This application relates to surgical staplers and removable power packs loadable into the surgical staplers to effect firing of the staples.
Surgical staplers are used in various medical applications where a device is needed to join and dissect anatomical tissue. However, there are drawbacks and costs associated with use of surgical staplers. Currently staplers are either fully disposable, reusable or partially reusable. Due to contamination during the surgical procedure, e.g., exposure to the patient's body fluids, the staplers are required to be sterilized after use, a time consuming and expensive process, with possible risks of infection if not properly sterilized as contaminants adhered to the surgical stapler from a previous use could be transferred to another patient. To avoid the risks of resterilization, some surgical staplers are disposed after use in the surgical procedure. These staplers can be reloaded to fire multiple cartridges of staples, but after the procedure, the staplers are discarded. However, the practice of using single use disposable surgical staplers is costly.
In certain procedures, high forces are required to fire the staples through tissue into contact with the anvil for formation. This is compounded when multiple rows of staples are fired either simultaneously or sequentially from the stapler. Therefore, powered staplers have been introduced to reduce the force requirements of the user. Such powered staplers have motor driven mechanisms (assemblies) to advance components within the stapler to fire the staples from the cartridge through tissue. Such powered staplers, if reusable, are subject to the same aforementioned costs and risk of resterilization. However they suffer from additional drawbacks since the sterilization process and/or heat or chemicals used in the sterilization process can damage the electronic components of the drive assemblies, which may shorten the lifespan of the surgical stapler or adversely affect its function if resterilization compromises the function of the motor or drive assembly. If the stapler is disposable, the stapler becomes more costly since the electronic components, which add to the cost of the stapler, are also discarded with the stapler.
It would be advantageous to provide a cost effective, efficient, simple to use and advanced assemblies for powering surgical instruments which overcome the drawbacks of manual actuation without suffering from the disadvantages of current power driven staplers.
Further, it would be advantageous to provide such surgical instruments which include systems to evaluate various parameters and functionalities to improve operation of the instruments and improve the surgical procedures and outcomes.
The present invention overcomes the deficiencies and disadvantages of the prior art. The present invention advantageously provides surgical staplers that overcome the drawbacks discussed above by having a fully enclosed and removable power pack. The surgical staplers according to the present disclosure may be used multiple times without the need to sterilize the power pack between uses because the power pack is fully enclosed and sealed by the surgical stapler handle assembly or housing, thereby preventing contact between the power pack and the patient and/or patient's bodily fluids or the like. Thus, the surgical staplers of the present disclosure advantageously reduce the time, resources and/or costs for preparing the surgical stapler for its next use. The present disclosure also provides power packs that are cost effective, efficient and easily loadable into surgical staplers where they engage structure in the housing to effect varied functions of the stapler.
In accordance with one aspect of the present invention, a power pack removably loadable into a compartment of a surgical fastener applier is provided. The power pack has a) a first motor and b) a first drive mechanism having a first engagement member, the first drive mechanism operably connected to the motor and the first engagement member removably engageable with a firing mechanism of the surgical fastener applier when the power pack is loaded into the compartment to effect movement of the firing mechanism from a first position to the second position. A rotatable screw is rotatable by the motor to effect linear movement of the first engagement member and an encoder is positioned within the power pack to detect movement of the rotatable screw to determine a firing position of the firing mechanism.
In some embodiments, the encoder is mounted to the rotatable screw to detect a rotational position of the screw to determine the axial position of the first engagement member which in turn detects the axial position of the firing mechanism of the surgical stapler, the encoder rotatable with rotation of the rotatable screw and rotatable relative to a code wheel fixedly mounted within the power pack.
In other embodiments, the encoder is connected to the first drive mechanism and moves linearly with linear movement of the first drive mechanism to detect a linear position of the first drive mechanism to thereby detect a position of the firing mechanism. The encoder can be mounted to a collar of the first drive mechanism, the collar including a region forming the first engagement member.
In some embodiments, the power pack includes a second motor, a second rotatable screw operatively connected to and rotatable by the second motor and a second drive mechanism operatively connected to the second rotatable screw and having a second engagement member removably engageable with an articulating mechanism in the housing of the surgical fastener applier to effect movement of the articulation mechanism to effect articulation of first and second jaws of the surgical stapler from a linear position to an angled position. A second encoder is positioned within the power pack to detect movement of the second rotatable screw to determine an articulation position of the articulation mechanism.
In accordance with another aspect of the present invention, a surgical fastener applier is provided comprising a housing containing a compartment therein, an elongated member extending distally from the housing, and a first jaw and a second jaw at a distal portion of the elongated member, at least the first jaw movable with respect to the second jaw to clamp tissue between the first and second jaws. A firing mechanism is positioned within the housing the firing mechanism movable between a first position and a second position, wherein movement to the second position effects firing of fasteners into the tissue clamped between the first and second jaws. A power pack is removably loadable into the compartment, the power pack having a) a first motor and a first engagement member removably engageable with the firing mechanism when the power pack is loaded into the compartment to effect movement of the firing mechanism from the first position to the second position; and b) a second motor and a second engagement member removably engageable with an articulating mechanism in the housing of the surgical fastener applier to effect movement of an articulation mechanism to effect articulation of the first and second jaws from a linear position to a position angled with respect to a longitudinal axis of the elongated member. A firing position is determined based on a first motor count of the first motor and an articulation position is determined based on a second motor count of the second motor.
In some embodiments, an encoder communicates the motor counts to a microprocessor within the power pack for adjustment of a motor speed. In some embodiments, a predetermined time for completion of a firing stroke of the firing mechanism is preset. In some embodiments, if an amperage of the first motor increases above a predetermined threshold, a speed of the motor is slowed and the present time is adjusted accordingly.
In accordance with another aspect of the present invention, a power pack removably loadable into a compartment of a surgical fastener applier is provided. The power pack has a first motor and a first engagement member removably engageable with a firing mechanism within the housing of the surgical fastener applier when the power pack is loaded into the compartment, the first engagement member movable axially in response to rotation of a first screw operatively connected to the first motor. At least one thrust bearing limits axial movement of the first screw. Linear movement of the first engagement member effects movement of the firing mechanism from the first position to the second position. A first load cell is engageable by the bearing to measure a force during firing.
In some embodiments, the power pack includes a second motor and a second engagement member removably engageable with an articulation mechanism within the housing when the power pack is loaded into the compartment, the second engagement member movable axially in response to rotation of a second screw operatively connected to the second motor, wherein linear movement of the second engagement member effects movement of the articulation mechanism to effect articulation of the first and second jaws and at least one bearing limits axial movement of the second screw. A second load cell is engageable by the bearing to measure an articulation force.
In accordance with another aspect of the present invention, a surgical fastener applier is provided comprising:
In some embodiments, the cover includes a member movable into contact with an activation switch in the power pack when the cover is closed. In some embodiments, the power pack has a printed circuit board in communication with the switch.
In accordance with another aspect of the present invention, a surgical fastener applier is provided comprising:
In some embodiments, the power pack presets the motor to correspond to the type of staple cartridge detected. The type of staple cartridge detected can be a length of a linear array of staples within the cartridge and/or a size of the staples within the cartridge.
In some embodiments, a motor in the power pack for firing staples cannot be actuated if the reader detects the staple cartridge has already been fired.
In some embodiments, the surgical fastener applier has a window adjacent the housing exhibiting a desired clamp force dependent on the type of cartridge and/or the type of cartridge selected.
In accordance with another aspect of the present invention, a surgical fastener applier is provided comprising:
In some embodiments, the power pack has a first drive mechanism engageable with the firing mechanism, and the power pack cannot be removed from the compartment if the first drive mechanism in not in a home position. In some embodiments, the power pack has a second drive mechanism engageable with the articulation mechanism, and the power pack cannot be removed from the compartment if the articulation mechanism in not in a home position.
In some embodiments, opening of the jaws disables a firing mode. In some embodiments, closing of the jaws disables an articulation mode.
In accordance with another aspect of the present disclosure, a surgical fastener applier is provided comprising:
In some embodiments, the power pack can be removed from the compartment only if the first and second engagement members are in the home position.
In some embodiments, neither a firing switch nor an articulation switch can be activated if the cover is not in the closed position.
In accordance with another aspect of the present invention, a method for powering a surgical stapler is provided comprising:
In some embodiments, the firing mode cannot be effected if a cover of the compartment is not in the closed position. In some embodiments, the power pack cannot be removed from the compartment if the articulation mechanism and the firing mechanism are not in the home position. In some embodiments, a switch for actuating the firing mechanism cannot be actuated if a switch for the articulation mechanism is activated. In some embodiments, a switch for actuating the articulation mechanism cannot be actuated if a switch for the firing mechanism is activated.
So that those having ordinary skill in the art to which the subject invention appertains will more readily understand how to make and use the surgical apparatus disclosed herein, preferred embodiments thereof will be described in detail hereinbelow with reference to the drawings, wherein:
The present disclosure provides power packs, containing a battery and power train, which are loadable into a surgical stapler to power various functions of the surgical stapler to reduce the forces exerted by the clinician otherwise required if manual force was utilized. The present disclosure also provides surgical staplers designed to receive the power pack and to interact with the power pack to effect firing of the staplers. In some embodiments, the power pack can be used to effect articulation of the jaw assembly of the stapler to pivot the jaw assembly with respect to the longitudinal axis of the stapler. Each of these embodiments is discussed in detail below.
The power pack can also be utilized for powering endoscopic linear staplers, other types of staplers as well as other surgical instruments. Examples of these instruments are also discussed below.
