阅读说明：本技术 手术装置中的应变计稳定化 (Strain gauge stabilization in surgical devices ) 是由 约瑟夫·艾辛格 于 2020-03-06 设计创作，主要内容包括：本发明涉及手术装置中的应变计稳定化,并提供了适配器组合件且其包括具有近端部分和远端部分并限定纵向轴线的管状壳体；负荷感测组合件,其布置在管状壳体内,在近侧表面和远侧表面之间接触,所述近侧和远侧表面垂直于纵向轴线,所述负荷感测组合件配置成测量施加在管状壳体上的负荷,所述负荷感测组合件包括传感器主体；和万向架,所述万向架设置在传感器主体表面与所述近侧表面或所述远侧表面中的至少一个之间,所述万向支架配置成将传感器主体与施加在垂直于纵向轴线的平面上的负荷隔离。(The present invention relates to strain gauge stabilization in a surgical device and provides an adapter assembly and includes a tubular housing having a proximal end portion and a distal end portion and defining a longitudinal axis; a load sensing assembly disposed within the tubular housing in contact between a proximal surface and a distal surface, the proximal and distal surfaces being perpendicular to the longitudinal axis, the load sensing assembly configured to measure a load exerted on the tubular housing, the load sensing assembly comprising a sensor body; and a gimbal disposed between the sensor body surface and at least one of the proximal surface or the distal surface, the gimbal configured to isolate the sensor body from loads exerted on a plane perpendicular to the longitudinal axis.)

1. An adapter assembly, comprising:

a tubular housing having a proximal end portion and a distal end portion and defining a longitudinal axis; and

a load sensing assembly disposed within the tubular housing in contact between a proximal surface and a distal surface, each of the proximal surface and the distal surface being perpendicular to the longitudinal axis, the load sensing assembly configured to measure a load exerted on the tubular housing, the load sensing assembly comprising a sensor body, wherein at least one of the proximal surface or the distal surface comprises a first surface feature and the sensor body comprises a second surface feature engaged with the first surface feature.

2. The adapter assembly of claim 1, wherein the first surface feature is a convex surface feature and the second surface feature is a concave surface feature.

3. The adapter assembly of claim 2, wherein the first surface feature is a ridge having a first curved cross-section.

4. The adapter assembly of claim 3, wherein the second surface feature is a groove having a second curved cross-section.

5. The adapter assembly of claim 4, wherein the first curved cross-section and the second curved cross-section have the same radius.

6. The adapter assembly of claim 5, wherein the sensor body is configured to pivot about a pivot axis that is transverse to a longitudinal axis defined by the sensor body.

7. The adapter assembly of claim 6, wherein the pivot axis is defined by the spine and passes through each center of the first and second curved cross-sections.

8. The adapter assembly of claim 1, wherein the first surface feature is a concave surface feature and the second surface feature is a convex surface feature.

9. The adapter assembly of claim 8, wherein the first surface feature is a groove having a first curved cross-section.

10. The adapter assembly of claim 9, wherein the second surface feature is a ridge having a second curved cross-section.

11. The adapter assembly of claim 10, wherein the first curved cross-section and the second curved cross-section have the same radius.

12. The adapter assembly of claim 11, wherein the sensor body is configured to pivot about a pivot axis that is transverse to a longitudinal axis defined by the sensor body.

13. The adapter assembly of claim 6, wherein the pivot axis is defined by the spine and passes through each center of the first and second curved cross-sections.

Technical Field

The present disclosure relates to surgical devices. More particularly, the present disclosure relates to a handheld electromechanical surgical system for performing surgical procedures having reusable components with load sensing devices.

Background

One type of surgical device is a circular clamping, cutting and stapling device. Such devices may be used in surgical procedures to reattach previously transected rectal sections or similar procedures. Conventional circular clamping, cutting and stapling devices include a pistol or linear grip-type structure having an elongate shaft extending therefrom and a staple cartridge supported on a distal end of the elongate shaft. In this case, the physician may insert the loading unit portion of the circular stapling device into the patient's rectum and maneuver the device up the patient's colon canal toward the transected rectal portion. The loading unit includes a cartridge assembly having a plurality of staples. Along a proximal portion of the transected colon, the anvil assembly may be tucked therein. Alternatively, if desired, the anvil portion may be inserted into the colon through an incision adjacent to the transected colon. The anvil and cartridge assembly are approximated toward one another, and staples are ejected from the cartridge assembly toward the anvil assembly to form the staples in the tissue to achieve an end-to-end anastomosis, and the annular knife is activated to core a portion of the clamped tissue portion. After the end-to-end anastomosis has been achieved, the circular stapling device is removed from the surgical site.

Many surgical device manufacturers have also developed proprietary powered drive systems for operating and/or manipulating end effectors. The powered drive system may include a reusable powered handle assembly and a disposable end effector removably connected to the powered handle assembly.

Many existing end effectors for use with existing powered surgical devices and/or handle assemblies are driven by a linear driving force. For example, end effectors for performing an internal gastrointestinal tract anastomosis procedure, an end-to-end anastomosis procedure, and a transverse anastomosis procedure are actuated by a linear driving force. As such, these end effectors are incompatible with surgical devices and/or handle assemblies that use rotational motion.

In order for a linearly driven end effector to be compatible with a powered surgical device that uses rotational motion to deliver power, an adapter is required to interconnect the linearly driven end effector with the powered rotationally driven surgical device. These adapters are also reusable and therefore need to be able to withstand multiple sterilization cycles. As these adapters become more complex and include various electronic components, it is desirable that the electronic components disposed within the adapters be capable of withstanding multiple autoclave cycles.

Disclosure of Invention

Powered surgical devices may include various sensors for providing feedback during operation thereof. However, one limitation of the electronics and sensors used in the operating room sterile environment is that they need to be designed to withstand multiple cleaning and autoclaving cycles. To gather information on the mechanical force exerted by the powered surgical device, a load sensing device, such as a load sensor, is disposed on one or more mechanical components of the powered surgical device and/or an adapter coupled thereto.

