Surgical instruments and devices and methods facilitating the manufacture of the same

An assembly tool for facilitating assembly of a surgical instrument includes a handle, a neck extending from the handle, and a portion of or an entire pivot pin engaged with the neck via a frangible connection. The pivot pin is engagable with the surgical instrument. The frangible connection is configured to break upon application of stress thereto above a threshold, thereby separating the pivot pin (or portion thereof) from the neck. A method of assembling using such an assembly tool includes positioning a component of a surgical instrument for receipt of a pivot pin, manipulating the assembly tool to operably engage the pivot pin with the component, and manipulating the assembly tool to apply stress to the frangible connection to break-off the pivot pin (or portion thereof) from the assembly tool along the frangible connection.

BACKGROUND

Technical Field

The present disclosure relates to surgical instruments and, more particularly, to surgical forceps configured for treating tissue, and devices and methods facilitating the manufacture of the same.

Background of Related Art

A surgical forceps is a plier-like device which relies on mechanical action between its jaws to grasp, clamp, and constrict tissue. Energy-based surgical forceps utilize both mechanical clamping action and energy to treat, e.g., coagulate, cauterize, and/or seal, tissue.

Generally, surgical instruments, including surgical forceps, can be classified as disposable instruments, e.g., instruments that are discarded after a single use, or reusable instruments, e.g., instruments capable of being sterilized for repeated use. As can be appreciated, those instruments that are configured for single-use must be cost-efficient while still being capable of effectively performing their intended functions.

SUMMARY

As used herein, the term “distal” refers to the portion that is being described which is further from a user, while the term “proximal” refers to the portion that is being described which is closer to a user. Further, to the extent consistent, any of the aspects described herein may be used in conjunction with any or all of the other aspects described herein.

An assembly tool provided in accordance with the present disclosure and configured for facilitating assembly of a surgical instrument includes a handle, a neck extending distally from the handle and defining a longitudinal axis, and a portion of or an entire first pivot pin engaged with the neck via a frangible connection and extending distally from the neck along the longitudinal axis. The first pivot pin is engagable with the surgical instrument as part of the assembly thereof. The frangible connection is configured to break upon application of stress thereto above a threshold, thereby separating the first pivot pin (or portion thereof) from the neck.

In an aspect of the present disclosure, the entire first pivot pin is engaged with the neck.

In another aspect of the present disclosure, a plurality of second pivot pins are aligned in end-to-end relation along the longitudinal axis and engaged with one another via frangible connections. One of the plurality of second pivot pins is engaged with the first pivot pin via a frangible connection. Each of the frangible connections is configured to break upon application of stress thereto above a threshold, thereby separating the corresponding pivot pin from the neck.

In yet another aspect of the present disclosure, the frangible connections define increasing thresholds in a distal-to-proximal direction such that a distal-most pivot pin is broken off prior to breaking of any of the other frangible connections.

In aspects of the present disclosure, the first pivot pin and each of the plurality of second pivot pins may be similar to one another, or may be include at least two different configurations.

In still another aspect of the present disclosure, a first component of the first pivot pin is engaged with the neck. The first component is configured to engage a second component to form the first pivot pin. The first and second components may be configured to engage one another via threaded engagement, friction-fitting, or in any other suitable fashion.

In still yet another aspect of the present disclosure, the threshold is configured to facilitate breaking-off of the first component from the neck after the first and second components are engaged with one another.

In an aspect of the present disclosure, the neck of the assembly tool is releasably engagable with the handle of the assembly tool.

A method of assembling a surgical instrument, or portion thereof, provided in accordance with aspects of the present disclosure includes positioning one or more components of a surgical instrument for receipt of a pivot pin, manipulating an assembly tool having the pivot pin (or a portion thereof) engaged thereon such that the pivot pin (or portion thereof) operably engages the one or more components of the surgical instrument, and manipulating the assembly tool to apply stress to a frangible connection between the assembly tool and the pivot pin (or portion thereof). The applied stress is above a threshold such that the pivot pin (or portion thereof) breaks off from the assembly tool along the frangible connection, thereby separating the pivot pin (or portion thereof) from the assembly tool.

In an aspect of the present disclosure, the entire pivot pin initially engages with the assembly tool. In such aspects, the entire pivot pin breaks off from the assembly tool along the frangible connection.

In another aspect of the present disclosure, a first part of the pivot pin engages the assembly tool. In such aspects, the method may include operably engaging a second part of the pivot pin with the one or more components of the surgical instrument, and engaging the first and second parts of the pivot pin with one another. The first and second parts of the pivot pin may be engaged with one another via threaded engagement, friction-fitting, or in any other suitable fashion.

