Positioning markers, surgical instruments and surgical systems

Abstract

The present application discloses a positioning mark, a surgical instrument including the positioning mark, and a surgical system, wherein the positioning mark is used to mark the marked object in the positioning navigation system, and the positioning mark includes a positioning element, a main body, and a connecting piece, wherein the positioning element is used to actively or passively send a signal; the main body is used to carry the positioning element; the connecting piece is arranged on the main body and is used to detachably connect the positioning mark to the marked object; the connecting piece is plug-connected to the main body and has a first connection relationship and a second connection relationship. Under the first connection relationship, there is a predetermined positioning relationship between the connecting piece and the main body, and the connecting piece can move relative to the main body to form a second connection relationship when a predetermined force is applied. Under the second connection relationship, the predetermined positioning relationship is changed and there is a reset obstacle between the connecting piece and the main body to reset to the first connection relationship. The positioning mark disclosed in the present application, the surgical instrument including the positioning mark, and the surgical system avoid the positioning mark from being reused.

Description

Technical Field

[0001] The present application relates to the field of positioning and navigation, and in particular to positioning markers, surgical instruments and surgical systems. Background Art

[0002] In the process of positioning and navigation relying on positioning markers, the positioning marker is the target for the computer to know the position of the marked object in the actual space. The system needs to control the tool to perform various operations in an orderly manner according to the predetermined plan based on the positioning of the target. The smoothness and accuracy of the target information acquisition directly affects the smoothness and navigation accuracy of the positioning and navigation process.

[0003] For example, in the positioning and navigation process of computer-assisted surgery, positioning markers are used to mark anatomical structures, surgical tools, and robotic arms. The computer recognizes the position of the positioning markers to obtain information about the surgical tools and anatomical structures in the actual space, and further controls the surgical tools to perform the surgery accurately and orderly according to the predetermined surgical plan.

[0004] During surgical operations, one or more positioning markers are usually detachably mounted on the marked object to facilitate the reuse of the positioning markers. However, repeated disassembly and assembly of the positioning markers will cause wear and tear on the installation site, leading to imperceptible looseness of the installation. Positioning errors will occur when the system performs positioning based on the inaccurately installed positioning markers. In addition, if, for example, reflective sheets or reflective balls are used as positioning markers, the positioning markers are exposed to the surgical environment during the operation, and body fluids and debris may splash and contaminate the positioning markers. Both the contamination itself and wiping contamination may cause positioning errors in the positioning markers, and in severe cases, they may even fail. In addition, reusable positioning markers need to be removed from the frame for storage and preservation when not in use. The positioning markers may be scratched or damaged during storage and transportation, and scratches and damage may cause a decrease in the positioning accuracy of the positioning markers.

[0005] Therefore, if the positioning marker is reused, the positioning marker will be contaminated, scratched, damaged, or worn out during disassembly and assembly, which will affect the positioning accuracy. Moreover, the above-mentioned effects are not easily perceived by the naked eye and will have an unpredictable impact on the surgical results. Even if the positioning accuracy of the positioning marker is found to be insufficient during the operation, a new reflective marker must be temporarily replaced, which will affect the smooth progress of the operation. Summary of the invention

[0006] The present application provides a positioning mark, a surgical instrument and a surgical system to prevent the positioning mark from being reused.

[0007] The first aspect of the present application provides a positioning marker for marking a marked object in a positioning navigation system, comprising a positioning element, a main body and a connector, wherein the positioning element is used to actively or passively send a signal; the main body is used to carry the positioning element; the connector is arranged on the main body and is used to detachably connect the positioning marker to the marked object; wherein the connector is plug-connected to the main body and has a first connection relationship and a second connection relationship, and under the first connection relationship, there is a predetermined positioning relationship between the connector and the main body, and the connector can move relative to the main body when a predetermined force is applied to form a second connection relationship, and under the second connection relationship, the predetermined positioning relationship is changed and there is a reset obstacle between the connector and the main body to reset to the first connection relationship. In a first possible implementation, the predetermined positioning relationship includes an axial positioning relationship and a radial positioning relationship.

[0008] In combination with the above possible implementation manner, in a second possible implementation manner, the predetermined positioning relationship includes an axial positioning relationship and a radial positioning relationship.

[0009] In combination with the above possible implementation manners, in a third possible implementation manner, under the second connection relationship, at least one of the axial positioning relationship and the radial positioning relationship in the predetermined positioning relationship is changed.

[0010] In combination with the foregoing possible implementation manner, in a fourth possible implementation manner, the connecting member and the main body are configured to move so that the connecting member is at least partially detached from / disconnected from the main body.

[0011] In combination with the foregoing possible implementation manners, in a fifth possible implementation manner, the movement is a non-resettable unidirectional movement.

[0012] In combination with the above possible implementation modes, in a sixth possible implementation mode, a one-way stepping mechanism is constructed between the main body and the connecting member to achieve non-resettable one-way movement, and the one-way stepping mechanism includes a ratchet and a pawl that can be deformed in the radial direction.

[0013] In combination with the above possible implementation modes, in a seventh possible implementation mode, under the first connection relationship, the pawl and the ratchet tooth form axial positioning and / or radial positioning in a positioning relationship.

[0014] In combination with the above possible implementation modes, in an eighth possible implementation mode, the ratchet is a circumferentially arranged flange, and the ratchet is multiple and distributed along the circumferential direction.

