Surgical instrument having lockout mechanism

Abstract

The present disclosure provides a surgical instrument including a lockout assembly that can be unlocked by a surgical staple cartridge, the lockout assembly preventing distal advancement of a pair of closure plates and a drive bar of the surgical instrument when in a locked position and allowing distal advancement of the pair of closure plates and a drive bar when in an unlocked position.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to the field of surgical instruments, and more particularly, to surgical instruments having a lockout mechanism. [Background technology]

[0002] Surgical instruments such as surgical staplers / anastomosis instruments are typically used to deploy staples into tissue to reduce or eliminate tissue bleeding and require sealing of tissue as it is cut, for example to promote healing. Surgical staplers / anastomosis instruments (linear staplers / anastomosis instruments, right angle staplers / anastomosis instruments, etc.) may include an end effector assembly having a staple cartridge portion and a staple anvil portion, the end effector assembly configured to secure tissue between the staple cartridge portion and the staple anvil portion, the staple cartridge portion including a replaceable staple cartridge configured to removably store surgical staples therein, and the staple anvil portion including staple forming pockets for forming the staples. Such surgical staplers / anastomosis instruments generally include a closure mechanism for moving one of the staple cartridge portion and the staple anvil portion relative to the other, and a drive bar for driving the staples.

[0003] In use, the staple cartridge portion and the staple anvil portion of the end effector assembly of the surgical stapler / stapler are closed to form a closure mechanism to capture tissue between the staple cartridge portion and the staple anvil portion. The drive bar then pushes the staples so that they deploy from the staple cartridge, pass through the tissue and form against the staple forming pockets of the staple anvil portion to seal the tissue layers together. The staples are typically arranged in the form of several staple lines or rows to more securely secure the tissue layers together. The end effector assembly may or may not include a cutting member that can be advanced between the staple lines to cut the tissue after the tissue layers have been sealed together.

[0004] In one aspect, the closing action to close the end effector assembly and the driving action to drive the staples may not be permitted unless a surgical staple cartridge is installed within the surgical instrument, which could otherwise damage the surgical instrument or cause an error.

[0005] In another aspect, the closing action to close the end effector assembly and the driving action to drive the staples may not be allowed when a used surgical staple cartridge is installed within the surgical instrument and may otherwise damage or cause malfunction of the surgical instrument.

[0006] In a further aspect, staple cartridges and surgical instruments are typically provided in a variety of models for different tissue sites and situations. A particular model of staple cartridge may be used for one or more models of surgical instruments. If an incompatible staple cartridge is installed in a surgical instrument, the closing action to close the end effector assembly and the driving action to drive the staples may not be acceptable, or may affect the tissue seal quality, cause the surgical instrument to malfunction, or even damage the surgical instrument and staple cartridge.

[0007] Therefore, a staple cartridge having a lockout mechanism is needed to avoid the above situation. Summary of the Invention

[0008] The present disclosure provides a surgical instrument having a lockout mechanism that can lock the closure plate and drive bar of the surgical instrument when the surgical instrument is not installed with a surgical staple cartridge (of a compatible model) and when a used surgical staple cartridge is installed to prevent closure of the end effector assembly and driving of staples.

[0009] The present disclosure provides a surgical instrument including a proximally positioned handle assembly, a shaft assembly extending distally from the handle assembly, and an end effector assembly coupled to the handle assembly via the shaft assembly and configured to be manipulated by the handle assembly to transition between an open configuration and a closed configuration, the end effector assembly including a pair of hook-shaped members, a pair of closure plates positioned between the pair of hook-shaped members and configured to be manipulated by the handle assembly to advance distally to transform the end effector assembly from the open configuration to the closed configuration, a drive bar disposed between the pair of closure plates and configured to be manipulated by the handle assembly to advance distally; and a lockout assembly pivotally mounted on and disposed between the pair of closure plates and configured to pivot between a locked position in which the lockout assembly prevents the pair of closure plates and the driving bar from advancing distally and an unlocked position in which the lockout assembly allows the pair of closure plates and the driving bar to advance distally.