Powered surgical devices that utilize strain gauges enable a user to obtain force sensing feedback, which may provide a number of advantages. Benefits of force monitoring include anvil detection, staple detection, cutting, controlling tissue compression from tissue damage that occurs when maximizing staple formation consistency, making overload adjustments to the stroke to optimize staple formation, tissue thickness identification, and the like. Due to the sensitivity of the load sensing device, any unexpected forces or strains acting on the strain gauge can negatively affect the accuracy of the device.

The present disclosure provides an adapter assembly having a load sensing device and a gimbal arranged under constraints of the load sensing device. The load sensing device is disposed between two parallel opposing surfaces and measures the strain applied thereto as a result of actuation of various actuation assemblies within the adapter assembly. The position of the load sensing device between the two opposing parallel surfaces introduces an off-axis change in the direction of the trocar assembly, which changes the load on the load sensing device, thereby changing the accuracy of the measurement. The placement of the gimbal allows the load sensing device to be loaded with only uniaxial strain, i.e., in the longitudinal direction, without additional moment or off-axis loading, i.e., loading in a plane perpendicular to the longitudinal axis. The gimbal is a double rocking mechanism that allows rotation of the load point on the load sensing device so that changes in the orientation of the trocar assembly do not affect the load condition of the load sensing device.

The load sensing device is also coupled to signal processing and conditioning circuitry that is packaged separately from the load sensing device. These circuits process the change in resistance of the load sensing device and determine the load applied thereto. In particular, the components of the signal processing circuitry are typically disposed on a printed circuit board ("PCB") that houses other electronic and electrical components associated with the powered surgical device. These circuit components are remotely located from the load sensing device due to their size and shape, which prevents the PCB from abutting the load sensing device. Thus, these circuits are connected to the load sensing device by wired connections that include long leads (e.g., flexible printed circuit traces in excess of 10 centimeters) for transmitting analog signals from the load sensing device to the signal processing circuitry. Longer wired connections result in signal loss and also increase the chance of failure due to exposure to sterilization and disinfection cycles. The harsh environment created by the sterilizing solution and the residual moisture from the autoclaving process can damage components and coatings in the flexible circuit, resulting in signal degradation. In addition, in surgical devices that use saline irrigation, the saline further destroys the mechanical integrity of these circuits, resulting in signal attenuation.

In addition, the spacing between the load sensing device and the signal processing circuit also affects the fidelity of the analog sense signal sent from the load sensing device. The analog voltage signal is a low voltage signal and is therefore more susceptible to interference from the load measured by the load sensing device due to moisture ingress in the PCB, solder connections and/or traces, small contaminants including flux and autoclave mineral deposits, and radio frequency interference due to long conductor travel distances. Remotely placing the signal processing circuitry also results in lower bit resolution. Furthermore, conventional signal processing circuits used with load sensing devices do not have the ability to compensate for zero balance fluctuations in the load sensing device due to inconsistencies in the sensor body housing the load sensing device (e.g., during manufacture and assembly of the sensor). As used herein, the term "zero balance" refers to a baseline signal from the load sensing device corresponding to a condition in which the load sensing device is unloaded.

The present disclosure provides a combination load sensing assembly having one or more load sensing devices and signal processing circuitry disposed within a gas-tight housing of the sensor. This eliminates the problem of transmitting analog load sensing signals along long leads and protects the load sensing device and signal processing circuitry from exposure to factors including sterilization cycles (e.g., autoclaving). In addition, the signal processing circuit is programmable to optimize the sensor signal by adjusting gain and offset values of the sensor signal.

Conventional load sensing devices utilizing strain gage technology typically suffer from a lack of adjustability or adjustability of the load sensing device. In particular, variations in the load sensing device, tolerances in the sensor body, placement of the load sensing device, and other factors result in zero balance variations, which results in a variable zero balance value throughout the load sensing device. Unfortunately, in conventional load sensing devices, zero balance cannot be adjusted for each individual load sensing device. The present disclosure provides a signal processing circuit that can be programmed to adjust zero balance after manufacturing and/or assembly of a load cell.

The present disclosure provides a number of embodiments, each of which includes a number of aspects. Various aspects of the embodiments are interchangeable among the disclosed embodiments. According to one embodiment of the present disclosure, an adapter assembly includes: a tubular housing having a proximal end portion and a distal end portion and defining a longitudinal axis. The adapter assembly also includes a load sensing assembly disposed within the tubular housing and in contact between a proximal surface and a distal surface, the proximal and distal surfaces being perpendicular to the longitudinal axis, the load sensing assembly configured to measure a load exerted on the tubular housing, the load sensing assembly including a sensor body. The adapter assembly includes a gimbal disposed between the sensor body surface and at least one of the proximal surface or the distal surface, the gimbal configured to isolate the sensor body from loads applied in a plane perpendicular to the longitudinal axis.

According to another embodiment of the present disclosure, a surgical device includes: a handle assembly including a controller; and an adapter assembly having: a tubular housing having a proximal end portion and a distal end portion and defining a longitudinal axis; a load sensing assembly disposed within the tubular housing and in contact between a proximal surface and a distal surface, the proximal and distal surfaces being perpendicular to the longitudinal axis, the load sensing assembly being configured to measure a load exerted on the tubular housing. The load sensing assembly includes a sensor body; and a gimbal disposed between the sensor body surface and at least one of the proximal surface or the distal surface, the gimbal configured to isolate the sensor body from loads applied in a plane perpendicular to the longitudinal axis; and a surgical end effector configured to be coupled to the distal end portion of the adapter assembly.

According to an aspect of any one of the above embodiments, the load sensing assembly further comprises: a load sensor circuit disposed within the sensor body. The adapter assembly may also include a signal processing circuit disposed within the sensor body and electrically coupled to the load cell circuit.

