JP5507093B2 - Surgical end effector with support retention feature - Google Patents

Description

Disclosure details

(Field of the Invention)
The present invention relates generally to a support for a surgical instrument and a support configured to be removably attached to an end effector assembly of a surgical instrument.

[Related technologies]
Surgical instruments such as surgical staplers can be configured to deploy staples to tissue during the surgical process. In various embodiments, the surgical stapler can include an end effector configured to be located at the distal end of the surgical stapler. The end effector is positioned inside the cannula or trocar and can be configured to slide at least a portion of the cannula or trocar into the cannula or trocar. Can be used to treat. In various embodiments, the end effector can comprise a first jaw member having a staple cartridge and, in addition, a second jaw member having an anvil. The first jaw member and the second jaw member can be moved proximally relative to each other, and a compressive force can be applied with a tissue layer interposed therebetween. In at least one embodiment, the staple cartridge can removably receive staples therein and the anvil can deform the staples when the staples are deployed from the staple cartridge.

  In some cases, the tissue layer may be relatively thin, contain a large amount of moisture, and / or be non-uniform in thickness, causing staples to not stay well within the tissue. To remedy this problem, the elements of the support can be used to support the tissue and staple it across the tissue. In at least one embodiment, the elements of the support can be removably attached to the first jaw member and the second jaw member before the first jaw member and the second jaw member are inserted into the surgical site. In various embodiments, the elements of the support can distribute the compressive force applied by the anvil over the surface area of the support to form a more uniform compressed shape of the tissue within the tissue. In at least one embodiment, the uniform compressed shape of the tissue increases the likelihood of proper stapling within the tissue.

  In various embodiments, attaching the support element to the end effector jaw member can be difficult for the surgeon. In at least one embodiment, an adhesive configured to removably retain the support element may be used to attach the support element to one jaw member. In such an embodiment, the surgeon must take great care in aligning the elements of the support and the jaw members as the adhesive can quickly bond the support to the jaw members. In this case, it is necessary to remove the support element from the jaw member and replace it with a new support element. As a result, the surgeon must spend valuable time positioning and aligning the support elements with the end effector jaw members. Improvements to these are needed.

[Summary of the Invention]
According to at least one aspect of the present invention, the support element and / or the surgical instrument end effector assists the surgeon or other physician in properly aligning and attaching the support element to the end effector. Features can be provided. In at least one embodiment, the support element can include at least one member extending from the support element, the member defined within the staple cavity and / or anvil defined within the staple cartridge. It can be configured to engage one of the anvil pockets. In at least one such embodiment, for example, the member is friction fit and / or press fit into the staple cavity and / or anvil pocket to allow removal of the support element into one of the staple cartridge and the anvil. Can be held. In various embodiments, a notch or slot is defined in one of the staple cartridge and / or anvil, the notch configured to receive a portion of the support element and removably retain the support element. it can. In at least one embodiment, the support element can include a protrusion extending from the support element, the protrusion being removable in a dissection member path provided in at least one of the staple cartridge and the anvil. Can be configured to engage. In such embodiments, the protrusion can be engaged, for example, press fit, friction fit, and / or the path.

  In accordance with at least one aspect of the present invention, the support element and the end effector can be provided with cooperating features, such as a lip, whereby the support element can be snapped to the end effector. . In various embodiments, the end effector can include an elastic member extending from the end effector, the elastic member can be in partial contact with an element of the support and removably holds the support to the end effector. Can be made. In at least one embodiment, one or more of the staple cartridge and the anvil can be provided with a plurality of retaining elements, wherein the support element is partially frictionally fitted to the retaining element, and the support element is attached to the staple cartridge and / or Or it can be removably held on the anvil.

  In accordance with at least one aspect of the present invention, the support element can be removably attached to a sleeve that can be configured to slide over at least one of the staple cartridge and the anvil of the end effector. In at least one embodiment, the element of the support can include a side that is attachable to the sleeve, and additionally includes a body configured to engage the staple when deployed from the staple cartridge. be able to. In this embodiment, the main body can be removably held on the sleeve using the side portion. In at least one embodiment, for example, a recess and / or a perforation may be defined between the side of the support element and the body to separate the body from the side. In at least one embodiment, as a result, the sleeve can be removed from the support by perforation and / or recesses after the staple is deployed to the body.

  In accordance with at least one aspect of the present invention, a package including a support element can be used to quickly align and position the support element within the end effector. In various embodiments, the package can include a first portion, a second portion, and a support element removably attached to the first portion. In at least one embodiment, the second portion is configured to be movable between a first position and a second position adjacent to an element of the support. In various embodiments, the support element is exposed when the second portion is in the second position, thereby positioning the package midway between the open end effector jaw members, and the exposed support element. And one jaw member of the end effector are engaged. In various embodiments, the support can include an adhesive, and the support can be held on one jaw member. After the support element is engaged with one of the jaw members, the second part can be withdrawn from the end effector and the first part can be removed from the support element.

  According to at least one aspect of the present invention, the support element may be secured to at least one of an end effector anvil and a staple cartridge. In various embodiments, the anvil and / or staple cartridge can be provided with one or more holes or openings therein to receive one or more securing members to hold the elements of the support to the anvil or staple cartridge. It can be configured as follows. In various embodiments, the securing member can be removed from the hole in the anvil and / or staple cartridge to separate the support element from the end effector. The fixation member can also be configured to be removed from the support element and formed of a bioabsorbable material for absorption into the patient's body. In at least one embodiment, the support element is attachable to the end effector by one or more removable clips.

  According to at least one form of the invention, the support element removably attached to the end effector may comprise an inert adhesive. In various embodiments, the surgeon can position and align the elements of the support to the end effector multiple times without adhering an inert adhesive to the end effector. Once the surgeon has properly aligned the support element to the end effector, the surgeon can then add the reactive agent to the inert adhesive. In various embodiments, the reactive agent activates the adhesive, which allows the active agent to removably adhere the support element to a portion of the end effector. In at least one embodiment, the support element can be provided with a recess that receives an applicator to facilitate the addition of the reactive agent to the inert adhesive.

  According to at least one aspect of the present invention, the end effector has a retractable holding member, and the element of the support can be held by the end effector. In various embodiments, the retaining member is movable between a first or distal position and a second or proximal position. In at least one embodiment, the flexible member is operably engaged with the handle portion and the surgeon can manipulate the handle portion to retract the flexible member relative to the end effector. In various embodiments, the flexible member can maintain the elements of the support in place while the staples are deployed through the support. In at least one embodiment, the retaining member can be retracted relative to the end effector, whereby the support can be separated from the end effector and removed from the surgical site.

  The foregoing features and advantages of the invention, as well as other features and advantages, and methods for achieving the same, will become apparent from the following description of embodiments of the invention, taken in conjunction with the accompanying drawings, wherein Will be better understood.

[Detailed explanation]
Several exemplary embodiments are described below for an overall understanding of the structure, function, manufacture, and application of the devices disclosed herein and the principles of the method. One or more examples of these embodiments are illustrated in the accompanying drawings. The devices and methods described in detail herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and the scope of the various embodiments of the present invention is defined only by the claims. Those skilled in the art will understand this. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and changes are intended to be included in the scope of the present invention.

  In various embodiments, referring to FIGS. 1 and 2, an end effector of a surgical instrument can removably attach at least one element of a support “B”. In at least one embodiment, the end effector can be configured to engage and pinch the tissue “T”, deploy staples to the tissue, and dissect tissue and support elements. In this embodiment, the end effector is then removed from the tissue, leaving the staple and support elements attached to the tissue on both sides of the incision “I”. In various embodiments, the surgical instrument can include at least one element of a handle assembly, an end effector assembly, an instrument shaft, and a support removably attached to the end effector assembly. In at least one embodiment, referring to FIG. 3, the handle assembly 12 can be attached to the first end 13 or proximal end of the instrument shaft 16, and in addition, the end effector assembly 14 can be attached to the instrument shaft 16. It can be configured to attach to the second end 15 or distal end. In various embodiments, at least a portion of the end effector assembly 14 and the instrument shaft 16 are located within or at least partially within a cannula or trocar in the patient's body during a minimally invasive surgical procedure. Can be configured to be inserted inside. Various surgical instruments are disclosed in US patent application Ser. No. 11 / 329,020 filed Jan. 10, 2006, entitled “Surgical Instrument Having an Articulating End Effector”, US patent application Ser. No. 343,321 Invention name “Surgical Cutting and Fastening Instrument with Closure Trigger Locking Mechanism” and US Patent Application No. 11 / 529,935 filed September 29, 2006 “Surgical Staples Having Attached Drivers and Stapling” Instruments for Deploying the Same ", the entire disclosures of which are incorporated herein by reference.

  In various embodiments, the end effector of the surgical instrument can include a first jaw member and a second jaw member, at least one of the first jaw member and the second jaw member moving relative to the other jaw member. And the tissue can be sandwiched between them. In various embodiments, referring to FIGS. 4-11, the first jaw member 20 can include a staple cartridge 22, and in addition, the second jaw member 24 can include an anvil 26. In at least one embodiment, the staple cartridge 22 can include a deck 28 that defines a plurality of staple cavities 30 therein. The anvil 26 can include an anvil cover 27 and an anvil surface 32, in which an anvil pocket 34 is defined. In various embodiments, each staple cavity 30 can be configured to removably receive a staple therein, and each anvil pocket 34 can be configured to deform at least a portion of the staple when the staple is deployed. In various embodiments, at least one of the staple cartridge and the anvil can include one or more grasping features 35, or ridges, and can be configured to grasp tissue within the end effector.

