surgical forceps
The surgical device with a jaw mechanism and articulation system addresses positioning and lesion creation challenges in cardiac ablation, enabling precise clamping and resection for effective cardiac tissue treatment.
Patent Information
- Application Number
- JP2023221307
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-12-13
- Filing Date
- 2023-12-27
- Publication Date
- 2025-09-26
- Estimated Expiration
- 2040-01-07
AI Technical Summary
Existing surgical devices face challenges in accurately positioning ablation devices at specific locations within the heart, particularly for procedures involving pulmonary veins, and in creating continuous, transmural lesions due to the heart's complex anatomy.
A surgical device with an end effector featuring a first and second jaw, an articulation mechanism, and a pivotally mounted crank that allows for precise movement between open, intermediate, and closed positions, enabling effective clamping and resecting of tissue, with electrodes for radiofrequency ablation.
Enhances the ability to accurately position the device and create continuous lesions, improving the efficacy of cardiac ablation procedures by providing precise tissue clamping and resection capabilities.
Smart Images

Figure 0007744964000001 
Figure 0007744964000002 
Figure 0007744964000003
Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 790,938, filed January 10, 2019, U.S. Provisional Patent Application No. 62 / 796,998, filed January 25, 2019, U.S. Provisional Patent Application No. 62 / 874,150, filed July 15, 2019, and U.S. Provisional Patent Application No. 62 / 947,573, filed December 13, 2019, which are incorporated by reference.
[0002] FIELD OF THE DISCLOSURE The present disclosure is directed to medical instruments and devices and related methods, and more particularly to surgical devices for clamping and resecting tissue and related methods. [Background technology]
[0003] This disclosure discusses atrial fibrillation as a common cardiac arrhythmia, affecting a significant number of people in the United States alone. Ablation of cardiac tissue is a commonly performed procedure for treating cardiac arrhythmias to create scar tissue that disrupts the pathways of errant electrical impulses in the cardiac tissue. Ablation has been achieved or proposed using a variety of techniques, such as freezing via cryogenic probes, heating via radiofrequency (RF) energy, surgical cutting, and other techniques. As used herein, "ablation" can refer to the removal or destruction of function in a body part, such as cardiac tissue, regardless of the device or process used to perform the ablation. Also, as used herein, "transmural" can refer to penetrating a wall or thickness, such as the wall or thickness of a hollow organ or vessel. Generally, ablation of cardiac tissue can be performed in an open surgical procedure, in which the sternum is split to allow the surgeon direct access to the heart, or through a minimally invasive route, such as via a catheter introduced into the heart between the ribs or through a vein.
[0004] The present disclosure contemplates that although the forceps-type ablation device was designed for use in conjunction with a coronary artery bypass graft procedure, a small percentage of patients with atrial fibrillation who undergo a coronary artery bypass graft procedure are treated for atrial fibrillation.
[0005] The present disclosure considers that problems encountered in cardiac ablation procedures can include difficulties in accurately locating target tissue and difficulties with ablation of tissue. For example, in some situations, the structure of the heart can make it difficult to position an ablation device at a specific desired location in the heart. As an example, some ablation procedures involve isolating pulmonary veins. Because the pulmonary veins are located on the posterior side of the heart, it can be difficult to position an ablation device to achieve the desired ablation. As another example, in some situations, it can be difficult to create a continuous, sufficiently deep (e.g., transmural) line of ablated tissue, which may be necessary to electrically isolate a portion of the heart. This difficulty can be particularly relevant when the ablation procedure involves sequentially creating a series of shorter lesions at different locations that are intended to together form a continuous lesion. [Prior art documents] [Patent documents]
[0006] [Patent Document 1] U.S. Patent No. 8,876,820 [Patent Document 2] U.S. Patent No. 9,924,998 Summary of the Invention [Problem to be solved by the invention]
[0007] While known devices have been safely and effectively used to clamp and resect tissue (such as cardiac tissue), improvements in the structure and operation of surgical devices for clamping and resecting tissue could be beneficial to users (e.g., surgeons) and patients. The present disclosure includes various improvements that can enhance the structure, operation, and methods of use of surgical devices for clamping and resecting tissue, such as cardiac tissue. [Means for solving the problem]
[0008] It is a first aspect of the present disclosure to provide an end effector for a surgical device comprising a first jaw, a second jaw, and an articulation mechanism operable to move the first jaw between an open position in which the first and second jaws are separated and substantially non-parallel, an intermediate position in which the first and second jaws are separated and substantially parallel, and a closed position in which the first and second jaws are substantially adjacent and substantially parallel. The articulation mechanism may include a first jaw mount coupled to the first jaw, the first jaw mount being movable along a path, movement of the first jaw mount along the path causing rotation and translation of the first jaw mount and the first jaw, thereby moving the first jaw between an open position, an intermediate position, and a closed position; and a pivotally mounted crank, the crank operably coupling the actuator linkage to the first jaw mount such that moving the actuator linkage rotates the crank, and rotation of the crank moves the first jaw mount along the path.
[0009] In more detailed embodiments of the first aspect, the path may include at least one straight portion and at least one curved portion. The path may be defined at least in part by a slot. A first pin may be movably disposed in the slot for movement along the path. The first jaw mount may include the first pin. Movement of the first jaw mount along the path may include movement of the first pin along the slot. The first jaw mount may include a second pin movably disposed in the slot for movement along the path.
[0010] In a more detailed embodiment of the first aspect, the end effector may include a connecting linkage having a proximal end and a distal end, the connecting linkage operably interposed between the actuator linkage and the crank. The proximal end of the connecting linkage may be pivotally coupled to the actuator linkage and / or the distal end of the connecting linkage may be pivotally coupled to the crank. The proximal end of the connecting linkage may include a guide portion slidably disposed in a guide slot. The guide slot may be generally linear and / or oriented generally in line with the actuator linkage.
[0011] In a more detailed embodiment of the first aspect, the crank may include a first arm and a second arm. The first arm of the crank may be operably coupled to the actuator linkage, and / or the second arm of the crank may be slidably and / or pivotally coupled to the first jaw mount. The second arm of the crank may include a crank slot, and / or the first jaw mount may include a pin. As the crank rotates and the first jaw mount moves along the path, the pin can move along the crank slot. The crank slot may be substantially straight, and / or the crank slot may be oriented substantially radially relative to the axis of rotation of the crank.
[0012] In a more detailed embodiment of the first aspect, each of the first jaw and the second jaw may include a first end portion proximate the articulation mechanism and a second end portion generally away from the articulation mechanism, each second end portion terminating at a respective tip.
[0013] In a more detailed embodiment of the first aspect, a surgical device may include a shaft, an end effector as described above disposed at a distal end of the shaft, and a handle disposed at a proximal end of the shaft. The handle may include an actuator operably coupled to an actuator linkage, and / or the actuator linkage may extend longitudinally through the shaft to the end effector. The end effector may include a head including at least partially an articulation mechanism, and the first jaw and / or the second jaw may be disposed generally distally on the head and / or the first jaw and second jaw may be oriented generally laterally from the head.
[0014] In more detailed embodiments of the first aspect, in the open position, the tips of the first jaw and / or the second jaw can be spaced apart and / or at least partially define an opening. Each of the tips of the first jaw and / or the second jaw can be configured to releasably couple with at least one of the first end portion and / or the second end portion of the flexible guide. The tip of the first jaw can be configured to magnetically releasably couple with the first end portion of the flexible guide, and / or the tip of the second jaw can be configured to magnetically releasably couple with the second end portion of the flexible guide.
[0015] In more detailed embodiments of the first aspect, each of the first jaw and / or the second jaw may include a plurality of substantially straight portions interspersed with curved portions. At least one of the first jaw and / or the second jaw may be configured to resect tissue clamped therebetween. Each of the first jaw and / or the second jaw may include a pair of elongated, spaced-apart electrodes operably coupled to a source of radio frequency energy to resect tissue clamped between the first and second jaws. The electrodes of each pair of electrodes may be spaced apart by about 0.1 mm to about 3.0 mm.
[0016] It is a second aspect of the present disclosure to provide a surgical device comprising: a distal handle including an actuator; a shaft extending distally from the handle, the shaft including an actuator linkage extending therethrough, the actuator linkage operably coupled to the actuator; and / or an end effector disposed at a distal end of the shaft. The end effector may include a head, a first jaw disposed distally on the head, a second jaw disposed distally on the head, and / or an articulation mechanism. The articulation mechanism may include a connecting linkage having a proximal end and / or a distal end, the proximal end of the connecting linkage pivotally coupled to the distal end of the actuator linkage; a pivotally attached crank having a first arm and a second arm, the first arm pivotally coupled to the distal end of the connecting linkage; and / or a first jaw mount fixedly secured to the first jaw, the first jaw mount pivotally and slidably coupled to the second arm of the crank, wherein movement of the actuator on the handle is operable to move the first jaw from an open position in which the first and second jaws are separated and substantially non-parallel to a closed position in which the first and second jaws are substantially adjacent and substantially parallel.
