System of surgical staple cartridges with absorbable staples

Abstract

A staple cartridge is disclosed that includes bioabsorbable staples, the staples being configured to be bioabsorbable within a desired time frame.

Description

[Technical Field]

[0001] (Cross-reference of related applications) This application claims interest under § 119(e) of U.S. Patent Act pursuant to U.S. Provisional Patent Application No. 63 / 186,519, filed on 10 May 2021, with the title of the invention, "ABSORBABLE METAL STAPLE," and the full disclosure of this provisional patent is incorporated herein by reference. [Background technology]

[0002] This invention relates to surgical staples for compressing and juxtaposing patient tissue. During surgical procedures, clinicians can use surgical stapling devices to staple and cut patient tissue. A surgical stapling device may include a staple cartridge, which removably houses staples deployed into patient tissue by the firing mechanism of the surgical stapling device. When deployed, the staples pierce a first side of the tissue and are then deformed by the anvil of the surgical stapling device, which is positioned on a second or opposite side of the tissue. The deformed staples constrict or compress the tissue to prevent, or at least reduce, bleeding from the incision formed by the stapling device.

[0003] Staples can be made from bioabsorbable materials so that they can dissolve and release tissue after a sufficient amount of time has elapsed since the surgical procedure. While it is desirable for the staples to eventually dissolve and release tissue, they must maintain their structural integrity for a certain period of time, i.e., a bio-erosion timeframe, to allow for sufficient tissue healing. When selecting an appropriate bioabsorbable material so that the staples can meet the bio-erosion timeframe, many factors are considered, such as the stiffness of the staples, the strength of the staples, the ductility of the staple material, the safety of the material used (e.g., toxicity concerns), and / or the compatibility of the material with electrosurgical instruments. In comparison, stents, which are often implanted to keep arteries open, are often made of alloys that resist or prevent bio-erosion of the underlying structure, even if the stent surface contains a dissolvable coating. [Brief explanation of the drawing]

[0004] The various features of the embodiments described herein, along with their advantages, can be understood by carrying out the invention described below in conjunction with the following accompanying drawings. [Figure 1] This is a perspective view of staples for use with surgical stapling devices. [Figure 2] Figure 1 is a side view of the staple. [Figure 3] Figure 1 is a top view of the stapler. [Figure 4] This is a cross-sectional view of the staple in Figure 1, taken along line 4-4 in Figure 3. [Figure 5] This is a partial cross-sectional perspective view of a staple cartridge assembly showing staples ejected from the staple cartridge assembly by a launching member. [Figure 6] This is a plan view of the staple cartridge installed inside the end effector. [Figure 7] This is a magnified plan view of a portion of a staple cartridge. [Figure 8]It is a side view of a wire staple. [Figure 9] It is an isometric view of an end effector of a surgical stapling instrument with an anvil shown in the open position. [Figure 10] It is an elevation view of a staple. [Figure 11] It is an elevation view of an asymmetric staple. [Figure 12] It is an elevation view of another asymmetric staple. [Figure 13] It is an elevation view of another asymmetric staple. [Figure 14] It is a perspective view of an end effector assembly configured to engage, cut, staple, and apply a single piece of battless material to tissue. [Figure 15] It is a perspective view of the end effector assembly of FIG. 14 after the end effector has been utilized to engage, cut, staple, and apply a single piece of battless material to tissue. [Figure 16] It is an elevation view of a staple having rounded corners according to at least one embodiment. [Figure 16A] It is a view showing a wire staple embedded in a patient's tissue according to at least one embodiment. [Figure 16B] It is a view showing the wire staple of FIG. 16A in a partially dissolved functional state. [Figure 16C] It is a view showing the wire staple of FIG. 16A in a mostly dissolved non-functional state. [Figure 16D] It is a view showing the wire staple of FIG. 16A in a completely dissolved state. [Figure 17] It is a perspective view of a wire staple including a polished surface according to at least one embodiment. [Figure 18] It is a perspective view of a wire staple having a knurl according to at least one embodiment. [Figure 19] It is a perspective view of a wire staple defining an internal punched-out spot according to at least one embodiment. [Figure 20]Figure 19 is an elevation view of a wire staple. [Figure 21] This is a cross-sectional view of the wire staple in Figure 19, along line 21-21 in Figure 20. [Figure 22] This is a cross-sectional view of the wire staple in Figure 19, along line 22-22 in Figure 20. [Figure 23] This is an elevation view of a wire staple and staple driver according to at least one embodiment. [Figure 24] This is an elevation view of a wire staple and staple driver according to at least one embodiment. [Figure 25] This is an elevation view of a wire staple and staple driver according to at least one embodiment. [Figure 26] This is an elevation view of a wire staple according to at least one embodiment, having a staple tip sharper than the staple tip of the staple in Figure 25. [Figure 27] A perspective view of a wire staple and staple driver according to at least one embodiment. [Figure 28] Figure 27 is an elevation view of the wire staple and staple driver. [Figure 29] Figure 27 is a perspective view of the staple driver. [Figure 30] Figure 27 is a cross-sectional view of a wire staple and staple driver. [Figure 31] Figure 27 is a cross-sectional view of a wire staple and staple driver. [Figure 32] Figure 27 is a cross-sectional view of a wire staple and staple driver. [Figure 33] A perspective view of a wire staple and staple driver according to at least one embodiment. [Figure 34] This is a cross-sectional view of wire staples positioned in different staple drivers according to at least one embodiment. [Figure 35]This is a cross-sectional view of a wire stapler and staple driver according to at least one embodiment, showing a wire staple deflected to contact a staple driver during the staple firing process. [Figure 36] This is a cross-sectional view of a wire stapler and stapler according to at least one embodiment, showing a wire staple deflected downward toward the seat of the stapler driver during the staple firing process. [Figure 37] This is a partial cross-sectional view of a staple cartridge, which includes a staple cavity, a staple driver movably positioned within the staple cavity, and staples that can be ejected from the staple cavity. [Figure 38] A perspective view of a stapler and stapler driver according to at least one embodiment. [Figure 38A] This diagram shows the staples in the launch configuration shown in Figure 38. [Figure 39] This graph shows the healing time of tissue. [Figure 40] This graph shows the healing of tissue. [Figure 41] This graph shows the strength of tissue during the healing process. [Figure 42] This is a diagram illustrating the tissue healing process. [Figure 43] This graph shows the elongation and stress of a specific metal. [Figure 44] This graph shows the corrosion rate and alloy percentage of specific metals. [Figure 45A] This figure shows a coated wire staple embedded in patient tissue according to at least one embodiment. [Figure 45B] This figure shows a coated wire staple in a partially melted, functional state. [Figure 45C] This figure shows a coated wire staple in a functional state, with most of it melted. [Figure 45D]This figure shows wire staples in a completely melted state. [Figure 46] This is a cross-sectional view of a staple wire according to at least one embodiment. [Figure 47] This is a cross-sectional view of a coated staple wire according to at least one embodiment. [Figure 48] This is a cross-sectional view of a staple wire with a thin coating, according to at least one embodiment. [Figure 49] This is a cross-sectional view of a staple wire with a thick coating, according to at least one embodiment. [Figure 50] This is a cross-sectional view of a staple wire having a powder coating according to at least one embodiment. [Figure 51] This is a cross-sectional view of a staple wire having two coatings, according to at least one embodiment. [Figure 52] This is a cross-sectional view of a staple wire having an impregnated coating according to at least one embodiment. [Figure 53] This is a cross-sectional view of a staple having an impregnated coating and a localized coating according to at least one embodiment. [Figure 54] This is a cross-sectional view of a hollow staple wire according to at least one embodiment. [Figure 55] This is a cross-sectional view of a staple wire including an inner substrate and an outer substrate according to at least one embodiment. [Figure 56] This is a cross-sectional view of a staple filled with a therapeutic agent according to at least one embodiment. [Figure 57] Figure 55 shows a cross-sectional view of a staple wire, including a coating, according to at least one embodiment. [Figure 58] This is a cross-sectional view of a coated staple according to at least one embodiment. [Figure 59] This is a cross-sectional view of coated staples having different coating thicknesses according to at least one embodiment. [Figure 60] This figure shows a wire staple manufacturing process according to at least one embodiment. [Figure 61] This figure shows a staple manufacturing process according to at least one embodiment, in which a first coating is applied before the staple formation step in the process and a second coating is applied after the staple formation step. [Figure 62] This figure shows the process by which staples are coated while they are positioned within a staple cartridge, according to at least one embodiment. [Figure 63] This figure shows a staple manufacturing process according to at least one embodiment. [Figure 64] This figure shows a staple manufacturing process, including a coating reflow process, according to at least one embodiment. [Figure 65] This diagram shows staples being cut from a multi-layer sheet of material. [Figure 66] Figure 65 is a perspective view of the staples. [Figure 67] This is a cross-sectional view of the staple in Figure 66, along line 67-67 in Figure 66. [Figure 67A] This figure shows the coating on the staples, as shown in Figure 66. [Figure 68] This is a perspective view of a surgical staple cartridge, which includes staples, a staple driver, and threads configured to eject staples from the staple cartridge. [Figure 69] This is a perspective view of another surgical staple cartridge, which includes staples with an integrated staple driver and threads configured to eject staples from a staple cartridge. [Figure 70] This is a perspective view of a surgical system including a staple assembly tool for inserting staples into a staple cartridge. [Figure 71] This is a plan view of multiple staple lines after they have been implanted in the patient's tissue. [Figure 72] This is a partial plan view of a staple cartridge containing wire staples and punched staples, according to at least one embodiment. [Figure 73A] This figure shows a staple pattern, embedded in patient tissue in an unabsorbed state, according to at least one embodiment. [Figure 73B] This figure shows the staple pattern of Figure 73A in a partially absorbed state. [Figure 73C] This figure shows the staple pattern in Figure 73A, which is in a more absorbed state compared to Figure 73B. [Figure 73D] This figure shows the staple pattern in Figure 73A, which is in a more absorbed state, compared to Figure 73C, which shows the outer two longitudinal staple rows almost completely absorbed. [Figure 74] This figure shows tissue stapled by overlapping staple launches according to at least one embodiment. [Figure 75A] This figure shows a staple pattern embedded in patient tissue, which also includes, in at least one embodiment, a decoy staple configured to be bioabsorbed before the staples in the staple pattern. [Figure 75B] Figure 75A shows a staple decoy that is beginning to be absorbed by the body before the staples are fully absorbed. [Figure 75C] This figure shows the further bioabsorption of the staple decoy in Figure 75A while the staples are beginning to be absorbed by the body. [Figure 75D] This figure shows the dissolution of the staple decoy in Figure 75A before the staples dissolve. [Figure 76] This figure shows wire staples having different wire diameters, embedded in patient tissue, according to at least one embodiment. [Figure 77] This figure shows staples of different sizes and coatings embedded in patient tissue according to at least one embodiment. [Figure 78]This is a partial plan view of a staple cartridge comprising a staple cavity and two staples housed in each staple cavity, according to at least one embodiment. [Figure 79] This is a partial plan view of a staple cartridge comprising, according to at least one embodiment, a longitudinal row of staple cavities, each containing one staple, and a longitudinal row of staple cavities, each containing two staples. [Figure 80] This is a partial plan view of a staple cartridge comprising one staple housed in a proximal staple cavity and two staples housed in a distal staple cavity, according to at least one embodiment. [Figure 81] This is a partial plan view of a staple cartridge comprising coated staples and uncoated staples according to at least one embodiment. [Figure 82] This is a partial plan view of a staple cartridge comprising, according to at least one embodiment, an uncoated staple in a proximal staple cavity and a coated staple in a distal staple cavity. [Figure 83] This is a partial plan view of a staple cartridge comprising staples having different wire diameters, according to at least one embodiment. [Figure 84] This is a partial plan view of a staple cartridge, according to at least one embodiment, which includes thin staples in a proximal staple cavity and thick staples in a distal staple cavity. [Figure 85] This is a partial plan view of a staple cartridge, according to at least one embodiment, which includes a thick staple in a proximal staple cavity and a thin staple in a distal staple cavity. [Figure 86] This figure shows a bioabsorbable patch applied over a staple line, according to at least one embodiment. [Figure 87]This is a perspective view of a surgical staple assembly and tissue prior to tissue incision and stapling, according to various aspects of this disclosure. [Figure 88] Figure 87 is a perspective view of a surgical staple assembly and tissue after tissue incision and stapling, showing layers of buttresses stapled to tissue according to various aspects of this disclosure. [Figure 89] Figure 87 shows a perspective view of the surgical staple assembly and tissue after tissue incision and stapling, and after the dissolution of the buttress layer within the patient, according to various aspects of this disclosure. [Figure 90] Figure 87 is a schematic diagram illustrating a schedule showing the disassembly and bioresorption of the staples and buttresses of the surgical staple assembly according to various aspects of this disclosure. [Figure 91] This is a schematic diagram of a schedule showing the disassembly and bioresorption of staples and buttresses of another surgical staple assembly according to various aspects of the present disclosure. [Figure 92] A perspective view of a surgical staple assembly and its structure according to various aspects of the present disclosure, further showing a layer of buttresses releasably fixed to the surgical staple assembly, the layer of buttresses including an array of through-holes aligned with the staple legs. [Figure 93] A perspective view of a surgical staple assembly and its tissue according to various aspects of the present disclosure, further showing a layer of buttresses releasably fixed to the surgical staple assembly, the layer of buttresses including an array of longitudinal ridges aligned with rows of staples. [Figure 94] A perspective view of a surgical staple assembly and its structure according to various aspects of this disclosure, further showing a layer of buttresses releasably fixed to the surgical staple assembly, the layer of buttresses being positioned to accommodate projections from the deck, and including an array of dimensionally defined slots. [Figure 95] A perspective view of a surgical stapled assembly and tissue, further illustrating a multilayer buttress releasably fixed to tissue according to various aspects of the present disclosure. [Figure 96]A perspective view of a surgical staple assembly and tissue, further illustrating a corrugated buttress releasably fixed to a surgical staple assembly according to various aspects of the present disclosure. [Figure 97] These are cross-sectional elevation views of a staple cartridge and a buttress releasably fixed to the staple cartridge, according to various embodiments of the present disclosure. [Figure 98] This is a cross-sectional elevation view of a portion of a surgical staple fastening assembly, including a staple cartridge, a buttress releasably fixed to the staple cartridge, and an anvil, showing a firing element in the intermediate firing stroke of the staple cartridge according to various aspects of the present disclosure. [Figure 99] A surgical staple fastening assembly according to various aspects of the present disclosure further includes a buttress releasably fixed to a staple cartridge, the buttress having through holes adapted to receive staple legs through it during the firing stroke, and is shown in a cross-sectional elevation view of a portion of the surgical staple fastening assembly including the staple cartridge and anvil of Figure 98 during the firing stroke. [Figure 100] This is a block diagram of a surgical instrument programmed to control the distal translation of a displacement member, according to various aspects of the present disclosure. [Figure 101] This is a perspective view of an end effector assembly configured to engage, cut, staple, and apply embedded auxiliary material to tissue, according to at least one aspect of the present disclosure. [Figure 102] Figure 101 is a perspective view of the end effector assembly after the end effector has been used to engage, cut, staple, and apply the embedded auxiliary material to the tissue. [Figure 103] This is a perspective view of a stapled tissue and an embedded auxiliary material applied to the stapled tissue, according to at least one aspect of the present disclosure. [Figure 104] Figure 102 is a partial perspective view of a stapled tissue. [Figure 105]This figure shows the disassembly sequence of a staple and an embedded auxiliary material portion held in place by the staple, according to at least one aspect of the present disclosure. [Figure 106] This is a top view of an embedded auxiliary material, comprising an embedded auxiliary material portion and staples deployed within the embedded auxiliary material portion from a staple cartridge, according to at least one aspect of the present disclosure. [Figure 107] This is a top view of an embedded auxiliary material, comprising an embedded auxiliary material portion and staples deployed within the embedded auxiliary material portion from a staple cartridge, according to at least one aspect of the present disclosure. [Figure 108] This is a perspective view of stapled tissue showing multiple firings of a surgical stapler according to at least one aspect of the present disclosure, with staples overlapping from subsequent firings. [Figure 109] This is a perspective view of an end effector assembly configured to engage, cut, staple, and apply an implantable auxiliary material containing a drug to tissue, according to at least one aspect of the present disclosure. [Figure 110] The present disclosure shows a disintegration sequence of a staple containing a material configured to deliver radiotherapy to a stapled tissue, according to at least one aspect of this disclosure. [Figure 111] This is a perspective view of a surgical staple fastening device comprising a handle, a shaft assembly, and a surgical end effector. [Figure 112] Figure 1 is a perspective view of the shaft assembly and a portion of the handle. [Figure 113] Figure 1 is an exploded view of the surgical end effector. [Figure 114] Figure 1 is a perspective view of the surgical end effector, showing the anvil in the open position and the cartridge / retainer assembly, which includes a staple retainer attached to a surgical staple cartridge, removed from the channel of the surgical end effector. [Figure 115]Figure 114 is a perspective view of a surgical end effector, showing the surgical staple cartridge of the cartridge / retainer assembly seated within the channel of the surgical end effector, with the staple retainer removed from the surgical staple cartridge. [Figure 116] This is a perspective view of a packaging assembly embodiment, comprising the cartridge / retainer assembly shown in Figure 114, housed inside a sealed container with a pouch, and a drying element also contained within the sealed pouch. [Figure 117] This is a perspective view of another packaging assembly embodiment in which the cartridge / retainer assembly is immovably seated in a cartridge tray that is housed in a sealed container having a pouch, and the drying element is also contained within the sealed pouch. [Figure 118] A perspective view of another packaging assembly embodiment in which a cartridge / retainer assembly is immovably seated within a cartridge tray component of a sealable container, and the container further comprises an upper member in a partially open position configured to be attached to the cartridge tray and together establish a sealing seal, and the container further includes a drying element therein. [Figure 119] This is an exploded view of an embodiment of a staple retainer, a drying element, and a surgical staple cartridge, in which the drying element is positioned between the staple retainer and the surgical staple cartridge. [Figure 120] Figure 119 is a side view of the staple retainer connected to a surgical staple cartridge, where the drying element is trapped between the staple retainer and the deck of the surgical staple cartridge, forming a cartridge / retainer assembly. [Figure 121] Another embodiment of the drying element is an exploded view of the staple retainer shown in Figure 119, where the drying element is positioned between the staple retainer and the surgical staple cartridge, and is formed together with a plurality of staple-retaining projections configured to be inserted into corresponding staple cavities within the surgical staple cartridge to restrain staples therein. [Figure 122]Figure 121 is a cross-sectional view of a portion of the staple retainer connected to the surgical staple cartridge, where the drying element is trapped between the staple retainer and the deck of the surgical staple cartridge, and the staple-holding projection of the staple retainer is received into the corresponding staple cavity of the surgical staple cartridge, thereby constraining the staples contained therein onto the corresponding staple driver. [Figure 123] A perspective view of another packaging assembly embodiment, which comprises a cartridge / retainer assembly housed inside a sealed container with a pouch, the cartridge / retainer assembly comprising a staple retainer connected to a surgical staple cartridge, and a drying element attached to the staple retainer. [Figure 124] A perspective view of another packaging assembly embodiment, in which the cartridge / retainer assembly comprises a staple retainer connected to a surgical staple cartridge, and the cartridge / retainer assembly is housed inside a container having a sealed pouch, which is received between upper drying elements supported within the sealed pouch. [Figure 125] Figure 124 shows a cartridge / retainer assembly and an upper drying element, and Figure 124 shows a perspective view of another packaging assembly embodiment in which the upper drying element is housed in a retainer tube that is contained within a container having a sealed pouch. [Figure 126] This is an exploded view of a staple retainer, a tubular drying element, and a surgical staple cartridge, in which the surgical staple cartridge is received within a tubular drying element, and a staple retainer is attached to the surgical staple cartridge, trapping a portion of the tubular drying element between the staple retainer and the deck surface of the surgical staple cartridge. [Figure 127] Figure 126 is an exploded end view of the staple retainer, tubular drying element, and surgical staple cartridge, in which the surgical staple cartridge is inserted into the tubular drying element. [Figure 128]A perspective view of another packaging assembly embodiment comprising a staple retainer attached to a surgical staple cartridge to form a cartridge / retainer assembly, wherein the cartridge / retainer assembly is received within a tubular drying element and housed inside a container having a sealed pouch. [Figure 129] This is a perspective view of another embodiment of a drying element, in which the drying element is removably mounted on the deck surface of a surgical staple cartridge, and the surgical staple cartridge is stored in a sealed container. [Figure 130] This is a perspective view of another embodiment of a drying element configured to immobilely support a cartridge / retainer assembly within a sealable container for storage and transport purposes. [Figure 131] A perspective view of another packaging assembly embodiment in which a cartridge / retainer assembly is housed inside a container having a sealed pouch, and a surgical staple cartridge is attached to a staple retainer that forms a cartridge / retainer assembly, the surgical staple cartridge having an RFID chip associated with a sensor. [Figure 132] This flowchart illustrates the process of a surgical stapler controller, in which a sensor communicating with the controller monitors the amount of moisture absorbed by the surgical staple cartridge (Figure 131) while it is stored in the airtight pouch (Figure 131), and the controller prevents the surgical stapler from operating when the detected amount of moisture exceeds a predetermined acceptable moisture level. [Figure 133] This flowchart illustrates another process of a surgical stapler controller, in which a sensor communicating with the controller monitors the amount of temperature the surgical staple cartridge (Figure 131) experiences while it is stored in the hermetically sealed pouch (Figure 131), and the controller prevents the surgical stapler from operating when the detected amount of temperature exceeds a predetermined acceptable temperature level. [Figure 134]A sensor communicating with the controller monitors the amount of moisture and temperature experienced by the surgical staple cartridge (Figure 131) while it is stored in the hermetically sealed pouch (Figure 131). The controller prevents the surgical stapler from operating when the detected amount of moisture exceeds a predetermined moisture level and / or when the detected amount of temperature exceeds a predetermined temperature level. This flowchart illustrates another process of the surgical stapler controller. [Figure 135] A perspective view of another packaging assembly embodiment comprising a staple retainer attached to a surgical staple cartridge to form a cartridge / retainer assembly, wherein the cartridge / retainer assembly is housed inside a container having a sealed pouch, and the pouch has an indicator associated with a sensor. [Figure 136] A perspective view of another packaging assembly embodiment comprising a staple retainer attached to a surgical staple cartridge to form a cartridge / retainer assembly, wherein the cartridge / retainer assembly is housed inside a container having a sealed pouch, the pouch being filled with nitrogen or argon gas. [Figure 137] This is an embodiment of another staple retainer and an exploded view of a surgical staple cartridge, wherein the staple retainer comprises a plurality of staple-retaining protrusions protruding from its lower surface, the staple-retaining protrusions being inserted into corresponding staple cavities within a surgical staple cartridge to restrain staples therein. [Figure 138] This is a cross-sectional view of a portion of the staple retainer of Figure 137 connected to the surgical staple cartridge of Figure 137, where the staple-holding projection of the staple retainer is received within the corresponding staple cavity of the surgical staple cartridge, thereby securing the staples contained therein in a fixed position on the staple driver. [Figure 139]This is a cross-sectional view of a portion of the cartridge body of a surgical staple cartridge, in which a bioabsorbable staple is received in a corresponding staple cavity within the cartridge body, including an inner cavity wall; the bioabsorbable staple is supported on a staple driver within the staple cavity; the bioabsorbable staple includes a staple coating; heat is applied to the bioabsorbable staple to make the staple coating tacky, temporarily adhering the bioabsorbable staple to the inner cavity wall and the corresponding portion of the staple driver. [Figure 140] This is a cross-sectional view of a portion of the cartridge body of another surgical staple cartridge, in which a bioabsorbable staple is received in a corresponding staple cavity within the cartridge body, the bioabsorbable staple is supported on a staple driver within the staple cavity, and a vapor corrosion inhibitor is applied to the bioabsorbable staple while it is inside the staple cavity. [Figure 141] This is an exploded view of a surgical staple fastener cartridge / retainer assembly and surgical end effector, in which the anvil of the surgical end effector is in the open position, the cartridge / retainer assembly comprises a staple retainer connected to a surgical staple cartridge, and the pretreatment element is attached to the staple retainer and saturated with a pretreatment medium configured to treat the stapling lower surface of the anvil. [Figure 142A] This is a side view of the cartridge / retainer assembly of Figure 141, positioned for insertion into the surgical end effector of Figure 141. [Figure 142B] Another side view of the cartridge / retainer assembly of Figure 141, partially inserted into the channel of the surgical end effector of Figure 141. [Figure 142C] Another side view of the cartridge / retainer assembly in Figure 141, where the anvil of the surgical end effector is closed over the pretreatment element to seat the surgical staple cartridge within the channel and move the pretreatment medium to the stapling-forming underside of the anvil. [Figure 142D]Figure 141 is another side view of the cartridge / retainer assembly after the anvil has been moved to the open position and the staple retainer has been removed from the surgical staple cartridge. [Figure 143] This is a perspective view of a surgical staple cartridge seated within the channel of the surgical end effector of a surgical staple fastener, with the anvil in the open position, the pretreatment element positioned on the deck surface of the surgical staple cartridge, and the pretreatment element saturated with a pretreatment medium configured to treat the stapling-forming underside of the anvil. [Figure 144A] A side view of the surgical end effector of Figure 143, showing the anvil in the open position, the cartridge / retainer assembly positioned for insertion into the channel of the surgical end effector, and the cartridge / retainer assembly comprising a staple retainer attached to the surgical staple cartridge of Figure 143. [Figure 144B] Another side view of the surgical end effector in Figure 144A, where the cartridge / retainer assembly is partially seated in the channel. [Figure 144C] Figure 144A is another side view of the surgical end effector after the surgical staple cartridge has been seated in the channel and the staple retainer has been removed from the surgical staple cartridge. [Figure 144D] Figure 143 is another side view of the surgical end effector, surgical staple cartridge, and pretreatment element. [Figure 144E] Figure 143 shows another side view of the surgical end effector, surgical staple cartridge, and pretreatment element, with the anvil moved to the closed position and the pretreatment medium being transferred to the stapling-forming underside of the anvil. [Figure 144F] Figure 143 is another side view of the surgical end effector and surgical staple cartridge after the anvil has moved to the open position and the pre-treatment element has been removed from the deck of the surgical staple cartridge. [Figure 145]A perspective view of a staple cartridge assembly including an identification chip, according to at least one embodiment. [Figure 146] This is an exploded view of a staple cartridge assembly, according to at least one embodiment, which includes a visual mark for identifying the bioabsorbability of the staples contained within. [Figure 146A] This is a perspective view of a staple cartridge with an identification mechanism at its distal end. [Figure 146B] This is a perspective view of a staple cartridge, including a cartridge body molded from metal flakes for identification purposes. [Figure 146C] This is a perspective view of a staple cartridge, including the cartridge body which is equipped with an identification mark. [Figure 146D] This is a perspective view of a staple cartridge including a cartridge body with a protrusion selectively positioned for identification purposes. [Figure 146E] This is a perspective view of a staple cartridge having a cartridge body and a cartridge pan containing an identification mark. [Figure 146F] This is a perspective view of a staple cartridge assembly including an embedded layer with an identification mark. [Figure 147] A perspective view of a staple cartridge insertable into the end effector of a surgical staple fastening device, according to at least one embodiment. [Figure 148] Figure 147 shows the compatibility between surgical stapling devices and specific staple cartridges. [Figure 149] This figure shows the compatibility and incompatibility of different surgical staple cartridge fasteners with the staple cartridge shown in Figure 148. [Figure 149A] This is a side view of a surgical instrument including an end effector and a firing member, with the end effector in the closed or clamped position and the firing member in the proximal or non-firing position. [Figure 149B] Figure 149A is a side view of the surgical instrument, with the end effector in the closed or clamped position and the firing member in the distal or firing position. [Figure 149C] Figure 149A is a cross-sectional end view of the end effector, with the end effector in the closed or clamped position. [Figure 150] A logic diagram of a control system for a surgical instrument or tool according to at least one aspect of this disclosure is shown. [Figure 151] This figure shows a method for adaptively controlling a surgical stapling device based on the type of staple cartridge identified by a clinician or control circuit, according to at least one aspect of the present disclosure.