According to another aspect of any of the above embodiments, the gimbal has a tubular shape with a width, a thickness, and a radius. The proximal surface of the gimbal and the distal surface of the gimbal include a pair of peaks. Each of the proximal and distal surfaces of the gimbal defines a waveform having a wavelength defined by r, where r is a radius of the tubular shape having an amplitude equal to a thickness of the tubular shape. The gimbal further includes a proximal surface and a distal surface, each of the proximal surface of the gimbal and the distal surface of the gimbal having an undulating shape. The sensor body includes a tubular portion, and the gimbal is disposed on the tubular portion.

According to one embodiment of the present disclosure, an adapter assembly includes: a tubular housing having a proximal end portion and a distal end portion and defining a longitudinal axis. The adapter assembly also includes a load sensing assembly disposed within the tubular housing and in contact between the proximal surface and the distal surface. Each of the proximal and distal surfaces is perpendicular to the longitudinal axis. A load sensing assembly configured to measure a load exerted on the tubular housing. The load sensing assembly also includes a sensor body, wherein at least one of the proximal surface or the distal surface includes a first surface feature, and the sensor body includes a second surface feature that engages the first surface feature.

According to one aspect of the above embodiment, the first surface features are convex surface features and the second surface features are concave surface features. The first surface feature may be a ridge having a first curved cross-section. The second surface feature may be a groove having a second curved cross-section. The first curved cross-section and the second curved cross-section have the same radius. The sensor body is configured to pivot about a pivot axis that is transverse to a longitudinal axis defined by the sensor body. The pivot axis is defined by the spine and passes through each center of the first and second curved cross-sections.

According to another aspect of the above embodiment, the first surface features are concave surface features and the second surface features are convex surface features. The first surface feature is a groove having a first curved cross-section. The second surface feature is a ridge having a second curved cross-section. The first curved cross-section and the second curved cross-section have the same radius. The sensor body is configured to pivot about a pivot axis that is transverse to a longitudinal axis defined by the sensor body. The pivot axis is defined by the spine and passes through each center of the first and second curved cross-sections.

Drawings

Embodiments of the present disclosure are described herein with reference to the accompanying drawings, wherein:

fig. 1 is a perspective view of a handheld surgical device, an adapter assembly, an end effector with a reload, and an anvil assembly according to an embodiment of the present disclosure;

FIG. 2 is a perspective view illustrating the connection of the adapter assembly and the handle assembly of FIG. 1 according to an embodiment of the present disclosure;

FIG. 3 is a perspective view of the internal components of the handle assembly according to an embodiment of the present disclosure;

FIG. 4 is a perspective view of the adapter assembly of FIG. 1 without a refill according to an embodiment of the present disclosure;

FIG. 5 is a side cross-sectional view of the refill of FIG. 1 according to an embodiment of the present disclosure;

FIG. 6A is a perspective view of a distal portion of an adapter assembly according to an embodiment of the present disclosure;

FIG. 6B is a cross-sectional view of a distal portion of an adapter assembly according to an embodiment of the present disclosure;

FIG. 7 is a perspective view of an electrical assembly of the adapter assembly of FIG. 1, in accordance with an embodiment of the present disclosure;

fig. 8 is a perspective view of a distal portion of the electrical assembly of fig. 7, in accordance with an embodiment of the present disclosure;

FIG. 9 is a perspective top view of a load sensing assembly of the electrical assembly of FIG. 7, in accordance with an embodiment of the present disclosure;

FIG. 10 is a bottom perspective view of the load sensing assembly of FIG. 9;

FIG. 11 is a cross-sectional side view of the load sensing assembly of FIG. 9;

FIG. 12 is a perspective top view of the load sensing assembly of FIG. 8 without the cover;

FIG. 13 is a perspective top view of the load sensing assembly of FIG. 8 without the load sensor circuitry and the signal processing circuitry;

FIG. 14 is a perspective top view of a cover of the load sensing assembly of FIG. 9, in accordance with an embodiment of the present disclosure;

FIG. 15 is a bottom perspective view of the cover of FIG. 14;

FIG. 16 is a side view of a gimbal disposed over a portion of the load sensing assembly of FIG. 8 according to the present disclosure.

FIG. 17 is a top view of a load sensing assembly and support block according to an embodiment of the present disclosure;

FIG. 18 is a perspective view of the load sensing assembly and support block of FIG. 17;

FIG. 19 is a top view of a load sensing assembly and support block according to an embodiment of the present disclosure;

FIG. 20 is a perspective view of the load sensing assembly and support block of FIG. 19;

FIG. 21 is a top view of a load sensing assembly and support block according to an embodiment of the present disclosure;

FIG. 22 is a perspective view of the load sensing assembly and support block of FIG. 21;

FIG. 23 is a perspective view of a load sensing assembly, compliant gimbal and support block according to an embodiment of the present disclosure;

FIG. 24 is a cross-sectional view of a pin connector of the load sensing assembly of FIG. 9, in accordance with an embodiment of the present disclosure; and

FIG. 25 is a top schematic view of a load sensor circuit and signal processing circuit according to an embodiment of the present disclosure; and

fig. 26 is an electrical schematic diagram of the signal processing circuit of fig. 25, according to an embodiment of the present disclosure.

Detailed Description

Embodiments of the present disclosure will now be described in detail with reference to the drawings, wherein like reference numerals designate identical or corresponding elements in each of the several views. The embodiments may be combined in any manner consistent with the functionality of the devices and/or methods disclosed herein. As used herein, the term "clinician" refers to a doctor, nurse, or any other medical professional and may include support personnel. Throughout this specification, the term "proximal" will refer to the portion of the device or component thereof that is closer to the clinician, and the term "distal" will refer to the portion of the device or component thereof that is further from the clinician. The term "substantially equal" means that the two values are ± 5% of each other. Furthermore, in the drawings and in the following description, terms such as front, rear, upper, lower, top, bottom, and the like are used simply for convenience of description and are not intended to limit the present disclosure. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail.