[0017] In a more detailed embodiment of the second aspect, the first jaw mount may be movable along a path. Movement of the first jaw mount along the path may cause rotation and / or translation of the first jaw mount and the first jaw, thereby moving the first jaw from an open position to a closed position. Rotation of the crank may move the first jaw mount along the path. The first jaw and / or the second jaw may extend generally transversely to the shaft. Movement of an actuator on the handle may be operable to move the first jaw between an open position, an intermediate position in which the first jaw and the second jaw are separated and substantially parallel, and / or a closed position. The second arm of the crank may include a crank slot, and / or the first jaw mount may include a pin. The pin may move along the crank slot as the crank rotates. The proximal end of the connecting linkage may include a guide slidably disposed in the guide slot. The guide slot may be generally linear and / or oriented generally in line with the actuator linkage. The actuator may include a plunger that is pushed distally to move the first jaw from the open position to the closed position. The shaft may be substantially rigid. At least a portion of the shaft may be bendable. The shaft may be substantially straight. Each of the first jaw and / or the second jaw may terminate at a respective tip. In the open position, the tip of the first jaw and / or the tip of the second jaw may be spaced apart and / or may at least partially define an opening. The tip of the first jaw and / or the tip of the second jaw may be configured to releasably couple to a respective end portion of the elongate flexible guide. Each of the first jaw and / or the second jaw may include a plurality of substantially straight portions interspersed with curved portions. Each of the first jaw and / or the second jaw may include at least one electrode operably coupled to a source of radio frequency energy for ablating tissue clamped between the first jaw and / or the second jaw.
[0018] A third aspect of the present disclosure provides a surgical device comprising: a shaft; and / or an end effector disposed on a distal end of the shaft, the end effector comprising a head, the head comprising an articulation mechanism operable to move a first jaw between an open position in which the first and second jaws are separated and substantially non-parallel, and a closed position in which the first and second jaws are substantially adjacent and substantially parallel. Each of the first and / or second jaws may comprise a first substantially straight portion proximate the head, a second substantially straight portion, a third substantially straight portion distal to the head, a first curved portion between the first and second substantially straight portions, and / or a second curved portion between the second and third substantially straight portions. The first jaw and / or the second jaw may each terminate at a respective tip proximate the third substantially straight portion. In the open position, the tip of the first jaw and / or the tip of the second jaw may be spaced apart and / or may at least partially define an opening.
[0019] In more detailed embodiments of the third aspect, the articulation mechanism may be operable to rotate and / or translate the first jaw between an open position, an intermediate position in which the first jaw and the second jaw are separated and / or substantially parallel, and / or a closed position. The first substantially straight portion, the second substantially straight portion, and / or the third substantially straight portion of the first jaw may be oriented obliquely with respect to one another. The first substantially straight portion, the second substantially straight portion, and / or the third substantially straight portion of the second jaw may be oriented obliquely with respect to one another. The first substantially straight portion, the second substantially straight portion, and / or the third substantially straight portion of the first jaw may be substantially coplanar. The first substantially straight portion, the second substantially straight portion, and / or the third substantially straight portion of the second jaw can be substantially coplanar. The first substantially straight portion, the second substantially straight portion, and / or the third substantially straight portion of the second jaw can be substantially coplanar with the shaft.
[0020] In more detailed embodiments of the third aspect, the second substantially straight portion of the first jaw may be longer than at least one of the first substantially straight portion of the first jaw and / or the second substantially straight portion of the first jaw. The second substantially straight portion of the first jaw may be longer than both the first substantially straight portion of the first jaw and / or the second substantially straight portion of the first jaw.
[0021] In a more detailed embodiment of the third aspect, the first jaw and / or the second jaw can be disposed generally distally on the head. The first jaw and / or the second jaw can be oriented generally laterally from the head. In the closed position, the second substantially straight portion of the first jaw can be oriented approximately perpendicular to the shaft.
[0022] In a more detailed embodiment of the third aspect, in the closed position, the first substantially straight portion of the first jaw can extend generally diagonally distally and / or laterally away from the head. The third substantially straight portion of the first jaw can extend generally diagonally proximally and laterally away from the second curved portion. The second jaw can be rigidly positioned relative to the shaft. The first substantially straight portion, the second substantially straight portion, and / or the third substantially straight portion of the second jaw can be substantially flush with the shaft.
[0023] In a more detailed embodiment of the third aspect, the device may include a handle disposed proximally on the shaft, the handle including an actuator operably connected to the articulation mechanism. The tip of the first jaw and / or the tip of the second jaw may be configured to releasably couple to respective end portions of the elongated flexible guide. Each of the first jaw and / or the second jaw may include at least one electrode operably coupled to a source of radio frequency energy for ablating tissue clamped between the first jaw and / or the second jaw. The articulation mechanism may include a first jaw mount coupled to the first jaw, the first jaw mount being movable along a path, wherein movement of the first jaw mount along the path causes rotation and / or translation of the first jaw mount and the first jaw, thereby moving the first jaw between the open and closed positions, and / or a pivotally mounted crank, the crank operably coupling the actuator linkage to the first jaw mount such that moving the actuator linkage rotates the crank, and rotation of the crank moves the first jaw mount along the path.
[0024] It is a fourth aspect of the present disclosure to provide a guide for a surgical device comprising an elongate, flexible guide body having a first end portion and a second end portion, a first guide connector disposed on the first end portion, and / or a second guide connector disposed on the second end portion. The first guide connector may be selectively releasably connectable to the second guide connector and / or to at least one of a first tip of a first jaw of the surgical device and / or a second tip of a second jaw of the surgical device. The second guide connector may be selectively releasably connectable to the first guide connector and / or to at least one of the first tip and / or second tip. When the first guide connector is connected to the second guide connector, the guide can form a closed loop.
[0025] In a more detailed embodiment of the fourth aspect, the first guide connector may include a first permanent magnet. The second guide connector may include a second permanent magnet. The first permanent magnet and / or the second permanent magnet may be oriented with opposite magnetic poles facing away from the guide body, thereby magnetically coupling the first guide connector and the second guide connector to one another to form the guide into a closed loop. The first guide connector may include a cover configured to receive the first permanent magnet. The first permanent magnet may be securely housed within the cover of the first guide connector. The second guide connector may include a cover configured to receive the second permanent magnet. The second permanent magnet may be securely housed within the cover of the second guide connector.
[0026] In a more detailed embodiment of the fourth aspect, the guide body may be generally tubular.
[0027] In more detailed embodiments of the fourth aspect, the surgical apparatus may include a surgical device including a handle, a shaft extending distally from the handle, and / or an end effector disposed proximate the distal end of the shaft and including a first jaw and a second jaw, and / or a guide as described above.
[0028] It is a fifth aspect of the present disclosure to provide a method of using a surgical device, the method including the steps of: positioning a guide adjacent to the heart so that an elongated, flexible guide extends from a first end portion of the guide through the transverse sinus from right to left, inferiorly adjacent the left pulmonary vein, and through the oblique sinus from left to right to a second end portion of the guide; connecting the first end portion of the guide to a tip of a first jaw of a forceps; connecting the second end portion of the guide to a tip of a second jaw of the forceps; pulling the guide forward generally from right to left to position the first and second jaws adjacent to the left atrium; and / or clamping a portion of the left atrium between the first and second jaws.
[0029] In a more detailed embodiment of the fifth aspect, the method may include clamping the portion of the left atrium and then at least partially ablating the portion of the left atrium between the first and second jaws. The ablating the portion of the left atrium between the first and second jaws may include applying bipolar radio frequency energy to the portion of the left atrium between the first and second jaws using first and second electrodes arranged generally parallel on the first jaw and third and fourth electrodes arranged generally parallel on the second jaw.
[0030] In a more detailed embodiment of the fifth aspect, the step of positioning the elongated, flexible guide proximate the heart may include: positioning the guide proximate the heart so that the guide extends from a first end portion of the guide through the oblique sinus from left to right, superiorly adjacent the right pulmonary vein, and right to left through the transverse sinus to a second end portion of the guide; releasably coupling the first end portion to the second end portion to form the guide into a closed loop; moving the guide so that the guide extends from the releasably coupled first and second end portions from right to left through the transverse sinus, inferiorly adjacent the left pulmonary vein, and left to right through the oblique sinus to the releasably coupled first and second end portions; and / or decoupling the first end portion from the second end portion. Releasably coupling the first end portion to the second end portion may include releasably magnetically coupling a first permanent magnet disposed in the first end portion of the guide to a second permanent magnet disposed in the second end portion of the guide.