[0005] Throughout the drawings, corresponding reference numerals indicate corresponding parts. The examples described herein illustrate various embodiments of the invention in one form and should not be construed as limiting the scope of the invention in any way. [Modes for carrying out the invention]

[0006] The applicant of this application also owns the following U.S. patent applications filed on the same day as this application, each of which is incorporated herein by reference in its entirety: - U.S. Patent Application, Invention Title: "METHOD FOR IMPLEMENTING A STAPLE SYSTEM", Agent Reference Number: END9311USNP1 / 200978-1M - U.S. Patent Application, Title of Invention: "ADAPTIVE CONTROL OF SURGICAL STAPLING INSTRUMENT BASED ON STAPLE CARTRIDGE TYPE", Agent Reference Number: END9311USNP2 / 200978-2 - U.S. Patent Application, Title of Invention: "BIOABSORBABLE STAPLE COMPRISING MECHANISMS FOR SLOWING THE ABSORPTION OF THE STAPLE", Agent Reference Number: END9311USNP3 / 200978-3 - U.S. Patent Application, Title of Invention: "BIOABSORBABLE STAPLE COMPRISING MECHANISM FOR DELAYING THE ABSORPTION OF THE STAPLE", Agent Reference Number: END9311USNP4 / 200978-4 - U.S. Patent Application, Title of Invention: "ABSORBABLE SURGICAL STAPLES COMPRISING SUFFICIENT STRUCTURAL PROPERTIES DURING A TISSUE HEALING WINDOW", Agent Reference Number: END9311USNP6 / 200978-6 - U.S. Patent Application, Invention Title: "METHOD FOR DELIVERING A STAPLE IN SITU PAIRED TO THE IN SITU ENVIRONMENT", Agent Reference Number: END9311USNP7 / 200978-7 - U.S. Patent Application, Title of Invention: "ABSORBABLE STAPLE COMPRISING STRAIN LIMITING FEATURES", Agent Reference Number: END9311USNP8 / 200978-8 - U.S. Patent Application, Title of Invention: "ABSORBABLE SURGICAL STAPLE COMPRISING AT LEAST TWO COATINGS", Agent Reference Number: END9311USNP9 / 200978-9 - U.S. Patent Application, Invention Title "STAPLE CARTRIDGE COMPRISING LUBRICATED STAPLES", Agent Reference Number END9311USNP10 / 200978-10 - U.S. Patent Application, Title of Invention: "DISSIMILAR STAPLE CARTRIDGES WITH DIFFERENT BIOABSORBABLE COMPONENTS", Agent Reference Number: END9311USNP11 / 200978-11 - U.S. Patent Application, Title of Invention "CARTRIDGE ASSEMBLIES WITH ABSORBABLE METAL STAPLES AND ABSORBABLE IMPLANTABLE ADJUNCTS", Agent Reference Number END9311USNP12 / 200978-12, and - U.S. Patent Application, Title of Invention: "PACKAGING ASSEMBLIES FOR SURGICAL STAPLE CARTRIDGES CONTAINING BIO-ABSORBABLE STAPLES", Agent Reference Number: END9311USNP13 / 200978-13.