  In addition to the above, referring to FIGS. 4-11, the end effector assembly 14 can include at least one element of a support 36 and / or 36 ′, which includes a first jaw member and a second jaw member. And can be removably retained on one of the deck 28 and / or the surface 32, for example. In at least one embodiment, the surface of the support element can be configured to contact tissue when the tissue is sandwiched between the first jaw member and the second jaw member. In this embodiment, the surface of the support can distribute the compressive clamping force against the tissue, remove excess moisture from the tissue, and / or improve staple binding. In various embodiments, one or more support elements may be located in the end effector assembly. In at least one embodiment, referring to FIG. 11, one of the elements of support 36 a can be attached to staple cartridge 22 and one of the elements of support 36 a ′ can be attached to anvil 24. In at least one other embodiment, for example, two elements of the support 36 may be located on the deck 28 and one of the elements of the support 36 ′ may be located on the surface 32. In various other embodiments, an appropriate number of support elements can be placed in the end effector assembly. In any case, in various embodiments, one or more support elements are formed of, for example, a bioabsorbable material, a biodegradable material, and / or a dissolvable material, and absorbed, decomposed, and / or absorbed during the healing process. Or it can be dissolved. In at least one embodiment, one or more support elements can include, for example, a therapeutic agent at least in part, and the therapeutic agent can be released over time to aid in tissue healing. Further, in various embodiments, the one or more support elements can include, for example, a non-absorbable material and / or a non-soluble material.

  In various embodiments, referring to FIGS. 6, 7, 9, and 10, the end effector assembly can include at least one coupling member or securing member, such as the anvil and staple cartridge of the support. At least one of them can be detachably held. In at least one embodiment, each coupling member, such as, for example, coupling member 38 can include a body 40, which can be cylindrical, for example. In at least one of such embodiments, the coupling member 38 may also include an outwardly extending head 42 to prevent the coupling member from sliding down from a hole or opening 44 provided in the support element. Or at least can be prevented. In various other embodiments, the coupling member can take various other shapes as appropriate to hold the elements of the support to the end effector. In at least one embodiment, the one or more coupling members can be provided with a fastener that can be configured to removably hold the support to the staple cartridge and / or anvil.

  In various embodiments, referring to FIGS. 7 and 9, the head 42 can include a recess 43 that can be configured to receive a driver, press, or other suitable device. In at least one embodiment, for example, the driver or press engages the recess 43 to insert the coupling member 38 through the support element and engages one of the staple cartridge deck 28 and the anvil face 32. be able to. In one such embodiment, deck 28 and / or surface 32 can include a hole 46 and can be configured to receive at least a portion of a coupling member, such as body 40. In various embodiments, the outer periphery of the body 40 and the inner periphery of the hole 46 can cooperate to hold the coupling member 38 in a friction fit or press fit with one of the anvil and staple cartridge. In addition to the above, referring to FIGS. 6 and 10, the support element may include preformed holes 44, for example, coupling member 38 may pass through holes 44 and enter holes 46. be able to. In at least one embodiment, the elements of the support 36 may be positioned adjacent to or opposite one of the deck 28 and the face 32 so that the holes 44 in the support are axially aligned with the holes 46. In this case, the coupling member 38 penetrates through the hole 44 of the support body and enters the hole 46 so that the support element can be removably held on one of the deck 28 and the surface 32.

  In addition to the above, the coupling member can include a screw, such as a threaded engagement with a staple cartridge and / or an anvil hole. In various embodiments, such screws can be configured to thread-engage with self-tapping screws and / or screws cut into holes. In embodiments that use a self-tapping coupling member, the coupling member can be used with support elements, staple cartridges, and / or anvils that have not been previously perforated. In any case, the coupling of the coupling member to the anvil or staple cartridge aperture is sufficient to hold the support in place, but the support can be peeled from the staple cartridge and / or deck when necessary. In at least one embodiment, the outwardly extending head 42 is configured to be embedded in an inclined countersunk hole surrounding the hole 46 so that the tissue contacting surface of the support element is flat or at least substantially flat, This reduces the risk of getting caught or obstructed by the coupling member.

  In various embodiments, the coupling member can be configured to be removed from the end effector and deployed along the elements of the support. In at least one embodiment, the head of the coupling member can be configured to be separated from the body of the coupling member, the head being deployed with the elements of the support while the body remains attached to the end effector. In other various embodiments, the entire coupling member may remain attached to the end effector when the support element is removed from the end effector. In any case, in at least one embodiment, the coupling member can be made at least in part from at least one of a bioabsorbable material, a biodegradable material, and a soluble material, Absorbed, decomposed and / or dissolved. In various embodiments, for example, the coupling member can include a therapeutic agent, which can be released over time to aid in tissue healing. Further, in various embodiments, the coupling member can include non-absorbable and / or non-soluble materials such as plastic.

  In various embodiments, the coupling members can be arranged in any suitable pattern or shape. In at least one embodiment, the coupling member can be disposed along the outer periphery of the element of the support 36, for example. In at least one embodiment, the coupling member is positioned proximate one or more sides and / or ends of the support element, for example, such that the end effector is inserted through the trocar or engaged with tissue. Prevents or at least assists in preventing the support from peeling off the staple cartridge deck and / or anvil surface when combined. In various embodiments, the coupling member can be used with any suitable adhesive, such as cyanoacrylate, to cause the end effector to releasably retain a support element, or at least a portion of the support. In at least one embodiment, the adhesive may be applied to the coupling member before the coupling member engages the support element, staple cartridge, and / or anvil hole.

  In various embodiments, referring to FIGS. 12-14, at least one resilient member can be used to releasably hold the element of the support to the staple cartridge and / or anvil of the end effector. In at least one embodiment, at least one elastic member, eg, elastic member 150 or 150 ′, may have a first end, such as first end 152 or 152 ′, which includes first jaw member 120 and It is configured to be attached to one of the second jaw members 124 or integrally formed. In at least one embodiment, each elastic member 150 can include a second end, such as second end 154 or 154 ′, for example, a support element, such as an element of support 136 or 136 ′. The at least one of the first jaw member and the second jaw member is configured to be detachably held by being brought into contact therewith. In various embodiments, the second end 154 can include a tip 158, which can be configured to grip at least some of the elements of the support 136, for example. In various embodiments, the tip 158 has a contour and / or structure with an uneven or ribbed surface, which allows, for example, frictional engagement with a support element.

  In various embodiments, referring again to FIGS. 12-14, a plurality of resilient members can be provided on at least two sides of the jaw member, thereby retaining the sides of the support element on the jaw member. can do. In at least one embodiment, the first end 152 of each elastic member 150 may be connected to each other by a connection member or bar, such as a connection member 156 or 156 '. In various embodiments, the connecting member 156 can be attached to the second jaw member 124 so that the connecting member 156 can support the elastic member 150. In other various embodiments, the plurality of elastic members 150 can be attached to at least one of the first jaw member and the second jaw member without using a connecting member. In this embodiment, for example, the first end of the elastic member can be directly attached to one of the first jaw member and the second jaw member.

  In addition to the above, in various embodiments, at least one elastic member is biased against an element of the support so that the elastic member provides a holding force to the element of the support and One of the one jaw member and the second jaw member can be detachably held. In at least one embodiment, the support element has a tissue contacting portion 159 or 159 ′ and two sides 160 or 160 ′ extending generally perpendicular or perpendicular to the tissue contacting portion 159 or 159 ′. Can do. In at least one of this embodiment, the tissue contacting portion 159 can be positioned proximate to or in contact with the deck 128, and in addition, the side portion 160 is configured to contact the sidewall 121 of the first jaw member 120. it can. Similarly, the tissue contact portion 159 ′ can be positioned proximate to or in contact with the surface 132, and in addition, the side portion 160 ′ can be configured to contact the sidewall 125 of the second jaw member 124. In various embodiments, each second end 154 of each elastic member 150 is configured to be engageable with an element side 160 of the support 136 and can provide a retention force. In at least one embodiment, the elastic member 150 can be configured to remove the support 136, for example, after the staple is deployed through the support and / or when the support is detached from the end effector. In at least one embodiment, the elastic member may be formed of an elastic material such as metal or plastic.

  In various embodiments, referring to FIGS. 15-18, the retaining member can be configured to move between a first position and a second position within the end effector, and the support element can be removed from the end effector. Can hold. In at least one embodiment, the end effector assembly 214 can include a first jaw having a staple cartridge 222 and a second jaw having an anvil 226, and the retaining member 262 moves relative to the staple cartridge 222 and the anvil 226. can do. In various embodiments, the retention member 262 is movable between a first position or extended position near the distal end 264 and a second position or retracted position near the proximal end 263. In the extended position, the retaining member 262 can maintain the support 236 in place as the end effector 214 is inserted into the surgical site. Thereafter, the end effector 214 can be closed, for example, with the tissue sandwiched, and the staples can be deployed to the tissue through the support. In various embodiments, the retaining member 262 can be moved to a retracted position, which allows the retaining member 262 to be operably removed from the support 236. In at least one embodiment, the retention member 262 can be retracted before the staple is deployed. In any case, the result is that the end effector 214 is opened and withdrawn from the surgical site, leaving the stapled support and tissue.

