ELECTROSURGICAL DEVICE
Patent Information
- Application Number
- DE102017100406
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2016-01-12
- Filing Date
- 2017-01-11
- Publication Date
- 2025-08-21
- Estimated Expiration
- 2037-01-11
Smart Images

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Abstract
Description
Field of the invention
[0001] Embodiments of the present invention described herein relate to an electrosurgical device, and more particularly to electrosurgical forceps wherein a mechanical blade provides a tissue cutting function in combination with electrosurgical electrodes that provide a tissue coagulating or sealing action. Background of the invention and prior art
[0002] Electrosurgical instruments offer advantages over conventional surgical instruments because they can be used for coagulation and sealing of tissue. One such prior art arrangement is known from US 2015 / 0 223 870 A1, which describes an endoscopic bipolar forceps comprising a housing and a shaft, the shaft having an electrosurgical end effector at its distal end, which comprises two jaw members for grasping tissue between them. Each jaw member is adapted to be connected to an electrosurgical energy source, thereby enabling the sealing of tissue held between the jaw members. A drive arrangement is housed in the housing to move the jaw members.A movable handle is also provided, so that movement of the handle actuates the control assembly to move the jaw members relative to each other. A knife channel is part of the end effector to allow forward and backward movement of a blade within the knife channel, in turn enabling tissue cutting.
[0003] Further prior art arrangements include the following: US 5 776 130 A, US 8 114 118 B2, US 6 599 295 B1, US 5 730 740 A, US 5 104 397 A, US 4 800 880 A, WO 98 / 14 124 A1, US 2012 / 0 109 186 A1, US 5 352 235 A, WO 2014 / 074 807 A1, US 7 846 161 B2, WO 2008 / 024 911 A2, US 5 776 130 A, US 6 039 733 A, US 6 179 834 B1, US 7 131 971 B2, US 7 766 910 B2, EP 2 628 459 A2, US 2014 / 0 221 999 A1, US 7 083 618 B2, US 2009 / 0 248 020 A1, US 2015 / 0 209 103 A1, US 5 797 938 A and US 7,101,373 B2. Brief description of the invention
[0004] Embodiments of the present invention provide an improved surgical instrument comprising an end effector attached to the end of an elongated shaft extending from a handle. The end effector is capable of performing various functions, including grasping, cutting, sealing, and / or coagulating tissue, and one of the operations is controlled by a clamp-handle mechanism as described herein. The clamp-handle mechanism includes an actuator, a drive shaft, and a spring assembly for transmitting movement from the actuator to the drive shaft, which in turn controls the end effector. The clamp-handle mechanism is arranged to limit the amount of force transmitted from the clamp-handle mechanism to the end effector, thus preventing damage to the tissue being operated on.Specifically, when the actuator is operated by the user, the spring assembly is arranged to transmit the movement of the actuator to the drive shaft and the end effector. At the same time, the spring assembly is arranged to compress to absorb some of the force exerted by the user, particularly in the event that tissue is clamped between the end effector. In this way, such a design prevents the end effector from inadvertently damaging the tissue by applying excessive clamping force.
[0005] According to one aspect, a surgical instrument is provided comprising a handle, an elongated shaft extending from the handle, an end effector disposed at the distal end of the elongated shaft, a drive shaft within the elongated shaft, the drive shaft being connected to the end effector at its distal end and slidably extending through a component within the handle at its proximal end, and a clamping handle mechanism disposed on the handle and movable between a first position and a second position, wherein moving the clamping handle mechanism from its first position to its second position causes longitudinal movement of the component, which in turn causes the end effector to change from a first state to a second state, the component having a collar through which the drive shaft extends,wherein the collar includes a chamber therein, the chamber having side walls, the instrument further comprising a spring received within the chamber, the spring surrounding the drive shaft and being disposed between the drive shaft and the side walls of the chamber.
[0006] The spring acts to limit the force transmitted from the clamping handle mechanism to the end effector. This is particularly important when, for example, the end effector is formed by a pair of clamping jaws arranged to move between an open and closed position in order to clamp intermediate tissue. Therefore, when tissue is clamped between the clamping jaws, it is important to limit the force exerted by the clamping handle, as this can lead to tissue damage. By enclosing the spring within a chamber, a longer spring can be used to ensure that the spring never reaches its block length during use, in which case the spring would no longer act to limit the force exerted by the clamping jaws and the tissue would again be at risk of damage.
[0007] In one embodiment, the chamber extends through at least 25% of the longitudinal dimension of the collar. In another arrangement, the chamber extends through at least 50% of the longitudinal dimension of the collar. Alternatively, the chamber extends through at least 75% of the longitudinal dimension of the collar.
[0008] The spring can be dimensioned to fit tightly over the drive shaft. The chamber can then be dimensioned so that the spring also has a tight fit with respect to the chamber's side walls. Where the chamber is cylindrical, the side walls can also have a circular cross-section.
[0009] Part of the clamping handle mechanism may also be arranged around the outside of the collar.
[0010] The instrument may comprise a second component, wherein one end of the spring is disposed within the collar and the opposite end of the spring contacts the second component. The second component may have a second collar, the second collar also comprising a chamber, wherein the opposite end of the spring may be disposed within the chamber of the second collar.
[0011] According to a second aspect, there is provided an actuating mechanism for a surgical instrument as described herein, the actuating mechanism comprising: a drive shaft connected at its distal end to an end effector, wherein longitudinal movement of the drive shaft causes a change in the state of the end effector; and an actuating assembly connected to the proximal end of the drive shaft such that movement of the actuating assembly causes longitudinal movement of the drive shaft, the actuating assembly comprising: a user-operable clamping handle movable from a first position to a second position; a first component having a first chamber, the first chamber being longitudinally movable as the clamping handle is movable from a first position to a second position;a second component having a second chamber, the second component being attached to the drive shaft for movement therewith; and a force-absorbing element having a distal end received within the first chamber and a proximal end received within the second chamber, the force-absorbing element being compressible between the first and second components.
[0012] As described above, such an arrangement acts to limit the force transmitted to the end effector, thereby preventing tissue damage. By enclosing the force-absorbing element within the first and second components, a longer force-absorbing element can be used to ensure that the force-absorbing element never reaches its block length during use, in which case the force-absorbing element would no longer function to limit the force exerted by the jaws, and the tissue would again be at risk of damage. The force-absorbing element can be a spring, for example, a spirally wound spring.
[0013] To ensure the above, in one embodiment, the first chamber and the second chamber are of corresponding length, selected such that the force absorption element does not compress to its block length in any position when the trigger is actuated between the first position and the second position. This ensures that excessive force cannot be applied. To achieve this, in some embodiments, the first chamber comprises at least 25%, and more preferably at least 50%, and even more preferably at least 75%, of the axial length of the first component. Additionally, in some embodiments, the second chamber comprises at least 25%, and more preferably at least 50%, of the axial length of the second component. By providing space for the force absorption element in both chambers, a longer force absorption element can be used than would otherwise be the case.
[0014] In other arrangements, it may be possible to provide only the first chamber in the first component (without a second chamber in the second component), or the second chamber in the second component (without the first chamber in the first component), rather than both chambers simultaneously. While this would reduce the available space for the force absorption element and thus be less preferred, it may still provide some of the described advantages, depending on the length of the chambers provided.
[0015] In one embodiment, the clamping handle is pivotally mounted so that it is pivotally movable from its first position to its second position, the first component having a collar, and the clamping handle having a yoke portion. The arrangement is then such that the yoke portion of the clamping handle abuts the collar of the first component, with pivotal movement of the yoke on the clamping handle causing axial movement of the first component in the longitudinal direction. Such a design provides a reliable and easy-to-assemble assembly.
[0016] Where the force-absorbing element is a spring, the drive shaft may extend from the first component within the interior of the spring. In particular, the spring may be dimensioned to fit tightly over the drive shaft, and further, the first and second chambers may be dimensioned such that the spring has a tight fit with respect to the side walls of the chambers. Such arrangements help maintain the structural integrity of the first component, and the tight fit achieved minimizes unwanted rotation of parts and maximizes the axial movement of the mechanism.
[0017] In one embodiment, the drive shaft is connected to the second component using a snap-in arrangement. This provides convenience during assembly. Specifically, the first component and the spring can be first threaded onto the drive shaft in that order, and then the second component can be connected to the end of the drive shaft by snapping it into place to hold the other components in place.
[0018] In embodiments, the force-absorbing element is compressible between the first and second components to limit the longitudinal movement of the drive shaft. Limiting the longitudinal movement of the drive shaft limits the force the end effector can exert on tissue captured therebetween and prevents excessive force from being exerted.
[0019] Specifically, in some embodiments, the arrangement is such that when tissue is grasped by the end effector during use, the force exerted on the end effector by the drive shaft is limited by a compressive force of the force-absorbing element. In such cases, when a user attempts to exert an operating force on the trigger that is greater than a desired force, the compressive force of the force-absorbing element is exceeded, the force-absorbing element compresses to absorb the force, and the force is not transferred from the drive shaft to the end effector, thereby preventing excessive gripping force from being exerted on the tissue.
[0020] According to a further aspect, a surgical instrument is provided which comprises a handle and an end effector, wherein the handle comprises an actuating mechanism according to the second aspect described above for moving the end effector between a first state and a second state.
[0021] Finally, according to a further aspect, a surgical instrument is also provided, which comprises a handle, an elongated shaft extending from the handle, an end effector arranged at the distal end of the elongated shaft, a drive shaft within the elongated shaft, the drive shaft being connected to the end effector at its distal end, and an actuation mechanism having a user-operable control operatively connected to the drive shaft via a force-absorbing element, the arrangement of the actuation mechanism being such that when tissue is engaged by the end effector, the force exerted by the drive shaft on the end effector is limited by the force-absorbing element, wherein when a user attempts to exert an operating force on the user-operable control that is greater than a desired force,a compression force of the force-absorbing element is overcome, the force-absorbing element compresses to absorb the force, and the force is not transferred from the drive shaft to the end effector. As outlined above, such functionality prevents excessive force from being exerted on the tissue. In such embodiments, the force-absorbing element is a spring. Within the above outlined, the actuation mechanism may comprise a first component attached to the end of the drive shaft and a second component slidably mounted on the drive shaft and arranged to move in response to the control to be actuated by the user, the first and second components having respective oppositely facing cavities within which the force-absorbing element is mounted.to be compressed during use. The provision of the cavities allows the use of a longer force-absorbing element, such as a spring, than would otherwise be the case, so that a compression point at which the force-absorbing element cannot further compress to absorb excessive user force is not reached.