[0007] The applicant of this application also owns the following U.S. patent applications filed on February 26, 2021, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 17 / 186,269, Title of Invention: "Method of Powering and Communicating with a Staple Cartridge" - U.S. Patent Application No. 17 / 186,273, Title of Invention: "Method of Powering and Communicating with a Staple Cartridge" - U.S. Patent Application No. 17 / 186,276, Title of Invention: "Adjustable Communication Based on Available Bandwidth and Power Capacity" - U.S. Patent Application No. 17 / 186,283, Title of Invention: "Adjustment to Transfer Parameters to Improve Available Power" - U.S. Patent Application No. 17 / 186,345, Title of Invention: "Monitoring of Manufacturing Life-Cycle", - U.S. Patent Application No. 17 / 186,350, Title of Invention: "Monitoring of Multiple Sensors Over Time to Detect Moving Characteristics of Tissue," - U.S. Patent Application No. 17 / 186,353, Title of Invention: "Monitoring of Internal Systems to Detect and Track Cartridge Motion Status" - U.S. Patent Application No. 17 / 186,357, Title of Invention: "DISTAL COMMUNICATION ARRAY TO TUNE FREQUENCY OF RF SYSTEMS", - U.S. Patent Application No. 17 / 186,364, Title of Invention: "STAPLE CARTRIDGE COMPRISING A SENSOR ARRAY", - U.S. Patent Application No. 17 / 186,373, Title of Invention: "STAPLE CARTRIDGE COMPRISING A SENSING ARRAY AND A TEMPERATURE CONTROL SYSTEM", - U.S. Patent Application No. 17 / 186,378, Title of Invention: "STAPLE CARTRIDGE COMPRISING AN INFORMATION ACCESS CONTROL SYSTEM", - U.S. Patent Application No. 17 / 186,407, Title of Invention: "STAPLE CARTRIDGE COMPRISING A POWER MANAGEMENT CIRCUIT", - U.S. Patent Application No. 17 / 186,421, Title of Invention: "STAPLING INSTRUMENT COMPRISING A SEPARATE POWER ANTENNA AND A DATA TRANSFER ANTENNA", - U.S. Patent Application No. 17 / 186,438, Title of Invention: "SURGICAL INSTRUMENT SYSTEM COMPRISING A POWER TRANSFER COIL", and - U.S. Patent Application No. 17 / 186,451, Title of Invention: "STAPLING INSTRUMENT COMPRISING A SIGNAL ANTENNA".

[0008] The applicant of this application also owns the following U.S. patent applications filed on 29 October 2020, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 17 / 084,179, Title of Invention: "SURGICAL INSTRUMENT COMPRISING A RELEASABLE CLOSURE DRIVE LOCK", - U.S. Patent Application No. 17 / 084,190, Title of Invention: "SURGICAL INSTRUMENT COMPRISING A STOWED CLOSURE ACTUATOR STOP", - U.S. Patent Application No. 17 / 084,198, Title of Invention: "SURGICAL INSTRUMENT COMPRISING AN INDICATOR WHICH INDICATES THAT AN ARTICULATION DRIVE IS ACTUATABLE", - U.S. Patent Application No. 17 / 084,205, Title of Invention: "SURGICAL INSTRUMENT COMPRISING AN ARTICULATION INDICATOR", - U.S. Patent Application No. 17 / 084,258, Title of Invention: "METHOD FOR OPERATING A SURGICAL INSTRUMENT", - U.S. Patent Application No. 17 / 084,206, Title of Invention: "SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK", - U.S. Patent Application No. 17 / 084,215, Title of Invention: "SURGICAL INSTRUMENT COMPRISING A JAW ALIGNMENT SYSTEM", - U.S. Patent Application No. 17 / 084,229, Title of Invention: "SURGICAL INSTRUMENT COMPRISING SEALABLE INTERFACE", - U.S. Patent Application No. 17 / 084,180, Title of Invention: "SURGICAL INSTRUMENT COMPRISING A LIMITED TRAVEL SWITCH", - U.S. Design Patent Application No. 29 / 756,615, Title of Invention: "SURGICAL STAPLING ASSEMBLY", - U.S. Design Patent Application No. 29 / 756,620, Title of Invention: "SURGICAL STAPLING ASSEMBLY", - U.S. Patent Application No. 17 / 084,188, Title of Invention: "SURGICAL INSTRUMENT COMPRISING A STAGED VOLTAGE REGULATION START-UP SYSTEM", - U.S. Patent Application No. 17 / 084,193, Title of Invention: "SURGICAL INSTRUMENT COMPRISING A SENSOR CONFIGURED TO SENSE WHETHER AN ARTICULATION DRIVE OF THE SURGICAL INSTRUMENT IS ACTUATABLE".

[0009] The applicant of this application also owns the following U.S. patent applications filed on April 11, 2020, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 16 / 846,303, title of invention "METHODS FOR STAPLING TISSUE USING A SURGICAL INSTRUMENT" (currently U.S. Patent Application Publication No. 2020 / 0345353). - U.S. Patent Application No. 16 / 846,304, Title of Invention: "ARTICULATION ACTUATORS FOR A SURGICAL INSTRUMENT" (currently U.S. Patent Application Publication No. 2020 / 0345354), - U.S. Patent Application No. 16 / 846,305, Title of Invention: "ARTICULATION DIRECTIONAL LIGHTS ON A SURGICAL INSTRUMENT" (currently U.S. Patent Application Publication No. 2020 / 0345446), - U.S. Patent Application No. 16 / 846,307, Title of Invention: "SHAFT ROTATION ACTUATOR ON A SURGICAL INSTRUMENT" (currently U.S. Patent Publication No. 2020 / 03453549), - U.S. Patent Application No. 16 / 846,308, Title of Invention: "ARTICULATION CONTROL MAPPING FOR A SURGICAL INSTRUMENT" (currently U.S. Patent Publication No. 2020 / 0345355), - U.S. Patent Application No. 16 / 846,309, Title of Invention: "INTELLIGENT FIRING ASSOCIATED WITH A SURGICAL INSTRUMENT" (currently U.S. Patent Application Publication No. 2020 / 0345356), - U.S. Patent Application No. 16 / 846,310, Title of Invention: "INTELLIGENT FIRING ASSOCIATED WITH A SURGICAL INSTRUMENT" (currently U.S. Patent Application Publication No. 2020 / 0345357), - U.S. Patent Application No. 16 / 846,311, Title of Invention: "ROTATABLE JAW TIP FOR A SURGICAL INSTRUMENT" (currently U.S. Patent Publication No. 2020 / 0345358), - U.S. Patent Application No. 16 / 846,312, Title of Invention: "TISSUE STOP FOR A SURGICAL INSTRUMENT" (currently U.S. Patent Publication No. 2020 / 0345359), - U.S. Patent Application No. 16 / 846,313, title of invention "ARTICULATION PIN FOR A SURGICAL INSTRUMENT" (currently U.S. Patent Application Publication No. 2020 / 0345360).

[0010] The entire disclosure of U.S. Provisional Patent Application No. 62 / 840,715, filed on April 30, 2019, with the title of the invention, "SURGICAL INSTRUMENT COMPRISING AN ADAPTIVE CONTROL SYSTEM," is incorporated herein by reference.

[0011] The applicant of this application owns the following U.S. patent applications filed on February 21, 2019, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 16 / 281,658, Title of Invention: "Methods for Controlling a Powered Surgical Stapler That Has Separate Rotary Closure and Fire Systems" (currently U.S. Patent Publication No. 2019 / 0298350), - U.S. Patent Application No. 16 / 281,670, Title of Invention: "STAPLE CARTRIDGE COMPRISING A LOCKOUT KEY CONFIGURED TO LIFT A FIRING MEMBER" (currently U.S. Patent Application Publication No. 2019 / 0298340), - U.S. Patent Application No. 16 / 281,675, title of invention: "surgical staplers with arrangements for maintaining a firing member thereof in a locked configuration unless a compatible cartridge has been installed therein" (currently U.S. Patent Application Publication No. 2019 / 0298354). - U.S. Patent Application No. 16 / 281,685, Title of Invention: "SURGICAL INSTRUMENT COMPRISING CO-OPERATING LOCKOUT FEATURES" (currently U.S. Patent Publication No. 2019 / 0298341), - U.S. Patent Application No. 16 / 281,693, Title of Invention: "SURGICAL STAPLING ASSEMBLY COMPRISING A LOCKOUT AND AN EXTERIOR ACCESS ORIFICE TO PERMIT ARTIFICIAL UNLOCKING OF THE LOCKOUT" (currently U.S. Patent Application Publication No. 2019 / 0298342), - U.S. Patent Application No. 16 / 281,704, Title of Invention: "SURGICAL STAPLING DEVICES WITH FEATURES FOR BLOCKING ADVANCEMENT OF A CAMMING ASSEMBLY OF AN INCOMPATIBLE CARTRIDGE INSTALLED THEREIN" (currently U.S. Patent Application Publication No. 2019 / 0298356), - U.S. Patent Application No. 16 / 281,707, Title of Invention: "STAPLING INSTRUMENT COMPRISING A DEACTIVATABLE LOCKOUT" (currently U.S. Patent Publication No. 2019 / 0298347), - U.S. Patent Application No. 16 / 281,741, Title of Invention: "SURGICAL INSTRUMENT COMPRISING A JAW CLOSURE LOCKOUT" (currently U.S. Patent Publication No. 2019 / 0298357), - U.S. Patent Application No. 16 / 281,762, Title of Invention: "SURGICAL STAPLING DEVICES WITH CARTRIDGE COMPATIBLE CLOSURE AND FIRING LOCKOUT ARRANGEMENTS" (currently U.S. Patent Publication No. 2019 / 0298343), - U.S. Patent Application No. 16 / 281,666, Title of Invention: "SURGICAL STAPLING DEVICES WITH IMPROVED ROTARY DRIVEN CLOSURE SYSTEMS" (currently U.S. Patent Publication No. 2019 / 0298352), - U.S. Patent Application No. 16 / 281,672, Title of Invention: "SURGICAL STAPLING DEVICES WITH ASYMMETRIC CLOSURE FEATURES" (currently U.S. Patent Application Publication No. 2019 / 0298353), - U.S. Patent Application No. 16 / 281,678, title of invention "ROTARY DRIVEN FIRING MEMBERS WITH DIFFERENT ANVIL AND CHANNEL ENGAGEMENT FEATURES" (currently U.S. Patent Application Publication No. 2019 / 0298355), and - U.S. Patent Application No. 16 / 281,682, Title of Invention: "SURGICAL STAPLING DEVICE WITH SEPARATE ROTARY DRIVEN CLOSURE AND FIRING SYSTEMS AND FIRING MEMBER THAT ENGAGES BOTH JAWS WHILE FIRING" (currently U.S. Patent Application Publication No. 2019 / 0298346).

[0012] The applicant of this application owns the following U.S. provisional patent applications filed on February 19, 2019, each of which is incorporated herein by reference in its entirety. - U.S. Provisional Patent Application No. 62 / 807,310, Title of Invention: "Methods for Controlling a Powered Surgical Stapler That Has Separate Rotary Closure and Fire Systems," - U.S. Provisional Patent Application No. 62 / 807,319, Title of Invention: "SURGICAL STAPLING DEVICES WITH IMPROVED LOCKOUT SYSTEMS", - U.S. Provisional Patent Application No. 62 / 807,309, Title of Invention: "SURGICAL STAPLING DEVICES WITH IMPROVED ROTARY DRIVEN CLOSURE SYSTEMS".

[0013] The applicant of this application owns the following U.S. provisional patent applications filed on March 28, 2018, each of which is incorporated herein by reference in its entirety. - U.S. Provisional Patent Application No. 62 / 649,302, Title of Invention: "INTERACTIVE SURGICAL SYSTEMS WITH encrypted COMMUNICATION CAPABILITIES", - U.S. Provisional Patent Application No. 62 / 649,294, Title of Invention: "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD", - U.S. Provisional Patent Application No. 62 / 649,300, Title of Invention: "SURGICAL HUB SITUATIONAL AWARENESS", - U.S. Provisional Patent Application No. 62 / 649,309, Title of Invention: "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER" - U.S. Provisional Patent Application No. 62 / 649,310, Title of Invention: "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS", - U.S. Provisional Patent Application No. 62 / 649,291, Title of Invention: "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT", - U.S. Provisional Patent Application No. 62 / 649,296, Title of Invention: "Adaptive Control Program Updates for Surgical Devices", - U.S. Provisional Patent Application No. 62 / 649,333, Title of Invention: "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER", - U.S. Provisional Patent Application No. 62 / 649,327, Title of Invention: "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES", - U.S. Provisional Patent Application No. 62 / 649,315, Title of Invention: "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK", - U.S. Provisional Patent Application No. 62 / 649,313, Title of Invention: "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES", - U.S. Provisional Patent Application No. 62 / 649,320, Title of Invention: "Drive arrangements for robot-asposed surgical platforms," - U.S. Provisional Patent Application No. 62 / 649,307, Title of Invention: "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS", and - U.S. Provisional Patent Application No. 62 / 649,323, Title of Invention: "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS".

[0014] The applicant of this application owns the following U.S. provisional patent application filed on March 30, 2018, which is incorporated herein by reference in its entirety. - U.S. Provisional Patent Application No. 62 / 650,887, Title of Invention: "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES".

[0015] The applicant of this application owns the following U.S. patent application filed on December 4, 2018, which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 16 / 209,423, title of invention: "Method of Compressing Tissue Within a Stapling Device and Simultaneously Displaying the Location of the Tissue Within the Jaws" (currently published as U.S. Patent Application Publication No. 2019 / 0200981).

[0016] The applicant of this application owns the following U.S. patent applications filed on August 20, 2018, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 16 / 105,101, Title of Invention: "METHOD FOR FAbricating SURGICAL STAPLER ANVILS" (currently U.S. Patent Publication No. 2020 / 0054323), - U.S. Patent Application No. 16 / 105,183, Title of Invention: "REINFORCED DEFORMABLE ANVIL TIP FOR SURGICAL STAPLER ANVIL" (currently U.S. Patent No. 10,912,559), - U.S. Patent Application No. 16 / 105,150, Title of Invention: "SURGICAL STAPLER ANVILS WITH STAPLE DIRECTING PROTRUSIONS AND TISSUE STABILITY FEATURES" (currently U.S. Patent Publication No. 2020 / 0054326), - U.S. Patent Application No. 16 / 105,098, Title of Invention: "FABRICATING TECHNIQUES FOR SURGICAL STAPLER ANVILS" (currently U.S. Patent Application Publication No. 2020 / 0054322), - U.S. Patent Application No. 16 / 105,140, ​​Title of Invention: "SURGICAL STAPLER ANVILS WITH TISSUE STOP FEATURES CONFIGURED TO AVOID TISSUE PINCH" (currently U.S. Patent No. 10,779,821), - U.S. Patent Application No. 16 / 105,081, Title of Invention: "METHOD FOR OPERATING A POWERED ARTICULATABLE SURGICAL INSTRUMENT" (currently U.S. Patent Application Publication No. 2020 / 0054320), - U.S. Patent Application No. 16 / 105,094, Title of Invention: "SURGICAL INSTRUMENTS WITH PROGRESSIVE JAW CLOSURE ARRANGEMENTS" (currently U.S. Patent Publication No. 2020 / 0054321), - U.S. Patent Application No. 16 / 105,097, Title of Invention: "POWERED SURGICAL INSTRUMENTS WITH CLUTCHING ARRANGEMENTS TO CONVERT LINEAR DRIVE MOTIONS TO ROTARY DRIVE MOTIONS" (currently U.S. Patent Publication No. 2020 / 0054328). - U.S. Patent Application No. 16 / 105,104, Title of Invention: "POWERED ARTICULATABLE SURGICAL INSTRUMENTS WITH CLUTCHING AND LOCKING ARRANGEMENTS FOR LINKING AN ARTICULATION DRIVE SYSTEM TO A FIRING DRIVE SYSTEM" (currently U.S. Patent No. 10,842,492), - U.S. Patent Application No. 16 / 105,119, Title of Invention: "ARTICULATABLE MOTOR POWERED SURGICAL INSTRUMENTS WITH DEDICATED ARTICULATION MOTOR ARRANGEMENTS" (currently U.S. Patent Publication No. 2020 / 0054330), - U.S. Patent Application No. 16 / 105,160, Title of Invention "SWITCHING ARRANGEMENTS FOR MOTOR POWERED ARTICULATABLE SURGICAL INSTRUMENTS" (currently U.S. Patent No. 10,856,870), and - U.S. Design Patent Application No. 29 / 660,252, Title of Invention: "SURGICAL STAPLER ANVILS".

