DK202370195A1

DK202370195A1 - Surgical instrument for minimally invasive surgery

Info

Publication number: DK202370195A1
Application number: DKPA202370195A
Authority: DK
Inventors: Emil Cederfeldt Larsen Frederik; Sølbeck Peter
Original assignee: Flexlogical Aps
Priority date: 2021-05-10
Filing date: 2023-04-25
Publication date: 2023-05-04
Also published as: CN117460470A; DK181495B1; WO2022238258A3; DK202170220A1; DK202370196A1; WO2022238258A2

Abstract

A surgical instrument (1) comprising a hollow shaft (2) and an end effector (3) comprising a first leg (4) pivotally connected to said hollow shaft (2) along a first pivot axis (PA1) and a second leg (5) pivotally connected to said hollow shaft (2) along a second pivot axis (PA2). Linear movement of an elongated actuator element (7), extending within said hollow shaft (2), along a shaft center axis (A1) generates pivoting movement of said first leg (4) and/or said second leg (5). The actuator element (7) comprises at least one linear slot (8) engaging a first cam element (9a) arranged on said first leg (4) and/or a second cam element (9b) arranged on said second leg (5). The first cam element (9a) has a first center axis (A3) and the second cam element (9b) has a second center axis (A4) extending parallel with said first and second pivot axes (PA1, PA2).

Description

DK 2023 70195 A1 1

SURGICAL INSTRUMENT FOR MINIMALLY INVASIVE SURGERY

TECHNICAL FIELD

The disclosure relates to a surgical instrument comprising a shaft and an end effector having a first leg and a second leg pivotally connected to a distal end of the shaft.

BACKGROUND

Minimally invasive surgery requires surgical instruments which engage tissue through small incisions or natural orifices in the body of a patient, and often reduces the recovery time and number of complications in comparison with traditional open surgery.

It is advantageous 1f the minimally invasive surgical instrument can be used for carrying out several related or independent functions. For example, a number of different end effectors can be connected to one instrument shaft, allowing substantially one instrument to be used for different functions such as holding, cutting, or cauterizing tissue.

US 2015/190160 Al shows a surgical instrument comprising an end effector for securely holding and manipulating tissues.

Manipulation includes cutting, sectioning, stapling, clamping, cauterizing, grasping, holding, or scraping of tissue. The end effector includes two arms pivotally connected to one another, at least one of the arms including a plurality of ridges extending in a direction substantially

DK 2023 70195 A1 2 perpendicular to a longitudinal axis of the surgical instrument.

Furthermore, the instrument being safe both for the user and the patient, as well as reliable, is a base requirement on such instruments. For minimally invasive electrosurgical instruments in particular, it/s important that neither the user nor the patient is at risk of being injured by, e.g., any electrical currents traveling through the instrument.

Nevertheless, the instrument has to be as small as possible, at least in directions radial to the instrument center axis, in order to be minimally invasive.

Furthermore, it is preferable if some versatility is built into the minimally invasive surgical instrument, such that the user has the best possible conditions for engaging tissue.

Preferably, the user of the surgical instrument can hold the handle of the surgical instrument ergonomically, e.g. allowing the user to maintain his/her wrist straight, reducing the force necessarily applied by the user onto the handle of the instrument in order to keep the instrument and its end effector closed or opened or to maintain a secure grip on tissue.

Hence, there is a need for providing an improved minimally invasive surgical instrument that is safe and reliable to use while at the same time allowing the user to operate the instrument ergonomically.

DK 2023 70195 A1 3

SUMMARY

It is an object to provide an improved surgical instrument.

The foregoing and other objects are achieved by the features of the independent claims. Further implementation forms are apparent from the dependent claims, the description, and the figures.

According to a first aspect, there is provided a surgical instrument comprising a hollow shaft, an end effector comprising a first leg and a second leg, the first leg being pivotally connected to a distal end of the hollow shaft along a first pivot axis and the second leg being pivotally connected to the distal end along a second pivot axis, the first leg and the second leg being configured to pivot in opposite directions to and from a plane comprising a shaft center axis of the hollow shaft, an actuating arrangement comprising an elongated actuator element extending at least partially within the hollow shaft along the shaft center axis and being configured to move along the shaft center axis, a distal end of the actuator element comprising at least one linear slot configured to engage at least one of a first cam element arranged on the first leg and a second cam element arranged on the second leg, the first cam element having a first center axis and the second cam element having a second center axis, the first and second center axes extending parallel with the first pivot axis and the second pivot axis, linear movement of the elongated actuator element along the shaft center axis generating pivoting movement of the first leg and/or the second leg by means of the engagement of the

DK 2023 70195 A1 4 first cam element and/or the second cam element with the linear slot(s).

This surgical instrument allows the user to maintain a firm grip on the tissue without having to use much gripping or holding force, reducing strain and muscle fatigue for the user/surgeon. Furthermore, it is easier for the user to place and hold the surgical instrument ergonomically, e.g. allowing the user to maintain his/her wrist straight, relative the shaft and end effector, which is comfortable for an extended time period. The configuration of the actuation increases the force applied onto tissue without affecting the size of the surgical instrument. Furthermore, the configuration allows for a simpler and more reliable actuation, simplifying assembly and reducing manufacturing costs.

In a possible implementation form of the first aspect, the first leg and the second leg are pivotally connected to the hollow shaft by means of connection elements, a first connection element being arranged on at least one of the first leg and the second leg, the first connection element (s) being configured to engage at least one second connection element arranged on the hollow shaft, allowing the legs of the end effector to be pivoted around a fixed axis regardless of the actuation procedure.

In a further possible implementation form of the first aspect, the first connection element is a protrusion extending from the first leg and/or the second leg along the first pivot axis or the second pivot axis, and the second connection element is a corresponding recess extending at least into at

DK 2023 70195 A1 least a section of the hollow shaft along the first pivot axis or the second pivot axis, providing a relatively simple connection.