The loadable power packs of the present disclosure are mountable into the handle housing of the surgical instrument, and are maintained in a sterile environment within the surgical instrument so they can be removed and reused. This enables the power pack to be removed from the stapler and reused in another procedure and/or instrument without the complexities, time, costs and risks of resterilization of the power pack. The sealed environment of the battery and power train within the housing also enables certain features/components to be used which might not otherwise be practical if sterilization of the internal power pack was required. Thus, by preventing contact between the power pack and the patient and/or bodily fluids and the external environment, resterilization is not required. The power pack can be used with surgical instruments discarded after use (fully disposable instruments), partially disposable surgical instruments or with fully reusable/sterilizable instruments with the advantage that the power pack need not be discarded or sterilized. Thus, the surgical stapler of the present disclosure advantageously reduces the time, resources and/or costs for preparing the surgical stapler for its next use.
The power packs are easily loadable in the surgical instrument, preferably the handle assembly or housing of the instrument, to easily and securely engage structure in the housing to effect movement of such structure in the instrument. The power packs are also easily disengageable from the structure for removal from the housing for subsequent reuse. The power packs can be configured so they can be loadable and engageable in various types of surgical instruments. The power pack is fully enclosed and sealed by the handle housing so there is no need to sterilize the power pack between uses. The power pack can include a replaceable battery pack so the battery can be changed during a surgical procedure.
In some embodiments the power packs includes sensors, encoders or measurement devices to assess/detect certain functions of the surgical instruments. In some embodiments, automatic adjustments are made via a microprocessor in the power pack to account for such assessment and detection.
Referring now to the drawings and particular embodiments of the present disclosure, wherein like reference numerals identify similar structural features of the devices disclosed herein, there are illustrated several embodiments of the surgical instruments and removable power pack of the present disclosure.
With reference to
The power pack is engageable with a staple drive (staple firing) mechanism of the surgical stapler so that once it is loaded in the stapler, actuation of the motor within the power pack effects firing of the staples through tissue. In some embodiments, the power pack is engageable with an articulation mechanism wherein actuation of the motor effects articulation of the stapler. The powered articulation can be in addition to the powered staple firing or alternatively the stapler could have powered articulation and manual staple firing. A specific embodiment of such powered articulation included with powered firing is shown in
The term “surgical fasteners” as used herein encompasses staples having legs which are deformed by an anvil, two part fasteners wherein a fastener or staple component with legs is received and retained in a second component (retainer), and other types of fasteners which are advanced through tissue of a patient in performing surgical procedures.
The term “proximal” as used herein denotes the region closer to the user and the term “distal” as used herein denotes the region further from the user. The terms “top” or “upper” and “bottom” or “lower” refer to the orientation of the instruments as shown in the orientation of the instrument in
Turning first to
The surgical stapler, also referred to herein as the or surgical fastener applying instrument or surgical fastener applier, is designated generally by reference numeral 1 and includes a proximal portion 1a, a distal portion 1b and an elongated or endoscopic portion 6 (also referred to as an elongated tubular portion or shaft) extending between the proximal portion 1a and the distal portion 1b. A handle assembly 2 with a housing 4 (also referred to herein as a handle housing) is positioned at the proximal portion 1a and is configured to house and protect internal mechanisms of the stapler including the removable power pack when loaded (mounted) therein. At the distal portion 1b are opposing members, i.e., jaws, 8a, 8b, configured to clamp and constrain tissue during operation of the surgical stapler. At least one of the jaws is movable with respect to the other jaw from an open position to receive tissue between the jaws and a closed position to clamp tissue between the jaws. Thus, one of the jaws can be stationary and the other jaw movable with respect to the stationary jaw or alternatively both jaws can move, e.g., pivot, toward each other. In the embodiment of
The elongated tubular member 6 extends distally from the housing 4 and is configured to fit through a surgical port (trocar) used for laparoscopic surgery. The endoscopic portion 6 can be of varying dimensions and in some embodiments is configured to fit through a 10 mm trocar, although other dimensions for fitting through other size trocars are also contemplated such as trocars ranging from 5 mm to 15 mm. It is advantageous to minimize the diameter of the endoscopic portion to minimize the size of the patient's incision. With the jaws 8 in the clamped position, the outer diameter of the elongated member 6 is maintained as the cross-sectional dimension of the closed jaws 8 preferably does not exceed the cross-sectional dimension (i.e., diameter) of the tubular member 6.
The surgical stapler 1 can in some embodiments include a joint 10 that provides for the articulation of the opposing members 8, i.e., pivoting of the jaw assembly (Jaws 8) to angular positions with respect to the longitudinal axis of elongated member 6. Articulation can be achieved by linear motion of elongated members extending through the endoscopic portion 6 which are slidable to angle the jaw assembly. A rotational member or knob 12 is configured to rotate, with respect to the handle assembly, the elongated member 6 and connected jaws 8 about the axis of the elongated member 6 to change the position of the jaws 8. Articulation is effected by manual manipulation of a lever adjacent the handle 2. A handle lever 14, linked to an axially movable clamping bar, is pivotable from a first position to a second position closer to stationary handle 16 to effect movement of the jaw 8b toward the jaw 8a from an open (unclamped) position to a clamping position, also referred to as a closed position of the jaws 8. Release of handle lever 14 returns the jaw 8b to its open position. Stationary handle 16 for grasping by the user is ergonomically designed for comfort of use. In summary, the surgical stapler operates by manual pivoting of the lever 14 toward stationary handle 16 to clamp the tissue between jaws 8, followed by powered firing of the staples from jaw 8b, through the clamped tissue and into contact with the staple forming pockets of the anvil of jaw 8b. Prior to firing, the jaws 8 can be rotated to a desired orientation by rotation of endoscopic portion 6 via knob 12 and/or articulated about joint 10, via movement of the elongated articulation members, to a desired angled position with respect to the longitudinal axis of endoscopic portion 6. In the embodiment of
The housing 4 of the handle assembly 2 of the surgical stapler is configured to receive the loadable/removable power pack 18 in a receptacle (compartment) 20 as shown in
The handle assembly 2 includes a cover 22 for opening and closing the receptacle 20. The compartment cover 22 is shown as being hingedly attached to the housing 4, but may alternatively be fully removable or attached in some other manner such as a slidable connection or the like. The cover 22 is shown pivotable mounted to a top portion of the housing 4 (in the orientation of
When the cover 22 is in a closed position, the seal of the cover 22 is in contact with the rim of the housing 2 such that the receptacle 20, and the power pack 18 if inserted into the receptacle 20, is sealed from the environment exterior to the surgical stapler. The top seal 24 can be attached to the cover 22 and in some embodiments can be in the form of an elastomer that is compressed by the housing, e.g., tightly fits slightly within the housing or is pressed on the rim of the housing 2. In other embodiments, the elastomer seal 24 can be on the housing 2, i.e., extending around the perimeter of the rim of the compartment 20, and is compressed by the cover 22 to seal between the cover 22 and housing 4. Other seals can also be provided within the surgical stapler to seal/protect the power pack 18 from contaminants, e.g., body fluids. These seals are discussed in more detail below.
Turning now to the power pack of the present disclosure, and with reference to
Connected to the end of lead screw 36 (the end opposite the connection to the gear 30) is a drive mechanism 40. The drive mechanism 40 is configured to move in a linear motion (in an axial direction) along the lead screw 36 in response to rotation of the lead screw 36. For example, the drive mechanism 40 may include internal threads that engage external threads of the lead screw 36 and may include slides engaged in a track that prevent the drive mechanism 40 from rotating and therefore cause the drive mechanism 40 to move linearly (axially) in response to rotation of the lead screw 36. As depicted in
The power pack 18 can have features/structure to constrain the motor 32. In the embodiment of
The drive mechanism 40 includes a first output flag or yoke 42, which is discussed in more detail below, configured to engage a staple firing mechanism, e.g., firing rod 46, extending longitudinally within the handle 4. The staple firing rod 46 is operatively connected to a firing rod in the endoscopic portion 6 which is operatively engageable with a series of staple drivers in jaw 8b to advance the fasteners (staples) from the fastener jaw 8b. Alternatively, the firing rod 46 can extend through the endoscopic portion 6 and itself engage the stapler drivers as shown in
The power pack 18 can also include in some embodiments one or more sensors to indicate the position of the firing rod 46 to indicate to the clinician the status of staple firing. The embodiment of
It is also contemplated that in alternate embodiments, the sensor(s) can be carried by the handle housing rather than (or in addition to) the power pack and utilized to detect the positioning of the flag 42 and/or firing rod 46 and/or detect the position of the articulation flag and/or articulation rod in the embodiments discussed below which have powered articulation.
It is also contemplated that a sensor(s) can be provided to detect the position of the clamping rod for clamping the jaws. The sensor can be provided in (or supported by) the power pack or alternatively the sensor(s) can be carried by the handle housing rather than (or in addition to) the power pack and utilized to detect the positioning of the jaws by detecting the position of the flag engaging the jaw clamping rod and/or detecting the position of the jaw clamping rod in the embodiments which have powered clamping.
Note the sensor can be provided in some embodiments; in other embodiments, no sensor is provided.