[0015] In combination with the above possible implementation methods, in a ninth possible implementation method, the main body includes an upper end and a lower end, the upper end is used to carry the positioning element, and the lower end is provided with a cavity, the cavity contains a connecting piece, and the connecting piece has a connecting hole for connecting the positioning mark to the marked object, and the opening direction of the connecting hole is consistent with the opening direction of the cavity.

[0016] In combination with the above possible implementation modes, in a tenth possible implementation mode, the cavity runs through the upper end and the lower end, and the opening of the cavity at the lower end is smaller than the outer circumference of the pawl.

[0017] In combination with the above possible implementation modes, in an eleventh possible implementation mode, no resetting guide structure is provided between the connecting member and the main body to form a resetting obstacle.

[0018] In combination with the above possible implementation methods, in a twelfth possible implementation method, the first connection relationship is the axial hole cooperation between one end of the connecting piece and the main body, and the connecting piece is moved to disengage from the axial hole cooperation with the main body, and the reset guide structure is the chamfer or fillet of the joint of the connecting piece and / or the main body to form the axial hole cooperation.

[0019] In combination with the foregoing possible implementations, in a thirteenth possible implementation manner, the predetermined force is a force caused by the marker to pull the connector when the positioning element is removed.

[0020] The second aspect of the present application proposes a surgical instrument for a surgical navigation system, comprising a positioning mark, a positioning part and a functional part, wherein the positioning mark is used to mark the marked object, and the positioning mark is the positioning mark of the first aspect; the positioning part is used to carry the positioning mark; the functional part has a predetermined position relationship with the positioning part, and the functional part is used to perform at least part of the surgical operation; wherein, the third aspect of the present application proposes a surgical system, comprising a positioning mark, a locator, a controller and an actuator, wherein the positioning mark is used to mark anatomical tissue and / or equipment, and the positioning mark is the positioning mark of the first aspect of the present application; the locator is used to obtain the position information of the marked anatomical tissue and / or equipment according to the positioning mark; the controller is used to control the surgical system to execute a predetermined surgical plan according to the position information obtained by the locator; the actuator is used to carry surgical tools.

[0021] The positioning marker proposed in the first aspect of the present application is provided with a main body and a connecting piece. Among them, when the main body and the connecting piece are in a first connection relationship, the positioning element is fixed relative to the marked object, and the position of the positioning element can be used to accurately represent the position of the marked object; when the main body and the connecting piece move under the action of an external force to form a second connection relationship with a reset obstacle, the positioning element can no longer accurately represent the position of the marked object, and the connection relationship between the main body and the connecting piece cannot or is difficult to be reset to the first connection relationship. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is a schematic diagram of the overall structure of the first positioning mark of this application;

[0023] Figure 2 This is a schematic diagram of the internal structure of the first connection relationship of the first positioning mark of the present application;

[0024] Figure 3 For this application Figure 2 Schematic diagram of the structure at A in the middle;

[0025] Figure 4 This is a schematic diagram of the internal structure of the second connection relationship of the first positioning mark of this application;

[0026] Figure 5 This is a schematic diagram of the main structure of the first positioning mark of this application;

[0027] Figure 6 This is a schematic diagram of the structure of the first positioning mark connector of this application;

[0028] Figure 7 This is a schematic diagram of a second positioning mark structure according to an embodiment of the present application;

[0029] Figure 8 This is a schematic diagram of a third positioning mark structure according to an embodiment of the present application;

[0030] Fig. 9 This is a schematic diagram of a fourth positioning mark structure according to an embodiment of the present application;

[0031] Fig.10 This is a schematic diagram of a fifth positioning mark structure according to an embodiment of the present application;

[0032] Fig.11 This is a schematic diagram of the structure of an elastic element in a fifth positioning mark according to an embodiment of the present application;

[0033] Fig.12 This is a schematic diagram of a sixth positioning mark structure according to an embodiment of the present application;

[0034] Figure markings: 1-positioning element, 2-main body, 201-opening, 3-connecting piece, 301-matching section, 4-pin, 401-edge, 5-cavity, 501-positioning section, 502-lower connection, 6-ratchet, 601-upper slope, 602-lower slope, 610-lower triangular slope, 7-pawl, 700-embedded part, 701-surface, 71-protrusion, 710-upper triangular slope, 8-connecting hole, 9-ring, 11-space, 1001-first junction, 1002-second junction. DETAILED DESCRIPTION

[0035] The features and exemplary embodiments of various aspects of the present application will be described in detail below. In order to make the purpose, technical solutions and advantages of the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are only intended to explain the present application, rather than to limit the present application. For those skilled in the art, the present application can be implemented without the need for some of these specific details. The following description of the embodiments is only to provide a better understanding of the present application by illustrating the examples of the present application.

[0036] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the statement "include..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0037] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The embodiments will be described in detail below in conjunction with the accompanying drawings.

[0038] In the first aspect, the positioning mark proposed in the present application includes a positioning element, a main body equipped with the positioning element, and a connector for detachably connecting the main body to the marked object. Among them, the positioning element can actively or passively send a signal, and the positioning navigation system can determine the position of the positioning mark by identifying the signal. The connector is plug-connected to the main body and has a first connection relationship and a second connection relationship. Under the first connection relationship, there is a predetermined positioning relationship between the connector and the main body. When the connector is subjected to a predetermined force, it can move relative to the main body to form a second connection relationship. Under the second connection relationship, the predetermined positioning relationship is changed and there is a reset obstacle between the connector and the main body to reset to the first connection relationship. According to the degree of the reset obstacle, the connection state of the connector and the main body under the second connection relationship can be divided into non-resettable or lacking a reset guide.