  In various embodiments, the retaining member can have a proximal end that is operatively engaged with a lever or other actuation mechanism of the handle portion of the surgical stapling instrument, thereby allowing the surgeon to Can remotely control the retraction of the holding member as described above. In at least one embodiment, the retention member 262 can have a distal end that is releasably retained with the retention bar 264 to remove the retention member 262 from the retention bar 264. The holding member 262 is configured to apply a force. Thereafter, the holding member 262 is moved backward by a distance L to the proximal side and moved to the second position. In at least one embodiment, the retaining member 262 can be retracted, for example, through a path or hole 266 in the support 236 until it is sufficiently removed from the support. In at least one embodiment, the hole 266 can guide and surround the retaining member 262 as the retaining member 262 is retracted. In various embodiments, the retaining member can be formed of a flexible wire. In at least one embodiment, the end effector may include two or more support elements held on the end effector by a retractable holding member. In at least one of these embodiments, referring to FIGS. 17 and 18, the end effector 214 has a retaining member 262 'that can maintain the support 236' in place.

  In various embodiments, the end effector assembly can include a cutting member that can be configured to cut one or more support elements. In at least one embodiment, the cutting member is activated relative to the end effector by the surgical instrument firing drive and is guided to the cutting member slot in the end effector anvil and / or staple cartridge. In at least one embodiment, referring to FIG. 19, the upper portion 267 of the dissecting member 268 is configured to slide within a slot in the anvil, and in addition, the lower portion 269 of the dissecting member slides within the slot within the staple cartridge. It is configured as follows. In various embodiments, the cutting member 268 can include a blade 270 that has a slope that rises to the right, ie, the lower end of the cutting edge is located distal to the upper end. In at least one embodiment, this configuration is configured to incise the support without substantially pushing the support distally and without disturbing the alignment of the support within the end effector. In at least one alternative embodiment, referring to FIG. 20, the blade 270 'of the cutting member 268' has a downward slope, i.e., the lower end of the cutting edge is located proximal to the upper end. In yet another embodiment, referring to FIG. 21, the blade 270 '' of the cutting member 268 '' includes a first portion 270a '' having a right-up slope and a second portion 270b '' having a right-down slope. And have.

  As noted above, the end effector assembly can include a staple cartridge, an anvil, and at least one support element intermediate the staple cartridge and the anvil. In at least one embodiment, referring to FIGS. 22-24, a support element, such as support 336, snaps onto at least one of staple cartridge 322 and / or anvil (not shown). Can be removably retained within the end effector. Referring to FIGS. 23 and 24, the staple cartridge 322 can include a first sidewall 320 and a second sidewall 304, and can include a lip 306 extending outwardly from at least one of the first sidewall and the second sidewall. In various embodiments, the support 336 has at least one extension at least partially along the length of the first end 308 or side, the second end or side 310, and the ends 308, 310. A lip 312. In at least one embodiment, referring to FIG. 24, the lip 312 can be configured to snap fit with the lip 306 to releasably hold the support 336 to the staple cartridge 322.

  In addition to the above, referring to FIG. 24, the support 336 can include a surface 316 that can be positioned proximate to or in contact with the deck 328 of the staple cartridge 322. In at least one embodiment, the side edges 308, 310 can have side walls that can extend perpendicular or perpendicular to the surface 316. In this embodiment, the lip 312 can extend from this side wall and couple to the back side of the lip 306 of the staple cartridge 322. In various embodiments, the lip 312 of the support 336 can be separated from the lip 306 of the staple cartridge 322 once the staple is deployed from the staple cartridge 322. More particularly, when the staple is deployed, the staple contacts the support 336 and exerts a pushing force on the support 336, causing the support 336 to separate from the staple cartridge 322. As an advantageous result, the support 336 can be automatically separated from the staple cartridge 322 when the staple is deployed from the staple cartridge 322 and / or when the end effector is opened as described above.

  In various embodiments, referring to FIGS. 23 and 24, the support element can have at least one member extending from the support element, the member including the support and staple cartridge and / or anvil. One of the two can be removably held. In at least one embodiment, member 318 can extend from support 336 in a direction perpendicular or perpendicular to surface 316. In various embodiments, the member 318 can be engaged with one of the staple cavities 320 and / or the anvil pocket by a friction fit or press fit to removably retain the support element on one of the staple cartridge and the anvil. Can do. Similar to the above, in various embodiments, the staples deployed from the staple cavities 320 exert a pushing force on the support 336 causing the member 318 to separate from the staple cavities 320. In various embodiments, the staple penetrates the protrusion 318 and / or the support 336 to secure the support to the tissue as described above.

  As illustrated in FIG. 23, the support element can include one or more members or protrusions extending from the support element, holding the support element to one of the staple cartridge and the anvil. In various embodiments, referring to FIGS. 25-26, for example, one or more members 318 'can extend from elements of the support 336'. In at least one embodiment, member 318 'can be press fit into staple cavities 320' of staple cartridge 322 'and / or anvil pocket (not shown) of the anvil so that the member can support elements of the staple cartridge and And / or can be friction fitted to the anvil as described above. As will be described in detail below, the staple cartridge and / or anvil, in addition to the staple cavity of the staple cartridge and the anvil pocket of the anvil, are provided with slots or holes therein to receive protrusions or retaining elements extending from the elements of the support. can do.

  In various embodiments, referring to FIG. 33, at least one of the end effector anvil and the staple cartridge may include a slot and / or groove, the slot and / or groove defining an element of the support as an end effector assembly. It can be configured to be removably held in a solid body. In at least one embodiment, the staple cartridge 722 can include at least one hole 704 therein that can be configured to receive a protrusion 706 extending from the support 736. In at least one such embodiment, the protrusion 706 can be received in the hole 704 by press fit and / or friction fit to removably retain the support 736. In at least one embodiment, referring to FIG. 33, support 736 can include a body 708 having a surface 710 that can be configured to be positioned in close proximity and / or abutment with deck 728. In various embodiments, for example, the protrusion 706 can extend from the body 708 in a direction orthogonal or perpendicular to a plane defined by the surface 710.

  In various embodiments, for example, the protrusion 706 can include a first portion 712 or leg and a second portion 714 or foot 714, the first portion 712 can be configured to penetrate the hole 704 and the second portion 714. Can have dimensions and shapes that are slightly larger than the holes 704. In at least one such embodiment, the protrusion 706 can be inserted and pushed into the hole 704 until at least a portion of the second portion 714 protrudes from the hole 704. In various embodiments, the protrusion 706 can deflect inward when inserted into the hole 704 and snap back outward when penetrated. Additionally or alternatively, the second portion 714 can be inserted into the hole 704 while being compressed and expand upon penetration. In any case, the second portion 714 engages in the vicinity of the hole 704 on the back side of the deck 728, and the support 736 can be removably snapped to the staple cartridge 702. In at least one embodiment, the protrusion 706 is removably retained in the hole 704 until the staple is deployed from the staple cartridge and a force is applied and / or when the end effector is opened as described above.

  In various embodiments, referring to FIG. 27, for example, staple cartridge 322 ″ and / or anvil 326 ″ can have a notch 334 ″ configured to receive a support 336 ″. . In at least one embodiment, the notch 334 "can be configured to removably retain the support 336" in the staple cartridge 322 ". In at least one such embodiment, the support 336 '' is press fit between the holding elements 302 '', 304 '' and the friction between the support 336 '' and the holding elements 302 '', 304 ''. In order to overcome, it is necessary to apply power. In various embodiments, the retaining elements 302 ", 304" can include lips or protrusions, which can prevent or at least prevent the support 336 "from floating upwards. In various embodiments, referring to FIG. 28, the end effector assembly can include a staple cartridge 422 and an anvil 426, at least one of the staple cartridge and the anvil extending from the first retaining element 402 and / or A second retaining element 404 can be included. In at least one embodiment, the first retaining element 402 and the second retaining element 404 can extend substantially perpendicular and / or perpendicular to the deck 428 and / or the surface 432, thereby ending the elements of the support 436. It can be held by the effector. In various embodiments, the first retaining element 402 and the second retaining element 404 can removably retain the support 436 in a friction fit therebetween. In at least one embodiment, there is a sufficient coefficient of friction between the sidewall and the retaining element so that the support does not dislodge when the end effector is inserted into the surgical site and manipulated. When the staple is deployed against the soft tissue, the end effector is reopened and, in various embodiments, can overcome the frictional force between the support 436 and the retaining element 402.

  In various embodiments, referring to FIG. 32, the end effector of a surgical stapling instrument can include an anvil and a staple cartridge (not shown), and as described above, the anvil is operatively engaged with the staple cartridge. Thus, the end effector can be configured to sandwich the tissue. In at least one embodiment, the anvil 626 can include a surface 632 and in addition a slot 602 in which a cutting member such as a cutting member 668 can be slidably received. In various embodiments, although not shown, the staple cartridge can also include a slot configured to slidably receive the cutting member 668. In any case, the cutting member 668 can include a blade, such as a blade 670, which can be configured to cut through soft tissue and / or support 636 located within the end effector.

  In at least one embodiment, referring again to FIG. 32, support 636 can include a body having a surface, such as surface 604, such that the surface is positioned proximate to anvil surface 632, for example. Can be configured. In various embodiments, the support 636 can further include a protrusion 606 that extends from the body in a direction orthogonal and / or perpendicular to the surface 604. In at least one embodiment, the protrusion 606 can be configured to be inserted into and engaged with the dissecting member slot 602 and the support 636 can be removably retained on the anvil 626. Although not shown, the elements of the support can include similar features that can hold the support to the staple cartridge.