[0022] In other embodiments, another force absorption element, such as a pneumatic or hydraulic cylinder, or a compressible elastomeric material, may be used instead of the spring. Brief description of the drawings
[0023] Embodiments of the invention will now be further described by way of example only and with reference to the accompanying drawings, in which like reference numerals refer to like parts and in which: Fig. 1 is a side view of an electrosurgical instrument according to an embodiment of the present invention; Fig. 2 is a side view of a handle of the electrosurgical instrument according to the embodiment of the present invention; Fig. 3 is an exploded view of an electrosurgical instrument according to the embodiment of the present invention; Fig. 4 a cross-sectional view of the clamping mechanism of the electrosurgical instrument from Fig. 3 in open arrangement; Fig. 5a a cross-sectional view of the clamping mechanism of the electrosurgical instrument of Fig. 3 in closed arrangement; Fig. 5b a cross-sectional view of the clamping mechanism of the electrosurgical instrument of Fig. 3 in a closed arrangement with tissue clamped therein; Fig. 6 a cross-sectional view of a part of the clamping mechanism of the electrosurgical instrument of Fig. 3 shows; Fig. 7 a perspective view of the clamping mechanism of the electrosurgical instrument of Fig. 3 shows; Fig. 8a-f the assembly of a part of the electrosurgical instrument from Fig. 3 show; Fig. 9a-b Cross-sectional views of a part of the electrosurgical instrument from Fig. 3 are; Fig. 10a-c a blade guide part of the electrosurgical instrument made of Fig. 3 show; Fig. 11 a locking part of the electrosurgical instrument made of Fig. 3 shows; Fig. 12 a blade angle alignment part of the electrosurgical instrument from Fig. 3 shows; Fig. 13a-b Cross-sectional views of the blade angle alignment part of the electrosurgical instrument from Fig. 3 show; Fig. 14a-b a blade angle control wheel part of the electrosurgical instrument from Fig. 3 show; Fig. 15a-b the rotational movement of the blade angle control wheel of the electrosurgical instrument Fig. 3 show; Fig. 16a-d the rotational movement of the end effector of the electrosurgical instrument Fig. 3 show; Fig. 17 a cross-sectional view of the electrosurgical instrument from Fig. 3 and illustrates a wiring path; Fig. 18a-b show details of an electrical wiring path used in the electrosurgical instrument of Fig. 3 is used; Fig. 19 shows further details of an electrical wiring path used in the electrosurgical instrument of Fig. 3 is used; Fig. 20a-b Side views of part of the cutting mechanism of the electrosurgical instrument from Fig. 3 are; Fig. 21 is a cross-sectional view of a portion of the cutting mechanism of the electrosurgical instrument of Fig. 3 is; Fig. 22 is a cross-sectional view of another part of the cutting mechanism of the electrosurgical instrument of Fig. 3 shows; Fig. 23 a partially transparent perspective view of the cutting mechanism of the electrosurgical instrument of Fig. 3 is; Fig. 24a-c the assembly of a part of the cutting mechanism of the electrosurgical instrument from Fig. 3 show; Fig. 25a-c Cross-sectional views of the cutting mechanism and the clamping mechanism of the electrosurgical instrument from Fig. 3 show; Fig. 26a-f are cross-sectional views illustrating the operation of the locking mechanism of the electrosurgical instrument of Fig. 3 illustrate; Fig. 27 is a diagram showing the cutting mechanism of the electrosurgical instrument Fig. 3 illustrates; Fig. 28a-b are line drawings showing the cutting mechanism of the electrosurgical instrument from Fig. 3 illustrate; Fig. 29a-b a blade angle alignment part of the electrosurgical instrument from Fig. 3 show; Fig. 30 is a perspective view of a portion of the clamping mechanism of the electrosurgical instrument of Fig. 3 is; Fig. 31 a partial cross-sectional view of the cutting mechanism and the clamping mechanism of the electrosurgical instrument of Fig. 3 is; Fig. 32 a partial cross-sectional view of the cutting mechanism and the clamping mechanism of the electrosurgical instrument of Fig. 3 is; Fig. 33 the blade angle control wheel part and the electrode control switch of the electrosurgical instrument Fig. 3 shows; Fig. 34 the blade angle control wheel part of the electrosurgical instrument Fig. 3 shows; Fig. 35a-b show the handle of the electrosurgical instrument of Fig. held by users with different sized hands; Fig. 36a-c the rotational movement of the end effector of the electrosurgical instrument Fig. 3 show; Fig. 37 the rotational movement of the blade angle control wheel of the electrosurgical instrument Fig. 3 shows; Fig. 38 is a schematic perspective view of an example of an end effector; Fig. 39 is an enlarged perspective view of a portion of the end effector of Fig. 38 is; Fig. 40 is a schematic cross-sectional view of a part of the end effector of Fig. 38 is; Fig. Figure 41 is a schematic perspective view of an alternative end effector; Fig. 42 is an enlarged perspective view of a portion of the end effector of Fig. 41 is, Fig. 43 a schematic cross-sectional view of a part of the end effector of Fig. 41 is, Fig. 44 is a schematic cross-sectional view of part of another alternative end effector; Fig. 45 is an illustration of an electrosurgical system including a generator and an instrument according to embodiments of the invention; Fig. 46 furthermore a locking part of the electrosurgical instrument from Fig. 3 shows and Fig. 47a-e the distal end of the in the electrosurgical instrument from Fig. 3 used cutting blade. Description of the embodiments
[0024] An embodiment of the invention will now be described. First, a brief overview of the overall embodiment will be given, followed by detailed descriptions of specific aspects thereof. 1. Overview of the structure of the instrument
[0025] Fig. 1 shows an electrosurgical instrument 1 according to an example of the present invention. The instrument 1 comprises a proximal handle portion 10, an outer shaft 12 extending in a distal direction from the proximal handle portion 10, and a distal end effector 14 attached to a distal end of the outer shaft 12. The end effector 14 may, for example, be a set of opposed jaws arranged to open and close and include one or more electrodes disposed on or formed by their opposed inner surfaces and which, in use, have terminals for receiving a radiofrequency (RF) electrosurgical signal for sealing or coagulating tissue. The jaws are further provided with a slot or other opening in the opposed inner surfaces through whichwhich may protrude a mechanical cutting blade or the like when activated by the user. In use, the handle 10 is activated by the user in a first way to clamp tissue between the jaws 14 and in a second way to supply RF current to the electrodes to coagulate the tissue. The jaws 14 may be curved so that the active elements of the instrument 1 are always visible. This is important in vessel sealing devices used to operate on body regions that make it difficult for the user to see the device during use. The handle 10 may be activated by the user in a third way to cause the blade to protrude between the jaws 14, thereby cutting tissue clamped between them. After completing the required cutting and sealing, the user may release the tissue from the jaws 14.
[0026] The handle 10 comprises, as in Fig. 2, a housing 20 made of two shell moldings 300, 302, which accommodates all components required for the actuation and rotation of the clamping jaws 14, the coagulating and cutting of tissue. The shell moldings in the assembled device are ultrasonically welded after the internal components have been arranged inside them. The handle 10 comprises a clamping handle 22 for clamping tissue between the clamping jaws 14, a trigger 24 for cutting the tissue, a switch 26 for activating and deactivating the RF supply to the electrodes in the clamping jaws 14 for coagulating tissue, and a rotary wheel 28 for rotating the clamping jaws 14 to reach tissue at different angles. The handle 10 is constructed so that the instrument 1 and all its functions can be operated with just one hand, with all operating mechanisms being easily accessible.
[0027] Fig. Figure 3 shows all of the features of instrument 1 required to perform its functions, including those housed in the two shell moldings 300, 302 of the housing 20. To clamp tissue between the jaws 14, a clamping mechanism is actuated using the clamping handle 22. The clamping handle 22 further includes a collar ring 304 having a hinge 306 that acts as a pivot point about which the clamping handle 22 rotates. The hinge 306 may, for example, be two outwardly directed pins that engage corresponding moldings 308 formed integrally with the shell moldings 300, 302 to provide an anchor point about which the clamping handle 22 rotates. The clamping mechanism further includes a collar ring molding 310, a spring 312, and an inner molding 314, as shown in Fig. 4 to 7, all of which are arranged along a drive shaft 316.
[0028] The collar ring 304 includes a through-opening 318 in which the collar ring molding 310 is received. The opening 318 has a larger diameter at the top than at the bottom, with the collar ring molding 310 being arranged to be received in the lower part of the opening 318, as Fig. 8a. When assembled, the collar ring molding 310 fits easily through the larger part of the opening 318 so that the collar ring 304 is received between two flanges 800, 802, as Fig. 8b-c show. As Fig. As shown in Figure 8d, the collar ring 304 is then pushed upward to engage the smaller portion of the through-hole 318 with the collar ring molding 310. Once the joint 306 is connected to the joint moldings 308 within the housing 20, the collar ring molding 310 is retained in the lower portion of the opening 318, where it can rotate freely within the opening 318.
[0029] The collar ring molding 310, the spring 312 and the inner molding 314 are, as in Fig. 6, are held between protruding elements 600, 602 such that they cannot move axially beyond these protruding elements 600, 602. In this regard, the protruding elements 602 at the proximal end of the drive shaft 316 are compressible to allow the drive shaft 316 to pass through a channel 604 in the proximal end of the inner mold part 314. The drive shaft 316 is pushed through the channel 604 until it reaches an opening 606, at which point the protruding elements 602 are no longer compressed so that they lie flush against the walls of the drive shaft 316. Instead, the protruding elements 602 fan out and press against the walls of the opening 606 so that the width of the protruding elements 602 extends beyond the diameter of the channel 604. Consequently, the drive shaft 316 cannot be retracted through the channel 604 and is locked.
[0030] The spacing between the protruding elements 600, 602 is selected such that the spring 312 is at least partially compressed between the collar ring molding 310 and the inner molding 314. This pre-compression is essential to ensure that the correct clamping load is applied when the clamping mechanism is activated, as described in more detail below. Both the collar ring molding 310 and the inner molding 314 include chambers (cavities) 608, 610 into which the spring 312 extends. In particular, a substantial portion of the length of the collar ring molding 310 accommodates the spring 312. This arrangement allows for a longer spring 312, which is important to ensure that the spring 312 never reaches its block length during use.
[0031] The main body of the drive shaft 316 lies within the outer shaft 12, with the distal end of the drive shaft 316 being connected to both the distal end of the outer shaft 12 and the clamping jaws 14. The drive shaft 316 moves axially within the outer shaft 12, and this axial movement moves the clamping jaws 14 from an open to a closed position, as shown in Fig. 4 and Fig. 5a. The drive shaft 316 is coupled to the jaws 14, for example, by a drive pin 400 in a cam slot 402, with movement of the drive pin 400 in the cam slot 402 moving the jaws 14 between the open and closed positions. The connection between the drive shaft 316, the outer shaft 12, and the jaws 14 is such that rotational movement of the drive shaft 316 is transmitted to the outer shaft 12 and the jaws 14.
[0032] The outer shaft 12 and the drive shaft 316 are connected at a further point by a shaft molding 320. The shaft molding 320 is received in a socket 322 of the housing 20 and thus connects the outer shaft 12 to the housing 20. The outer shaft 12 is attached to the shaft molding 320 by any suitable means, such as by locking projections 900 that cooperate with corresponding grooves 902 in the shaft molding 320, as shown in Fig. 9b. The drive shaft 316 is guided through an opening (not shown) adapted to the T-shaped cross section of the drive shaft 316 through the body of the shaft molding 320, as shown by Fig. 10a. The shaft molding 320 is arranged so that it can rotate freely in the socket 322. The shaft molding 320 can, for example, comprise cylindrical flange elements 904, 906 that rotate in concentric mating surfaces 908, 910 provided in the shell moldings 300, 302. Thus, the shaft molding 320 rotates with the drive shaft 316, which in turn transmits this rotational movement to the outer shaft 12 and the clamping jaws 14. The shaft molding 320 thus functions as a rotational guide and axial guide for the drive shaft 316.
[0033] The clamp handle 22 includes a latching element 324 arranged to cooperate with a latching molding 326 provided in the proximal end 328 of the housing 20. The latching molding 326 may be secured by any suitable means, such as a molding pin 330 formed integrally with one of the shell moldings 300, 302, as shown in Fig. 3, or simply by the molding walls 1100, which are formed integrally with the shell molding 300, as in Fig. 11, are held in place. When the clamping handle 22 is driven toward the housing 20 to close the clamping jaws 14, the latching element 324 enters the housing 20 through an opening 1102 and engages the latching molding 326 to hold the clamping handle 22 in this position. As shown in Fig. 26a to 26f, the locking molding 326 includes a two-way spring 1104 and a cam path 1106 along which the locking element 324 moves. As shown in Fig. 46, the latching mechanism may also include an override component 4600 to allow the user to manually release the latching element 324 if it becomes stuck, as well as a locking component 4602 to disable the latching mechanism entirely. The override component 4600 and the locking component 4602 may be provided on the latching molding 326 or integrated into the interior of the housing 20.
[0034] As described above, the handle 10 further comprises a rotary wheel 28, wherein the rotary wheel 28 is arranged to enclose the inner mold part 314. For this purpose, the rotary wheel 28 and the inner mold part 314 have interlocking elements 1200, 1202, as shown in Fig. 12. These interlocking elements 1200, 1202 connect in such a way that the rotary wheel 28 and the inner mold part 314 rotate together, while still allowing axial movement of the inner mold part 314 within the rotary wheel 28, as can be seen from Fig. 13a-b. Thus, rotation of the rotary wheel 28 causes the inner mold part 314 to rotate, which consequently causes the drive shaft 316 and the collar ring mold part 310 to rotate. For stability reasons, the rotary wheel 28 includes cylindrical surfaces 1204 that slide in rotation on inner mating surfaces (not shown) that are integrally formed with the shell mold parts 300, 302.