The present disclosure relates to powered surgical devices having electronic sensors for monitoring mechanical strains and forces exerted on components of the powered surgical devices. More particularly, the present disclosure relates to a load measuring sensor including a load sensing device and analog and digital circuits that are hermetically sealed such that the load sensor is configured to withstand harsh environments. In the event that the electrical connections of the powered surgical device are damaged during use, the measurement signal output by the sensor of the present disclosure remains unchanged. Furthermore, the sensor is programmable to allow adjustment of gain and offset values in order to optimize the measurement signal.

Referring to fig. 1, powered surgical device 10 includes a handle assembly 20, the handle assembly 20 being configured for selective connection with an adapter assembly 30, the adapter assembly 30 in turn being configured for selective connection with an end effector such as a ring shaped reload 40. Although commonly referred to as powered surgical devices, it is contemplated that the surgical device 10 may be manually actuated and may include various configurations.

The handle assembly 20 includes a handle housing 22 having a lower housing portion 24, an intermediate housing portion 26 extending from the lower housing portion 24 and/or supported on a portion of the lower housing portion 24, and an upper housing portion 28 extending from the intermediate housing portion 26 and/or supported on a portion of the intermediate housing portion 26. As shown in fig. 2, the distal portion of the upper housing portion 28 defines a nose or connecting portion 28a configured to receive a proximal end portion 30b of the adaptor assembly 30.

Referring to fig. 3, the handle assembly 20 includes one or more motors 36 coupled to a battery 37. The handle assembly 20 also includes a main controller 38 for operating the motor 36 and other electronic components of the handle assembly 20, the adapter assembly 30, and a reload 40. The motor 36 is coupled to a corresponding drive shaft 39 (fig. 2) configured to engage the socket 33 on the proximal end portion 30b such that rotation of the drive shaft 39 is imparted on the socket 33. Actuation assemblies 52 (fig. 6B) are coupled to respective sockets 33. Actuation assembly 52 is configured to convert the rotational motion of socket 33 into linear motion and actuate reload 40 (fig. 1) along with anvil assembly 58.

Referring to fig. 4, the adaptor assembly 30 includes a tubular housing 30a extending between a proximal end portion 30b configured for operable connection to the connecting portion 28a of the handle assembly 20 and an opposite distal end portion 30c configured for operable connection to the refill 40. In this manner, the adaptor assembly 30 is configured to convert the rotational motion provided by the handle assembly 20 into axial translation, which can be used to advance/retract a trocar member 50 (fig. 5) slidably disposed within the distal end portion 30c of the adaptor assembly 30 to fire the staples of the reload 40.

Referring to fig. 2, the connection portion 28a includes an electrical receptacle 29 having a plurality of electrical contacts 31 in electrical communication with the electronic components (e.g., the main controller 38) and the electrical components (e.g., the battery 37) of the handle assembly 20. The adapter assembly 30 includes corresponding electrical connectors 32 configured to engage the electrical receptacles 29. The electrical connector 32 also includes a plurality of electrical contacts 34 that engage and are electrically connected to their corresponding electrical contacts 31.

Referring to fig. 4, the trocar member 50 is slidably disposed within the tubular housing 30a of the adapter assembly 30 and extends through the distal end portion 30c thereof. In this manner, trocar member 50 is configured for axial translation, which in turn causes corresponding axial translation of anvil assembly 58 (fig. 1) of reload 40 to fire staples (not shown) disposed therein. The trocar member 50 includes a proximal end that is coupled to the tubular housing 30a of the adapter assembly 30. The distal end portion of trocar member 50 is configured to selectively engage anvil assembly 58 (fig. 4) of reload 40. In this manner, when anvil assembly 58 is connected to trocar member 50, as will be described in detail below, axial translation of trocar member 50 in a first direction results in opening of anvil assembly 58 relative to reload 40, and axial translation of trocar member 50 in a second, opposite direction results in closing of anvil assembly 58 relative to reload 40.

As shown in fig. 1 and 5, the reload 40 is configured for operable connection to the adapter assembly 30 and is configured to fire and form an annular array of surgical staples and sever a ring of tissue. The reload 40 comprises a housing 42 having a proximal end portion 42a and a distal end portion 42b and a cartridge 44 fixedly secured to the distal end portion 42b of the housing 42. The proximal end portion 42a of the housing 42 is configured for selective connection to the distal end portion 30c of the adapter assembly 30 and includes means for ensuring radial alignment of the refill 40 relative to the adapter assembly 30.

Referring to fig. 5, the housing 42 of the refill 40 includes an outer cylindrical portion 42c and an inner cylindrical portion 42 d. The outer cylindrical portion 42c and the inner cylindrical portion 42d of the reload 40 are coaxial and define a groove 46. The groove 46 of the reload 40 includes a plurality of longitudinally extending ridges or splines 48 projecting from an inner surface thereof that is configured to radially align the anvil assembly 58 relative to the reload 40 during the stapling procedure.

Referring now to fig. 6A-8, the adapter assembly 30 includes an electrical assembly 60 disposed within the adapter assembly and configured for electrical connection with the handle assembly 20 and the reload 40 and between the handle assembly 20 and the reload 40. The electrical assembly 60 provides communication (e.g., identification data, life cycle data, system data, load sensing signals) with the main controller 38 of the handle assembly 20 through the electrical receptacle 29.

The electrical assembly 60 includes an electrical connector 32, a proximal harness assembly 62 having a ribbon cable, a distal harness assembly 64 having a ribbon cable, a load sensing assembly 66, and a distal electrical connector 67. The electrical assembly 60 also includes a distal electrical connector 67 configured to selectively mechanically and electrically connect to a chip assembly (not shown) of the refill 40.