[0017] The applicant of this application owns the following U.S. patent applications and U.S. patents, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 15 / 386,185, Title of Invention: "SURGICAL STAPLING INSTRUMENTS AND REPLACEABLE TOOL ASSEMBLIES THEREOF" (currently U.S. Patent No. 10,639,035), - U.S. Patent Application No. 15 / 386,230, Title of Invention: "ARTICULATABLE SURGICAL STAPLING INSTRUMENTS" (currently U.S. Patent Publication No. 2018 / 0168649), - U.S. Patent Application No. 15 / 386,221, Title of Invention: "LOCKOUT ARRANGEMENTS FOR SURGICAL END EFFECTORS" (currently U.S. Patent No. 10,835,247), - U.S. Patent Application No. 15 / 386,209, Title of Invention: "SURGICAL END EFFECTORS AND FIRING MEMBERS THEREOF" (currently U.S. Patent No. 10,588,632), - U.S. Patent Application No. 15 / 386,198, Title of Invention: "LOCKOUT ARRANGEMENTS FOR SURGICAL END EFFECTORS AND REPLACEABLE TOOL ASSEMBLIES" (currently U.S. Patent No. 10,610,224) - U.S. Patent Application No. 15 / 386,240, Title of Invention: "SURGICAL END EFFECTORS AND ADAPTABLE FIRING MEMBERS THEREFOR" (currently U.S. Patent Application Publication No. 2018 / 0168651), - U.S. Patent Application No. 15 / 385,939, Title of Invention: "STAPLE CARTRIDGES AND ARRANGEMENTS OF STAPLES AND STAPLE CAVITIES THEREIN" (currently U.S. Patent No. 10,835,246), - U.S. Patent Application No. 15 / 385,941, Title of Invention: "SURGICAL TOOL ASSEMBLIES WITH CLUTCHING ARRANGEMENTS FOR SHIFTING BETWEEN CLOSURE SYSTEMS WITH CLOSURE STROKE REDUCTION FEATURES AND ARTICULATION AND FIRING SYSTEMS" (currently U.S. Patent No. 10,736,629). - U.S. Patent Application No. 15 / 385,943, Title of Invention: "SURGICAL STAPLING INSTRUMENTS AND STAPLE-FORMING ANVILS" (currently U.S. Patent No. 10,667,811), - U.S. Patent Application No. 15 / 385,950, Title of Invention: "SURGICAL TOOL ASSEMBLIES WITH CLOSURE STROKE REDUCTION FEATURES" (currently U.S. Patent No. 10,588,630), - U.S. Patent Application No. 15 / 385,945, Title of Invention: "STAPLE CARTRIDGES AND ARRANGEMENTS OF STAPLES AND STAPLE CAVITIES THEREIN" (currently U.S. Patent No. 10,893,864), - U.S. Patent Application No. 15 / 385,946, Title of Invention: "SURGICAL STAPLING INSTRUMENTS AND STAPLE-FORMING ANVILS" (currently U.S. Patent Publication No. 2018 / 0168633), - U.S. Patent Application No. 15 / 385,951, Title of Invention: "SURGICAL INSTRUMENTS WITH JAW OPENING FEATURES FOR INCREASING A JAW OPENING DISTANCE" (currently U.S. Patent No. 10,568,626), - U.S. Patent Application No. 15 / 385,953, Title of Invention: "METHODS OF STAPLING TISSUE" (currently U.S. Patent No. 10,675,026), - U.S. Patent Application No. 15 / 385,954, Title of Invention: "FIRING MEMBERS WITH NON-PARALLEL JAW ENGAGEMENT FEATURES FOR SURGICAL END EFFECTORS" (currently U.S. Patent No. 10,624,635), - U.S. Patent Application No. 15 / 385,955, Title of Invention: "SURGICAL END EFFECTORS WITH EXPANDABLE TISSUE STOP ARRANGEMENTS" (currently U.S. Patent No. 10,813,638), - U.S. Patent Application No. 15 / 385,948, Title of Invention: "SURGICAL STAPLING INSTRUMENTS AND STAPLE-FORMING ANVILS" (currently U.S. Patent Publication No. 2018 / 0168584), - U.S. Patent Application No. 15 / 385,956, Title of Invention: "SURGICAL INSTRUMENTS WITH POSITIVE JAW OPENING FEATURES" (currently U.S. Patent No. 10,588,631), - U.S. Patent Application No. 15 / 385,958, Title of Invention: "SURGICAL INSTRUMENTS WITH LOCKOUT ARRANGEMENTS FOR PREVENTING FIRING SYSTEM ACTUATION UNLESS AN UNSPENT STAPLE CARTRIDGE IS PRESENT" (currently U.S. Patent No. 10,639,034), - U.S. Patent Application No. 15 / 385,947, Title of Invention: "STAPLE CARTRIDGES AND ARRANGEMENTS OF STAPLES AND STAPLE CAVITIES THEREIN" (currently U.S. Patent No. 10,568,625), - U.S. Patent Application No. 15 / 385,896, Title of Invention: "METHOD FOR RESETTING A FUSE OF A SURGICAL INSTRUMENT SHAFT" (currently U.S. Patent Publication No. 2018 / 0168597), - U.S. Patent Application No. 15 / 385,898, Title of Invention: "STAPLE-FORMING POCKET ARRANGEMENT TO ACCOMMODATE DIFFERENT TYPES OF STAPLES" (currently U.S. Patent No. 10,537,325), - U.S. Patent Application No. 15 / 385,899, Title of Invention: "SURGICAL INSTRUMENT COMPRISING IMPROVED JAW CONTROL" (currently U.S. Patent No. 10,758,229), - U.S. Patent Application No. 15 / 385,901, Title of Invention: "STAPLE CARTRIDGE AND STAPLE CARTRIDGE CHANNEL COMPRISING WINDOWS DEFINED THEREIN" (currently U.S. Patent No. 10,667,809), - U.S. Patent Application No. 15 / 385,902, title of invention "SURGICAL INSTRUMENT COMPRISING A CUTTING MEMBER" (currently U.S. Patent No. 10,888,322). - U.S. Patent Application No. 15 / 385,904, Title of Invention: "STAPLE FIRING MEMBER COMPRISING A MISSING CARTRIDGE AND / OR SPENT CARTRIDGE LOCKOUT" (currently U.S. Patent No. 10,881,401), - U.S. Patent Application No. 15 / 385,905, Title of Invention: "FIRING ASSEMBLY COMPRISING A LOCKOUT" (currently U.S. Patent No. 10,695,055), - U.S. Patent Application No. 15 / 385,907, Title of Invention: "SURGICAL INSTRUMENT SYSTEM COMPRISING AN END EFFECTOR LOCKOUT AND A FIRING ASSEMBLY LOCKOUT" (currently U.S. Patent Publication No. 2018 / 0168608), - U.S. Patent Application No. 15 / 385,908, Title of Invention: "FIRING ASSEMBLY COMPRISING A FUSE" (currently U.S. Patent Application Publication No. 2018 / 0168609), - U.S. Patent Application No. 15 / 385,909, Title of Invention: "FIRING ASSEMBLY COMPRISING A MULTIPLE FAILED-STATE FUSE" (currently U.S. Patent Application Publication No. 2018 / 0168610), - U.S. Patent Application No. 15 / 385,920, Title of Invention: "STAPLE-FORMING POCKET ARRANGEMENTS" (currently U.S. Patent No. 10,499,914), - U.S. Patent Application No. 15 / 385,913, Title of Invention: "ANVIL ARRANGEMENTS FOR SURGICAL STAPLERS" (currently U.S. Patent Publication No. 2018 / 0168614), - U.S. Patent Application No. 15 / 385,914, Title of Invention: "Method of Deforming Staples from Two Different Types of Staple Cartridges with the Same Surgical Stapling Instrument" (currently U.S. Patent Publication No. 2018 / 0168615), - U.S. Patent Application No. 15 / 385,893, Title of Invention: "BILATERALLY ASYMMETRIC STAPLE-FORMING POCKET PAIRS" (currently U.S. Patent No. 10,682,138), - U.S. Patent Application No. 15 / 385,929, Title of Invention: "Closure Members with Cam Surface Arrangements for Surgical Instruments with Separate and Distinct Closure and Fire Systems" (currently U.S. Patent No. 10,667,810), - U.S. Patent Application No. 15 / 385,911, Title of Invention: "SURGICAL STAPLERS WITH INDEPENDENTLY ACTUATABLE CLOSING AND FIRING SYSTEMS" (currently U.S. Patent No. 10,448,950), - U.S. Patent Application No. 15 / 385,927, Title of Invention: "SURGICAL STAPLING INSTRUMENTS WITH SMART STAPLE CARTRIDGES" (currently U.S. Patent Application Publication No. 2018 / 0168625), - U.S. Patent Application No. 15 / 385,917, Title of Invention: "STAPLE CARTRIDGE COMPRISING STAPLES WITH DIFFERENT CLAMPING BREADTHS" (currently U.S. Patent Publication No. 2018 / 0168617), - U.S. Patent Application No. 15 / 385,900, Title of Invention: "STAPLE-FORMING POCKET ARRANGEMENTS COMPRISING PRIMARY SIDEWALLS AND POCKET SIDEWALLS" (currently U.S. Patent No. 10,898,186), - U.S. Patent Application No. 15 / 385,931, Title of Invention: "NO-CARTRIDGE AND SPENT CARTRIDGE LOCKOUT ARRANGEMENTS FOR SURGICAL STAPLERS" (currently U.S. Patent Publication No. 2018 / 0168627), - U.S. Patent Application No. 15 / 385,915, Title of Invention "FIRING MEMBER PIN ANGLE" (currently U.S. Patent No. 10,779,823), - U.S. Patent Application No. 15 / 385,897, Title of Invention: "STAPLE-FORMING POCKET ARRANGEMENTS COMPRISING ZONED FORMING SURFACE GROOVES" (currently U.S. Patent Publication No. 2018 / 0168598), - U.S. Patent Application No. 15 / 385,922, Title of Invention: "SURGICAL INSTRUMENT WITH MULTIPLE FAILURE RESPONSE MODES" (currently U.S. Patent No. 10,426,471), - U.S. Patent Application No. 15 / 385,924, Title of Invention: "SURGICAL INSTRUMENT WITH PRIMARY AND SAFETY PROCESSORS" (currently U.S. Patent No. 10,758,230), - U.S. Patent Application No. 15 / 385,910, Title of Invention: "ANVIL HAVING A KNIFE SLOT WIDTH" (currently U.S. Patent No. 10,485,543), - U.S. Patent Application No. 15 / 385,903, Title of Invention: "Closure Member Arrangements for Surgical Instruments" (currently U.S. Patent No. 10,617,414), - U.S. Patent Application No. 15 / 385,906, Title of Invention: "FIRING MEMBER PIN CONFIGURATIONS" (currently U.S. Patent No. 10,856,868), - U.S. Patent Application No. 15 / 386,188, Title of Invention: "STEPPED STAPLE CARTRIDGE WITH ASYMMETRICAL STAPLES" (currently U.S. Patent No. 10,537,324), - U.S. Patent Application No. 15 / 386,192, Title of Invention: "STEPPED STAPLE CARTRIDGE WITH TISSUE RETENTION AND GAP SETTING FEATURES" (currently U.S. Patent No. 10,687,810) - U.S. Patent Application No. 15 / 386,206, Title of Invention: "STAPLE CARTRIDGE WITH DEFORMABLE DRIVER RETENTION FEATURES" (currently U.S. Patent Application Publication No. 2018 / 0168586), - U.S. Patent Application No. 15 / 386,226, Title of Invention: "DURABILITY FEATURES FOR END EFFECTORS AND FIRING ASSEMBLIES OF SURGICAL STAPLING INSTRUMENTS" (currently U.S. Patent Publication No. 2018 / 0168648), - U.S. Patent Application No. 15 / 386,222, Title of Invention: "SURGICAL STAPLING INSTRUMENTS HAVING END EFFECTORS WITH POSITIVE OPENING FEATURES" (currently U.S. Patent Publication No. 2018 / 0168647), - U.S. Patent Application No. 15 / 386,236, Title of Invention: "CONNECTION PORTIONS FOR DEPOSABLE LOADING UNITS FOR SURGICAL STAPLING INSTRUMENTS" (currently U.S. Patent Publication No. 2018 / 0168650), - U.S. Patent Application No. 15 / 385,887, Title of Invention: "Method for Attaching a Shaft Assemblely to a Surgical Instrument and, Alternatively, to a Surgical Robot" (currently U.S. Patent No. 10,835,245) - U.S. Patent Application No. 15 / 385,889, Title of Invention: "SHAFT ASSEMBLY COMPRISING A MANUALLY-OPERABLE RETRACTION SYSTEM FOR USE WITH A MOTORIZED SURGICAL INSTRUMENT SYSTEM" (currently U.S. Patent Application Publication No. 2018 / 0168590), - U.S. Patent Application No. 15 / 385,890, Title of Invention: "SHAFT ASSEMBLY COMPRISING SEPARATELY ACTUATABLE AND RETRACTABLE SYSTEMS" (currently U.S. Patent No. 10,675,025), - U.S. Patent Application No. 15 / 385,891, Title of Invention: "SHAFT ASSEMBLY COMPRISING A CLUTCH CONFIGURED TO ADAPT THE OUTPUT OF A ROTARY FIRING MEMBER TO TWO DIFFERENT SYSTEMS" (currently U.S. Patent Application Publication No. 2018 / 0168592), - U.S. Patent Application No. 15 / 385,892, Title of Invention: "SURGICAL SYSTEM COMPRISING A FIRING MEMBER ROTATABLE INTO AN ARTICULATION STATE TO ARTICULATE AN END EFFECTOR OF THE SURGICAL SYSTEM" (currently U.S. Patent No. 10,918,385), - U.S. Patent Application No. 15 / 385,894, Title of Invention: "SHAFT ASSEMBLY COMPRISING A LOCKOUT" (currently U.S. Patent No. 10,492,785), - U.S. Patent Application No. 15 / 385,895, Title of Invention: "SHAFT ASSEMBLY COMPRISING FIRST AND SECOND ARTICULATION LOCKOUTS" (currently U.S. Patent No. 10,542,982), - U.S. Patent Application No. 15 / 385,916, Title of Invention "SURGICAL STAPLING SYSTEMS" (currently U.S. Patent Publication No. 2018 / 0168575), - U.S. Patent Application No. 15 / 385,918, Title of Invention "SURGICAL STAPLING SYSTEMS" (currently U.S. Patent Publication No. 2018 / 0168618), - U.S. Patent Application No. 15 / 385,919, Title of Invention "SURGICAL STAPLING SYSTEMS" (currently U.S. Patent Publication No. 2018 / 0168619), - U.S. Patent Application No. 15 / 385,921, Title of Invention: "SURGICAL STAPLE CARTRIDGE WITH MOVABLE CAMMING MEMBER CONFIGURED TO DISENGAGE FIRING MEMBER LOCKOUT FEATURES" (currently U.S. Patent No. 10,687,809), - U.S. Patent Application No. 15 / 385,923, Title of Invention "SURGICAL STAPLING SYSTEMS" (currently U.S. Patent Publication No. 2018 / 0168623), - U.S. Patent Application No. 15 / 385,925, Title of Invention: "JAW ACTUATED LOCK ARRANGEMENTS FOR PREVENTING ADVANCEMENT OF A FIRING MEMBER IN A SURGICAL END EFFECTOR UNLESS AN UNFIRED CARTRIDGE IS INSTALLED IN THE END EFFECTOR" (currently U.S. Patent No. 10,517,595), - U.S. Patent Application No. 15 / 385,926, Title of Invention: "AXIALLY MOVABLE CLOSURE SYSTEM ARRANGEMENTS FOR APPLYING CLOSURE MOTIONS TO JAWS OF SURGICAL INSTRUMENTS" (currently U.S. Patent Publication No. 2018 / 0168577), - U.S. Patent Application No. 15 / 385,928, Title of Invention: "Protective Cover Arrangements for a Joint Interface Between a Movable Jaw and Actuator Shaft of a Surgical Instrument" (currently U.S. Patent Publication No. 2018 / 0168578), - U.S. Patent Application No. 15 / 385,930, Title of Invention: "SURGICAL END EFFECTOR WITH TWO SEPARATE COOPERATING OPENING FEATURES FOR OPENING AND CLOSING END EFFECTOR JAWS" (currently U.S. Patent Publication No. 2018 / 0168579), - U.S. Patent Application No. 15 / 385,932, Title of Invention: "ARTICULATABLE SURGICAL END EFFECTOR WITH ASYMMETRIC SHAFT ARRANGEMENT" (currently U.S. Patent Publication No. 2018 / 0168628), - U.S. Patent Application No. 15 / 385,933, Title of Invention: "ARTICULATABLE SURGICAL INSTRUMENT WITH INDEPENDENT PIVOTABLE LINKAGE DISTAL OF AN ARTICULATION LOCK" (currently U.S. Patent No. 10,603,036), - U.S. Patent Application No. 15 / 385,934, Title of Invention: "ARTICULATION LOCK ARRANGEMENTS FOR LOCKING AN END EFFECTOR IN AN ARTICULATED POSITION IN RESPONSE TO ACTUATION OF A JAW CLOSURE SYSTEM" (currently U.S. Patent No. 10,582,928), - U.S. Patent Application No. 15 / 385,935, Title of Invention: "Laterally Actuable Articulation Lock Arrangements for Locking an End Effector of a Surgical Instrument in an Articulated Configuration" (currently U.S. Patent No. 10,524,789), - U.S. Patent Application No. 15 / 385,936, Title of Invention: "ARTICULATABLE SURGICAL INSTRUMENTS WITH ARTICULATION STROKE AMPLIFICATION FEATURES" (currently U.S. Patent No. 10,517,596), - U.S. Patent Application No. 14 / 318,996, Title of Invention: "FASTENER CARTRIDGES INCLUDING EXTENSIONS HAVING DIFFERENT CONFIGURATIONS" (currently U.S. Patent Application Publication No. 2015 / 0297228), - U.S. Patent Application No. 14 / 319,006, Title of Invention: "FASTENER CARTRIDGE COMPRISING FASTENER CAVITIES INCLUDING FASTENER CONTROL FEATURES" (currently U.S. Patent No. 10,010,324), - U.S. Patent Application No. 14 / 318,991, Title of Invention: "SURGICAL FASTENER CARTRIDGES WITH DRIVER STABILIZING ARRANGEMENTS" (currently U.S. Patent No. 9,833,241), - U.S. Patent Application No. 14 / 319,004, Title of Invention: "SURGICAL END EFFECTORS WITH FIRING ELEMENT MONITORING ARRANGEMENTS" (currently U.S. Patent No. 9,844,369), - U.S. Patent Application No. 14 / 319,008, Title of Invention: "FASTENER CARTRIDGE COMPRISING NON-UNIFORM FASTENERS" (U.S. Patent No. 10,299,792), - U.S. Patent Application No. 14 / 318,997, Title of Invention: "FASTENER CARTRIDGE COMPRISING DEPLOYABLE TISSUE ENGAGING MEMBERS" (currently U.S. Patent Publication No. 10,561,422), - U.S. Patent Application No. 14 / 319,002, Title of Invention: "FASTENER CARTRIDGE COMPRISING TISSUE CONTROL FEATURES" (currently U.S. Patent No. 9,877,721), - U.S. Patent Application No. 14 / 319,013, Title of Invention "FASTENER CARTRIDGE ASSEMBLIES AND STAPLE RETAINER COVER ARRANGEMENTS" (currently U.S. Patent Application Publication No. 2015 / 0297233), and - U.S. Patent Application No. 14 / 319,016, title of invention "FASTENER CARTRIDGE INCLUDING A LAYER ATTACHED THERETO" (currently U.S. Patent No. 10,470,768).