[0039] When the positioning marker is installed on the marked object, the connector is plugged into the main body to form a first connection relationship with a predetermined positioning relationship. Based on the predetermined positioning relationship, the positioning element and the marked object have a correct positional relationship, and the positioning element can correctly represent the position of the marked object.

[0040] When the positioning mark is removed, an external force is applied to the main body to separate the connector and the marked object. During the separation process, the force of the marked object pulling the connector causes the connector to move relative to the main body, and the movement changes the predetermined positioning relationship between the connector and the main body and forms a second connection relationship. Under the second connection relationship, there is a reset obstacle between the connector and the main body. Among them, the force of pulling the connector is the predetermined force to produce the movement. The predetermined positioning relationship is changed so that the positioning element and the marking object no longer have a correct positional relationship, and the position information of the marked object cannot be correctly represented by the positioning element.

[0041] Furthermore, the reset obstacle between the connector and the main body prevents the connector and the main body from being reset to the predetermined positioning relationship under the first connection relationship, and the incorrect positional relationship between the positioning element and the marked object makes the positioning mark unusable again.

[0042] Specifically, Figure 1-6 As shown, the positioning mark includes a positioning element 1 , a main body 2 and a connecting piece 3 arranged in the main body 2 .

[0043] like Figure 1 As shown, the positioning element 1 is a circular reflector. As a positioning element 1 that passively emits signals, the reflector can passively reflect the infrared light emitted by the navigation system so that the navigation system can know its position. The reflection area of ​​the circular reflector is circular. When it is recognized by the navigation system, the reflected image formed by the reflection area is recognized as a circle or an ellipse. The center of the circle or the ellipse can be easily analyzed, and based on the center, a coordinate point with a fixed positioning relationship with the marked object can be quickly determined. Of course, the choice of the positioning element 1 is not limited to reflectors, but can also be a reflective ball or an active light-emitting diode, an electromagnetic generator, etc. In the implementation method based on the reflector, the shape of the reflector is not limited to a circle, but can also be a regular shape such as an ellipse, a diamond, a rectangle, etc. that can easily identify the center of its reflected image.

[0044] like Figure 2 , Figure 3 and Figure 5 As shown, the main body 2 is a shell-like part with a disc at the upper end and a column at the lower end. A cavity 5 penetrating the column and the disc is provided inside the main body 2, and the cavity 5 is cylindrical as a whole. A sinking area for embedding the positioning element 1 is provided on the top surface of the disc, and the sinking area is as thick as the positioning element 1. A positioning section 501 with a smaller inner diameter is provided at one end of the cavity 5 close to the disc, and the step is set at a right angle. The cavity 5 forms a constricted opening 201 at the lower end of the column, and the inner diameter of the opening 201 is smaller than the inner diameter of the inner wall of the cavity.

[0045] Two flanges serving as ratchet teeth 6 are arranged on the inner wall of the cavity near the opening 201. The cross-sectional shapes of the two flanges are both tooth-shaped inclined downwards, and the flanges have an upper inclined surface 601 and a lower inclined surface 602. The angle b of the upper inclined surface 601a downwards relative to the vertical opening is smaller than the angle a of the lower inclined surface 602a downwards relative to the vertical opening. In this embodiment, the angle a is 60 degrees and the angle b is 50 degrees.

[0046] like Figure 2 and Figure 6 As shown, the connector 3 is accommodated in the cavity 5, and the connector 3 includes a matching section 301 and four ratchet claws 7. The matching section 301 is a column, and the angles between the upper and lower surfaces of the column and the side surface are both right angles. A connecting hole 8 for connecting with the marked object is opened inside the matching section 301. Among them, a retaining edge protruding from the aperture of the connecting hole 8 is arranged at the entrance of the connecting hole 8, and the ratchet claw 7 is located at one end of the matching section 301 and matches with the ratchet teeth 6. The ratchet claw 7 specifically includes a vertical section connected to the matching section 301 and a hook-shaped clamping section 700 extending radially outward and arranged below the vertical section. The upper surface 701 of the clamping section 700 extends obliquely upward from the vertical section. The outer diameter of the clamping section 700 is smaller than the inner diameter of the inner wall of the cavity and larger than the inner diameter of the opening 201. The height of the clamping section 700 is smaller than the distance between the second flange located below and the opening 201. Among them, the ratchet claw 7 forms a cantilever structure as a whole, and the vertical section is arranged to have a certain elasticity, and the ratchet claw 7 can be deformed radially.

[0047] The positioning mark is connected to the marked object through the column pin 4. The column pin 4 includes a columnar body, a connector provided at the top of the columnar body and matching the connecting hole 8, and a positioning edge 401 provided at the middle and lower part of the columnar body, and the outer diameter of the positioning edge 401 is the same as the inner diameter of the opening 201. A groove matching the retaining edge is provided at the junction of the connector and the columnar body.