5 In a further possible implementation form of the first aspect, the linear slot(s) extend(s) along a transverse axis, the transverse axis extending between the plane and the first pivot axis, and between the plane and the second pivot axis, the first cam element comprising a first cam surface configured to rotate around the first center axis, and the first pivot axis and the first center axis extending on opposite sides of the plane, the second cam element comprising a second cam surface configured to rotate around the second center axis, the second pivot axis and the second center axis extending on opposite sides of the plane, a first engagement surface of the linear slot(s) being configured to engage the first cam surface of the first cam element, and a second engagement surface of the linear slot(s) being configured to engage the second cam surface of the second cam element, the linear movement of the actuator element along the shaft center axis simultaneously generating rotary movement of the first cam surface around the first center axis, by means of the first engagement surface, and rotary movement of the second cam surface around the second center axis, by means of the second engagement surface, the rotary movement generating the pivoting movement of the first leg around the first pivot axis and the pivoting movement of the second leg around the second pivot axis.

This allows for reliable actuation which has a small form factor such that the size of the surgical instrument can be kept small.

The distance between pivot axes

DK 2023 70195 A1 6 and center axis allows a solution that generates the largest moment, and hence force, possible.

In a further possible implementation form of the first aspect, a distance between the first pivot axis and the first center axis, and a distance between the second pivot axis and the second center axis, remains constant throughout the pivoting movement.

In a further possible implementation form of the first aspect, the first pivot axis extends at a first side of the plane and the second pivot axis extends at a second side of the plane.

In a further possible implementation form of the first aspect, the first cam surface extends at least partially symmetrically around the first center axis and the second cam surface extends at least partially symmetrically around the second center axis, facilitating identical pivoting movement of the first and second legs of the end effector.

In a further possible implementation form of the first aspect, the distal end of the actuator element comprises a first linear slot and a second linear slot extending coaxially along the transverse axis, the first linear slot comprising the first engagement surface configured to engage the first cam surface, and the second slot comprising the second engagement surface configured to engage the second cam surface, allowing the components for pivoting each leg are kept at least partially separate.

DK 2023 70195 A1 7

In a further possible implementation form of the first aspect, the first cam surface comprises a first convex surface and a second convex surface, the first convex surface, and the second cam surface comprises a first convex surface and a second convex surface, the first convex surface and the second convex surface extending symmetrically on opposite sides of the second center axis.

In a further possible implementation form of the first aspect, a distance from the first center axis or the second center axis to a point on the first convex surface is identical to a distance from the first center axis or the second center axis to a symmetrically corresponding point on the second convex surface.

In a further possible implementation form of the first aspect, when the actuator element is in a first end position and simultaneously the end effector is in an open position, the first cam surface is in a first angular position relative the first center axis and the first engagement surface, and the second cam surface is in a first angular position relative the second center axis and the second engagement surface.

In a further possible implementation form of the first aspect, when the actuator element moves in a direction from the first end position, towards the end effector, to a second end position, linear movement of the first engagement surface and the second engagement surface along the shaft center axis generates a force onto the first cam surface such that the first cam element rotates around the first center axis, and onto the second cam surface such that the second cam element

DK 2023 70195 A1 8 rotates around the second center axis, providing a simple yet reliable way of transferring the linear movement of the actuator element to pivoting movement of the legs of the end effector.

In a further possible implementation form of the first aspect, when the actuator element is in the second end position and simultaneously the end effector is in a closed position, the first cam surface is in a second angular position relative the first center axis and the first engagement surface, and the second cam surface is in a second angular position relative the second center axis and the second engagement surface.

In a further possible implementation form of the first aspect, the distal end of the actuator element comprises a protrusion extending along an axis parallel to the first pivot axis, and a protrusion extending along an axis parallel to the second pivot axis, and the first leg comprises a first arched slot configured to engage one of the protrusions, and the second leg comprises a second arched slot configured to engage the other of the protrusions.

In a further possible implementation form of the first aspect, the first linear slot and the second linear slot are linear and extend on opposite sides of the plane, at an angle <45° to the plane, and one of the protrusions is arranged adjacent the first slot and extends in a first direction along the axis, and the other of the protrusions is arranged adjacent the second slot and extends in a second direction, opposite the first direction, along the axis.

DK 2023 70195 A1 9

In a further possible implementation form of the first aspect, the actuator element is configured to be actuated manually and/or automatically.

In a further possible implementation form of the first aspect, the end effector is configured to adopt an open position, a closed position, and at least one intermediate position, the end effector comprising a first leg and a second leg configured to pivot in opposite directions to and from a plane, the first leg being configured to pivot around a first pivot axis, the second leg being configured to pivot around the first pivot axis or a second pivot axis parallel with the first pivot axis, a longitudinal axis of the end effector extending perpendicular to the first pivot axis and the second pivot axis, the first leg having a first tissue engagement surface comprising a plurality of first serrations, the second leg having a second tissue engagement surface configured to compress tissue together with the first tissue engagement surface of the first leg when the end effector is in one of the closed position or the intermediate position, each first serration extending across the first tissue engagement surface in a direction of travel parallel to the first pivot axis, the first serration having a non-linear extent when viewed along the direction of travel and wherein, optionally, the second tissue engagement surface of the second leg comprises a plurality of second serrations, each second serration extending across the second tissue engagement surface in a direction of travel parallel to the first pivot axis and/or the second pivot axis, the second serration having a non-linear extent when viewed along the direction of travel.

This surgical instrument allows the user to achieve a firm grip on the tissue in two directions, both along the longitudinal axis of the end effector and along the transverse axis of the end effector. This facilitates a safer operating procedure, since the risk of tissue slipping is significantly reduced, if not eliminated.