The power pack in some embodiments has a battery pack that is removably mounted in or on the power pack. This is discussed in more detail in conjunction with
Turning now to the loading of the power pack 18 into the surgical stapler 1, as seen in
The output flag 42 of power pack 18 is configured to engage a bossed end 44 of the firing rod 46 when the power pack 18 is fully inserted into the receptacle 20 of the handle assembly 2. As shown, the output flag (yoke) 42 has a receiving or mounting feature or member (also referred to as the engagement feature (member) or firing rod engagement feature (member) in the form of two arms 43a and a slot 43b therebetween, configured to frictionally (and releasably) engage the bossed end 44, the feature aligning with the bossed end 44 during insertion. (The aforedescribed guiding structure on the power pack 18 and internal wall of the compartment 20 aid such alignment).
In use, the cover 22 of stapler 1 is opened and the power pack 18 is inserted into receptacle 20 of sterile handle assembly 2 (of sterile stapler 1), with the output flag 42 of the power pack 18 engaging a corresponding feature, e.g., boss 44 of elongated drive rod 46, in the handle assembly 2 as discussed above. Then, the cover 22 is closed to seal the power pack 18 within the receptacle 20 from the external environment and the surgical stapler 1 may be actuated, i.e., manually clamped, articulated and/or rotated if desired, and the motor actuated to effect staple firing. After applications of fasteners and release (unclamping of the jaws from tissue), the cover 22 can be opened and the power pack 18 removed and charged while the stapler and handle assembly are resterilized if the stapler is a reusable instrument or the stapler and handle assembly are disposed of if the stapler is a single use disposable instrument. The power pack 18, due to its sealed configuration discussed above, can be reused without requiring sterilization by insertion into the receptacle 20 of a resterilized handle assembly or a sterile handle assembly of an unused disposable handle assembly. Thus, as can be appreciated, the removable power pack 18 does not need to be subjected to the sterilization process and, therefore, contact between the harsh temperatures and/or chemicals of the sterilization process is advantageously avoided. Also, by being able to reuse the power pack without sterilization, significant cost savings are achieved compared to if the power pack is not resterilizable, is disposed of along with the disposable stapler.
Note that in the embodiment of
In an alternate embodiment, shown schematically in
In the embodiment of
The power pack 18 is also not limited to use with endoscopic linear staplers, nor is it limited to use with staplers.
By way of example, the power pack 18 can be used with a circular stapler that applies circular arrays of staples such as shown in
By way of another example, the power pack can be used with a linear stapler that applies transverse rows of staples in a linear direction, i.e., parallel to the longitudinal axis of the stapler, such as shown in
The power pack 18 can also be used with single firing instruments that fire a single staple, clip, tack, etc. into body tissue. Two examples of such instruments are illustrated in
Another example of a single firing instrument is illustrated in
In the embodiments of
Turning first to the embodiment of
Connected to the end of lead screw 144 (the end opposite of the connection to the disc 154) is a drive mechanism 142. The drive mechanism 142, like drive mechanism 40 of
The drive mechanism 142, like drive mechanism 140 of
The belt drive 160 differs from belt drive 140 of
The belt drive 180 differs from belt drive 140 of
The belt drive 200 differs from belt drive 180 of
It should be appreciated that the foregoing belt drive mechanisms can be used as an alternative to the gear mechanism in power pack 18 as well as an alternative to one or both of the gear mechanisms of power pack 90 discussed below.
In the foregoing embodiments, the power pack 18 was described for powering staple firing. In an alternate embodiment, the power pack can include a drive mechanism for effecting articulation. This motor powered articulation can be in addition to the motor powered staple firing, or alternatively, the power pack can be used solely for powered articulation. The embodiment of
With initial reference to
The power pack in the embodiment of
More specifically, with reference to
Connected to the end of lead screw 86 (the end opposite the connection to the gear 84) is a drive mechanism 80 which is configured to move in a linear motion (in an axial direction) along the lead screw 86 in response to rotation of the lead screw 86. Drive mechanism 80 includes a flag or yoke 82 identical to yoke 42 of power pack 18 discussed above, which engages flange or boss 76 of firing rod 75 within housing 64 of stapler 61. The connection of the flag 82 to the firing rod 76, the motor and gear mechanism, and the drive mechanism 80 of power pack 90 are the same as the power pack 18 and therefore the aforedescribed functions and features/components of power pack 18 for staple firing are fully applicable to the function and features/components of power pack 90 for staple firing so for brevity are not fully repeated herein. It should also be appreciated that the alternative mechanisms for motor powered stapled firing, such as the various belt drive mechanisms discussed above and/or illustrated in the Figures, can also be used in the power pack 90 to effect staple firing. Additionally, the various sensors discussed above with regard to sensing the firing stroke can also be provided in power pack 90 for the same uses.
Power pack 90 also has an articulation assembly, shown in detail in
Connected to the end of lead screw 98 (the end opposite the connection to the gear 92) is a drive mechanism 95 configured to move in a linear motion (in an axial direction) along the lead screw 98 in response to rotation of the lead screw 98. For example, the drive mechanism 95, like drive mechanisms 40 and 80 described above, may include internal threads that engage external threads of the lead screw 98 and may include slides engaged in a track that prevent the drive mechanism 95 from rotating and therefore cause the drive mechanism 95 to move linearly (axially) in response to rotation of the lead screw 98. As depicted, the power pack 90 has a compact configuration as the lead screw 98 extends alongside, slightly spaced from, the motor 96 and gear box 93, i.e., both the motor 96/gear box 93 and lead screw 98 extending longitudinally with the lead screw 98 parallel to the motor 96. The drive mechanism 95 is connected to a proximal end of lead screw 98. The drive mechanism 95 has an articulation rod engagement feature in the form of a flange or yoke 94 extending therefrom having legs 99a and a recess 99b to engage an articulation rod 79 within the housing 63. In the illustrated embodiment (see e.g.,
The articulation assembly of the power pack 90 is oriented in the opposite direction from the staple firing assembly to minimize the space required in the power pack 90, thereby providing the power pack with a compact configuration. As can be appreciated by reference to
The power pack 90, like power pack 18 can have features/structure to constrain the motors 84 and 96. In the embodiment of
The power pack 90 can include guides, e.g., projections 90a, 90b, either axially aligned or axially offset, similar to guides 28 of power pack 18 for alignment with guiding structure in the compartment of stapler 61. This can prevent misloading of the power pack.
In use, with the cover 62 of stapler 61 in the open position, power pack 90 is loaded into the compartment of the handle housing 63. The cover 62 is closed to seal the power pack 90 from contaminants in same manner as cover 22 of stapler 1. Upon loading of the power pack 90, flag 82 of the drive mechanism 80 of the staple firing assembly engages flange 76 of firing rod 75 and flag 94 of drive mechanism 95 of the articulation assembly engages flange or bossed end 78 of articulation rod 79. Actuation of the motor 96 effects linear motion of the flag 94 which moves the articulation rod 79 linearly (axially). The articulation rod 79 is either directly coupled to the joint 69, or coupled to another member or multiple members which are coupled to the joint 69. When moved linearly, the articulation rod 79 effects movement of the jaws 68A, 68b of the stapler 61 to angular positions with respect to the longitudinal axis of the stapler 61. Note the articulation drive assembly operates in a similar manner as the firing drive assembly of power pack 18 in that when the power pack 90 is secured to the tube 79 by the second output flag 94, linear motion generated at the second output flag 94 is transferred to linear motion of the tube 79.
Actuation of the motor 83 effects linear motion of the flag 82 which moves the firing rod 75 linearly (axially). The firing rod 75 either extends through the elongated portion 66 for engagement of the firing mechanism in the jaw 68b or is coupled to another elongated component(s) extending through the endoscopic portion 66 to engage the firing mechanism in the jaw 68b. Note that the articulation rod or tube 79 can be configured to receive the firing rod 75 so that the firing rod 75 can move within the tube 79 to effect firing and the articulation rod 79 can slide linearly over the firing rod to effect articulation.
After use, the cover 62 can be opened and the power pack 90 removed and charged while the handle assembly 63 (and stapler 61) is sterilized or disposed of if the stapler is a disposable instrument. The power pack 90, like power pack 18 described above, may be reused without requiring sterilization by being inserted into the receptacle of the now-sterilized handle assembly 63 or a different sterile handle assembly. Thus, the removable power pack 90, like power pack 18, does not need to be subjected to the sterilization process and, therefore, contact between the harsh temperatures and/or chemicals of the sterilization process is advantageously avoided.
One or more seal's are utilized for sealing power pack 18 and power pack 90 within the handle assembly 2 or 63 so that the power pack remains sterile and is not exposed to bodily fluids during surgical procedures. For example, as discussed above, in the stapler 1 of
Turning first to the embodiment of
In use, the battery pack 408 can be aseptically preloaded in the power pack 406, either by a user or packaged with the battery pack 408 preloaded, and the power pack 406 is aseptically preloaded into the surgical instrument. During a surgical procedure, in the event of a battery failure, the cover 407 can be opened and the power pack 406 can be removed intraoperatively from compartment 404, the battery pack 408 removed from cavity 410, a new (second) charged battery (battery pack) aseptically placed in cavity 410 and the power pack 406 with the replacement battery pack reloaded into compartment 404. In an alternative use, during a surgical procedure, in the event of a battery failure, the cover 407 can be opened and with the power pack 406 remaining in compartment 404, the battery pack 408 is removed from cavity 410 of the power pack 406 and a new (second) charged replacement battery (battery pack) aseptically placed in cavity 408 while the power pack 406 remains loaded (positioned) within the compartment 404 of the surgical instrument.