The electrical connector 32 of the electrical assembly 60 is supported within the proximal end portion 30b of the adapter assembly 30. The electrical connector 32 includes electrical contacts 34 that enable electrical connection to the handle assembly 20. The proximal wire harness assembly 62 is electrically connected to the electrical connector 32 disposed on the printed circuit board 35.

The load sensing assembly 66 is electrically connected to the electrical connector 32 via the proximal and distal harness assemblies 62, 64. The load sensing assembly is also electrically connected to the distal harness assembly 64 via a sensor flex cable. As shown in fig. 6A and 6B, the actuation assembly 52 coupled to the trocar member 50 extends through the load sensing assembly 66. Load sensing assembly 66 provides strain measurements applied to adapter assembly 30 during movement of trocar member 50 when coupled to anvil assembly 58 during clamping, stapling, cutting and other mechanical actuations.

For a detailed description of an exemplary powered Surgical stapler including an adapter assembly and a reload, reference may be made to U.S. patent application publication No. 2016/0310134 entitled "hand-held electro-mechanical Surgical System" filed 2016, 4, 12, by Contini et al, which is incorporated by reference above.

Referring to fig. 9-13, the load sensing assembly 66 includes a sensor body 68 having a platform 70 and a tubular portion 72 extending a distance "d" from the platform 70. The sensor body 68 also defines a lumen 73 and a tubular portion 72 through the platform 70, thereby dividing the platform 70 into a first portion 74 and a second portion 76. The lumen 73 allows the actuation assembly 52 to pass therethrough. The sensor body 68 may be formed from any suitable material, such as stainless steel, that allows the sensor body 68 to elastically deform when stressed. In an embodiment, the sensor body 68 may be made of stainless steel, such as 17-4 stainless steel heat treated to H-900 standard.

The tubular portion 72 may have any suitable shape, such as cylindrical, faceted, or a combination thereof, as shown in FIG. 10. More specifically, the tubular portion 72 includes a plurality of sidewalls 72a interconnected by radiused corners 72 b. The tubular portion 72 also includes a bottom contact surface 72 c. The platform 70 also includes a top (e.g., distal) surface 78 and a bottom (e.g., proximal) surface 80 (fig. 10) and a first slot 82 defined within the first portion 74 of the platform 70 and a second slot 84 defined through the second portion 76 of the platform 70. Slots 82 and 84 work in conjunction with the design of sensor body 68 to provide uniform bending when loaded. The uniform load and resulting strain output results in the load sensor circuit 86 (fig. 11 and 12) of the load sensing assembly 66 to provide a linear strain output at the first portion 74 of the platform 70, which is measured by the load sensor circuit 86, which is secured to the first portion 74 and covered by the cover 88, as shown in fig. 11.

Referring to fig. 6A and 6B, a load sensing assembly 66 is disposed between the support block 54 and the connector sleeve 56. In particular, the tubular portion 72 of the sensor body 68 on the bottom contact surface 72c rests on the support block 54, and the top surface 78 of the platform 70 abuts the proximal end of the connector sleeve 56. During operation (i.e., clamping, stapling, and cutting) of the surgical device 10, the sensor body 68 elastically deforms (similar to a support beam) in proportion to the forces applied to the support block 54 and the connector sleeve 56. In particular, the deflection of the sensor body 68 applies a force to the load cell circuit 86 (fig. 11 and 12) which deforms, causing its resistance to increase, which is reflected in its measurement signal. Changes in the baseline of the measurement signal are indicative of forces exerted on the support block 54 and the connector sleeve 56, which generally describe the forces encountered during clamping, stapling, and cutting.

Referring to fig. 16, the adapter assembly 30 further includes a gimbal 81 disposed above the tubular portion 72. The gimbal 81 may be formed of any high tensile strength material, such as stainless steel and other metals. Gimbal 81 has a tubular shape with a width "d", a thickness "t", and a radius "r". The width "d" is substantially equal to the distance "d". Gimbal 81 includes a top (e.g., distal) surface 83a and a bottom (e.g., proximal) surface 83 b. Each of the top surface 83a and the bottom surface 83b has a wave-like shape having one or more waves 85a and 85b, respectively. The waveforms 85a and 85b may have a wavelength based on the radius "r" of the gimbal 81, i.e., "π r", and an amplitude substantially equal to the thickness "t" of the gimbal 81. Each of the waveforms 85a and 85b includes a plurality of peaks 87a and 87b, respectively.

A gimbal 81 is disposed between the bottom surface 80 of the platform 70 and the support block 54. More specifically, a top surface 83a of the gimbal 81 is in contact with the bottom surface 80 of the platform 70, and a bottom surface 83b of the gimbal 81 is in contact with the distal surface of the support block 54. Since each of the top surface 83a and the bottom surface 83b includes the peaks 87a and 87b, respectively, the peaks 87a and 87b are in contact with their respective surfaces, i.e., the bottom surface 80 and the support block 54.

When the load sensing assembly 66 is compressed between the support block 54 and the connector sleeve 56, the support block 54 exerts a pressure on the gimbal 81. In addition to longitudinal compression, the gimbal 81 eliminates lateral movement of the support block 54. This is because of the double-rocking configuration of the gimbal 81 due to the top surface 83a and the bottom surface 83b having the undulating shape. In particular, the gimbal 81 rotates about the contact points, i.e., peaks 87a and 87b, between the top surface 83a and the bottom surface 83b and the bottom surface 80 of the sensor body 68 and the support block 54. Two peaks 87a and 87b are included on each of the top surface 83a and the bottom surface 83b, which isolate the sensor body 68 by preventing off-axis loading, i.e., stress applied in a plane perpendicular to the longitudinal axis X-X defined by the sensor body 68, which is measured by the load sensor circuit 86. This allows the load cell circuit 86 to measure only the stress applied in the longitudinal direction, which provides an accurate measurement.