  In various embodiments, the cutting member slot 602 can include a first side wall 608 and a second side wall 610, and the protrusion 606 is frictionally engaged and / or press-fitted between the first and second side walls. 606 can be removably retained in slot 602. In at least one embodiment, the slot 602 can include a transverse portion 612 that can receive a cam member 631 extending from the cutting member 668 that is configured to maintain the anvil 626 in the closed position. it can. In at least one embodiment, the protrusion 606 can include at least one tab 614 extending from the protrusion 606 that extends at least partially into the transverse portion 612 and retains the protrusion 606 in the slot 602. To help. In various embodiments, the protrusion can include an elastic feature that can apply a biasing force to the side wall of the slot 602 when press-fitted into the slot 602.

  In various embodiments, in addition to the above, the cutting member 668 can be configured to cut the protrusion 606 as it advances within the anvil 626 and separates the first portion 618 from the second portion 620. In at least one embodiment, the grooves 616 can reduce the cross-sectional thickness of the support 636 and reduce the force of cutting the support laterally. In various embodiments, the size and dimension of the one or more grooves 616 can be configured such that at least a portion of the protrusion 606 is narrower than the first portion 618 and / or the second portion 620. As described above, at least one of the grooves 616 may be V-shaped, for example, so that the cutting edge 670 can contact the protrusion 606 at or near the V-shaped tip. In various embodiments, although not shown, for example, the protrusion 606 can include at least one perforation therein, which can reduce the force in cutting the protrusion.

  In various embodiments, in addition to or in lieu of the apparatus for attaching the support described above, the elements of the support can be attached to the end effector of the surgical instrument with an adhesive. In at least one embodiment, referring to FIGS. 29 and 30, the end effector assembly 514 can include a staple cartridge path 522 having a deck surface 528 in addition to an anvil 526 having a surface 532. In at least one embodiment, a support element, such as support 536, for example, can be located proximate one of surface 532 and deck surface 528, which support 536 includes a body 502 and at least one handle portion 506. be able to. In at least one such embodiment, the handle portion 506 extends from the body 502 and the surgeon can utilize the handle portion 506 to position and align the support 536 within the end effector assembly. In at least one embodiment, the handle portion 506 can extend parallel to and / or across the plane of the surface 504.

  In various embodiments, referring to FIGS. 29 and 30, the elements of the support can include an inert adhesive, such as adhesive 512, on the surface of the support. The adhesive can be applied to the surface before the surface is positioned on one of the staple cartridge deck and anvil surfaces. In at least one embodiment, the adhesive 512 can be configured to removably adhere, for example, the surface 504 to the surface 532 and / or the deck 528 when activated by the reactive agent. Similar to the above, such an activated adhesive can be used to removably retain surface 504 in contact with surface 532 and / or deck 528. In various embodiments, the activated adhesive is configured to remove the support from the deck and / or surface upon application of a force, such as when the staple is deployed from the staple cartridge and / or when the end effector is opened. it can. In various embodiments, the inert adhesive can be applied along the periphery of the support body 502, for example, a reactive agent can be easily added to the inert adhesive.

  In various embodiments, the inert adhesive on the support can include one component of the two-component adhesive and the reactive agent can include the other component of the two-component adhesive, thereby Mixing the two components activates the adhesive. That is, as described below, the inert adhesive can include materials that are inert until introduced into the reactants. In at least one embodiment, the inert adhesive and the reactive agent can comprise, for example, an epoxy suitable for surgery. In various embodiments, the inert adhesive can include a water-stable material that is substantially insoluble and / or substantially non-reactive with water. In at least one embodiment, the adhesive may comprise a material such as, for example, a hot melt adhesive, silicone, urethane, cyanoacrylate, hydrogel, and / or isocyanolate, and any suitable monomer and / or polymer. it can. In various embodiments, suitable adhesives and attachment devices are disclosed in US Pat. No. 5,263,629, issued November 23, 1993, entitled “Method and Apparatus for Achieving Hemostasis Along a Staple Line”, 2003. US Pat. No. 6,656,193 issued on Dec. 2, “Device for Attachment of Buttress Material to a Surgical Fastening Device”, US Pat. No. 6,592,597 issued Jul. 15, 2003 “Adhesive for Attaching Buttress Material to a Surgical Fastening Device”, US Pat. No. 6,273,897 issued on August 14, 2001, “Surgical Bettress and Surgical Stapling Apparatus”, and September 30, 2003 US Patent Application No. 10 / 674,303 filed in Japanese Patent Application “Apparatus and Method for Attaching a Surgical Buttress to a Stapling Apparatus” It can include, the entire disclosures of which are incorporated herein by reference. In various embodiments, the reactant is a material comprising at least one aerobic initiator, anaerobic initiator, quaternary ammonium salt or compound, and / or any other suitable radical mechanism initiator such as an anionic initiator. For example, the material disclosed in US patent application Ser. No. 11 / 479,424 filed Jun. 30, 2006, entitled “Absorbable Cyanoacrylate Compositions”, the entire disclosure of which is incorporated herein by reference. Are incorporated herein by reference. In various embodiments, adhesives and / or reactive agents may be used, such as those sold by Closure Medical Corporation. In at least one embodiment, the adhesive can be configured to be activated by ultraviolet light or any suitable photochemical process. A variety of such adhesives are commercially available from, for example, Henkel Loctite Corporation.

  In addition to the above, in various embodiments, by using an inert adhesive on the support element, the surgeon can attach the support element to the anvil surface and / or without instantaneously adhering the adhesive. It can be positioned and repositioned on the staple cartridge deck. In at least one embodiment, the inert adhesive does not adhere to the face and / or deck unless a reactive agent is added. This feature eliminates the need for the surgeon to properly position the support element on the first attempt, and allows the support element to be repositioned multiple times on the deck and / or face for proper adaptation and alignment. Provides a significant advantage. In various embodiments, at least one retaining member or alignment member, such as retaining member 318 (FIG. 23) is used with an adhesive / reactant, eg, the end effector surface and / or deck prior to addition of the reactant. The support element may be held on the substrate.

  In various embodiments, the support element can include at least one groove or pathway that can be configured to receive a reactive agent. In at least one embodiment, referring to FIG. 29, the support 536 can include a recess 508 located intermediate the body 502 and the handle portion 506. More specifically, the first concave portion 508 is provided between the first side portion of the main body 502 and the first handle portion 506, and in addition, the second concave portion 508 is provided between the second side portion of the main body 502 and the second handle portion 506. It can be provided in the middle. In various embodiments, at least a portion of the inert adhesive 512 on the support 536 extends along the recess 508, and an applicator, such as an applicator 514, is inserted into the recess 508 to allow the reactive agent to the adhesive 512. It can be added to activate the adhesive. In at least one embodiment, as a result, the recess 508 facilitates the addition of the reactants. In various embodiments, the reactant applicator 514 can include an absorbent tip 516 and can be configured to removably store and add an amount of reactant.

  In various embodiments, referring to FIGS. 30 and 31, at least one perforation can be formed in an element of the support 536, for example, at least one handle portion 506 can be separated from the body 502. In at least one embodiment, perforation 510 is provided intermediate body 502 and handle portion 506, and when sufficient force is applied to handle portion 506, the elements of the support are split along the line or trajectory defined by perforation 510. be able to. In various embodiments, the perforations 510 can be located near and / or in the recesses 508, thereby reducing the thickness of the material in and / or near the recesses 508 of the support and making the handle portion 506 easy. It can be separated from the main body 502. In at least one embodiment, as a result of the above, the elements of the support can be located in the end effector, the reactive agent can be added to an inert adhesive on the support, and at least one handle portion Can be removed from the central body of the support.

  In various embodiments, the support element, inert adhesive, and reactive agent can be included, for example, in a surgical accessory kit. In at least one embodiment, an inert adhesive can be pre-applied to the support. In another embodiment, the surgeon uses the kit to apply an inert adhesive to the surface of the support and allows the adhesive to “set” or harden or dry, and position the surface without substantially adhering to the surface. can do. In at least one embodiment, the support element can then be positioned on one of the staple cartridge or anvil of the end effector. In at least one such embodiment, as described above, the support can include at least one handle extending from the support, and the surgeon can grasp the handle to manipulate the support relative to the end effector. . The end effector anvil is then closed onto the support and held in place until the reactants are added. In that case, referring to FIG. 31, the handle portion can be moved when the anvil is closed. Alternatively, the surgeon can wait for the activated adhesive to at least partially cure before removing the handle. In any case, the end effector can then be inserted into the surgical site and the support can be stapled to the tissue as described above. In various embodiments, one or more handle portions can be disconnected from the body of the support after the staples are engaged with tissue.

  In various embodiments, a package assembly that includes at least one support element can include means for activating an inert adhesive on the support. In at least one embodiment, the package assembly can contain an amount of a reactive agent therein that can be activated by contact with an inert adhesive when released. In various other embodiments, the package assembly can include an initiator that can be configured to react an inert adhesive with other chemicals within the package assembly. In further various embodiments, the inert adhesive can be configured to activate when fully pressurized. The pressure can be generated when the anvil of the end effector closes onto the support and presses the staple cartridge. Such materials can include one or more pressure sensitive adhesives such as, for example, silicone adhesives and acrylic adhesives. In various embodiments, the package can include a support element with a biocompatible hot melt adhesive located thereon, which can be configured to melt upon the application of heat generated by an exothermic chemical reaction. . In at least one embodiment, for example, an initiator can be mixed with a chemical to cause an exothermic reaction to generate heat in a localized portion of the adhesive. In various embodiments, a removable sheet material or other suitable separation device can be used to separate the initiator from the chemical, so that the initiator and chemical are exposed to each other when the sheet is removed. Can do. In at least one such embodiment, the initiator can include, for example, an oxidant or any suitable chemical compound that can readily transfer oxygen atoms, and the chemical can be oxidized by, for example, an oxidant. And iron or an iron compound that causes an exothermic reaction.