In the alternate embodiment of
In use, as with power pack 406 described above, the battery pack 420 can be preloaded, i.e., pre-mounted, onto the power pack 406 (by the user or prepackaged) and can be removed and replaced with another (second) charged battery (battery pack) during a surgical procedure by first removing the power pack 406 from the compartment 404 of stapler 1 or alternatively the battery pack 420 can be removed from the power pack 406 and replaced by another charged battery pack while the power pack 406 remains in the compartment 404.
In the alternate embodiment of
In the loaded position, the battery pack can protrude slightly above the plane of the top edges 404a of the compartment 402 as shown in
In use, the battery pack 440 can be preloaded in the power pack 430, either by a user or packaged with the battery pack 440 preloaded. During a surgical procedure, in the event of a battery failure, the cover 407 can be opened, power pack 430 removed from compartment 404, the battery pack 440 removed from cavity 434, a new (second) charged battery (battery pack) aseptically placed in cavity 434 and the power pack 440 with a replacement battery pack reloaded into compartment 404. In an alternative use, during a surgical procedure, in the event of a battery failure, the cover 407 can be opened and with the power pack 430 remaining in compartment 404, the battery pack 440 is removed from cavity 434 of the power pack 440 and a new (second) charged battery (battery pack) aseptically placed in cavity 434 while the power pack 430 remains loaded (positioned) within the compartment 404.
Note the battery packs disclosed herein can include custom cells or alternatively off the shelf batteries. The use of the term battery pack as used herein encompasses different types of batteries and different housings for the batteries which are mounted on or inserted either fully or partially into the power pack housing (which contains the powertrain therein) to operatively connect with the motor in the power pack.
The battery packs can be retained, e.g., locked, in or on the power pack housing in various ways such as a latch, spring loaded engagement, frictional engagement, interlocking tabs, etc., and such mountings can also include a release button for disengaging/removing the battery pack from the power pack.
As noted above, the power pack 90 can be used with the other staplers disclosed herein, e.g. circular staplers, linear staplers, as well as other instruments wherein two powered functions are desired. The first motor assembly can effect linear motion of a first elongated member to, effect a first function of the stapler, e.g., clamping, articulation, firing, and the second motor assembly can effect linear motion of a second elongated member to effect a second different function of the stapler, e.g., clamping, articulation, firing. In the embodiment of
Initially, with reference to
With continued reference to the diagram of
The foregoing is shown in the stapler of
The steps for loading the powertrain and using the instrument will now be described in conjunction with the flow chart of
To use the stapler, the clamping handle is closed to move the jaws to the closed position for insertion through the trocar. Once inserted, if articulation is desired, the handle is unclamped to move the jaws to the open position and the articulation switch, e.g., a rocker switch or other switches preferably accessible on either side of the instrument, is pivoted to move the jaws from the 0 position to the left or right. The encoder via a motor count detects the articulated position of the jaws which in some embodiments can be visually displayed on an instrument or power pack screen. After reaching the articulated position of the jaws, tracked via the motor count, the articulation switch is released to maintain the jaws in this position. In some embodiments a double pump articulation switch can be utilized to bring articulation back to zero automatically.
Next, the jaws are clamped via the manually actuated handle, which enables activation of the firing mode. With the jaws closed, the firing switch is actuated, to advance the firing rod and knife bar to apply staples and cut tissue. A motor count tracks the position of the firing rod. That is, the motor encoder detects motor location within a full stroke, i.e., informs what portion of the cycle (revolutions) of the complete cycle the firing mechanism is in along the firing stroke. The count correlates to the amount of spins of the driveshaft, effectively controlling the distance of the drive mechanism, e.g., collar. The number of revolutions is tied into a predetermined (selected) speed and a predetermined time. The motor speed can be automatically adjusted during use. Note as the motor operates, if there is a spike in amperage, the central processing unit will slow down the motor rpm, and the time cycle will be adjusted accordingly, along with the encoder detection of the full stroke.
In some embodiments, to effect firing, the firing trigger needs to be pressed a first time as a pre-actuation mode and then pressed a second time to advance the firing rod and knife bar. After application of staples, the firing rod and knife bar are retracted to the home position. The articulation switch is then actuated to return the articulation motor and thus the jaws to the home position. The jaws are closed by the clamping handle and the instrument is removed from the patient's body through the trocar. Note an abort switch can be provided to reverse motor rotation to retract the firing mechanism and knife bar during the procedure.
After removal of the instrument, the jaws are open and the spent cartridge is removed. If additional staples are required a fresh cartridge is loaded into the cartridge receiving jaws and the instrument jaws are closed and the instrument is inserted through the trocar (returning to block 7 of the diagram of
As noted above, in some embodiments, a switch is located on the power pack which is actuated by the instrument cover when the cover is closed. This is shown in
The cover can have a seal about its periphery and/or a seal around the periphery of the opening to the compartment can be provided, as discussed above, to seal the power pack within the compartment to prevent entry of contaminants.
Below is a chart summarizing the safety mechanisms of the surgical instrument in accordance with some embodiments:
Turning first to
Deployment screw 818 differs froth these deployment screws in that it supports an electromechanical encoder 810. More particularly, the encoder 810 is mounted to encoder holder 812 which has a post 813 inserted into opening 826 at a proximal (back) end of screw 818. Other ways to mount the encoder to the screw are also contemplated. Code wheel 814 is mounted in opening 816a of proximal chassis 816. When the motor is actuated to rotate the deployment screw 818 as described herein to advance the collar 756 and firing mechanism, the static (fixed) code wheel 814 reads the discrete positions of the encoder and sends a signal to the CPU within the power pack indicative of such reading/position. Such rotation count determines the location of the firing mechanism and thus the location of the I-beam firing the staples from the cartridge. Note the number of discrete positions can vary and in some embodiments there are 64 discrete positions.
In the alternate embodiment of
Note an encoder similar to that of
A screen can be provided on the top of the powertrain to indicate the firing, clamping and/or articulation modes/positions. The screen can be visible through a clear window in the housing of the instrument. An example of the screen is shown in
In alternate embodiments of the present invention, the surgical instruments have features to aid staple size selection. These instruments can also provide motor speed adjustments to accommodate different tissue thicknesses.
These features include a measurement device such as a force gauge, a strain gauge pressure sensor or other gauges/sensors to measure one or more of i) the clamping force on tissue clamped between the instrument jaws; ii) the clamping pressure on the tissue clamped between the jaws and/or iii) tissue density within the jaws of the instrument. The gauges/sensors can be placed on various locations of the instrument, including proximal and distal portions. Alternatively, the sensors/gauges can be placed on the loadable power pack. These variations are discussed in detail below with reference to
In some embodiments a screen is located in the handle housing (see screen 613 of
Turning first to
The instrument 600 of
The cartridge jaw 607 is shown in the open position in
Upon manual clamping of the handle 609, i.e. movement toward stationary handle 611, to effect closure of the cartridge jaw 607, the clamp rod 620, which is operatively connected to the clamping handle 609, is pulled proximally, thereby pulling the attached clamp adapter 622 proximally. This moves the through pin 604 which is attached to clamp adapter 622, proximally within the cam slot 603 to move the cartridge jaw 607 toward the anvil jaw 605 to a clamped (closed) position as the cartridge jaw 607 pivots about pivot pin 624. The clamp pin 604 translates in the slot 603 relative to the location of the clamp rod position. The cartridge jaw 607 rotates around the pivot pin 624 relative to the location of the clamp pin 604 in the cam slot. The pin/slot arrangement is shown in
In the embodiments of
In an alternate embodiment, the load cell 606 is located in the distal clamp adapter 610. The load cells herein can form transducers for converting force into a measurable electrical signal. The distal clamp adapter 610 is actuated, i.e., moved axially, by the clamp laminates 616 which are connected to the clamp rod 620 which is movable to close and open the cartridge jaw 607. Note the laminates have slots which interact with the wall of the clamp rod 620 to move with the clamp rod, thus they are floatably connected to the clamp shaft. The load cell 606 is shown located at a proximal portion of the clamp adapter 610 where it is hooked to the clamp laminates 616, however it could be located at other regions of the clamp adapter 610. Axial movement of the clamp rod 620 moves the clamp adapter 610 to measure force as the cartridge jaw 607 is moved to the closed position.
In an alternate embodiment, the load cell 608 is located at a distal end of the clamp rod 620. It is shown at the distalmost end of the clamp rod 620, where the clamp rod 620 is hooked to the clamp laminates 616, but alternately can be located at other regions of the clamp rod 620. Axial movement of the clamp rod 620 measures force as the cartridge jaw 607 is moved to the closed position.
Note these load cells 604, 606 and 608 are positioned at the distal region of the instrument adjacent and proximal of the instrument jaws 605, 607 and proximal of the jaw pivot pin 624. Note load cell 604 provides an example of the measurement device on a load cell pin of the instrument; load cells 606, 608 provide an example of the measurement device on an axially movable part tied into jaw movement placed under load during clamping of the jaws on tissue. In this manner, clamping pressure or clamping force can be measured. Tissue density can also be measured.
