Patent Application
20250143680
The present disclosure relates generally to surgical instrument assemblies, for example handheld surgical instrument assemblies that can be employed for use in minimally invasive surgical (MIS) procedures.
Surgical tools are often designed and constructed with various components to have certain kinematic architectures at the handle and frame, and to ultimately furnish certain functionalities and performances at an end effector. Drawbacks can arise among the architectures depending on how the handle and frame and components are arranged and configured with respect to one another.
Reusable surgical medical devices often require data storage of the number of times the device has been used during surgical procedure for device lifecycle management. This data is stored externally for standard surgical instruments. This may include a pen and paper tracking method, a spreadsheet, a data reading device with accompanying software, etc. But this method is not always reliable as it may be skipped or become untethered from the device.
One well-established usage counting means involves scanning machine-readable codes, e.g., QR codes, to identify a device, increment a count in the external data storage, and warn users when the device is approaching end of life.
Another usage counting means involves a built-in device counter that increments as the user activates an input on the device. This input can be a user input that is part of the primary usage mechanism of the device, or it can be a separate mechanism individually activated by the user. For example, a medical inhaler for aerosolized medicine delivery may have a built-in counter that increments when the user performs an action to deliver the medication, or it can have a separate feature that can be engaged independently to increment a count.
Reusable medical devices often have a limited amount of use before they must be reprocessed or made obsolete, either to avoid degradation of device performance or of material integrity. The ability to warn the user that the device is approaching the end of usable life can be critical in certain circumstances to ensure patient safety. Additionally, a use error or a misuse scenario may lead to user continuing device usage past the end of life of the device. In these scenarios, hazards to patient and operator safety could arise. To avoid these risks, medical device manufacturers may choose to integrate obsolescence features to their device. One such means to perform obsolescence may involve preventing a critical device mechanism from activating once certain criteria have been reached. This can be accomplished through electronic disengagement, mechanical movement restriction, or planned failure of a component. For example, a disposable camera may prevent film advancement once the remaining film count has incremented to zero by deactivating the advancing mechanisms software, physically breaking the advancement gear pawl, or engage a lock-out pawl that prevents advancement gear rotation. Another example may be a single use sterile glucose test strip that interfaces with glucose testing machines. The engagement feature may be warped or broken as part of the insertion or usage process, preventing non-sterile reuse of the device.
Medical devices containing long narrow lumens often pose a cleanability challenge. Many laparoscopic devices which incorporate such elongate shaft members also include a method to boost cleanability within the long narrow lumens such as a flush port. This flush port can be exposed to patient blood and tissue during surgical application, which in turn adds bioburden and introduces new cleanability and drainage challenges. Device manufacturers may incorporate one-way valves, physical covers, or port seals to mitigate the contamination risk. But each one of these solutions may also decrease the effectiveness of the flush port.
Cable-driven medical instruments can pose additional reprocessing difficulties. For instance, due to thermal expansion between materials of different thermal properties, a cable-driven device is subjected to additional stress in high temperature sterilization processes. Therefore, for safe reprocessing, reusable instruments with cable-driven mechanisms may need a tension-relief feature to extend the device usage life.
Several of these mechanisms suitable for a reusable medical device have been described in this section, but user compliance and usability decrease as the amount of required user actions and reprocessing complexity increases. To ensure patient safety, there is a need for a streamlined solution that incorporates medical device life cycle management, obsolescence, flush port protection, and device tension relief.
In an embodiment, a surgical instrument assembly may include a frame body, an input body, and an indexing body. The input body can be moved with respect to the frame body. The input body has a first position with respect to the frame body, and has a second position with respect to the frame body. The indexing body is prompted to move with respect to the frame body by way of the input body. The indexing body can be moved to a multitude of indexed positions with respect to the frame body. Upon attainment by the indexing body of a final indexed position of the multitude of indexed positions, movement of the input body with respect to the frame body is fully constrained.
In another embodiment, a surgical instrument assembly may include a frame body, an input body, and a tensioning body. The input body can be moved with respect to the frame body. The input body has a first position with respect to the frame body, and has a second position with respect to the frame body. The tensioning body is prompted to move with respect to the frame body by way of the input body. The surgical instrument assembly has a use state and a non-use state. The use state can be established when the input body is in the first position, and the non-use state can be established when the input body is in the second position. When the surgical instrument assembly is in the use state, a first tension is provided to one or more transmission cables by way of the tensioning body. Movement of the input body from the first position and to the second position provides a second tension to the transmission cable(s) by way of the tensioning body. The second tension is less than the first tension.
In another embodiment, a surgical instrument assembly may include a frame body, an input body, and an indexing body. The input body can be moved with respect to the frame body. The indexing body is prompted to move with respect to the frame body by way of the input body. The indexing body can be moved to a multitude of indexed positions with respect to the frame body. Each of the multitude of indexed positions constitutes a use count of the surgical instrument assembly. Advancement of the indexing body to each of the multitude of indexed positions serves to increment the use count of the surgical instrument assembly.
In another embodiment, a method of counting uses of a surgical instrument assembly may include numerous steps. One step involves moving an input body with respect to a frame body from a first position and to a second position. Movement of the input body from the first position and to the second position serves to prompt movement of an indexing body with respect to the frame body to an indexed position. The indexed position is of a multitude of indexed positions. When the input body is in the first position, a use state of the surgical instrument assembly is established. When the input body is in the second position, a reprocessing-ready state of the surgical instrument is established. Another step of the method involves incrementing a use count of the surgical instrument assembly upon advancement of the indexing body to each of the multitude of indexed positions and upon establishment of each reprocessing-ready states of the surgical instrument assembly.
In another embodiment, a method of de-tensioning a surgical instrument assembly may include numerous steps. One step involves moving an input body to a first position with respect to a frame body. A use state of the surgical instrument assembly is established when the input body is in the first position and a first tension is provided to one or more transmission cables by way of a tensioning body. Another step of the method involves moving the input body to a second position with respect to the frame body. A non-use state of the surgical instrument assembly is established when the input body is in the second position and a second tension is provided to the transmission cable(s) by way of the tensioning body. The second tension is less than the first tension.