[0010] According to a preferred embodiment, the lockout assembly includes a lockout member pivotally mounted between a pair of closure plates via a pivot and a spring member configured to bias the lockout member toward the locked position.

[0011] According to a preferred embodiment, the lockout member includes a first hook-shaped arm extending distally and a second hook-shaped arm extending proximally, and when the lockout member is in the locked position, the first hook-shaped arm prevents the driving bar from advancing distally and the second hook-shaped arm prevents the pair of closure plates from advancing distally, and when the lockout member is pivoted to the unlocked position, the first hook-shaped arm allows the driving bar to advance distally and the second hook-shaped arm allows the pair of closure plates to advance distally.

[0012] According to a preferred embodiment, the first hook-shaped arm has an upwardly curved end and the second hook-shaped arm has a downwardly curved end, and when the lockout member is in the locked position, the end of the first hook-shaped arm engages the drive bar or is distal to the drive bar to prevent the drive bar from advancing distally and the end of the second hook-shaped arm engages a pin secured between the pair of hook-shaped members or is proximal to the pin to prevent the pair of closure plates from advancing distally; and when the lockout member is in the unlocked position, the end of the first hook-shaped arm disengages from the drive bar or is no longer distal to the pin to allow the drive bar to advance distally and the end of the second hook-shaped arm disengages from the pin or is no longer proximal to the pin to allow the pair of closure plates to advance distally.

[0013] According to a preferred embodiment, a pair of closure plates are configured to removably hold a surgical staple cartridge including a staple driver configured to be pushed distally by a drive bar to move from an undriven position to a driven position, and when the surgical staple cartridge is installed in a fixed position between the pair of closure plates along an installation direction of the surgical staple cartridge, a first hook-shaped arm is configured to be engaged by the staple driver in the undriven position to pivot the lockout member toward the unlocked position, and the first hook-shaped arm is configured not to engage the staple driver in the driven position to maintain the lockout member in the locked position.

[0014] In accordance with a preferred embodiment, the upper ends of the pair of closure plates are each provided with a notch, each notch configured to receive a corresponding protrusion on a surgical staple cartridge that is compatible with the surgical instrument to enable the surgical staple cartridge to be placed in a fixed position between the pair of closure plates.

[0015] According to a preferred embodiment, the inner side of the pair of closure plates is provided with one or more ribs extending along the installation direction of the surgical staple cartridge, and the one or more ribs are configured to be received within corresponding slots provided on the surgical staple cartridge that is compatible with the surgical instrument.

[0016] According to a preferred embodiment, the lockout member further comprises a stepped portion located between the first hook-shaped arm and the second hook-shaped arm, a distal facing surface of the first end of the spring member abutting the stepped portion, a second end of the spring member being fixed to one of the hook-shaped member, the closure plate and the drive bar, and a proximal facing surface of the portion of the spring member between the first and second ends abutting the pivot.

[0017] According to a preferred embodiment, the spring member has a slot extending longitudinally of the spring member, and the lockout member is adapted to pass through the slot such that a first hook-shaped arm is positioned distally of the spring member and a second hook-shaped arm is positioned proximally of the spring member.

[0018] In accordance with a preferred embodiment, the dimension of the notch along the installation direction of the surgical staple cartridge is related to the locked and unlocked positions of the lockout member.

[0019] According to a preferred embodiment, the notch has a substantially triangular contour with one apex of the triangular contour pointing in the direction of installation of the surgical staple cartridge. [Brief description of the drawings]

