The present disclosure relates to endoscopic instruments, and more specifically, to biopsy forceps for use in endoscopic procedures.
Tissue samples are often examined to determine the presence of a pathological disorder. Endoscopic biopsy forceps may be used in conjunction with an endoscope for taking certain tissue samples from the human body for analysis. Often, the samples must be obtained from deep within the body at a location that is difficult to access by simply using forceps jaws (i.e., tissue from an area accessible via a tortuous biliary path). In certain cases, the quality of tissue that is easily accessible by a physician may not be satisfactory for pathologists to make an accurate diagnosis. Furthermore, forceps jaws are often difficult to maneuver for tangential bites.
The present disclosure is directed to a biopsy forceps device comprising a tension member extending from a proximal end to a distal end and an end effector including first and second jaws movable between an open configuration, in which the jaws are separated from one another to receive target tissue therebetween , and a closed configuration, in which cutting edges of the jaws are moved toward one another to cut a portion of the target tissue from surrounding tissue, the first and second jaws defining a tissue receiving space therebetween to house the cut tissue, the first and second jaws being pivotable relative to one another, the end effector further including a tension member attachment extending from a distal end to a proximal end coupled to the tension member, the distal end of the tension member attachment terminating at a sharp spike configured to penetrate the tissue, the tension member attachment being movably coupled to the first and second jaws so that distal movement of the tension member attachment moves the jaws to the open configuration while proximal movement thereof moves the jaws to the closed configuration.
In an embodiment, the first and second jaws include concave inner surfaces defining a substantially hemispherical cup.
In an embodiment, the tension member attachment includes a proximal part and a distal part, the distal part including first and second cam slots, the first and second cam slots being positioned on opposing outer surfaces of the tension member attachment.
In an embodiment, the first and second jaws each include a cam pin, the cam pin of the first jaw being slidably received within the first cam slot while the cam pin of the second jaw is slidably received within the second cam slot so that movement of tension member attachment relative to the cam pins of the first and second jaws pivots the first and second jaw in opposing directions.
In an embodiment, the first and second cam slots are substantially arcuate in shape, the first and second cam slots curving in opposite directions and crossing one another with a medial portion of each cam slot overlapping.
In an embodiment, the proximal part of the tension member attachment includes a blind hole open at a proximal end in which a distal end of the control wire is received.
In an embodiment, the end effector has a length of less than 5 mm.
In an embodiment, the end effector has a length of less than approximately 4.95 mm.
In an embodiment, the device further includes a clevis, the clevis including first and second arms extending distally from a proximal portion, the proximal portion including a central lumen sized and shaped to receive the tension member attachment therethrough, the arms defining a jaw receiving space therebetween for receiving a proximal portion of each of the first and second arms, the first jaw being pivotably coupled to the first arm and the second jaw being pivotably coupled to the second arm.
The present disclosure is also directed to biopsy forceps system for sampling tissue comprising a proximal assembly including an actuator, a tension member extending from a distal end to a proximal end coupled to the proximal assembly and a distal assembly including first and second jaws movable between an open configuration, in which the jaws are separated from one another to receive target tissue therebetween, and a closed configuration, in which cutting edges of the jaws are moved toward one another to cut the target tissue from surrounding tissue, the first and second jaws defining a tissue receiving space therebetween to house the cut tissue, the first and second jaws being pivotable relative to one another, the distal assembly further including a tension member attachment extending from a distal end to a proximal end coupled to the tension member, the distal end of the tension member attachment terminating at a tissue penetrating spike, the tension member attachment movably coupled to the first and second jaws so that distal movement of the tension member attachment pivots the jaws to the open configuration while proximal movement of the tension member attachment pivots the jaws to the closed configuration wherein actuation of the proximal assembly causes the tension member attachment to move proximally and distally relative to the first and second jaws.
In an embodiment, the actuator comprises a handle and a spool, the spool being coupled to the control wire and slidable along a longitudinal axis of the handle.
In an embodiment, the tension member attachment includes a proximal part and a distal part, the distal part including first and second cam slots, the first and second cam slots being positioned on opposing outer surfaces of the tension member attachment.
In an embodiment, each of the first and second jaws includes a cam pin, the cam pin of the first jaw being slidably received in the first cam slot while the cam pin of the second jaw is slidably received the second cam slot so that movement of the tension member attachment relative to the first and second jaws pivots the first and second jaws in opposing directions.