  In various embodiments, the package can include a support element on which is placed a biocompatible hot-melt adhesive that dissolves when subjected to heat generated by a power source, such as a battery. It can be configured as follows. In at least one embodiment, the package can include a power source. In further various embodiments, the energy source can be attached to, for example, a portion of the end effector, a support element, an end effector sleeve, and / or a support applicator. In various embodiments, the package assembly can include a first contact and a second contact, and / or any other suitable conductor and resistor, thereby completing the operation of the battery and the electrical circuit. Can be configured to In at least one embodiment, the power source is activated by, for example, a switch on the package, which sends electrical energy to the contacts.

  In various embodiments, the anvil of the end effector assembly can include a removable portion or sleeve that can be configured to slide over the second portion of the anvil and attach to the end effector assembly. In at least one embodiment, as described in detail below, the elements of the support can be attached to the sleeve prior to assembling the sleeve to the end effector assembly. In at least one embodiment, referring to FIG. 34, the sleeve 802 slides over the anvil portion 826 and is maintained in place by either snap fit or press fit. In at least one such embodiment, the sleeve 802 can be configured to at least partially cover the outer periphery 804 of the anvil portion 826, and the sleeve 802 can be configured to be engageable with the outer periphery 804. In various embodiments, the sleeve 802 can include an anvil pocket 806 formed in the working surface 808, which can be configured to deform staples deployed from a staple cartridge as described above. In various embodiments, the sleeve 802 can be cast or machined from a piece of metal into any suitable shape and can be formed of any suitable material such as, for example, aluminum.

  As described above and with reference to FIG. 34, a support 836 can be mounted on the sleeve 802, and at least a portion of the support 836 can be removably attached to the sleeve 802, for example, with an adhesive. In at least one embodiment, referring to FIG. 35, the support 836 ′ can include a body 812 ′ and at least one side 814 ′, the side 814 ′ being removable by an adhesive 810 ′. Can be attached to. In various embodiments, the side 814 'can be separated from the sleeve 802' when a force is applied. In at least one embodiment, as described above, the force can be generated when the staple is deployed from the staple cartridge and engages the support. In various embodiments, referring to FIG. 36, the elements of the support can further include at least one perforation and / or recess, thereby supporting the tissue contacting portion of the support to the end effector. It can be separated from a part of the body. In at least one embodiment, the support 836 '' can include a body 812 '' that can be configured to contact tissue located within the end effector, in addition, an anvil sleeve, such as with an adhesive 810 '', for example. Sides 814 '' that can be bonded to 802 '' can be included. In various embodiments, the support 836 '' can further include one or more perforations 816 '' therein that are located intermediate the body 812 '' and the side 814 ''. be able to. In addition to or in lieu of separating the side 814 '' described above from the sleeve 802 '', the body 812 '' moves along the track defined by the perforations 816 '' when a force is applied. Can be configured to be separated from '. In at least one such embodiment, the side 814 "can remain attached to the sleeve 802" after the body 812 "has separated. In other various embodiments, referring to FIG. 37, the sleeve 802 ′ ″ can include a support element, such as a support 836 ′ ″, and includes one or more recesses 818 ′ ″. The recess 818 '' 'is located between the body 812' '' and the side 814 '' 'and separates the body 812' '' from the side 814 '' 'in the same manner as described above. be able to.

  In addition to the above, in various embodiments, the end effector can be separated from the tissue and the support stapled to the tissue when the body is removed from the side. In at least one embodiment, for example, the used sleeve 802 is slid out of the anvil portion 826, discarded, and replaced with another sleeve. In at least one such embodiment, the replacement sleeve is positioned with a support element, eg, support 836, and the end effector can be reused. In various embodiments, the discarded sleeve is sterilized as described below, and another support element can be attached and reused.

  In various embodiments, a package including a support element can be configured to attach the support element to one of an end effector anvil and a staple cartridge. In at least one embodiment, referring to FIGS. 38-40, the package 902 can include a first portion 904 having a surface 905 that can be configured to removably retain an element of the support 936. In various embodiments, the surface 908 of the support 936 can include an adhesive 910 that can be configured to removably attach the support 936 to the anvil 926. In addition to the first portion 904, the package 902 can include a second portion 906 attached to the first portion 904, and the second portion 906 can be attached to a second element of the support, such as the support 937, for example. . In various embodiments, like the support 936, the support 937 can include an adhesive that removably attaches the support 937 to the staple cartridge 922. To remove the first portion 904 and the second portion 906 from the support element, the surgeon grasps and pulls at least one of the first portion 904 and the second portion 906 away from the support element, as shown in FIG. As a result, the package 902 can be moved from the first attached position to the second removed position.

  In various embodiments, referring to FIGS. 41-46, a package assembly that includes at least one support element can include an outer package 901 'that can enclose the inner package 902' in a sterile environment. In use, the surgeon can open the outer package 901 ', remove the inner package 902', and manipulate the inner package 902 'to expose the support 936'. In at least one embodiment, the inner package 902 ′ can include a cover sheet having a first portion 904 ′ and a second portion 906 ′, the first portion and the second portion being first and second as shown in FIG. The support 936 'can be configured to at least partially encapsulate when in position. In various embodiments, the surgeon grasps the pull tab 938 'located at the second end 940' of the second portion 906 'as shown in FIG. By moving 'to the second position, the second portion 906' can be rotated relative to the first portion 904 '. In at least one such embodiment, the surgeon rotates the second portion 906 ′ relative to the first portion 904 ′ until the second portion 906 ′ is at least partially located near the first portion 904 ′. be able to.

  Thereafter, in various embodiments, the support 936 'can be aligned with one of the end effector anvil and / or staple cartridge as described above. In at least one embodiment, referring to FIGS. 45 and 46, for example, the inner package 902 ′ is inserted intermediate the anvil 926 ′ and staple cartridge 922 ′ within the end effector 914 ′ and the support 936 ′ is inserted into the staple cartridge. 922 ′. In various embodiments, as described above, the anvil 926 ′ is rotated toward the staple cartridge 922 ′ and pressed onto the package 902 ′ and the support 936 ′ such that the support 936 ′ is against the staple cartridge 922 ′. When pressed, the adhesive 910 secures the support 936 '. Thereafter, the anvil 926 'can be reopened to release or remove the sheet 918' from the support 936 '.

  In various alternative embodiments, the package assembly can include one or more drawstrings, which can be configured to remove the cover sheet from the support in the package assembly. In at least one such embodiment, the cover sheet is manipulated to expose the support, the support is secured to the end effector, the pull string is pulled proximally or distally, and the cover sheet is supported by the support sheet. Can be removed from. In various other embodiments, referring to FIGS. 47 and 48, the drawstring can be attached to a portion of the support, for example, the handle portion of the support can be removed from the tissue contacting portion of the support. In at least one such embodiment, the support 1002 can be sandwiched between the anvil of the end effector and the staple cartridge to apply force to the drawstring 1006 attached to the handle portion 1004 of the support 1002. In various embodiments, as a result, the distal end 1003 of the support 1002 can be pulled to the proximal end 1005 by the drawstring 1006 and the handle portion 1004 can be disconnected from the tissue contacting portion 1036 along the perforation 1008. In at least one embodiment, the support 1002 can further include a hole 1010 that can be provided at the distal end of the tissue contacting portion 1036 between the handle portion 1004 and the tissue contacting portion 1036. A non-contact portion is defined in advance to reduce the force required to remove the handle portion 1004. In at least one embodiment, referring to FIG. 49, at least one drawstring 1006 ′ is attached to the handle portion 1004 ′ of the support 1002 ′, the proximal end 1005 is pulled toward the distal end 1003, and the handle portion 1004 is attached. Can be removed.

  In various embodiments, an applicator may be used to attach the support element to at least one of the end effector anvil and staple cartridge. In at least one embodiment, referring to FIGS. 50-53, the applicator assembly 1102 can include an applicator 1104 and at least one support 1136 element, the applicator 1104 supporting the support 1136. At least one surface can be included. In at least one such embodiment, applicator 1104 can include a top surface 1106 and a bottom surface 1108, each of which can be configured to removably receive at least one element of support 1136. In various embodiments, the elements of each support 1136 can be removably attached to the top and bottom surfaces of the applicator 1104 using, for example, an adhesive and / or a mechanical attachment member. Referring to FIGS. 50 and 51, each element of the support 1136 can include a surface 1110 that can be at least partially coated with an adhesive and held to the end effector. In at least one such embodiment, the adhesive can be applied to a plurality of locations 1112 on the support 1136.