[0018] The applicant of this application owns the following U.S. patent applications filed on June 24, 2016, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 15 / 191,775, Title of Invention: "STAPLE CARTRIDGE COMPRISING WIRE STAPLES AND STAMPED STAPLES" (currently U.S. Patent Application Publication No. 2017 / 0367695), - U.S. Patent Application No. 15 / 191,807, Title of Invention: "STAPLING SYSTEM FOR USE WITH WIRE STAPLES AND STAMPED STAPLES" (currently U.S. Patent No. 10,702,270), - U.S. Patent Application No. 15 / 191,834, Title of Invention: "STAMPED STAPLES AND STAPLE CARTRIDGES USING THE SAME" (currently U.S. Patent No. 10,542,979), - U.S. Patent Application No. 15 / 191,788, Title of Invention "STAPLE CARTRIDGE COMPRISING OVERDRIVEN STAPLES" (currently U.S. Patent No. 10,675,024), and - U.S. Patent Application No. 15 / 191,818, title of invention "STAPLE CARTRIDGE COMPRISING OFFSET LONGITUDINAL STAPLE ROWS" (currently U.S. Patent No. 10,893,863).

[0019] The applicant of this application owns the following U.S. patent applications filed on June 24, 2016, each of which is incorporated herein by reference in its entirety. - U.S. Design Patent Application No. 29 / 569,218, Title of Invention: "SURGICAL FASTENER" (currently U.S. Design Patent No. D826,405), - U.S. Design Patent Application No. 29 / 569,227, Title of Invention: "SURGICAL FASTENER" (currently U.S. Design Patent No. D822,206), - U.S. Design Patent Application No. 29 / 569,259, Title of Invention: "SURGICAL FASTENER CARTRIDGE" (currently U.S. Design Patent No. D847,989), - U.S. Design Patent Application No. 29 / 569,264, Title of Invention: "SURGICAL FASTENER CARTRIDGE" (currently U.S. Design Patent No. D850,617).

[0020] The applicant of this application owns the following patent applications filed on April 1, 2016, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 15 / 089,325, Title of Invention: "METHOD FOR OPERATING A SURGICAL STAPLING SYSTEM" (currently U.S. Patent Application Publication No. 2017 / 0281171), - U.S. Patent Application No. 15 / 089,321, Title of Invention: "MODULAR SURGICAL STAPLING SYSTEM COMPRISING A DISPLAY" (currently U.S. Patent No. 10,271,851), - U.S. Patent Application No. 15 / 089,326, Title of Invention: "SURGICAL STAPLING SYSTEM COMPRISING A DISPLAY INCLUDING A RE-ORIENTABLE DISPLAY FIELD" (currently U.S. Patent No. 10,433,849), - U.S. Patent Application No. 15 / 089,263, Title of Invention: "SURGICAL INSTRUMENT HANDLE ASSEMBLY WITH RECONFIGURABLE GRIP PORTION" (currently U.S. Patent No. 10,307,159), - U.S. Patent Application No. 15 / 089,262, Title of Invention: "ROTARY POWERED SURGICAL INSTRUMENT WITH MANUALLY ACTUATABLE BAILOUT SYSTEM" (currently U.S. Patent No. 10,357,246), - U.S. Patent Application No. 15 / 089,277, Title of Invention: "SURGICAL CUTTING AND STAPLING END EFFECTOR WITH ANVIL CONCENTRIC DRIVE MEMBER" (currently U.S. Patent No. 10,531,874), - U.S. Patent Application No. 15 / 089,296, Title of Invention: "Interchangeable Surgical Tool Assembled with a Surgical End Effector That Is Selectively Rotatable About a Shaft Axis" (currently U.S. Patent No. 10,413,293), - U.S. Patent Application No. 15 / 089,258, Title of Invention: "SURGICAL STAPLING SYSTEM COMPRISING A SHIFTABLE TRANSMISSION" (currently U.S. Patent No. 10,342,543), - U.S. Patent Application No. 15 / 089,278, Title of Invention: "SURGICAL STAPLING SYSTEM CONFIGURED TO PROVIDE SELECTIVE CUTTING OF TISSUE" (currently U.S. Patent No. 10,420,552), - U.S. Patent Application No. 15 / 089,284, Title of Invention: "SURGICAL STAPLING SYSTEM COMPRISING A CONTOURABLE SHAFT" (currently U.S. Patent Publication No. 2017 / 0281186), - U.S. Patent Application No. 15 / 089,295, Title of Invention: "SURGICAL STAPLING SYSTEM COMPRISING A TISSUE COMPRESSION LOCKOUT" (currently U.S. Patent No. 10,856,867), - U.S. Patent Application No. 15 / 089,300, Title of Invention: "SURGICAL STAPLING SYSTEM COMPRISING AN UNCLAMPING LOCKOUT" (currently U.S. Patent No. 10,456,140), - U.S. Patent Application No. 15 / 089,196, Title of Invention: "SURGICAL STAPLING SYSTEM COMPRISING A JAW CLOSURE LOCKOUT" (currently U.S. Patent No. 10,568,632), - U.S. Patent Application No. 15 / 089,203, Title of Invention: "SURGICAL STAPLING SYSTEM COMPRISING A JAW ATTACHMENT LOCKOUT" (currently U.S. Patent No. 10,542,991), - U.S. Patent Application No. 15 / 089,210, Title of Invention: "SURGICAL STAPLING SYSTEM COMPRISING A SPENT CARTRIDGE LOCKOUT" (currently U.S. Patent No. 10,478,190), - U.S. Patent Application No. 15 / 089,324, title of invention "SURGICAL INSTRUMENT COMPRISING A SHIFTING MECHANISM" (currently U.S. Patent No. 10,314,582). - U.S. Patent Application No. 15 / 089,335, Title of Invention: "SURGICAL STAPLING INSTRUMENT COMPRISING MULTIPLE LOCKOUTS" (currently U.S. Patent No. 10,485,542), - U.S. Patent Application No. 15 / 089,339, Title of Invention: "SURGICAL STAPLING INSTRUMENT" (currently U.S. Patent Publication No. 2017 / 0281173), - U.S. Patent Application No. 15 / 089,253, Title of Invention: "SURGICAL STAPLING SYSTEM CONFIGURED TO APPLY ANNULAR ROWS OF STAPLES HAVING DIFFERENT HEIGHTS" (currently U.S. Patent No. 10,413,297), - U.S. Patent Application No. 15 / 089,304, Title of Invention: "SURGICAL STAPLING SYSTEM COMPRISING A GROOVED FORMING POCKET" (currently U.S. Patent No. 10,285,705), - U.S. Patent Application No. 15 / 089,331, Title of Invention: "ANVIL MODIFICATION MEMBERS FOR SURGICAL STAPLERS" (currently U.S. Patent No. 10,376,263), - U.S. Patent Application No. 15 / 089,336, Title of Invention: "STAPLE CARTRIDGES WITH ATRAUMATIC FEATURES" (currently U.S. Patent No. 10,709,446), - U.S. Patent Application No. 15 / 089,312, Title of Invention: "CIRCULAR STAPLING SYSTEM COMPRISING AN INCISABLE TISSUE SUPPORT" (currently U.S. Patent Application Publication No. 2017 / 0281189), - U.S. Patent Application No. 15 / 089,309, Title of Invention "CIRCULAR STAPLING SYSTEM COMPRISING ROTARY FIRING SYSTEM" (currently U.S. Patent No. 10,675,021), and - U.S. Patent Application No. 15 / 089,349, Title of Invention: "CIRCULAR STAPLING SYSTEM COMPRISING LOAD CONTROL" (currently U.S. Patent No. 10,682,136).

[0021] The applicant of this application also owns the following U.S. patent applications filed on December 30, 2015, which are incorporated herein by reference in their entirety. - U.S. Patent Application No. 14 / 984,488, Title of Invention: "MECHANISMS FOR COMPENSATING FOR BATTERY PACK FAILURE IN POWERED SURGICAL INSTRUMENTS" (currently U.S. Patent No. 10,292,704), - U.S. Patent Application No. 14 / 984,525, Title of Invention: "MECHANISMS FOR COMPENSATING FOR DRIVETRAIN FAILURE IN POWERED SURGICAL INSTRUMENTS" (currently U.S. Patent No. 10,368,865), - U.S. Patent Application No. 14 / 984,552, title of invention "SURGICAL INSTRUMENTS WITH SEPARABLE MOTORS AND MOTOR CONTROL CIRCUITS" (currently U.S. Patent No. 10,265,068).

[0022] The applicant of this application also owns the following U.S. patent applications, filed on 9 February 2016, which are incorporated herein by reference in their entirety. - U.S. Patent Application No. 15 / 019,220, Title of Invention: "SURGICAL INSTRUMENT WITH ARTICULATING AND AXIALLY TRANSLATABLE END EFFECTOR" (currently U.S. Patent No. 10,245,029), - U.S. Patent Application No. 15 / 019,228, Title of Invention: "SURGICAL INSTRUMENTS WITH MULTIPLE LINK ARTICULATION ARRANGEMENTS" (currently U.S. Patent No. 10,433,837), - U.S. Patent Application No. 15 / 019,196, Title of Invention: "SURGICAL INSTRUMENT ARTICULATION MECHANISM WITH SLOTTED SECONDARY CONSTRAINT" (currently U.S. Patent No. 10,413,291), - U.S. Patent Application No. 15 / 019,206, Title of Invention: "SURGICAL INSTRUMENTS WITH AN END EFFECTOR THAT IS HIGHLY ARTICULATABLE RELATIVE TO AN ELONGATE SHAFT ASSEMBLY" (currently U.S. Patent No. 10,653,413), - U.S. Patent Application No. 15 / 019,215, Title of Invention: "SURGICAL INSTRUMENTS WITH NON-SYMMETRICAL ARTICULATION ARRANGEMENTS" (currently U.S. Patent Publication No. 2017 / 0224332), - U.S. Patent Application No. 15 / 019,227, Title of Invention: "ARTICULATABLE SURGICAL INSTRUMENTS WITH SINGLE ARTICULATION LINK ARRANGEMENTS" (currently U.S. Patent Application Publication No. 2017 / 0224334), - U.S. Patent Application No. 15 / 019,235, Title of Invention: "SURGICAL INSTRUMENTS WITH TENSIONING ARRANGEMENTS FOR CABLE DRIVEN ARTICULATION SYSTEMS" (currently U.S. Patent No. 10,245,030), - U.S. Patent Application No. 15 / 019,230, Title of Invention "ARTICULATABLE SURGICAL INSTRUMENTS WITH OFF-AXIS FIRING BEAM ARRANGEMENTS" (currently U.S. Patent No. 10,588,625), and - U.S. Patent Application No. 15 / 019,245, title of invention "SURGICAL INSTRUMENTS WITH CLOSURE STROKE REDUCTION ARRANGEMENTS" (currently U.S. Patent No. 10,470,764).