In yet another aspect of the present disclosure, manipulation of the assembly tool applies stress to the frangible connection to break off the first part from the assembly tool along the frangible connection after the first and second parts of the pivot pin are engaged with one another.

In still another aspect of the present disclosure, manipulating the assembly tool to operably engage the pivot pin (or portion thereof) with the one or more components includes manipulating the assembly tool in at least two different directions.

In still yet another aspect of the present disclosure, positioning the one or more components of the surgical instrument for receipt of the pivot pin includes aligning apertures defined through first and second jaw members. Further, in such aspects, manipulating the assembly tool enables insertion of the pivot pin (or portion thereof) through the aligned apertures to thereby pivotably couple the first and second jaw members to one another.

A method of assembling one or more surgical instruments, in accordance with aspects of the present disclosure, includes positioning one or more first components of a first surgical instrument for receipt of a first pivot pin, manipulating an assembly tool having a plurality of pivot pins engaged thereon such that the first pivot pin of the plurality of pivot pins operably engages the first component(s), manipulating the assembly tool to apply stress to a first frangible connection engaging the first pivot pin with the assembly tool such that the first pivot pin breaks off from the assembly tool, positioning one or more second components of the first surgical instrument or of a second surgical instrument for receipt of a second pivot pin, manipulating the assembly tool such that the second pivot pin of the plurality of pivot pins operably engages the second component(s), and manipulating the assembly tool to apply stress to a second frangible connection engaging the second pivot pin with the assembly tool such that the second pivot pin breaks off from the assembly tool.

In aspects, the threshold for breaking the second frangible connection is greater than the threshold for breaking the first frangible connection to facilitate breaking-off of the first pivot pin before breaking-off of the second pivot pin.

DETAILED DESCRIPTION

Turning toFIGS. 1A and 2,FIG. 1Adepicts a endoscopic surgical forceps10andFIG. 2depicts a hemostat-style forceps10′. The aspects and features of the present disclosure are applicable to forceps10, forceps10′, or any other suitable surgical instrument. Obviously, different electrical and mechanical connections and considerations apply to each particular type of instrument; however, the aspects and features of the present disclosure remain generally consistent regardless of the particular instrument used.

Referring toFIG. 1A, forceps10generally includes a housing20, a handle assembly30, a rotating assembly70, an activation switch4, and an end effector assembly100. Forceps10further includes a shaft12having a distal end14configured to mechanically engage end effector assembly100and a proximal end16that mechanically engages housing20. Forceps10also includes cable2that connects forceps10to an energy source (not shown), e.g., a generator or other suitable power source, although forceps10may alternatively be configured as a battery-powered device. Cable2includes a wire (or wires) (not shown) extending therethrough that has sufficient length to extend through shaft12in order to provide energy to one or both tissue-treating surfaces114,124(FIG. 1B) of jaw members110,120, respectively. However, energy may be supplied to respective tissue-treating surfaces114,124(FIG. 1B) of jaw members110,120in any other suitable fashion, e.g., via conductive structural components of forceps10, brush-contacts, etc. Activation switch4is coupled between tissue-treating surfaces114,124(FIG. 1B) of jaw members110,120, respectively, and the source of energy for enabling the selective supply of energy to jaw members110,120for treating tissue grasped therebetween. Rotating assembly70is rotatable in either direction to rotate end effector assembly100relative to housing20.

Handle assembly30includes a fixed handle50and a movable handle40. Fixed handle50is integrally associated with housing20and movable handle40is movable relative to fixed handle50. More specifically, movable handle40is pivotably coupled to housing20within housing20via a pivot pin (not shown) and operably coupled to a drive assembly (not shown) disposed within housing20such that movable handle40and the drive assembly (not shown), together, mechanically cooperate to impart movement of one or both of jaw members110,120about a pivot pin103between a spaced-apart position and an approximated position to grasp tissue between jaw members110,120. As shown inFIG. 1A, movable handle40is initially spaced-apart from fixed handle50and, correspondingly, jaw members110,120are disposed in the spaced-apart position. Movable handle40is depressible from this initial position to a depressed position corresponding to the approximated position of jaw members110,120.