The measurement device can alternatively be positioned further proximally of the jaws 605, 607 as shown for example in
In the foregoing embodiments, the measurement devices are positioned distal of the handle housing 602. In the alternate embodiments of
More specifically,
In alternate embodiments, the load pin can be located at one or more of the pin locations on the clamp pivot plate 640. The pivot plate 640 is connected at one end to link or clamp yoke 645 via pin 642a and at the other end to clamp adapter 632 via pin 642c. Link 645 is connected to clamping handle 609 at the opposing end. Pin 642b, positioned between pins 642a and 642c connects to the adapter 632. Pins 642a, 642b, 642c form load pins for force measurement based on movement of the pivot plate during clamping of the jaws 607, 605 initiated by manual movement of handle 603. It should be appreciated that only one, only two or all three load pins 642a, 642b and 642c could be used in a single instrument. When clamping handle 609 is moved toward stationary handle 611, it causes movement of yoke 645 which pivots the plate 640 clockwise about pivot pin 642b to move the proximal clamp adapter 632 proximally to effect proximal movement of the clamp rod 620 which moves the cam pin 604 (
In the embodiment of
As in the embodiments above, when provided on the instrument, the measurement device, e.g., the force gauge/strain gauge can be in line with the clamp linkage of the disposable instrument and/or in line with the clamp rod. It can be in the front of the clamp stroke, in the middle or in the back at or near the proximal clamp adapter. It can be inside or outside the handle housing. It can also be offset from the clamp rod such as below or side by side with the clamp bar. It could also be in line in the tube, distal of the handle so it does not need to rotate. It can also be inside the distal jaws of the instrument.
As noted above, the load cell can in alternative embodiments be located in the removable power pack as shown in
The force gauge is powered from power module and communicates with the power module microprocessor.
Thrust (axial) bearings and radial bearings on opposing ends of the screw 710 provide centering and axial alignment of the screw 710 during use. These thrust and radial bearings function in the same manner as thrust bearings 768, 780 and radial bearings 757, 782 of screw 754 of the embodiment of FIG. 59B of co-pending application Ser. No. 16/792,110, filed May 15, 2020, the entire contents of which are incorporated by reference as noted above. As shown. thrust bearing 716 is mounted at the distal end of screw 710 and thrust bearing 736 is mounted at the proximal end of the screw 710, proximal of collar 712, to resist any axial force applied to the rotating screw 710 and maintain its axial position. Radial bearings 724, 734 are provided to resist radial loads (forces that are perpendicular to the direction of the screw) and are located on the respective distal and proximal ends of the screw 710 with radial bearing 724 distal of thrust bearing 716 and radial bearing 734 proximal of thrust bearing 736. The thrust bearings 716, 736 are slip fit over the outer diameter of the deployment screw 710 (
Collar 712 has mounted thereto a pair of left and right track bearings 714 which function in the same manner as left track bearings 779 and a pair right track bearings 778, e.g., traveling along tracks in the 760, 762, described in detail in the Ser. No. 16/792,110 application, thereby preventing rotation out of the track as forces are translated linearly along shaft as the nut translates forward and backward. The tracks can be attached to or integrated (monolithic) with the chassis. The collar 712, like collar 756 of FIG. 59A of the Ser. No. 16/792,110 application includes a blade/tab extending inwardly from the wall which engages a circumferential recess (groove) in the deployment disk of the stapler which is attached to (or extends from) the firing rod of the stapler. In this manner, axial movement of collar 712 (via ball screw 710 when actuated by the motor) moves the deployment disk axially, the collar traveling along the respective left and right tracks (runners) via respective left and right bearings 714.
The deployment screw 710 includes a load cell or strain gauge 730 at the proximal end which is sandwiched between distal and proximal plates 738b, 738a. The deployment screw 710 further includes a load cell or strain gauge 720 at the distal end which is sandwiched between distal and proximal plates 718b, 718a. These load cells behind the thrust bearings measure force during firing. This can prevent the motor from being faulted. If the load cell detects an energy spike, a signal is sent to the microprocessor within the power pack 700 to slow down the motor.
The articulation screw 750 has distal thrust and axial bearings 762,763 (
The present invention can also provide a system that indicates to the user acceptable ranges for fastener application. Forces, tissue or clamping pressures, and/or tissue densities measured or calculated by the sensors/gauges as disclosed herein can are displayed on the power module TTF, LCD or Human Machine Interface screen on the instrument housing to give real-time feedback to the surgeon. Based on forces, measured pressure and densities pre-calculated from tissue testing which provide a baseline and maximum and interim values, the Human Machine Interface (HMI) screen will indicate if the measurement is within an optimal range for acceptable staple line outcome. This can be understood with reference to the diagram of
If the measured parameter is outside the acceptable range, then firing is disabled and the instrument recommends, e.g., via a screen or other indicator on the instrument or power module, alternative size staple load either smaller or larger in size.
Note the Human Machine Interface screen will indicate whether it is in the acceptable range (thin/less dense/low pressure or medium/average density/nominal pressure or thick/more dense/high pressure). It is contemplated that in some systems, the optimal force/pressure/density of tissue would be staple load size agnostic and the same ranges would apply to all load sizes. In other systems, a staple size selector switch on the power module is provided so the forces/pressure/density would be staple load size specific and in certain applications provide more precise indications/motor controls.
In some embodiments, if a strain gauge reading records a force/pressure or tissue density within a predetermined range so the stapling function is indicated, i) the power module microprocessor will enable the firing sequence of the device to deploy staples and ii) the power module microprocessor will disable the articulation functionality of the device. On the other hand, if a strain gauge reading records a force/pressure or tissue density outside a predetermined range so the stapling function is not indicated, the power module microprocessor will disable the firing sequence of the device putting it in a lockout condition not allowing staple firing.
In some embodiments, the surgeon will be provided the option to override the device.
A gauge in the form of a cartridge can be provided in some embodiments so the surgeon can load and clamp on tissue prior to selecting a cartridge load size. This cartridge load gauge enables the surgeon to select a proper cartridge size without potentially wasting the wrong size cartridge. The surgeon will load the gauge (dummy cartridge) into the instrument. Then the surgeon palpates tissue with the jaws to determine staple height size and the device will indicate an optimal cartridge size such as via an output on the screen. The surgeon then removes the dummy cartridge and inserts the indicated staple cartridge in the cartridge jaw. These steps are shown in the flow chart of
A clamp indicator in the window/can be provided to show where in the range the tissue falls based on the cartridge selected. The firing speed via AI (machine inference) can be controlled based on the cartridge selected and/or clamp indication measurements.
In some embodiments, the power pack can have a reader, such as an RFID reader, for detecting a type of staple cartridge prior to loading the staple cartridge in the instrument. The staple cartridge can have a code or tag, such as an RFID tag, and would be held adjacent the loaded power pack for detection of the type of cartridge, i.e., the size of the staples in the cartridge and/or the length of the arrays of staples within the cartridge. When detected, a signal is sent to the control module within the power pack to indicate which cartridge size is selected so the clamp force can be adjusted accordingly, and in some embodiments, indicated in the window/screen of the power module. The microprocessor can also preset the motor to correspond to the type of cartridge selected. The control module can be configured so that if a cartridge is loaded without its chip being read by the RFID reader, then the instrument cannot be actuated, e.g., cannot be fired. It can also be configured, so that the reader will detect if the cartridge has been fired (spent), i.e., devoid of staples, and if spent, the instrument cannot be actuated e.g., cannot be fired. The RFID tag can be on the plastic cartridge cover to minimize interference or assembled into the cartridge. Note alternatives to RFID readers to identify cartridge type, e.g., size, are also contemplated, with such identifiers communicating with the microprocessor in the power pack to adjust the clamping and/or firing parameters.
The logic circuit in some embodiments could be as follows: 1) load the power pack (in the home position) into the instrument compartment (the instrument cannot be actuated unless a power pack is loaded); 2) close the cover to enable the switch for articulation and the switch for firing (an enable mode); 3) select a cartridge and hold it adjacent the power pack to activate the load cells and to send a signal to the microprocessor confirming the cartridge has not been previously fired and to set the firing speed and adjust for other parameters, e.g., staple line length and firing stroke; 4) once all is active, place the cartridge in the instrument jaw; 5) the articulation switch and firing switch can be activated for performing the surgical procedure.
In some embodiments, a supercapacitor on the PCB can be provided to store enough energy to maintain microprocessor memory if the battery is exchanged or if the wrong size cartridge is utilized (wasted).
The load cell can be utilized in some embodiments for data acquisition to provide post procedure evaluation. In the manual option, the sales/OR staff will download case data from the power module via data transfer interface (e.g., USB). Data will be sent to HQ for trending and optimization for future cases. The feedback can be used to provide surgeons with ideal load selection. Note this would require staff present to input outcomes. In an alternative automatic option, the sales/OR staff will connect to the device via Bluetooth/wireless on their iPad or other mobile device and the data will be sent from the sales staff iPad (or other device) for trending and optimization for future cases. Other data collected and stored for such uses can further include biometrics, number of devices fired by the power pack; the length of the surgical procedures, forces generated, tissue information, operation of the stapling components and power pack components and other parameters of the tissue, surgical procedure, stapling instruments and/or power pack.
The foregoing measurement devices were discussed for use in surgical staplers. They can be used in open and endoscopic and laparoscopic staplers. However, they can also be used to measure pressure, force and/or tissue density in other instruments with clampable jaws such as graspers, energy devices, shears, clip appliers (where the measurement would prompt the surgeon to check clip closure based on force feedback of clip deployment).
Note the output can be digital. The output can be serial. It can be measured by voltage output.
A firing profile graph can be shown through HMI on the power module, visible through an instrument screen. High/low lines as with a statistical process control chart (SPC) will allow the surgeon to maintain a “safe” firing speed. That is, the graph will provide an indication to the surgeons where they are during the stroke. For example, if force is too high, they may want to take action to reduce the force or pause firing. An example of a chart is provided in
In the foregoing embodiments, use of the power pack of the present disclosure to fire staples such as in endoscopic linear staplers, open surgery linear staplers, circular staplers, as well as firing single clips or tacks were disclosed as examples. It should be appreciated that the power packs of the present disclosure can also be used to power functions of other surgical instruments.