In another embodiment, a handheld surgical instrument assembly may include a handle assembly, a frame body, a shaft body, a flush port, an end effector assembly, and one or more transmission cables. The flush port is in fluid communication with the shaft body. The transmission cable(s) extends from the handle assembly to the end effector assembly. The transmission cable(s) transmits actions to the end effector assembly. An input body can be moved with respect to the frame body. An indexing body can be moved with respect to the frame body. Movement of the indexing body serves to effect a use count of the handheld surgical instrument assembly. A tensioning body can be moved with respect to the frame body. Movement of the tensioning body serves to effect a tension of the transmission cable(s). A cover body can be moved with respect to the frame body. Movement of the cover body serves to effect accessibility and inaccessibility of the flush port. A single user input action to the input body and movement of the input body with respect to the frame body concurrently moves the indexing body with respect to the frame body, moves the tensioning body with respect to the frame body, and moves the cover body with respect to the frame body.
In another embodiment, a surgical instrument assembly may include a frame body, an input body, an indexing body, and an obsolescence body. The input body can be moved with respect to the frame body. The indexing body is prompted to move with respect to the frame body by way of the input body. The obsolescence body can be moved with respect to the frame body. Upon movement of the obsolescence body, movement of the input body with respect to the frame body is fully constrained. Movement of the obsolescence body and full constraint of the input body with respect to the frame body is prompted by way of attainment of a final indexed position of the indexing body, or is prompted by way of an event trigger.
Further scope of applicability of the present disclosure will become apparent from the detailed description given hereinafter. But it should be understood that the detailed description and specific examples, while indicating exemplary embodiments of the disclosure, are given by way of illustration only, since various changes and modifications within the spirit and scope of the disclosure will become apparent to those skilled in the art from this detailed description
The present disclosure will become more fully understood from the detailed description given below and the accompanying drawings, which are given by way of illustration only, and do not limit the present disclosure, and wherein:
Multiple embodiments of surgical instrument assemblies and handheld surgical instrument assemblies and medical devices are depicted in the figures and detailed in this description. Definitions of certain technical terms used herein are presented prior to particular figure references in this description:
Body-A body is a discrete continuous component that can be used as structural components to form an assembly or sub-assembly. The displacement/motion state of a body can be completely defined with respect to a reference ground by six degrees of freedom (DoF). A body may be rigid or compliant. One or more discrete bodies may be connected via joints to form an assembly. These bodies, together as an assembly, may still be termed as a body. In certain scenarios, a body may be produced out of many discrete rigid bodies joined by rigid joints. The resulting body, alternatively, may also be a single/monolithic structure. In certain scenarios, a body may be compliant but still discrete and continuous.
Mechanism/Joint/Connector—In general, there may be a certain equivalence between the terms “mechanism” and “joint.” A “joint” may be alternatively referred to as a “connector” or a “constraint.” All of these can be viewed as allowing certain rigid body motion(s) along certain degree(s) of freedom between two bodies and constraining the remaining motions. A mechanism generally comprises multiple joints and bodies. Typically, a joint may be of simpler construction, while a mechanism may be more complex as it can comprise multiple joints. Generally, a joint refers to a mechanical connection that allows motions as opposed to a fixed joint (e.g., welded, bolted, screwed, or glued jointly). In the latter case, fixed joint, two bodies are fused with each other and are considered one and the same in the kinematic sense (because there is no relative motion allowed or there are no relative degrees of freedom between the two bodies). The term “fixed joint” may be used herein to refer to this kind of joint between two bodies. When reference to the term “joint” is made, it means a connection that allows at least some motions or degrees of freedom, e.g., a pin joint, a pivot joint, a universal joint, a ball and socket joint, etc.
Degree of Freedom (DoF)—As noted, a joint or mechanism allows certain rigid body motions between two bodies and constrains the remaining motions. “Degrees of freedom” is a technical term to capture or convey these allowed “motions.” In total, there are six independent motions and therefore six degrees of freedom possible between two rigid bodies when there is no joint between them: three translational DoFs and three rotational DoFs. A joint will allow anywhere between zero and six DoFs between the two bodies. For the case when the joint allows zero DoFs, this effectively becomes a “fixed joint,” as described above, where the two bodies are rigidly fused or connected to each other. In this case, from a kinematic sense, the two bodies are one and the same. For the case when the joint allows six DoFs, this effectively means that the joint does not constrain any motions between the two bodies. In other words, the motions of the two bodies are entirely independent of each other.
Degree of Constraint (DoC)—“Degree of constraint” refers to directions along which relative motion is constrained between two bodies. Since relative motion is constrained, these are directions along which motion and loads (i.e., forces or moments) can be transmitted from one body to the other body. Since the joint does not allow relative motion between the two bodies in the DoC direction, if one body moves in the DoC direction, it drives along with it the other body along that direction. In other words, motions are transmitted from one rigid body to another in the DoC directions. Consequently, loads are also transmitted from one rigid body to another in the DoC directions, which are sometimes also referred to as the load bearing directions or simply bearing directions. The term “retention” may also be used in the context of a DoC direction. For example, one body may be constrained or equivalently retained with respect to a second body along a certain DoC. This means that relative motion is not allowed between the two bodies in the DoC direction, or equivalently the direction of constraint, or equivalently the direction of retention. Retention of all six DoFs means the same thing as having six DoCs between two bodies.
Local Ground—In the context of an assembly of bodies connected by joints (e.g., a multi-body system, a mechanism), one or more bodies may be referred to as the “reference” or “ground” or “local ground.” The body referred to as the local ground is not necessarily an absolute ground (i.e., attached or bolted to the actual ground). Rather, the body that is selected as a local ground simply serves as a mechanical reference with respect to which the motions of all other bodies are described or investigated.
Axial Design—A configuration or arrangement where the primary components or elements are aligned along a common central axis. In this design, the central axis acts as a reference line around which the components are organized or positioned. This axial alignment enables efficient transfer of forces or signals along the axis, and it is commonly used in various applications such as mechanical systems, electrical connectors, or structural designs where linear alignment and axial symmetry are desired.
Radial Design—A configuration or arrangement where the primary components or elements are positioned around a central point or axis, radiating outward in a circular or spoke-like pattern. In this design, the central point serves as the focal point from which the components span outward in a symmetrical manner. Radial designs are commonly used in various applications such as mechanical systems, electronic circuit boards, or architectural layouts where balanced distribution, equal access, or efficient energy transfer from a central source are desired.