[0031] In a more detailed embodiment of the fifth aspect, the forceps may include a handle, a shaft extending distally from the handle, and an end effector disposed on a distal end of the shaft, the end effector including a first jaw and a second jaw. Positioning the first jaw and the second jaw proximate the left atrium may include positioning the first jaw at least partway through the transverse sinus and positioning the second jaw at least partway through the oblique sinus. Clamping a portion of the left atrium between the first jaw and the second jaw may include clamping a portion of the left atrium surrounding a right pulmonary vein. The method may include resecting a portion of the left atrium surrounding the right pulmonary vein between the first jaw and the second jaw. The method may include clamping a portion of the left atrium surrounding the left pulmonary vein between a first jaw and a second jaw, and / or ablating a portion of the left atrium surrounding the left pulmonary vein between the first jaw and the second jaw. The portion of the left atrium surrounding the right pulmonary vein and / or the portion of the left atrium surrounding the left pulmonary vein may not overlap, and / or the respective ablating operations may form spaced pulmonary vein isolation lesions. The portion of the left atrium surrounding the right pulmonary vein and / or the portion of the left atrium surrounding the left pulmonary vein may overlap between the right pulmonary vein and / or the left pulmonary vein, and / or the respective ablating operations may form figure-eight shaped lesions.
[0032] In a more detailed embodiment of the fifth aspect, clamping a portion of the left atrium between the first jaw and the second jaw may include clamping the left atrium such that the portion of the left atrium between the first jaw and the second jaw simultaneously surrounds the right and left pulmonary veins. The method may include, after clamping the portion of the left atrium, at least partially resecting the portion of the left atrium between the first jaw and the second jaw. Resecting the portion of the left atrium between the first jaw and the second jaw may include forming a complete box-shaped lesion around the right and left pulmonary veins in a single resection operation without repositioning the first jaw and / or the second jaw.
[0033] In a more detailed embodiment of the fifth aspect, the step of coupling a first end portion of the guide to a tip of a first jaw of the forceps may include releasably coupling the first end portion of the guide to a tip of the first jaw of the forceps, and the step of coupling a second end portion of the guide to a tip of the second jaw of the forceps may include releasably coupling the second end portion of the guide to a tip of the second jaw of the forceps.
[0034] In a more detailed embodiment of the fifth aspect, the forceps may include a shaft, a handle disposed proximally on the shaft, and / or an end effector disposed distally on the shaft, the end effector including a first jaw and / or a second jaw. Positioning the first jaw and / or the second jaw proximate the left atrium may include positioning the shaft in a generally anterior-to-posterior direction along an aspect of the right side of the heart. The forceps may include a shaft, a handle disposed proximally on the shaft, and / or an end effector disposed distally on the shaft, the end effector including the first jaw and / or the second jaw. Clamping a portion of the left atrium between the first jaw and the second jaw may include operating an actuator on the handle, the actuator being operably coupled to move the first jaw from an open position to a closed position.
[0035] Example embodiments are described in combination with the accompanying drawings. [Brief explanation of the drawings]
[0036] [Figure 1] FIG. 1 is a perspective view of an example surgical device. [Figure 2] FIG. 1 is a detailed perspective view of an example end effector. [Figure 3] FIG. 10 is a side view of an example end effector with the jaws in an open position. [Figure 4] FIG. 10 is a side view of an example end effector with the jaws in an intermediate position. [Figure 5] FIG. 10 is a side view of an example end effector with the jaws in a closed position. [Figure 6] FIG. 2 is a perspective cutaway view of an example joint mechanism. [Figure 7] FIG. 2 is a perspective cutaway view of an example joint mechanism. [Figure 8] FIG. 1 is an exploded perspective view of an example end effector with an example articulation mechanism. [Figure 9] FIG. 2 is a detailed internal perspective view of an example head shell portion. [Figure 10] FIG. 2 is a detailed internal perspective view of an example head shell portion. [Figure 11] FIG. 10 is a side view of the interior of an example handle. [Figure 12] FIG. 10 is a detailed view of the inward-facing (eg, tissue-clamping) surface of an example first jaw. [Figure 13] FIG. 10 is a detailed view of the inward-facing (eg, tissue-clamping) surface of an example second jaw. [Figure 14] FIG. 10 is a cross-sectional view of an example first jaw. [Figure 15] FIG. 2 is a perspective view of an example guide portion. [Figure 16] FIG. 10 is a perspective view of an example guide attached to the tip of the jaws of the forceps. [Figure 17] FIG. 10 is a detailed exploded perspective view of an example guide connector. [Figure 18] 1A-1C are simplified posterior perspective views of the heart showing example operations using guides and / or forceps. [Figure 19] 1A-1C are simplified posterior perspective views of the heart showing example operations using guides and / or forceps. [Figure 20] 1A-1C are simplified posterior perspective views of the heart showing example operations using guides and / or forceps. [Figure 21] 1A-1C are simplified posterior perspective views of the heart showing example operations using guides and / or forceps. [Figure 22] 1A-1C are simplified posterior perspective views of the heart showing example operations using guides and / or forceps. [Figure 23]1A-1C are simplified posterior perspective views of the heart showing example operations using guides and / or forceps. [Figure 24] 1A-1C are simplified posterior perspective views of the heart showing example operations using guides and / or forceps. [Figure 25] FIG. 1 is a simplified superior perspective view of a heart showing an example forceps. [Figure 26] FIG. 1 is a schematic posterior view of the left atrium of the heart showing an example box-shaped defect. [Figure 27] FIG. 1 is a schematic posterior view of the left atrium of the heart showing an example pulmonary vein isolation defect. [Figure 28] FIG. 1 is a schematic posterior view of the left atrium of the heart showing an example figure-eight lesion. DETAILED DESCRIPTION OF THE INVENTION
[0037] All figures are in accordance with at least some aspects of the present disclosure.
[0038] Example embodiments according to the present disclosure are described and illustrated below to encompass devices, methods, and techniques related to medical treatment. Of course, it will be apparent to those skilled in the art that the embodiments described below are examples and may be reconfigured without departing from the scope and spirit of the present disclosure. It is also understood that variations of the example embodiments contemplated by those skilled in the art may also comprise part of the present disclosure. However, for clarity and accuracy, the example embodiments as discussed below may include optional steps, methods, and features that those skilled in the art would recognize as not being required to fall within the scope of the present disclosure.
[0039] The present disclosure includes, inter alia, medical instruments and devices and related methods, and more particularly, surgical devices for clamping and ablating tissue and related methods. Some example embodiments according to at least some aspects of the present disclosure may be particularly useful in connection with ablation of cardiac tissue, such as to treat cardiac arrhythmias such as atrial fibrillation, for reasons detailed above in the introduction and in the patent documents incorporated by reference herein.
[0040] 1 is a perspective view of an example surgical device, such as a surgical forceps 100, in accordance with at least some aspects of the present disclosure. In some example embodiments, the surgical forceps 100 may include a handle 200 generally disposed at a proximal end 302 of an elongated shaft 300. An end effector 400 may be disposed at a distal end 304 of the shaft 300. The end effector 400 may include one or more jaws, such as a first jaw 502 and / or a second jaw 504, which may be generally disposed distally at the head 402. The handle 200 may include an actuator, such as a plunger 202, which may be operable to move the first jaw 502 and / or the second jaw 504 relative to the head 402, such as to close (e.g., clamp) on the target tissue 102.
[0041] As used herein, "proximal" may generally refer to a direction toward the end of the handle 200 of the surgical forceps 100. As used herein, "distal" may generally refer to a direction toward the end of the end effector 400 of the surgical forceps 100.
[0042] 2 is a detailed perspective view of an example end effector 400 according to at least some embodiments of the present disclosure. First jaw 502 and second jaw 504 may each include a respective first end portion 506, 508 proximate head 402 and a respective second end portion 510, 512 generally distal from head 402. Each second end portion 510, 512 may terminate at a respective tip 514, 516. In the open position of FIG. 2 , jaws 502, 504 may define an opening 518 between spaced apart tips 514, 516.
[0043] FIG. 3 is a side view of an example end effector 400 with jaws 502, 504 in an open position, FIG. 4 is a side view of an example end effector 400 with jaws 502, 504 in an intermediate position, and FIG. 5 is a side view of an example end effector 400 with jaws 502, 504 in a closed position, all according to at least some aspects of the present disclosure.