In
In
The power packs 18 and 90 disclosed herein can be used in surgery where the clinician manually clamps the jaws and actuates the motor or motors to provide powered staple firing and/or powered jaw articulation. It is also contemplated that the power packs 18 and 90 can be used with robotic driven surgical staplers wherein clamping, motor actuation and any other functions of the instrument are performed robotically, including remote robotic control.
The staplers disclosed herein, or certain components thereof, can be made of environmental friendly biodegradable materials. For example, the handle can be made of biodegradable material. Such material can include for example corn based lactic acid. The packaging for the surgical staplers and/or the packaging for the power packs and/or the battery packs can also be composed of biodegradable materials to minimize the carbon footprint.
Although the apparatus and methods of the subject disclosure have been described with respect to preferred embodiments, those skilled in the art will readily appreciate that changes and modifications may be made thereto without departing from the spirit and scope of the present disclosure as defined by the appended claims.
Additionally, persons skilled in the art will understand that the elements and features shown or described in connection with one embodiment may be combined with those of another embodiment without departing from the scope of the present invention and will appreciate further features and advantages of the presently disclosed subject matter based on the description provided.
Throughout the present invention, terms such as “approximately,” “generally,” “substantially,” and the like should be understood to allow for variations in any numerical range or concept with which they are associated. For example, it is intended that the use of terms such as “approximately” and “generally” should be understood to encompass variations on the order of 25%, or to allow for manufacturing tolerances and/or deviations in design.
Although terms such as “first,” “second,” “third,” etc., may be used herein to describe various operations, elements, components, regions, and/or sections, these operations, elements, components, regions, and/or sections should not be limited by the use of these terms in that these terms are used to distinguish one operation, element, component, region, or section from another. Thus, unless expressly stated otherwise, a first operation, element, component, region, or section could be termed a second operation, element, component, region, or section without departing from the scope of the present disclosure.
Each and every claim is incorporated as further disclosure into the specification and represents embodiments of the present disclosure. Also, the phrases “at least one of A, B, and C” and “A and/or B and/or C” should each be interpreted to include only A, only B, only C, or any combination of A, B, and C.
This application claims priority from provisional application Ser. No. 62/962,388, filed Jan. 17, 2020 and, from provisional application Ser. No. 62/876,586, filed Jul. 19, 2019. The entire contents of each of these applications are incorporated herein by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/US2020/042033 | 7/15/2020 | WO |
Publishing Document | Publishing Date | Country | Kind |
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WO2021/016006 | 1/28/2021 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
2636136 | Henry | Apr 1953 | A |
2942603 | Geyer | Jun 1960 | A |
3442240 | Loughman et al. | May 1969 | A |
3494799 | Pedone, Jr. | Feb 1970 | A |
3734207 | Fishbein | May 1973 | A |
4250613 | Sauerwein | Feb 1981 | A |
4705038 | Sjostrom et al. | Nov 1987 | A |
4867158 | Sugg | Sep 1989 | A |
5207697 | Carusillo et al. | May 1993 | A |
5261877 | Fine | Nov 1993 | A |
5467911 | Tsuruta et al. | Nov 1995 | A |
5518163 | Hooven | May 1996 | A |
5551622 | Yoon | Sep 1996 | A |
5553675 | Pitzen et al. | Sep 1996 | A |
5651491 | Heaton et al. | Jul 1997 | A |
5680981 | Milii et al. | Oct 1997 | A |
5814058 | Carlson et al. | Sep 1998 | A |
5954259 | Viola et al. | Sep 1999 | A |
6054777 | Soh | Apr 2000 | A |
6331181 | Tierney | Dec 2001 | B1 |
6331761 | Kumar et al. | Dec 2001 | B1 |
6512348 | Wellisz et al. | Jan 2003 | B1 |
6530931 | Rosenberg | Mar 2003 | B1 |
6533157 | Whitman | Mar 2003 | B1 |
6716233 | Whitman | Apr 2004 | B1 |
6843303 | Siak et al. | Jan 2005 | B2 |
6846307 | Whitman et al. | Jan 2005 | B2 |
6981141 | Mahne et al. | Dec 2005 | B1 |
7160311 | Blatter | Jan 2007 | B2 |
7416101 | Shelton, IV et al. | Aug 2008 | B2 |
7422136 | Marczyk | Sep 2008 | B1 |
7422139 | Shelton, IV et al. | Sep 2008 | B2 |
7461767 | Viola et al. | Dec 2008 | B2 |
7464847 | Viola et al. | Dec 2008 | B2 |
7537602 | Whitman | May 2009 | B2 |
7568603 | Shelton, IV et al. | Aug 2009 | B2 |
7699855 | Anderson | Apr 2010 | B2 |
7717312 | Beetel | May 2010 | B2 |
7766210 | Shelton, IV et al. | Aug 2010 | B2 |
7793812 | Moore et al. | Sep 2010 | B2 |
7815092 | Whitman et al. | Oct 2010 | B2 |
7845538 | Whitman | Dec 2010 | B2 |
7922063 | Zemlok et al. | Apr 2011 | B2 |
7947034 | Whitman | May 2011 | B2 |
7950560 | Zemlok et al. | May 2011 | B2 |
7959050 | Smith et al. | Jun 2011 | B2 |
7963433 | Whitman et al. | Jun 2011 | B2 |
8006885 | Marczyk | Aug 2011 | B2 |
8011551 | Marczyk et al. | Sep 2011 | B2 |
8012170 | Whitman et al. | Sep 2011 | B2 |
8016855 | Whitman et al. | Sep 2011 | B2 |
8016858 | Whitman | Sep 2011 | B2 |
8021373 | Whitman et al. | Sep 2011 | B2 |
8056786 | Whitman et al. | Nov 2011 | B2 |
8056791 | Whitman | Nov 2011 | B2 |
8062311 | Litscher et al. | Nov 2011 | B2 |
8074858 | Marczyk | Dec 2011 | B2 |
8142473 | Cunningham | Mar 2012 | B2 |
8157150 | Viola et al. | Apr 2012 | B2 |
8181839 | Beetel | May 2012 | B2 |
8186555 | Shelton, IV et al. | May 2012 | B2 |
8205779 | Ma et al. | Jun 2012 | B2 |
8240536 | Marczyk | Aug 2012 | B2 |
8240537 | Marczyk | Aug 2012 | B2 |
8241322 | Whitman et al. | Aug 2012 | B2 |
8245899 | Swensgard et al. | Aug 2012 | B2 |
8251994 | McKenna et al. | Aug 2012 | B2 |
8257387 | Cunningham | Sep 2012 | B2 |
8276801 | Zemlok et al. | Oct 2012 | B2 |
8342377 | Milliman et al. | Jan 2013 | B2 |
8342378 | Marczyk et al. | Jan 2013 | B2 |
8353440 | Whitman et al. | Jan 2013 | B2 |
8409175 | Lee et al. | Apr 2013 | B2 |
8409222 | Whitfield et al. | Apr 2013 | B2 |
8444036 | Shelton, IV | May 2013 | B2 |
8453907 | Laurent et al. | Jun 2013 | B2 |
8453914 | Laurent et al. | Jun 2013 | B2 |
8459521 | Zemlok et al. | Jun 2013 | B2 |
8459525 | Yates et al. | Jun 2013 | B2 |
8479969 | Shelton, IV | Jul 2013 | B2 |
8499992 | Whitman et al. | Aug 2013 | B2 |
8517241 | Nicholas et al. | Aug 2013 | B2 |
8551025 | Soltz | Oct 2013 | B2 |
8556151 | Viola | Oct 2013 | B2 |
8573462 | Smith et al. | Nov 2013 | B2 |
8573463 | Scirica et al. | Nov 2013 | B2 |
8602287 | Yates et al. | Dec 2013 | B2 |
