Patent Publication Number: US-2022233231-A1

Title: Fallopian tube sealing device

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63/140,375 filed Jan. 22, 2021, the entire disclosure of which is incorporated by reference herein. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to surgical devices and, more specifically, devices and methods for sealing fallopian tubes. 
     2. Discussion of Related Art 
     Due to a history of pelvic disease, adhesions, tubal disease or hydrosalpinx, many women experience difficulty conceiving. As a result, in vitro fertilization (IVF) has become a popular alternative to traditional conception. One of the inherent risks associated with IVF is the occurrence of an ectopic pregnancy wherein the fertilized egg(s) implants within the fallopian tube instead of the uterus. In the case of hydrosalpinx an abnormal buildup of fluid may affect IVF success. 
     Surgical procedures such as salpingectomies or laparoscopic tubal ligations are typically performed to lower the risk of ectopic pregnancies and to minimize the effects of unilateral or bilateral hydrosalpinx. As with all procedures, these have their own risks and associated complications. Sealing the fallopian tubes may be an alternative solution with minimal risk. 
     SUMMARY 
     This disclosure relates generally to surgical devices that can be used through a hysteroscopic approach to seal fallopian tubes without leaving foreign materials within the body cavity. In addition, the surgical devices disclosed herein may be used in a medical office without the need for general anesthesia. 
     The present disclosure relates to a device for sealing tissue within an anatomical structure (e.g., fallopian tube) and includes a handle having an elongated shaft extending therefrom. A reciprocating element is disposed within the elongated shaft and is configured for reciprocation therein, the reciprocating element including a distal end extending from a distal end of the elongated shaft. A rope-like filament is secured to the distal end of the reciprocating element, the rope-like filament remaining exposed relative to the distal end of the elongated shaft during reciprocation thereof. A motor is disposed within the handle and is configured to induce reciprocation of the reciprocating element upon activation thereof. The motor is adapted to connect to a generator configured to selectively supply power to the motor upon activation thereof. 
     In aspects according to the present disclosure, a switch is operably coupled to the motor and is operably associated with the handle. In other aspects according to the present disclosure, the rope-like filament is wound around the distal end of the reciprocating element. In yet other aspects according to the present disclosure, the rope-like filament is void of any sharp edges. 
     In aspects according to the present disclosure, the motor cooperates with a cam to induce reciprocating motion of the reciprocating element. In other aspects according to the present disclosure, the cam is disposed within the elongated shaft. In still other aspects according to the present disclosure, the cam is disposed within the handle. 
     The present disclosure relates to a method for sealing tissue within an anatomical structure and includes reciprocating a rope-like filament within a fallopian tube to induce an inflammatory response in the tissue. The rope-like filament is disposed on a distal end of a reciprocating element disposed within an elongated shaft extending from a handle. The reciprocating element is operably connected to a motor disposed within the handle and is configured to induce reciprocation of the reciprocating element upon activation thereof. The motor is adapted to connect to a generator configured to selectively supply power to the motor upon activation thereof. 
     In aspects according to the present disclosure, the method further includes a switch operably coupled to the motor and disposed in the handle. In other aspects according to the present disclosure, the method includes winding the rope-like filament around the distal end of the reciprocating element. 
     In aspects according to the present disclosure, the rope-like filament is void of any sharp edges. In other aspects according to the present disclosure, the motor cooperates with a cam to induce reciprocating motion of the reciprocating element. In still other aspects according to the present disclosure, the cam is disposed within the elongated shaft. In yet other aspects according to the present disclosure, the cam is disposed within the handle. 
     Further, to the extent consistent, any of the aspects described herein may be used in conjunction with any or all of the other aspects described herein. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various aspects of the present disclosure are described hereinbelow with reference to the drawings, which are incorporated in and constitute a part of this specification, wherein: 
         FIG. 1  is a side view of an exemplary electrosurgical system provided in accordance with the present disclosure including a surgical device and a generator; 
         FIGS. 2A-2C  are enlarged, schematic views a rope or rope-like filament being secured to a distal end the surgical device; and 
         FIGS. 3A-3B  are schematic views of the surgical device shown reciprocating within a fallopian tube to induce an inflammatory response to seal the tube. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments of the present disclosure are now described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “clinician” refers to a doctor, a nurse, or any other care provider and may include support personnel. Throughout this description, the term “proximal” refers to the portion of the device or component thereof that is closer to the clinician and the term “distal” refers to the portion of the device or component thereof that is farther from the clinician. 
