Biopsy forceps with tissue-piercing member

Abstract

A biopsy forceps device includes a control member, a yoke coupled to the member, and jaws coupled to the yoke. In an open configuration, the jaws are separated to receive target tissue. In a closed configuration, cutting edges of the jaws are moved toward each other to cut tissue. A capsule slidably receives a portion of the jaws and the yoke. When withdrawn proximally to a first position within the capsule, the jaws are constrained to the closed configuration. When the jaws are moved to a second position, portions of the jaws are freed from the constraining capsule and separated. When the yoke and the jaws are moved distally and the jaws are moved to the open configuration, tissue-contacting structures of the yoke extend distally to engage tissue between the jaws to again anchor lateral movement of the engaged tissue as the jaws contact the tissue.

Description

[0001] Inventors: Dipak Kumar Sharma and Shitendra Prakash

[0002] CLAIM

[0003] This disclosure claims priority to U.S. Provisional Patent Application Serial No. 62 / 969,392, filed February 3, 2020; the disclosure of which is hereby incorporated by reference. TECHNICAL FIELD

[0004] The present disclosure relates to endoscopic instruments, and more particularly, to biopsy forceps for use in endoscopic procedures. BACKGROUND

[0005] Tissue samples are often examined to determine the presence of a pathological disorder. Endoscopic biopsy forceps can be used in conjunction with an endoscope for obtaining certain tissue samples from the human body for analysis. Often, the samples must be obtained from locations deep within the body that are difficult to access by simply using a forceps jaw (e.g., tissue from areas accessible via a tortuous path). In some cases, the quality of the tissue that is easily accessible can not be satisfactory to a pathologist to make an accurate diagnosis. Furthermore, forceps jaws are known to be difficult to manipulate for tangential bites. SUMMARY

[0006] The present disclosure relates to a biopsy forceps device. The biopsy forceps device includes a control member extending from a proximal end to a distal end, a yoke coupled to the distal end of the control member, the yoke including a tissue contact structure extending distally from a distal end of the yoke, and first and second jaws coupled to the yoke. The first and second jaws are biased toward an open configuration in which the jaws are separated from one another to receive a target tissue therebetween, and the first and second jaws are movable to a closed configuration in which cutting edges of the jaws are moved toward one another to cut a portion of the target tissue from around the tissue, the first and second jaws defining a tissue receiving space therebetween to accommodate the cut tissue. The device further includes a capsule slidably receiving a proximal portion of each of the first and second jaws and the yoke. The first and second jaws are constrained to the closed configuration when withdrawn proximally to a first position within the capsule; and the first and second jaws are configured such that when the first and second jaws are moved to a second position distal to the first position, the distal portions of the jaws are unbound from the capsule and separate from one another to the open configuration under their natural biasing forces; the tissue contact structure is positioned such that when the yoke and the first and second jaws are moved distally and the first and second jaws are moved to the open configuration, the tissue contact structure extends distally to engage a portion of the tissue between the first and second jaws to re-anchor lateral movement of the engaged portion of the tissue when the first and second jaws contact tissue adjacent to the engaged portion of the tissue.

[0007] In one embodiment, the first and second jaws include concave inner surfaces defining substantially hemispherical cups.

[0008] In one embodiment, the yoke includes a radially extending protrusion that contacts an inner surface of the capsule to center the yoke and the first and second jaws within the capsule.

[0009] In one embodiment, the first jaw is coupled to a first side of the yoke that is diametrically opposed to a second side of the yoke with respect to a longitudinal axis of the capsule, the second jaw being coupled to the second side.

[0010] In one embodiment, the control member is non-rotatably coupled to the yoke, and the yoke and the first and second jaws are rotatably received within the capsule such that rotation of the control wire causes the yoke and the first and second jaws to rotate within the capsule.

[0011] In one embodiment, the device further includes a handle held outside of a body of a user of the device during use of the device, the handle including a first actuator operable to move the control wire proximally and distally relative to the capsule and a second actuator to rotate the control wire about a longitudinal axis of the capsule.

[0012] In one embodiment, the end effector has a length of less than 4 mm.

[0013] In one embodiment, the end effector has a length of no more than 3.5 mm.

[0014] In one embodiment, the device further includes a flexible elongate member extending from a proximal end coupled to the handle to a distal end coupled to the capsule, the elongate member receiving the control member therein.

[0015] In one embodiment, the elongate member is sized to be slidably received within a working channel of an endoscope.

[0016] In one embodiment, the elongate member is coupled to the capsule via a bushing.