8602288 | Shelton, IV et al. | Dec 2013 | B2 |
8608045 | Smith et al. | Dec 2013 | B2 |
8622274 | Yates et al. | Jan 2014 | B2 |
8631998 | Viola | Jan 2014 | B1 |
8636736 | Yates et al. | Jan 2014 | B2 |
8636766 | Milliman et al. | Jan 2014 | B2 |
8657174 | Yates et al. | Feb 2014 | B2 |
8657177 | Scirica et al. | Feb 2014 | B2 |
8662371 | Viola | Mar 2014 | B2 |
8672206 | Aranyi et al. | Mar 2014 | B2 |
8690913 | Whitman | Apr 2014 | B2 |
8708213 | Shelton, IV et al. | Apr 2014 | B2 |
8733614 | Ross et al. | May 2014 | B2 |
8752748 | Whitman et al. | Jun 2014 | B2 |
8764749 | Mckenna et al. | Jul 2014 | B2 |
8777945 | Floume et al. | Jul 2014 | B2 |
8795313 | Liang et al. | Aug 2014 | B2 |
8800837 | Zemlok | Aug 2014 | B2 |
8820603 | Shelton, IV et al. | Sep 2014 | B2 |
8821514 | Aranyi | Sep 2014 | B2 |
8827134 | Viola et al. | Sep 2014 | B2 |
8834466 | Cummings et al. | Sep 2014 | B2 |
8851355 | Aranyi et al. | Oct 2014 | B2 |
8864753 | Nau, Jr. et al. | Oct 2014 | B2 |
8875973 | Whitman | Nov 2014 | B2 |
8899462 | Kostrzewski et al. | Dec 2014 | B2 |
8911471 | Spivey et al. | Dec 2014 | B2 |
8955732 | Zemlok et al. | Feb 2015 | B2 |
8960520 | McCuen | Feb 2015 | B2 |
8967443 | McCuen | Mar 2015 | B2 |
8968276 | Zemlok et al. | Mar 2015 | B2 |
8968285 | Twomey et al. | Mar 2015 | B2 |
8991677 | Moore et al. | Mar 2015 | B2 |
8998058 | Moore et al. | Apr 2015 | B2 |
9017355 | Smith et al. | Apr 2015 | B2 |
9028478 | Mueller | May 2015 | B2 |
9072523 | Houser et al. | Jul 2015 | B2 |
9084601 | Moore et al. | Jul 2015 | B2 |
9095339 | Moore et al. | Aug 2015 | B2 |
9101358 | Kerr et al. | Aug 2015 | B2 |
9113874 | Shelton, IV et al. | Aug 2015 | B2 |
9113880 | Zemlok et al. | Aug 2015 | B2 |
9113901 | Allen, IV et al. | Aug 2015 | B2 |
9186143 | Timm et al. | Nov 2015 | B2 |
9192381 | Marczyk | Nov 2015 | B2 |
9241716 | Whitman | Jan 2016 | B2 |
9265585 | Wingardner et al. | Feb 2016 | B2 |
9301772 | Kimball et al. | Apr 2016 | B2 |
9320520 | Shelton, IV et al. | Apr 2016 | B2 |
9326770 | Shelton, IV et al. | May 2016 | B2 |
9326812 | Waaler et al. | May 2016 | B2 |
9351727 | Leimbach et al. | May 2016 | B2 |
9364220 | Williams | Jun 2016 | B2 |
9364224 | Nicholas et al. | Jun 2016 | B2 |
9370360 | Marczyk | Jun 2016 | B2 |
9370364 | Smith et al. | Jun 2016 | B2 |
9393015 | Laurent et al. | Jul 2016 | B2 |
9398911 | Auld | Jul 2016 | B2 |
9402604 | Williams et al. | Aug 2016 | B2 |
9414818 | Azarbarzin et al. | Aug 2016 | B2 |
9421003 | Williams et al. | Aug 2016 | B2 |
9421014 | Ingmanson et al. | Aug 2016 | B2 |
9433415 | Marczyk et al. | Sep 2016 | B2 |
9451958 | Shelton, IV et al. | Sep 2016 | B2 |
9468454 | Johnson et al. | Oct 2016 | B2 |
9474513 | Ishida | Oct 2016 | B2 |
9474528 | Marczyk | Oct 2016 | B2 |
9484657 | Martin et al. | Nov 2016 | B2 |
9486214 | Shelton, IV | Nov 2016 | B2 |
9492167 | Shelton, IV et al. | Nov 2016 | B2 |
9504520 | Worell et al. | Nov 2016 | B2 |
9517068 | Shelton, IV et al. | Dec 2016 | B2 |
9539006 | Collings et al. | Jan 2017 | B2 |
9549750 | Shelton, IV et al. | Jan 2017 | B2 |
9554803 | Smith et al. | Jan 2017 | B2 |
9561031 | Heinrich et al. | Feb 2017 | B2 |
9585672 | Bastia | Mar 2017 | B2 |
9592056 | Mozdzierz et al. | Mar 2017 | B2 |
9597081 | Swayze et al. | Mar 2017 | B2 |
9615828 | Scirica | Apr 2017 | B2 |
9622744 | Smith et al. | Apr 2017 | B2 |
9636091 | Beardsley et al. | May 2017 | B2 |
9649110 | Parilhar et al. | May 2017 | B2 |
9655614 | Swensgard et al. | May 2017 | B2 |
9662110 | Huang et al. | May 2017 | B2 |
9675348 | Smith et al. | Jun 2017 | B2 |
9685281 | Wang et al. | Jun 2017 | B2 |
9687230 | Leimbach et al. | Jun 2017 | B2 |
9687234 | Smith et al. | Jun 2017 | B2 |
9687236 | Leimbach et al. | Jun 2017 | B2 |
9687253 | Detry et al. | Jun 2017 | B2 |
9700310 | Moragan et al. | Jul 2017 | B2 |
9700318 | Scirica et al. | Jul 2017 | B2 |
9743928 | Shelton, IV et al. | Aug 2017 | B2 |
9750499 | Leimbach et al. | Sep 2017 | B2 |
9775610 | Nicholas et al. | Oct 2017 | B2 |
9782172 | Whitman | Oct 2017 | B2 |
9782187 | Zergiebal et al. | Oct 2017 | B2 |
9788836 | Overmyer et al. | Oct 2017 | B2 |
9797486 | Zergiebal et al. | Oct 2017 | B2 |
9801626 | Parilhar et al. | Oct 2017 | B2 |
9826976 | Parihar et al. | Nov 2017 | B2 |
9833235 | Penna et al. | Dec 2017 | B2 |
9844368 | Boudreanx et al. | Dec 2017 | B2 |
9844375 | Overmyer et al. | Dec 2017 | B2 |
9867612 | Parilhar et al. | Jan 2018 | B2 |
9877720 | Worrell et al. | Jan 2018 | B2 |
9901344 | Moore et al. | Feb 2018 | B2 |
9901346 | Moore et al. | Feb 2018 | B2 |
9907552 | Measamer et al. | Mar 2018 | B2 |
9924942 | Swayze et al. | Mar 2018 | B2 |
9936949 | Measamer et al. | Apr 2018 | B2 |
9936951 | Hufhagel et al. | Apr 2018 | B2 |
9937626 | Rockrohr | Apr 2018 | B2 |
9949737 | Zergiebel et al. | Apr 2018 | B2 |
9955965 | Chen et al. | May 2018 | B2 |
9955966 | Zergiebel | May 2018 | B2 |
9962157 | Sapre | May 2018 | B2 |
9962159 | Heunrich et al. | May 2018 | B2 |
9974539 | Yates et al. | May 2018 | B2 |
9980729 | Moore et al. | May 2018 | B2 |
9991069 | Nicholas et al. | Jun 2018 | B2 |
10004498 | Morgan et al. | Jun 2018 | B2 |
10041822 | Zemlok | Aug 2018 | B2 |
10045778 | Yates | Aug 2018 | B2 |
10052100 | Morgan et al. | Aug 2018 | B2 |
10064621 | Kerr et al. | Sep 2018 | B2 |
10070861 | Spivey et al. | Sep 2018 | B2 |
10076379 | Boudreaux | Sep 2018 | B2 |
10085752 | Williams et al. | Oct 2018 | B2 |
10111662 | Zemlok et al. | Oct 2018 | B2 |
10111665 | Aranyi et al. | Oct 2018 | B2 |
10117654 | Ingmanson et al. | Nov 2018 | B2 |
10136887 | Shelton, IV et al. | Nov 2018 | B2 |
10143472 | Williams | Dec 2018 | B2 |
10149683 | Smith et al. | Dec 2018 | B2 |
10172612 | Frushour | Jan 2019 | B2 |
10178992 | Wise et al. | Jan 2019 | B2 |
10180463 | Beckman et al. | Jan 2019 | B2 |
10182816 | Shelton, IV | Jan 2019 | B2 |
10190888 | Hryb et al. | Jan 2019 | B2 |
10220522 | Rockrohr | Mar 2019 | B2 |
10226249 | Jaworek et al. | Mar 2019 | B2 |
10226250 | Beckman et al. | Mar 2019 | B2 |
10245033 | Overmyer et al. | Apr 2019 | B2 |
10426468 | Contini | Oct 2019 | B2 |
10194907 | Marczyk et al. | Dec 2019 | B2 |
10507034 | Timm | Dec 2019 | B2 |
10568651 | Kostrzewski | Feb 2020 | B2 |
10617415 | Wenchell et al. | Apr 2020 | B2 |
10695060 | Satti, III | Jun 2020 | B2 |
10709512 | Bajo et al. | Jul 2020 | B2 |
10722312 | Marshall et al. | Jul 2020 | B2 |
10736706 | Scheib | Aug 2020 | B2 |
10765486 | Bajo et al. | Sep 2020 | B2 |
10779822 | Yates | Sep 2020 | B2 |
10779901 | Zietlow et al. | Sep 2020 | B2 |
10780539 | Shelton, IV | Sep 2020 | B2 |
10821046 | Hares et al. | Nov 2020 | B2 |
10874391 | Shelton, IV | Dec 2020 | B2 |
10905422 | Bakos et al. | Feb 2021 | B2 |
10959806 | Hibner | Mar 2021 | B2 |
11197672 | Dunki-Jacobs | Dec 2021 | B2 |
20020096341 | Hagan | Jul 2002 | A1 |
20020143346 | McGuckin, Jr. et al. | Oct 2002 | A1 |
20030105475 | Sancoff | Jun 2003 | A1 |
20030149424 | Barlev | Aug 2003 | A1 |
20050021018 | Anderson et al. | Jan 2005 | A1 |