[0044] 1-3, in the open position, the first jaw 502 and the second jaw 504 may be separated and substantially non-parallel. With reference to FIG. 4, in the intermediate position, the first jaw 502 and the second jaw 504 may be separated and substantially parallel. With reference to FIG. 5, in the closed position, the first jaw 502 and the second jaw 504 may be substantially adjacent and substantially parallel. As used herein with reference to the jaws 502, 504 in the closed position, "substantially adjacent" may also include a small gap between the jaws 502, 504, such as due to the thickness of the target tissue 102 (FIG. 1) that may be clamped between the jaws 502, 504.
[0045] 3-5, movement of the first jaw 502 from the open position (FIG. 3) to the intermediate position (FIG. 4) may involve a substantial angular change (e.g., pivot or rotation) relative to the head 402, such as about an axis of rotation that is generally perpendicular to the shaft 300. Movement of the first jaw 502 from the intermediate position (FIG. 4) to the closed position (FIG. 5) may involve a substantial translation relative to the head 402, such as while the first jaw 502 and the second jaw 504 remain substantially parallel.
[0046] In some embodiments, the first jaw 502 may be movable relative to the head 402, while the second jaw 504 may be fixed (e.g., remain stationary) relative to the head 402. In some situations, having a single stationary jaw 504 may be advantageous because it may provide the surgeon with a fixed, known point of reference when positioning the forceps 100 ( FIG. 1 ). In other example embodiments, both the first jaw 502 and the second jaw 504 may be movable relative to the head 402. For purposes of clarity and brevity, the description herein focuses on the movement of the first jaw 502 and the associated components that facilitate such movement. However, those skilled in the art will understand that substantially similar components may be used to facilitate the movement of the second jaw 504, thereby providing alternative example embodiments in which both the first jaw 502 and the second jaw 504 may be movable relative to the head 402 between open, intermediate, and closed positions, and such embodiments are within the scope of the present disclosure.
[0047] In some example embodiments, the shaft 300 may be substantially rigid. In other example embodiments, at least a portion of the shaft 300 may be bendable or compliant (e.g., plastically deformable), allowing a user to configure the shaft 300 to accommodate a patient's particular anatomy. In some example embodiments, the shaft may be substantially straight (e.g., linear). In other example embodiments, the shaft 300 may include at least one curved portion. For example, the shaft 300 may be generally C-shaped (e.g., one curve) or S-shaped (e.g., two curves in opposite directions).
[0048] 6 and 7 are perspective cutaway views of an example articulation mechanism 600 (FIGS. 6 and 7 are perspective views of different sides of the same example device), FIG. 8 is an exploded perspective view of an example end effector 400 including the example articulation mechanism 600, and FIGS. 9 and 10 are detailed interior perspective views of example head shell portions 404, 406, all according to at least some aspects of the present disclosure. Generally, the articulation mechanism 600 may be operable to move the first jaw 502 between an open position, an intermediate position, and a closed position through manipulation of the actuator 202 (FIG. 1) by a user. In embodiments including a movable second jaw 504, a similar articulation mechanism may be utilized in association with the second jaw 504.
[0049] 6-10 , an exemplary articulation mechanism 600 may include a first jaw mount 602 that may be coupled to (e.g., rigidly secured to) the first jaw 502. In some example embodiments, the first jaw mount 602 may be integrally formed with at least a portion of the first jaw 502, such as that shown in FIG. 8. In other embodiments, the first jaw 502 may be secured to a separate component that includes the first jaw mount 602.
[0050] In some example embodiments, the first jaw mount 602 can be movable relative to the head 402 along a path 604 ( FIGS. 9 and 10 ), which can cause the first jaw mount 602 and the first jaw 502 to rotate and / or translate between an open position, an intermediate position, and / or a closed position. For example, the first jaw 502 can rotate approximately 45 degrees between the open position and the intermediate position, and / or the first jaw can translate approximately 10 mm between the intermediate position and the closed position. For example, the first jaw mount 602 can include a first pin 606 and / or a second pin 608, which can be slidably and / or rotatably movable along the path 604, which can be defined at least in part by one or more slots. For example, the path 604 may be at least partially defined by a slot 610 in the inner surface of the outer shell portion 404 of the head 402, and / or the path 604 may be at least partially defined by a slot 612 in the inner surface of the outer shell portion 406 of the head 402. While the illustrated embodiment utilizes pins 606, 608 movable within the slots 610, 612 to facilitate movement of the first jaw mount 602 along the path 604, it is within the scope of the present disclosure to utilize other components and / or mechanisms, such as tracks, rollers, sliders, etc., to facilitate movement of the first jaw mount 602 along the path 604.
[0051] 9 and 10 , in some exemplary embodiments, the path 604 (and / or slots 610, 612) may comprise at least one generally straight portion 614 and / or at least one generally curved portion 616. In some embodiments comprising two pins 606, 608 that travel along the path 604 defined by the slots 610, 612, the generally curved portion 616 may be operable to substantially pivot or rotate the first jaw mount 602 (and attached first jaw 502) relative to the head 402. The length, orientation, and / or curvature of the generally curved portion 616 can establish the range of angular rotation of the first jaw mount 602 and / or the amount of translation of the first jaw mount 602 relative to the head 402. Similarly, in some embodiments comprising two pins 606, 608 that move along a path 604 defined by slots 610, 612, the generally straight portion 614 may be operable to translate the first jaw mount 602 (and attached first jaw 502) relative to the head 402 without substantially changing the angle of the first jaw mount 602 relative to the head 402. The length and / or orientation of the generally straight portion 614 can establish the range of translation of the first jaw mount 602 relative to the head 402. It is within the scope of the present disclosure to utilize any combination of generally curved portion 616 and / or generally straight portion 614 to provide the desired path 604 to obtain the desired movement of the first jaw mount 602 (and attached first jaw 502). For example, an alternative path may include a continuous curve that varies in curvature over its length. Or, for example, an alternative path may include two generally straight portions 614 interposed by a curved portion 616 .
[0052] 6-10 , in some example embodiments, the articulation mechanism 600 may include a crank 618 pivotally mounted relative to the head 402. For example, the crank 618 may be pivotally disposed within the head 402, such as by a pivot pin 620 received within the pivot holes 408, 410 of the shell portions 404, 406, respectively. The crank 618 may be operably coupled to the first jaw mount 602 to move the first jaw mount 602 along the path 604. For example, rotation of the crank 618 may move the first jaw mount 602 along the path 604.
[0053] In some example embodiments, the crank 618 may comprise a first arm 622 that may be operably coupled to the actuator linkage 306 and / or a second arm 624 that may be operably coupled to the first jaw mount 602. The actuator 202 ( FIG. 1 ) may be operably coupled to the actuator linkage 306, which may extend generally longitudinally through the shaft 300. Some example embodiments may comprise a connecting linkage 626 that interposes the actuator linkage 306 and the crank 618. The articulation mechanism 600 may be configured such that movement of the actuator 202 (e.g., via the actuator linkage 306 and / or the connecting linkage 626) causes rotation of the crank 618. When the crank 618 rotates, the second arm 624 may move the first jaw mount 602 along the path 604 to move the first jaw 502 between an open position, an intermediate position, and / or a closed position.
[0054] While the crank 618 in the illustrated embodiment includes two generally separately extending arms 622, 624, it is within the scope of this disclosure to utilize cranks with arms that are not substantially separately formed. For example, such a crank may be in the form of a generally approximately 120-degree circular section in which the area between the arms is at least partially continuous. In some exemplary embodiments, connecting the arms 622, 624 together at a location radially away from the axis of rotation can increase the strength of the crank 618, thereby increasing the maximum allowable torque and / or force for a given material and thickness. In some exemplary embodiments, varying the effective length of the arms 622, 624 (e.g., the radial distance between the pivot pin 620 and the first pin 606 and / or between the pivot pin 620 and the pivotable connection 632 (described below)) can facilitate varying the maximum allowable torque and / or force.
[0055] In some example embodiments, the distance between the pivot axis (e.g., pivot pin 620) of the crank 618 and the path 604 (along which the first pin 606 travels) may vary over the length of the path 604. Accordingly, the second arm 624 of the crank 618 may be slidably and / or pivotally coupled to the first jaw mount 602. For example, the second arm 624 of the crank 618 may include a crank slot 628 that can slidably and / or pivotally receive the first pin 606 of the first jaw mount 602 such that the first pin 606 moves along the crank slot 628 as the first jaw mount 602 moves along the path 604. In some example embodiments, the crank slot 628 may be substantially straight and / or may be oriented substantially radially relative to the axis of rotation of the crank 618 (e.g., pivot pin 620).
