MECHANICAL LOCKOUT FOR ULTRASONIC SURGICAL INSTRUMENT

• US 20190314055A1
• Filed: 04/12/2018
• Published: 10/17/2019
• Est. Priority Date: 04/12/2018
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon, LLC (Johnson & Johnson)
• Inventors: Brady, John E., Cuti, Alexander R., Fiebig, Kevin M., Burkart, Ellen, Harris, Demetrius N., Kolpitcke, Andrew, Krumm, Amy M., Kuhn, Matthew T., Lesko, Jason R., Leuck, Stephen M., Lucas, Guion Y., McLain, Cameron D., Meyers, Andrew S., Otrembiak, Candice, Waters, Grace E.
• Granted Patent: US 10,945,755 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/2804 with two or more pivotal connections A61B17/29 takes precedence
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 17/320092 with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
• CPC Class Codes: A61B 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• CPC Class Codes: A61B 2017/00402 Piezo electric actuators
• CPC Class Codes: A61B 2017/00424 ergonomic, e.g. fitting in fist
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/320074 blade
• CPC Class Codes: A61B 2017/320088 with acoustic insulation, e.g. elements for damping vibrations between horn and surrounding sheath
• CPC Class Codes: A61B 2017/320094 additional movable means performing clamping operation
• CPC Class Codes: A61B 2017/320095 with sealing or cauterizing means
• CPC Class Codes: A61B 2018/00589 Coagulation
• CPC Class Codes: A61B 2018/0063 Sealing
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2090/0808 for indicating correct assembly of components, e.g. of the surgical apparatus

Abstract

An ultrasonic surgical instrument includes a first modular assembly including at least one operator input feature an ultrasonic transducer supported by the first modular assembly, and a second modular assembly configured to be removably coupled with the first modular assembly. The second modular assembly includes at least a portion of an end effector extending distally from a distal end portion of the second modular assembly. The instrument includes a mechanical lockout assembly configured to switch between at least an unlocked configuration and a locked configuration. In the locked configuration, the first modular assembly and the second modular assembly are partially coupled together such that the operator is physically prevented from activating the instrument using the operator input feature. In the unlocked configuration, the first modular assembly and the second modular assembly are completely coupled together and the operator is able to activate the instrument using the operator input feature.

Claims

1. An ultrasonic surgical instrument, comprising:

(a) a first modular assembly including at least one operator input feature;

(b) an ultrasonic transducer supported by the first modular assembly;

(c) a second modular assembly configured to be removably coupled with the first modular assembly, wherein the second modular assembly further includes at least a portion of an end effector extending distally from a distal end portion of the second modular assembly; and

(d) a mechanical lockout assembly configured to switch between at least an unlocked configuration and a locked configuration,

wherein in the locked configuration, the first modular assembly and the second modular assembly are partially coupled together such that the operator is physically prevented from activating the instrument using the operator input feature, and

wherein in the unlocked configuration, the first modular assembly and the second modular assembly are completely coupled together and the operator is able to activate the instrument using the operator input feature.

2. The ultrasonic surgical instrument of claim 1, wherein the first modular assembly further includes a handle assembly, a proximal outer sheath, and an ultrasonic blade, wherein the second modular assembly further includes a clamp arm assembly and a distal outer sheath, wherein the mechanical lockout assembly further includes at least one lockout member having a body that includes a lockout feature, wherein the lockout feature includes at least one of a curve, a change in angle, a slot, or a proximal extrusion from the body, wherein in the locked configuration, the lockout feature prevents rotation of the clamp arm assembly relative to the ultrasonic blade, and wherein in the unlocked configuration, the proximal outer sheath is configured to couple with the distal outer sheath allowing closure of the clamp arm assembly relative to the ultrasonic blade.

3. The ultrasonic surgical instrument of claim 2, wherein in the locked configuration, the lockout member prevents actuation of the clamp arm assembly due to an interference with both the clamp arm assembly and the distal outer sheath.

4. The ultrasonic surgical instrument of claim 2, wherein the mechanical lockout assembly further includes a pin that pivotably couples the distal outer sheath with both the clamp arm assembly and the lockout member.

5. The ultrasonic surgical instrument of claim 2, wherein the proximal outer sheath includes a projection that displaces the lockout member distally when coupling the proximal outer sheath with the distal outer sheath.