20050033352 | Zepf | Feb 2005 | A1 |
20050107809 | Litscher et al. | May 2005 | A1 |
20050187576 | Whitman | Aug 2005 | A1 |
20060017210 | Sato | Jan 2006 | A1 |
20060037766 | Gass | Feb 2006 | A1 |
20070023477 | Whitman | Feb 2007 | A1 |
20070118163 | Boudreaux et al. | May 2007 | A1 |
20070139915 | Walters | Jun 2007 | A1 |
20080039884 | Nohilly | Feb 2008 | A1 |
20080077149 | Hoegerle | Mar 2008 | A1 |
20080203135 | Viola et al. | Aug 2008 | A1 |
20080255597 | Pravong et al. | Oct 2008 | A1 |
20080281353 | Aranyi et al. | Nov 2008 | A1 |
20080296346 | Shelton, IV | Dec 2008 | A1 |
20090012520 | Hixson | Jan 2009 | A1 |
20090095790 | Whitman | Apr 2009 | A1 |
20090108048 | Zemlok | Apr 2009 | A1 |
20090110533 | Jinno | Apr 2009 | A1 |
20090171243 | Hibner | Jul 2009 | A1 |
20090182193 | Whitman | Jul 2009 | A1 |
20090209979 | Yates et al. | Aug 2009 | A1 |
20090250501 | Sonnenschein | Oct 2009 | A1 |
20090312603 | Lam et al. | Dec 2009 | A1 |
20100170931 | Viola | Jul 2010 | A1 |
20100213240 | Kostrzewski | Aug 2010 | A1 |
20100258327 | Esenwein | Oct 2010 | A1 |
20100320252 | Viola | Dec 2010 | A1 |
20110011915 | Shelton, IV | Jan 2011 | A1 |
20110012446 | Maute | Jan 2011 | A1 |
20110017801 | Zemlok | Jan 2011 | A1 |
20110022032 | Zemlok et al. | Jan 2011 | A1 |
20110082471 | Holcomb et al. | Apr 2011 | A1 |
20110125176 | Yates et al. | May 2011 | A1 |
20110220381 | Friese | Sep 2011 | A1 |
20110282381 | Cronin et al. | Nov 2011 | A1 |
20110295242 | Spivey et al. | Dec 2011 | A1 |
20120061446 | Knodel | Mar 2012 | A1 |
20120110810 | Houser et al. | May 2012 | A1 |
20120172924 | Allen, IV | Jul 2012 | A1 |
20120199632 | Spivey | Aug 2012 | A1 |
20120223121 | Viola | Sep 2012 | A1 |
20120286021 | Kostrzewski | Nov 2012 | A1 |
20120292367 | Morgan | Nov 2012 | A1 |
20120298719 | Shelton, IV | Nov 2012 | A1 |
20130098968 | Aranyi | Apr 2013 | A1 |
20130181033 | Shelton, IV et al. | Jul 2013 | A1 |
20130193189 | Swensgard | Aug 2013 | A1 |
20130296886 | Green | Nov 2013 | A1 |
20130331847 | Smith | Dec 2013 | A1 |
20140001235 | Shelton, IV | Jan 2014 | A1 |
20140005718 | Shelton, IV et al. | Jan 2014 | A1 |
20140012289 | Snow et al. | Jan 2014 | A1 |
20140058363 | Berkelaar | Feb 2014 | A1 |
20140114334 | Olson | Apr 2014 | A1 |
20140166023 | Kishi | Jun 2014 | A1 |
20140175150 | Shelton, IV | Jun 2014 | A1 |
20140207125 | Applegate et al. | Jul 2014 | A1 |
20140213848 | Moskowitz et al. | Jul 2014 | A1 |
20140246471 | Jaworek | Sep 2014 | A1 |
20140246474 | Hall | Sep 2014 | A1 |
20140257252 | Ishida | Sep 2014 | A1 |
20140276471 | Emery | Sep 2014 | A1 |
20140277334 | Yu | Sep 2014 | A1 |
20140291383 | Spivey | Oct 2014 | A1 |
20140305987 | Parihar | Oct 2014 | A1 |
20140305992 | Kimsey | Oct 2014 | A1 |
20140305995 | Shelton, IV et al. | Oct 2014 | A1 |
20140309665 | Parihar | Oct 2014 | A1 |
20140309666 | Shelton, IV | Oct 2014 | A1 |
20140364890 | Moody | Dec 2014 | A1 |
20150053737 | Leimbach | Feb 2015 | A1 |
20150090760 | Giordano et al. | Apr 2015 | A1 |
20150126977 | Azarbarzin et al. | May 2015 | A1 |
20150133979 | Johnson | May 2015 | A1 |
20150150547 | Ingmanson | Jun 2015 | A1 |
20150209035 | Zemlok | Jul 2015 | A1 |
20160058443 | Yates et al. | Mar 2016 | A1 |
20160095585 | Zergiebel et al. | Apr 2016 | A1 |
20160106401 | Beardsley | Apr 2016 | A1 |
20160175062 | Limon | Jun 2016 | A1 |
20160213436 | Inoue | Jul 2016 | A1 |
20160220247 | Timm et al. | Aug 2016 | A1 |
20160220268 | Shelton, IV et al. | Aug 2016 | A1 |
20160249922 | Morgan et al. | Sep 2016 | A1 |
20160270780 | Hall | Sep 2016 | A1 |
20160310134 | Contini et al. | Oct 2016 | A1 |
20160361131 | Dachs | Dec 2016 | A1 |
20160374666 | DiNardo et al. | Dec 2016 | A1 |
20170007254 | Jaworek | Jan 2017 | A1 |
20170007255 | Jaworek et al. | Jan 2017 | A1 |
20170035421 | Marczyk | Feb 2017 | A1 |
20170066119 | Fu | Mar 2017 | A1 |
20170079640 | Overmyer et al. | Mar 2017 | A1 |
20170079642 | Overmyer et al. | Mar 2017 | A1 |
20170128071 | Holsten et al. | May 2017 | A1 |
20170164945 | Chowaniec | Jun 2017 | A1 |
20170172574 | Zemlok et al. | Jun 2017 | A1 |
20170189020 | Harris et al. | Jul 2017 | A1 |
20170281167 | Shelton, IV et al. | Oct 2017 | A1 |
20170290583 | Reed et al. | Oct 2017 | A1 |
20170296176 | Contini et al. | Oct 2017 | A1 |
20180000483 | Leimbach et al. | Jan 2018 | A1 |
20180056496 | Rubens | Mar 2018 | A1 |
20180110519 | Lytle, IV et al. | Apr 2018 | A1 |
20180133883 | Nicholas et al. | May 2018 | A1 |
20180250002 | Eschbach | Sep 2018 | A1 |
20180317964 | Evans et al. | Nov 2018 | A1 |
20180340806 | Zemlok | Nov 2018 | A1 |
20180360486 | Beaupre | Dec 2018 | A1 |
20180368822 | Shelton et al. | Dec 2018 | A1 |
20190000577 | Shelton | Jan 2019 | A1 |
20190008512 | Nicholas et al. | Jan 2019 | A1 |
20190038283 | Shelton, IV | Feb 2019 | A1 |
20190053796 | Miller et al. | Feb 2019 | A1 |
20190059923 | Tillman | Feb 2019 | A1 |
20190069887 | Satti, III et al. | Mar 2019 | A1 |
20190069895 | Satti, III et al. | Mar 2019 | A1 |
20190069896 | Satti, III et al. | Mar 2019 | A1 |
20190117222 | Shelton, IV et al. | Apr 2019 | A1 |
20190142421 | Shelton, IV | May 2019 | A1 |
20190142423 | Satti, III | May 2019 | A1 |
20190183594 | Shelton, IV et al. | Jun 2019 | A1 |
20190239966 | Xu | Aug 2019 | A1 |
20190261991 | Beckman | Aug 2019 | A1 |
20200205817 | Nielsen et al. | Jul 2020 | A1 |
20200315725 | Graves et al. | Oct 2020 | A1 |
20210322007 | Satti, III | Oct 2021 | A1 |
Number | Date | Country |
---|---|---|
106456172 | Sep 2019 | CN |
0685203 | Dec 1995 | EP |
0699418 | Mar 1996 | EP |
0705571 | Apr 1996 | EP |
1889576 | Feb 2008 | EP |
2243432 | Oct 2010 | EP |
2243433 | Oct 2010 | EP |
3005954 | Apr 2016 | EP |
3078334 | Oct 2016 | EP |
3178413 | Jun 2017 | EP |
3189790 | Jul 2017 | EP |
2792316 | Jan 2018 | EP |
5415704 | Nov 2013 | JP |
WO 2006112849 | Jan 2006 | WO |
WO 2010006057 | Jan 2010 | WO |
WO 2017154007 | Sep 2017 | WO |
WO 2019045995 | Mar 2019 | WO |
WO 2019046132 | Mar 2019 | WO |
WO 2021016006 | Jan 2021 | WO |
Entry |
---|
European Search Report (dated Mar. 3, 2022) from European Application No. EP 20766786. |
International search report and written opinion for international application PCT/US2022/016892 dated May 13, 2022. |
International search report and written opinion for international application PCT/US2018/048020 dated Oct. 30, 2018. |
International search report for international application PCT/US2018/046370 dated Nov. 6, 2018. |
International search report and written opinion for international application PCT/US2020/018714 dated Aug. 4, 2020. |
International Search Report and Written Opinion dated Nov. 13, 2020 for International Application No. PCT/US2020/042033. |
Search Report for European Application EP 18849700 dated Jun. 8, 2021. |
Number | Date | Country | |
---|---|---|---|
20210322007 A1 | Oct 2021 | US |
Number | Date | Country | |
---|---|---|---|
62876586 | Jul 2019 | US | |
62962388 | Jan 2020 | US |