[0048] Figure 2 It is a schematic diagram of the connection structure between the positioning mark and the pin 4. The connector is plugged into the connecting hole 8, and the cooperation of the retaining edge and the groove realizes the axial positioning of the connector 3 and the pin 4, and the outer periphery of the retaining edge and the inner periphery of the groove form a first radial positioning of the connector 3 and the pin 4, and the opening 201 cooperates with the axial hole of the positioning edge 401 to form a second radial positioning of the connector 3 and the pin 4. The first radial positioning and the second radial positioning jointly realize the radial positioning of the connector 3 relative to the pin 4.

[0049] In addition, the engaging section 700 of the pawl 7 is located in the middle of the two flanges and engages with them, and the matching section 301 cooperates with the axial hole of the positioning section 501, so as to realize the axial positioning and radial positioning of the connecting member 3 and the main body 2, that is, the connecting member 3 and the main body 2 form a first connection relationship and have a predetermined positioning relationship. When the positioning mark satisfying the positioning relationship is installed on the marked object through the matching of the connecting member 3 and the pin 4, the positioning element 1 and the marked object have a correct positional relationship, and can correctly indicate the orientation of the marked object. Among them, the positioning section 501 cooperates with the axial hole of the matching section 301 to radially position the connecting member 3 relative to the main body 2 at the first place, and the engagement of the two flanges as the ratchet 6 with the pawl 7 to radially position the connecting member 3 relative to the main body 2 at the second place, and the radial positioning at the two places ensures the reliability of the radial positioning between the main body 2 and the connecting member 3. While the radial positioning is performed at the second place, the engagement of the two flanges with the pawl 7 forms the axial positioning of the connecting member 3 relative to the main body 2.

[0050] In the process of assembling the positioning mark, the connector 3 enters the cavity 5 from top to bottom. The assembly at this time is mainly to enable the engaging section 700 of the pawl 7 to enter between the two flanges of the ratchet 6 and engage with them to form a preset connection state of the positioning mark before use. Figure 2 Figure 3 The internal structure of the positioning mark shown in the figure, because the pawl 7 has radial deformation ability, when the connector 3 is moving downward, the force generated by the contact between the clamping section 700 and the upper inclined surface 601a of the first flange makes the pawl 7 have a tendency to contract in the radial direction, and the clamping section 700 of the pawl 7 can rely on the guiding effect of the upper inclined surface 601a to enter the middle of the two flanges and then assemble the connector 3 and the main body 2 into the first connection relationship. In addition, in the first connection relationship, the lower inclined surface 602a of the first flange fits with the upper surface 701 of the clamping section 700, and when the pawl 7 is separated from the first connection relationship upward along the lower inclined surface 602a, the interaction between the lower inclined surface 602a and the upper surface 701 makes the pawl 7 have a tendency to expand outward in the radial direction, and the tendency to expand outward cannot allow the pawl 7 to escape upward from the first connection relationship through the lower inclined surface 602a.

[0051] When the connector 3 moves downward relative to the main body 2, the ratchet 6 and the pawl 7 realize a non-resettable one-way movement as a one-way stepping mechanism. At this time, the matching section 301 of the connector 3 is separated from the axial hole of the positioning section 501. Combined with the aforementioned flange shape, the engaging section 700 of the pawl 7 can enter under the second flange by relying on the guiding effect of the upper inclined surface 601b of the second flange. The radial size and axial height of the space under the second flange no longer match the engaging section 700, and the connector 3 and the main body 2 form a second connection relationship through movement. Figure 4The figure shows a schematic diagram of the positioning mark under the second connection relationship in the present embodiment. Under this connection relationship, the axial positioning and radial positioning of the connector 3 and the main body 2 are changed, and the positioning element 1 therefore loses the correct connection relationship with the connected object. In addition, similar to the assembly between the connector 3 and the main body 2, the clamping portion 700 cannot be reset to between the two flanges through the second flange. The right angle of the lower connection 502 and the right angle setting at the corner of the positioning section 301 also further increase the difficulty of resetting. When used again, the axial and radial positioning relationship between the connector 3 and the main body 2 is changed so that the connector is swaying in the axial and radial directions relative to the main body, providing the operator with a clear reminder that it cannot be used again. In addition, since the diameter of the opening 201 is smaller than the outer diameter of the clamping section 700, the clamping section 700 will not completely fall out of the main body 2 below the second flange, thereby avoiding the connector 3 from falling off.

[0052] During specific use, the operator applies an axial pressing force to the main body 2 to install the assembled positioning mark to the pin 4 by plugging. During the pressing process, the connector 3 is axially subjected to the driving force between the ratchet 6 and the pawl 7 and the axial resistance generated by the pin 4. The driving force is transmitted to the engaging portion 700 through the lower surface 601a of the ratchet 6. The engaging portion 700 is axially limited in one direction by the ratchet 6 to cause the connector 3 and the main body 2 to move downward together relatively statically. The connector 3 moving downward overcomes the axial resistance between the pin and the connecting head of the pin 4 through the connecting hole 8 to achieve axial positioning. At the same time, the opening 201 cooperates with the axial hole of the peripheral edge 401 to achieve radial positioning. At this point, the positioning element 1 in the positioning mark has a correct positional relationship with the object to be marked, and the positioning element 1 correctly represents the position of the object to be marked.