[0017] In one embodiment, the capsule is rotated about a longitudinal axis of the capsule.

[0018] In one embodiment, the elongate member is formed as a flexible coil. In one embodiment, the tissue engaging structure is formed as a tissue penetrating spike.

[0019] In one embodiment, the device further includes a plurality of protrusions at a distal end of the capsule extending radially inward toward a longitudinal axis of the capsule to prevent the first and second jaws from sliding distally out of the capsule.

[0020] The present disclosure also relates to a method for obtaining a tissue sample, the method comprising inserting a distal portion of a biopsy forceps assembly to a target region within a living body, the distal portion comprising: a control member extending from a proximal end to a distal end, and an end effector comprising first and second jaws movable between an open configuration in which the first and second jaws are separated from one another to receive a target tissue therebetween, and a closed configuration in which cutting edges of the first and second jaws are moved toward one another to sever the target tissue from the surrounding tissue, the first and second jaws defining a tissue receiving space therebetween to accommodate the severed tissue; moving the control member distally relative to the first and second jaws to move a yoke coupled between the control member and the first and second jaws distally such that a distal projection of the yoke member contacts the target tissue, the yoke being coupled to the first and second jaws such that distal movement of the yoke moves the first and second jaws to the open configuration; and moving the control member proximally relative to the first and second jaws to move the jaws to the closed configuration such that the cutting edges of the first and second jaws sever the target tissue portion from the surrounding tissue.

[0021] In one embodiment, the method further comprises inserting the biopsy forceps assembly through a working channel of an endoscope.

[0022] In one embodiment, the yoke and the first and second jaws are slidably received within the capsule, and wherein the yoke comprises a plurality of radial projections sized to slidably engage an inner surface of the capsule to maintain the yoke and the first and second jaws centered within the capsule.

[0023] In one embodiment, the tissue further comprises a handle held outside a body of a user of the device during use of the device, the handle comprising a first actuator operable to move the control member proximally and distally relative to the capsule, and a second actuator to rotate the control member about a longitudinal axis of the capsule.

[0024] In one embodiment, the method further comprises rotating the second actuator in a first direction to rotate the distal portion of the biopsy forceps assembly relative to the handle about the longitudinal axis of the capsule. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 A partial cross-sectional view of an end effector of a forceps device in a closed configuration is shown in accordance with one example embodiment of the present disclosure;

[0026] Figure 2 A partial cross-sectional view of an end effector of Figure 1 in an open configuration is shown;

[0027] Figure 3It shows Figure 1 A partially transparent perspective view of the capsule of the end effector;

[0028] Figure 4 The combination is shown Figure 1 A partial cross-sectional view of the handle assembly of the clamping device used in the end effector;

[0029] Figure 5 The image shows an object adjacent to the target in an open state. Figure 1 A partial sectional view of the end effector; and

[0030] Figure 6 Demonstrates the capture of the target organization Figure 1 A partial sectional view of the end effector.

[0031] Figure 7 It shows Figure 1 A partial sectional view of the clamp device. Detailed Implementation

[0032] This disclosure incorporates by reference the entire disclosure of co-pending U.S. Patent Application Serial No. 16 / 253,951, filed January 22, 2019, entitled "Biopsy Forceps with Cam Mechanism". This disclosure may be further understood with reference to the following description and accompanying drawings, wherein similar elements are referred to by the same reference numerals. This disclosure relates to an endoscopic forceps assembly for cutting and preserving tissue samples. Exemplary embodiments of this disclosure describe a forceps assembly that can be advanced through a flexible endoscope (including, for example, SpyScope). TM This refers to the working channel of an endoscope device, or any other device specifically designed and / or sized for use with the forceps assembly, and its advancement into the tissue channel. Current embodiments also include a more compact forceps design to increase the forceps assembly's passage through greater curvature within the working channel of the endoscope device, as well as its maneuverability along tortuous paths (which traverse the lumen of organs, for example, in living tissue). It should be noted that the terms "proximal" and "distal" as used herein refer to the user facing the device (proximal) and the user away from the device (distal).

[0033] like Figures 1-4 and Figure 7 As shown, a clamp assembly 10 according to an exemplary embodiment of the present disclosure includes a distal end effector 100, a proximal actuator assembly 102, and an elongated member 104 connecting the end effector 100 to the proximal actuator assembly 102. Figure 2As shown, the end effector 100 includes a first jaw 106, a second jaw 108, and a yoke 110, which are slidably received within a capsule 113. The yoke 110 is coupled to the first and second jaws 106, 108, and also receives and is coupled to the core wire 112. The proximal end of the capsule 113 is coupled to an elongated member 104 via a bushing 117.