[0056] In some example embodiments including a connecting linkage 626, a proximal end of the connecting linkage 626 may be coupled to a distal end of the actuator linkage 306 by a pivotable connection 630. The distal end of the connecting linkage 626 may be coupled to the crank first arm 622 by a pivotable connection 632. The pivotable connection 630 between the distal end of the actuator linkage 306 and the proximal end of the connecting linkage 626 may include one or more guides 634, 636 that may be slidable within respective guide slots 638, 640 in the inner surface of the outer shell portions 404, 406 of the head 402. In some example embodiments, the guide slots 638, 640 may be generally linear and / or positioned substantially axially relative to the shaft 300 such that the actuator linkage 306 moves generally proximally and distally in a substantially straight line (e.g., generally in line with the actuator linkage 306).
[0057] 11 is a side view of the interior of an example handle 200 in accordance with at least some embodiments of the present disclosure. Generally, the handle 200 may be constructed and / or operated as described in U.S. Patent Application Publication No. 20000024324, which is incorporated by reference. The handle 200 may include grippers 204, 206, 208. The handle 200 may include a port 210 through which wires 212 or tubes may extend from the interior to the exterior of the handle 200. For example, wires 212 for ablation electrodes or sensors in the jaws 502, 504 may be routed through the shaft 300, into the handle 200, and out through the port 210.
[0058] In some exemplary embodiments, the handle 200 can house the actuator mechanism 214. In this example embodiment, the plunger 202 can be used to articulate one or more of the jaws 502, 504. The plunger 202 can be generally aligned with the shaft 300. With the plunger 202 in a fully retracted or proximal position, the first jaw 502 can be in an open position (FIG. 3). When the plunger 202 is pushed distally, the first jaw 502 can move from the open position (FIG. 3) to an intermediate position (FIG. 4). Further pushing on the plunger 202 can move the first jaw 502 from the intermediate position (FIG. 4) to a closed position (FIG. 5).
[0059] In some exemplary embodiments, the actuator mechanism 214 may include a locking mechanism. For example, the plunger 202 may include a generally longitudinal slot 216 with a wide proximal opening 218. When the jaws 502, 504 are in the closed position, the opening 218 may align with a locking button 220, which may be spring biased to force the locking button 220 into the opening 218, thereby preventing the plunger 202 from moving proximally and maintaining the jaws 502, 504 in the closed position. Pressing the locking button 220 disengages the locking button 220 from the opening 218, thereby releasing the plunger 202 and allowing it to move proximally to open the jaws 502, 504.
[0060] In some example embodiments, the actuator mechanism 214 may be configured to control and / or limit the amount of force that may be applied by the jaws 502, 504 when the plunger 202 is depressed. For example, the actuator mechanism 214 may include a release rod 222 and a force-limiting spring 224. The release rod 222 may be slidable relative to the actuator linkage 306, while the force-limiting spring 224 may be positioned to apply a distal force to the actuator linkage 306. When the plunger 202 is depressed, the force-limiting spring 224 may be compressed between the step 226 in the plunger 202 and the actuator linkage 306. Thus, pressing the actuator 202 applies a load to the force-limiting spring 224, which is transferred to the actuator linkage 306, causing the actuator linkage 306 to move distally. If, while plunger 202 continues to be depressed, the jaw clamp load exceeds a desired maximum, force-limiting spring 224 further compresses and release rod 222 moves distally without moving actuator linkage 306. Thus, force-limiting spring 224 effectively limits the maximum jaw clamp load. Those skilled in the art will recognize that tissue clamping pressure can be a function of the jaw clamp force and the area of tissue being clamped. Actuator mechanism 214 can include a return spring 228 that can be operable to move actuator linkage 306 proximally upon release of actuator 202.
[0061] Figure 12 is a detailed view of an inward-facing (e.g., tissue-clamping) surface of exemplary first jaw 502, Figure 13 is a detailed view of an inward-facing (e.g., tissue-clamping) surface of exemplary second jaw 504, and Figure 14 is a cross-sectional view of exemplary first jaw 502, all according to at least some aspects of the present disclosure. Although Figure 14 shows certain components and dimensions associated with first jaw 502, second jaw 504 may include similar components with similar dimensions unless expressly indicated.
[0062] 2, 8, and 12-14, in some exemplary embodiments, the first jaw 502 may include a substantially rigid jaw beam 520 extending generally from a proximal end portion 506 (e.g., adjacent the first jaw mount 602) to a distal end portion 510 (e.g., adjacent the tip 514). Similarly, the second jaw 504 may include a substantially rigid jaw beam 522 extending generally from a proximal end portion 508 to a distal end portion 512 (e.g., adjacent the tip 516). The jaw beams 520, 522 may be constructed from stainless steel, for example, which may provide desired bending strength and act as a heat sink during some procedures involving ablation. Other biocompatible materials providing suitable mechanical and thermal properties, such as other metals (e.g., aluminum), may be used for alternative jaw beams.
[0063] In some exemplary embodiments, an insulator 524, 526 may be disposed on each respective jaw portion, such as on an inward-facing surface of each respective jaw beam 520, 522. The insulators 524, 526 may be constructed from a non-conductive material, such as molded plastic. Other biocompatible materials that provide suitable insulating and thermal properties may be used for alternative insulators.
[0064] In some example embodiments, the jaws 502, 504, such as those configured for radio frequency (RF) ablation, may include one or more electrodes, which may be disposed on (e.g., at least partially mounted within) the insulators 524, 526. For example, the electrodes may be bonded to or overmolded onto the insulators 524, 526. The first jaw may include one or more elongated, spaced-apart electrodes, i.e., first electrode 528 and / or second electrode 530. Similarly, the second jaw may include one or more elongated, spaced-apart electrodes, i.e., third electrode 532 and / or fourth electrode 534. In some example embodiments, the electrodes 528, 530, 532, 534 may be configured to perform bipolar radio frequency ablation of the target tissue 102 clamped between the jaws 502, 504. Each electrode 528, 530, 532, 534 may have a width 536, which may be the width of a surface facing the tissue in a direction generally perpendicular to the electrode's local elongate direction. In embodiments with two or more electrodes 528, 530, 532, 534 per jaw 502, 504, the electrodes 528, 530, 532, 534 may be spaced apart by an electrode spacing 538. Each electrode 528, 530, 532, 534 may extend beyond the surface of the insulator 524, 526 by a protrusion height 540. Each electrode 528, 530, 532, 534 may be spaced apart from the respective jaw beam 520, 522 by an insulation depth 542. Each electrode 528, 530, 532, 534 may have an electrode height 572.
[0065] In some exemplary embodiments, the electrode width 536 may be between about 0.1 mm and about 2.0 mm. In some exemplary embodiments, the electrode width 536 may be between about 0.2 mm and about 0.4 mm. In the exemplary embodiment shown in Figures 12-14, the electrode width 536 may be about 0.30 mm. In some exemplary embodiments, each electrode 528, 530, 532, 534 may have substantially the same width 536, which may be substantially constant over the length of each electrode 528, 530, 532, 534. In other embodiments, the width 536 may vary over the length of the electrodes 528, 530, 532, 534 and / or may differ between electrodes 528, 530, 532, 534.
[0066] In some exemplary embodiments, the electrode spacing 538 may be between about 0.1 mm and about 3.0 mm. In some exemplary embodiments, the electrode spacing 538 may be between about 0.3 mm and about 0.6 mm. In the exemplary embodiment shown in FIGS. 12-14, the electrode spacing 538 may be about 0.43 mm. In some exemplary embodiments, the electrode spacing 538 may be substantially constant across the length of the plurality of electrodes 528, 530, 532, 534 such that the electrodes 528, 530, 532, 534 are substantially parallel in any localized region. In other embodiments, the electrode spacing 538 may vary across the length of the plurality of electrodes 528, 530, 532, 534 such that the electrodes 528, 530, 532, 534 may be closer together in some regions and / or farther apart in other regions.
[0067] In some exemplary embodiments, the protrusion height 540 may be between about 0.0 mm (e.g., flush) and about 0.5 mm. In some exemplary embodiments, the protrusion height 540 may be between about 0.1 mm and about 0.2 mm. In the exemplary embodiment shown in FIGS. 12-14, the protrusion height 540 may be about 0.15 mm. In some exemplary embodiments, the protrusion height 540 may be substantially constant over the length of a particular electrode 528, 530, 532, 534 and / or may be substantially the same for two or more electrodes 528, 530, 532, 534. In other embodiments, the protrusion height 540 may vary over the length of the electrode 528, 530, 532, 534 and / or may vary between electrodes 528, 530, 532, 534.