This and other aspects will be apparent from the examples described below.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following detailed portion of the present disclosure, the aspects, embodiments, and implementations will be explained in more detail with reference to the example embodiments shown in the drawings, in which:

Fig. 1 shows a perspective view of a surgical instrument in accordance with an example of the embodiments of the disclosure;

Fig. 2 shows an exploded view of the example of Fig. 1;

Fig. 3 shows an exploded view of an actuator element of a surgical instrument in accordance with an example of the embodiments of the disclosure;

Figs. 4a to 4c show partial side views of actuator elements in accordance with examples of the embodiments of the disclosure;

Fig. 5 shows a partial perspective view of a hollow shaft of a surgical instrument in accordance with an example of the embodiments of the disclosure;

Fig. 6 shows a perspective end view of a hollow shaft of a surgical instrument in accordance with an example of the embodiments of the disclosure;

Fig. 7 shows a partial perspective view of an end effector of a surgical instrument in accordance with an example of the embodiments of the disclosure;

Figs. 8a and 8b show perspective side views of an end effector of a surgical instrument in accordance with an example of the embodiments of the disclosure;

Figs. 9a to 9c show side views of a surgical instrument in accordance with an example of the embodiments of the disclosure, wherein the end effector is in a closed position, an intermediate position, and an open position;

Figs. 10a and 10b show side views of cam elements of a surgical instrument in accordance with examples of the embodiments of the disclosure;

Fig. 11 shows partial perspective views of an end effector and actuator element in accordance with an example of the embodiments of the disclosure;

Fig. 12a to 12c¢ show side views of a surgical instrument in accordance with an example of the embodiments of the

DK 2023 70195 A1 12 disclosure, wherein the end effector is in a closed position, an intermediate position, or an open position, and the actuator element correspondingly is in a second end position or a first end position;

Fig. 13 shows a perspective view of a surgical instrument in accordance with an example of the embodiments of the disclosure;

Figs. l4a to l4c show partial perspective views of an end element and a hollow shaft of a surgical instrument in accordance with examples of the embodiments of the disclosure;

Figs. 15a and 15b show a partial perspective view and a top view of an end effector of a surgical instrument in accordance with an example of the embodiments of the disclosure;

Fig. 16 shows a partial perspective view of an end effector of a surgical instrument in accordance with an example of the embodiments of the disclosure;

Fig. 17 shows partial perspective views of end effectors of a surgical instrument in accordance with an example of the embodiments of the disclosure;

Fig. 18 shows a cross-sectional view of two serration configurations of a leg of an end effector of a surgical instrument in accordance with an example of the embodiments of the disclosure;

DK 2023 70195 A1 13

Figs. 19a to 19d show partial perspective views of an end effector of a surgical instrument in accordance with an example of the embodiments of the disclosure.

DETAILED DESCRIPTION

The surgical instrument 1 comprises a hollow shaft 2, an actuating arrangement 6, and an end effector 3, which are all shown in varying detail in Figs 1 to 19d, in particular in

Figs. 9a to 9c and 12a to l2c which illustrate different positions of the end effector 3. The hollow shaft 2 is an elongated body of a suitable material, such as e.g. stainless steel, aluminium, carbon fiber-reinforced composite material, or any combination of at least two of these materials.

By "surgical instrument” is meant a device by means of which tissue of a patient is engaged either manually by a further individual such as a surgeon or by means of a surgical robot.

The end effector 3 is adapted for manipulating tissue. “Manipulation” includes procedures such as severing, ligation clipping, injecting, burning, cutting, grasping, tearing, and stitching. One or several procedures may be executed simultaneously. “Tissue” includes veins, arteries, intestines, or umbilical cords (non-exhaustive lists).

The actuating arrangement 6 comprises at least an elongated actuator element 7 extending at least partially within the hollow shaft 2 along the shaft center axis Al, i.e., the center axis of the hollow shaft 2. The actuator element 7 may

DK 2023 70195 A1 14 comprise at least one of a wire, a hose, and a rod. A distal end of the actuator element 7 is operably connected to a proximal end of the end effector 3, and the actuator element 7 is configured to move along the shaft center axis Al in order to maneuver the end effector 3, i.e., moving the end effector 3, or rather the end effector legs 4, 5 between an open position PO1, a closed position PO2, and intermediate position(s) PO3. The actuator element 7 may be configured to be actuated manually and/or automatically.

The end effector 3 is operated by the pivoting movement of a first leg 4 and/or a second leg 5 of the end effector 3. The pivoting movement is generated in part by means of the above- mentioned linear movement of the elongated actuator element 7 along the shaft center axis Al.

The first leg 4 and the second leg 5 of the end effector 3 may be configured to pivot in opposite directions to and from a plane PL. The first leg 4 is configured to pivot around a first pivot axis PAl and the second leg 5 being configured to pivot around the first pivot axis PAl (not shown) or around a second pivot axis PA2 parallel with the first pivot axis

PAl as shown in Fig. 6.

The first pivot axis PAl and the second pivot axis PA2 may extend parallel to, or coplanar with, the plane PL.

Furthermore, the first pivot axis PAl and the second pivot axis PA2 may be arranged coplanarly in at least one plane PL2 perpendicular to the plane PL, as shown in Figs. 5 and 19a.

DK 2023 70195 A1 15

The first leg 4 and the second leg 5 may be configured to pivot one at a time or simultaneously towards and away from the plane PL. The simultaneous pivoting of the first leg 4 and the second leg 5 may be at identical or different speeds.

Furthermore, the first leg 4 and the second leg 5 may be configured to extend at identical or different angles to the plane PL when in one of the open position PO1, the closed position PO2, or the intermediate position PO3.