[0034] like Figure 4 As shown, the proximal actuator assembly 102 includes a handle 114, which includes a proximal thumb loop 116 and a reel 118 that slides relative to the handle 114 on a longitudinally slotted member 115. In this embodiment, an elongated member 104 is formed as a flexible coil member and houses a control wire 112 extending from the proximal actuator assembly 102 to the end effector 100. The control wire 112 is coupled to the reel 118, and the elongated member 104 is coupled to the distal end of the longitudinally slotted member 115 such that as the reel 118 moves proximally and distally on the longitudinally slotted member 115, the control wire 112 moves proximally and distally within the elongated member 104.

[0035] As indicated above, the yoke 110 is connected to the control wire 112 and the claws 106, 108, while the capsule is connected to the elongated member 104 via the bushing 117. Therefore, as the control wire 112 moves proximally and distally through the elongated member 104 via the movement of the reel 118 on the longitudinally slotted member 115, the yoke 110 and the claws 106, 108 move proximally and distally through the capsule 113. The claws 106, 108 are configured to be biased toward an open tissue-receiving morphology. Therefore, as the claws 106, 108 move distally to extend out of the capsule 113, the claws 106, 108 separate from each other, allowing the target tissue to be received therein.

[0036] When the clasps 106 and 108 are pulled proximally back into the capsule 113, the radially outer surfaces of the clasps 106 and 108 contact the wall of the capsule 113 and are forced back toward the tissue grasping configuration. As will be described below, in the tissue grasping configuration, the clasps 106 and 108 are pulled together to grasp, cut, and retain the tissue received therein. To facilitate a wide range of applications and reach target anatomical regions with small cross-sections, the elongated biopsy forceps assembly 10 can be configured in lengths between 270 cm and 300 cm, and more preferably between 270 cm and 290 cm.

[0037] As in Figure 1 and 2As can be seen, the yoke 110 includes two radially projecting portions 120 that extend radially outward from the yoke 110 to engage the inner surface of the capsule 113. As the yoke 110 and the latches 106, 108 move proximally and distally within the capsule 113, the projecting portions 120 hold the yoke 110 and the latches 106, 108 centered within the capsule 113. The capsule 113 has two protrusions 119 at its distal end, which prevent the latches 106, 108 from sliding distally out of the capsule 113. The protrusions 119 are sized and shaped to engage with the projecting portions 120 as the latches 106, 108 and the yoke 110 move distally out of the distal end of the capsule 113.

[0038] The yoke 110 also includes tissue-penetrating spikes 122 projecting distally therefrom. In this embodiment, the spikes 122 extend substantially along the longitudinal axis L of the capsule 113, such that when the claws 106, 108 move between an open configuration and a tissue-grasping configuration, the spikes 122 remain substantially centered between the claws 106, 108. Because the claws 106, 108 open by their own natural biasing force and do not require a linkage (e.g., a four-bar linkage) to connect the claws 106, 108 to the control wire 112, the spikes 122 can pass directly along the longitudinal axis L without interfering with the movement of the claws 106, 108.

[0039] Figure 2 An end effector 100 with first and second jaws 106, 108 in an open tissue receiving configuration is shown. In this embodiment, the first and second jaws 106, 108 are typically cup-shaped with a convex outer surface and a concave inner surface, such that in a closed configuration, an internal tissue receiving space 109 is formed between the first and second jaws 106, 108. The outer peripheral edges of the first and second jaws 106, 108 are formed as tissue cutting edges 130, 132, configured to engage with each other in the closed configuration. For example, in this embodiment, the peripheries of the first and second jaws 106, 108 include complementary serrated edges or teeth, such that the apex of the serrations of the first jaw 106 fits within the valley of the serrations of the second jaw 108, and vice versa. In another embodiment, the distal cutting edges 130, 132 may be straight cutting edges.

[0040] like Figure 4As shown, control cable 112 extends from proximal end 142 to distal end 144. Proximal end 142 is connected to spool 118 via sleeve 143, and distal end 144 is connected to yoke 110. In this embodiment, sleeve 143 is a thiocyanate tube crimped onto control cable 112. Sleeve 143 is connected to rotary knob 145, which is received within a longitudinally slotted member 115 distal to spool 118, such that when rotary knob 145 is rotated about longitudinally slotted member 115, control cable 112 rotates relative to handle 114. Sleeve 143 is rotatably connected to spool 118 such that when control cable 112 is rotated via rotary knob 145, spool remains in place and does not rotate. Furthermore, as Figure 4 As can be seen, the proximal end of the elongated member 104 is connected to the distal end of the handle 114 via the retainer 147.