[0023] The applicant of this application also owns the following U.S. patent applications, filed on February 12, 2016, which are incorporated herein by reference in their entirety. - U.S. Patent Application No. 15 / 043,254, Title of Invention: "MECHANISMS FOR COMPENSATING FOR DRIVETRAIN FAILURE IN POWERED SURGICAL INSTRUMENTS" (currently U.S. Patent No. 10,258,331), - U.S. Patent Application No. 15 / 043,259, Title of Invention: "MECHANISMS FOR COMPENSATING FOR DRIVETRAIN FAILURE IN POWERED SURGICAL INSTRUMENTS" (currently U.S. Patent No. 10,448,948), - U.S. Patent Application No. 15 / 043,275, Title of Invention "MECHANISMS FOR COMPENSATING FOR DRIVETRAIN FAILURE IN POWERED SURGICAL INSTRUMENTS" (currently U.S. Patent Application Publication No. 2017 / 0231627), and - U.S. Patent Application No. 15 / 043,289, title of invention "MECHANISMS FOR COMPENSATING FOR DRIVETRAIN FAILURE IN POWERED SURGICAL INSTRUMENTS" (currently U.S. Patent Application Publication No. 2017 / 0231628).

[0024] The applicant of this application owns the following patent applications filed on June 18, 2015, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 14 / 742,925, Title of Invention: "SURGICAL END EFFECTORS WITH POSITIVE JAW OPENING ARRANGEMENTS" (currently U.S. Patent No. 10,182,818), - U.S. Patent Application No. 14 / 742,941, Title of Invention: "SURGICAL END EFFECTORS WITH DUAL CAM ACTUATED JAW CLOSING FEATURES" (currently U.S. Patent No. 10,052,102), - U.S. Patent Application No. 14 / 742,933, Title of Invention: "SURGICAL STAPLING INSTRUMENTS WITH LOCKOUT ARRANGEMENTS FOR PREVENTING FIRING SYSTEM ACTUATION WHEN A CARTRIDGE IS SPENT OR MISSING" (currently U.S. Patent No. 10,154,841), - U.S. Patent Application No. 14 / 742,914, Title of Invention: "MOVABLE FIRING BEAM SUPPORT ARRANGEMENTS FOR ARTICULATABLE SURGICAL INSTRUMENTS" (currently U.S. Patent No. 10,405,863), - U.S. Patent Application No. 14 / 742,900, Title of Invention: "ARTICULATABLE SURGICAL INSTRUMENTS WITH COMPOSITE FIRING BEAM STRUCTURES WITH CENTER FIRING SUPPORT MEMBER FOR ARTICULATION SUPPORT" (currently U.S. Patent No. 10,335,149), - U.S. Patent Application No. 14 / 742,885, title of invention "DUAL ARTICULATION DRIVE SYSTEM ARRANGEMENTS FOR ARTICULATABLE SURGICAL INSTRUMENTS" (currently U.S. Patent No. 10,368,861), and - U.S. Patent Application No. 14 / 742,876, title of invention "PUSH / PULL ARTICULATION DRIVE SYSTEMS FOR ARTICULATABLE SURGICAL INSTRUMENTS" (currently U.S. Patent No. 10,178,992).

[0025] The applicant of this application owns the following patent applications filed on March 6, 2015, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 14 / 640,746, Title of Invention: "POWERED SURGICAL INSTRUMENT" (currently U.S. Patent No. 9,808,246), - U.S. Patent Application No. 14 / 640,795, Title of Invention: "MULTIPLE LEVEL THRESHOLDS TO MODIFY OPERATION OF POWERED SURGICAL INSTRUMENTS" (currently U.S. Patent No. 10,441,279), - U.S. Patent Application No. 14 / 640,832, Title of Invention: "Adaptive Tissue Compression Techniques to Adjust Closure Rates for Multiple Tissue Types" (currently U.S. Patent No. 10,687,806), - U.S. Patent Application No. 14 / 640,935, Title of Invention: "OVERLAID MULTI SENSOR RADIO FREQUENCY (RF) ELECTRODE SYSTEM TO MEASURE TISSUE COMPRESSION" (currently U.S. Patent No. 10,548,504), - U.S. Patent Application No. 14 / 640,831, Title of Invention: "Monitoring Speed ​​Control and Precision Increasing of Motor for Powered Surgical Instruments" (currently U.S. Patent No. 9,895,148), - U.S. Patent Application No. 14 / 640,859, Title of Invention: "TIME DEPENDENT EVALUATION OF SENSOR DATA TO DETERMINE STABILITY, CREEP, AND VISCOELASTIC ELEMENTS OF MEASURES" (currently U.S. Patent No. 10,052,044), - U.S. Patent Application No. 14 / 640,817, Title of Invention: "INTERACTIVE FEEDBACK SYSTEM FOR POWERED SURGICAL INSTRUMENTS" (currently U.S. Patent No. 9,924,961), - U.S. Patent Application No. 14 / 640,844, Title of Invention: "CONTROL TECHNIQUES AND SUB-PROCESSOR CONTAINED WITHIN MODULAR SHAFT WITH SELECT CONTROL PROCESSING FROM HANDLE" (currently U.S. Patent No. 10,045,776), - U.S. Patent Application No. 14 / 640,837, Title of Invention: "SMART SENSORS WITH LOCAL SIGNAL PROCESSING" (currently U.S. Patent No. 9,993,248), - U.S. Patent Application No. 14 / 640,765, Title of Invention: "SYSTEM FOR DETECTING THE MIS-INSERTION OF A STAPLE CARTRIDGE INTO A SURGICAL STAPLER" (currently U.S. Patent No. 10,617,412), - U.S. Patent Application No. 14 / 640,799, Title of Invention "SIGNAL AND POWER COMMUNICATION SYSTEM POSITIONED ON A ROTATABLE SHAFT" (currently U.S. Patent No. 9,901,342), and - U.S. Patent Application No. 14 / 640,780, title of invention "SURGICAL INSTRUMENT COMPRISING A LOCKABLE BATTERY HOUSING" (currently U.S. Patent No. 10,245,033).

[0026] The applicant of this application owns the following patent applications filed on February 27, 2015, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 14 / 633,576, Title of Invention: "SURGICAL INSTRUMENT SYSTEM COMPRISING AN INSPECTION STATION" (currently U.S. Patent No. 10,045,779), - U.S. Patent Application No. 14 / 633,546, Title of Invention: "SURGICAL APPARATUS CONFIGURED TO ASSESS WHETHER A PERFORMANCE PARAMETER OF THE SURGICAL APPARATUS IS WITHIN AN ACCEPTABLE PERFORMANCE BAND" (currently U.S. Patent No. 10,180,463), - U.S. Patent Application No. 14 / 633,560, Title of Invention: "SURGICAL CHARGING SYSTEM THAT CHARGES AND / OR CONDITIONS ONE OR MORE BATTERIES" (currently U.S. Patent Application Publication No. 2016 / 0249910), - U.S. Patent Application No. 14 / 633,566, Title of Invention: "CHARGING SYSTEM THAT ENABLES EMERGENCY RESOLUTIONS FOR CHARGING A BATTERY" (currently U.S. Patent No. 10,182,816), - U.S. Patent Application No. 14 / 633,555, Title of Invention: "SYSTEM FOR MONITORING WHETHER A SURGICAL INSTRUMENT NEEDS TO BE SERVICED" (currently U.S. Patent No. 10,321,907), - U.S. Patent Application No. 14 / 633,542, Title of Invention: "REINFORCED BATTERY FOR A SURGICAL INSTRUMENT" (currently U.S. Patent No. 9,931,118), - U.S. Patent Application No. 14 / 633,548, Title of Invention: "POWER ADAPTER FOR A SURGICAL INSTRUMENT" (currently U.S. Patent No. 10,245,028), - U.S. Patent Application No. 14 / 633,526, Title of Invention: "ADAPTABLE SURGICAL INSTRUMENT HANDLE" (currently U.S. Patent No. 9,993,258), - U.S. Patent Application No. 14 / 633,541, title of invention "MODULAR STAPLING ASSEMBLY" (currently U.S. Patent No. 10,226,250), and - U.S. Patent Application No. 14 / 633,562, title of invention "SURGICAL APPARATUS CONFIGURED TO TRACK AN END-OF-LIFE PARAMETER" (currently U.S. Patent No. 10,159,483).

[0027] The applicant of this application owns the following patent applications filed on December 18, 2014, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 14 / 574,478, Title of Invention: "SURGICAL INSTRUMENT SYSTEMS COMPRISING AN ARTICULATABLE END EFFECTOR AND MEANS FOR ADJUSTING THE FIRING STROKE OF A FIRING MEMBER" (currently U.S. Patent No. 9,844,374), - U.S. Patent Application No. 14 / 574,483, Title of Invention: "SURGICAL INSTRUMENT ASSEMBLY COMPRISING LOCKABLE SYSTEMS" (currently U.S. Patent No. 10,188,385), - U.S. Patent Application No. 14 / 575,139, Title of Invention: "Drive Arrangements for Articulatable Surgical Instruments" (currently U.S. Patent No. 9,844,375), - U.S. Patent Application No. 14 / 575,148, Title of Invention: "LOCKING ARRANGEMENTS FOR DETACHABLE SHAFT ASSEMBLIES WITH ARTICULATABLE SURGICAL END EFFECTORS" (currently U.S. Patent No. 10,085,748), - U.S. Patent Application No. 14 / 575,130, Title of Invention: "SURGICAL INSTRUMENT WITH AN ANVIL THAT IS SELECTIVELY MOVABLE ABOUT A DISCRETE NON-MOVABLE AXIS RELATIVE TO A STAPLE CARTRIDGE" (currently U.S. Patent No. 10,245,027), - U.S. Patent Application No. 14 / 575,143, Title of Invention: "SURGICAL INSTRUMENTS WITH IMPROVED CLOSURE ARRANGEMENTS" (currently U.S. Patent No. 10,004,501), - U.S. Patent Application No. 14 / 575,117, Title of Invention: "SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND MOVABLE FIRING BEAM SUPPORT ARRANGEMENTS" (currently U.S. Patent No. 9,943,309), - U.S. Patent Application No. 14 / 575,154, Title of Invention: "SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND IMPROVED FIRING BEAM SUPPORT ARRANGEMENTS" (currently U.S. Patent No. 9,968,355), - U.S. Patent Application No. 14 / 574,493, title of invention "SURGICAL INSTRUMENT ASSEMBLY COMPRISING A FLEXIBLE ARTICULATION SYSTEM" (currently U.S. Patent No. 9,987,000), and - U.S. Patent Application No. 14 / 574,500, title of invention "SURGICAL INSTRUMENT ASSEMBLY COMPRISING A LOCKABLE ARTICULATION SYSTEM" (currently U.S. Patent No. 10,117,649).

[0028] The applicant of this application owns the following patent applications filed on March 1, 2013, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 13 / 782,295, Title of Invention: "ARTICULATABLE SURGICAL INSTRUMENTS WITH CONDUCTIVE PATHWAYS FOR SIGNAL COMMUNICATION" (currently U.S. Patent No. 9,700,309), - U.S. Patent Application No. 13 / 782,323, Title of Invention: "ROTARY POWERED ARTICULATION JOINTS FOR SURGICAL INSTRUMENTS" (currently U.S. Patent No. 9,782,169), - U.S. Patent Application No. 13 / 782,338, Title of Invention: "THUMBWHEEL SWITCH ARRANGEMENTS FOR SURGICAL INSTRUMENTS" (currently U.S. Patent Publication No. 2014 / 0249557), - U.S. Patent Application No. 13 / 782,499, Title of Invention: "ELECTROMECHANICAL SURGICAL DEVICE WITH SIGNAL RELAY ARRANGEMENT" (currently U.S. Patent No. 9,358,003), - U.S. Patent Application No. 13 / 782,460, Title of Invention: "MULTIPLE PROCESSOR MOTOR CONTROL FOR MODULAR SURGICAL INSTRUMENTS" (currently U.S. Patent No. 9,554,794), - U.S. Patent Application No. 13 / 782,358, Title of Invention: "JOYSTICK SWITCH ASSEMBLIES FOR SURGICAL INSTRUMENTS" (currently U.S. Patent No. 9,326,767), - U.S. Patent Application No. 13 / 782,481, Title of Invention: "SENSOR STRAIGHTENED END EFFECTOR DURING REMOVAL THROUGH TROCAR" (currently U.S. Patent No. 9,468,438), - U.S. Patent Application No. 13 / 782,518, Title of Invention: "CONTROL METHODS FOR SURGICAL INSTRUMENTS WITH REMOVABLE IMPLEMENT PORTIONS" (currently U.S. Patent Application Publication No. 2014 / 0246475), - U.S. Patent Application No. 13 / 782,375, Title of Invention "ROTARY POWERED SURGICAL INSTRUMENTS WITH MULTIPLE DEGREES OF FREEDOM" (currently U.S. Patent No. 9,398,911), and - U.S. Patent Application No. 13 / 782,536, title of invention "SURGICAL INSTRUMENT SOFT STOP" (currently U.S. Patent No. 9,307,986).

[0029] The applicant of this application also owns the following patent applications filed on March 14, 2013, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 13 / 803,097, Title of Invention: "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE" (currently U.S. Patent No. 9,687,230), - U.S. Patent Application No. 13 / 803,193, Title of Invention: "CONTROL ARRANGEMENTS FOR A DRIVE MEMBER OF A SURGICAL INSTRUMENT" (currently U.S. Patent No. 9,332,987), - U.S. Patent Application No. 13 / 803,053, Title of Invention: "INTERCHANGEABLE SHAFT ASSEMBLIES FOR USE WITH A SURGICAL INSTRUMENT" (currently U.S. Patent No. 9,883,860), - U.S. Patent Application No. 13 / 803,086, Title of Invention: "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK" (currently U.S. Patent Application Publication No. 2014 / 0263541), - U.S. Patent Application No. 13 / 803,210, Title of Invention: "SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FOR SURGICAL INSTRUMENTS" (currently U.S. Patent No. 9,808,244), - U.S. Patent Application No. 13 / 803,148, Title of Invention: "MULTI-FUNCTION MOTOR FOR A SURGICAL INSTRUMENT" (currently U.S. Patent No. 10,470,762), - U.S. Patent Application No. 13 / 803,066, Title of Invention: "DRIVE SYSTEM LOCKOUT ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS" (currently U.S. Patent No. 9,629,623), - U.S. Patent Application No. 13 / 803,117, Title of Invention: "ARTICULATION CONTROL SYSTEM FOR ARTICULATABLE SURGICAL INSTRUMENTS" (currently U.S. Patent No. 9,351,726), - U.S. Patent Application No. 13 / 803,130, title of invention "DRIVE TRAIN CONTROL ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS" (currently U.S. Patent No. 9,351,727), and - U.S. Patent Application No. 13 / 803,159, title of invention "METHOD AND SYSTEM FOR OPERATING A SURGICAL INSTRUMENT" (currently U.S. Patent No. 9,888,919).