The first leg 4 of the end effector 3 may comprise a first tissue engagement surface 4a and the second leg 5 of the end effector 3 may comprise a second tissue engagement surface 5a, as shown in Figs. 13, 16, and 19a to 19d. The first tissue engagement surface 4a is configured to face the second tissue engagement surface 5a at least when the end effector 3 is in the closed position PO2, as shown in Figs. 9a, 12a, and 16.

The first tissue engagement surface 4a and the second tissue engagement surface 5a may extend substantially in parallel when the end effector 3 is in the closed position PO2. The second tissue engagement surface 5a is configured to compress tissue together with the first tissue engagement surface 4a, when the end effector 3 is in one of the closed position PO2 and the intermediate position PO3, depending on the thickness of the tissue.

As mentioned above, the end effector 3, and hence the surgical instrument, may be configured to adopt the open position POL, used for example when grasping tissue, the closed position

PO2, used for example when inserting the instrument into a body, and at least one intermediate position PO3, used for

DK 2023 70195 A1 16 example when holding tissue, the thickness of the tissue preventing the legs 4, 5 of the end effector 3 from being in direct contact and/or parallel with each other but rather forcing the legs 4, 5 to extend at an angle o >0° to each other.

As indicated in Fig. 9c, the first leg 4 and the second leg 5 may pivot with identical angular distance, such that each leg 4, 5 extends at an angle o/2 from plane PL. The legs may also extend at different angular speeds or with different angular distances so that they are not symmetrical around the plane PL when in the intermediate position PO3 or the open position POL].

The surgical instrument 1 may also comprise a handle (not shown) that can be operated by a user. A proximal end of the actuating arrangement 6 is, preferably, in such a case, connected to the handle. Nevertheless, the hollow shaft 2 and/or the actuating arrangement 6 may also be connected directly to a robot. The handle may be any kind of suitable handle such as a squeeze handle, and/or comprise a pistol grip and/or a ball joint facilitating movement of the handle relative the rest of the surgical instrument 1. “Proximal” refers to the end of a component that is closest to an at least virtual handle, i.e., closest to the robot or the individual operating the surgical instrument.

Correspondingly, “distal” refers to the end of a component that is farthest away from the robot or individual.

DK 2023 70195 A1 17

Figs. 2 to 12 show embodiments of a surgical instrument 1 comprising an elongated actuator element 7 extending at least partially within the hollow shaft 2 along the shaft center axis Al and being configured to move along the shaft center axis Al.

The first leg 4 and the second leg 5 of the end effector 3 may be pivotally connected to the hollow shaft 2 by means of connection elements 10, 11, shown in Figs. 2, 5 to 8a, 10a, and 12. A first connection element 10 is arranged on at least one of the first leg 4 and the second leg 5, preferably both, and the first connection elements 10 are configured to engage at least one corresponding second connection element 11 arranged on the hollow shaft 2.

The first connection element may be a protrusion 10a extending from the first leg 4 along the first pivot axis PAl, and/or a protrusion 10b and/or extending from the second leg 5 along the first pivot axis PAl (not shown) or along the second pivot axis PAZ.

The second connection element may be a corresponding recess lla extending at least into at least a section of the hollow shaft 2 along the first pivot axis PAl and/or a corresponding recess 1lb extending at least into at least a section of the hollow shaft 2 along the first pivot axis PAl (not shown) or along the second pivot axis PA2. The first pivot axis PAl may extend at a first side of the plane PL and the second pivot axis PA2 may extend at a second side of the plane PL, as shown in Fig. 5.

DK 2023 70195 A1 18

A distal end of the actuator element 7 comprises at least one linear slot 8 configured to engage at least one of a first cam element 9a arranged on the first leg 4 and a second cam element 9b arranged on the second leg 5. As shown in Figs. 7, 8b, and 10b, the first cam element 9a has a first center axis

A3 and the second cam element 9b has a second center axis A4.

The first and second center axes A3, A4 extend parallel with the first pivot axis PAl and the second pivot axis PA2.

Linear movement of the elongated actuator element 7 along the shaft center axis Al generates pivoting movement of the first leg 4 and/or the second leg 5 by means of engagement of the first cam element 9a and/or the second cam element 9b with the linear slot(s) 8, as shown in Figs. 9a to 9c and 12a to 12c.

Fig. 4a shows an embodiment comprising one linear slot 8 configured to engage both the first cam element 9a and the second cam element 9b, at opposite ends of the slot 8. Fig. 4b shows two aligned linear slots 8a, 8b, each slot being configured to engage one cam element, i.e., the upper slot 8a is configured to engage the first cam element 9a and the lower slot 8b is configured to engage the second cam element 9b, at slot ends adjacent each other. Fig. 4c shows a linear slot 8 being offset along its longitudinal axis, in a direction perpendicular to the center axis A, such that an upper part of the slot 8 is configured to engage the first cam element 9a and an offset lower part of the slot 8 is configured to engage the second cam element 9b.

DK 2023 70195 A1 19

The linear slot(s) 8, 8a, 8b may extend(s) along a transverse axis A2, the transverse axis A2 extending between the plane

PL and the first pivot axis PAl, and/or between the plane PL and the second pivot axis PA2. As shown in Figs. 4a to 4c the transverse axis A2 may be one common axis extending orthogonally to the plane PL. As shown in Figs. 11 and 12, the transverse axis A2 may be two separate axes extending at acute angles to the plane PL.

The above-mentioned first cam element 9a may comprise a first cam surface 12a configured to rotate around the first pivot axis PAl and the first center axis A3, and correspondingly, the second cam element 9b may comprise a second cam surface 12b configured to rotate around the first pivot axis PAL or the second pivot axis PA2 and the second center axis A4, as shown in Fig. 10b.