Axis and Direction—Axis refers to a specific line in space. A body may rotate with respect to (w.r.t.) another body about a certain axis. Alternatively, a body may translate w.r.t. another body in a certain direction. A direction is not defined by a particular axis and is instead commonly defined by multiple parallel axes. Thus, x-axis is a specific axis defined in space, while X direction refers to the direction of the x-axis or any other axis that is parallel to the x-axis. Different but parallel axes can have the same X direction. Direction only has an orientation and not a location in space. In at least some embodiments, and with particular reference to
Device Frame—When provided in an embodiment, the device frame refers to a structural body or subassembly, which may have relative motion amongst components, that may be part of a tool apparatus or surgical tool or handheld surgical instrument. In certain tool apparatuses, it may be connected to a handle assembly or handle body and/or an elongated device shaft or shaft body. Terms namely “device frame” and “frame” and “frame body” may be used interchangeably throughout the patent.
Device Shaft—When provided in an embodiment, a device shaft is generally a rigid extension of the frame, at its proximal end, which is a slender and elongated member, commonly a cylinder. An output body, such as an end-effector assembly or end effector body, may be constrained to the distal end of the device shaft. The tool shaft may simply be referred to as a shaft or shaft body. The axis of the tool shaft may be referred to as Device Shaft Axis throughout the description.
Counting Mechanism—Mechanism designed to keep track of the number of times a device has been used. This single counting mechanism may be capable of displaying various data. The use state of the device may be displayed for field use applications, additionally the cycle count may be displayed for reprocessing applications.
Thermal Counting Mechanism—A counting mechanism that utilizes changes in temperature to track and record counts. It operates on the principle that certain materials (such as nitinol or bimetallic strips) exhibit temperature-dependent characteristics, such as expansion or contraction, which interacts with an additional body resulting in a count reading.
Rotary Gear Display—Type of counting mechanism that utilizes rotating gears to visually indicate and track counts. The mechanism consists of interconnected gears with teeth or markings that increment or decrement with each rotation. As the gears rotate, the count is visually displayed by observing the position or alignment of the teeth or markings, providing a clear and intuitive representation of the count value.
Non-Back Drivable—A mechanical or electronic system that prevents reverse movement or unintended changes in its count. It is designed to ensure that once a count increment or decrement occurs, it cannot be easily reversed or manipulated by external forces or back-driving.
Transmission Member Tensioning Mechanism—Refers to a system or mechanism designed to adjust and maintain the tension of cables used within the device. It ensures that the cables are appropriately tightened to achieve optimal performance and functionality.
End of Life (E.O.L.)—The stage in its lifecycle where it is no longer supported, maintained, or used in clinical practice. It signifies the cessation of production, availability of spare parts, and official technical support from the manufacturer. The end of life phase can be prompted by factors such as technological advancements, regulatory changes, or the device reaching its expected operational lifespan.
Flush Port Exposure—In medical devices, this refers to the vulnerability that arises when a communication port on the device is directly accessible from the outside without proper security measures. This can lead to unauthorized access, tampering with patient data, and the injection of malicious commands. To mitigate these risks, robust security practices such as encryption, access controls, and regular security assessments should be implemented, along with network segmentation and firewalls to isolate the device from potentially malicious network traffic.
Use Condition—The Use Condition of the device is also defined by State A. Within this state the device is ready to be used in the field such that, per an embodiment, the device is tensioned, Counter displays the Use Status, and the Flush port is concealed. The device being tensioned means that forces and displacement from the Handle Body is able to be transferred to the End Effector Body. The Use status is a display icon which signals to the user that the device is ready for use. While concealing the flush port helps prevent excess bioburden from entering the flush port while in use.
Reprocessing/Storage Condition—The Reprocessing or Storage Condition of the device is also defined by State A′. Within this state, per an embodiment, the device is de-tensioned, Counter displays the remaining uses/indexed count, and the flush port is exposed. When the device is in the de-tensioned state the forces and displacements of the Transmission members are unable to effectively transfer input from the Handle Body to the End Effector Body, therefore the device is not fully operational. When in this State A′ the counter display may display an indexed value which can distinguish the life remaining in the device. Additionally, by being in State A′ the device can be reprocessed since the Flush Port is now exposed and able to be accessed within a cleaning procedure.
Obsolescence—The process where the device becomes outdated, no longer supported, or technologically obsolete. It occurs when newer and more advanced technologies, treatments, or regulatory standards surpass the capabilities of the device, rendering it less effective or unreliable. This may present risks to patient safety as the device may lack necessary updates, compatibility with other systems, or the ability to address emerging medical challenges. Proper management includes monitoring the device lifecycle, planning for upgrades or replacements, and ensuring regulatory compliance and patient safety throughout the transition to newer technologies.
Reprocessing—Refers to the sterile processing of a reusable medical device to eliminate contaminants and ensure compliance with applicable cleanliness, functionality, and sterility standards. Reprocessing may involve manual or automated procedures and employs techniques such as mechanical cleaning, lubrication, chemical disinfection, and thermal sterilization.
Embodiments described herein have several features, no single one of these features is solely responsible for their desirable attributes. Without limiting the scope of the disclosure, some of the advantageous features will now be discussed briefly.
With reference now to the figures, embodiments of a surgical instrument assembly 10, also called a handheld surgical instrument assembly per certain applications and implementations, are described and depicted herein. The surgical instrument assembly 10 can be equipped in a handheld surgical tool or instrument 12 (
In various embodiments, the surgical instrument assembly 10 can have a use count mechanism or assembly, an obsolescence mechanism or assembly, a tensioner or tensioning mechanism or assembly, and/or a flush port inaccessibility and accessibility mechanism or assembly, all described below in greater detail. The use count mechanism/assembly, when provided, can be employed to track the number of times a medical device and/or the surgical instrument assembly 10 is put to use in a surgical procedure and surgical operation to help manage device and instrument life cycle. As described in this patent, the use count mechanism/assembly is designed and constructed to accurately record and increment the uses of the particular device and/or instrument when employed in a surgical reprocessing workflow. The use count mechanism/assembly can be equipped with a non-back drivable function in order to furnish a more reliable, error-proof, and tamper-proof use count. Further, the tensioner or tensioning mechanism/assembly, when provided, serves to furnish a tension relief function in order to compensate and account for thermal expansion stresses that may be experienced amid reprocessing procedures such as in an autoclave machine or during steam sterilization, among other possibilities. A protective cover can be provided as part of the flush port inaccessibility and accessibility mechanism/assembly, when provided, to conceal and hide the flush port when not utilized, and thereby minimize or altogether thwart bioburden infiltration. Lastly, the obsolescence mechanism/assembly, when provided, serves to preclude and prevent unsanctioned and perhaps unsafe re-use of the surgical instrument assembly 10 that would surpass the instrument's intended useful life. Together or individually or in combination, these mechanisms and assemblies facilitate patient safety, instrument sterility, instrument life cycle management, and/or instrument reusability; still, a particular embodiment of the surgical instrument assembly 10 can exhibit one or more or none of these advancements, as well as other advancements not mentioned herein.