Referring toFIG. 2, forceps10′ is shown including two elongated shaft members12a,12b, each having a proximal end16a,16b, and a distal end14a,14b, respectively. Forceps10′ further includes an end effector assembly200similar to end effector assembly100(FIGS. 1A and 1B). More specifically, end effector assembly200includes first and second jaw members210,220attached to respective distal ends14a,14bof shaft members12a,12band pivotably coupled to one another about a pivot pin203. Each shaft member12a,12bincludes a handle17a,17bdisposed at the proximal end16a,16bthereof. Each handle17a,17bdefines a finger hole18a,18btherethrough for receiving a finger of the user. As can be appreciated, finger holes18a,18bfacilitate movement of the shaft members12a,12brelative to one another to, in turn, pivot jaw members210,220between a spaced-apart position and an approximated position for grasping tissue therebetween.

One of the shaft members12a,12bof forceps10′, e.g., shaft member12a, includes a proximal shaft connector19configured to connect the forceps10′ to a source of energy (not shown), e.g., a generator. Proximal shaft connector19secures a cable2′ to forceps10′ such that the user may selectively supply energy to jaw members210,220for treating tissue grasped therebetween. More specifically, an activation switch4′ is positioned to initiate the supply of energy to jaw members210,220upon sufficient approximation of shaft members12a,12b.

With reference toFIG. 1B, end effector assembly100of forceps10(FIG. 1A) is shown, keeping in mind that end effector assembly200includes similar features. Each jaw member110,120of end effector assembly100includes a proximal flange111,121and a distal jaw body112,122upon which respective tissue-treating surfaces114,124are defined. Proximal flanges111,121are pivotably coupled to one another about a pivot pin103. One or both of proximal flanges111,121is pivotably coupled to shaft12via pivot pin103and operably coupled to the drive assembly (not shown), e.g., via a pivot pin (not shown), such that movable handle40(FIG. 1A) is operable to pivot jaw members110,120relative to one another between the spaced-apart and approximated positions.

Turning now toFIGS. 3A-3B, an assembly tool300utilized to facilitate the assembly of forceps10(FIG. 1A) is shown configured for use in installing pivot pin103to pivotably couple jaw member110with jaw member120and shaft12. Assembly tool300may alternatively or additionally be configured for use in installing any other pivot pin associated with forceps10(FIG. 1A), e.g., the pivot pin (not shown) coupling movable handle40with housing20(FIG. 1A), the pivot pin (not shown) operably coupling the drive assembly (not shown) with end effector assembly100, etc., or for installing one or more pivot pins of any other suitable surgical instrument or component thereof.

Assembly tool300includes a handle310configured to be grasped by a user, a neck320extending distally from handle310, and pivot pin103engaged with and extending distally from neck320. Pivot pin103may be monolithically formed with neck320or otherwise engaged therewith to define a frangible section340between pivot pin103and neck320that is configured to break under a threshold amount of stress, thereby separating pivot pin103from neck320. Frangible section340defines a lower breaking-point as compared to pivot pin103, handle310, neck320, and the connection between handle310and neck320such that frangible section340breaks, thereby separating pivot pin103from neck320, prior to breaking of any of the other components or portions of assembly tool300. It is contemplated that neck320may be releasably coupled with handle310such that, after pivot pin103is broken off from neck320, a new neck320having another pivot pin attached thereto maybe loaded onto handle310for further use, e.g., for insertion of another pin associated with forceps10(FIG. 1A).

Referring toFIGS. 4A-4C, the use of assembly tool300for facilitating the assembly of forceps10(FIG. 1A), e.g., the pivotable coupling of jaw member110with jaw member120and shaft12(FIG. 1A) is detailed. Initially, with reference toFIG. 4A, proximal flanges111,121of jaw members110,120, respectively, are aligned with one another such that the pairs of apertures116,126defined through respective proximal flanges111,121are aligned with one another. Thereafter, with additional reference toFIG. 4B, handle310of assembly tool300is manipulated such that pivot pin103is inserted through each set of aligned apertures116,126to pivotably couple proximal flanges111,121to one another.

Referring also toFIG. 4C, once pivot pin103is inserted through each set of aligned apertures116,126sufficiently so as to pivotably couple proximal flanges111,121to one another, handle310is manipulated off-axis relative to pivot pin103and aligned apertures116,126so as to impart stress to the frangible section340defined between pivot pin103and neck320(as a result of pivot pin103being captured within apertures116,126and, thus, unable to move in accordance with the movement of handle310). Upon sufficient off-axis manipulation of handle310so as to impart the threshold amount of stress to frangible section340, pivot pin103is broken-off from neck320, leaving pivot pin103in position operably engaging proximal flanges111,121with one another. Although this may be sufficient to secure pivot pin103in position, pivot pin103may further be secured in position using end caps, adhesives, welding, any of the configurations detailed below, or other suitable mechanisms or methods, to inhibit dislodging of pivot pin103from apertures116,126.