[0020] The present disclosure and its features and advantages will be better understood by referring to the following description of exemplary embodiments of the disclosure in conjunction with the accompanying drawings, in which like elements are designated by like reference numerals. The drawings are not necessarily drawn to scale, and for clarity and conciseness, some parts may be omitted, and some drawings may be drawn in an exaggerated or sketchy manner. [Figure 1] 1 is an illustrative side view of a surgical instrument according to the present disclosure; [Diagram 2] 1 is an illustrative side view of a surgical staple cartridge according to the present disclosure; [Diagram 3] 2 is an exemplary enlarged partial view of the end effector portion of the surgical instrument shown in FIG. 1 with some components omitted. [Figure 4] 3 is an illustrative side view of the surgical instrument of FIG. 1 with the surgical staple cartridge of FIG. 2 installed thereon; [Diagram 5] FIG. 2 is an exemplary enlarged partial view of an end effector portion of the surgical instrument of FIG. 1 with some components omitted. [Figure 6]FIG. 6 is an exemplary enlarged partial view of the lockout assembly of FIG. 5. [Figure 7] 1 is an exemplary diagram of a lockout member of a lockout assembly according to the present disclosure; [Figure 8] 13A-13C are exemplary diagrams of a spring member of a lockout assembly according to the present disclosure. [Figure 9] FIG. 13 is an exemplary enlarged partial view of an end effector portion of a surgical instrument with the lockout assembly in an unlocked position and with some components omitted. [Figure 10] FIG. 13 is an exemplary enlarged partial view of an end effector portion of a surgical instrument installed with a used surgical staple cartridge, with some components omitted; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Exemplary embodiments of the present invention will be described in detail below with reference to the accompanying drawings. What is described herein is only an exemplary embodiment according to the present disclosure, and a person skilled in the art may envision other ways to implement the present disclosure based on the exemplary embodiments described herein, which are also within the scope of the present disclosure.

[0022] In the detailed description that follows, "proximal" refers to a direction toward an operator of a surgical instrument and "distal" refers to a direction away from the operator of a surgical instrument.

[0023] 1 illustratively illustrates a surgical instrument according to the present disclosure including a proximally positioned handle assembly 10, a shaft assembly 20 extending distally from the handle assembly 10, and an end effector assembly 30 coupled to the handle assembly 10 via the shaft assembly 20. An operator can control the end effector assembly 30 to switch between an open configuration and a closed configuration and control the driving of staples by manipulating the handle assembly 10. The end effector assembly 30 shown in FIG. 1 is in the open configuration, and a surgical staple cartridge 60 shown in FIG. 2 can be installed within the surgical instrument of FIG. 1.

[0024] 3-8, the end effector assembly 30 includes a pair of hook-shaped members 31, a pair of closure plates 32 positioned between the pair of hook-shaped members 31, and a driving bar 33 positioned between the pair of closure plates 32. The hook-shaped members 31 are generally U-shaped or C-shaped and are primarily used to hold other components. The closure plate 32 is used to hold a surgical staple cartridge and can be operated by the handle assembly 10 to advance distally with the surgical staple cartridge to place the end effector assembly 30 in a closed configuration. The driving bar 33 can be operated by the handle assembly 10 to advance distally and then drive the staples in the surgical staple cartridge. Specifically, the surgical staple cartridge includes a staple driver 61 for pushing and driving the staples from the staple cartridge. In an unused staple cartridge (see FIGS. 2 and 9), the staple driver 61 is in an initial (or unfired) position and a staple is housed within the staple cartridge, and in a used staple cartridge (see FIG. 10), the staple driver 61 is in a driven position and a staple has been driven from the staple cartridge. The drive bar 33 can engage the staple driver 61 as it moves distally to move the staple driver 61 from the unfired position to the fired position and then drive the staples.

[0025] An end effector assembly 30 according to the present disclosure further includes a lockout assembly 40 for locking both the closure plate 32 and the drive bar 33 from distal advancement when no staple cartridge is installed or when an incompatible or used staple cartridge is installed. The lockout assembly 40 is pivotally mounted between the pair of closure plates 32 and can pivot between a locked position and an unlocked position. In the locked position, the lockout assembly 40 can prevent the pair of closure plates 32 and the drive bar 33 from advancing in a distal direction, and in the unlocked position, the lockout assembly 40 can allow the pair of closure plates 32 and the drive bar 33 to advance in a distal direction.