[0035] To enable a user to rotate the jaws 14, the housing 20 has two openings 332, 334 through which notched portions 336 of the rotary wheel 28 extend. The two openings 332, 334 are located opposite each other on either side of the handle and are trapezoidal in shape. In particular, the trapezoidal openings have parallel sides that are at right angles to the longitudinal axis of the handle, and one of the parallel sides may be longer than the other, with the longer side at the front end of the opening and the shorter side at the rear end of the opening. The notched portions 336 are chamfered in a suitable manner so that they fit the user's thumb or fingers. To this end, the notched portions 336 are cut at an angle to the plane of rotation, as shown in Fig. 14a-b. In particular, the angle of the beveled part of the notched sections should substantially correspond to the angle of the outer housing in the area of the rotary wheel 28.
[0036] The rotary wheel 28 also comprises at least one stop element 1500 for limiting the degree of rotation, as in Fig. 15a-b. The stop element 1500 interacts with stop parts 1502, 1504, which are formed integrally with the housing 20. When the rotary wheel 28 is rotated, the stop element 1500 is blocked by the stop parts 1502, 1504, thereby preventing further rotation. The stop parts 1502, 1504 can, for example, limit the rotation of the rotary wheel to 270°. Similarly, the shaft molding 320 also includes a stop element 1600, which interacts with stop parts 1602, 1604, which are formed integrally with the housing 20, as shown in Fig. 16a-d. The stop element 1600 of the shaft molding 320 and its corresponding stop part 1602, 1604 are aligned with respect to the stop element 1500 of the rotary wheel 28 and its corresponding stop parts 1502, 1504 such that rotation is restricted to the same extent. This means that when the rotary wheel 28 rotates, the radial point at which the stop element 1500 is blocked on the rotary wheel 28 coincides with the radial point at which the stop element 1600 is blocked on the shaft molding 320. In Fig. 15b and Fig. 16a, the clamping jaws 14 were, for example, moved from a neutral orientation (which is Fig. 16b) is rotated 90° counterclockwise. This freedom of rotation means that the user can capture tissue from different angles without having to rotate the entire instrument 1.
[0037] As described above, the switch 26 is provided to enable or disable the RF signal applied to the electrodes in the jaws 14 via a suitable circuit, such as two ingress-protected switches on a small printed circuit board (PCB) 338. As Fig. 17, the PCB 338 is connected to a connecting cable 1700 to receive the RF output signal from a generator (not shown) and to electrical leads 1702, 1704 to supply the RF current to the electrodes in the clamp jaws 14, such as a lead for the active electrode and a lead for the counter electrode. As shown in Fig. 17 and Fig. As shown in Figure 18ab, the leads 1702, 1704 are wrapped beneath and around the shaft molding 320 before entering a guide slot 1800 in the interior cavity 1802 of the shaft molding 320 and extending down the outer shaft 12. Wrapping the shaft molding 320 with the leads 1702, 1704 in this manner holds the leads 1702, 1704 in a compact arrangement to allow for easy assembly while simultaneously allowing rotation of the drive shaft 316. In doing so, the leads 1702, 1704 are unwound and rewound with the rotation of the drive shaft 316. In addition, one of the shell moldings 300 also includes two molded compartments 1900, 1902 arranged sequentially to receive the line contacts 1904, 1906 that connect the active lines and return lines 1702, 1704 to the wiring 1908, 1910 of the intrusion-protected switches 338.The opposing shell molding 302 includes corresponding rib portions (not shown) to retain the contacts 1904, 1906 within the compartments 1900, 1902. Consequently, the two lead contacts 1904, 1906 are longitudinally separated such that only one contact can pass through each compartment 1900, 1902, providing a physical barrier between each compartment 1904, 1906 and each lead. This prevents the risk of insulation damage to one of the leads caused by the contacts 1904, 1906, while also protecting the contacts 1904, 1906 themselves from fluids that may travel along the outer shaft 12 and into the housing 20.
[0038] With reference to the cutting mechanism, a blade 340 is provided for cutting tissue clamped between the jaws 14 in a central path 342 along the length of the drive shaft 316. The mechanism for actuating the blade 340 along the path 342 and between the jaws 14 is actuated via the trigger 24. The trigger 24 actuates a drive assembly consisting of a trigger molding 344, a blade drive molding 346, a blade collar ring molding 348, a tension spring 350, and a blade molding 352. The drive assembly is arranged between the shaft molding 320 and the collar ring 304 of the clamping mechanism. As shown in Fig. 20a-b, the drive assembly functions as an offset slider-crank mechanism by which the force exerted by the user on the trigger 24 is converted into axial movement of the blade molding 352 along the drive shaft 316, which in turn drives the attached blade 340.
[0039] As from Fig. 21, Fig. 22 and Fig. 23, the blade molding 352 is arranged to be received in the blade collar ring molding 348. As Fig. 22, the blade collar ring molding 348 includes a lip edge 2200 that engages a recess 2202 extending around the periphery of the blade molding 352. As Fig. 23, the blade molding 352 has a T-shaped opening 2300 for receiving the drive shaft 316 and the blade 340. The blade molding 352 further includes an inner cutout 2100, as Fig. 21 shows, for the proximal end of the blade 340, wherein the end of the blade 2102 is shaped to fit the inner cutout 2100 of the blade molding 352 to allow easy assembly, as in Fig. 24a-c. The blade molding 352 is independently rotatable relative to the blade collar ring molding 348, allowing the two moldings to rotate concentrically. Consequently, the blade molding 352 is capable of rotating with the drive shaft 316.
[0040] The clamping jaws 14 can be curved, as described above. To allow the blade 340 to be slid around the curve while retaining sufficient cutting ability, the frictional force of the cutting blade 340 in the curved path must be minimized. The frictional force is a product of the coefficient of friction of the blade 340 in the path 342 and the force exerted by the bending of the blade 340 on the walls of the path 342. This frictional force can be reduced, for example, by adding a friction-reducing coating to both sides of the blade and / or, preferably, weakening the blade 340 to graduate the flexibility of the distal end of the blade so that it can bend along the path 342 while remaining rigid in the direction of the cutting force. The preferred weakening can be achieved, for example, by providing one or more openings 354 in the distal end, as in Fig. 3 and Fig. 47a-c, or by graduating the thickness of the blade 340, as in Fig. 47d. Alternatively, as shown in Fig. 47e, structured laser cutouts 4712 or chemical etching may be applied in the distal end to adjust the bending stiffness along the blade length, wherein the spacing of such cutouts may be constant or may increase gradually from the distal to the proximal end.
[0041] During use, blood and tissue may accumulate in the distal end of the instrument 1. In particular, blood and tissue may cause the blade 340 to become stuck inside the drive shaft 316. Therefore, the distal end of the drive shaft 316 may include cut-out portions 1000 to reduce the surface of the drive shaft 316 to which blood and tissue may adhere, as shown in Fig. 10b-c. The cut-out sections may, for example, be such that the distal end comprises two side walls without a base or such that the distal end comprises a base with forked side walls. 2. Operating the instrument
[0042] After describing the overall design of the device, the overall operation of electrosurgical instrument 1 during use will now be explained. This is followed by a further detailed description of the design and operation of specific aspects of the device.
[0043] As explained above, the handle 10 of the electrosurgical instrument is arranged to i) clamp tissue between a set of jaws 14, ii) lock the jaws in place (if the user so desires), iii) deliver an RF signal to electrodes in the jaws 14 to coagulate the tissue clamped between them, and iv) move a blade 340 between the jaws 14 to cut the tissue clamped between them. The handle 10 can also rotate the jaws 14 to allow the user to clamp tissue at different angles without having to rotate the entire handle 10. Consequently, the tissue clamped between the jaws can be sealed using the same electrosurgical instrument before or during cutting. Furthermore, this effect can be achieved by the instrument with one-handed operation by the surgeon. 2.1 Clamping mechanism
[0044] To clamp tissue between the jaws 14, the user pushes the clamp handle 22 toward the proximal end 328 of the housing 20 until the locking element 324 engages the locking molding 326 within the housing 20. This movement causes the clamp handle 22 to pivot about its hinge 306, as shown in Fig. 8e-f, and pushes the edge of the collar ring 304 against the flange 800 to move the collar ring molding 310, the spring 312 and the inner molding 314 along the drive shaft 316 in the proximal direction, as shown in Fig. 4 and Fig. 5a. As described above, the inner mold 314 is secured to the drive shaft 316 by means of protruding elements 602. Thus, when the inner mold 314 is axially retracted, the drive shaft 316 is also axially moved, causing the pin 400 to move into the cam slot 402 of the clamping jaws 14, thereby closing the clamping jaws 14. Thus, the force from the clamping handle 22 is transmitted to the drive shaft 316 via the spring mechanism of the collar ring mold 310, spring 312, and inner mold 314.
[0045] If tissue is clamped between the clamping jaws 14, as in Fig. As shown in Figure 5b, the spring 312 limits the force acting on the tissue. Once the axial movement of the collar ring molding 310, spring 312, and inner molding 314 is complete and the collar ring 304 continues to press against the flange 800, the threshold compression force of the spring 312 is finally reached, so that the spring 312 begins to compress between the collar ring molding 310 and the inner molding 314. If the spring 312 compresses further, the clamping handle 22 can be moved to the locked position without exerting any further force on the clamped tissue. This means that the force of the clamping handle 22 is no longer transmitted to the drive shaft 316, but is effectively absorbed by the spring 312. Thus, the spring 312 ensures that the correct amount of force is transmitted to the clamping jaws 14.Without the spring 312, actuation of the clamp handle 22 causes a continued increase in the force transmitted to the drive shaft 316 and subsequently to the jaws 14 and the tissue. This could cause mechanical damage to the tissue if the user continues to press the clamp handle 22 to engage the latching element 324.
[0046] As explained above, the chambers 608, 610 in the collar ring molding 310 and the inner molding 314 cooperate to allow for the provision of a larger spring 312. This allows for a greater spring travel, so that the spring 312 is not compressed to its deflection length during use. Once the spring 312 reaches its deflection length, it would no longer absorb the force exerted by the clamp handle 22, and the force would be retransmitted to the clamp jaws 14. 2.2 Locking mechanism
[0047] When tissue is clamped between the clamping jaws 14, the clamping jaws 14 can be locked in a closed position by engaging the locking element 324 on the clamping handle with the locking molding 326 inside the housing 20, as shown in Fig. 26a-f. As the latching element 324 enters the housing 20 through the opening 1102, the latching element 324 engages the latching molded part 326, whereby the molded part 326 is pushed downward in the housing 20 and thereby extends the spring 1104. As shown in Fig. 26b-c, the latching element 324 moves upwardly along the side of the cam path 1106 until it reaches its maximum position. At this point, the clamping handle 22 can no longer be compressed, and the spring 1104 pulls the latching molding 326 upwardly inside the housing 20 again, so that the latching element 324 is inserted into the V-shaped compartment of the cam path 1106 to hold the clamping handle 22 in the compressed position and the clamping jaws 14 in the closed position, as shown in Fig. 26d.
[0048] In this locked position, the user's hand is free to operate the other functions of instrument 1, as explained below.
[0049] To release the locking element 324 from the housing 20 and open the clamping jaws 14, the user must push the clamping handle 22 towards the housing 20 to release the locking element 324 from the compartment of the cam path 1106, as shown in Fig. 26e. The force of the spring 1104 pulls the latching molding 326 further up into the housing 20 so that the latching element 324 moves in the opposite direction down the side of the cam path 1106, as shown in Fig. 26e-f, and moved back out of the opening 1102. The locking molding 326 then returns to its original position inside the housing 20. 2.3 Cutting mechanism
[0050] When the jaws 14 are in a closed position, the user may wish to cut the tissue clamped between them. To cut the tissue, a blade 340 is advanced between the jaws 14 by actuating the drive assembly.