[0041] When the target tissue portion is captured within the end effector 100, the spikes 122 help maintain the target tissue portion in the desired position relative to the jaws 106, 108. Specifically, as Figure 5 and 6 As shown, when the claws 106 and 108 extend distally from the capsule and move to the open tissue receiving configuration, the spike 122 is centrally exposed between the now separated claws 106 and 108. As the end effector 100 advances distally toward the target tissue, the spike 122 penetrates the target tissue such that when the claws 106 and 108 are pulled toward each other, the engagement between the first claw 106 and / or the second claw 108 on either side of the spike 122 does not pull the target tissue away from the center. This pull-away from the center may include non-target tissue in the obtained sample, or remove some target tissue from the center, such that some of the target sample tissue is not included in the portion to be grasped and severed by the claws 106 and 108.

[0042] By keeping the tissue that the user has directly aimed at with the end effector centered between the jaws 106 and 108, the spike 122 ensures that the amount of target tissue included in the sample is maximized. Those skilled in the art will understand that other types of tissue centering structures can be used. For example, the spike 122 can be replaced by a protruding structure designed to engage the target tissue and otherwise maintain its centering between the jaws 106 and 108, terminating in a small flat square shape, an adhesive structure, a rough surface, etc., as long as the structure prevents, for example, lateral forces exerted by the jaws 106 and 108 against adjacent tissue.

[0043] In one exemplary embodiment, the end effector 100 has a reduced-length rigidity portion that allows the clamp assembly 10 of this embodiment to more easily traverse winding paths around sharp turning radii. For example, by eliminating the linkage associated with a particular end effector, the end effector 100 of this embodiment may have a rigidity portion of, for example, 3.5 mm. These components, and the shortening of the end effector 100, allow the end effector 100 to more easily traverse sharp curvatures within the living body. Furthermore, in conjunction with the barb 122, the reduced rigidity length of the end effector 100 reduces the number of bites required to grasp the desired amount of target tissue. This reduction in the number of bites required to grasp the desired amount of target tissue reduces the number of insertions of the end effector 100 into the tissue, thereby reducing trauma to surrounding tissues.

[0044] return Figure 1 An elongated member 104 is coupled to and extends proximally from a bushing 117. The elongated member 104 and bushing 117 can be coupled to each other by any of a variety of methods, including but not limited to welding, brazing, adhesives, etc. In one exemplary embodiment, the elongated member 104 may be formed of a flexible, tightly wound stainless steel helical coil and may also include a thin overlay or coating, such as a polytetrafluoroethylene (PTFE) layer as those skilled in the art will understand. The flexible coil 104 may have, for example, a circular, rectangular, or other cross-section. As those skilled in the art will understand, other cross-sectional shapes may be selected depending on the specific application. PTFE reduces friction between the endoscope's working channel and the elongated member 104, making it easier for the clamp assembly 10 to slide within the endoscope.

[0045] In use, the forceps assembly 10 is maintained in a closed position and inserted into the body, for example through the working channel of an instrument, such as an endoscope, which may be, for example, a SpyScope DS. For example, the endoscope may be inserted into the duodenum to retrieve tissue samples from the bile duct. Due to the complex anatomy and location of the bile duct, this typically requires the end effector 100 to be deployed at an acute angle relative to the longitudinal axis of the duodenum. The reduced rigidity length of the end effector 100 facilitates the forceps assembly 10 through these larger curves, thereby enhancing maneuverability and positioning to the desired location. The elongated member 104, together with the end effector 100, passes through the endoscope along a tortuous path to access the common bile duct. Once the distal end effector 100 has been positioned as needed adjacent to the target tissue, the reel 118 is advanced distally on the handle 114, thereby moving the control wire 112 and yoke 110 distally. This distal movement of the yoke 110 causes the claws 106 and 108 to move distally to extend the capsule 113.

[0046] As the claws 106 and 108 move distally out of the capsule 113, their natural biasing forces cause them to move apart into an open tissue-receiving configuration. When the claws 106 and 108 open and control the wire 112 to advance forward, the spikes 122 penetrate the target tissue, preventing lateral decentralization of the tissue. This helps increase the depth to which the sample obtained from the target tissue can be extended, such as... Figure 5 and Figure 6 As seen. The first and second claws 106, 108 then close by retracting the control wire 112 proximally, pulling the yoke 110 and the first and second claws 106, 108 proximally until contact between the claws 106, 108 and the capsule pulls the claws toward each other to grip and sever the target tissue.