Turning now toFIGS. 5A-5C, another assembly tool400provided in accordance with the present disclosure for facilitating the assembly of forceps10(FIG. 1A) is shown configured for use in installing a two-part pivot pin1103to pivotably couple jaw member110with jaw member120and shaft12, although assembly tool400may also be configured for use in installing a pivot pin of any other suitable surgical instrument or component thereof.

Two-part pivot pin1103includes a female component1110and a male component1120configured to engage female component1110. Female component1110includes a body1112defining an open end1113and a closed end1114, and a collar1118defined at closed end1114of body1112. An interior lumen1116extends inwardly from open end1113of body1112. Threading1117is disposed on the interior surface of body1112defined by interior lumen1116. Male component1120includes a body1122and includes a collar1128defined at an end thereof. Body1122of male component1120defines a diameter equal to or slightly less than that of lumen1116of female component1110and defines complementary threading1127on the exterior thereof to enable threading engagement of male component1120within female component1110. However, non-threaded engagement, e.g., friction-fitting, is also contemplated.

Assembly tool400is similar to assembly tool300(FIGS. 3A and 3B) and includes a handle410, a neck420extending distally from handle410, and male component1120of two-part pivot pin1103engaged with and extending distally form neck420. More specifically, collar1128of male component1120is monolithically formed with neck420or otherwise engaged therewith to define a frangible section440between male component1120of pivot pin1103and neck420. Frangible section440defines a lower breaking-point as compared to the threadings1117,1127of female and male components1110,1120, respectively, of two-part pivot pin1103, such that frangible section440breaks, thereby separating pivot pin1103from neck420, prior to breaking the threaded engagement between female and male components1110,1120, respectively, of two-part pivot pin1103. Assembly tool400may further include any of the aspects and features of assembly tool300(FIGS. 3A and 3B), detailed above, and vice versa.

Continuing with referring toFIGS. 5A-5C, the use of assembly tool400for facilitating the assembly of forceps10(FIG. 1A), e.g., the pivotable coupling of jaw member110with jaw member120and shaft12(FIG. 1A), is detailed. Initially, with reference toFIG. 5A, proximal flanges111,121of jaw members110,120, respectively, are aligned with one another such that the pairs of apertures116,126defined through respective proximal flanges111,121are aligned with one another. Female component1110of two-part pivot pin1103, led by open end1113of body1112, is then inserted through one set of aligned apertures116,126.

With additional reference toFIG. 5B, handle410of assembly tool400is manipulated such that male component1120of two-part pivot pin1103is inserted through the other set of aligned apertures116,126and into position adjacent female component1110. Thereafter, handle410is rotated about its longitudinal axis and relative to female component1110of two-part pivot pin1103so as to advance body1122of male component1120into lumen1116of body1112of female component1110in threaded engagement therewith.

Referring also toFIG. 5C, body1122of male component1120is fully engaged within lumen1116of body1112of female component1110such that two-part pivot pin1103pivotably couples proximal flanges111,121to one another and is retained in position via collars1118,1128of female and male components1110,1120, respectively, on either side of flanges111,121. At this point, assembly tool400may be broken off from two-part pivot pin1103and removed. In order to break-off assembly tool400from two-part pivot pin1103, handle410may be further rotated about its longitudinal axis, resulting in stress being imparted to frangible section440since male component1120is fully engaged within female component1110and, thus, cannot be rotated with the rotation of handle410. As noted above, as the frangible section440has a lower break-off point relative to surrounding components and engagements therebetween, male component1120is broken-off from neck420prior to breaking any other components or engagements. In embodiments where non-threaded engagement, e.g., friction-fitting, is provided, breaking-off of assembly tool400from pivot pin1103may be accomplished similarly as detailed above with respect to assembly tool300(FIGS. 4A-4C). It is also contemplated that two-part pivot pin1103(with or without threading) may be operably engaged with jaw members110,120without the use of assembly tool400, e.g., via any other suitable mechanism.