  To attach the support element to the end effector staple cartridge and / or anvil using an applicator, such as applicator 1104, for example, the applicator is positioned at least partially between the staple cartridge and the anvil. The anvil can be closed on the support. In various embodiments, referring to FIGS. 52 and 53, the applicator assembly 1102 is positioned at least partially between the anvil 1126 of the end effector 1114 and the staple cartridge 1122 to align the anvil 1126 with the support 1136. Can be closed on top of it. In at least one embodiment, the applicator 1104 can further include an alignment slot 1116 at the first end and a tongue 1117 at the second end, where the surgeon utilizes the alignment slot 1116 to move the applicator assembly 1102. It can be aligned and positioned within the end effector 1114. In at least one such embodiment, the alignment slot 1116 can be configured to receive the end effector 1114 in close proximity to the sidewall of the alignment slot 1116. The adhesive 1112 allows the elements of the support 1136 to adhere to the anvil 1126 and the staple cartridge 1122, and when the anvil 1126 is reopened, the applicator 1104 is removed from the end effector assembly 1114 and the elements of the support end. Remain in the effector.

  In various embodiments, for example, at least one protective sheet (not shown) similar to sheet 918 can be positioned over surface 1110 so that adhesive 1112 can be applied to the anvil and / or staple cartridge. Without gluing, the applicator 1104 can be positioned multiple times on one of the anvil and staple cartridge of the end effector 1114. In at least one such embodiment, the surgeon positions and aligns the applicator with the appropriate position of the end effector to bring the adhesive into contact with the staple cartridge and / or anvil of the end effector before removing the sheet. It's okay. In various embodiments, in addition to or instead of the tongue 1117, the applicator can include at least one gripping member, such as, for example, a gripping member 1134, which is easier for the surgeon to end. The applicator in the effector can be operated. In at least one embodiment, a first gripping member 1134 can be provided on the first side of the applicator 1104 and a second gripping portion 1134 can be provided on the second end of the applicator. In various embodiments, the gripping member can be provided with a ridge 1138 and configured to allow the surgeon to more easily handle the applicator 1104. For this purpose, a flexible or elastic material such as rubber may be used for at least a part of the gripping member 1134.

  In other various embodiments, although not shown, a package including at least one support element has a tubular sleeve configured to be positioned to enclose at least one of the anvil and the staple cartridge. Can do. In at least one embodiment, the support can include an adhesive configured to removably attach the elements of the support to at least one of the anvil and the staple cartridge. In at least one such embodiment, the tubular sleeve can be configured to receive at least one of an anvil and a staple cartridge therein such that the anvil and / or staple cartridge is aligned with the element of the support within the tubular sleeve. can do. In various embodiments, the tubular sleeve can have an intermediate wall extending between a first side and a second side of the inner periphery within the sleeve. In various embodiments, the intermediate wall can include a top surface and a bottom surface, each configured to removably retain a support element. In at least one such embodiment, the end effector can be aligned with the intermediate wall and closed onto the intermediate wall to attach the support to the anvil and / or staple cartridge.

  In various embodiments, the support dispenser can be used to remove the support. In at least one embodiment, referring to FIGS. 54 and 55, dispenser 1200 can be configured to remove support 1236 from a housing assembly having housing portions 1210, 1212. As described in detail below, the dispenser 1200 can include a roll of support or spool 1224, which can be removed from the spool 1224 and placed on the end effector of the surgical instrument as shown in FIG. In various embodiments, the support 1236 can be adhered or supported to the carrier strip 1202 and the support 1236 can be peeled from the carrier strip 1202 when the support 1236 is removed. In various embodiments, referring to FIGS. 54-57, the carrier strip 1202 can include a surface 1204 on which a support 1236 rests. In various embodiments, the support 1236 can be divided before and / or after placement on the surface 1204. In at least one embodiment, each element of the support 1236 can have a width less than or equal to the surface 1204, and in various embodiments, for example, a low-strength adhesive can be used to attach the elements of the support. Removably attached to the surface 1204 of the carrier 1202.

  In various embodiments, referring to FIGS. 54-57, the inner wall 1214 of the first housing portion 1210 can include a plurality of connectors 1216 protruding from the inner wall 1214. In at least one embodiment, the connector 1216 can engage with a connector extending from an inner wall of the second housing portion 1212 or a hole provided in the inner wall to secure the first housing portion and the second housing portion. In various embodiments, referring to FIG. 56, the dispenser 1200 can further include a spool pin 1242, which can rotatably support the spool 1224. In at least one such embodiment, the spool pin 1242 can engage a hole 1241 in the first housing portion 1210 and a hole (not shown) in the second housing portion 1212. In various embodiments, the spool pin 1242 can be rotatably mounted with the spool 1242. As described above, support 1236 and carrier strip 1202 can be removed from spool 1224 as support 1236 is removed. In at least one embodiment, force may be applied to support 1236 and manually withdrawn from dispenser 1200. In various other embodiments, as described in detail below, the support dispenser 1200 can further include a thumb roller 1234 that can be securely engaged with the support 1236 so that the surgeon or other physician can rotate the thumb roller 1234. Support 1236 can be extruded from dispenser 1200. In at least one embodiment, referring to FIG. 55, the dispenser 1200 can further include a thumb roller pin 1235, which allows the thumb roller 1234 to be rotatably supported within the dispenser housing. In at least one embodiment, thumb roller 1234 is attached to pin 1235 to rotate together about an axis defined in hole 1249 in first housing portion 1249 and hole (not shown) in second housing portion 1212. Can do.

  In various embodiments, referring to FIG. 55, the thumb roller 1234 can be configured to extend at least partially into the hole 1239 of the dispenser housing, which allows the surgeon to rotate the thumb roller 1234. In at least one embodiment, the thumb roller 1234 can be operably contacted or frictionally engaged with the support 1236 and / or the carrier 1202 such that rotation of the thumb roller 1234 can cause the support 1236 to move distally toward the drive roller 1232. Can be driven or guided. In addition to or in lieu of the above, the drive roller 1232 can be configured to operably contact or frictionally engage the support 1236 and / or the carrier 1202. In at least one embodiment, the drive roller 1232 can operably engage the thumb roller 1234 via, for example, a drive belt 1243, and rotation of the thumb roller 1234 is transmitted to the drive roller 1232. Although a drive belt is illustrated, any other suitable device may be used, such as a drive chain or band. In various embodiments, at least one of the housing portions 1210, 1212 can include a guide 1262 that can be configured to align the drive belt 1243 with the thumb roller 1234 and the drive roller 1232.

  As described above, the carrier strip 1202 can be separated from the support 1236 when the support 1236 is removed from the dispenser 1200. In various embodiments, the dispenser 1200 can further include a carrier strip collector 1228 and can be configured to wind up the carrier strip 1202 removed from the support 1236. In at least one embodiment, the carrier strip collector 1238 can be attached to at least one of the spool 1224 and the spool pin 1242, and the spool 1224 and the strip collector 1228 can rotate simultaneously. In at least one such embodiment, the carrier strip 1202 is wound on the strip collector 1228 in a direction opposite to the direction in which the support 1234 is removed from the spool 1224. As a result, the support 1234 can be taken out and the carrier strip 1202 can be taken up simultaneously. In various embodiments, the dispenser 1200 can further include a separation plate 1230 that can peel or separate the support 1234 from the carrier 1202. In at least one embodiment, the separation plate 1230 can include an end 1258 that can be turned proximally by the strip collector 1228 by turning the carrier 1202 as described above.

  Under various circumstances, sagging may occur in the carrier strip 1202 separated from the support 1236. In at least one embodiment, the dispenser 1200 can include one or more extension members to reduce sagging in the carrier strip 1202. In various embodiments, similar to the above, the dispenser 1200 can further include a pin 1218 that is inserted into a hole 1251 in the first housing portion 1210 and a hole (not shown) in the second housing portion 1212. The pressure roller 1222 can be rotatably supported by being rotatably supported. In various embodiments, and with particular reference to FIGS. 56 and 57, the dispenser 1200 can further include a second drive roller 1253 that can be configured to cooperate with the pressure roller 1222. In at least one embodiment, the second drive roller 1253 can be operably engaged with the thumb roller 1236 and the rotation of the thumb roller 1234 can be transmitted to the drive roller 1253. In various embodiments, the dispenser 1200 can further include a gear train that is a spur gear 1244 attached to at least one of the thumb roller 1234 and the pin 1235 and an intermediate that is rotatably supported by the pin 1247. It has a gear 1246 and a driven gear 1252 that can be operatively engaged with the drive roller 1253. In at least one such embodiment, the carrier strip 1202 can be positioned intermediate the drive roller 1253 and the pressure roller 1222 such that when the drive roller 1253 is rotated by the thumb roller 1234, the drive roller 1253 is The strip 1202 can be driven proximally. In at least one embodiment, the pressure roller 1222 and / or the drive roller 1253 can be formed of an at least partially compressible material so that the pressure roller 1222 holds the carrier strip 1202 against the drive roller 1253. Can do.

  As described above, with reference to FIGS. 54-57, the applicator 1200 can include a housing 1201 having a first portion 1210 and a second portion 1212, which can be configured to be coupled to each other. In at least one embodiment, the first and second portions of the housing 1201 can be screwed, snapped, and / or otherwise engaged with each other. In various embodiments, the first housing portion and the second housing portion can be removably engaged with each other, separating the first housing portion and the second housing portion and removing and replacing the spool of the used support. Can do. In at least one embodiment, the housing can include ergonomic features that allow the surgeon to easily grasp the housing.