     Referring now to  FIG. 1 , an electrosurgical system  1  is disclosed in accordance with the present disclosure and includes a generator  10  and a surgical device  100  including an end effector  140  couple to a distal end thereof. The generator  10  is configured to provide energy to the surgical device  100 . As detailed herein, the energy is provide to a motor to induce a reciprocating motion to the end effector of the surgical device  100 . 
     The surgical device  100  includes a handle  110 , an elongated body or shaft  112  extending from the handle  110 , and an end effector  140  supported by the distal portion of the elongated shaft  112 . The elongated shaft  112  may be flexible, semi-rigid, or rigid. In embodiments the elongated shaft  112  is curved along a longitudinal axis thereof to aid in insertion into a fallopian tube “FT” as detailed below. 
     End effector  140  includes a distal end  142  having a reciprocating element  144  disposed therein. Reciprocating element  144  is configured to extend from the distal end  142  and reciprocate within shaft  112  upon activation of a switch  132 . Switch  132  communicates with a motor  120  which, in turn, electrically couples to a cam  130  to induce reciprocation of reciprocating element  144  upon movement thereof. Other mechanisms are envisioned to induce reciprocation of reciprocating element  144 , e.g., pneumatic mechanisms, linkages, oscillators, solenoids, etc. Cam  130  may be disposed within handle  110  or be housed more distally within the instrument  100  or elongated shaft  112 . 
     Turning now to  FIGS. 2A-2C , prior to use, a distal end  144   a  of the reciprocating element  144  is extended to its distalmost position. A rope or rope-like filament  200  is wound around or otherwise secured to the distal end  144   a  of the reciprocating element  144 . Typically, only the portion of the distal end  144   a  of the reciprocating element  144  is wound with the rope  200  so as not to inadvertently separate the rope  200  from the distal end  144   a.    
     Once the rope  200  is secured about the distal end  144   a  of the reciprocating element  144 , the elongated shaft  112  may be inserted into the fallopian tube “FT” of a patient as shown in  FIGS. 3A and 3B . The flexibility of the elongated shaft  112  facilitates positioning of the distal end  144   a  and rope  200  proximate a desired area of treatment. Once inserted, the surgeon activates switch  132  which, in turn, activates motor  120  to rotate the cam  130  to reciprocate the reciprocating element  144  within shaft  112  causing the rope  200  to irritate, heat and burn the tissue proximate the distal end  144   a.    
     Using heat generated by the friction or abrasion of the rope  200  against the tissue of the tube “FT”, the rope  200  essentially burns the tissue which, in turn, induces an inflammatory response and the formulation of granulated tissue. As a result, the tube “FT” seals under the inflammatory response effectively blocking the tube “FT” and preventing a fertilized egg associated ectopic pregnancy or hydrosalpinx fluid from entering therein. By using a strictly mechanical approach to tissue response, potential complications from electrosurgical treatment of tissue (e.g., bipolar or monopolar) are avoided. Moreover, the rope  200  is void of sharp edges or areas of potential electrical arcing further mitigating areas of potential surgical concern with perforation of the tube “FT”. 
     The present disclosure relates to a method for sealing tissue within a fallopian tube “FT” and includes reciprocating a rope-like filament  200  within a fallopian tube “FT” to induce an inflammatory response in the tissue. The rope-like filament  200  is disposed on a distal end  144   a  of a reciprocating element  144  disposed within an elongated shaft  112  extending from a handle  110 . The reciprocating element  144  is operably connected to a motor  120  disposed within the handle  110  and is configured to induce reciprocation of the reciprocating element  144  upon activation thereof. The motor  120  is adapted to connect to a generator  10  configured to selectively supply power to the motor  120  upon activation thereof. 
     Sealing a fallopian tube “FT” with instrument  100  may be performed in a medical office without requiring general anesthesia and may be completed without leaving implanted or foreign materials within the patient. Further, the method of sealing the fallopian tube “FT” detailed above forms an immediate and temporary seal (or possibly a permanent seal) which may reduce the time of a subsequent surgical procedure, reduce the cost of a subsequent surgical procedure, and/or improve patient outcomes associated with sealing fallopian tubes. 
     While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Any combination of the above embodiments is also envisioned and is within the scope of the appended claims. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope of the claims appended hereto.