Turning toFIG. 6, another assembly tool500provided in accordance with the present disclosure for facilitating the assembly of forceps10(FIG. 1A), or any other suitable surgical instrument, is shown. Assembly tool500may be similar to assembly tools300,400(FIGS. 4A-4C and 5A-5C, respectively) except that, rather than providing a single pivot pin coupled thereto, assembly tool500includes a series of pivot pins503engaged therewith. Pivot pins503are arranged end-to-end with one another along a longitudinal axis of assembly tool500. A proximal-most pivot pin503ais engaged or formed with neck520of assembly tool500, while a distal-most pivot pin503bdefines a free distal end. A plurality of intermediate pivot pins503care interdisposed between proximal-most pivot pin503aand distal-most pivot pin503b. The pivot pins503may be different from one another and/or configured for engaging different portions of forceps10(FIG. 1A) or other suitable surgical instrument, or may be similar to one another and interchangeably usable for engaging one or more portions of forceps10(FIG. 1A) or for use in assembling multiple forceps10(FIG. 1A). Where different or specialized pivot pins503are provided, the pivot pins503may be arranged in the order in which they are to be needed during assembly.

A frangible portion540is defined between proximal-most pivot pin503aand neck520, between proximal-most pivot pin503aand the proximal-most intermediate pivot pin503c, between each of the intermediate pivot pins503c, and between the distal-most intermediate pivot pin503cand distal-most pivot pin503b. Similarly as detailed above, frangible portions540enable successive breaking off of pivot pins503from assembly tool500, while the more-proximal pivot pins503remain engaged with assembly tool500. Frangible portions540may define increasing breaking thresholds in the distal-to-proximal direction such that only the distal-most of the pivot pins503is broken off, while the other pivot pins503remain engaged. Alternatively, assembly tool500may include features to inhibit additional pivot pins503, other than the distal-most of the pivot pins503, to be broken off.

With reference toFIGS. 7A and 7B, another end effector assembly1200and assembly tool600for use therewith provided in accordance with the present disclosure are detailed. Although described together, it is contemplated that end effector assembly1200be assembled without use of assembly tool600. End effector assembly1200is similar to end effector assembly100(FIG. 1B) and includes first and second jaw members1210,1220, each including a proximal flange1211,1221and a distal jaw body1212,1222upon which respective tissue-treating surfaces1214,1224are defined. Proximal flanges1211,1221each define a pair of openings1215,1225for receipt of a pivot pin1203for pivotably coupling jaw members1210,1220to one another. Each opening1215,1225defines an enlarged-area portion1216a,1226aand reduced-area portion1216b,1226bin communication with and extending proximally from the respective enlarged-area portion1216a,1226a.

Pivot pin1203is engaged with neck620of assembly tool600, similarly as detailed above with respect to assembly tool300and pivot pin103(FIGS. 4A-4C). Pivot pin1203defines a generally cylindrical body1204having first and second ends1205a,1205b. A pair of spaced-apart annular ribs1206a,1206band1208a,1208bis monolithically formed with or engaged about pivot pin1203towards each of the first and second ends1205a,1205bthereof. Annular ribs1206a,1206band1208a,1208bdefine diameters greater than that of reduced-area portions1216b,1226bof openings1215,1225of proximal flanges1211,1221of jaw members1210,1220but less than that of enlarged-area portions1216a,1226aof openings1215,1225of proximal flanges1211,1221of jaw members1210,1220.

Continuing with reference toFIGS. 7A and 7B, in order to assemble end effector assembly1200using assembly tool600, proximal flanges1211,1221of jaw members1210,1220, respectively, are first aligned with one another such that openings1215,1225are aligned with one another. Thereafter, handle610of assembly tool600is manipulated such that pivot pin1203is inserted through enlarged-area portions1216a,1226aof openings1215,1225. More specifically, pivot pin1203is positioned such that a portion of each of proximal flanges1211,1221is disposed between each pair of annular ribs1206a,1206band1208a,1208b.

Once pivot pin1203is positioned such that a portion of each of proximal flanges1211,1221is disposed between each pair of annular ribs1206a,1206band1208a,1208b, handle610may further be manipulated so as to translate pivot pin1203proximally from the enlarged-area portions1216a,1226aof openings1215,1225to the reduced-area portions1216b,1226bof openings1215,1225. In this position, lateral movement of pivot pin1203is inhibited due to the portions of proximal flanges1211,1221being disposed between each pair of annular ribs1206a,1206band1208a,1208b. Pivot pin1203may be inhibited from returning distally once this position has been achieved directly, e.g., via closing or blocking enlarged-area portions1216a,1226aof openings1215,1225, or indirectly, e.g., via interference from other components of end effector assembly1200upon full assembly of end effector assembly1200.

With pivot pin1203in position as detailed above, handle610may be manipulated off-axis relative to pivot pin1203and openings1215,1225so as to impart stress to the frangible section640defined between pivot pin1203and neck620. Upon sufficient off-axis manipulation of handle610, pivot pin1203is broken-off from neck620, leaving pivot pin1203in position operably engaging jaw members1210,1220with one another.