[0051] The drive assembly is a three-pivot arrangement that functions as a slider-crank mechanism. When the user pulls the trigger 24 back toward the housing 20, as shown in Fig. 25b-c, the trigger molding 344 is levered about a pivot point A which is anchored to the housing 20, such as in the form of outwardly directed pins 358 which engage with corresponding moldings 356 which are integral with the shell moldings 300, 302 of Fig. 3. This causes the pivot point B connecting the trigger molding 344 and the drive molding 346 to be pushed past its central position, thereby translating the blade collar ring 348, the blade molding 352, and the blade 340 along the drive shaft 316 with a force sufficient to allow the blade 340 to cut the trapped tissue. In this regard, the force exerted on the trigger 24 is transmitted via the trigger molding 344 and the drive molding 346 to the blade collar ring 348 and the blade molding 352. As the pivot point B moves past the center point to its advanced position, the speed at which the blade collar ring 348 and the blade molding 352 are translated along the drive shaft 316 increases, thereby increasing the force acting on the blade 340.This increases the force with which the blade 340 cuts into the tissue without the user exerting additional force on the trigger 24.
[0052] The shaft molding 320 acts as a stop point for the blade collar ring 348 and the blade molding 352. Consequently, the pivot point B always remains above the other two pivot points A, C with respect to the drive shaft 316.
[0053] During actuation of the trigger 24, the force exerted on the trigger 24 is sufficient to overcome the compression force of the tension spring 350, so that the tension spring 350 extends along the same plane as the drive shaft 316 to allow axial movement of the blade collar ring 348 and the blade molding 352. Upon release of the trigger 24, the tension spring 350 is recompressed to retract the drive assembly to its original position. The tension of the tension spring 350 is sufficient to retract the blade 340 through thick tissue without user intervention. 2.4 Shaft rotation
[0054] During use, the user may need to access tissue from different angles without having to move the entire instrument 1. For this reason, the clamping jaws 14 are advantageously rotatable with respect to the handle 10 by means of the rotary wheel 28. This is particularly advantageous when the clamping jaws 14 are on a curved path, such as the one shown in Fig. 16a-d. As explained above, the rotary wheel 28 is connected to the inner mold part 314 via interlocking elements 1200, 1202, so that the inner mold part 314 rotates with the rotary wheel 28. Since the end of the drive shaft 316 is connected to the inner mold part 314, the drive shaft 316 also rotates, which in turn also rotates the clamping jaws 14 at their opposite end.
[0055] To enable this rotational movement without impairing the function of the clamping mechanism, the collar ring molding 310 is independently rotatable within the collar ring 304 so that the collar ring molding 310 also rotates with the drive shaft 316. Similarly, the blade molding 352 is independently rotatable within the blade collar ring 348 to enable rotation of the drive shaft 316 without impairing the function of the cutting mechanism.
[0056] To transmit the rotational movement to the outer shaft 12, the shaft molding 320 is rotatable in its socket 322. As described above, the shaft molding 320 acts as a rotation guide to control the rotational movement relative to the drive shaft 316 along the entire length of the instrument 1. In addition, the active lines and return lines 1702, 1704 are arranged within the housing 20 to prevent damage to these lines 1702, 1704 by the rotating components. As described above, the lines 1702, 1704 are wound around the shaft molding 320 to enable the degree of rotation of the drive shaft 316. Consequently, the lines 1702, 1704 are unwound and rewound around the shaft molding 320 as it rotates. 2.5 Electrode activation
[0057] With the jaws 14 in a closed position, the user may wish to coagulate and seal the tissue clamped between them. To this end, the user initiates electrode activation using switch 26 on the housing 20, which is conveniently located for easy access by the user while operating the device with one hand. This delivers an RF signal to the electrodes in the jaws 14 to coagulate and seal the tissue. The RF signal may have a pure or mixed waveform, depending on the desired effect.
[0058] After an overview of the structure and operation of the entire device, further detailed descriptions of the structure and operation of certain aspects of it follow. 3. Structure and operation of the clamping mechanism
[0059] As described above, the proximal handle portion 10 of the electrosurgical instrument 1 includes a first mechanism for actuating an aspect of a distal end effector 14 such that the end effector 14 transitions between a first and a second state. The end effector 14 may, for example, be a set of opposing jaws 14 arranged to be opened and closed. The mechanism used to initiate the movement of these jaws 14 is the so-called clamping mechanism, which includes a clamping handle 22 and two barrel-shaped molded parts 310, 314 with a spring 312 compressed therebetween, all elements being arranged along an elongated drive shaft 316 extending between the jaws 14 and the handle 10, as shown in Fig. 4 and Fig. 5a-b.
[0060] As from Fig. As can be seen in Figure 8a, the clamp handle 22 includes a collar ring 304 in which the collar ring molding 310 is received. The collar ring 304 includes an opening 318 shaped like a keyhole or the number 8. The opening 318 consists of two adjacent openings 804, 806, with the upper opening 804 having a larger diameter than the lower opening 806.
[0061] The collar ring molding 310 is a cylindrical or barrel-shaped component with two flange portions 800, 802 spaced longitudinally apart. The diameter of the proximal flange 800 is larger than that of the upper and lower openings 804, 806. The diameter of the distal flange 802 is smaller than the upper opening 804 but larger than the lower opening 806.
[0062] During assembly, the collar ring molding 310 is first inserted through the upper opening 804, as shown in Fig. 8b-c. Since the distal flange 802 is smaller than the upper opening 804, it passes through it easily, while the proximal flange 800 is large enough to prevent the collar ring molding 310 from being fully advanced through the upper opening 804. As shown in Fig. 8d, the collar ring 304 is then pushed upward to engage the lower opening 806 with the collar ring molding 310.
[0063] After assembly, the collar ring molding 310 remains within the lower opening 806 of the collar ring 304 and is arranged so that its two flanges 800, 802 are present on both sides of the collar ring 304, as shown in Fig. 8e. Because the lower opening 806 has a smaller diameter than both flanges 800, 802, the collar ring molding 310 cannot be removed by simply pushing it through the lower opening 806. In contrast, the body of the collar ring molding 310 between the two flanges 800, 802 has a slightly smaller diameter than the lower opening 806. Thus, the collar ring molding 310 is sufficiently loosely received in the lower opening 808 to allow rotational movement.
[0064] As from Fig. As can be seen in Figure 8e, the longitudinal distance between the two flanges 800, 802 is only slightly greater than the thickness of the collar ring 304, so that the latter fits snugly between the flanges 800, 802. This ensures that the movement of the clamping handle 22 is transmitted directly to the collar ring molding 310 and subsequently to the other components of the clamping mechanism. This is particularly important to ensure that the clamping jaws 14 respond to the movement of the clamping handle 22 and that there is no delayed reaction between actuation of the clamping handle 22 and the movement of the clamping jaws 14.
[0065] Once the collar ring molding 310 and the clamping handle 22 have been assembled, the remaining components can be assembled.
[0066] The drive shaft 316 is an elongated rod having one or more protruding elements 602 disposed at its proximal end, as shown in Fig. 6. The protruding elements 602 are flexible extensions that fan out from the surface of the drive shaft 316. This means that the protruding elements 602 are deformable so that they can be pressed flush against the surface of the drive shaft 316, but return to their original position when relieved of a counterforce. This allows the drive shaft 316 to be easily pushed through all components of the clamping mechanism during assembly, as described below.
[0067] The collar ring molding 310 has an internal cavity divided into two parts. The first part is a narrow channel or slot 607 for receiving the drive shaft 316, with the distal end of the collar ring molding 310 including an opening 311, as shown in Fig. 3, which fits the T-shaped cross-section of the drive shaft 316. The diameter of the channel 607 is only slightly wider than that of the drive shaft 316 to provide a tight fit for better stability. Upon insertion of the drive shaft 316, the protruding elements 602 are pressed flat to allow the drive shaft to be pushed fully through.
[0068] The second portion is a chamber 608 sufficiently large to accommodate one end of the spring 312. The chamber 608 may extend over any suitable portion of the length of the collar ring molding 310. For example, the length of the chamber 608 may be approximately 25% of the length of the collar ring molding 310 up to 75% of the length of the collar ring molding 310.
[0069] The chamber 608 is substantially larger than the collar ring molding channel 607, so that when the drive shaft 316 is pushed through the collar ring molding 310, the protruding elements 602 extend outward again into their original structure when they reach the chamber 608.
[0070] The collar molding 310 and clamp handle 22 assembly is slid along the drive shaft 316 until the collar molding 310 reaches a second set of protruding elements 600. These protruding elements 600 have a greater width than the opening 311 on the collar molding 310 to form an obstacle that prevents the collar molding 310 from moving further along the drive shaft 316. To this end, the protruding elements 600 must be sufficiently rigid so that the collar molding 310 cannot be pushed past them by applying force or pushing the protruding elements 600 inward.
[0071] The drive shaft 316 is then pushed through the center of the spring 312. The spring 312 preferably has a diameter only slightly larger than that of the drive shaft 316 to provide a tighter fit between the spring 312 and the drive shaft 316. The spring 312 is then pushed along the drive shaft 316 until the end of the spring 312 fills the chamber 608 of the collar ring molding 310.
[0072] The inner mold part 314 is a cylindrical or barrel-shaped component with an interior cavity divided into two sections. The first section is a chamber 610 in which one end of the spring 312 is received such that the spring 312 is partially enclosed by the collar ring mold part 310 and the inner mold part 314. The second section is a narrow channel or slot 603 for receiving the proximal end of the drive shaft 316. The channel 603 is divided into two parts 604, 606. The first part of the channel 604 is shaped to allow the drive shaft 316 to pass therethrough, flattening the flexible extensions 602 in the process. To this end, the diameter of the first channel part 604 is only slightly larger than that of the drive shaft 316 to provide a tight fit.The tight fit of the drive shaft 316 in both the collar ring molding channel 607 and the inner molding channel 603 means that the drive shaft 316 is held firmly in place. This increases the stability of the drive shaft 316 within the housing 20, which is particularly important for ensuring maximum control of the end effector 14.
[0073] The second portion of the channel 606 provides a shoulder 605 into which the protruding elements 602 can extend. Consequently, when the drive shaft 316 passes through the channel 604 and into the second channel portion 606, the flattened protruding elements 602 fan out back to their original uncompressed position. After the protruding elements 602 engage the shoulder 605 of the second channel portion 606, the drive shaft 316 cannot be retracted through the first channel portion 604 and is thus retained within the inner mold portion 314. To achieve this snap-in connection, a protruding element 602 is only required on one side of the drive shaft 316.
[0074] This snap connection is configured such that any axial movement of the inner mold part 314 is transmitted to the drive shaft 316. Similarly, any rotational movement of the inner mold part 314, for example, by the rotary wheel 28 formed around the inner mold part 314, is also transmitted to the drive shaft 316.
[0075] To complete the assembly of the clamping mechanism, the drive shaft 316 is simply pushed through the collar ring molding 310, the spring 312 and finally the inner molding 314 until the protruding elements 602 snap into the second channel portion 606.
[0076] Once positioned along the drive shaft 316, the collar ring molding 310, the spring 312, and the inner molding 314 are arranged such that the spring 312 is partially enclosed by the collar ring molding 310 and the inner molding 314. By providing the chamber 608 of the collar ring molding 310 and the chamber 610 of the inner molding 314, wherein a substantial portion of the spring 312 can be accommodated, a longer spring 312 can be used without requiring additional space within the handle 10. The larger the chamber 608 of the collar ring molding 310 and the chamber 610 of the inner molding, the longer the spring 312. In addition, the distance between the protruding elements 600, 602 means that the ends of the spring 312 are compressed by the end walls 612, 614 of the chamber 608 of the collar ring molding 310 and the chamber 610 of the inner molding, respectively, so that the spring 312 experiences an initial pre-compression during installation.This is important to ensure that the correct force is exerted on the clamping jaws 14 when the handle 22 is operated to activate the clamping mechanism.