6. The ultrasonic surgical instrument of claim 1, wherein the first modular assembly includes a handle assembly that includes a proximal outer sheath, and an ultrasonic blade, wherein the second modular assembly includes a clamp arm assembly and a distal outer sheath, wherein the mechanical lockout assembly further includes at least one projection operatively coupled with a clamp arm assembly, wherein in the locked configuration the projection is not received by a corresponding recess in the distal outer sheath, the locked configuration configured to prevent an operator from rotating the clamp arm assembly relative to the ultrasonic blade, and wherein in the unlocked configuration where the proximal outer sheath is coupled with the distal outer sheath, the projection is received by the corresponding recess in the distal outer sheath enabling the operator from rotating the clamp arm assembly relative to the ultrasonic blade.

7. The ultrasonic surgical instrument of claim 1, wherein the first modular assembly further includes a handle assembly that includes the operator input feature, wherein the operator input feature includes at least one energy control button separated by a passageway from a switch, wherein the mechanical lockout assembly further includes a barrier that includes a body portion and at least one aperture that translates between the locked configuration and the unlocked configuration within the passageway, wherein in the locked configuration, the body portion is disposed within the passageway between the energy control button and the switch preventing the switch from activating the instrument, and wherein in the unlocked configuration, the aperture is disposed within the passageway between the energy control button and the switch enabling the switch to activate the instrument.

8. The ultrasonic surgical instrument of claim 7, wherein the barrier includes a flexible member that is operatively coupled with the shaft assembly, wherein the flexible element is pushed into the passageway such that in the locked configuration the flexible member extends between the energy control button and the switch.

9. The ultrasonic surgical instrument of claim 7, wherein in the unlocked configuration, at least one of the energy control button or the switch extends at least partially through the aperture of the barrier and makes direct physical contact with the other of the energy control button or the switch through the aperture.

10. The ultrasonic surgical instrument of claim 7, wherein the second modular assembly further includes a shaft assembly, wherein the mechanical lockout assembly further includes an angled slide that is configured to be contacted by a projection of the shaft assembly, wherein the angled slide is configured to contact the barrier causing the mechanical lockout assembly to transition from the locked configuration to the unlocked configuration, and wherein in the locked configuration, the body portion of the barrier is disposed within the passageway between the energy control button and the switch preventing the switch from activating the instrument.

11. The ultrasonic surgical instrument of claim 1, wherein the first modular assembly includes the operator input feature, wherein the operator input feature includes at least one switch and a first portion of an energy control button, wherein the second modular assembly further includes a shaft assembly and a handle assembly that includes a second portion of the energy control button, wherein in the locked configuration when the shaft assembly is partially coupled with the handle assembly, misalignment of the first and second portions of the energy control button prevents the switch from activating the instrument, and wherein in the unlocked configuration when the shaft assembly is completely coupled with the handle assembly, alignment of the first and second portions of the energy control button enables the switch to activate the instrument.

12. The ultrasonic surgical instrument of claim 1, wherein the first modular assembly further includes a handle assembly that includes a trigger, wherein the second modular assembly further includes a shaft assembly, wherein the mechanical lockout assembly further includes a closure lever link operatively coupled with the trigger, wherein in the locked configuration when the shaft assembly is partially coupled with the handle assembly, the closure lever link is pulled over center in a first direction, preventing the closure lever link from being rotated closed which prevents the trigger from being actuated, and wherein in the unlocked configuration when the shaft assembly is completely coupled with the handle assembly, insertion of the shaft assembly causes the closure lever link to rotate in a second direction that is opposite the first direction allowing the trigger to be actuated.

13. The ultrasonic surgical instrument of claim 1, wherein the mechanical lockout assembly further includes a one-way door that is configured to be opened by coupling a handle assembly of the first modular assembly with a shaft assembly of the second modular assembly, wherein in the locked configuration when the shaft assembly is partially coupled with the handle assembly, the one-way door blocks access of the handle assembly from the shaft assembly, wherein in moving from the locked configuration to the unlocked configuration, as an outer sheath is rotated, a translatable jacket threadably coupled with the outer sheath translates longitudinally relative to the one-way door pivoting the one-way door to an open position allowing for coupling of the shaft assembly with the handle assembly, and wherein in the unlocked configuration when the shaft assembly is completely coupled with the handle assembly allowing actuation of the instrument using the operator input feature.

14. The ultrasonic surgical instrument of claim 1, wherein a proximal portion of a shaft assembly of the second modular assembly includes a projection, wherein the mechanical lockout assembly includes a coupling device operatively coupled to a handle assembly of the first modular assembly, and wherein the coupling device includes a guide track that is configured to translate and rotate the shaft assembly using the interaction between the projection of the shaft assembly and the guide track of the coupling device from the locked configuration when the shaft assembly is partially coupled with the handle assembly to the unlocked configuration when the shaft assembly is completely coupled with the handle assembly.