[0053] When removing the positioning mark, the operator pulls the main body 2 axially. The connector 3 is subjected to the static friction between the main body 2, the resistance between the ratchet and the pawl, and the axial static friction between the connector 3 and the pin 4. Among them, the sum of the static friction between the connector 3 and the main body 2 and the resistance between the ratchet 6 and the pawl 7 is less than the axial static friction of the connector 3 about to be separated from the pin 4. Therefore, in the first stage of the pulling process, the connector 3 and the pin 4 remain stationary, but move relative to the main body 2, and the pawl 7 is radially contracted by the guiding effect of the second flange, and the contracted pawl 7 causes the engaging section 700 to pass over the second flange; in the second stage of the pulling process, the engaging section 700 continues to move downward and is blocked by the main body opening 201 and cannot move further, and the connector 3 overcomes the axial static friction between the pin 4 and separates from it. The positioning relationship between the connector 3 and the main body 2 in the positioning mark after separation is changed, and the connector 3 cannot be reset to the correct position. After being reinstalled on the pin 4, the position of the marked object cannot be correctly represented. In addition, since there is no radial and axial positioning between the connecting member 3 and the main body 2, the connecting member 3 is wobbling relative to the main body 2. In this case, when the positioning mark is installed on the pin 4, the main body 2 is wobbling relative to the marked object, which can intuitively convey the damaged information to the user and prompt the user to replace it in time.

[0054] based on Figure 1-6 In the embodiment shown, in an optional embodiment, the cooperation between the ratchet 6 and the pawl 7 only forms radial positioning in the positioning relationship under the first connection relationship. For example, the number of flanges in the ratchet 6 is set to one, the ratchet 6 and the pawl 7 are provided with a shaft hole matching section of a certain length, and a blocking portion is provided above the positioning section 501. Under the first connection relationship, the shaft hole matching section of a certain length enables radial positioning between the connector 3 and the main body 2; the positioning section 501 is restricted by the blocking portion above and the pawl 7 is restricted by the flange below, so that the connector 3 forms an axial positioning between the blocking portion and a flange. At this time, the connector 3 and the main body 2 have a predetermined axial and radial positioning relationship. Through the action of a predetermined force, the engaging section 700 passes over the flange so that the connector 3 and the main body 2 form a second connection relationship that is the same as the above embodiment and cannot be reset to the first connection relationship. Under the second connection relationship, the positioning mark cannot correctly represent the position of the marked object, and its specific principles and processes are not repeated here.

[0055] In addition, in another optional embodiment, the cooperation between the ratchet 6 and the pawl 7 only forms the axial positioning in the positioning relationship under the first connection relationship. Figure 2Similar to the figure, the height of the engaging portion 700 of the pawl 7 is the same as the spacing distance between the two flanges, but the outer diameter of the engaging portion 700 is smaller than the inner diameter between the two flanges, and the axial hole of the positioning section 501 and the matching section 301 are positioned. In this way, in the first connection relationship, the cooperation between the ratchet 6 and the pawl 7 only forms axial positioning, while the cooperation between the axial hole of the positioning section 501 and the matching section 301 realizes radial positioning.

[0056] like Figure 7 As shown, in an optional embodiment, in Figure 1-6 On the basis of the embodiment shown, the length of the positioning section 501e is increased, so that when the positioning mark is in the second connection relationship, only the engaging section 700 of the pawl 7 enters below the second flange, while the matching section 301 of the connector 3 continues to match the axial hole of the positioning section 501e. In this way, the radial size and axial height of the space below the second flange no longer match the engaging section 700 of the pawl 7, so that the connector 3 does not have an axial positioning relationship with respect to the main body 2, but the matching of the matching section 301 and the positioning section 501e makes the connector 3 still have a radial positioning relationship with respect to the main body 2. Since the marking object needs to have a strict fixed position relationship or a correct position relationship when the positioning mark is used, the change of the axial positioning relationship alone will also cause the positioning mark to lose the correct position relationship with the connected object and cannot correctly represent the position of the marked object. In addition, the change of the axial positioning relationship is reflected in the positioning element being farther away from the marked object in the axial direction when the positioning mark is installed on the marked object. The farther axial distance prompts the operator to indicate that the positioning mark cannot be used again.

[0057] like Figure 8 As shown, in an optional embodiment, the positioning mark 1a and the main body 2a adopt the same arrangement as in the above-mentioned embodiment and the figure. The difference is that the ratchet 6a in the one-way stepping mechanism is arranged on the connecting member 3a and the pawl 7a is arranged on the main body 2a. Among them, the ratchet 6a is a flange distributed along the circumference of the connecting member 3a, and the pawl 7a includes two protrusions on the head and a radially deformable vertical section located below the protrusions. The two protrusions form a space matching the shape of the ratchet 6a, and the cross-sectional shapes of the protrusions and the flange are both triangular teeth. In addition, a matching section 301a matching the shaft hole of the positioning section 501a is arranged on the top of the connecting member 3a.

[0058] In the first connection relationship, the ratchet 6a is positioned by the two protrusions of the pawl 7a, and the matching section 301a and the positioning section 501a are fitted to form a shaft hole match, so that the connection member 3a and the main body 2a have a predetermined positioning relationship. Under the action of a predetermined force, the connection member 3a moves downward relative to the main body 2a, and the upper triangular inclined surface 710 of the protrusion 71 located below the pawl 7a and the lower triangular inclined surface 610 of the flange have a tendency to separate from each other. Since the pawl 7a can be radially deformed, the upper triangular inclined surface 710 will enter the space 11 located below the two protrusions 71 under the guidance of the lower triangular inclined surface 610, and the matching section 301a and the positioning section 501a also disengage from the shaft hole match, so that the connection member 3a and the main body 2a form a second connection relationship. In the second connection relationship, the space 11 below the protrusion 71 cannot effectively position the ratchet 6a, and the matching section 301a and the positioning section 501a are disengaged, and cannot be reset to the first connection relationship. Therefore, the axial positioning and radial positioning of the connecting member 3 and the main body 2a are changed, and the positioning mark loses its correct positional relationship with the connected object and cannot correctly represent the position of the marked object, and cannot be used again.