[0077] In addition, the inner mold part 314 may be received in another barrel-shaped mold part, such as the rotary wheel 28, as shown in Fig. 13a-b. Here, the inner mold part 314 rotates with the rotary wheel 28, but is free to move axially in the inner cavity 1300 of the rotary wheel 28 between a first position, as in Fig. 13a, and a second position as shown in Fig. 13b. Consequently, the rotation of the wheel 28 rotates the inner mold part 314, which in turn rotates the drive shaft 316 and the clamping jaws 14.
[0078] After all components have been assembled, the clamping handle 22 can be installed into the housing 20. For this purpose, the clamping handle 22 is connected to the housing at its hinge 306. The hinge 306 can, for example, be two outwardly extending pins that mate with corresponding hinge moldings 308 formed integrally with the shell moldings 300, 302. This provides an anchor point about which the clamping handle 22 can rotate.
[0079] Thus, the arrangement described above provides a mechanism for actuating the end effector 14 that can be easily and safely assembled without any additional components.
[0080] During use, the user pushes the clamp handle 22 toward the proximal end 328 of the housing 20, thereby rotating the clamp handle 22 about its pivot 306. In doing so, the collar ring 304 presses against the proximal flange 800, causing the collar ring molding 310 to move longitudinally. This longitudinal movement displaces the spring 312, the inner molding 314, and the drive shaft 316 back toward the proximal end of the handle portion 10, as shown in Fig. 5a. Since the drive shaft 316 is connected to the jaws 14, for example, by a pin 400 and cam slot 402 arrangement, the jaws 14 are moved from the open to the closed position. The force from the clamping handle 22 is transmitted to the drive shaft 316 via the spring mechanism of the collar ring molding 310, spring 312, and inner molding 314. This spring mechanism is particularly important because it limits the force acting on any tissue clamped between the jaws 14.
[0081] When the clamping handle 22 is pressed, the collar ring molding 310, the spring 312 and the inner molding 314 continue their axial movement until either the inner molding 314 reaches its most proximal position so that the clamping jaws 14 are completely closed, as shown in Fig. 5a, or the clamping jaws 14 cannot be closed further due to tissue 500 being clamped between them, as in Fig. 5b, in which case the clamping handle 22 is not fully actuated, so that it is held in place by the latching element 324. If the user continues to press the clamping handle 22 and the collar ring 304 continues to push against the flange 800, the threshold compression force of the spring 312 is finally reached, so that the spring 312 begins to be compressed between the collar ring molding part 310 and the inner molding part 314, as shown in Fig. 5b can be seen.
[0082] If the spring 312 is further compressed, the clamp handle 22 can be moved to the locked position without exerting any further force on the clamped tissue 500. This means that the force of the clamp handle 22 is no longer transmitted to the drive shaft 316, but is effectively absorbed by the spring 312. Thus, the spring 312 ensures that the correct amount of force is transmitted to the clamp jaws 14. Without the spring 312, actuation of the clamp handle 22 continues to increase the force exerted on the drive shaft 316 and, consequently, on the clamp jaws 14 and the tissue 500. This could result in mechanical damage to the tissue 500 as the user presses the clamp handle 22 to engage the latching element 324.
[0083] For this reason, pre-compression of spring 312 is important to ensure that spring 312 absorbs the force of handle 22 once inner molding 314 reaches its axial end position. Similarly, a longer spring 312 allows for a greater spring stroke, so that spring 312 is not fully compressed to its block length during use. Once spring 312 reaches its block length, it would no longer absorb the force exerted by clamping handle 22, and the force would be retransmitted to clamping jaws 14.
[0084] To hold the clamping jaws 14 in their closed position, the locking element 324 on the clamping handle 22 must be engaged with the locking molding 326 inside the proximal end 328 of the housing 20, as shown in Fig. 26a-f.
[0085] Fig. 11 shows that the snap-in molding 326 is a single, integrally molded component including a body portion 1108, a spring member 1104, and a cam path 1106. The proximal end 328 of the housing 20 has parallel walls 1100 defining a channel 1110 in which the body portion 1108 is received. The width of the channel 1110 is selected such that the body portion 1108 is retained within the channel 1110, yet is still able to slide up and down within the channel 1110 during use, as described below. To this end, the snap-in molding 326 is preferably made of a low-friction material, such as polytetrafluoroethylene (PTFE), to allow the body portion 1108 to slide easily within the channel 1110 without sticking.For further stability in the channel 1110, a shaped pin 330 may be provided in the housing 20, which engages a cam slot 331 provided on the body portion 1108, as shown in FIG. Fig. 46 shown.
[0086] The spring 1104 is placed at the end of the body portion 1108 and is arranged to bias the body portion 1108 upwardly within the channel 1110 toward the distal end of the housing 20. The spring 1104 may have any suitable construction; for example, the spring 1104 may have a curved shape or a loop shape, as shown in Fig. 11. The cam path 1106 is a protruding molded portion formed on the body portion 1108. The cam path 1106 includes a first cam surface 1112, a groove 1114, and a second cam surface 1116 to form a V-shaped molded portion.
[0087] The locking member 324 consists of an arm 1118 extending from the bottom of the clamp handle 22. The arm 1118 has a pin 1120 disposed at its end and adapted to move along the cam path 1106.
[0088] In use, the latching element 324 is inserted into the housing 20 through an opening 1102. The pin 1120 engages the latching molding 326 so that the body portion 1108 is pulled downward in the channel 1110, thereby expanding the spring 1104. As shown in Fig. 26b-c, the pin 1120 moves along the side of the first cam surface 1112 until it reaches the top of the "V." At this point, the clamp handle 22 can be depressed no further, and the spring 1104 pulls the body portion 1108 upward again within the channel 1110, causing the pin 1110 to push into the groove 1114, thereby holding the clamp handle 22 in the depressed position and the clamp jaws 14 in the closed position, as shown in Fig. 26d shown.
[0089] To engage the clamping handle 22, the user simply needs to activate the clamping handle in the fully depressed position, wait until the pin 1110 engages the groove 1114, and then release the clamping handle 22. In this engaged position, the user's hand is free to perform other functions of the instrument 1, such as operating the cutting mechanism using the trigger 24, rotating the clamping jaws 14 using the rotary wheel 28, or operating the electrodes in the clamping jaws 14 using the switch 26.
[0090] To release the locking element 324 from the housing 20 and open the clamping jaws 14, the user must push the clamping handle 22 once more toward the housing 20. This releases the pin 1120 from the groove 1114, as shown in Fig. 26e. When the pin 1120 exits the groove 1114, the force of the preloaded spring 1104 pulls the body portion 1108 back up in the channel 1110, so that the pin moves along the side of the second cam surface 1116, as shown in Fig. 26e-f. When the pin 1120 reaches the bottom of the second cam surface 1116, it pushes the body portion 1108 further upward within the channel 1110, allowing the pin 1120 to exit the opening 1102. The body portion 1108 can then return to its original position within the channel 1110.
[0091] To release the clamp handle 22, the user simply needs to push the clamp handle 22 toward the proximal end of the housing 20 and then allow the clamp handle 22 to return to its original open position.
[0092] Furthermore, the latching molding 324 may include an override button 4600 integrally formed on the body portion 1108, as shown in Fig. 46, wherein the override button 4600 is engaged to change the position of the cam path 1106 such that the pin 1120 automatically exits the groove 1114 and releases the clamp handle 22. Consequently, if the locking mechanism were to fail for any reason, the user would be able to release the clamp handle 22 to open the jaws 14.
[0093] The body portion 1108 may further be provided with an integrated locking bar 4602 to allow the user to release the entire locking mechanism, wherein the locking bar 4602 is movable between a first and a second position to manually slide the body portion 1108 within the channel 1110. When the locking bar 4602 is in the first position, the body portion 1108 is in its normal position, so the locking mechanism operates as above. The user can then move the locking bar 4602 to its second position, which moves the body portion 1108 upwardly within the channel 1110, allowing the pin 1120 to pass only through the second cam surface 1116, thereby preventing it from engaging the groove 1114.
[0094] Such a locking mechanism is also suitable for many end effectors. For example, such a locking element can be provided on the trigger 24 for the cutting mechanism to hold the cutting blade 340 in the activated position.
[0095] Upon release of the locking element 324, the clamp handle 22 can be moved back to its original position. In doing so, the collar ring 304 releases the load exerted on the proximal flange 800 and pushes against the distal flange 802, thereby pulling the collar ring molding 310 back to its original axial position. Consequently, the spring 312, the inner molding 314, and the drive shaft 316 are also axially retracted, which in turn returns the clamp jaws 14 to the open configuration. 4. Arrangement and operation of the cutting mechanism
[0096] Various features and aspects related to the structure and operation of the cutting mechanism will now be described. As described above, the proximal handle portion 10 of the electrosurgical instrument 1 includes a second mechanism for actuating another aspect of a distal end effector 14. For example, the end effector 14 may be a set of opposed jaws 14 and a blade 340, with the distal end of the blade 340 arranged to slide between the jaws 14 to cut tissue clamped between these jaws 14. The mechanism used to initiate movement of the blade 340, which is arranged in a central track 342 of the drive shaft 316, is called the cutting mechanism.The cutting mechanism includes a drive arm 2000, a blade drive molding 346, a blade collar ring molding 348, a blade molding 352, and a tension spring 350, all coupled together to form a 3-pivot point slider crank mechanism, as shown in FIG. Fig. 20a-b and Fig. 31 and Fig. 32 shown.
[0097] The drive arm 2000 is formed from a trigger 24 and the trigger molding 344, wherein the trigger 24 is a finger-gripping element for triggering the cutting mechanism and the trigger molding 344 is a collar ring with a C-shaped side profile and an opening 364 through which the drive shaft 316 is inserted. The point at which the trigger 24 and the trigger molding 344 meet forms a pivot point A about which the drive arm 2000 is rotated. This first pivot point A is anchored to the housing 20, for example, by means of outwardly facing pins 358 connected to corresponding moldings 356 formed integrally with the shell moldings 300, 302.
[0098] The distal end of the drive arm 2000, i.e., the end of the trigger molding 344, is pivotally connected to the blade drive molding 346 to form a second pivot point B. The blade drive molding 346 is an H-shaped frame with two parallel arms and a strut therebetween. Thus, the parallel arms of the blade drive molding 346 are pivotally connected to the trigger molding 344 at one end, for example, by means of outwardly facing pins 366 and mating connectors 368. At the opposite end, the parallel arms of the blade drive molding 346 are also pivotally connected to the blade collar ring molding 348 to form a third pivot point C, for example, by means of outwardly facing pins 372 and mating connectors 370.
[0099] As in Fig. 21 to 23, the blade collar ring molding 348 is a cylindrical or barrel-shaped component having a chamber 2104 in which the blade molding 352 sits, wherein the blade molding 352 is a cylindrical or barrel-shaped component having a body 362 that fits into the chamber 2104 of the blade collar ring molding 348. The blade molding 352 further includes a flange 360 having a diameter that is larger than that of the chamber 2104 such that the flange 360 abuts against the distal lip edge 2200 of the blade collar ring molding 348, as shown in Fig. 22. Consequently, the flange 360 ensures that the correct end of the blade molding 352 is inserted into the blade collar ring molding.
[0100] The body 362 is provided with a small groove 2202 around its periphery to provide a shoulder that engages the distal nose 2200, so that the blade molding 352 and the blade collar ring molding 348 are connected to each other via a snap-fit connection. The distal lip edge 2200 mates with the groove 2202 to retain the blade molding 352 within the blade collar ring molding 348 while allowing the blade molding 352 to rotate freely within the chamber 2104. Thus, the blade molding 352 and the blade collar ring molding 348 are free to rotate concentrically.
[0101] Once the blade collar ring molding 348 and the blade molding 352 are assembled, the blade 340 can be assembled as shown in Fig. 24a-c. In this regard, the blade molding 352 includes a T-shaped opening 2300 extending along its length and shaped to receive both the blade 340 and the drive shaft 316, as shown in Fig. 23 shown.