15. The ultrasonic surgical instrument of claim 1, wherein the mechanical lockout assembly includes:

(i) an outer tube collar coupled with a handle assembly of the first modular assembly, wherein the outer tube collar includes a spring leg that includes a distal end, wherein the distal end of the spring leg includes a resilient interference tab; and

(ii) a bayonet collar coupled with the shaft assembly, wherein the bayonet collar includes a bayonet projection that is configured to contact a cam surface of the spring leg as the bayonet collar is rotated relative to the outer tube collar from the locked configuration to the unlocked configuration;

(iii) a rotation collar that includes an aperture,

wherein in the locked configuration when the shaft assembly is partially coupled with the handle assembly, the interference tab of the outer tube collar deflects outwardly into an aperture of the rotation collar preventing activation of the instrument, and

wherein in the unlocked configuration when the shaft assembly is completely coupled with the handle assembly, the bayonet projection contacts the cam surface of the interference tab to deflect the interference tab inwardly, enabling activation of the instrument.

16. An ultrasonic surgical instrument, comprising:

(a) a handle assembly including at least one operator input feature;

(b) an ultrasonic transducer supported by the handle assembly;

(c) a shaft assembly configured to removably couple with the handle assembly, wherein the shaft assembly includes a distal end portion, wherein the shaft assembly further includes;

(i) an end effector extending distally from the distal end portion; and

(ii) a waveguide acoustically coupled with the ultrasonic transducer; and

(d) a mechanical lockout assembly configured to move between at least an unlocked configuration and a locked configuration,

wherein in the locked configuration, the handle assembly and the shaft assembly are partially coupled together such that the operator is physically prevented from activating the instrument using the operator input feature, and

wherein in the unlocked configuration, the handle assembly and shaft assembly are completely coupled together and the operator is able to activate the instrument using the operator input feature.

17. The ultrasonic surgical instrument of claim 16, wherein the operator input feature further includes at least one energy control button that is separated by a passageway within the handle assembly from a switch within the handle assembly, wherein the mechanical lockout assembly further includes a barrier that includes a body portion and at least one aperture extending at least partially through the body portion, wherein the barrier translates within the passageway between the locked configuration and the unlocked configuration, wherein in the locked configuration, the body portion is disposed within the passageway between the energy control button and the switch preventing the switch from activating the instrument, and wherein in the unlocked configuration, the aperture is disposed within the passageway between the energy control button and the switch enabling the switch to activate the instrument.

18. The ultrasonic surgical instrument of claim 16, wherein the mechanical lockout assembly further includes a one-way door that is configured to be opened by coupling the handle assembly with the shaft assembly, wherein in the locked configuration when the shaft assembly is partially coupled with the handle assembly, the one-way door blocks access of the handle assembly from the shaft assembly, wherein in moving from the locked configuration to the unlocked configuration, as an outer sheath is rotated, a translatable jacket threadably coupled with the outer sheath longitudinally translates relative to the one-way door pivoting the one-way door to an open position allowing for coupling of the shaft assembly with the handle assembly, and wherein in the unlocked configuration when the shaft assembly is completely coupled with the handle assembly allowing actuation of the instrument using the operator input feature.

19. A method of operating an ultrasonic surgical instrument, wherein the ultrasonic surgical instrument includes:

(a) a first modular assembly including at least one operator input feature;

(b) an ultrasonic transducer supported by the first modular assembly;

(c) a second modular assembly configured to removably couple with the first modular assembly, wherein the second modular assembly further includes at least a portion of an end effector extending distally from a distal end portion of the second modular assembly; and

(d) a mechanical lockout assembly configured to switch between at least an unlocked configuration and a locked configuration, the method comprising;

(a) inhibiting the operator input feature from activating the instrument while in the locked configuration when the first modular assembly and the second modular assembly are only partially coupled together which provides instant feedback to an operator;

(b) coupling the handle assembly and the shaft assembly completely together to disarm the mechanical lockout assembly; and

(c) activating the instrument using the operator input feature when in the unlocked configuration.

20. The method of claim 19, wherein the first modular assembly further includes a handle assembly that includes the at least operator input feature, wherein the operator input feature includes the energy control button separated by a passageway from a switch, wherein the mechanical lockout assembly further includes a barrier that includes a body portion and at least one aperture extending at least partially through the body portion,

wherein the inhibiting activation further includes inhibiting activation of the instrument when the body portion of the barrier is disposed within the passageway between the energy control button and the switch, and

wherein the coupling further includes translating the body portion of the barrier, so that the aperture of the body portion is disposed within the passageway between the energy control button and the switch enabling the switch to activate the instrument.