[0026] FIG. 5 illustrates the end effector assembly 30 without any staple cartridge attached, and the hook-shaped member 31 and the closure plate 32 on the side facing the reader are omitted to show the lockout assembly 40. FIGS. 5 and 6 illustrate the lockout assembly 40 in a locked position. With reference to FIGS. 6-8, the lockout assembly 40 includes a lockout member 41 and a spring member 42, a pivot 43 is fixed on and between the pair of closure plates 32, the lockout member 41 is pivotally mounted between the pair of closure plates 32 via the pivot 43, and the spring member 42 is used to apply torque to the lockout member 41 to bias the lockout member 41 toward the locked position. The lockout member 41 includes a first hook-shaped arm 411 extending distally and a second hook-shaped arm 412 extending proximally. 6, the first hook-shaped arm 411 can prevent or block the driving bar 33 from advancing distally, and the second hook-shaped arm 412 engages a pin or rivet 311 secured between the pair of hook-shaped members 31 to prevent the pair of closure plates 32 from advancing distally. Specifically, the end of the first hook-shaped arm 411 is curved upward, and the end of the second hook-shaped arm 412 is curved downward. When the lockout member 41 is in the locked position as shown in FIG. 6 , the end of the first hook-shaped arm 411 engages with the driving bar 33 to prevent the driving bar 33 from advancing distally or is positioned in the advancement path of the driving bar 33 to block the driving bar 33 from advancing distally, and the end of the second hook-shaped arm 412 engages with the pin 311 to prevent the pair of closure plates 32 from advancing distally or is positioned proximal to the pin 311 to engage with the pin as the lockout member moves distally with the closure plates 32 to prevent the lockout member 41 and the pair of closure plates 32 from advancing distally.In an alternative embodiment, the first hook-shaped arm 411 may have an upwardly opening notch for receiving a corresponding portion of the drive bar 33 when in the locked position, and the second hook-shaped arm 412 may have a downwardly opening notch for receiving the pin 311 when in the locked position.

[0027] When the lockout member 41 is rotated to the unlocked position (see FIG. 9 ), the first hook-shaped arm 411 disengages from the driving bar 33 or leaves the advancement path of the driving bar 33 allowing the driving bar 33 to advance distally, and the second hook-shaped arm 412 disengages from the pin 311 or is no longer positioned proximal to the pin 311 allowing the lockout member 41 and the pair of closure plates 32 to advance distally.

[0028] 7 and 8 show the specific structures of the lockout member 41 and the spring member 42. The lockout member 41 further includes a stepped portion 413 formed between the first hook-shaped arm 411 and the second hook-shaped arm 412, and the spring member 42 biases the lockout member 41 toward the locked position by applying a pressing force to the stepped portion 413. Specifically, a distally facing surface 42a of a first end (lower end in Figs. 6 and 8) of the spring member 42 abuts against the stepped portion 413, and a second end of the spring member 42 may be fixed to any one of the hook-shaped member 31, the closure plate 32, and the driving bar 33. To deflect the spring member 42 and obtain an initial spring force, a proximally facing surface 42b of a portion of the spring member 42 between the two ends of the spring member 42 abuts against the pivot 43. The spring member 42 may further include a slot 42c extending longitudinally of the spring member 42, and the lockout member 41 passes through the slot 42c such that the first hook-shaped arm 411 is positioned distally of the spring member 42 and the second hook-shaped arm 412 is positioned proximally of the spring member 42. Those skilled in the art will appreciate that the spring member 42 may be replaced by other spring members, such as a torsion spring, so long as the spring member 42 is capable of applying a torque to the lockout member 41.

[0029] The following will provide a detailed description of how the lockout assembly 40 is unlocked by the staple cartridge. As described above, a pair of closure plates 32 may be used to hold the staple cartridge, and the staple cartridge may be installed between the pair of closure plates 32 along the installation direction L. According to the present disclosure, each side of the staple cartridge is provided with a protrusion 62 (see FIG. 2) and a slot 63 extending along the installation direction L, and the positions and dimensions of the protrusion 62 and the slot 63 on different models of staple cartridges may be different to prevent improper installation. Correspondingly, as shown in FIG. 3 and FIG. 5, each top of the pair of closure plates 32 of the surgical instrument according to the present disclosure is provided with a notch 321, and each inner surface of the pair of closure plates 32 is provided with one or more ribs 322 extending along the installation direction L. In FIG. 3, the closure plate 32 close to the side facing the reader is omitted.