[0059] like Fig. 9 As shown, in an optional implementation, based on Figure 6 In the embodiment shown and described above, the other components adopt the same configuration, and only the interlocking section 302b cooperating with the opening 201b is added at the bottom of the connector 3b. In the first connection relationship, the connector 3b and the main body 2b realize axial and radial positioning through the cooperation between the matching section 301b and the positioning section 501b, the cooperation between the ratchet 6b and the pawl 7b, and the cooperation between the interlocking section 302b and the opening 201b. In the second connection relationship, the cooperation between the matching section 301b and the matching section 501b, the cooperation between the ratchet 6b and the pawl 7b, and the cooperation between the interlocking section 302b and the opening 201b are all separated from each other, and the axial positioning and radial positioning of the connector 3b and the main body 2b are changed, so the positioning mark loses the correct position relationship with the connected object and cannot correctly represent the position of the marked object, and cannot be used again.

[0060] like Fig.10 and Fig.11 As shown, in an optional embodiment, the pawl 7c in the one-way stepping mechanism is separated from the main body 2c and the connecting member 3c and independently forms an elastic component that needs to be assembled. Fig. 9As shown, the elastic component includes a plurality of ratchet claws 7c and a collar 9 carrying the ratchet claws 7c, and the collar 9 can enable the elastic component to be installed on the connecting member 3c. In this way, a one-way advancement mechanism is formed between the connecting member 3c and the main body 2c, so that the connecting member 3c and the main body 2c have a first connection relationship and a second connection relationship and can only be switched from the first connection relationship to the second connection relationship. Preferably, the collar 9 adopts a non-enclosed C-shaped ring, which is convenient for installing the elastic component through the gap of the C-shaped ring.

[0061] Furthermore, the ratchet 6c in the one-way advance mechanism is set as a step with a gradually changing size on the inner wall of the cavity of the main body 2c. Exemplarily, the number of steps is four and the inner diameter of the cavity 5c at different steps gradually increases from top to bottom. From top to bottom, the first step and the second step form a first junction 1001, the second step and the third step form a second junction 1002, and the inner diameter of the third step is greater than the outer diameter of the elastic component. In the first connection relationship, the pawl 7c is engaged with the first junction 1001 of the step, and the engaging section 302c at the bottom of the connecting member 3c cooperates with the opening 201c axial hole of the main body 2c, so that the main body 2c and the connecting member 3c have a predetermined relatively fixed axial and radial positioning relationship. Under the action of a predetermined force, the connector 3c and the pawl 7c move downward relative to the main body 2c. During the movement, the pawl 7c passes over the second junction 1002 of the step and enters the third step of the cavity 5c. At this time, the size of the second junction 1002 is larger than the size of the outer periphery of the top of the pawl 7c and loses the engagement with the pawl 7c. The engaging section 302c and the opening 201c of the main body 2c also disengage from the axial hole. The main body 2c and the connector 3c no longer have the predetermined axial and radial positioning relationship, and the positioning mark cannot correctly represent the position of the marked object. In addition, the pawl 7c cannot reversely pass over the second junction 1002 and return to the first junction 1001, and the positioning mark can no longer correctly represent the position of the marked object and cannot be reused.

[0062] like Fig.12 As shown, in an optional embodiment, no reset guide structure is provided between the connector 3d and the main body 2d to form a reset obstacle, making it difficult to reset the connector and the main body after the predetermined positioning relationship is changed. Specifically, the positioning mark includes a positioning element 1d, a main body 2d and a connector 3d. The positioning element 1d is a reflective sheet, the main body 2d is a shell with a cavity 5d provided inside, and the connector 3d is provided with a connecting hole 8d for connecting to the marked object. A positioning segment 501d is provided in the cavity 5d, and a mating segment 301d mating with the axial hole of the positioning segment 501d is provided on the connector 3d, and the axial hole of the positioning segment 501d and the mating segment 301d are both set at right angles.

[0063] In the first connection relationship, the positioning section 501d and the matching section 301d adopt an interference fit between the shaft hole, and a certain force is required between the two to make them separate from each other. Therefore, it is not difficult to understand that in the first connection relationship of this setting, the connector 3d and the main body 2d also have a predetermined axial positioning relationship and radial positioning relationship, and the positioning mark can be used to accurately characterize the position of the marked object. Under the action of a predetermined force, the shaft hole of the positioning section 501d and the matching section 301d are separated from each other to form a second connection relationship. Since the shaft holes of the positioning section 501d and the matching section 301d are both right angles, no guide is set to promote the connector to form the shaft hole with the main body, such as chamfers or fillets. In the cavity 5d with a small space, the operation of resetting the connector 3d and the main body 2d to the first connection relationship has certain difficulties. And in the second connection relationship, the connector 3d is not fixed relative to the main body 2d in the axial and radial directions, and the connector 3d can shake in the cavity of the main body 2d. The shaking information can also prompt the user that the positioning mark has expired and cannot be reused. In addition, this type of one-way advancement mechanism such as a pawl or ratchet is not provided, so that the structure of the connecting piece and the main body is simpler and convenient for processing.