[0068] In some exemplary embodiments, the insulation depth 542 may be between about 0.1 mm and about 5.0 mm. In some exemplary embodiments, the insulation depth 542 may be between about 0.8 mm and about 1.6 mm. In the exemplary embodiment shown in Figures 12-14, the insulation depth 542 may be about 1.25 mm. In some exemplary embodiments, the insulation depth 542 may be substantially constant over the length of a particular electrode 528, 530, 532, 534 and / or may be substantially the same for two or more electrodes 528, 530, 532, 534. In other embodiments, the insulation depth 542 may vary over the length of the electrode 528, 530, 532, 534 and / or may vary between electrodes 528, 530, 532, 534.
[0069] In some exemplary embodiments, the electrode height 572 may be between about 0.25 mm and about 3.0 mm. In some exemplary embodiments, the electrode height 572 may be between about 0.3 mm and about 0.7 mm. In the exemplary embodiment shown in Figures 12-14, the electrode height 572 may be about 0.5 mm. In some exemplary embodiments, the electrode height 572 may be substantially constant over the length of a particular electrode 528, 530, 532, 534 and / or may be substantially the same for two or more electrodes 528, 530, 532, 534. In other embodiments, the electrode height 572 may vary over the length of the electrode 528, 530, 532, 534 and / or may vary between electrodes 528, 530, 532, 534.
[0070] In some exemplary embodiments, the electrodes 528, 530, 532, 534 may extend substantially the entire length of the jaws 502, 504 between the head 402 and the tips 514, 516. In the exemplary embodiment shown in Figures 2, 12, and 13, the electrodes 528, 530, 532, 534 may be approximately 105 mm in length. In an alternative example embodiment with shorter jaws, the electrodes 528, 530, 532, 534 may be approximately 86 mm in length.
[0071] U.S. Patent Application Publication No. 2018 / 0122999, entitled “Ablation System, Clamp and Method of Use,” issued March 27, 2018, and incorporated by reference, describes various devices and methods for tissue ablation using radio frequency energy, some of which may be used in connection with certain exemplary embodiments according to at least some aspects of the present disclosure. In general, decreasing the electrode spacing 538 can result in a smaller lesion and / or faster ablation. In general, increasing the insulation depth 542 can result in a smaller lesion, faster ablation, and / or less energy per unit volume.
[0072] In some exemplary embodiments according to at least some aspects of the present disclosure, the jaws 502, 504 of the forceps 100 may be configured to facilitate positioning adjacent to a particular target tissue 102 and engaging the target tissue 102 in a desired manner. For example, the shape of the jaws 502 between the first end portions 506, 508 near the head 402 and the tips 514, 516 may be selected based on the target tissue 102 and / or the location of the target tissue 102 in relation to other anatomical structures. As described in detail below, some examples of the forceps 100 may be used to create a lesion around a pulmonary vein located generally in the posterior portion of the heart. If the heart is accessed via a median sternotomy, creating a lesion around the pulmonary vein may require positioning the forceps 100 at least in part around the posterior aspect of the heart while engaging the left atrium and avoiding nearby structures that will not be resected.
[0073] 12 and 13 , in some exemplary embodiments, the jaws 502, 504 may be formed from one or more substantially straight (e.g., generally linear) portions 544, 546, 548, 550, 552, 554, which may be interposed by one or more generally curved or bent portions 556, 558, 560, 562. For example, in the first jaw 502, the first substantially straight portion 544 may extend from the first end portion 506 to the first curved portion 556. The second substantially straight portion 546 may extend from the first curved portion 556 to the second curved portion 558. The third substantially straight portion 548 may extend from the second curved portion 558 to the second end portion 510. In some example embodiments, each of the substantially straight portions 544, 546, 548 can be oriented obliquely (e.g., non-parallel and non-perpendicular) relative to each of the other substantially straight portions 544, 546, 548. For example, the angle 564 between the first substantially straight portion 544 and the second substantially straight portion 546 can be from about 110 degrees to about 150 degrees, and / or the angle 566 between the second substantially straight portion 546 and the third substantially straight portion 548 can be from about 110 degrees to about 150 degrees. In the example embodiment shown in FIG. 12 , the portion 544 can have a length of about 2.9 cm, the portion 546 can have a length of about 5.0 cm, the portion 548 can have a length of about 2.8 cm, the angle 564 can be about 128 degrees, and / or the angle 566 can be about 133 degrees.
[0074] Similarly, in the second jaw 504, a first substantially straight portion 550 can extend from the first end portion 508 to the first curved portion 560. A second substantially straight portion 552 can extend from the first curved portion 560 to the second curved portion 562. A third substantially straight portion 554 can extend from the second curved portion 562 to the second end portion 512. In some example embodiments, each of the substantially straight portions 550, 552, 554 can be oriented obliquely (e.g., non-parallel and non-perpendicular) relative to each of the other substantially straight portions 550, 552, 554. For example, angle 568 between first substantially straight portion 550 and second substantially straight portion 552 can be from about 110 degrees to about 150 degrees, and / or angle 570 between second substantially straight portion 552 and third substantially straight portion 554 can be from about 110 degrees to about 150 degrees. In the exemplary embodiment shown in FIG. 13 , portion 550 can have a length of about 2.9 cm, portion 552 can have a length of about 5.0 cm, portion 554 can have a length of about 2.8 cm, angle 568 can be about 128 degrees, and / or angle 570 can be about 133 degrees.
[0075] In alternative exemplary embodiments with shorter jaws, portion 544 can have a length less than about 2.9 cm, portion 546 can have a length less than about 5.0 cm, portion 548 can have a length less than about 2.8 cm, angle 564 can be about 128 degrees, and / or angle 566 can be about 133 degrees. Similarly, portion 550 can have a length less than about 2.9 cm, portion 552 can have a length less than about 5.0 cm, portion 554 can have a length less than about 2.8 cm, angle 568 can be about 128 degrees, and / or angle 570 can be about 133 degrees.
[0076] In some exemplary embodiments, the first jaw 502 and the second jaw 504 may be shaped generally as mirror images of each other, which may facilitate clamping the target tissue 102 between the jaws 502, 504 over any portion of the length of the jaws 502, 504. In other embodiments, the first jaw 502 and the second jaw 504 may have different dimensions.
[0077] 3-5, 12, and 13, in some exemplary embodiments, each substantially straight portion 544, 546, 548 associated with a first jaw 502 may be substantially coplanar (e.g., may lie in substantially the same plane). Similarly, each substantially straight portion 550, 552, 554 associated with a second jaw 504 may be substantially coplanar. In other example embodiments, at least one of the substantially straight portions 544, 546, 548, 550, 552, 554 associated with a particular jaw 502, 504 may not be substantially coplanar with another substantially straight portion 544, 546, 548, 550, 552, 554 associated with that particular jaw 502, 504.
[0078] In some exemplary embodiments, the first and third substantially straight portions 544, 548, 550, 554 of each jaw 502, 504 can facilitate positioning of the forceps 100 at a desired location in a patient's anatomy. For example, the first and third substantially straight portions 544, 548, 550, 554 of each jaw 502, 504 can facilitate positioning of the forceps 100 on the posterior side of the heart (e.g., the left atrium) because they can point somewhat forward. Compared to fully curved jaws, the more positive forward orientation of the first and third substantially straight portions 544, 548, 550, 554 can improve positioning of the forceps 100 around the heart from an anterior surgical access location (e.g., a median sternotomy).
[0079] In some example embodiments, the second substantially straight portion 546, 552 of each jaw 502, 504 can facilitate the desired engagement of the forceps 100 with the target tissue. For example, the second substantially straight portion 546, 552 of each jaw 502, 504 can facilitate engagement of the forceps 100 with the left atrium (e.g., generally around the pulmonary veins). Compared to some fully curved jaws, the second substantially straight portion 546, 552 can generally engage the left atrium in a straight line between the right and left pulmonary veins, which can facilitate positioning a generally anterior clamp (and resection) location in the left atrium and / or forming an effective transmural lesion. Additionally, the second substantially straight portion 546, 552 can be less likely to slip off the posterior aspect of the left atrium compared to some fully curved jaws.
[0080] 1-5, 12, and 13, in some exemplary embodiments, the jaws 502, 504 may be disposed generally distally on the head 402 and / or may be oriented generally laterally from the head 402 (e.g., generally from the first end portions 506, 508 to the second end portions 510, 512). For example, the second substantially straight portion 546, 552 of each jaw 502, 504 may be oriented approximately perpendicular to the shaft 300. In the exemplary embodiment shown in FIGS. 1-5, 12, and 13, in the closed position, the second substantially straight portion 546, 552 may be oriented at an angle of approximately 98 degrees relative to the shaft 300. In an alternative example embodiment comprising shorter jaws, in the closed position, the second substantially straight portion 546, 552 may be oriented at an angle of approximately 98 degrees relative to the shaft 300. In some other embodiments, in the closed position, the second substantially straight portions 546, 552 may be oriented at an angle between about 45 degrees and about 135 degrees relative to the shaft 300. In other exemplary embodiments, the jaws 502, 504 may be oriented at other angles relative to the shaft 300, such as generally in line with the shaft 300 (e.g., extending generally directly distally).