  In other various embodiments, referring to FIGS. 58-61, the dispenser or applicator 1266 can have a spool 1267 from which the support 1236 can be removed, plus the carrier strip 1202 removed from the support 1236. A recovery spool 1270 that can be configured to recover Similar to the above, the support 1236 can be removed from the applicator 1266 via engagement of the support 1236, the thumb roller 1234, and / or the drive roller 1232. In at least one embodiment, the collection spool 1270 can also be operably engaged with the thumb roller 1234, and rotation of the thumb roller 1234 can rotate the spool 1270 and wind the carrier strip 1202 around it. In various embodiments, the applicator 1266 can include a gear train that includes a spur gear 1244 attached to at least one of a thumb roller 1234 and a pin 1235 and an intermediate rotatably supported on the pin 1247. It has a gear 1246 and a driven gear 1272 attached to at least one of the spool 1270 and the pin 1271. In at least one such embodiment, as a result, rotation of the thumb roller 1234 can drive the collection spool 1270 and apply force directly to the carrier strip 1202 to cause the carrier strip 1202 to be collected around the spool 1270.

  In various embodiments, referring to FIGS. 57 and 61, the support applicator 1200 and / or 1266 can be configured to support elements of the deck “D” and / or anvil “A” of the staple cartridge “SC”. Can be used to attach to “F”. In at least one embodiment, as shown in FIG. 61, the surgeon may first place an applicator 1266 at, for example, the first end 1276 of the deck D. Thereafter, the surgeon pulls the applicator toward the second end 1278 of deck D while rotating the thumb roller 1234 to remove the support 1236. As described above, the support 1236 can be divided into a plurality of elements, and in at least one embodiment, the length of the elements is such that the elements of the support exactly fit the staple cartridge deck and / or anvil surface. It's okay. In various other embodiments, the support element can be a continuous strip and the applicator includes a cutting member (not shown) that can be configured to cut the support to any suitable length. Can be included. In various embodiments, an element of the support may be provided with an adhesive or may be configured to removably hold the support with one of the deck and / or face.

  In various embodiments, the support element may be manufactured by injection molding. In at least one embodiment, an injection mold (not shown) is formed with one or more molding cavities, for example, capable of receiving molten material. In various embodiments, the molten material can include plastic and / or any other suitable support material. In various embodiments, the mold can further include at least one sprue hole and / or runner so that the molding cavity can be in fluid communication with the injection molding equipment. In at least one embodiment, the mold can include a first portion and a second portion, which can be separated once the molten material has fully solidified or cured within the molding cavity.

  In various embodiments, referring to FIGS. 62 and 63, the elements of the support 1336 can include a first surface 1302 and a second surface 1304, each of the first and second surfaces having a plurality of holes. That is, the recess 1306 can be included. In at least one embodiment, the recess 1306 can be formed from a molten material in a mold in an injection molding process. More particularly, the mold can include one or more depressions having a plurality of protrusions, and when molten material flows around the protrusions, the elements of the support 1336 solidify and are removed from the mold. A recess 1306 is formed in the portion of the support 1336 where the protruding portion exists.

  In various embodiments, the support 1336 can further include a plurality of walls, such as a wall 1305, for example. This wall 1305 is formed intermediate the first surface 1302 and the second surface 1304 and can define a recess 1306. In at least one embodiment, the wall 1305 can be formed perpendicular and / or perpendicular to the first and second surfaces, and the wall 1305 is formed such that the recesses 1306 form a pattern or grid within the support 1336. Can be configured and arranged. In various embodiments, the support 1336 can be configured to be elastic such that the first surface 1302 and / or the second surface 1304 are compressed together. In at least one such embodiment, the support 1336 can be compressed or press-fit between two or more holding members of the end effector, as described above. In various embodiments, the support element is compressed upon attachment to the end effector of the surgical instrument and can be expanded upon removal from the end effector. In at least one embodiment, the support 1336 can be compressed such that the first surface 1310 moves toward the second surface 1312. In any case, the wall 1305 can be configured to be deflected or crushed, and the portions of the support 1336 can be configured to elastically approach each other.

  The devices disclosed herein can be designed to be discarded after a single use, or they can be designed to be used multiple times. In either case, the device can be regenerated for reuse after at least one use. Regeneration can include any combination of the steps of cleaning or replacing certain parts and reassembling after disassembling the apparatus. In particular, the apparatus can be disassembled, and any number of specific parts or parts of the apparatus can be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, the device can be reassembled at the refurbishment facility for next use or reassembled by the surgical team immediately prior to surgery. Those skilled in the art will recognize that a variety of techniques can be used to regenerate the device, including disassembly, cleaning / replacement, and reassembly. All such techniques, and the devices regenerated as a result, are within the scope of this application.

  Preferably, the inventive steps described herein are performed prior to surgery. First, prepare a new or used instrument and clean it if necessary. And this instrument is sterilized. As one of the sterilization techniques, the device is enclosed in a sealed container such as a plastic or TYVEK bag. The container and instrument are then placed in a radiation field such as gamma rays, X-rays, high energy electrons, etc. that can penetrate the container. Radiation kills bacteria on the instrument and in the container. The sterilized instrument is then stored in the sterilized container. The sealed container keeps the instrument sterile until it is opened in a medical facility.

While this invention has been described as having an exemplary design, further modifications can be made within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention in accordance with the principles of the invention in general. Furthermore, it is intended to embrace deviations from the present disclosure as included in known or customary practices in the relevant technical field of the present invention.
Embodiment
(1) In an end effector assembly for use with a surgical stapler,
The end effector assembly comprises:
A staple cartridge having a deck;
An anvil having a surface;
An element of the support having an opening;
A coupling member;
Have
One of the deck and the surface defines a hole therein;
The support element is configured to be positioned intermediate the staple cartridge and the anvil such that the opening is substantially aligned with the aperture;
An end effector assembly, wherein the coupling member is positioned within the opening and the aperture and is configured to removably retain an element of the support on one of the staple cartridge and the anvil.
(2) In the end effector assembly according to Embodiment 1,
A plurality of coupling members,
Further comprising
A plurality of holes are defined in the one of the deck and the surface;
The support element includes a plurality of openings, and the plurality of coupling members are inserted into the plurality of holes and the plurality of openings so that the support element is removable from one of the staple cartridge and the anvil. An end effector assembly, wherein the opening is configured to substantially align with the plurality of holes so that it can be retained.
(3) In the end effector assembly according to Embodiment 1,
The end effector assembly, wherein the coupling member is configured to be removed from the hole when an element of the support is separated from the one of the staple cartridge and the anvil.
(4) In the end effector assembly according to Embodiment 1,
The end effector assembly, wherein the coupling member is configured to be removed from the opening when an element of the support is separated from the one of the staple cartridge and the anvil.
(5) In the end effector assembly according to Embodiment 1,
The end effector assembly, wherein the coupling member comprises a bioabsorbable material.
(6) In the end effector assembly according to Embodiment 1,
The end effector assembly, wherein the coupling member is configured to remain in the opening after an element of the support is separated from the one of the staple cartridge and the anvil.
(7) In the end effector assembly according to Embodiment 1,
The staple cartridge includes a staple cartridge path and a staple cartridge insertion portion,
The staple cartridge insertion portion is configured to accommodate a staple in a removable manner,
An end effector assembly, wherein the staple cartridge path is configured to receive the staple cartridge insert.
(8) In the end effector assembly according to Embodiment 1,
The end effector assembly, wherein the coupling member is configured to be press-fitted into the hole.
(9) In the end effector assembly according to Embodiment 1,
The coupling member has a head, and when the coupling member engages the hole, the head moves relative between an element of the support member and the one of the staple cartridge and the anvil. An end effector assembly configured to limit
(10) In an end effector assembly for use with a surgical stapler,
The end effector assembly comprises:
A staple cartridge;
With anvil,
An element of a support configured to be intermediate between the staple cartridge and the anvil;
A plurality of securing members configured to releasably retain the support element on one of the staple cartridge and the anvil;
An end effector assembly.
(11) The end effector assembly according to Embodiment 10,
One of the staple cartridge and the anvil has a plurality of holes,
An end effector assembly, wherein the securing member is removably press-fitted into the hole and is configured to hold an element of the support to the one of the staple cartridge and the anvil.
(12) The end effector assembly according to embodiment 10,
Each of the securing members has a head, and when the securing member engages the hole, the head is relative between an element of the support member and the one of the staple cartridge and the anvil. An end effector assembly configured to limit complete movement.
(13) In the end effector assembly according to embodiment 10,
A second element of the support configured to be intermediate between the staple cartridge and the anvil;
A plurality of second securing members configured to releasably retain an element of the support relative to the one of the staple cartridge and the anvil;
And an end effector assembly.
(14) In the end effector assembly according to Embodiment 10,
The end effector assembly, wherein the securing member includes a bioabsorbable material.
(15) In the end effector assembly according to embodiment 10,
The end effector assembly, wherein the securing member includes a clip.
(16) A support element for use with a surgical stapler, wherein the surgical stapler has a staple cartridge and an anvil, and one of the staple cartridge and the anvil has a plurality of holes. In the element of
The support element comprises:
The body,
A plurality of openings in the body;
Have
The support element is configured to be positioned intermediate the staple cartridge and the anvil such that the opening is substantially aligned with the aperture;
The opening is an element of a support configured to receive a coupling member therein and removably hold the body to the one of the staple cartridge and the anvil.