In an embodiment, the gimbal 81 may be disposed distal to the sensor body 68. More specifically, the gimbal 81 may be disposed between the connector sleeve 56 and the top surface 78 of the sensor body 68. Thus, the tubular portion 72 may be disposed on the top surface 78 rather than the bottom surface 80. In the distal configuration, the gimbal 81 may be disposed about the tubular portion 72 and function in the same manner as the proximal configuration described above.

In further embodiments, the sensor body 68 may be disposed between two gimbals 81, i.e., between the support block 54 and/or the connector sleeve 56. In further embodiments, the tubular portion 72 may be any suitable securing structure, such as a post, recess, or the like, that will allow the gimbal 81 to be secured to the sensor body 68.

In further embodiments, the gimbal 81 may have flat top and bottom surfaces 83a and 83b, and the surfaces in contact with the gimbal, such as the bottom surface 80 of the platform 70 and the distal surface of the support block 54, may have an undulating shape with one or more undulations 85a and 85b, as described above.

Referring to fig. 17 and 18, the adapter assembly 30 may include a support block 154 and a sensor body 168. Support block 154 and sensor body 168 may be used in place of support block 54 and sensor body 68 and gimbal 81 to isolate sensor assembly 66. The support block 154 includes a convex surface feature, namely a ridge 156 having a curved cross-section. Sensor body 168 includes a corresponding concave surface feature, namely a curved groove 170. A curved groove 170 is formed on the proximal surface of the tubular portion 72. The curved recess 170 and the ridge 156 are arranged along a pivot axis Y-Y transverse to the longitudinal axis X-X. Curved groove 170 and ridge 156 have substantially the same radius r2 such that ridge 156 fits within curved groove 170, thereby allowing sensor body 168 to pivot about pivot axis Y-Y relative to support block 154. The pivot axis Y-Y passes through the center of the arc defining the spine 156 and curved groove 170. The pivotal configuration of the ridge 156 and curved groove 170 isolates the sensor body 168 by preventing off-axis loads, i.e., stresses applied in a plane perpendicular to the longitudinal axis X-X lying on axis Y-Y, from being measured by the load sensor circuit 86. This allows the load cell circuit 86 to measure only the applied stress in the longitudinal direction, which provides an accurate measurement of the strain applied on the adapter assembly 30.

Referring to fig. 19 and 20, the adapter assembly 30 may include a support block 254 and a sensor body 268. The support block 254 and sensor body 268 may be used in place of the support block 54 and sensor body 68 and gimbal 81 to isolate the sensor assembly 66. The embodiment of fig. 19 and 20 is similar to the embodiment of fig. 17 and 18, with the concave and convex surfaces reversed in position. In particular, the support block 254 includes a concave surface feature, namely a curved groove 270 having a curved cross-section. The sensor body 268 includes a corresponding convex surface feature, namely the ridge 256. The ridges 256 and curved grooves 270 are disposed along a pivot axis Y-Y that is transverse to the longitudinal axis X-X. The ridge 256 and curved groove 270 have substantially the same radius r2 such that the curved groove 270 fits within the ridge 256, allowing the sensor body 268 to pivot about the pivot axis Y-Y relative to the support block 254. The pivoting configuration of the curved groove 270 and the spine 256 isolates the sensor body 268 by preventing off-axis loads, i.e., stresses applied in a plane perpendicular to the longitudinal axis X-X lying on axis Y-Y, from being measured by the load sensor circuit 86. This allows the load cell circuit 86 to measure only the applied stress in the longitudinal direction, which provides an accurate measurement of the strain applied on the adapter assembly 30.

Referring to fig. 21 and 22, the adapter assembly 30 may include a backing block 354 and a sensor body 368. A backing block 354 and sensor body 368 may be used in place of backing block 54 and sensor body 68 and gimbal 81 to isolate sensor assembly 66. The embodiment of fig. 21 and 22 is similar to the embodiment of fig. 19 and 20. In particular, the support block 354 also includes a concave surface feature, namely a curved groove 370 having a curved cross-section. In addition, a gimbal 181 is disposed between the supporting block 354 and the sensor body 368. The gimbal 181 includes a corresponding convex surface feature, namely a ridge 356 disposed on the first contact surface 181 a. The ridge 356 and the curved groove 370 are disposed along a pivot axis Y-Y that is transverse to the longitudinal axis X-X. The ridge protrusion 356 and the curved groove 370 have substantially the same radius r2 such that the curved groove 370 fits within the ridge protrusion 356, allowing the gimbal 181 to pivot about the pivot axis Y-Y relative to the support block 354.

In addition, gimbal 181 includes one or more concave surface features, namely curved groove 183 having a curved cross-section. The curved groove 183 is provided on the second contact surface 181b opposite to the first contact surface 181 a. The sensor body 368 includes a corresponding convex surface feature, namely a ridge 456. Ridge 456 and curved groove 183 are disposed along a pivot axis Z-Z that is transverse to longitudinal axis X-X and pivot axis Y-Y. Ridge 456 and curved groove 183 have substantially the same radius r3 such that curved groove 183 fits within ridge 456, thereby allowing gimbal 181 to pivot relative to sensor body 368 about pivot axis Z-Z. The dual pivot configuration of the gimbal 181 relative to the backing block 354 and sensor body 368 provides isolation of the sensor body 268 by preventing off-axis loads, i.e., stresses applied in a plane perpendicular to the longitudinal axis X-X in the Y-Y and Z-Z axes, which stresses are measured by the load sensor circuit 86. This allows the load cell circuit 86 to measure only the applied stress in the longitudinal direction, which provides an accurate measurement of the strain applied on the adapter assembly 30.