Various embodiments of the surgical instrument assembly 10 can have various combinations of the mechanisms and assemblies, and some individual components of the many mechanisms and assemblies may be shared, as will become evident as this description advances. For example, in an embodiment the surgical instrument assembly 10 can only have the use count mechanism/assembly, can only have the obsolescence mechanism/assembly, can only have the tensioner or tensioning mechanism/assembly, or can only have the flush port inaccessibility and accessibility mechanism/assembly. Still, in other embodiments the surgical instrument assembly 10 can have the use count mechanism/assembly and the obsolescence mechanism/assembly; can have the use count mechanism/assembly and the tensioner or tensioning mechanism/assembly; or can have the use count mechanism/assembly and the flush port inaccessibility and accessibility mechanism/assembly. In yet other embodiments, the surgical instrument assembly 10 can have the obsolescence mechanism/assembly and the tensioner or tensioning mechanism/assembly; or can have obsolescence mechanism/assembly and the flush port inaccessibility and accessibility mechanism/assembly. In another embodiment, the surgical instrument assembly 10 can have the tensioner or tensioning mechanism/assembly and the flush port inaccessibility and accessibility mechanism/assembly. In further embodiments, the surgical instrument assembly 10 can have the use count mechanism/assembly, the obsolescence mechanism/assembly, and the tensioner or tensioning mechanism/assembly; can have the use count mechanism/assembly, the obsolescence mechanism/assembly, and the flush port inaccessibility and accessibility mechanism/assembly; can have the use count mechanism/assembly, the tensioner or tensioning mechanism/assembly, and the flush port inaccessibility and accessibility mechanism/assembly; or can have the obsolescence mechanism/assembly, the tensioner or tensioning mechanism/assembly, and the flush port inaccessibility and accessibility mechanism/assembly. Still further, in an embodiment the surgical instrument assembly 10 can have all of the use count mechanism/assembly, the obsolescence mechanism/assembly, the tensioner or tensioning mechanism/assembly, and the flush port inaccessibility and accessibility mechanism/assembly.
Furthermore, the input body 16 is moveable with respect to the first/frame body 14, 20 during use of the surgical instrument assembly 10, and prompts movement of the indexing body 18 during use of the surgical instrument assembly 10. The user of the surgical instrument assembly 10 can interact with the instrument via the input body 16. The input body 16 can have a first position with respect to the first/frame body 14, 20, and can have a second position with respect to the first/frame body 14, 20. The input body 16 can be in the form of a counter ring body 22 or counter knob. In the embodiment of
With continued reference to
Furthermore, a second user input or user input action incites movement of the input body 16 with respect to the first body 14, and incites movement of the counter ring body 22 with respect to the frame body 20. In a medical setting, the second user input can be carried out by a nurse or personnel of a central sterile processing department (CSPD), as examples. In an embodiment, the second user input can be physical exertion from a user's hand (e.g., user's thumb and index finger) that moves the input body 16 with respect to the first body 14, and that moves the counter ring body 22 with respect to the frame body 20. The second user input can be rotational user input, per an embodiment. Further, in an embodiment, the second user input can be an alternative form of input that need not necessarily involve the user of the larger assembly or instrument; this applies to user inputs for the surgical instrument assembly 10 described elsewhere in this patent. For instance, the input can be generated by other mechanisms and assemblies that are disassociated from the user. As an example, a thermally activated switch can serve to impart the input action that incites movement of the input body 16 with respect to the first body 14, and that incites movement of the counter ring body 22 with respect to the frame body 20. The thermally activated switch can employ a bimetallic strip or nitinol or some other component or technique. Further, a temperature-deformable body can serve to impart the input action that incites movement of the input body 16 with respect to the first body 14, and that incites movement of the counter ring body 22 with respect to the frame body 20. In this example, upon experiencing an increase in temperature, the temperature-deformable body could prompt such movement itself or could permit such movement. Permitting such movement could involve relief of a movement constraint otherwise established between the input body 16 and first body 14, and between the counter ring body 22 and frame body 20 (e.g., a biasing exertion could, upon relief of the constraint, impart the relative movement). In examples in which initiation and prompting occurs via an elevation in temperature, the temperature increase can result from processing within an autoclave machine. In other examples, the input action that incites movement could be a consequence of conditions that the surgical instrument assembly 10 experiences. In the application of the handheld surgical instrument 12, the conditions could be abuse loads, inappropriate storage conditions, or other unwanted conditions. Moreover, the input body 16 and the associated input action could be various components, assemblies, and/or conditions that are suitable for inciting movement of the input body 16 with respect to the first body 14, and inciting movement of the counter ring body 22 with respect to the frame body 20.
