between the adjacent coils  36   a,    36   b . It is contemplated that the distal tip  36  may have any suitable length including any suitable number of coils and pitch of coils to make up the helical configuration thereof. A further-most distal end  42  of the distal tip  36  may be sharp, pointed, or otherwise tapered, such that the distal tip  36  is configured to pierce tissue during a rotation of the shaft  32  about the longitudinal axis “X.” 
     The distal tip  36  of the elongate guide member  30  is also configured to guide the distal tip  18  of the biopsy needle  12  towards target tissue. In particular, the distal tip  36  of the elongate guide member  30  defines a longitudinally-extending channel  44  that is coextensive with the channel  38  of the shaft  32 . As such, as the distal tip  18  of the biopsy needle  12  passes distally out of the shaft  32  of the elongate guide member  30 , the distal tip  18  of the biopsy needle  12  enters the channel  44  of the distal tip  36  of the elongate guide member  30 . The channel  44  of the distal tip  36  of the elongate guide member  30  has a diameter that is greater than a diameter of the distal tip  18  of the biopsy needle  12  to allow for the distal tip  18  of the biopsy needle  12  to pass therethrough during use. 
     In aspects, the distal tip  36  of the elongate guide member  30  may be radiopaque so that it can be seen with imaging systems such as X-ray, cone beam CT, CAT, fluoroscopy, etc. The distal tip  36  of the elongate guide member  30  may have fixation elements (e.g., barbs, teeth, hooks, or the like) disposed at a suitable distance proximal from the further-most end  42  thereof. The fixation elements (not shown) may assist in fixing the distal tip  36  in tissue and/or may provide tactile feedback to the clinician indicating that the distal tip  36  has reached a sufficient depth in tissue. In aspects, the distal tip  36  of the elongate guide member  30  may be coated with or fabricated from polytetrafluoroethene (PTFE), graphite, or other lubricating agents to minimize friction with tissue. In aspects, the distal tip  36  may be fabricated from a shape memory material (polymer or alloy), e.g., nickel titanium, such that the distal tip  36  may be configured to move from a first state, in which the distal tip  36  is linear, to a second state, in which the distal tip  36  assumes its helical configuration upon receiving an electrical impulse or upon changing to a particular temperature (e.g., body temperature). 
     Referring again to  FIGS. 1-3 , in use, the tissue biopsy system  10  may be used to sample tissue for biopsy. For example, the tissue biopsy system  10  may be utilized in performing a hysteroscopic tissue biopsy procedure. The elongate guide member  30  is positioned through a cervix “C” or other suitable natural or artificial tissue opening and guided to the target tissue site within the uterus “U” using medical imaging, such as, for example, a hysteroscope (not shown). In such embodiments, the elongated guide member  30  may be passed through a working channel of the hysteroscope or other access-providing device. Once elongate guide member  30  reaches the target tissue site, the further-most end  42  of the distal tip  36  of the elongate guide member  30  engages tissue “T” at the target tissue site within the uterus “U” and is rotated about its longitudinal axis “X.” Due to the helical configuration of the distal tip  36  of the elongate guide member  30  and the tapered configuration of the further-most end  42  thereof, the rotation of the elongate guide member  30  drives the further-most end  42  of the distal tip  36  into the tissue in a helical path. Continued rotation of the elongate guide member  30  screws the distal tip  36  into the tissue to a selected depth to fix the distal tip  36  in the tissue at the target tissue site. The selected depth may be determined by the surgeon, e.g., through visualization, or may be the maximum depth set by the elongated guide member  30 , e.g., according to the length of the distal tip  36 . To this end, a kit of elongate guide members  30  having different distal tip  36  lengths and/or an elongate guide member  30  having an adjustable-length distal tip  36 , e.g., via telescoping the distal tip  36  relative to shaft  32  or selecting a distal tip  36  of desired length from a lot of different-length distal tips  36  and releasably engaging that distal tip  36  with shaft  32 , may be provided. 
     With the distal tip  36  of the elongate guide member  30  fixed to the tissue, the biopsy needle  12  is positioned into the channel  38  of the shaft  32  of the elongate guide member  30  (e.g., via an entry opening at a proximal end of the shaft  32  or handle portion  34 ) and moved distally therethrough. The distal tip  18  of the biopsy needle  12  moves through the channel  38  of the shaft  32  and thereafter into the channel  44  of the distal tip  36 . The distal tip  36  of the biopsy needle  12  is driven distally through and relative to the distal tip  36  of the elongate guide member  30  to pierce the tissue to capture a sample of the tissue in the hollow interior  22  of the distal tip  18  of the biopsy needle  12 . Channel  44  guides the distal tip  18  of the biopsy needle  12  through tissue and may also serve as a visual indicator for the depth of insertion the distal tip  18  of the biopsy needle  12 . That is, distal  18  may piece the tissue to a selected depth corresponding or relative to the distal-most end of distal tip  36 , thus allowing surgeon to control the depth. 
     Upon capturing the tissue sample, the biopsy needle  12  is withdrawn proximally from the elongate guide member  30  and the elongate guide member  30  is reverse-rotated to detach the distal tip  36  thereof from the tissue to enable removal of the elongate guide member  30 . 
       FIG. 4  illustrates another embodiment of a tissue biopsy system  100 , similar to the tissue biopsy system  10  of  FIGS. 1-3 . The tissue biopsy system  100  includes a biopsy needle  112  and an elongate guide member  130 , each similar to the biopsy needle  12  and elongate guide member  30  described above with reference to  FIGS. 1-3 , except as explicitly contradicted below. Therefore, the biopsy needle  112  and elongate guide member  130  are only be described in the detail necessary to elucidate distinctions from the embodiment of  FIGS. 1-3 . 
     The biopsy needle  112  defines a longitudinally-extending passageway  120  configured for receipt of a distal tip  136  of the elongate guide member  130 . As such, instead of the elongate guide member  130  configured to guide the biopsy needle  112  through it, the biopsy needle  112  is slid distally over the distal tip  136  of the elongate guide member  130  while the distal tip  136  of the elongate guide member  130  remains disposed within the passageway  120  of the biopsy needle  112 , thus guiding the biopsy needle  112  about the elongated guide member  130 . During use, after capturing tissue within the distal tip  118  of the biopsy needle  112 , the elongate guide member  130  is rotated to detach the distal tip  136  thereof from the tissue prior to withdrawing the biopsy needle  112 . Alternatively, elongate guide member  130  and biopsy needle  112  may be withdrawn together with one another (with both rotating and translating or with both translating and just elongated guide member  130  rotating). 
     Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the present disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.