[0030] 4, after a compatible model staple cartridge is installed in the surgical instrument, protrusions 62 of the staple cartridge are received in notches 321 of the surgical instrument and one or more ribs 322 of the surgical instrument are slidably received in slots 63 of the staple cartridge, thereby allowing the staple cartridge to be installed in place on the surgical instrument and unlock lockout assembly 40. A non-compatible model staple cartridge cannot be installed in place within the surgical instrument because the protrusions of such staple cartridge cannot mate with the notches of the surgical instrument or the slots cannot mate with the ribs of the surgical instrument, thereby unlocking lockout assembly 40.

[0031] 9 illustratively illustrates an unused staple cartridge being placed in place within a surgical instrument to unlock the lockout assembly, with a portion thereof shown in cross section without the hook-shaped member 31 and closure plate 32 on the side facing the reader to show the interior of the lockout assembly 40. As can be seen from FIG. 9, when an unused staple cartridge 60 of a compatible model is placed in place within the surgical instrument, the bottom end of the staple driver 61, in the unfired position, can engage the hook-shaped arm 411 of the lockout member 41 and push the hook-shaped arm 411 downward, thus allowing the lockout member 41 to pivot about pivot 43 to the unlocked position, after which both the closure plate 32 and the drive bar 33 can advance distally.

[0032] From the above discussion, it can be seen that the compatibility of the shape and dimensions (particularly the dimensions along the installation direction L) of the staple cartridge protrusion 62 and the surgical instrument notch 321 affects whether the staple cartridge can be installed into position within the surgical instrument and then unlock the lockout assembly 40. Thus, the dimensions (particularly the dimensions along the installation direction L) of the notch 321 are related to the locked and unlocked positions of the lockout member 41. In a preferred embodiment, the notch 321 has a substantially triangular contour with one apex of the triangular contour facing towards the installation direction L of the surgical staple cartridge 60.

[0033] 10 shows an exemplary state in which a used staple cartridge is installed in place within a surgical instrument, with the hook-shaped member 31 and closure plate 32 on the side facing the reader omitted and a portion of the staple cartridge 60 shown in cross section to show the interior of the lockout assembly 40. As shown in the figure, when a used staple cartridge 60 of a compatible model is installed in place within the surgical instrument, the staple driver 61 in the driving position is positioned distal to the hook-shaped arm 411 and cannot engage with the hook-shaped arm 411, and therefore the lockout assembly 40 cannot be unlocked. In this case, the closure plate 32 and drive bar 33 are still locked by the lockout assembly 40 and cannot advance distally.

[0034] The scope of protection of the present disclosure is limited only by the claims. References herein to "various embodiments," "several embodiments," "one embodiment," or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the appearance of phrases such as "various embodiments," "several embodiments," "one embodiment," or "an embodiment" herein do not necessarily all refer to the same embodiment. Furthermore, in one or more embodiments, particular features, structures, or characteristics may be combined in any suitable manner. Thus, without any inconsistency, a particular feature, structure, or characteristic illustrated or described in connection with one embodiment may be combined in whole or in part with a feature, structure, or characteristic of one or more other embodiments, and the resulting modifications and variations are also within the scope of the present disclosure.

Claims

1. Handle assembly and A shaft assembly extending distally from the handle assembly, A surgical instrument comprising: an end effector assembly coupled to the handle assembly via the shaft assembly and configured to be operated by the handle assembly to transition between an open configuration and a closed configuration, wherein the end effector assembly A pair of hook-shaped members, A pair of closing plates positioned between the pair of hook-shaped members, configured to be operated by the handle assembly to advance distally to convert the end effector assembly from the open configuration to the closed configuration, A driving bar positioned between the pair of closing plates, configured to be operated by the handle assembly to advance distally, A surgical instrument comprising: a lockout assembly pivotably mounted on a pair of closure plates and positioned between them, and configured to pivot between a locked position that prevents the pair of closure plates and the drive bar from advancing distally and an unlocked position that allows the pair of closure plates and the drive bar to advance distally.