With continued reference to
In the embodiment of
In this embodiment a first user input or user input action actuates the lock button 26. In a medical setting, the first user input can be carried out by a nurse or personnel of the central sterile processing department (CSPD), as examples. Actuation can be effected via a user pressing the lock button 26 inward toward the frame body 20; still, other input actions and other ways of actuating the lock button 26 are possible in other embodiments. By pressing the lock button 26, according to this embodiment, the lock button 26 moves and is displaced radially inboard with respect to the frame body 20. Here, there is concurrent relative movement between the lock button 26 and counter ring body 22 upon its pressing, in addition to that between the lock button 26 and frame body 20. Actuation brings the lock button 26 from the ON state and to the OFF state. When ON, an interlock is activated between the lock button 26 and counter ring body 22, and when OFF, the interlock between the bodies is deactivated and removed. The interlock can be activated when the surgical instrument assembly 10 and handheld surgical instrument 12 is in the use state, as well as when the surgical instrument assembly 10 and handheld surgical instrument 12 is in the non-use state. The interlock can be effected via a mechanical and structural interference between the lock button 26 and the counter ring body 22, effectively joining the bodies together and providing a rigid joint therebetween that lacks degrees of freedom. Moreover, the lock button 26 can have an up position and locked state, and conversely can have a down position and unlocked state. The lock button 26 can have an unpressed position and locked state, and conversely can have a depressed position and locked state. The lock button 26 can be biased and urged toward its ON and locked state. Furthermore, in an embodiment that employs the tensioner or tensioning mechanism/assembly, the lock button 26 can hold the mechanism/assembly in a tensioned or un-tensioned state, depending on the implementation; still, a detent mechanism or a non-back drivable function or other retention body can hold the mechanism/assembly in the tensioned or un-tensioned state, per alternative embodiments.
In an alternative embodiment, the lock button 26 can incorporate a thermally-activated provision to help preclude excessive tensioning of transmission cables when they are under thermal expansion stress and when other components of potentially dissimilar material compositions are also under thermal expansion stress, further ensuring safe operating conditions for use of the surgical instrument assembly 10. The thermally-activated provision can take the form of a shape memory alloy (SMA) component, such as a thermal switch. The SMA component and its functionality can supplement user input action, or can altogether supersede it, rendering user input unneeded. In one implementation of this embodiment, the SMA component maintains the locked state and prevents movement of the input body 16 and counter ring body 22 when experiencing increased temperatures, thereby precluding placement of the transmission cables in a tensioned state that could otherwise over-tension them. Furthermore, and like other bodies described in this patent, the retention body 24 and lock body 26 need not be provided in a particular embodiment of the surgical instrument assembly 10.
Still referring to
In general, during use of the surgical instrument assembly 10 and amid performance of its function, discrete indexed positions of the multitude of indexed positions can serve to bring discrete indicium of the ratchet wheel body 28 in alignment with the viewing window 32 for display and viewing by the user of the instrument. Such alignment can occur with each rotational position of the ratchet wheel body 28 relative to the first/frame body 14, 20 and to the external cover body 30. Discrete indexed positions can be discrete rotational positions. The indicia can be a set of symbols, colors, numbers, and/or other representations that indicate the immediate condition and state of the instrument and/or end-of-life information of the instrument, among other possible representations and information conveyed to the user. The indicia can be a use count indicia, per an embodiment. By way of this functionality, each rotation of the input body 16 and counter ring body 22 can serve to increment a use count of the surgical instrument assembly 10, per an embodiment, conveying the end-of-life information, and hence allowing the user to track the usage and condition of the instrument. Moreover, functioning of the indexing body 18 and the ratchet wheel body 28 can be coupled with, and linked to, functioning of the counter ring body 22, as will become more apparent as this description proceeds.
With continued reference to
The obsolescence body 34 is moveable with respect to the first/frame body 14, 20 during use of the surgical instrument assembly 10 and when triggered and activated. In an embodiment, the obsolescence body 34 can be situated at the indexing body 18 and at the ratchet wheel body 28, and can be carried by the indexing body 18 and by the ratchet wheel body 28. The obsolescence body 34 can be in the form of a lock body 36 or obsolescence lock pin, per an embodiment. In the embodiment of
In the embodiment and application of the handheld surgical instrument 12, and with reference now to
In an embodiment, the cover body 42 is moveable with respect to the first/frame body 14, 20 during use of the surgical instrument assembly 10, and is caused to move via movement of the input body 16 and counter ring body 22. The cover body 42 is a component of the flush port inaccessibility and accessibility mechanism/assembly. During use of the surgical instrument assembly 10, when the input body 16 and counter ring body 22 is in its first position, the cover body 42 renders and makes a flush port 46 of the surgical instrument assembly 10 inaccessible. Conversely, when the input body 16 and counter ring body 22 is in its second position, the cover body 42 renders and makes the flush port 46 accessible. When inaccessible, the cover body 42 physically blocks and conceals and hides the flush port 46. And when accessible, the blocking and concealment via the cover body 42 is removed and absent, and the flush port 46 is available for a flushing procedure. Further, the cover body 42 has an ON state and position, and has an OFF state and position. In the ON state, the flush port 46 is accessible, and in the OFF state, the flush port 46 is inaccessible via the cover body 42. The cover body 42 can have a first position with respect to the first/frame body 14, 20, and can have a second position with respect to the first/frame body 14, 20. The first and second positions can be first and second discrete rotational positions with respect to the first/frame body 14, 20. The first position can constitute the OFF state, and the second position can constitute the ON state. In the embodiment and application of the handheld surgical instrument 12, the flush port 46 can exhibit fluid communication with an accompanying shaft body for flushing procedures thereof. With reference to
With continued reference to
During use of the surgical instrument assembly 10, when the input body 16 and counter ring body 22 is in its first position, a first tension and first tension magnitude is provided to the one or more transmission cables of the surgical instrument assembly 10 and/or of the handheld surgical instrument 12 via the tensioning body 44. Conversely, when the input body 16 and counter ring body 22 is in its second position, a second tension and second tension magnitude is provided to the one or more transmission cables of the surgical instrument assembly 10 and/or of the handheld surgical instrument 12 via the tensioning body 44. The first tension has a first value that is suitable for proper functioning and output and motion transmission from an input body 50 and to an output body 52 of the surgical instrument assembly 10 and/or of the handheld surgical instrument 12 via the one or more transmission cables. The second tension, on the other hand, has a second value that is unsuitable for proper functioning and output and motion transmission from the input body 50 and to the output body 52 via the one or more transmission cables. The second tension has a value that is less than that of the first tension. The one or more transmission cables exhibit a suitably tightened state when subject to the first tension, and, conversely, exhibit a comparatively loosened state when subject to the second tension. Further, the tensioning body 44 has an ON state and position, and has an OFF state and position. In the ON state, the first tension is provided to the one or more transmission cables; and in the OFF state, the second tension is provided to the one or more transmission cables. In this embodiment, a single DoF is provided between the tensioning body 44 and the input body 16 and counter ring body 22; the single DoF can be in the form of a screw pair, per an embodiment. Further, in this embodiment a single DoF is provided between the tensioning body 44 and the first/frame body 14, 20; the single DoF can be a single translational DoF, per an embodiment. Moreover, functioning of the tensioning body 44 can be coupled with, and linked to, functioning of the counter ring body 22, as will be described in greater detail below.