[0081] Figure 15 is a perspective view of an exemplary guide 700, Figure 16 is a perspective view of the example guide 700 attached to the tips 514, 516 of the jaws 502, 504 of the forceps 100, and Figure 17 is a detailed exploded perspective view of an exemplary guide connector 708, all according to at least some aspects of the present disclosure. Although Figure 17 illustrates certain components associated with the guide connector 708 associated with the first end portion 704 of the guide 700, the guide connector 710 associated with the second end portion 706 may include similar components unless expressly indicated.
[0082] 15-17 , in some exemplary embodiments, the guide portion 700 may comprise an elongated, flexible guide body 702 extending between a first end portion 704 and a second end portion 706. In some exemplary embodiments, the guide body 702 may be generally tubular. In some exemplary embodiments, the guide body 702 may have a diameter of about 2.0 mm to about 10.0 mm. In some exemplary embodiments, the guide body 702 may have a length of about 30 cm to about 180 cm. In the embodiment shown in FIGS. 15-17 , the guide body 702 may have a diameter of about 5 mm and / or a length of about 80 cm. The guide body 702 may be constructed from a thermoplastic elastomeric polymer, such as a thermoplastic vulcanizate (TPV) (e.g., Santoprene®). Other potentially suitable materials for the guide body 702 include biocompatible materials with suitable strength, flexibility, and kink resistance.
[0083] In some exemplary embodiments, one or more of the end portions 704, 706 may have a respective guide connector 708, 710 disposed thereon. In some exemplary embodiments, the guide connectors 708, 710 may be configured to releasably couple to one another, thereby forming the guide 700 into a closed loop. In some exemplary embodiments, the guide connectors 708, 710 may be configured to releasably couple to the tips 514, 516 of the jaws 502, 504 of the forceps 100 (see FIG. 16 ).
[0084] 17 , an exemplary guiding connector 708 may include a permanent magnet 712 that may be housed between a coupler 714 and a cover 716. For example, the cover 716 may be in the form of a hollow cylinder having a generally closed distal end and sized to receive the magnet 712. A proximal face 718 of the cover 716 may be permanently attached, such as by welding, to a distal face 720 of the coupler 714, thereby securely housing the magnet 712 within the cover 716. A proximal end portion 722 of the coupler 714 may be permanently secured within a cavity 724 in the first end portion 704 of the guiding body 702.
[0085] In some example guides 700 utilizing magnets 712 in the guiding connectors 708, 710, the magnets may be oriented so that the guiding connectors 708, 710 magnetically couple to one another, causing the guide 700 to form a complete closed loop. For example, the magnet 712 in the guiding connector 708 in the first end portion 704 may be oriented with its north pole facing distally (e.g., facing away from the guiding body 702). The magnet 712 in the guiding connector 710 in the second end portion 706 may be oriented with its south pole facing distally (e.g., facing away from the guiding body 702). Thus, the distal-most ends of the magnets 712 will attract rather than repel each other.
[0086] In some embodiments, the guiding connectors 708, 710 may be configured to magnetically releasably couple to the tips 514, 516 of the jaws 502, 504 of the forceps 100. For example, at least a portion of the jaws 502, 504 may be constructed from a ferromagnetic material that is attracted by the magnet 712 in the guiding connectors 708, 710. In some embodiments, the guiding connectors 708, 710 may be configured to mechanically releasably couple to the tips 514, 516 of the jaws 502, 504 of the forceps 100 via frictional engagement, latching, snap-fit structures, or the like. Additionally, some embodiments may utilize both mechanical and magnetic coupling. For example, with reference to FIGS. 8 and 15-17, the tips 514, 516 may include open-ended hollow portions that may receive at least a portion of the covers 716 of the guiding connectors 708, 710. The tips 514, 516 can mechanically prevent lateral movement of the guide connectors 708, 710, and the guide connectors can be magnetically held within the tips 514, 516 by attraction to the metal of the jaw beams 520, 522.
[0087] 18-24 are simplified posterior perspective views of a heart 800 illustrating exemplary operations using a guide 700 and / or forceps 100, all in accordance with at least some embodiments of the present disclosure. While the following description focuses, by way of example only, on the use of the guide 700 to assist in positioning the forceps 100 to form a "box lesion" around all four pulmonary veins in a single clamp-and-clip operation, those skilled in the art will recognize that the various steps and methods in the following description may be utilized in conjunction with the guide 700 and / or forceps 100 for other clamping and / or resection operations.
[0088] 18 , in an exemplary method, a first end portion 704 of a guide 700 may be routed posteriorly to a heart 800, such as through an oblique sinus 802 generally between an inferior vena cava 804 and a right pulmonary vein 806. This may include dissecting through a reflection of the pericardium between the right pulmonary vein 806 and the inferior vena cava 804.
[0089] 19 , in an exemplary method, the second end portion 706 of the guide 700 may be routed posteriorly of the heart 800, such as partway through the transverse sinus 808 between the right pulmonary vein 806 and the superior vena cava 810. This may include dissecting through a reflection of the pericardium between the right pulmonary vein 806 and the superior vena cava 810. The second end portion 706 may then be routed generally anteriorly between the superior vena cava 810 and the aorta 812.
[0090] Referring to FIG. 20, in an exemplary method, the second end portion 706 of the guide 700 can be routed through the remaining portion of the transverse sinus 808 generally between the aorta 812 and the left pulmonary vein 814.
[0091] 21 , in an exemplary method, the first end portion 704 and the second end portion 706 can be releasably joined such that the guide 700 generally forms a complete loop around the pulmonary veins 806, 814. For example, the guide connectors 708, 710 ( FIGS. 15 and 17 ) can be releasably coupled (e.g., magnetically) to one another.
[0092] Referring to FIG. 22, in an exemplary method, guide 700 (e.g., as a complete loop) can be pulled and / or rotated generally toward the patient's right such that guide 700 extends from posterior to anterior toward heart 800, with releasably coupled end portions 704, 706 generally to the patient's right.
[0093] 23 , in an exemplary method, releasably coupled end portions 704, 706 of guide 700 can be disconnected from one another. First end portion 704 of guide can be releasably connected to tip 514 of first jaw 502 of forceps 100. Second end portion 706 of guide 700 can be releasably connected to tip 516 of second jaw 504 of forceps 100.
[0094] 24 , in an exemplary method, the guide 700 is pulled generally toward the patient's left, which can pull the jaws 502, 504 of the forceps 100 into a position near the pulmonary veins 806, 814 and / or the left atrium 816. The forceps 100 can be inserted generally from the anterior right side of the patient's heart 800. The handle 200 can be positioned generally anteriorly, while the shaft 300 can extend generally posteriorly along the right side of the heart 800. The head 402 can be positioned generally to the right of the right pulmonary vein 806, in a right-posterior aspect of the heart 800. The tips 514, 516 of the jaws 502, 504 can be generally to the left of the left pulmonary vein 814. The first jaw 502 may extend generally from right to left, generally anterior and superior to the pulmonary veins 806, 814, and posterior to the superior vena cava 810 and the aorta 812 (e.g., generally through the transverse sinus 808). The second jaw 504 may extend generally from right to left, generally anterior and inferior to the pulmonary veins 806, 814, and superior to the inferior vena cava 804 (e.g., generally through the oblique sinus 802).
[0095] 25 is a simplified superior perspective view of a heart 800 illustrating an exemplary forceps 100 according to at least some embodiments of the present disclosure. The forceps 100 can be positioned such that the left atrium 816 ( FIG. 24 ) is clamped between the jaws 502, 504 without the jaws engaging the right atrium. The tips 514, 516 of the jaws 502, 504 can be positioned generally anterior to the left pulmonary vein 814. The jaws 502, 504 can be generally posterior to the left atrial appendage 818.