2. The surgical instrument according to claim 1, wherein the lockout assembly comprises a lockout member pivotably mounted between the pair of closing plates via a pivot, and a spring member configured to bias the lockout member toward the locked position.

3. The surgical instrument according to claim 2, wherein the lockout member comprises a first hook-shaped arm extending distally and a second hook-shaped arm extending proximally, and when the lockout member is in the locked position, the first hook-shaped arm prevents the driving bar from advancing distally, and the second hook-shaped arm prevents the pair of closure plates from advancing distally, and when the lockout member pivots to the unlocked position, the first hook-shaped arm allows the driving bar to advance distally, and the second hook-shaped arm allows the pair of closure plates to advance distally.

4. The surgical instrument according to claim 3, wherein the first hook-shaped arm has an upwardly curved end, and the second hook-shaped arm has a downwardly curved end, and when the lockout member is in the locked position, the end of the first hook-shaped arm engages with the drive bar or is located distal to the drive bar to prevent the drive bar from advancing distally, and the end of the second hook-shaped arm engages with a pin fixed between the pair of hook-shaped members or is located proximal to the pin to prevent the pair of closure plates from advancing distally, and when the lockout member is in the unlocked position, the end of the first hook-shaped arm disengages from the drive bar or is no longer located distal to the drive bar to allow the drive bar to advance distally, and the end of the second hook-shaped arm disengages from the pin or is no longer located proximal to the pin to allow the pair of closure plates to advance distally.

5. The surgical instrument according to claim 3 or 4, wherein the pair of closure plates are configured to removably hold a surgical staple cartridge including a staple driver configured to be pushed distally by the driving bar to move from an unstapled position to a stapled position, and when the surgical staple cartridge is set in a fixed position between the pair of closure plates along the installation direction of the surgical staple cartridge, the first hook-shaped arm is configured to engage with the staple driver in the unstapled position to pivot the lockout member toward the unlocked position, and the first hook-shaped arm is configured not to engage with the staple driver in the stapled position to keep the lockout member in the locked position.

6. The surgical instrument according to claim 5, wherein each of the upper ends of the pair of closure plates is provided with a notch, and each notch is configured to receive a corresponding projection provided on the surgical staple cartridge, so as to enable the surgical staple cartridge, which is fitted to the surgical instrument, to be positioned in a fixed position between the pair of closure plates.

7. The surgical instrument according to claim 6, wherein the dimensions of the notch along the installation direction of the surgical staple cartridge are associated with the locked position and the unlocked position of the lockout member.

8. The surgical instrument according to claim 6, wherein the notch has a substantially triangular contour, and one vertex of the triangular contour faces the direction of installation of the surgical staple cartridge.

9. The surgical instrument according to claim 5, wherein one or more ribs are provided on the inside of the pair of closure plates, extending along the installation direction of the surgical staple cartridge, and the one or more ribs are configured to be received in corresponding slots provided on the surgical staple cartridge that are compatible with the surgical instrument.

10. The surgical instrument according to claim 4, wherein the lockout member further comprises a stepped portion located between the first hook-shaped arm and the second hook-shaped arm, the distal surface of the first end of the spring member abuts against the stepped portion, the second end of the spring member is fixed to one of the hook-shaped member, the closing plate, and the drive bar, and the proximal surface of the portion of the spring member between the first end and the second end abuts against the pivot.

11. The surgical instrument according to claim 4, wherein the spring member has a slot extending in the longitudinal direction of the spring member, and the lockout member is adapted to pass through the slot such that the first hook-shaped arm is positioned distal to the spring member and the second hook-shaped arm is positioned proximal to the spring member.

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