With continued reference to
With reference to
Further, a subsequent second user input and user input action prompts transition and shifting to a subsequent, intervening non-use state X′. The quantity of intervening use and non-use states X, X′ can vary in various embodiments. In an example embodiment, the total number of use and non-use states of the surgical instrument assembly 10 can be ten (i.e., ten use states and ten non-use states); still, the number could be more or less in other embodiments. However many, once the final non-use state is reached and established, the second user input action is no longer effective and the surgical instrument assembly 10 cannot be transitioned and shifted out of the final non-use state. The surgical instrument assembly 10 remains in the final non-use state. Furthermore, in the embodiment of the obsolescence mechanism/assembly, the obsolescence body 34 can be triggered and activated at the final non-use state, which can be the final indexed position, per an embodiment. This constitutes the obsolescence state of the surgical instrument assembly 10. Moreover, in the embodiment in which the obsolescence mechanism/assembly and obsolescence body 34 can be triggered and activated via the event trigger such as the system level adverse event, such event occurrence and concomitant triggering can halt and stymie further transition at any of the intervening states—or even at the initial states—and prior to reaching the final non-use state.
Further, in the embodiment of
With general reference now to
The ratcheting functionality and its components serve to furnish rotational drive and movement of the ratchet wheel body 28 in an intended rotational direction (e.g., clockwise or counterclockwise), and precludes and prevents unwanted rotational drive and movement of the ratchet wheel body 28 in the opposite rotational direction (e.g., the other counterclockwise or clockwise). Rotational drive and concomitant incrementation of the use count and corresponding indicia of the ratchet wheel body 28 and of the surgical instrument assembly 10 hence only occurs in the intended rotational direction, and does not occur in the opposite, unintended rotational direction. Irreversibility of the use count mechanism/assembly is thereby furnished, precluding a misuse scenario in which incrementation of the use count would occur in the opposite, unintended rotational direction and inaccurate representations and information would consequently be displayed and conveyed to the user. The counter ring body 22 can still be rotated in the opposite rotational direction, per this embodiment, such as for the purpose of bringing the tensioning body 44 to its ON state.
In
Furthermore, the second set of drive pawls 80 is a radial set of drive pawls that are directed in the radial direction and radially outboard; in this regard, the first and second sets of drive pawls 78, 80 have an orthogonal arrangement relative to each other. The second set of drive pawls 80 engage with the second drive pawl teeth 84 via teeth-to-teeth engagement and abutment. The engagement is in the radial direction, per this embodiment. There are a pair of the second set of drive pawls 80 in this embodiment: a first drive pawl located and positioned on one side of the frame body 20 with respect to the ratchet wheel body 28, and a second drive pawl located and positioned on the opposite side of the frame body 20 with respect to the ratchet wheel body 28. The first and second drive pawls can be one-hundred-and-eighty rotational degrees (180°) apart from each other. The second set of drive pawls 80 is carried by the frame body 20 according to this embodiment. Each of the first and second drive pawls of the second set of drive pawls 80 is seated within cavities 88 residing and defined in the frame body 20. The cavities 88 serve as guides for movements of the first and second drive pawls of the second set of drive pawls 80. A single DoF is provided between the second set of drive pawls 80 and the frame body 20. The single DoF can be a single translational DoF, per an embodiment. A prismatic joint can be established between second set of drive pawls 80 and the frame body 20. A spring or other biasing member or compliant connector urges and biases the first and second drive pawls of the second set of drive pawls 80 radially outboard and toward the ratchet wheel body 28. Distal ends of the first and second drive pawls of the second set of drive pawls 80 are inclined and slanted for suitable ratcheting engagement with the second drive pawl teeth 84. The distal ends can exhibit a shape and size that complements that of the second drive pawl teeth 84. The ratchet wheel body 28 and frame body 20 are mechanically coupled together via the second set of drive pawls 80 and second drive pawl teeth 84.
Further, and with reference now to
With reference now to
A spring or other biasing member or body or compliant connector urges and biases the tensioning body 44 axially upward with respect to the counter ring body 22, urging and biasing surface-to-surface engagement between the tensioning peg 96 and cam profile surface 98. The tensioning body 44 moves and translates axially with respect to the counter ring body 22 and with respect to the frame body 20 when the surgical instrument assembly 10 and handheld surgical instrument 12 are in the use and non-use states. The axial movement is relative to the shaft axis SA. In
Further, according to an embodiment, in a rotational position, the counter ring body 22 provides full axial constraint between the tensioning body 44 and the frame body 20. In this position, a transmission member guide path of the tensioning body 44 is directly constrained by the frame body 20 through the counter ring body 22 and allows efficient transmission of forces or signal through the tensioning body 44. In another rotational position of the counter ring body 22 (alternative state of the counting mechanism), the tensioning body 44 is no longer rigidly axially constrained between the frame body 20 and the counter ring body 22. When the tensioning body 44 travels axially, the transmission member guide path translates, resulting in the overall cable path of the device to lengthen and reduces the transmission member tension. In this state of the device, the tensioning body 44 may also be biased axially to one direction with a force that is determined by a compliance member (e.g., a spring). The combination of these effects allows the tensioning body 44 to travel axially to balance the forces in the system in response to the transmission member changing tension during use or thermal cycling. During thermal cycling, a system without this tensioner limiter (tension relief) would result in the tension in the system increasing as the transmission member path will lengthen with respect to the transmission member length due to differences in coefficients of thermal expansion. The tensioning body 44 reduces the sensitivity of the transmission member path effect on the tension of the system as the transmission member path is more compliant when the tensioning body 44 is active which means it can compensate for variation in path length without changing the transmission member length. The tensioning body 44 not only provides tension relief to the system but also can be utilized as a mechanism which establishes a minimum tension in the system. This is beneficial as a zero tension may be undesired in some configurations as the device may be able to come apart or the transmission members will come out of the transmission member path if the system has zero tension. Furthermore, once reprocessed, per an embodiment and application, a user can activate the counter ring body 22 in the reverse direction to re-tension the device for use.