[0096] Figure 26 is a schematic posterior view of the left atrium 816 of heart 800 showing an example box-shaped lesion 820, Figure 27 is a schematic posterior view of the left atrium 816 of heart 800 showing example pulmonary vein isolation lesions 822, 824, and Figure 28 is a schematic posterior view of the left atrium 816 of heart 800 showing an example figure-of-eight shaped lesion 826 (e.g., comprising overlapping lesions 828, 830), all according to at least some aspects of the present disclosure. Generally, the procedures described above with respect to Figures 18-25 can be used to create the box-shaped lesion 820 of Figure 26, such as in a single clamping and ablation step. Alternatively, similar procedures may be used to create the pulmonary vein isolation lesions 822, 824 of Figure 27 and / or the figure-of-eight shaped lesion 826 of Figure 28. Generally, these alternative procedures may include two or more clamping and resection steps, such as one approach from the left and one approach from the right, where only a portion of the left atrium 816 is clamped and resected at a time. In some such procedures, the forceps 100 may extend partially posteriorly around the heart such that the tips 514, 516 of the jaws 502, 504 are positioned between the left pulmonary vein 814 and the right pulmonary vein 806.
[0097] Some exemplary devices according to at least some aspects of the present disclosure may incorporate tip bias to account for the effect of tissue on the angular relationship between the jaws. For example, closing the jaws of an example forceps on tissue may cause bending stresses to bend the jaws apart. Thus, the angular position of the jaws when closed on tissue may differ from the angular position of the jaws when closed in an empty space. Some exemplary embodiments may account for such differences, for example, by constructing the end effector so that the jaws are slightly non-parallel in the empty closed position. For example, the tips of the jaws may be biased inward by about 0.020 inches from parallel in the empty closed position, which may result in the jaws being substantially parallel in the closed position when tissue is present between them. More generally, in some example embodiments, the end effector and jaws may be designed so that the jaws are substantially parallel when actuated on tissue.
[0098] Following the above description and summary of the invention, it should be apparent to those skilled in the art that, while the methods and apparatus described herein constitute example embodiments according to the present disclosure, it is understood that the scope of the disclosure contained herein is not limited to the detailed embodiments described above, and that modifications may be made without departing from the scope as defined by the following claims. Likewise, it is understood that it is not necessary to meet any or all of the particular advantages or objects disclosed herein to fall within the scope of a claim, and / or that unforeseen advantages may exist even though they may not be explicitly recited herein. [Explanation of symbols]
[0099] 100 surgical forceps 102 Target tissue 200 handle 202 Plunger, actuator 204, 206, 208 Gripping part Port 210 212 Wire 214 Actuator Mechanism 216 Slots 218 Proximal Opening 220 Locking button 222 Liberation Rod 224 Force limiting spring 226 Step 228 Return spring 300 shaft 302 proximal end 304 Distal end 306 Actuator Link Mechanism 400 End Effector 402 Head 404, 406 outer shell 408, 410 pivot hole 502 First Jaw 504 Second Jaw 506, 508 First end portion, proximal end portion 510, 512 second end portion, distal end portion 514, 516 Tip 518 Opening 520, 522 Chin beam 524, 526 Insulators 528 First Electrode 530 Second electrode 532 Third Electrode 534 Fourth Electrode 536 Electrode width 538 Electrode Spacing 540 protruding height 542 Insulation Depth 544, 550 first substantially straight portion 546, 552 second substantially straight portion 548, 554 Third substantially straight section 556, 560 First curved portion 558, 562 Second curved section 564, 566, 568, 570 angle 572 Electrode height 600 Joint Mechanism 602 First jaw attachment 604 Routes 606 First Pin 608 Second Pin 610, 612 slots 614 Straight part 616 Curved Part 618 Crank 620 Pivot pin 622 First Arm 624 Second Arm 626 Connecting link mechanism 628 crank slot 630 Pivotable connection 632 Connection 634, 636 Information Department 638, 640 Guide slot 700 Information Department 702 Guide body 704 first end portion 706 Second end portion 708, 710 Guidance connector 712 Permanent Magnets 714 Coupler 716 Cover 720 distal surface 722 Proximal end portion 724 Cavity 802 Oblique Cave 804 Inferior vena cava 806 Right pulmonary vein 808 Yokodo 810 Superior vena cava 812 aorta 814 Left pulmonary vein 816 Left atrium 818 Left atrial appendage 820 Box-shaped obstacle 822, 824 Pulmonary vein isolation disorder 826 Figure-eight obstacle
Claims
1. a distal handle comprising an actuator; a shaft extending distally from the distal handle, the shaft having an actuator linkage extending therethrough, the actuator linkage operably coupled to the actuator; an end effector disposed at a distal end of the shaft; Equipped with The end effector head, a first jaw disposed distally on the head; a second jaw disposed distally on the head; and Joint mechanism, Equipped with The joint mechanism includes: a connecting linkage having a proximal end and a distal end, the proximal end of the connecting linkage pivotally coupled to the distal end of the actuator linkage; a pivotally mounted crank having a first arm and a second arm, the first arm pivotally coupled to the distal end of the connecting linkage; and a first jaw mount fixedly secured to the first jaw, the first jaw mount pivotally and slidably coupled to the second arm of the crank; Equipped with a surgical device, wherein movement of the actuator in the handle is operable to distally move the actuator linkage and move the first jaw from an open position in which the first jaw and the second jaw are separated and substantially non-parallel to a closed position in which the first jaw and the second jaw are substantially adjacent and substantially parallel.
2. 2. The surgical device of claim 1, wherein the first jaw mount is movable along a path, and wherein movement of the first jaw mount along the path causes rotation and translation of the first jaw mount and the first jaw, thereby moving the first jaw from the open position to the closed position.
3. The surgical device of claim 1 , wherein rotation of the crank moves the first jaw mount along a path.
4. The surgical device of claim 1 , wherein the first jaw and the second jaw extend generally transversely to the shaft.
5. 2. The surgical device of claim 1, wherein movement of the actuator on the handle is operable to move the first jaw between the open position, an intermediate position in which the first jaw and the second jaw are separated and substantially parallel, and the closed position.
6. the second arm of the crank includes a crank slot and the first jaw mount includes a pin; The surgical device of claim 1 , wherein the pin moves along the crank slot as the crank rotates.
7. the proximal end of the connecting linkage includes a guide portion slidably disposed within a guide slot; The surgical device of claim 1 , wherein the guide slot is generally linear and oriented generally in line with the actuator linkage.
8. The surgical device of claim 1 , wherein the actuator comprises a plunger that is pushed distally to move the first jaw from the open position to the closed position.
9. The surgical device of claim 1 , wherein the shaft is substantially rigid.
10. The surgical device of claim 1 , wherein at least a portion of the shaft is bendable.
11. The surgical device of claim 1 , wherein the shaft is substantially straight.
12. each of the first jaw and the second jaw terminates in a respective tip; The surgical device of claim 1 , wherein in the open position, the tip of the first jaw and the tip of the second jaw are spaced apart to at least partially define an opening.
13. The surgical device of claim 12, wherein the tip of the first jaw and the tip of the second jaw are configured to releasably couple to respective end portions of an elongate flexible guide.
14. The surgical device of claim 1 , wherein the first jaw and the second jaw each include a plurality of substantially straight portions interspersed with curved portions.
15. 10. The surgical device of claim 1, wherein the first jaw and the second jaw each include at least one electrode operably coupled to a source of radio frequency energy for ablating tissue clamped between the first jaw and the second jaw.
16. Further comprising a guide portion, the guide portion comprising: an elongated flexible guide body having a first end portion and a second end portion; a first guiding connector disposed in the first end portion; a second guiding connector disposed in the second end portion; and Equipped with the first guiding connector is selectively releasably connectable to the second guiding connector and to at least one of the first tip of the first jaw and the second tip of the second jaw; the second guiding connector is selectively releasably connectable to the first guiding connector and to at least one of the first tip and the second tip; The surgical device of claim 1 , wherein the guide portion forms a closed loop when the first guiding connector is connected to the second guiding connector.
17. the first guiding connector comprises a first permanent magnet; the second guiding connector comprises a second permanent magnet; 17. The surgical device of claim 16, wherein the first and second permanent magnets are oriented with opposite magnetic poles facing away from the guide body, thereby magnetically coupling the first and second guiding connectors to one another and forming the guide into the closed loop.
18. the first guiding connector includes a cover configured to receive the first permanent magnet; The surgical device of claim 17, wherein the first permanent magnet is securely housed within the cover of the first guiding connector.
19. the second guiding connector includes a cover configured to receive the second permanent magnet; The surgical device of claim 18, wherein the second permanent magnet is securely housed within the cover of the second guiding connector.
20. The surgical device of claim 16 , wherein the guide body is generally tubular.
Citation Information
Patent Citations
JP1979147088U
Surgical holding device
JP2012501736A
Surgical clamp possessing a combined parallel and scissor style clamp head
US20050165429A1
Ablation device and system for guiding ablation device into body
US20070208336A1
Surgical clamp
US20100185232A1