The first cam element 9a and the second cam element 9b, and/or the first cam surface 12a and the second cam surface 12b, may be identical. The first cam surface 12a may extend at least partially symmetrically around the first center axis A3 and the second cam surface 12b may correspondingly extend at least partially symmetrically around the second center axis A4.

Furthermore, the first cam surface 12a and the second cam surface 12b may be configured such that they have curved segments, preferably symmetrically arranged curved segments, as shown in Figs. 7 and 10b.

The first cam surface 12a may comprise a first convex surface and a second convex surface, the first convex surface and the second convex surface extending symmetrically on opposite

DK 2023 70195 A1 20 sides of the first center axis A3. The second cam surface 12b may correspondingly comprise a first convex surface and a second convex surface, the first convex surface and the second convex surface extending symmetrically on opposite sides of the second center axis A4. As shown in Fig. 10b, a distance d3 from the first center axis A3 or the second center axis A4 to a point on the first convex surface may be identical to a distance d4 from the first center axis A3 or the second center axis A4 to a symmetrically corresponding point on the second convex surface. Correspondingly, a distance from the first pivot axis PAl to a point on the first convex surface may be identical to a distance from the second pivot axis PA2 to a symmetrically corresponding point on the second convex surface.

The first cam element 9a may be arranged such that the first pivot axis PAl and the first center axis A3 extend on opposite sides of the plane PL, as indicated in Figs. 7 and 10a.

Correspondingly, the second cam element Sb may be arranged such that the second pivot axis PA2 and the second center axis A4 extending on opposite sides of the plane PL.

The surgical instrument 1 may be configured such that a distance dl between the first pivot axis PAl and the first center axis A3, and a distance d2 between the second pivot axis PA? and the second center axis A4, remains constant throughout the pivoting movement.

As mentioned above, the linear slots 8, 8a, 8b are configured to engage the first cam element 9a and/or the second cam element 9b. As shown in Figs. 4a to 4c, the linear slot(s) 8

DK 2023 70195 A1 21 may comprise a first engagement surface 17a configured to engage the first cam surface 12a of the first cam element 9a, and a second engagement surface 17b configured to engage the second cam surface 12b of the second cam element 9b.

The linear movement of the actuator element 7 along the shaft center axis Al generates, optionally simultaneously, rotary movement of the first cam surface 12a around the first center axis A3, by means of the first engagement surface 17a, and rotary movement of the second cam surface 12b around the second center axis A4, by means of the second engagement surface 17b. The rotary movement, in turn, generates the pivoting movement of the first leg 4 around the first pivot axis PAl and the pivoting movement of the second leg 5 around the second pivot axis PA2.

As shown in Figs. 4b and 4c, the distal end of the actuator element 7 may comprise a first linear slot 8a and a second linear slot 8b extending coaxially along the transverse axis

A2. The first linear slot 8a comprises the first engagement surface 17a configured to engage the first cam surface 12a, and the second slot 8b comprises the second engagement surface 17b configured to engage the second cam surface 12b.

When the actuator element 7 is in a first end position Pl and simultaneously the end effector 3 is in an open position POL, as shown in Fig. 9c, the first cam surface 12a may be in a first angular position relative the first center axis A3 and the first engagement surface 17a, and correspondingly, the second cam surface 12b may be in a first angular position

DK 2023 70195 A1 22 relative the second center axis A4 and the second engagement surface 17b.

When the actuator element 7 moves in a direction from the first end position Pl, away from or towards the end effector 3, to a second end position P2 wherein the end effector 3 simultaneously is in a closed position PO2, linear movement of the first engagement surface 17a and the second engagement surface 17b along the shaft center axis Al may generate a force onto the first cam surface 12a such that the first cam element 9a rotates around the first pivot axis PAl and the first center axis A3, and onto the second cam surface 12b such that the second cam element 9b rotates around the first pivot axis PAl or the second pivot axis PA2 and the second center axis Ad.

When the actuator element 7 is in the second end position P2 and simultaneously the end effector 3 is in a closed position

PO2, as shown in Fig. 9a, the first cam surface 12a is in a second angular position relative the first center axis A3 and the first engagement surface 17a, and the second cam surface 12b is in a second angular position relative the second center axis A4 and the second engagement surface 17b.

The distal end of the actuator element 7 may comprise a protrusion 15a extending along an axis A5 parallel to the first pivot axis PAl, and a protrusion 15b extending along an axis A6 parallel to the second pivot axis PA2, as shown in

Fig. 11. In such embodiments, the first leg 4 comprises a first arched slot 16a configured to engage one of the protrusions 15a, and the second leg 5 comprises a second

DK 2023 70195 A1 23 arched slot 16b configured to engage the other of the protrusions 15b.

In such an embodiment, the first linear slot 8a and the second linear slot 8b may be linear and extend on opposite sides of the plane PL, at an angle <45° to the plane PL, as shown in

Figs. 11 and 12. One of the protrusions 15a is arranged adjacent the first slot 8a and extends in a first direction along the axis A5. Correspondingly, the other of the protrusions 15b is arranged adjacent the second slot 8b and extends in a second direction, opposite the first direction, along the axis AG.

The surgical instrument 1 may comprise an end effector 3 in accordance with any one of the embodiments described below.

Figs. 13 and 14 show embodiments of a surgical instrument 1 for electrosurgery.

As previously described, the end effector 3 of the surgical instrument 1 may comprise a first leg 4 and a second leg 5 configured to pivot in opposite directions to and from a plane

PL, the first leg 4 and the second leg 5 being pivotally connected to a distal end of the hollow shaft 2. The end effector 3 may furthermore be configured to receive and conduct electrical current.

The elongated actuator element 7 extends at least partially within the hollow shaft 2, and a distal end of the actuator element 7 is operably connected to a proximal end of the end

DK 2023 70195 A1 24 effector 3. The actuator element 7 may be configured to conduct electrical current to the end effector 3.