[0102] The proximal end of the blade 340 includes an engagement element 2102 that extends further than the general profile of the remainder of the blade 340, that is, it does not lie in the same axial plane. As shown in Fig. As shown in Figure 24c, the body 362 further includes a recess 2100 in which the engagement element 2102 is retained. To facilitate positioning, the proximal end of the blade 340 is cut at a first point opposite the engagement element 2102 to provide a beveled edge 2400 and is cut at a second point adjacent the engagement element 2102 to provide a recessed portion 2402. Thus, the proximal end of the blade 340 has an L-shaped profile.
[0103] In order to arrange the blade 340 in the arrangement of blade molding 352 and blade collar ring molding 348, the blade 340 is aligned at an angle to the longitudinal axis of the instrument 1 opposite the T-shaped opening 2300 such that the engagement element 2102 and the beveled edge 2400 can be introduced into the inner cavity 2404 of the blade molding 352, as in Fig. 24a-b. Then, the blade 340 is pulled downward in line with the longitudinal axis to press the engagement element 2102 into the recess 2100, as shown in Fig. 24c. Thus, the engagement element 2102 is effectively hooked to the shoulder 2406 of the blade molding 352, thereby retaining the proximal end of the blade 340 within the internal cavity 2404.
[0104] The drive shaft 316 can then be inserted through the T-shaped opening 2300 with the blade 340 received in the central track 342 as shown by Fig. 22 and Fig. 23. Thus, longitudinal movement of the assembly of blade collar ring molding 348 and blade molding 352 along drive shaft 316 displaces blade 340 along path 342.
[0105] To complete the blade trigger assembly, a tension spring 350 extends between the blade collar ring molding 348 and the drive arm 2000, for example, by means of hooks 2002, 2004.
[0106] During use, the user pulls the trigger 24 back to the housing 20 as shown in Fig. 25b-c, such that the drive arm 2000 is pivoted about the first pivot point A. This forces the second pivot point B forward in the distal direction, causing the drive molding 346 to force the assembly of blade collar ring molding 348 and blade molding 352 along the drive shaft. The load exerted on the trigger 24 is therefore transferred via the trigger molding 344 and the drive molding 346 to the blade collar ring molding 348 and the blade molding 352. Because the proximal end of the blade 340 is retained in the blade molding 352 as described above, the blade 340 slides along the central track 342 with the assembly of the blade collar ring molding 348 and the blade molding 352. Because the blade molding 352 is independently rotatable within the blade collar ring molding 348, the drive shaft 316 can be rotated without affecting the operation of the cutting mechanism.
[0107] The operation of the mechanism is optimized to provide good force transmission at the beginning of the path of the blade 340, when the user's finger is extended and less powerful, and also at the end of the path of the blade 340, where more forces act against the path of the blade 340, such as the force of the spring 350, friction within the track 342, and the force required to penetrate thick tissue. As can be seen from Fig. As can be seen in Figure 27, a constant force is exerted by the user on the trigger 24. The mechanism converts this trigger force into a high output force of the blade 340, which decreases as the blade 340 is displaced along the path 342 and increases again when the blade 340 reaches the jaws 14. When the pivot point B moves from its retracted position to its advanced position, as shown in Fig. 28a-b, such that β > 90°, the speed at which the blade collar ring 348 and the blade molding 352 are translated along the drive shaft 316 is increased, thereby increasing the force of the blade 340. Thus, the mechanism is capable of advancing the blade 340 with sufficient force to effectively cut the tissue clamped between the jaws 14 without the user having to apply additional force to the trigger 24.
[0108] Furthermore, the cutting mechanism may be required to slide the blade 340 around a curved set of jaws 14, which increases the frictional forces opposing the movement of the blade 340. The frictional force is a product of the coefficient of friction of the blade 340 within the path 342 and the force the blade 340 exerts on the walls of the path 342 as a result of the flexion.
[0109] To reduce this frictional force, the lateral flexibility of the distal end of the blade can be graded. Such graded flexibility can be achieved, for example, by preferably weakening the blade 340 such that it is able to bend along the path 342 while remaining rigid in the direction of the cutting force. A preferred weakening can be achieved, for example, by providing one or more openings or one or more slots 354 in the distal end, as shown in Fig. 47a. Such openings may be of constant or varying size or shape, depending on the required degree of flexibility. For example, in Fig. 47b, two adjacent openings 4702, 4704 of different sizes are provided, with the larger opening 4702 providing a higher degree of flexibility than the smaller opening 4704. As a further example, in Fig. 47c, three openings 4706, 4708, 4710 of varying size and shape are provided, with the largest opening 4706 being located most distally to provide increased flexibility in this region. A preferred weakening may be further achieved by graduating the thickness of the blade 340 so that the distal end of the blade 340 is beveled 4700, as shown in Fig. 47d shown.
[0110] Alternatively, patterned laser cuts 4712 or chemical etching in the distal end may be applied to control the flexural strength over a length of the blade 340, as shown in Fig. 47e, where the distance between such cuts can be constant or increase gradually from the distal to the proximal end.
[0111] Preferably, the blade 340 is divided into at least three regions of varying flexibility, for example, a distal region, a middle region, and a proximal region, wherein the distal region has greater lateral flexibility than the middle region, and the middle region has greater flexibility than the proximal region. For example, the distal region may be formed by a beveled end 4700 to provide the greatest degree of flexibility; the middle region may be formed with an opening 354 to provide a relatively lesser degree of flexibility; and the proximal region may be formed by a solid rod to provide even less flexibility, as in Fig. 47a. In another, in Fig. In the example shown in Figure 47b, the distal region has a large opening 4702 to provide the greatest degree of flexibility; the middle region includes a smaller opening 4704 to provide reduced flexibility; and the proximal region is again a solid rod with the least degree of flexibility. The distal region, the middle region, and the proximal region can be obtained using any suitable combination of the preferred weakening described above.
[0112] Another way to reduce the frictional force due to the curved path is to apply a low-friction coating to at least one side of the distal end of the blade 340. For example, the blade may be coated, for example, using physical vapor deposition (PVD) or chemical vapor deposition (CVD) processes with a low-friction or non-stick material, such as a PTFE composite or other low-friction polymer composite. 5. Drainage openings
[0113] Various further features and aspects relating to the structure of the drive shaft 316 will now be described. As described above, the drive shaft 316 is an elongated rod having a T-shaped cross-section, as shown in Fig. 10a. The drive shaft 316 includes a slot or track 342 along its length adapted to receive another elongated member, such as the cutting blade 340 used in the cutting mechanism described above. In one application, the cutting blade 340 is caused to slide along the length of the drive shaft 316 to displace the distal end of the cutting blade 340 between the jaws 14 to cut tissue clamped therebetween.
[0114] Over time, blood and tissue can accumulate in the distal end of the instrument 1, particularly along the outer shaft 12 and the drive shaft 316. This accumulation of blood and tissue can cause the blade 340 to stick in the drive shaft 316, reducing the functionality of the instrument 1, particularly the cutting mechanism. To prevent this, portions of the distal end of the drive shaft 316 are cut out to reduce the contact area between the drive shaft 316 and the blade 340, and thus also the surface area to which blood and tissue can stick.
[0115] These cut-out sections can create openings such as those in Fig. 10b-c, such that the distal end of the drive shaft 316 includes a supporting base with bifurcated sidewalls. The cutout portions may also extend to the base of the drive shaft 316 such that the distal end includes bifurcated sidewalls and an open bottom. To maximize the amount of drainage provided by these openings 1000, the openings preferably constitute more than 50% of the depth of the drive shaft 316.
[0116] Thus, these openings provide 1000 drainage openings between the central track 342 and the exterior of the drive shaft 316. 6. Rotary wheel and switch
[0117] Various further features and aspects relating to the operation of the adjustment wheel 28 (also referred to herein as the rotary wheel) will now be described. The adjustment wheel 28 is provided to allow the user to rotate the outer shaft 12, upon which the end effector 14 is mounted. To reduce the required space and thus create a more compact instrument, the internal volume 1300 of the adjustment wheel 28 is also used to provide movement space for the inner molded part 314, which forms part of the previously described clamping mechanism. With such an arrangement, a more compact mechanism can be obtained.
[0118] In detail, the rotary wheel 28 (also referred to herein as the thumbwheel) comprises a tooth-like plastic wheel having a plurality of notched portions 336 arranged around its outer diameter. The thumbwheel 28 has the appearance of a gear, with the notched, cut-out portions arranged to ergonomically accommodate a user's thumb. In this regard, and as shown in Fig. 13a, Fig. 13b, especially in Fig. 14a, the notched portions are at an angle to the rotational plane of the adjustment wheel during use, so that in general, the adjustment wheel or rotary wheel 28 has a slightly frustoconical shape that is wider at an end remote from the user than at the end closest to the user. The notched portions 336 each extend from the distal edge of the adjustment wheel to the proximal edge and are curved or saddle-like in shape to accommodate a user's thumb during use. As detailed in Fig. 14a, the angular shape of the notched portions 336 to achieve the truncated cone shape of the rotary wheel 28 generally matches the angle of the body of the instrument. In Fig. In Figure 14a, the dot-dash lines illustrate the angular shape of the notches 336 around the edge of the wheel 28, which can be viewed distally as tangential to the angle of the instrument's outer walls at the point around the wheel, and particularly the portion of the instrument's outer walls immediately forward of the wheel. Such an arrangement, in which the angled notches of the outer edge of the rotary wheel match the angle of the instrument's wall around the wheel, provides a comfortable and ergonomic shape that is easy to use by the surgeon.
[0119] With respect to the number of notched portions 336 around the outer diameter of the wheel 28, as shown in one embodiment, eight notched portions are evenly spaced around the outer diameter of the wheel. In other embodiments, a fewer or greater number of notched portions may be used, for example, as few as six or seven, or as many as nine or ten. If a larger wheel 28 is to be employed, a greater number of notched portions 336 may be provided; conversely, if a smaller wheel is to be employed, the number of portions may be fewer. In this regard, the actual size of each notched portion 336 should typically remain the same, as the notched portions are ergonomically selected to comfortably accommodate a user's thumb.
[0120] Regarding the positioning of the adjusting wheel 28 within the instrument, as shown in Fig. 2, the rotary or adjusting wheel 28 is positioned vertically aligned below the switch 26 and is spaced from the adjusting wheel in a direction orthogonal to a longitudinal axis, which is defined, for example, by the longitudinal direction of the drive shaft 316. In particular, the hand switch 26 lies directly on an axis orthogonal to this longitudinal axis, which also passes through the adjusting wheel 28. Furthermore, as shown in Fig. 14a and Fig. 14b, the switch 26 is relatively large and extends across the dial from one side of the instrument's upper surface to the other. The switch 26 is curved in nature to generally match the curved upper surface of the instrument's outer wall and has ridges, grooves, or other raised projections on its outer surface to assist the user in grasping the switch for depressing it with their thumb. The surface area of the switch 26 is relatively large, namely more than 3 cm 2 or even 5 cm 2This provides a large surface area to allow ergonomic activation by the user. The vertical orientation of switch 26 directly above control wheel 28 also allows ergonomic activation. As explained elsewhere, switch 26, when in use, serves to cause an RF coagulation signal to be delivered to the end effector for coagulating tissue therein.
[0121] Regarding the ergonomics of the switch and the adjustment wheel, Fig. 35a and Fig. 35b shows two corresponding representations of different users with hands of different sizes. As shown, the switch 26, because it has a relatively large surface area, is easy to operate by users with hands of different sizes while simultaneously operating the clamp handle 22 (and the blade trigger 24, if desired).