Moreover, according to an embodiment, the minimum tension in the transmission cables 62 is greater than zero when the surgical instrument assembly 10 and handheld surgical instrument 12 is in the use state. Further, the position of the tensioning body 44 is constrained by the position of the cam profile surface 98 and frame body 20. The interface between the transmission cables 62 and the transmission member guide path located on the tensioning body 44 may be a cylindrical joint with 2 DoF allowing for rotation and axial movement per unit length of the transmission cables 62. More generally due to geometry of common the interface between these two bodies may be at minimum a prismatic joint with 1 DoF allowing axial motion per unit length of the transmission cables 62. Further, per an embodiment, the cam profile surface 98 can be unidirectional whereby it would limit the position of the tensioning body 44 in one axial direction by not the other. In an embodiment in which the cam function serves as a one DoF screw pair, the tensioning body 44 may be permitted to translate within tensioner slot guides in a range that is between a frame body hard stop and the cam profile surface 98. Further, when in the non-use state, the position of the tensioning body 44 can be directly proportional to the compliant feature or connecting body of the tensioning body 44, when provided, such as a spring. As the position of the tensioning body 44 is no longer simultaneously constrained by the rigid body of the frame body 20 and the cam profile surface 98 of the counter ring body 22, instead the tensioning body 44 has freedom to translate within the frame body 20.
Further, in an alternative embodiment, the tensioning body 44 need not have a spring or other biasing member or body or compliant connector. Here, as the surgical instrument assembly 10 and handheld surgical instrument 12 shift from the use state to the non-use state, the tensioning body 44 can, in a sense, float freely within a tensioner slot guide resulting in zero tension provided to the transmission cables 62. Absent any biasing exertion, all DoC between the transmission cables 62 and the tensioning body 44 is removed. Tension provided to the transmission cables 62 can be maintained at zero so long as suitable clearance is provided in the system.
Furthermore, an embodiment providing thermal counting may be provided. Here, the counting mechanism may consist of smart actuators such as shape memory alloy (SMA). An example of an SMA is a thermally activated bi-metallic strip or a nitinol wire. These SMAs can generate relatively large displacements when activated, due to the geometry and construction of the SMA being determined by the amount of displacement generated per unit change in temperature. Variations of the SMA include bi-stable mechanism which toggle when a target temperature is reached, or a variable configuration, in which each incremental change in temperature results in an incremental change in shape. The ability of an SMA to restore back to its nominal position after experiencing thermal deformation allows the material to act as an actuation mechanism. This mechanism allows multiple cycles to be performed and used as an integral to an indexing mechanism which can count various events. The use of thermally activated materials such as these can provide benefits to the general counting mechanism.
An example, of how thermally activated materials can be beneficial to previously described mechanisms, would be used to generate the input force and generate displacement of the counter ring body 22. This prevents the necessity for external user input to cycle the surgical instrument assembly 10. A body can be introduced into the system which comprises of a SMA material that deforms in response to temperature change. The absence of user input both eliminates a user action as well as automates the counting mechanism, thus enabling the counting mechanism to self-index and count in absence of user presence. This may be beneficial in the application of a surgical device in which reprocessing is completed through a method of steam sterilization. During a steam sterilization cycle the temperature increases to ˜135 degree C. before restoring back to ambient of ˜23 degrees C.; this change in temperature is suitable to cause actuation based on the construction and geometry of a SMA. Within the steam sterilization cycle the device may be placed in a tray or wrapped in a barrier to ensure sterility when the cycle is complete, therefore the device may be unreachable by user interaction for the time which it is wrapped. Prior to unwrapping, the deformation of the SMA at elevated temperatures would provide the necessary input force and displacement to advance the counting mechanism and when ambient temperatures are restored the SMA will generate force and displacement in the opposite direction, thus restoring the counting mechanism to the initial state but index one forward.
Alternative to being the input force of the counting mechanism, an SMA has other practical applications within the counting mechanism. An SMA can replace any of the compliant bodies or springs within the system. Having a spring which is only active at set temperature ranges may allow for the counting mechanism to only be activated at target temperatures. For example, using an SMA as a member within the lock button 26 prevents the user from rotating the counter ring body 22 unless temperature of the device is below (or above) a certain value. In practice, the thermally actuated material configuration is an automatic safety switch to the system. This occurs by the material changing the present state of the counting mechanism at an elevated temperature. The thermally activated material can assist in preventing permanent damage to the device due to the stress build up caused by the thermal deformation of dissimilar materials.
Further, in some embodiments the counting mechanism can act in reverse, rather than a user input driving the counting mechanism and de-tensioning the device. The counting mechanism is driven by the tensioning body 44 such that when the tensioning body 44 experiences a predetermined maximum force it drives the ratchet wheel body 28 forward and indexes the system. In this embodiment, the counter counts the number of over-stress events of the device. This can be useful as over-stress can lead to accelerated device wear or even device damage, the tracked information can determine when the device would need to be obsoleted. Further, in alternate embodiments, the counter is engaged with an electrical port, and the insertion of an electrical connector to the electrical port indexes the ratchet wheel body 28. In some embodiments, the counter input body mechanism interfaces with a sterilization tray. The insertion of the device onto the sterilization tray indexes the ratchet wheel body 28. In some embodiments, a specialized tool may need to be inserted to increment the counter; here, the tool will only be provided to trained sterile processing personnel.
Further, per various embodiments, the rotation of the counter ring body 22 causes rotation of the ratchet wheel body 28. The angle per incrementation on the ratchet wheel body 28 can vary on the number of uses built into the device counter, but the angle per rotation for the counter ring body 22 may be a set value that is needed to generate enough rotation to fully expose the flush port 46 or enough travel to fully de-tension the transmission cables 62. In some embodiments, a dwell is built into the rotation engagements such that some components in the counter assembly may finish rotation first but continues to rotate to allow other components to finish rotation.