The hollow shaft 2 of the surgical instrument 1 may comprise a plurality of radial layers, i.e., at least one inner layer and one outer layer, each layer forming a cylindrical hollow structure. The different layers are arranged in abutment with each other, e.g., by being molded or laminated on top of each other.

The radial layers comprise at least an inner core layer 2a and an outer peripheral layer 2b, as shown in Fig. 13. The peripheral layer 2b may extend along at least a part of the hollow shaft 2 in the direction of a shaft center axis Al of the hollow shaft 2.

The inner core layer 2a comprises electrically conductive material. The peripheral layer 2b comprises at least one of a section of the conductive material being anodized and/or an anodized coating applied onto the conductive material. The outer peripheral layer 2b preferably has a dielectric strength of <30 000 volt/mm. The anodized coating of the outer peripheral layer 2b may comprise Teflon. The inner core layer 2a, and optionally the outer peripheral layer 2b, may comprise aluminium.

The surgical instrument 1 may further comprise a non- conductive sheath 21, as shown in Figs. 13 and 14a, the sheath 21 being configured to enclose the hollow shaft 2. The sheath 21 may comprise HDPE material. The sheath 21 may be one

DK 2023 70195 A1 25 integral element of comprise at least two radial layers, the layers optionally comprising different materials.

The surgical instrument 1 may further comprise a non- conductive end element 22 configured to at least partially cover a distal end of the hollow shaft 2. The end element 22 may extend along an end surface, an inner surface, and/or an outer surface of the distal end of the hollow shaft 2 as shown in Figs. 13 and l14a to lic.

The end element 22 may at least partially protrude radially past a circumference of the peripheral layer 2b of the hollow shaft 2, as shown in Fig. 14b, forming a flange configured to engage a distal end of the sheath 21. The flange prevents the sheath 21 from moving longitudinally along shaft center axis

Al, such that the sheath 21 for example remains in place on the hollow shaft 2 as the surgical instrument 1 is being retracted from the body of a patient.

The electrosurgical instrument 1 may comprise an end effector 3 in accordance with any one of the embodiments described below.

As mentioned above, the first leg 4 of the end effector 3 may comprise a first tissue engagement surface 4a and the second leg 5 of the end effector 3 may comprise a second tissue engagement surface Sa. The first tissue engagement surface 4a is configured to face the second tissue engagement surface ba at least when the end effector 3 is in the closed position

PO2, as shown in Figs. 9a, 12a, and 16.

DK 2023 70195 A1 26

Furthermore, the first leg 4 may comprise a first body 4b extending from the first tissue engagement surface 4a, and the second leg 5 may comprise a second body 5b extending from the second tissue engagement surface 5a.

At least one of the first body 4b and the second body 5b may comprise an electrically conductive tissue engagement section 23, as indicated in Figs. 19a to 19d. The tissue engagement section 23 of the first body 4b may taper in a direction at least partially away from the first tissue engagement surface 4a and away from the second leg 5. Correspondingly, the tissue engagement section 23 of the second body 5b may taper in a direction at least partially away from the second tissue engagement surface 5a and away from the first leg 4. The first body 4b and/or the second body 5b may at least partially taper in directions along a transverse axis A2 extending perpendicular to plane PL. The tissue engagement section 23 may taper towards an apex having a minimum radius of 0.1 mm.

The tissue engagement section 23 may be configured to conduct current to tissue not engaged by the first tissue engagement surface 4a or the second tissue engagement surface 5a. The tissue engagement section 23 may comprise a different material and/or have a different conductivity than the rest of the first body 4b and/or the second body 5b.

The end effector 3 may be configured to adopt an open position

PO1, a closed position PO2, and at least one intermediate position PO3, as mentioned above and shown in Figs. 9a to 9c and 12a to 12c. The end effector 3 comprises, as also mentioned previously, a first leg 4 and a second leg 5

DK 2023 70195 A1 27 configured to pivot in opposite directions to and from plane

PL. The first leg 4 is configured to pivot around a first pivot axis PAl and the second leg 5 is configured to pivot around the first pivot axis PAl or a second pivot axis PA2 parallel with the first pivot axis PAL.

The first tissue engagement surface 4a of the first leg 4 may comprise a plurality of first serrations 13, as shown in Figs. 8a to 9c, 11 to 13, and 15a to 19d. As already mentioned, the second tissue engagement surface 5a of the second leg 5 may be configured to compress tissue together with the first tissue engagement surface 4a of the first leg 4, at least when the end effector 3 is in the closed position PO2 and/or the intermediate position PO3.

The first serrations 13 of the first tissue engagement surface 4a may extend non-linearly in at least one direction parallel to the first pivot axis PAl, as shown in Figs. 1, 8a, 8b, 11, 15a, and 15b. The first serrations 13 and/or the second serrations 14 may extend non-linearly with a substantially sine waveform S1, optionally a stepped sine waveform S2, a direction of travel of the sine waveform parallel to the first pivot axis PAl and/or the second pivot axis PA2. By direction of travel is meant the direction of propagation, would the sine wave be, e.g., a sound wave.

The second tissue engagement surface 5a of the second leg 5 may comprise a plurality of second serrations 14, the second serrations 14 extend non-linearly in directions parallel to the first pivot axis PAl and/or the second pivot axis PA2.

DK 2023 70195 A1 28

The first serrations 13 of the first tissue engagement surface 4a may be configured to intermesh alternatingly with the second serrations 14 of the second tissue engagement surface 5a when the end effector 3 is in the closed position PO2, as shown most clearly in Fig. 16. Ridges formed by the first serrations 13 extend into valleys formed between the second serrations 14. Correspondingly, ridges formed by the second serrations 14 extend into valleys formed between the first serrations 13.