[0122] Back to Fig. 12, as previously described, the adjusting wheel 28 has an internal cavity 1300 which, in use, is received within the inner mold part 314. As previously described, the inner mold part 314 includes a chamber 610 and has a T-shaped severed portion 1208 therein through which the drive shaft 316 is received and secured, as previously described. The inner mold part 314 is snapped into the internal cavity of the wheel 28, and flanges 1206, as in Fig. 12 and Fig. 29a and Fig. 29b, are provided around the outer edge of the cylindrical inner cavity 1300 of the adjusting wheel 28 to hold the inner mold part 314 in place within the cavity once it is inserted therein. The inner cavity 1300 of the adjusting wheel 28 is further provided with locking elements 1200 that interact with corresponding locking elements 1202 provided around the outer periphery of the inner mold part 314. The respective locking elements 1200 and 1202 include corresponding raised step portions that fit side-by-side circumferentially around the inner surface of the cavity 1300 when the adjusting wheel 28 and the inner mold part 314 are in the correct rotational alignment relative to each other. The respective locking elements 1200 and 1202 are provided so that, in use, the inner mold part 314 can slide from side to side within the inner cavity of the wheel 28, but cannot rotate within the wheel 28.Instead, the interacting locking elements 1202 and 1200 act such that the inner mold part 314 rotates with the rotary wheel 28 when the latter is rotated. In this way, any torque imparted to the rotary wheel 28 by the user is transferred to the inner mold part 314 and then to the drive shaft 316 to rotate the drive shaft supporting the end effector. Fig. 29a and Fig. 29b show the inner mold part 314 inserted into the inner cavity of the adjusting wheel 28 and illustrate how the inner mold part 314 can slide axially within the inner cavity 1300 of the wheel 28.
[0123] Fig. 13a and Fig. 13b further illustrate in greater detail how the inner mold member 314 is capable of moving within the inner cavity 1300 of the wheel 28. As described above, the drive shaft 316 passes through the T-shaped opening 1208 in the inner mold member 314 and is secured therein by means of projecting snap-lock or latching elements 602 provided on the end of the drive shaft. The latching or locking elements 602 are in the form of spring metal tabs that are also capable of passing through the T-shaped opening 1208 in the inner mold member 314 and are then received in a second channel portion 606 of the inner mold member, forming a cavity that allows the spring tabs to spring apart, thereby securing the drive shaft within the inner mold member. The inner mold part 314 is then pressed into the inner cavity of the adjusting wheel 1208 and held in place by the locking projections 1206, as described above.The inner mold part can move axially within the inner cavity 1300 to engage the inner surface of the distal wall of the wheel 28, as shown in FIG. Fig. 13a, or, at its opposite end of extension, into engagement against the engagement elements 1206 on the distal edge of the wheel. Thus, the inner mold part 314 is provided with a degree of axial sliding movement within the cavity of the adjusting wheel 28, which is required as part of the mechanism for controlling the force exerted by the user on material contained within the jaws, as described above.
[0124] The locking feature of the inner molded part 314 in the inner cavity of the adjusting wheel 28 greatly improves the assembly of the device and makes the assembly of the device significantly easier and therefore cheaper. To position the adjusting wheel in the housing, as shown in Fig. As shown in Figure 33, the outer distal wall 1310 of the adjusting wheel 28 is concentric with and flush with an inner support wall 1320 provided as a projection from the housing of the device. This also allows for easy and accurate assembly and positioning of the wheel 28 within the housing. 7. Rotation control of the drive shaft
[0125] As explained above, the shaft 12 with the end effector 14 thereon is rotatable to allow the end effector 14 to be moved to desired rotational positions for cutting and coagulating tissue. However, to prevent the cable connections to the end effector from being overstressed by excessive rotation of the shaft in one direction, causing the cabling to become coiled, twisted, or subjected to excessive stress, a mechanism for controlling the rotation of the shaft 12 is required, particularly to limit the amount of rotation and thus prevent excessive stress on the cabling. Furthermore, positive control of the rotation of the shaft 12 improves the ergonomic experience of the instrument during use and the user's perception of quality.
[0126] To provide rotation control of the shaft, in one embodiment, an arrangement shown in Fig. 15a and Fig. 15b and Fig. 16a to 16d. With respect to Fig. 15, the adjusting wheel 28 is provided with notched portions 36 on its proximal surface (i.e., rear surface facing the user) with a ring 1506 that projects slightly from the proximal surface, which is concentrically aligned with the axis of the wheel 28. The ring 1506 rests, in use, on guide stop elements 1502 and 1504, which are projections on the inner surface of the outer housing that project to be able to contact the outer periphery of the ring 1506. Because of their positioning on the housing with respect to the axis of the ring, the stop member 1502 is smaller than the stop member 1504, but both stop members 1502 and 1504 have angled upper guide surfaces 1510 and 1512, respectively (see Fig. 15a) which are in contact with the outer peripheral surface of the ring 1506, which forms part of the adjusting wheel, and help to support and guide the adjusting wheel during its rotation.
[0127] In addition to providing a guiding function, the stop members 1502 and 1504 also function as a stop member to prevent rotation of the adjusting wheel beyond the angular position of the stop members. To this end, the ring 1506 is provided with a rectangular stop projection 1500 extending radially therefrom. When the adjusting wheel 28 is rotated, the stop projection 1500 abuts against corresponding stop surfaces 1514 and 1516 of the stop members 1502 and 1504. The stop surfaces are angled to be parallel to the rectangular stop projection 1500 when the stop position is positioned at an angle to abut them.
[0128] The stop members 1502 and 1504 arranged as described above are positioned and of such a length that they provide a known rotational dimension of the wheel 28 from the stop member 1500 to the stop element 1502. In the presently described and in Fig. 15a and Fig. In the arrangement shown in Figure 15b, the stop members 1502 and 1504 are positioned on the housing at a distance from each other to allow the adjustment wheel to rotate 270° from stop to stop. The degree of rotation can be easily varied by increasing or decreasing the distance between the stop members, with the stop members being adjusted accordingly in terms of the length and angle of the guide and stop surfaces to meet the wheel and the stop members substantially perpendicularly, respectively. For example, the stop members can be positioned and shaped to provide an angular rotation of the wheel between 250° and 300°.
[0129] The above describes the rotation control applied to the thumbwheel (and then, via the thumbwheel, the shaft). Fig. 16a to 16d show another rotation control mechanism applied to the shaft at the opposite end of the shaft using the shaft molding 320. Here, the shaft molding is provided with a rectangular stop member 1600 projecting therefrom. The inner surface of the outer housing is further provided with corresponding molded stop members 1602 and 1604, shown as a member with steps that provide corresponding stop surfaces that offer corresponding parallel stop surfaces to the rectangular stop member 1600 at corresponding angular positions of the shaft molding 320. In the example shown, the molded stop members are positioned on the housing and offer corresponding stop surfaces to the stop member 1600 to allow 270° of rotation of the shaft 12, moving the end effector from stop to stop.In further embodiments, the molded stop portions 1602 and 1604 may be positioned to provide stop surfaces to the stop element 1600 at other rotational angular positions of the molded portion 320 to provide a greater or lesser degree of rotation, for example, from 180° to 360°, or more preferably from 250° to 300°, or most preferably 270°.
[0130] The corresponding rotation control mechanisms provided in the adjusting wheel 28 and in the shaft molding 320 can be provided independently of one another, i.e., they do not both have to be provided in a particular embodiment, but rather only one or the other can be provided to provide rotation control of the shaft. However, it is advantageous in terms of operation and perceived quality of the device if both rotation control mechanisms are provided in one device and are aligned such that they provide a stopping of the rotation at the correspondingly same points in both directions of rotation. Such an arrangement means that the rotation of the shaft is stopped independently at both ends of the handle portion 10, and it becomes very difficult for a user to force further undesired rotation of the shaft beyond the permitted limits set by the stops.
[0131] An alternative rotation control mechanism is in Fig. 36 and Fig. 37 shown. Fig. Figure 36 again shows the shaft molding 320, but here the molding is provided with a ring 3220 on which are mounted a primary rectangular stop element 3202 extending radially therefrom and secondary position marking elements 3204, 3206, and 3208 arranged substantially equiangularly around the ring 3220, preferably in orthogonal positions. The secondary position marking elements 3204, 3206, and 3208 form small raised projections that are not large enough to engage the stop surfaces 3212 and 3214.
[0132] The stop surfaces 3212 and 3214 are provided as integral molded parts with the outer housing and are positioned here to allow rotation of the shaft molding 320 by 180°. In this regard, the stop element 320 comes into contact with the stop surfaces 3212 and 3214 at the ends of the rotation range to prevent further rotation of the shaft molding. Thus, as in Fig. 36a to 36c, the shaft molding 320 carrying the shaft 12 can rotate over 180° to allow rotational positioning of the end effector as desired.
[0133] Further provided is a resilient protrusion 3216 comprising a plastic protrusion of substantially triangular cross-section extending upwardly from the molded part-forming stop surface 3214 such that its tip contacts an outer peripheral surface of the ring 3220. The secondary position markers in the form of small, raised protrusions press against the tip of the resilient protrusion when the shaft molded part 320 rotates, causing the tip of the resilient protrusion to move from its rest position to allow the corresponding protrusion to move past the tip.The effect of this process is to provide some user feedback, as the user must apply more force to move the mechanism past the rotational positions where the raised protrusions contact the tip of the resilient protrusion, as sufficient force must be provided for the tip of the resilient protrusion to flex in order for the protrusion to move past the tip. The result is that the user perceives an increase in the force required to rotate the shaft beyond the rotational positions of the raised protrusions, and thus an intuitive indication of the rotational position of the shaft and, hence, the end effector is provided to the user. Such a haptic feedback mechanism therefore allows for user-friendly and simple operation of the device.
[0134] Fig. 37 shows the corresponding setting wheel 28 for the mechanism in Fig. 36. Here, the thumbwheel is also provided with respective small stops 3222, arranged orthogonally at 90° intervals around the thumbwheel. A similar mechanism may be provided for the resilient projection 3216 extending from the housing to provide similar haptic feedback as in the case of the stem molding 320. In such an arrangement, haptic feedback regarding the rotational position of the stem is provided from both ends of the handle, thus improving the user's perception of the device. 8. Cabling
[0135] At this point, further features and aspects relating to the wiring within the handle 10 will be described. As described above, the switch button 26 is provided to enable and disable the RF signal for operating the electrodes in the end effector 14 via a suitable circuit, for example, via two intrusion-proof switches on a small printed circuit board (PCB) 338. As shown in Fig. 17, the PCB 338 is connected to a connecting line 1700 for receiving the RF output from a generator (not shown) and electrical wiring 1702, 1704 for providing the RF current to the electrodes in the jaws 14, for example, a cable for the active electrode and one for the counter electrode.
[0136] In the arrangement, the wiring 1702, 1704 is routed from the electrodes down the outer shaft 12, along the drive shaft 316 and up to the shaft molding 320, as shown by Fig. 17. As shown in Fig. As shown in Figure 9b, the shaft molding 320 is a cylindrical or barrel-shaped component with an opening 912 at the distal end to receive the outer shaft 12. The outer shaft 12 is secured to the shaft molding 320, for example, by locking projections 900 that cooperate with corresponding grooves 902 in the shaft molding 320. Consequently, when the shaft molding 320 rotates, the outer shaft 12 rotates with it. The shaft molding 320 further includes another opening 914 at the proximal end, the opening 914 having a T-shape to receive the drive shaft 316, which extends through the internal cavity 1802 of the shaft molding 320 and down the length of the outer shaft 12. Thus, the drive shaft 316 is able to slide within the shaft molding 320 and the outer shaft 12, but any rotational movement of the drive shaft 316 is transmitted to the shaft molding 320 and subsequently the outer shaft 12.
[0137] As in Fig. As shown in Figure 18a, the electrode cables 1702, 1704 are guided from the inner cavity 1802 through an opening 1800 in the wall of the shaft molding 320 before being wrapped over and around the body 1804 of the shaft molding 320. Wrapping the cables 1702, 1704 around the shaft molding 320 in this manner keeps the cables 1702, 1704 in a compact arrangement to prevent the cables 1702, 1704 from interfering with the assembly of the rest of the instrument 1. Furthermore, the winding of the cables 1702, 1704 around the shaft molding 320 means that when the shaft molding 320 rotates with the drive shaft 316, the cables 1702, 1704 unwind and rewind with the rotation without the cables 1702, 1704 being overstretched and thereby short-circuited. In particular, winding the cables 1702, 1704 in this particular manner allows up to 270° of rotation, as described with respect to Fig. 15ab and Fig. 16a-d.