[0030] The applicant of this application also owns the following patent application filed on March 7, 2014, which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 14 / 200,111, title of invention "CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS" (currently U.S. Patent No. 9,629,629).

[0031] The applicant of this application also owns the following patent applications filed on March 26, 2014, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 14 / 226,106, Title of Invention: "POWER MANAGEMENT CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS" (currently U.S. Patent Publication No. 2015 / 0272582), - U.S. Patent Application No. 14 / 226,099, Title of Invention "STERILIZATION VERIFICATION CIRCUIT" (currently U.S. Patent No. 9,826,977), - U.S. Patent Application No. 14 / 226,094, Title of Invention: "VERIFICATION OF NUMBER OF BATTERY EXCHANGES / PROCEDURE COUNT" (currently U.S. Patent Publication No. 2015 / 0272580), - U.S. Patent Application No. 14 / 226,117, Title of Invention: "POWER MANAGEMENT THROUGH SLEEP OPTIONS OF SEGMENTED CIRCUIT AND WAKE UP CONTROL" (currently U.S. Patent No. 10,013,049), - U.S. Patent Application No. 14 / 226,075, Title of Invention: "MODULAR POWERED SURGICAL INSTRUMENT WITH DETACHABLE SHAFT ASSEMBLIES" (currently U.S. Patent No. 9,743,929), - U.S. Patent Application No. 14 / 226,093, Title of Invention: "FEEDBACK ALGORITHMS FOR MANUAL BAILOUT SYSTEMS FOR SURGICAL INSTRUMENTS" (currently U.S. Patent No. 10,028,761), - U.S. Patent Application No. 14 / 226,116, Title of Invention: "SURGICAL INSTRUMENT UTILIZING SENSOR ADAPTATION" (currently U.S. Patent Publication No. 2015 / 0272571), - U.S. Patent Application No. 14 / 226,071, Title of Invention: "SURGICAL INSTRUMENT CONTROL CIRCUIT HAVING A SAFETY PROCESSOR" (currently U.S. Patent No. 9,690,362), - U.S. Patent Application No. 14 / 226,097, Title of Invention: "SURGICAL INSTRUMENT COMPRISING INTERACTIVE SYSTEMS" (currently U.S. Patent No. 9,820,738), - U.S. Patent Application No. 14 / 226,126, Title of Invention: "INTERFACE SYSTEMS FOR USE WITH SURGICAL INSTRUMENTS" (currently U.S. Patent No. 10,004,497), - U.S. Patent Application No. 14 / 226,133, Title of Invention: "MODULAR SURGICAL INSTRUMENT SYSTEM" (currently U.S. Patent Publication No. 2015 / 0272557), - U.S. Patent Application No. 14 / 226,081, Title of Invention: "SYSTEMS AND METHODS FOR CONTROLLING A SEGMENTED CIRCUIT" (currently U.S. Patent No. 9,804,618), - U.S. Patent Application No. 14 / 226,076, Title of Invention: "POWER MANAGEMENT THROUGH SEGMENTED CIRCUIT AND VARIABLE VOLTAGE PROTECTION" (currently U.S. Patent No. 9,733,663), - U.S. Patent Application No. 14 / 226,111, Title of Invention "SURGICAL STAPLING INSTRUMENT SYSTEM" (currently U.S. Patent No. 9,750,499), and - U.S. Patent Application No. 14 / 226,125, title of invention "SURGICAL INSTRUMENT COMPRISING A ROTATABLE SHAFT" (currently U.S. Patent No. 10,201,364).

[0032] The applicant of this application also owns the following patent applications filed on September 5, 2014, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 14 / 479,103, Title of Invention: "CIRCUITRY AND SENSORS FOR POWERED MEDICAL DEVICE" (currently U.S. Patent No. 10,111,679), - U.S. Patent Application No. 14 / 479,119, Title of Invention: "ADJUNCT WITH INTEGRATED SENSORS TO QUANTIFY TISSUE COMPRESSION" (currently U.S. Patent No. 9,724,094), - U.S. Patent Application No. 14 / 478,908, Title of Invention: "Monitoring Device Degradation Based on Component Evaluation" (currently U.S. Patent No. 9,737,301), - U.S. Patent Application No. 14 / 478,895, Title of Invention: "Multiple Sensors with One Sensor Affecting a Second Sensor's Output or Interpretation" (currently U.S. Patent No. 9,757,128), - U.S. Patent Application No. 14 / 479,110, Title of Invention: "POLARITY OF HALL MAGNET TO IDENTIFY CARTRIDGE TYPE" (currently U.S. Patent No. 10,016,199), - U.S. Patent Application No. 14 / 479,098, Title of Invention: "SMART CARTRIDGE WAKE UP OPERATION AND DATA RETENTION" (currently U.S. Patent No. 10,135,242), - U.S. Patent Application No. 14 / 479,115, Title of Invention "MULTIPLE MOTOR CONTROL FOR POWERED MEDICAL DEVICE" (currently U.S. Patent No. 9,788,836), and - U.S. Patent Application No. 14 / 479,108, title of invention "LOCAL DISPLAY OF TISSUE PARAMETER STABILIZATION" (currently U.S. Patent Application Publication No. 2016 / 0066913).

[0033] The applicant of this application also owns the following patent applications filed on April 9, 2014, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 14 / 248,590, Title of Invention: "MOTOR DRIVEN SURGICAL INSTRUMENTS WITH LOCKABLE DUAL DRIVE SHAFTS" (currently U.S. Patent No. 9,826,976), - U.S. Patent Application No. 14 / 248,581, Title of Invention: "SURGICAL INSTRUMENT COMPRISING A CLOSING DRIVE AND A FIRING DRIVE OPERATED FROM THE SAME ROTATABLE OUTPUT" (currently U.S. Patent No. 9,649,110), - U.S. Patent Application No. 14 / 248,595, Title of Invention: "SURGICAL SYSTEM COMPRISING FIRST AND SECOND DRIVE SYSTEMS" (currently U.S. Patent No. 9,844,368), - U.S. Patent Application No. 14 / 248,588, Title of Invention: "POWERED LINEAR SURGICAL STAPLER" (currently U.S. Patent No. 10,405,857), - U.S. Patent Application No. 14 / 248,591, Title of Invention: "SURGICAL INSTRUMENT COMPRISING A GAP SETTING SYSTEM" (currently U.S. Patent No. 10,149,680), - U.S. Patent Application No. 14 / 248,584, Title of Invention: "MODULAR MOTOR DRIVEN SURGICAL INSTRUMENTS WITH ALIGNMENT FEATURES FOR ALIGNING ROTARY DRIVE SHAFTS WITH SURGICAL END EFFECTOR SHAFTS" (currently U.S. Patent No. 9,801,626), - U.S. Patent Application No. 14 / 248,587, Title of Invention: "POWERED SURGICAL STAPLER" (currently U.S. Patent No. 9,867,612), - U.S. Patent Application No. 14 / 248,586, Title of Invention "DRIVE SYSTEM DECOUPLING ARRANGEMENT FOR A SURGICAL INSTRUMENT" (currently U.S. Patent No. 10,136,887), and - U.S. Patent Application No. 14 / 248,607, title of invention "MODULAR MOTOR DRIVEN SURGICAL INSTRUMENTS WITH STATUS INDICATION ARRANGEMENTS" (currently U.S. Patent No. 9,814,460).

[0034] The applicant of this application also owns the following patent applications filed on April 16, 2013, each of which is incorporated herein by reference in its entirety. - U.S. Provisional Patent Application No. 61 / 812,365, Title of Invention: "SURGICAL INSTRUMENT WITH MULTIPLE FUNCTIONS PERFORMED BY A SINGLE MOTOR", - U.S. Provisional Patent Application No. 61 / 812,376, Title of Invention: "LINEAR CUTTER WITH POWER", - U.S. Provisional Patent Application No. 61 / 812,382, Title of Invention: "LINEAR CUTTER WITH MOTOR AND PISTOL GRIP", - U.S. Provisional Patent Application No. 61 / 812,385, Title of Invention: "SURGICAL INSTRUMENT HANDLE WITH MULTIPLE ACTUATION MOTORS AND MOTOR CONTROL", and - U.S. Provisional Patent Application No. 61 / 812,372, Title of Invention: "SURGICAL INSTRUMENT WITH MULTIPLE FUNCTIONS PERFORMED BY A SINGLE MOTOR".

[0035] The applicant of this application owns the following U.S. provisional patent applications filed on 28 December 2017, the entirety of each of these disclosures is incorporated herein by reference. - U.S. Provisional Patent Application No. 62 / 611,341, Title of Invention: "INTERACTIVE SURGICAL PLATFORM", - U.S. Provisional Patent Application No. 62 / 611,340, Title of Invention "CLOUD-BASED MEDICAL ANALYTICS", and - U.S. Provisional Patent Application No. 62 / 611,339, Title of Invention: "ROBOT ASSISTED SURGICAL PLATFORM".

[0036] The applicant of this application owns the following U.S. provisional patent applications filed on March 28, 2018, each of which is incorporated herein by reference in its entirety. - U.S. Provisional Patent Application No. 62 / 649,302, Title of Invention: "INTERACTIVE SURGICAL SYSTEMS WITH encrypted COMMUNICATION CAPABILITIES", - U.S. Provisional Patent Application No. 62 / 649,294, Title of Invention: "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD", - U.S. Provisional Patent Application No. 62 / 649,300, Title of Invention: "SURGICAL HUB SITUATIONAL AWARENESS", - U.S. Provisional Patent Application No. 62 / 649,309, Title of Invention: "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER" - U.S. Provisional Patent Application No. 62 / 649,310, Title of Invention: "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS", - U.S. Provisional Patent Application No. 62 / 649,291, Title of Invention: "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT", - U.S. Provisional Patent Application No. 62 / 649,296, Title of Invention: "Adaptive Control Program Updates for Surgical Devices", - U.S. Provisional Patent Application No. 62 / 649,333, Title of Invention: "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER", - U.S. Provisional Patent Application No. 62 / 649,327, Title of Invention: "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES", - U.S. Provisional Patent Application No. 62 / 649,315, Title of Invention: "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK", - U.S. Provisional Patent Application No. 62 / 649,313, Title of Invention: "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES", - U.S. Provisional Patent Application No. 62 / 649,320, Title of Invention: "Drive arrangements for robot-asposed surgical platforms," - U.S. Provisional Patent Application No. 62 / 649,307, Title of Invention: "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS", and - U.S. Provisional Patent Application No. 62 / 649,323, Title of Invention: "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS".

[0037] The applicant of this application owns the following U.S. patent applications filed on March 29, 2018, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 15 / 940,641, Title of Invention: "INTERACTIVE SURGICAL SYSTEMS WITH encrypted COMMUNICATION CAPABILITIES" (currently U.S. Patent Publication No. 2019 / 0207911), - U.S. Patent Application No. 15 / 940,648, Title of Invention: "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES" (currently U.S. Patent Publication No. 2019 / 0206004), - U.S. Patent Application No. 15 / 940,656, Title of Invention: "Surgical hub coordination of control and communication of operating room devices" (currently U.S. Patent Publication No. 2019 / 0201141), - U.S. Patent Application No. 15 / 940,666, Title of Invention: "Spatial awareness of surgical hubs in operating rooms" (currently U.S. Patent Publication No. 2019 / 0206551), - U.S. Patent Application No. 15 / 940,670, Title of Invention: "Cooperative utilization of data derived from secondary sources by intelligent surgical hubs" (currently U.S. Patent Publication No. 2019 / 0201116), - U.S. Patent Application No. 15 / 940,677, Title of Invention: "Surgical hub control arrangements" (currently U.S. Patent Publication No. 2019 / 0201143), - U.S. Patent Application No. 15 / 940,632, Title of Invention: "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD" (currently U.S. Patent Application Publication No. 2019 / 0205566), - U.S. Patent Application No. 15 / 940,640, Title of Invention: "Communication Hub and Storage Device for Storage Parameters and Status of a Surgical Device to Be Shared with Cloud-Based Analytical Systems" (currently U.S. Patent Publication No. 2019 / 0200863), - U.S. Patent Application No. 15 / 940,645, Title of Invention: "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT" (currently U.S. Patent No. 10,892,899), - U.S. Patent Application No. 15 / 940,649, Title of Invention: "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME" (currently U.S. Patent Publication No. 2019 / 0205567), - U.S. Patent Application No. 15 / 940,654, Title of Invention "SURGICAL HUB SITUATIONAL AWARENESS" (currently U.S. Patent Application Publication No. 2019 / 0201140), - U.S. Patent Application No. 15 / 940,663, Title of Invention: "SURGICAL SYSTEM DISTRIBUTED PROCESSING" (currently U.S. Patent Application Publication No. 2019 / 0201033), - U.S. Patent Application No. 15 / 940,668, Title of Invention: "AGGREGATION AND REPORTING OF SURGICAL HUB DATA" (currently U.S. Patent Application Publication No. 2019 / 0201115), - U.S. Patent Application No. 15 / 940,671, Title of Invention: "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER" (currently U.S. Patent Application Publication No. 2019 / 0201104), - U.S. Patent Application No. 15 / 940,686, Title of Invention: "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE" (currently U.S. Patent Application Publication No. 2019 / 0201105), - U.S. Patent Application No. 15 / 940,700, Title of Invention: "STERILE FIELD INTERACTIVE CONTROL DISPLAYS" (currently U.S. Patent Publication No. 2019 / 0205001), - U.S. Patent Application No. 15 / 940,629, Title of Invention: "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS" (currently U.S. Patent Application Publication No. 2019 / 0201112), - U.S. Patent Application No. 15 / 940,704, Title of Invention: "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT" (currently U.S. Patent Application Publication No. 2019 / 0206050), - U.S. Patent Application No. 15 / 940,722, Title of Invention: "Characterization of Tissue Irregularities Through the Use of Mono-Chromatic Light Refractivity" (currently U.S. Patent Application No. 2019 / 0200905), - U.S. Patent Application No. 15 / 940,742, title of invention "DUAL CMOS ARRAY IMAGING" (currently published as U.S. Patent Application Publication No. 2019 / 0200906).

[0038] The applicant of this application owns the following U.S. patent applications filed on March 29, 2018, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 15 / 940,636, title of invention "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES" (currently U.S. Patent Application Publication No. 2019 / 0206003). - U.S. Patent Application No. 15 / 940,653, title of invention "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS" (currently U.S. Patent Application Publication No. 2019 / 0201114). - U.S. Patent Application No. 15 / 940,660, Title of Invention: "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER" (currently U.S. Patent Application Publication No. 2019 / 0206555), - U.S. Patent Application No. 15 / 940,679, Title of Invention: "CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET" (currently U.S. Patent Application Publication No. 2019 / 0201144), - U.S. Patent Application No. 15 / 940,694, Title of Invention: "Cloud-based Medical Analytics for Medical Facility Segmented Individualization of Instrument Function" (currently U.S. Patent Publication No. 2019 / 0201119), - U.S. Patent Application No. 15 / 940,634, Title of Invention: "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES" (currently U.S. Patent Publication No. 2019 / 0201138), - U.S. Patent Application No. 15 / 940,706, title of invention "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK" (currently U.S. Patent Application Publication No. 2019 / 0206561), and - U.S. Patent Application No. 15 / 940,675, title of invention "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES" (currently U.S. Patent No. 10,849,697).