[0064] based on Figure 1-6 In the embodiment shown, in an optional implementation, the number of the pawls 7 is not limited to four, for example, it can be two, three, five, etc., to ensure that the cooperation between the pawl 7 and the ratchet 6 can not only ensure the connection strength and stability but also flexibly realize the radial deformation ability, and it can be freely selected according to actual conditions.

[0065] based on Figure 1-6 In the embodiment shown, in an optional implementation, the selection of the angle b of the upper inclined surface 601a relative to the vertical surface opening downward and the angle a of the lower inclined surface 602a relative to the vertical surface opening downward is not limited to the above embodiment. In principle, the angle a can be selected to be less than or equal to 90 degrees, and the angle b can be less than 90 degrees. The angle a is less than or equal to 90 degrees to ensure that the engaging portion 700 cannot move from the bottom of the flange to the top of the flange, resulting in reset obstacles and assembly guarantees, and the angle b is less than 90 to provide a guide for the movement of the pawl 7.

[0066] based on Figure 1-6In the embodiment shown, in another optional implementation, the method of realizing the positioning mark and the positioning of the pin 4 is not limited to the above-mentioned method of matching the connecting hole 8 and the connector, and the opening 201 and the positioning edge 401. The axial positioning and radial positioning of the pin 4 and the connector 3 when plugged in can also be realized directly by the connecting hole 8 without setting the peripheral edge 401. For example, the matching of the pin 4 and the connecting hole 8 is set as an interference fit of the shaft hole, and the interference fit of the shaft hole makes a certain friction force caused by pressure exist between the matching surfaces of the connecting hole 8 and the pin 4. The friction force realizes the axial positioning of the pin 4 and the connector 3, and the shaft hole fit itself realizes the radial positioning of the pin 4 and the connector 3.

[0067] based on Figure 1-6 In the embodiment shown, in an optional implementation, the axial distance between the opening 201 and the second flange is reduced to be the same as the height of the engaging section 700, and the outer diameter of the engaging section 700 is smaller than the inner diameter of the inner wall of the cavity. In this way, after the connector 3 and the main body enter the second connection relationship from the first connection relationship, the predetermined axial positioning relationship and radial positioning relationship between the connector 3 and the main body 2 are changed. However, in the second connection relationship, the engaging section 700 is fixed in the axial direction relative to the main body 1, but not in the radial direction. When the positioning mark is installed on the marked object again, the positioning mark may shake in the radial direction, and the radial shaking prompts the operator to indicate that the positioning mark cannot be used again.

[0068] In a second aspect, the present application proposes a surgical instrument, which includes the positioning mark, the positioning part and the functional part described in the first aspect, wherein the positioning part is used to carry the positioning mark, the functional part has a predetermined positional relationship with the positioning part, and is used to perform at least part of the surgical operation.

[0069] In an optional embodiment, the surgical instrument is a probe used for alignment in surgical operations, and the probe package is used to carry a positioning frame with multiple positioning marks and a probe tip for contacting the patient's anatomical structure. There is a fixed positional relationship between the probe tip and the positioning frame, and the positioning mark and the positioning frame are detachably connected. During the alignment process, the system obtains the position information of the positioning mark, and in combination with the above-mentioned fixed positional relationship, it can match the point contacted by the probe tip with the corresponding point in the three-dimensional model of the surgical plan in the computer-assisted surgery (Computer Aided Surgery-CAS) system. After the probe is used, the positioning mark is removed. After removal, the positioning element no longer has the correct positional relationship with the marked object and cannot or is difficult to restore the correct positional relationship, and the positioning mark cannot be reused.

[0070] In an optional embodiment, the surgical instrument is an end effector used to perform surgical operations in surgical operations, and the end effector is provided with an end reference frame and carries surgical tools, and the end reference frame is provided with multiple positioning marks and has a fixed positional relationship with the surgical tools. During the operation, the system can accurately obtain the position information of the surgical tools in the surgical system through the position information of the positioning marks, combined with the fixed positional relationship between the positioning marks and the surgical tools, and further guide the operator to manipulate the end effector to perform the operation. Similarly, the positioning marks cannot be reused or are difficult to reuse after removal.

[0071] The surgical instruments mentioned or not mentioned above are all marked with the non-reusable positioning marks in the first aspect. The principle of avoiding reuse has been specifically explained in the first aspect and will not be repeated here.

[0072] In the third aspect, the present application proposes a surgical system, comprising the positioning mark described in the first aspect, the positioning mark is used to mark anatomical tissue and / or equipment, and also includes a locator, a controller and an actuator, wherein the locator is used to obtain the position information of the marked object according to the positioning mark; the controller is used to control the surgical system to execute a predetermined surgical plan according to the position information obtained by the locator; and the actuator is used to carry surgical tools.

[0073] It is easy to understand that the positioning navigation system based on positioning markers is an important part of the surgical robot system. Relying on the calibration of positioning markers, the surgical robot system can accurately obtain the position information of anatomical structures, surgical tools and other marked instruments in the surgical space, and achieve precise control of surgical tools and other instruments based on this position information.