[0138] The electrical wiring 1702, 1704 is then routed along the top of the housing 20. In this regard, one of the tray moldings 300 is provided with two compartments 1900, 1902 arranged side by side to receive the cable contacts 1904, 1906 that connect the active and return cables 1702, 1704 to the wiring 1908, 1910 of the intrusion-resistant switches 338. All electrical cables 1702, 1704, 1908, 1910 are routed into and around the compartments 1900, 1902, so that only one contact 1904, 1906 is accommodated in each compartment 1900, 1902. Routing of the cables may be facilitated by guide sections 1912, 1914, 1916 that guide a set of cables 1702, 1910 around the exterior of the compartments 1900, 1902. In each compartment, the respective active cable 1702 is longitudinally aligned with the cable 1908, and the return cable 1704 is longitudinally aligned with the cable 1910.
[0139] Consequently, the two cable contacts 1904, 1906 are longitudinally separated so that only one contact can pass through each compartment 1900, 1902, providing a physical barrier between each contact 1904, 1906 and the wiring. This eliminates the risk of damage to the insulation of one of the cables by the contacts 1904, 1906 themselves.
[0140] The cables 1702, 1704, 1908, 1910 are all inserted into their respective compartments 1900, 1902 via small openings 1918, 1920, 1922, 1924 in the compartment walls. Preferably, the dimensions of the openings 1918, 1920, 1922, 1924 are such that only one electrical cable passes through. The opposing shell molding 302 also includes corresponding rib members (not shown) to retain the contacts 1904, 1906 in the compartments 1900, 1902, forming a substantially sealed housing. This is important to minimize the permeability of the compartments 1900, 1902 to protect the contacts 1904, 1906 from any fluid that might penetrate along the outer shaft 12 and into the housing 20, which would cause short-circuiting of the contacts 1904, 1906. 9. End effectors
[0141] Exemplary end effectors that can be used with the device will now be described. The examples to be described are mentioned only for the sake of completeness, and it is clear that other end effectors can be used with the instrument, provided they are capable of being driven by the drive shaft 316. This means that embodiments of the invention are not limited to the specific end effectors described herein, but other end effectors can also be used.
[0142] Fig. 38 to 44 show exemplary instruments in which electrically conductive stop elements are arranged on one or both of the sealing electrodes. With respect to Fig. 38, an end effector, generally indicated at 3801, includes an upper jaw 3802 pivotally connected to a lower jaw 3803 about a pivot point 3804. Flanges 3805 are provided at the proximal end of the upper jaw 3802, while flanges 3806 are provided at the proximal end of the lower jaw 3803. The flanges 3805 and 3806 each have slots 3807 through which a drive pin 3808 extends such that proximal and distal movement of the drive pin 3808 (via a drive mechanism (not shown)) causes the jaws 3802, 3803 to pivot between an open and a closed position.
[0143] A metallic clamp 3809 is provided on the inner surface of the upper jaw 3802, while a metallic clamp 3810 is provided on the inner surface of the lower jaw 3803. When the jaws 3802, 3803 pivot to their closed position, the metallic clamps 3809, 3810 come close to each other to grasp tissue (not shown) between them.
[0144] The upper clamp 3809 has a generally planar surface, except for an elongated depression (in Fig. 38 not visible) running along its length. The lower clamping piece 3810 has a corresponding recess 3811, wherein the recesses in the clamping pieces 3809, 3810 accommodate the longitudinal movement of a cutting blade (not shown). The lower clamping piece 3810 is further provided with a plurality of metallic stop elements 3812 arranged along the length of the clamping piece and on both sides of the recess 3811. The stop elements 3812 will now be described with reference to Fig. 39 and Fig. 40 will be described in more detail.
[0145] Each metallic stop element 3812 consists of the upper bulge of a stop element 3813 received in an insulating element 3814 so as to enclose the stop element, isolating it from the rest of the clamping piece 3810. Each insulating element 3814 and stop element 3813 is disposed in a corresponding opening 3851 provided in the clamping piece 3810, so that the upper portion of the insulating element forms an insulating ring 3816 around each stop element 3812.
[0146] When the clamping jaws 3802, 3803 are moved to their closed position (as in Fig. 40), the stop elements 3812 contact the upper clamp 3809, maintaining a separation between the upper and lower clamps of between 20 µm and approximately 350 µm (0.00079 inches to approximately 0.014 inches). In use, an electrosurgical coagulation voltage is applied between the clamps 3809, 3810, and the separation between the clamps ensures effective sealing of tissue grasped between the jaws 3802, 3803. At the same time, electrical shorting between the clamps is prevented because the stop elements 3812 are electrically insulated so that they do not carry the same electrical potential as the rest of the clamp 3810.The metallic stop elements 3812 are rigid, allowing consistent separation of the surfaces of the clamping pieces, while it is feasible for the electrical potential of the stop elements 3813 to be monitored to detect when they contact the upper clamping piece 3809 to indicate the closing of the clamping jaws.
[0147] Fig. 41 to 43 show an alternative arrangement in which the metallic stop elements 3812 are mounted directly on the lower clamping piece 3810, without the insulating elements surrounding the stop elements. In this arrangement, insulating elements 3817 are provided on the upper clamping piece 3809 in corresponding relationship to each of the stop elements. In this manner, when the jaws 3802, 3803 are closed, the insulating elements 3817 ensure that no electrical shorting occurs between the upper clamping piece 3809 and the lower clamping piece 3810. The metallic stop elements 3812 ensure that the appropriate separation of the jaws is maintained during the application of electrosurgical energy to seal tissue grasped between the jaws.
[0148] Fig. 44 finally shows a further alternative in which the metallic stop elements 3812 are again mounted directly on the lower clamping piece 3810. In this arrangement, a metallic counter-holder 3818 is arranged opposite each stop element, wherein each metallic counter-holder 3818 is surrounded by an insulating element 3819 in order to be insulated from the rest of the upper clamping piece 3809. When the clamping jaws are closed, metal-to-metal contact occurs between the stop elements 3812 and the metallic counter-holders 3818, wherein the insulation of the counter-holders ensures that electrical short-circuiting between the clamping pieces 3809, 3810 is again prevented. Here, too, the electrical potential of each of the metallic counter-holders can be monitored to detect when they assume the potential of the lower clamping piece, which indicates the closing of the clamping jaws. 10. Electrosurgical system
[0149] With reference to Fig. 45, the instrument 1 is provided, in use, to be connected to an electrosurgical generator 4500 having a controllable radio frequency (RF) source therein (not shown) which, in use, generates an RF coagulation signal that coagulates or seals tissue when applied thereto via the electrodes of the end effector of the instrument 1. The electrosurgical generator 4500 includes control input switches 4504 and 4502 to respectively allow the generator to be turned on and off and to allow controlling the power of the RF coagulation signal delivered to the instrument 1. In this respect, the electrosurgical generator 4500 is conventional.
[0150] The instrument 1 is connected, in use, to the generator 4500 by a control and power supply line 4506, which includes separate electrical lines to allow delivery of an RF signal to the end effector of the instrument 1 via the previously described internal wiring, and further to allow receipt of a control signal from the switch 26 of the instrument 1 to cause the electrosurgical generator to output an RF coagulation signal for the instrument 1. In use, the surgeon activates the generator via an on / off switch 4504 and selects the coagulation or sealing signal strength to be generated by the internal RF source using knobs 4502.During a surgical procedure using the instrument, when a sealing or coagulation RF signal is required at the end effector, the surgeon controls the generator to generate such a signal by pressing the instrument's switch 26. The generated RF signal is then transmitted to the end effector via electrical leads 4506. That is, pressing switch 26 during use causes the delivery of an RF coagulation or sealing signal to the appropriate electrodes contained within the end effector. 11. Summary
[0151] In light of the above, embodiments of the invention therefore provide an advanced electrosurgical forceps instrument that allows for simple and ergonomic one-handed operation by the user, provides rotational flexibility of the end effector, controls the force applied by the end effector to the grasped tissue to prevent excessive force from being applied, and allows for convenient mechanical cutting of the grasped tissue while simultaneously providing electrosurgical coagulation or sealing of the tissue. Furthermore, the instrument was designed to be easily and inexpensively assembled while simultaneously providing a compact instrument thanks to efficient use of the available space in its internal activation mechanism.
[0152] Various further modifications to the above-described embodiments, whether by addition, elimination, or substitution, will be apparent to those skilled in the art to provide additional embodiments, each of which, in its entirety, is within the scope of the appended claims.
Claims
[1] Actuating mechanism for a surgical instrument (1), which comprises: a drive shaft (316) connected at its distal end to an end effector (14), wherein longitudinal movement of the drive shaft (316) causes a change in the state of the end effector (14); and an actuating assembly connected to the proximal end of the drive shaft (316) such that movement of the actuating assembly causes movement of the drive shaft (316) in the longitudinal direction, the actuating assembly comprising: a user-operable clamping handle (22) movable from a first position to a second position; a first component (310) having a first chamber (608), the first component (310) being longitudinally movable as the clamping handle (22) is movable from a first position to a second position; a second component (314) having a second chamber (610), the second component (314) being attached to the drive shaft (316) for movement therewith; and a force absorption element (312) having a distal end received within the first chamber (608) and a proximal end received within the second chamber (610), wherein the force absorption element (312) is compressible between the first and second components (310, 314), wherein the arrangement is such that when tissue is engaged by the end effector (14) during use of the actuating mechanism, the force exerted on the end effector (14) by the drive shaft (316) is limited by a compression force of the force absorption element (312), wherein when a user attempts to apply an operating force to the clamp handle (22) that is greater than a desired force, the compression force of the force absorption element (312) is exceeded, the force absorption element (312) is compressed to absorb the force, and the force is not transmitted from the drive shaft (316) to the end effector (14). [2] The actuating mechanism of claim 1, wherein the force absorbing member (312) is a spring, and the first chamber (608) and the second chamber (610) are of corresponding lengths selected such that the force absorbing member (312) does not compress to its block length in any position when the clamp handle (22) is actuated between the first position and the second position. [3] The actuating mechanism of claim 1 or 2, wherein the first chamber (608) comprises at least 25%, and more preferably at least 50%, and even more preferably at least 75%, of the axial length of the first component (310). [4] Actuating mechanism according to one of claims 1 to 3, wherein the second chamber (610) comprises at least 25%, and more preferably at least 50%, of the axial length of the second component (314). [5] An actuating mechanism according to any one of claims 1 to 4, wherein the clamping handle (22) is pivotally mounted so as to be pivotally movable from its first position to its second position, the first component (310) having a flange (800), and the clamping handle (22) having a yoke portion (304), the arrangement being such that the yoke portion (304) of the clamping handle (22) abuts the flange (800) of the first component (310), the pivoting movement of the yoke portion (304) on the clamping handle (22) causing axial movement of the first component (310) in the longitudinal direction. [6] An actuating mechanism according to any one of claims 1 to 5, wherein the drive shaft (316) extends from the first component (310) to the second component (314) within the interior of the force absorption element (312). [7] The actuating mechanism of claim 6, wherein the force absorbing element (312) is a spring and is dimensioned to fit tightly over the drive shaft (316). [8] The actuating mechanism of claim 7, wherein the first and second chambers (608, 610) are dimensioned such that the spring (312) has a close fit with respect to the side walls of the chambers (608, 610). [9] An actuating mechanism according to any one of claims 1 to 8, wherein the drive shaft (316) is connected to the second component (314) using a latching arrangement. [10] An actuating mechanism according to any one of claims 1 to 9, wherein the force absorbing element (312) is compressible between the first and second components (310, 314) to limit the longitudinal movement of the drive shaft (316). [11] Actuating mechanism according to one of the preceding claims, wherein the force absorption element (312) is a spring. [12] Surgical instrument (1) comprising an end effector (14) and an actuating mechanism according to any one of claims 1 to 11 for moving the end effector (14) between a first state and a second state.
Citation Information
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