Referring to FIG. 23, another embodiment of gimbal 281 is shown. Referring to fig. 23, the adapter assembly 30 further includes a gimbal 281 disposed above the tubular portion 72. Gimbal 281 may be formed of any resilient, conformable material, such as silicone rubber. Suitable silicone rubbers include Room Temperature Vulcanizing (RTV) silicone rubbers; high Temperature Vulcanized (HTV) silicone rubber and Low Temperature Vulcanized (LTV) silicone rubber. These rubbers are known and readily commercially available, for example, all from Dow Corning

735 Black RTV and732 RTV; and 106RTV silicone rubber and 90RTV silicone rubber both from general electric. Other suitable silicone materials include silanes, siloxanes (e.g., polydimethylsiloxanes), such as fluorosilicones, dimethylsiloxanes, liquid silicone rubbers, such as vinyl-crosslinked heat-curable rubbers or silanol room temperature-crosslinked materials, and the like. Gimbal 81 includes a top (e.g., distal) surface 283a and a bottom (e.g., proximal) surface 283 b.

A gimbal 281 is provided between the sensor body 68 and the support block 54. More specifically, a top surface 283a of the gimbal 281 is in contact with the tubular portion 72 of the sensor body 68, and a bottom surface 283b of the gimbal 281 is in contact with the distal surface of the support block 54. When the load sensing assembly 66 is compressed between the support block 54 and the connector sleeve 56, the support block 54 exerts a pressure on the gimbal 281. In addition to the longitudinal compression, the lateral movement of the support block 54 is counteracted due to the compression of the gimbal 281.

With respect to the embodiment of fig. 17-23, the orientation of the sensor body 68, gimbals 181 and 281, concave and convex surface features may be reversed, and may be disposed distal to the sensor body 68 such that the interface is disposed distal to the sensor body 68. More specifically, the concave or convex features described above may be formed on the top surface 78 of the connector sleeve 56 and the sensor body 68 rather than on the tubular portion 72.

Referring to fig. 11, 12 and 25, the load cell circuit 86 is coupled to a signal processing circuit 90 that includes a flexible circuit board 92 having a contact portion 94 and a signal processing circuit portion 96. The contact portion 94 is interconnected with the signal processing circuit portion 96 via a flexible strip 98 and includes a plurality of first through contacts 100. The signal processing circuit 90 includes analog and digital circuit components (e.g., controller 130) configured to perform signal processing on the signals from the load cell circuit 86 and output measurement signals to the handle assembly 20.

The flexible circuit board 92 may be any suitable dielectric multilayer flexible material, such as those available from DuPont, Wilmington, Del

Materials, liquid crystal polymer materials, and the like. In embodiments, the flexible circuit board 92 may include additional dielectric layers that stiffen the flexible circuit board 92 so that the solder connections of the components positioned along the flexible circuit board 92 are not subject to undesirable movement due to thermal expansion and/or mechanical movement of the load sensing assembly 66. In an embodiment, the flexible circuit board 92 may be manufactured in a flat state (fig. 25) and formed during soldering to the sensor body 68 (fig. 11). In other embodiments, the flexible circuit board 92 may be pre-bent using a fixture with or without heat to form the desired shape shown in FIG. 11.

The contact portion 94 is configured to be coupled to a load sensor circuit 86 that includes one or more load sensing devices 102 interconnected by a plurality of traces or other conductors. In embodiments, the load sensing device 102 may be a strain gauge, a pressure sensor (e.g., a pressure sensing membrane), or any other suitable transducer device configured to measure a mechanical force and/or strain and output an electrical signal in response thereto. Signal output is achieved when the load sensing circuitry 86 is bonded to the sensor body 68 such that the load sensing device 102 is located in various regions of linear strain output when the load sensing assembly 66 is elastically deformed.

The load sensor circuit 86 may be a single circuit board, such as a flexible circuit board, with the load sensing device 102 disposed thereon and electrically interconnected via internal traces. The load sensing device 102 is also electrically coupled to the plurality of second through contacts 101 via traces. In an embodiment, the load sensing device 102 may be attached to the first portion 74 of the platform 70 separately rather than through the load sensor circuit 86 and then wired together to provide an electrical coupling.

The plurality of load sensing devices 102 may be arranged in various configurations on the load sensor circuit 86 to implement a temperature compensation or other resistor network, such as a wheatstone bridge, wherein two load sensing devices 102 are arranged to move in response to tension in the load sensing assembly 66 and two load sensing devices 102 are arranged to move in response to compression in the load sensing assembly 66. As shown in fig. 25, the configuration of four load sensing devices 102 can provide maximum signal output and temperature compensation and is referred to as a full bridge circuit.

Referring to fig. 13, the first portion 74 also includes a recess 104 having a measuring surface 106 for connecting the load cell circuit 86 and the contact portion 94 of the signal processing circuit 90. In an embodiment, the load sensor circuit 86 may be coupled to the measurement surface 106 such that the signal processing circuit 90 outputs a measurement signal in response to the sensor body 68. Pocket 104 also includes a slot 108 having a plurality of pins 110 therethrough.

As shown in fig. 11, the slot 108 passes through the pocket 104 to the bottom surface 80. The pin 110 is electrically connected to the signal processing circuit 90 through a plurality of second through contacts 101 (fig. 25). In particular, when the load sensor circuit 86 is coupled to the pocket 104, the second through contact 101 is inserted over the pin 110. Thereafter, first pass-through contact 100 of contact portion 94 is also inserted onto pin 110. The first and second through contacts 100 and 101 are aligned such that after the pin 110 is soldered thereto, the signal processing circuit 90 and the load cell circuit 86 are electrically coupled to the pin 110 and to each other. In an embodiment, there may be four pins 110, with two of the pins 110 acting as communication lines, the remaining two pins 110 providing power for energizing the load sensor circuit 86 and the signal processing circuit 90. After soldering, the flexible circuit board 92 may be arranged to fit within the cover 88.

In an embodiment, the flexible circuit board 92 may be folded and/or bent as shown in fig. 11 and 12. In further embodiments, the support structure 112 may be disposed within the pocket 104. The support structure 112 includes one or more surfaces 114 to which the flexible circuit board 92 is attached. The support structure 112 may have any suitable shape such that the flexible circuit board 92 conforms to the shape of the support structure 112. The flexible circuit board 92 may be secured to the support structure 112 in any suitable manner, e.g., adhesive, fasteners, etc.