FIG. 1 is a perspective view of an end effector assembly configured to engage, dissect, staple, and attach a support element to tissue in accordance with one non-limiting embodiment of the present invention. FIG. 2 shows the end of FIG. 1 after use of an end effector to engage, dissect, staple, and attach a support element to tissue, according to one non-limiting embodiment of the present invention. It is a perspective view of an effector assembly. FIG. 3 is a perspective view of an end effector attached to the distal end of a surgical instrument according to one non-limiting embodiment of the present invention. FIG. 4 is a perspective view of an open end effector assembly with at least one support element disposed thereon, according to one non-limiting embodiment of the present invention. 5 is a perspective view of the staple cartridge of the end effector assembly of FIG. 4 with the support removably retained. FIG. 6 is an exploded perspective view of the staple cartridge and the support shown in FIG. 7 is a perspective view of a coupling member configured for use with the end effector assembly of FIG. FIG. 8 is a perspective view of the anvil of the end effector assembly of FIG. 4 with releasably holding at least one support element. FIG. 9 is a side view of the coupling member of FIG. FIG. 10 is an exploded perspective view of the anvil and support of FIG. FIG. 11 is a perspective view of a staple cartridge and anvil of an end effector assembly with attached support elements, according to one non-limiting embodiment of the present invention. FIG. 12 is an exploded view of an end effector assembly having a staple cartridge and an anvil according to one non-limiting embodiment of the present invention. FIG. 13 is an exploded view in which some of the components of the end effector assembly of FIG. 12 are removed. FIG. 14 is a front view of the end effector assembly of FIG. FIG. 15 is a perspective view of an end effector assembly according to another non-limiting embodiment of the present invention. 16 is a partial perspective view with parts removed of the end effector assembly of FIG. 15 having a retractable member configured to removably retain at least one support element. 17 is an end view of the end effector assembly of FIG. 15 taken along line 17-17 of FIG. 18 is an exploded partial perspective view of the end effector assembly of FIG. FIG. 19 is a side view of a cutting member configured for use with an end effector assembly according to one non-limiting embodiment of the present invention. FIG. 20 is a side view of a cutting member configured for use with an end effector assembly, according to one non-limiting embodiment of the present invention. FIG. 21 is a side view of a cutting member configured for use with an end effector assembly, according to one non-limiting embodiment of the present invention. FIG. 22 is a perspective view of a staple cartridge with removable support elements according to one non-limiting embodiment of the present invention. FIG. 23 is an exploded perspective view of the support element and staple cartridge of FIG. 22 with a plurality of members extending. 24 is a cross-sectional view taken along line 24-24 of FIG. 22, illustrating the member of FIG. 23 engaged with a staple cavity, according to one non-limiting embodiment of the present invention. FIG. 25 is a cross-sectional view of a support element including a member engaged with a staple cavity of a staple cartridge, according to one non-limiting embodiment of the present invention. 26 is an exploded view of FIG. 25 illustrating the separation of the members from the staple cavities of the staple cartridge, according to one non-limiting embodiment of the present invention. FIG. 27 illustrates an end effector having an end effector anvil configured to removably retain a support element and a retention element extending from a staple cartridge, according to one non-limiting embodiment of the present invention. It is an exploded sectional view of an assembly. FIG. 28 illustrates an end effector having an end effector anvil configured to removably retain a support element and a retention element extending from a staple cartridge, according to one non-limiting embodiment of the present invention. It is an exploded sectional view of an assembly. FIG. 29 is a cross-sectional view of an end effector illustrating a support element having a recess positioned within the end effector according to one non-limiting embodiment of the present invention. FIG. 30 is a cross-sectional view of an end effector illustrating a support element having perforations and recesses positioned within the end effector according to one non-limiting embodiment of the present invention. FIG. 31 is a perspective view with elements of the support of FIG. 30 partially removed from an intermediate position. FIG. 32 is a cross-sectional view of an anvil having a support element engaged in a cutting member slot, according to one non-limiting embodiment of the present invention. FIG. 33 is a cross-sectional view of a staple cartridge with a support element removably retained in accordance with one non-limiting embodiment of the present invention. FIG. 34 is a cross-sectional view of a support element removably located on an anvil according to one non-limiting embodiment of the present invention. FIG. 35 is a detailed view of a support element removably disposed on an anvil according to one non-limiting embodiment of the present invention. FIG. 36 is a detailed view of the support elements removably disposed on the anvil, according to one non-limiting embodiment of the present invention. FIG. 37 is a detailed view of a support element removably disposed on an anvil according to one non-limiting embodiment of the present invention. FIG. 38 is a package assembly including a support element according to one non-limiting embodiment of the present invention, wherein the package assembly is positioned on an end effector of an open surgical instrument. FIG. FIG. 39 is a perspective view of the package assembly of FIG. 38 showing the end effector closed on the package and support elements. FIG. 40 illustrates the end effector anvil engaging the support element and the package removed from the support element, according to one non-limiting embodiment of the present invention. FIG. FIG. 41 is a perspective view of a package assembly for use with a support element in a sterile external package according to one non-limiting embodiment of the present invention. 42 is a perspective view of the internal package of the package assembly of FIG. 41 in an unopened state. FIG. 43 is a perspective view in which the package of FIG. 42 is partially opened. FIG. 44 is a perspective view of the package of FIG. 42 opened. 45 is a perspective view of the package of FIG. 42 positioned in the open end effector. 46 is a perspective view of the package of FIG. 45 partially removed from the end effector. FIG. 47 is a perspective view of an applicator assembly for use with a support element positioned within an end effector of a surgical instrument, according to one non-limiting embodiment of the present invention. 48 is a plan view of the applicator assembly of FIG. 47. FIG. FIG. 49 is a plan view of an applicator assembly according to another non-limiting embodiment of the present invention. FIG. 50 is a perspective view of a support applicator assembly according to one non-limiting embodiment of the present invention. 51 is another perspective view of the support applicator assembly of FIG. 50. FIG. FIG. 52 is a perspective view of the support applicator assembly of FIG. 50 positioned within an end effector of a surgical instrument. 53 is a perspective view of the support applicator assembly of FIG. 50 partially removed from the end effector. FIG. 54 is a perspective view of a support applicator configured to attach at least one support element to an end effector of a surgical instrument, according to one non-limiting embodiment of the present invention. FIG. 55 is an exploded view of the support applicator of FIG. FIG. 56 is an elevational view with some of the components of the support applicator of FIG. 54 removed. FIG. 57 is a perspective view in which some of the parts of the support applicator of FIG. 54 have been removed. FIG. 58 is a perspective view of another support applicator configured to attach at least one support element to an end effector of a surgical instrument, according to another non-limiting embodiment of the present invention. It is. FIG. 59 is an exploded perspective view of the support applicator of FIG. 60 is an elevational view with some of the components of the support applicator of FIG. 58 removed. 61 is a perspective view with parts removed of the support applicator of FIG. 58. FIG. FIG. 62 is a perspective view of a support element, according to one non-limiting embodiment of the present invention. 63 is a cross-sectional view of the elements of the support of FIG. 62 taken along line 63-63 of FIG.

Claims (7)

In an end effector assembly for use with a surgical stapler,
The end effector assembly comprises:
A staple cartridge having a deck , wherein the deck has a surface, a plurality of holes defined in the surface, and a longitudinal slot that substantially bisects the surface ;
A blade positioned to travel distally within the longitudinal slot;
An anvil having a surface;
A first element of a support having a first opening , wherein the first element of the support is such that the first opening is substantially aligned with a first hole selected from the plurality of holes. A first element of a support configured to be positioned intermediate the staple cartridge and the anvil on a first side of a longitudinal slot ;
A second element of a support having a second opening, wherein the second element of the support is such that the second opening is substantially aligned with a second hole selected from the plurality of holes. A second element of the support configured to be positioned intermediate the staple cartridge and the anvil on a second side of the longitudinal slot opposite the first element of the support;
First and second coupling members , wherein the first coupling member is located within the first opening and the first hole to removably retain the first element of the support in the staple cartridge The second coupling member is located within the second opening and the second hole and is configured to removably hold the second element of the support to the staple cartridge; First and second coupling members ;
Have
At least the first coupling member is
A head having an outer periphery larger than the first opening of the first element of the support, wherein the head is configured to have a first of the support when the first coupling member is engaged with the first hole. A head configured to engage an element and prevent the first element of the support from lifting from the surface of the deck;
A main body removably located within the first hole, wherein the main body has an outer periphery smaller than the outer periphery of the head, and a side wall of the first opening is engaged with the outer periphery of the main body. The first element of the support is configured to prevent sliding along the surface of the deck, and the body is received within a first end coupled to the head and the first hole. A main body having a second end portion, the head portion of the first coupling member extending outward from the main body,
Have
The end effector assembly , wherein the head is removable from the body when at least a portion of the first element of the support is removed from the staple cartridge . The end effector assembly according to claim 1,
A plurality of coupling members,
Further comprising
A plurality of holes are defined before Symbol surface,
The third element of the supporting bearing member includes a plurality of openings, said plurality of coupling members are inserted into said plurality of holes and said plurality of apertures, removably third element of the support before Symbol AMBI Le retention An end effector assembly, wherein the opening is configured to substantially align with the plurality of holes. The end effector assembly according to claim 1,
Said first coupling member, the the first element of the support to separate the staple cartridge or al, configured to be detached from the first hole, the end effector assembly. The end effector assembly according to claim 1,
Said first coupling member, the the first element of the support to separate the staple cartridge or al, configured to be detached from said first opening, the end effector assembly. The end effector assembly according to claim 1,
The first effector assembly is formed of a bioabsorbable material. The end effector assembly according to claim 1,
It said first coupling member, after the first element of the support is separated the staple cartridge or al, configured to remain within said first opening, the end effector assembly. The end effector assembly according to claim 1,
The first effector assembly is configured to be press-fitted into the first hole.

Images