In an embodiment, the first and second cam slots are arcuate, curve in opposite directions and cross one another.
In an embodiment, the system further includes a clevis, the clevis including first and second arms extending distally from a proximal portion of the clevis, the proximal portion including a central lumen sized and shaped to receive the tension wire attachment therein, each of the arms defining a jaw receiving space therebetween for receiving a proximal portion of a corresponding one of the first and second arms, the first jaw being pivotably coupled to the first arm via and the second jaw being pivotably coupled to the second arm.
The present disclosure is also directed to a method of obtaining a tissue sample comprising inserting a distal portion of a biopsy forceps assembly to a target area within a living body, the distal portion including a tension member extending from a proximal end to a distal end and an end effector including first and second jaws movable between an open configuration in which the first and second jaws are separated from one another too receive target tissue therebetween, and a closed configuration, in which cutting edges of the first and second jaws are moved toward one another to cut the target tissue away from surrounding tissue, the first and second jaws defining a tissue receiving space therebetween to house the cut tissue, moving the tension member distally relative to the first and second jaws to move a tension member attachment coupled to the tension member distally so that a spike on a distal end of the tension member attachment penetrates the target tissue, the tension member attachment being movably coupled to the first and second jaws so that distal movement of the tension member attachment relative to the first and second jaws pivots the first and second jaws to the open configuration, and moving the tension member proximally relative to the first and second jaws to pivot the jaws to the closed configuration so that the cutting edges of the first and second jaws sever the target tissue received therebetween from the surrounding tissue.
In an embodiment, the method further includes inserting the biopsy forceps assembly through the working channel of an endoscope.
In an embodiment, the tension member attachment includes a proximal part and a distal part, the distal part including first and second cam slots, the first and second cam slots being positioned on opposing outer surfaces of the core wire attachment.
In an embodiment, the first and second jaws each include a cam pin, the cam pin of the first jaw being sized and shaped to slidably move within the first cam slot to pivot the first jaw in a first direction while the cam pin of the second jaw is configured slidably move within the second cam slot to pivot the second jaw in a second, opposing direction.
In an embodiment, the method further comprises actuating the distal portion via a proximal assembly coupled to the proximal end of the tension member.
The present disclosure may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present disclosure relates to an endoscopic forceps assembly for severing and retaining tissue samples. Exemplary embodiments of the present disclosure describe a forceps assembly that can be advanced through a working channel of an endoscope, including, for example, a SpyScope™, or any other endoscopic device specifically designed and/or sized for use with the forceps assembly, and into a tissue tract. Current embodiments also include a more compact forceps design for increasing the passability and maneuverability of the forceps assembly through tight curvatures within the working channels of the endoscopic devices as well as through a tortuous lumen of a living body. It should be noted that the terms “proximal” and “distal,” as used herein, are intended to refer to toward (proximal) and away from (distal) a user of the device.
A forceps assembly, according to an exemplary embodiment of the present disclosure, is depicted in
The clevis 110 is substantially U-shaped and includes a central lumen 134. The clevis 110 includes a pair of arms 136 extending distally from a generally cylindrical proximal portion 138. The central lumen 134 passes through the proximal portion 138 and is sized and shaped to receive the control wire attachment 112 therein. Each arm 136 has a generally curved outer surface and a generally flat inner surface and includes a pivot hole 140 to receive the cylindrical extrude features 122 from the jaws 106, 108 therein. A jaw receiving space 143 is defined between the two arms 136,137 to receive the tangs 119, 126 of the first and second jaws 106, 108, respectively. The pivot pin 124 extends through the pivot pin holes 124 of the arms 136 as well as the mounting holes 122 of the first and second jaws 106, 108 to connect the clevis 110 to the first and second jaws 106, 108 and permit pivotal movement of the first and second jaws 106, 108 relative to one another and the clevis 110. The control wire attachment 112 extends through the clevis lumen 134 and connects to a distal end of the control wire 120 housed within the elongate member 104. These connections couple the distal assembly 100 to the proximal assembly 102 while the control wire 120 and control wire attachment 112 are used to actuate the jaws 106, 108, as described in further detail below.