In further embodiments, a wrap 116 may be provided on the flexible circuit board 92 to insulate the electronic components of the signal processing circuit portion 96 and prevent a short circuit if the flexible circuit board 92 contacts the inner surface of the cover 88. The wrap 116 may be a polyimide tape or an ionomer resin tape, such as from dupont, wilmington, terawal, respectivelyAnd

shrink wrap, polyisoprene film, low hardness potting compounds, parylene coatings, and other dielectric materials and applications suitable for insulating electronic circuits.

Referring to fig. 10-13, pin 110 is secured within head 118, and head 118 hermetically seals pocket 104 at bottom surface 80. As shown in fig. 24, each pin 110 is encapsulated in a glass sleeve 120, and then each glass sleeve is embedded in a peripheral housing 122. This configuration seals the interior from the exterior of the lid 88 and pocket 104 once the head 118 is joined to the slot 108 at the bottom surface 80 of the platform. The head 118 may be bonded (e.g., welded) to the bottom surface 80.

A hermetic seal may be formed by passing the pins 110 through their respective glass sleeves 120, after which the pins 110 and their glass sleeves 120 are inserted into corresponding holes of the peripheral housing 122 of the head 118. The entire assembly of pin 110, glass sleeve 120 and peripheral housing 122 is heated. Upon heating, the bore of the peripheral housing 122, which may be formed of any suitable metal (e.g., stainless steel), expands and the glass sleeve 120 fills the void. Pins 110 formed of metal expand minimally and, upon cooling, glass sleeves 120 provide a compression seal around their respective pin 110 and bore of peripheral housing 122. As shown in fig. 8, pin 110 is coupled to flex cable 65, which in turn is coupled to distal harness assembly 64.

Referring to fig. 13, the pocket 104 also includes a step 124 along the entire perimeter of the pocket 104. The step 124 is sized and shaped to correspond to a flange 126 of the cover 88, as shown in fig. 14 and 15, to allow for the formation of an airtight seal. In addition, flange 126 is configured to fit within step 124 and is coplanar with step 124. This allows the flange 126 to rest on the flat surface portion of the step 124.

The cover 88 may be formed of a similar material as the sensor body 68. The cover 88 may be secured to the sensor body 68 in any suitable manner to ensure that the signal processing circuitry 90 is hermetically sealed within the cover 88. In an embodiment, the cover 88 and the sensor body 68 may be formed of a metal, such as stainless steel, and the cover 88 may be welded (e.g., by a laser) to the platform 70 around their respective peripheries. The cover 88 may be manufactured using a deep drawing process, which provides for economical manufacture. In embodiments, the sensor body 68 and the cover 88 may be manufactured using any suitable method, such as machining, metal injection molding, 3-D printing, and the like.

With continued reference to fig. 14 and 15, the lid 88 includes a top wall 89, a pair of opposing side walls 91a and 91b connected by a pair of opposing walls 93a and 93 b. Walls 93a and 93b may have an arcuate shape to accommodate signal processing circuit 90. In embodiments, the walls 89, 91a, 91b, 93a, 93b may have any suitable shape for enclosing the signal processing circuitry 90. More specifically, walls 89, 91a, 91b, 93a, 93b define an interior cavity 95 that fits over signal processing circuit 90. The internal cavity 95 may also encapsulate the signal processing circuit 90 in a thermal management material. In an embodiment, the internal cavity 95 may be filled with a thermal management material, for example, by using a predetermined metered syringe. The signal processing circuit 90 attached to the sensor body 68 is then inserted into the filled interior cavity 95, after which the cover 88 is secured to the sensor body 68 as described above. After securing the cover 88, the thermal management material may flow within the cavity 95 and the pocket 104 in fluid communication with the cavity 95.

Referring to fig. 25 and 26, the signal processing circuit 90 includes a controller 130 having a memory device 132, which may be an electrically erasable programmable read only memory ("EEPROM") or any other suitable non-volatile memory device. The controller 130 may be any suitable microcontroller or any other processor, such as those available from ARM, Inc. of Cambridge, UKA microcontroller. The controller 130 may include analog-to-digital converters, digital-to-analog converters, timers, clocks, watchdog timers and other functional components that enable the controller 130 to process analog measurement signals from the load sensing apparatus 102. In particular, the controller 130 is configured to amplify the signal from the load sensing device 102 of the load sensor circuit 86, filter the analog signal, and convert the analog signal to a digital signal. The controller 130 is also configured to transmit digital signals to the main controller 38 of the handle assembly 20, which controls the operation of the surgical device 10 based on the digital signals indicative of the sensed mechanical load.

The controller 130 is programmable to allow adjustment of gain and offset parameters for processing the analog signal. In particular, the controller 130 stores the zero balance values and corresponding gain and offset parameters in the memory device 132. After the load sensing assembly 66 is assembled, the load sensor circuit 86 is calibrated. In an embodiment, the load cell circuit 86 may be periodically recalibrated to ensure accurate measurements. The calibration may be performed at zero balance, i.e., when the load cell circuit 86 is unloaded. If the load sensor circuit 86 is outputting any signal even in the unloaded state, or conversely, does not output enough signal in response to the loaded state, the controller 130 is programmed to compensate for this difference. This is accomplished by adjusting the gain and offset parameters of the controller 130, which allows the controller 130 to adjust the analog signal to correspond to a zero-balance condition. The controller 130 may be programmed by the main controller 38, as described above, the main controller 38 being coupled to the controller 130 by the pins 110.

It should be understood that various modifications can be made to the embodiments of the presently disclosed adapter assembly. Accordingly, the foregoing description is not to be construed in a limiting sense, but is made merely as illustrative of the present embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the disclosure.