In another embodiment, the tensioner or tensioning mechanism/assembly can involve a pulley type body which has functionality as a transmission member path which is in mechanical engagement with the counter ring body 22 and the transmission cables 62. The activation of the counter ring body 22 subsequently displaces the pulley body in such a way that the transmission member path length increases and the resulting transmission member tension decreases. In some embodiments, several of these bodies may be arranged in a staggered configuration to achieve different tension reduction. In some embodiments, the angular displacement of the pulley bodies may be modulated and secured with rack and pawl features. In some embodiments, the angular displacement of the pulley bodies may be mechanically engaged with the frame body 20 with a compliant connector to maintain the same transmission member tension in response to thermal expansion stress.
An embodiment has an effect on different keying features within the assembly. An example of obsolescence of the counter affecting other features includes the tensioner or tensioning mechanism/assembly of the surgical instrument assembly 10. The tensioner or tensioning mechanism/assembly has a functional effect based on the state of the counter. During a use state, the tensioning body 44 is fully constrained between the frame body 20 and counter ring body 22. This directly correlates with the compression spring sitting in a non-fired state covering the flush port 46. During a non-use state, the compression spring is fired with the tensioning peg 96 changing orientation and allowing flush port accessibility. It is during the obsolescence state that the drive pawls and obsolescence pin is fired to cancel the tensioning mechanism within the device. In correlation with the prior feature, the flush port 46 is also no longer activated when the device reaches the obsolescence state. When the counter reaches the obsolescence state, the flush port cover body 42 of the counter ring body 22 blocks the flush port 46 and restricts the device from having any fluid inserted within the device.
Further, in other embodiments, a main body such as the frame body 20 contains a lock-out pawl that is mechanically engaged with the main body of the device and the ratchet wheel body 28, which contains a lock-out groove. The overall assembly has two states. In one state, the lock out pawl enforces a one-way incrementation of the counter index dial through a ratchet engagement feature. In another state, the lock-out pawl extends radially into a groove on the ratchet wheel body 28, directly and permanently preventing rotation of the counter index dial in both directions and indirectly preventing the rotation of the cam collar in both directions. This prevents the re-tensioning of the device. In some embodiments, the lock-out state groove is above the “zero” or non-usable count position of the counter index dial. In some embodiments, an axial lock-out pawl on the ratchet wheel body 28 may also extend into a groove on a static component of the device to achieve lock-out.
Further, in some embodiments, a severing component may be deployed by a feature on the counter ring body 22. When the ratchet wheel body 28 rotates into a pre-determined location, a lock pawl may extend into the severing component and dislodge the safety pin to cause the device cables to be severed. In some embodiments, the electrical connection cables may be severed instead.
Further, in some embodiments, a shield may be deployed by a feature on the ratchet wheel body 28. When the ratchet wheel body 28 rotates onto a pre-determined location, a shield may be deployed to obstruct the electrical connection port permanently.
A fully accessible counting mechanism designed to accurately track the number of times a medical device has been sterile processed is provided. The mechanism, per varying embodiments, utilizes a combination of mechanical numerical indexing to display remaining use count, a lock-out system to prevent unsafe usage past the pre-determined use count, a back-drive rotation lock-out to prevent reversing count, a rotational cover to hide cleaning ports and ensure sterility during surgical use, and an activation of a cable de-tensioning system to relief thermal expansion stress during steam sterilization.
Further, in various embodiments, input to the counter ring body 22 may no longer be external user input; rather, the counter ring body 22 could be activated via an internal SMA such as a bi-metallic strip or nitinol wire. The applied load of the SMA may be able to change the state of the device from the use state to the non-use state, but applying a force in a single direction while heated and then applying a restorative force when cooled. Alternative, an SMA may be used to change the state of the system in a single direction by applying a load resulting in unidirectional motion when thermally cycled. This could for example change the state from the non-use state to the use state, but not from the use state to the non-use state. Further, in various embodiments, one or more interlocks within the surgical instrument assembly 10 could be thermally-activated, as described; this could involve the cover body 42 self-closing without impact to other mechanisms/assemblies. Further, in various embodiments, there may be a seal within the device which when active prevents bioburden or contaminates from entering freely while in the use state, but the seal can be deactivated during reprocessing. A SMA could deactivate the seal or other interlock during thermal cycling enabling the device to be reprocessed in a different state than the use state.
The figures are not necessarily to scale, and some features may be exaggerated or minimized to show key details of components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.
This disclosure is not intended to limit the scope to medical devices or the healthcare industry. For example, the designs and constructions and components and assemblies described herein may be applied to conventional electro-mechanical control systems and industrial applications.
Furthermore, in general, while a multitude of embodiments have been depicted and described with a multitude of components in each embodiment, in alternative embodiments of the surgical instrument assembly the components of various embodiments could be intermixed, combined, and/or exchanged for one another. In other words, components described in connection with a particular embodiment are not necessarily exclusive to that particular embodiment.
As used herein, the terms “general” and “generally” and “substantially” are intended to account for the inherent degree of variance and imprecision that is often attributed to, and often accompanies, any design and manufacturing process, including engineering tolerances—and without deviation from the relevant functionality and intended outcome—such that mathematical precision and exactitude is not implied and, in some instances, is not possible. In other instances, the terms “general” and “generally” and “substantially” are intended to represent the inherent degree of uncertainty that is often attributed to any quantitative comparison, value, and measurement calculation, or other representation.
It is to be understood that the foregoing is a description of one or more aspects of the disclosure. The disclosure is not limited to the particular embodiment(s) disclosed herein, but rather is defined solely by the claims below. Furthermore, the statements contained in the foregoing description relate to particular embodiments and are not to be construed as limitations on the scope of the disclosure or on the definition of terms used in the claims, except where a term or phrase is expressly defined above. Various other embodiments and various changes and modifications to the disclosed embodiment(s) will become apparent to those skilled in the art. All such other embodiments, changes, and modifications are intended to come within the scope of the appended claims.
As used in this specification and claims, the terms “e.g.,” “for example,” “for instance,” “such as,” and “like,” and the verbs “comprising,” “having,” “including,” and their other verb forms, when used in conjunction with a listing of one or more components or other items, are each to be construed as open-ended, meaning that the listing is not to be considered as excluding other, additional components or items. Other terms are to be construed using their broadest reasonable meaning unless they are used in a context that requires a different interpretation.
This application claims the benefit of U.S. Provisional Patent Application No. 63/547,037, with a filing date of Nov. 2, 2023, the contents of which are hereby incorporated by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63547037 | Nov 2023 | US |