The control wire attachment 112, as shown in
In an exemplary embodiment, the distal assembly 100 has a rigid portion with a reduced length of, for example, 4.95 mm, when compared to standard forceps end effectors. Specifically, the jaws 106, 108 are reduced in length by approximately 0.3 mm to a rigid length of, for example, 3.48 mm. Furthermore, the clevis 110 is reduced in length by 1.278 mm to a rigid length of, for example, 2.85 mm. The shortening of these components and, thus, the distal assembly 100, allows the distal assembly 100 to more easily pass through acute curvatures within a living body. Furthermore, the reduced rigid length of the distal assembly 100, in combination with the spike 150, reduces the number of bites required to grab the target tissue, resulting. This reduction in the number of bites required to grab the target tissue results in a smaller number of insertions of the distal assembly 100 into the tissue, reducing trauma to the surrounding tissue.
Turning back to
The control wire 120, as depicted in
The handle 114 is hollow and defines a lumen 182 which houses the coil retainer 180. Dual fixation flanges 184 on the coil retainer 180 prevent longitudinal movement of the coil retainer 180 within the handle 114. Specifically, the flanges 184 are configured to mate with corresponding grooves 186 formed within the handle 114 perpendicular to the longitudinal axis of the lumen 182. A proximal end 188 of the coil 178 is welded to the coil retainer 180 with a proximal-most face of the coil 178 abutting a distal face of the coil retainer 180. In another embodiment, the coil retainer 180 may be formed integrally with the coil 178. As noted above, the coil retainer flanges 186 prevent the coil retainer 180 from moving longitudinally within the lumen 182 of the handle 114.
Still referring to
Both the clevis 110 and the jaws 106, 108 may be formed of, for example, stainless steel. Alternatively, these components may be formed from aluminum, brass, polymeric materials, nitinol, titanium, or any other suitable biocompatible material. The components may be manufactured through various methods such as, for example, injection molding, precision machining, casting, etc. Other components including the control wire 120, core attachment member 112 and the pins 123, 124, 125, 127, also can be manufactured from stainless steel or any other suitable biocompatible material, such as those described above.
In use, the forceps assembly 10 is maintained in the closed configuration and inserted into the body, e.g., through the working channel of an insertion instrument such as the endoscope 20 which may be, for example, a SpyScope DS™. The PTFE coating of the flexible coil 178 allows the coil 178 to be inserted through the endoscope and into the body with minimal friction while the smaller dimensions of the distal end effector assembly 100 makes delivery through tightly curved tortuous passageways easier because the length of the stiff components of the device (i.e., jaws 104, 106, clevis 110, control wire retainer 112) is reduced in comparison to traditional biopsy forceps. Specifically, in this embodiment, when a SpyScope is inserted into the biliary tract, it forms an acute angle due to the complex anatomy and location of the biliary tract. The reduced rigid length of the distal assembly is 4.95 mm facilitates passage of the assembly 10 through these tight curves, enhancing maneuverability and positioning at a desired location. The coil 178 along with the distal assembly 100 is passed along the tortuous path and, in this exemplary application, positioned in the common bile duct (CBD) 30, as seen in
However, in this embodiment, the distal end 244 of the wire attachment 212 includes a knuckle spike feature 250. Specifically, the knuckle spike 250 includes a hooked portion 251, which facilitates tissue anchoring. Furthermore, the knuckle spike 250 allows the tissue to be pulled into the first and second jaws 106, 108 as they are closing, thereby further improving the depth to which tissue may be bitten by the first and second jaws 106, 108.
A control wire attachment 312, according to another exemplary embodiment depicted in
Another exemplary embodiment of a control wire attachment 412 is shown in
In another exemplary embodiment shown in
It will be appreciated by those skilled in the art that changes may be made to the embodiments described above without departing from the inventive concept thereof. It should further be appreciated that structural features and methods associated with one of the embodiments can be incorporated into other embodiments. It is understood, therefore, that this disclosure is not limited to the particular embodiment disclosed, but rather modifications are also covered within the scope of the present disclosure as defined by the appended claims.
The present disclosure claims priority to U.S. Provisional Patent Application Ser. No. 62/633,856 filed Feb. 22, 2018; the disclosure of which is incorporated herewith by reference.
Number | Date | Country | |
---|---|---|---|
62633856 | Feb 2018 | US |