[0074] refer to Figure 2Taking the positioning and navigation process of computer-assisted surgery as an example, in order to ensure that the positioning mark is not damaged, a detachable positioning mark is usually installed on the marked object such as the surgical tool, the robotic arm, the end effector or the positioning frame at the patient's anatomical structure before the operation. When the positioning mark is installed on the marked object, the connector and the main body have a predetermined positioning relationship, and the positioning mark and the marked object have a correct positional relationship, so the position of the marked object can be normally characterized. The navigation system can accurately calculate the position information of the marked object based on the position information of the positioning mark, and then reflect the specific surgical conditions of the surgical tools, robotic arms, end effectors and anatomical structures in the surgical environment. The operator can operate the actuator to perform the surgical operation based on the accurate positioning and navigation information. After the operation is completed, the positioning mark is removed from the marked object. During the removal process, the operator applies a lifting force to the main body 2, and the lifting force causes the predetermined force to be synchronously applied to the connecting member 3, so that the connecting member 3 moves relative to the main body 2, and the main body 2 and the connecting member 3 no longer have a predetermined positioning relationship, and the predetermined positioning relationship cannot or is difficult to reset, and the positioning mark's function of correctly representing the marked object fails. Therefore, after use, the positioning mark loses its correct positional relationship with the marked object, and the positioning mark cannot correctly represent the position of the marked object and cannot be used again.

[0075] Although the present application has been described in detail above with general descriptions and specific implementation schemes, it is obvious to those skilled in the art that some modifications or improvements can be made to the present application. Therefore, these modifications or improvements made without departing from the spirit of the present application are within the scope of protection claimed in the present application.

Claims

1. A positioning marker, used to mark an object in a positioning navigation system, characterized in that: include: Positioning elements for active or passive signaling; A main body, comprising an upper end and a lower end, wherein the upper end is used to carry the positioning element; A connecting member, disposed at the lower end and used for being detachably connected to the marked object, and the connecting member can be moved relative to the main body when a predetermined force is applied to the connecting member; Wherein, the connecting member is plug-connected with the main body and has a first connection relationship and a second connection relationship, and under the first connection relationship, there is a predetermined positioning relationship between the connecting member and the main body so that the connecting member is fixed to the main body; When the connecting member is acted upon by the predetermined force in the first connection relationship, it moves relative to the main body to form the second connection relationship, and the predetermined positioning relationship in the second connection relationship is changed so that the connecting member can shake relative to the main body; and there is a resetting obstacle between the connecting member and the main body in the second connection relationship, which prevents the two from resetting to the first connection relationship; The predetermined force is the force of the marked object pulling the connecting piece when the positioning element is removed from the marked object.

2. The positioning mark according to claim 1, characterized in that: The predetermined positioning relationship includes an axial positioning relationship and a radial positioning relationship.

3. The positioning mark according to claim 1, characterized in that: In the second connection relationship, the axial positioning relationship in the predetermined positioning relationship is changed or both the axial positioning relationship and the radial positioning relationship are changed.

4. The positioning mark according to claim 1, characterized in that: The connector and the body are configured such that the movement causes the connector to at least partially disengage / disconnect from the body.

5. The positioning mark according to claim 1, characterized in that: The movement is a one-way movement that cannot be reset.

6. The positioning mark according to claim 5, characterized in that: A one-way stepping mechanism is constructed between the main body and the connecting member to realize the non-resettable one-way movement, and the one-way stepping mechanism includes a ratchet and a pawl that can be deformed in the radial direction.

7. The positioning mark according to claim 6, characterized in that: In the first connection relationship, the pawl and the ratchet tooth form axial positioning and / or radial positioning in the positioning relationship.

8. The positioning mark according to claim 6, characterized in that: The ratchet is a flange arranged in the circumferential direction, and the ratchet is in multiple numbers and distributed in the circumferential direction.

9. The positioning mark according to claim 6, characterized in that: The lower end is provided with a cavity, in which the connecting piece is accommodated. The connecting piece has a connecting hole for connecting the positioning mark to the marked object, and the opening direction of the connecting hole is consistent with the opening direction of the cavity.

10. The positioning mark according to claim 9, characterized in that: The cavity passes through the upper end and the lower end, and an opening of the cavity at the lower end is smaller than an outer circumference of the pawl.

11. The positioning mark according to claim 1, characterized in that: No resetting guide structure is provided between the connecting member and the main body to form the resetting obstacle.

12. The positioning mark according to claim 11, characterized in that: The first connection relationship is the axial hole cooperation between one end of the connecting member and the main body, the movement causes the connecting member to disengage from the axial hole cooperation with the main body, and the reset guide structure is the chamfer or fillet of the joint of the connecting member and / or the main body forming the axial hole cooperation.

13. A surgical instrument for a surgical navigation system, characterized in that: Also includes: A positioning mark, used to mark an object to be marked, wherein the positioning mark is the positioning mark according to any one of claims 1 to 12; A positioning part, used for carrying the positioning mark; The functional part has a predetermined positional relationship with the positioning part, and the functional part is used to perform at least part of the operation of the surgical operation.

14. A surgical system, characterized in that: It comprises: a positioning mark for marking anatomical tissue and / or equipment, wherein the positioning mark is a positioning mark as claimed in any one of claims 1 to 12; A locator, used to obtain position information of the marked anatomical tissue and / or device according to the positioning mark; A controller, configured to control a surgical system to execute a predetermined surgical plan according to the position information acquired by the locator; as well as Actuator, used to carry surgical tools.

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