The first serrations 13 and the second serrations 14 may at least partially intermesh such that any tissue located between the first leg 4 and the second leg 5 is prevented from moving in at least directions parallel with the first pivot axis PAL and the second pivot axis PA2 and directions parallel with the longitudinal axis A7 of the end effector 3. Preferably, the first serrations 13 and the second serrations 14 prevent tissue from moving in any direction.

The ridge and/or the valley may have a substantially triangular cross-section, the cross-section intersecting the ridge and/or the valley along a longitudinal axis A7 of the end effector 3 and in the plane of symmetry PL3, as shown in

Figs. 15a and 18. The ridge and/or the valley may have a plane of symmetry PL3 extending perpendicular to the plane PL, and parallel, or coplanar, with the shaft center axis Al, as shown in Fig. 15a. An apex of the ridge and/or a bottom of the valley may comprise either a sharp bend, as shown in Figs. 15a to 16, or a rounded bend, as indicated in Fig. 18. By “sharp bend” 1s meant an apex or bottom which has no transition area between the sides of the ridge or valley,

DK 2023 70195 A1 29 making the ridge or valley discontinuous such that the apex or bottom forms a sharp edge without a radius. Oppositely, by “rounded bend” is meant an apex or bottom which has a transition area between the sides of the ridge or valley, making the ridge or valley continuous such that the apex or bottom forms a curve with a radius.

A first side of the ridge and/or the valley may be longer or shorter than a second side of the ridge and/or the valley as seen in a direction from a distal tip of the end effector 3 towards the first pivot axis PAl and the second pivot axis

PA2, as shown in Fig. 15a. The first serrations 13 and the second serrations 14 may, in other words, have substantially sawtooth cross-sections, the cross-sections extending in the plane of symmetry PL3.

At least two ridges and/or valleys of the first serrations 13 and/or of the second serrations 14 may have different cross- sectional shapes. The first side and/or the second side of the ridge and/or the valley may be either concave or convex (not shown). Furthermore, a side of the ridge and/or the valley may extend at an angle to the plane PL of between 15° and 135°.

The various aspects and implementations have been described in conjunction with various embodiments herein. However, other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed subject-matter, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word "comprising” does not exclude other elements

DK 2023 70195 A1 30 or steps, and the indefinite article "a” or "an” does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

The reference signs used in the claims shall not be construed as limiting the scope. Unless otherwise indicated, the drawings are intended to be read e.g., cross-hatching, arrangement of parts, proportion, degree, etc. together with the specification, and are to be considered a portion of the entire written description of this disclosure. As used in the description, the terms “horizontal”, “vertical”, “left”, “right”, “up” and “down”, as well as adjectival and adverbial derivatives thereof e.g., “horizontally”, “rightwardly”, “upwardly”, etc., simply refer to the orientation of the illustrated structure as the particular drawing figure faces the reader. Similarly, the terms “inwardly” and “outwardly” generally refer to the orientation of a surface relative to its axis of elongation, or axis of rotation, as appropriate.

Claims

DK 2023 70195 A1 31 CLAIMS

1. A surgical instrument (1) comprising -a hollow shaft (2); -an end effector (3) comprising a first leg (4) and a second leg (5), said first leg (4) being pivotally connected to a distal end of said hollow shaft (2) along a first pivot axis (PA1) and said second leg (5) being pivotally connected to said distal end along a second pivot axis (PA2), said first leg (4) and said second leg (5) being configured to pivot in opposite directions to and from a plane (PL) comprising a shaft center axis (Al) of said hollow shaft (2), an actuating arrangement (6) comprising: --an elongated actuator element (7) extending at least partially within said hollow shaft (2) along said shaft center axis (Al) and being configured to move along said shaft center axis (AI), a distal end of said actuator element (7) comprising at least one linear slot (8) configured to engage at least one of a first cam element (9a) arranged on said first leg (4) and a second cam element (9b) arranged on said second leg (5), said first cam element (9a) having a first center axis (A3) and said second cam element (9b) having a second center axis (A4), said first and second center akxes (A3, A4) extending parallel with said first pivot axis (PAL) and said second pivot axis (PA2), linear movement of said elongated actuator element (7) along said shaft center axis (Al) generating pivoting movement of said first leg (4) and/or said second leg (5) by means of said engagement of said first cam element (9a) and/or said second cam element (9b) with said linear slot(s) (8).

DK 2023 70195 A1 32

2. The surgical instrument (1) according to claim 1, wherein said first leg (4) and said second leg (5) are pivotally connected to said hollow shaft (2) by means of connection elements (10, 11), a first connection element (10) being arranged on at least one of said first leg (4) and said second leg (5), said first connection element (s) (10) being configured to engage at least one second connection element (11) arranged on said hollow shaft (2).

3. The surgical instrument (1) according to claim 1 or 2, wherein said linear slot (s) (8) extend(s) along a transverse axis (A2), said transverse axis (A2) extending between said plane (PL) and said first pivot axis (PAl), and between said plane (PL) and said second pivot axis (PA2), said first cam element (9a) comprising a first cam surface (12a) configured to rotate around said first pivot axis (PAL) and said first center axis (A3), and said first pivot axis (PAl) and said first center axis (A3) extending on opposite sides of said plane (PL), sald second cam element (9b) comprising a second cam surface (12b) configured to rotate around said first pivot axis (PAL) and or said second pivot axis (PA2) and said second center axis (A4), sald second pivot axis (PA2) and said second center axis (A4) extending on opposite sides of said plane (PL), a first engagement surface (17a) of said linear slot (s) (8) being configured to engage said first cam surface (12a) of said first cam element (9a), and a second engagement surface (17b) of said linear slot(s) (8) being configured to engage said second cam surface (12b) of said second cam element (9b),

DK 2023 70195 A1 33 said linear movement of said actuator element (7) along said shaft center axis (Al) simultaneously generating rotary movement of said first cam surface (12a) around said first pivot axis (PAl) and said first center axis (A3), by means of said first engagement surface (17a), and rotary movement of said second cam surface (12b) around said first pivot axis (PAl) or said second pivot axis (PA2) and sald second center axis (A4), by means of said second engagement surface (17b), sald rotary movement generating said pivoting movement of said first leg (4) around said first pivot axis (PAl) and said pivoting movement of said second leg (5) around said second pivot axis (PA2).