[0047] When the first and second jaws 106, 108 are closed, the tissue captured in the tissue receiving space 109 of the first and second jaws 106, 108 is severed from the tissue by the cutting edges along the contours of the first and second jaws 106, 108, and the severed tissue sample remains between the closed jaws 106, 108. Once the tissue has been collected in the tissue receiving space 109 between the first and second jaws 106, 108, the forceps assembly 10 is retracted proximally from the endoscope, and the tissue is retrieved from the first and second jaws 106, 108 for diagnostic purposes. If more tissue is required for diagnostic purposes, the forceps assembly 10 can be reinserted through the endoscope to further extract tissue in the same manner.

[0048] Those skilled in the art will understand that changes can be made to the embodiments described above without departing from their inventive concept. It should also be understood that structural features and methods associated with one of the embodiments may be incorporated into other embodiments. Therefore, it should be understood that this disclosure is not limited to the specific embodiments disclosed, but modifications are also covered within the scope of this disclosure as defined by the appended claims.

Claims

1. A biopsy forceps device, comprising: A control member extending from a proximal end to a distal end; A yoke, the yoke being connected to the distal end of the control member, the yoke including a tissue contact structure extending distally from the distal end of the yoke; First and second jaws are connected to the yoke, the first and second jaws being biased toward an open configuration in which the jaws are separated from each other to receive target tissue therebetween, and the first and second jaws being movable to a closed configuration in which the cutting edges of the jaws are moved toward each other to cut a portion of the target tissue from around the tissue, the first and second jaws defining a tissue receiving space therebetween to accommodate the cut tissue; and A capsule, the capsule being slidably receiving the proximal portion of each of the first and second claws and the yoke; The first and second claws are restrained to the closed configuration when retracted proximally to a first position within the capsule; and the first and second claws are configured such that when the first and second claws move to a second position distal to the first position, the distal portions of the claws are released from the constraint of the capsule and separate from each other to the open configuration under their natural bias force; the tissue contact structure is positioned such that when the yoke and the first and second claws move distally and the first and second claws move to the open configuration, the tissue contact structure extends distally to engage the tissue portion between the first and second claws, to re-anchor the lateral movement of the engaged tissue portion when the first and second claws contact the tissue adjacent to the engaged tissue portion; The yoke includes several radially extending protrusions that contact the inner surface of the capsule to center the yoke and the first and second claws within the capsule. and The capsule includes a plurality of protrusions located at its distal end, the plurality of protrusions extending radially inward toward the longitudinal axis of the capsule to prevent the first and second claws from sliding distally out of the capsule.

2. The device of claim 1, wherein the first and second claws include a concave inner surface defining a substantially hemispherical cup.

3. The device according to claim 1 or 2, wherein the first claw is coupled to a first side of the yoke, the first side being diametrically opposed to a second side of the yoke relative to the longitudinal axis of the bladder, and the second claw is coupled to the second side.

4. The apparatus of claim 3, wherein the control member is non-rotatably coupled to the yoke, and the yoke and the first and second claws are rotatably received in the capsule, such that rotation of the control wire causes the yoke and the first and second claws to rotate within the capsule.

5. The apparatus according to any one of claims 1 to 4, further comprising: The handle is held outside the user-accessible body of the device during use. The handle includes a first actuator and a second actuator, the first actuator being operable to move the control wire proximally and distally relative to the capsule, and the second actuator causing the control wire to rotate about the longitudinal axis of the capsule.

6. The device according to any one of claims 1 to 5, wherein the end effector has a length of less than 4 mm.

7. The apparatus of claim 6, wherein the end effector has a length not exceeding 3.5 mm.

8. The apparatus according to claim 5, further comprising: A flexible, elongated member extending from a proximal end to a distal end, the proximal end being connected to the handle and the distal end being connected to the capsule, the elongated member receiving the control member therein.

9. The apparatus of claim 8, wherein the elongated member is sized to be slidably received within the working channel of the endoscope.

10. The device of claim 8, wherein the elongated member is connected to the bladder via a bushing.

11. The device of claim 8, wherein the capsule rotates about the longitudinal axis of the capsule.

12. The apparatus of claim 8, wherein the elongated member is formed as a flexible coil.

13. The device according to any one of claims 1 to 12, wherein the tissue-jointing structure is formed as a tissue-penetrating spike.

14. The device of claim 1, wherein when the first and second claws and the yoke are displaced distally from the distal end of the bladder, the size and shape of the protrusion of the bladder are configured to engage with the radial protrusion of the yoke.

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