4. The surgical instrument (1) according to any one of the previous claims, wherein a distance (dl) between said first pivot axis (PAl) and said first center axis (A3), and a distance (d2) between said second pivot axis (PA2) and said second center axis (A4), remains constant throughout said pivoting movement.

5. The surgical instrument (1) according to any one of the previous claims, wherein said first pivot axis (PAl) extends at a first side of said plane (PL) and said second pivot axis (PA2) extends at a second side of said plane (PL).

6. The surgical instrument (1) according to any one of the previous claims, wherein said first cam surface (l2a) extends at least partially symmetrically around said first center axis (A3) and said second cam surface (12b) extends at least partially symmetrically around said second center axis (A4).

DK 2023 70195 A1 34

7. The surgical instrument (1) according to any one of claims 3 to 6, wherein said distal end of said actuator element (7) comprises a first linear slot (8a) and a second linear slot (8b) extending coaxially along said transverse axis (A2), said first linear slot (8a) comprising said first engagement surface (17a) configured to engage said first cam surface (12a), and said second slot (8b) comprising said second engagement surface (17b) configured to engage said second cam surface (12b).

8. The surgical instrument (1) according to any one of claims 3 to 7, wherein, when said actuator element (7) is in a first end position (Pl) and simultaneously said end effector (3) is in an open position (POL), said first cam surface (12a) is in a first angular position relative said first center axis (A3) and said first engagement surface (17a), and said second cam surface (12b) is in a first angular position relative said second center axis (A4) and said second engagement surface (17b). 9, The surgical instrument (1) according to claim 8, wherein, when said actuator element (7) moves in a direction from said first end position (Pl), towards said end effector (3), to a second end position (P2), linear movement of said first engagement surface (17a) and sald second engagement surface (17b) along said shaft center axis (Al) generates a force onto said first cam surface (12a) such that said first cam element (9a) rotates around said first pivot axis (PAl) and said first center axis (A3), and

DK 2023 70195 A1 35 onto said second cam surface (12b) such that said second cam element (9b) rotates around said first pivot axis (PAl) or sald second pivot axis (PA2) and said second center axis (24).

10. The surgical instrument (1) according to claim 8 or 9, wherein, when said actuator element (7) is in said second end position (P2) and simultaneously said end effector is in a closed position (PO2), said first cam surface (12a) is in a second angular position relative said first center axis (A3) and said first engagement surface (17a), and said second cam surface (12b) is in a second angular position relative said second center axis (A4) and said second engagement surface (17b).

11. The surgical instrument (1) according to any one of claims 1 to 6, wherein said distal end of said actuator element (7) comprises a protrusion (15a) extending along an axis (A5) parallel to said first pivot axis (PAl), and a protrusion (15b) extending along an axis (A6) parallel to said second pivot axis (PA2), and wherein said first leg (4) comprises a first arched slot (léa) configured to engage one of said protrusions (15a), and said second leg (5) comprises a second arched slot (16b) configured to engage the other of said protrusions (15b).

12. The surgical instrument (1) according to claim 11, wherein said first linear slot (8a) and said second linear slot (8b) are linear and extend on opposite sides of said plane (PL), at an angle <45° to said plane (PL), and

DK 2023 70195 A1 36 wherein one of said protrusions (15a) is arranged adjacent said first slot (8a) and extends in a first direction along said axis (A5), and the other of said protrusions (15b) is arranged adjacent said second slot (8b) and extends in a second direction, opposite said first direction, along said axis (A6).

13. The surgical instrument (1) according to any one of the previous claims, wherein said actuator element (7) is configured to be actuated manually and/or automatically.

14. The surgical instrument (1) according to any one of the previous claims, wherein said end effector (3) is an end effector is configured to adopt an open position (PO1l), a closed position (P02), and at least one intermediate position (PO3), said end effector (3) comprising a first leg (4) and a second leg (5) configured to pivot in opposite directions to and from a plane (PL), said first leg (4) being configured to pivot around a first pivot axis (PAl), said second leg (5) being configured to pivot around said first pivot axis (PAl) or a second pivot axis (PA2) parallel with said first pivot axis (PAl), a longitudinal axis (A7) of said end effector (3) extending perpendicular to said first pivot axis (PAl) and said second pivot axis (PA2), said first leg (4) having a first tissue engagement surface (4a) comprising a plurality of first serrations (13), sald second leg (5) having a second tissue engagement surface (5a) configured to compress tissue together with said first tissue engagement surface (4a) of said first leg (4) when

DK 2023 70195 A1 37 said end effector (3) is in one of said closed position (PO2) or said intermediate position (PO3), each first serration (13) extending across said first tissue engagement surface (4a) in a direction of travel parallel to said first pivot axis (PAl), said first serration (13) having a non-linear extent when viewed along said direction of travel and wherein, optionally, sald second tissue engagement surface (5a) of said second leg (5) comprises a plurality of second serrations (14), each second serration (14) extending across said second tissue engagement surface (5a) in a direction of travel parallel to said first pivot axis (PAl) and/or said second pivot axis (PA2), said second serration (14) having a non-linear extent when viewed along said direction of travel.