[0039] The applicant of this application owns the following U.S. patent applications filed on March 29, 2018, each of which is incorporated herein by reference in its entirety. - U.S. Patent Application No. 15 / 940,627, Title of Invention: "Drive Arrangements for Robot-Assised Surgical Platforms" (currently U.S. Patent Application Publication No. 2019 / 0201111), - U.S. Patent Application No. 15 / 940,637, Title of Invention: "Communication Arrangements for Robot-Assised Surgical Platforms" (currently U.S. Patent Publication No. 2019 / 0201139), - U.S. Patent Application No. 15 / 940,642, titled "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS" (currently, U.S. Patent Application Publication No. 2019 / 0201113), - U.S. Patent Application No. 15 / 940,676, titled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS" (currently, U.S. Patent Application Publication No. 2019 / 0201142), - U.S. Patent Application No. 15 / 940,680, titled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS" (currently, U.S. Patent Application Publication No. 2019 / 0201135), - U.S. Patent Application No. 15 / 940,683, titled "COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS" (currently, U.S. Patent Application Publication No. 2019 / 0201145), - U.S. Patent Application No. 15 / 940,690, titled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS" (currently, U.S. Patent Application Publication No. 2019 / 0201118), - U.S. Patent Application No. 15 / 940,711, titled "SENSING ARRANGEMENTS FOR Robot-Assisted Surgical PlatformS" (currently, U.S. Patent Application Publication No. 2019 / 0201120).

[0040] Numerous specific details are set forth in order to provide a complete understanding of the overall structure, function, manufacture, and use of the embodiments as described in the specification and shown in the accompanying drawings. Well-known operations, components, and elements are not described in detail so as not to obscure the embodiments described herein. The reader will understand that the embodiments described and illustrated herein are non-limiting examples, and thus that the specific structural and functional details disclosed herein may be representative and exemplary. Modifications and variations can be made without departing from the scope of the claims.

[0041] The terms "comprise", "comprises", and any other forms of "comprise" (such as "comprising"), "have", "has", and any other forms of "have" (such as "having"), "include", "includes", and any other forms of "include" (such as "including"), and "contain", "contains", and any other forms of "contain" (such as "containing") are non-restrictive linking verbs. As a result, a surgical system, device, or apparatus that "comprises", "has", "includes", or "contains" one or more elements has those one or more elements but is not limited to having only those one or more elements. Similarly, an element of a system, device, or apparatus that "comprises", "has", "includes", or "contains" one or more features has those one or more features but is not limited to having only those one or more features.

[0042] The terms “proximal” and “distal” are used herein in reference to the clinician operating the handle portion of a surgical instrument. “Proximal” refers to the part closest to the clinician, and “distal” refers to the part further away from the clinician. For convenience and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein in reference to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be restrictive and / or absolute.

[0043] Various exemplary apparatuses and methods for performing laparoscopic and minimally invasive surgical procedures are provided. However, it will be readily apparent to the reader that the various methods and apparatuses disclosed herein can be used in many surgical procedures and applications, including, for example, those related to incisional surgical procedures. By continuing to read the “Modes for Carrying Out the Invention” section herein, the reader will further understand that the various instruments disclosed herein can be inserted into the body in any way, for example, through a pre-existing opening, through an incision or puncture hole formed in the tissue, etc. The working portion, or end-effector, of these instruments can be inserted directly into the patient’s body, or through an access device having a working passage through which the end-effector and elongated shaft of the surgical instrument can be advanced.

[0044] A surgical stapling system may comprise a shaft and an end effector extending from the shaft. The end effector comprises a first jaw and a second jaw. The first jaw comprises a staple cartridge. The staple cartridge is insertable into and removable from the first jaw, although other embodiments can be conceived in which the staple cartridge is not removable from the first jaw, or at least not easily replaceable from the first jaw. The second jaw comprises an anvil configured to deform staples ejected from the staple cartridge. The second jaw is pivotable relative to the first jaw about a closing axis, although other embodiments can be conceived in which the first jaw is pivotable relative to the second jaw. The surgical stapling system further comprises an articulating joint configured to rotate, i.e., articulate, the end effector relative to the shaft. The end effector is rotatable about an articulating axis extending through the articulating joint. Other embodiments can also be conceived in which the articulating joint is not included.

[0045] A staple cartridge comprises a cartridge body. The cartridge body includes a proximal end, a distal end, and a deck extending between the proximal and distal ends. During use, the staple cartridge is positioned on the first side of the tissue to be stapled, and the anvil is positioned on the second side of the tissue. The anvil is moved toward the staple cartridge to press and clamp the tissue against the deck. Staples, which are then removably stored within the cartridge body, can be deployed into the tissue. The cartridge body includes a defined staple cavity, and staples are removably stored within the staple cavity. The staple cavity is arranged in six longitudinal rows. Three rows of staple cavities are positioned on the first side of the longitudinal slots, and three rows of staple cavities are positioned on the second side of the longitudinal slots. Other devices for staple cavities and staples may also be possible.

[0046] The staples are supported by a staple driver within the cartridge body. The driver is movable between a first, i.e., non-firing position and a second, i.e., firing position, to eject the staples from the staple cavity. The driver is held within the cartridge body by a retainer extending around the lower perimeter of the cartridge body and includes an elastic member configured to grip the cartridge body and hold the retainer relative to the cartridge body. The drivers are movable between their non-firing positions and their firing positions by threads. The threads are movable between a proximal position adjacent to the proximal end and a distal position adjacent to the distal end. The threads include a plurality of inclined surfaces configured to slide beneath the driver and lift the driver, on which the staples are supported and directed toward the anvil.

[0047] In addition to the above, the thread is moved distally by the launching member. The launching member is configured to contact the thread and push it toward its distal end. A longitudinal slot defined within the cartridge body is configured to receive the launching member. The anvil also includes a slot configured to receive the launching member. The launching member further comprises a first cam that engages with a first jaw and a second cam that engages with a second jaw. When advancing the launching member distally, the first and second cams can control the distance between the deck of the staple cartridge and the anvil, i.e., the tissue gap. The launching member also comprises a knife configured to excise tissue trapped between the staple cartridge and the anvil. It is desirable that the knife be positioned at least partially proximal to the inclined surface so that the staple is ejected ahead of the knife.

[0048] Various staples disclosed herein include, for example, flat staples that can be cut and / or punched from a sheet of material. The sheet of material may be metallic and may include, for example, stainless steel and / or titanium. In at least one example, a sheet of material is made by tracing, etching, and / or cutting a contour, and this is processed and / or laser-cut to form a staple into a manufactured shape. A staple includes a pair of staple legs and a staple base or crown from which the staple legs extend. Each staple leg includes a staple tip or puncture portion configured to puncture tissue and contact a corresponding molded pocket of the anvil of a surgical staple fastener. The staple legs are configured to deform to form a molded configuration and fix tissue. The staple legs define a plane that is laterally offset from the plane defined by the base of the staple, but is at least substantially parallel. Embodiments in which the first and second planes are not parallel are conceivable.

[0049] A punched staple 100 is shown in Figures 1-4. The staple 100 includes a proximal staple leg 110, a distal staple leg 120, and a staple base 130. The staple 100 further includes vertical transition portions or blends 118, 128 and lateral transition portions or blends 116, 126. The vertical transition portions 118, 128 bend the legs 110, 120 vertically or upward from the staple base 130, or extend from the staple base 130. The lateral transition portions 116, 126 extend the staple legs 110, 120 laterally outward or at least substantially perpendicular to the staple base 130. The staple legs 110, 120 define a first plane, and the staple base 130 defines a second plane. The vertical transition sections 118, 128 and the lateral transition sections 116, 126 together allow the staple legs 110, 120 to be laterally offset and parallel to the staple base 130. In other words, the first plane is offset from the second plane and is at least substantially parallel to the second plane. In Figures 1 to 4, the first plane is offset in the negative Y direction perpendicular to the vertical Z direction. Other staples may be used with multiple staples 100, and these other staples include a first plane offset in the positive Y direction. By using both types of staples, staple rows can be nested or interwoven, and the staple legs of adjacent rows are at least substantially aligned and / or share a common longitudinal axis. In various examples, staple rows can be nested to provide higher density staple rows.

[0050] In addition to the above, the proximal staple leg 110 includes a roughly rectangular cross-section with a flat surface and corners. The corners of the cross-section have chamfered, rounded, and / or stamped edges 114 to reduce the exposure of sharp edges to patient tissue. Nevertheless, the proximal staple leg 110 is equipped with a sharp tip 112 configured to cut patient tissue. Similarly, the distal staple leg 120 has a roughly rectangular cross-section with a flat surface 125 and chamfered, rounded, and / or stamped corners 124 to reduce the exposure of sharp edges to patient tissue. Like the proximal staple leg 110, the distal staple leg 120 is equipped with a sharp tip 122 configured to cut patient tissue.

[0051] The staple base 130 comprises an upper portion 136 configured to contact and support the patient's tissue. The upper portion 136 of the staple base 130 comprises tissue contact surfaces 137, 138, and 139 and a chamfered, rounded, and / or stamped edge 134 to reduce the exposure of sharp edges to the patient's tissue. The staple base 130 further comprises a lower portion 135 including a drive cam 132 configured to engage directly with the thread. The lower portion 135 further comprises a bottom edge 131 that rests on the apex of the thread rail and a distal shoulder 133 that loses contact with the thread rail as the thread moves distally.

[0052] In addition to the above, the legs 110 and 120 of the staple 100 extend in a first plane, and the drive cam 132 of the staple 100 is defined in a second plane. The second plane is parallel to the first plane, or at least substantially parallel. When the legs 110 and 120 are deformed, they trap patient tissue within the staple 100 outside the second plane. In particular, such a configuration allows a larger volume of tissue to be trapped within the staple 100 compared to wire staples defined in a single plane. That said, such wire staples are preferred in many cases and can be used in combination with punched staples in some cases.

[0053] A staple cartridge 2100 comprising a cartridge body 2110 is shown in Figure 5. The cartridge body 2110 comprises a deck 2114 and a plurality of staple cavities 2120a and a plurality of staple cavities 2120b. Staple cavities 2120a are similar in many respects to staple cavities 2120b. For example, both staple cavities 2120a and 2120b include a central slot 2121 having a proximal end and a distal end, a proximal staple leg guide 2122 extending laterally from the proximal end of the central slot 2121, and a distal staple leg guide 2123 extending laterally from the distal end of the central slot 2121. Thus, staple cavities 2120a and staple cavities 2120b are oriented in different directions. More specifically, the staple leg guides 2122 and 2123 of the staple cavity 2120a extend toward the staple cavity 2120b, and similarly, the staple leg guides 2122 and 2123 of the staple cavity 2120b extend toward the staple cavity 2120a. However, any preferred arrangement can be utilized.

[0054] Staples 2130a, which are similar in many respects to staple 100, are positioned within each staple cavity 2120a, and staples 2130b, which are similar in many respects to staple 100, are positioned within each staple cavity 2120b. Furthermore, staples 2130a and 2130b are similar in many respects. For example, each staple 2130a includes a base or crown portion 2131, a proximal leg portion 2132 extending from the proximal end of the base portion 2131, and a distal leg portion 2133 extending from the distal end of the base portion 2131. Thus, staples 2130a and 2130b are adapted in a manner for fitting into staple cavities 2120a and 2120b, respectively. For example, when staple 2130a is positioned in staple cavity 2120a and staple 2130b is positioned in staple cavity 2120b, the legs 2132 and 2133 of staple 2130a extend toward staple 2130b, and the legs 2132 and 2133 of staple 2130b extend toward staple 2130a. However, other arrangements are also possible.

[0055] The staples 2130 are driven between a non-firing position and a firing position by a firing member, for example, a thread 2140. The thread 2140 includes a wedge 2145 that directly engages with the staples 2130 and is configured to lift the staples 2130 toward an anvil, for example, an anvil 2190. The thread 2140 includes a wedge 2145 for each longitudinal row of staples 2130, but the thread 2140 may have any preferred number of wedges 2145. Each wedge 2145 includes a drive surface 2141 that is angled to slide beneath the staples 2130 as the thread 2140 advances from the proximal end of the staple cartridge 2100 toward the distal end of the staple cartridge 2100. The base 2131 of each staple 2130 includes a drive surface 2135 that is angled to be directly contacted by the drive surface 2141. In other words, each staple 2130 includes its own integrated driver having a driving surface 2135. The staple 2130 is made of metal, and consequently, the integrated driver is also made of metal. Thus, the staples disclosed herein may be made of any suitable material. Further details can be found in U.S. Patent Application No. 14 / 836,411, issued July 23, 2019, as U.S. Patent No. 10,357,251, which is incorporated herein by reference in its entirety.

[0056] Figure 6 shows a staple cartridge 300, which includes staple cavities 320a to 320f formed within the cartridge body 302, arranged in six laterally spaced longitudinal rows 500, 502, 504, 506, 508, and 510, each having three rows on each side of an elongated slot 310 defined within the cartridge body 302. The staples 222 shown in Figure 8 are located within each staple cavity 320a to 320f. The staple cartridge 300 further includes four laterally spaced longitudinal rows of staple drivers 330a, 330b, 370a, and 370b, as shown in Figure 7. The inner staple drivers 330a are slidably mounted in the corresponding staple cavities 320b and 320c, so that each driver 330a supports two staples 222 (one in staple cavity 320b and one in staple cavity 320c). Similarly, the inner drivers 330b are slidably mounted in staple cavities 320d and 320e, so that each driver 330b supports two staples 222 (one in staple cavity 320d and one in staple cavity 320e). The outer drivers 370a and 370b are slidably mounted in staple cavities 320a and 320f, respectively. Each of the outer drivers 370a and 370b supports a single staple 222.

[0057] Referring particularly to Figure 9, a portion of the staple cartridge 300 has been removed, exposing a portion of the elongated channel 16, such as recesses 212, 214, and several components of the staple cartridge 300 in the unfired position. Specifically, the cartridge body 302 has been removed. The wedge thread 400 is shown in its proximal unfired position and is in longitudinal sliding contact with the cartridge tray or pan 224 of the staple cartridge 300. The wedge thread 400 includes wedge thread cams 410, 420 that push the double drivers 330a, 330b and single drivers 370b, 370b upward as the wedge thread 400 moves distally. Accordingly, staples 222 (not shown in Figure 9) placed on drivers 330a, 330b, 370a, and 370b are also pushed upward to contact an anvil-forming pocket 202 defined within the anvil 18, thereby forming a closed staple. Further details can be found in U.S. Patent Application No. 11 / 216,562, issued 2 March 2010 as U.S. Patent No. 7,669,746, the entire disclosure of which is incorporated herein by reference in its entirety.

[0058] Staple 2230 is shown in Figure 10. Staple 2230 includes a base 2231, a first leg 2232a extending from the base 2231, and a second leg 2232b extending from the base 2231. The first leg 2232a comprises a first portion 2233a connected to the base 2231 and a second portion 2234a extending from the first portion 2233a. The second leg 2232b comprises a first portion 2233b connected to the base 2231 and a second portion 2234b extending from the first portion 2233b. The base 2231, the first portion 2233a, and the first portion 2233b may include, for example, a substantially V-shaped configuration. In various examples, the second portion 2234a extends inward from the first portion 2233a at the joint 2235a, and similarly, the second portion 2234b extends inward from the first portion 2233b at the joint 2235b. The base 2231, the first leg 2232a, and the second leg 2232b can be configured and positioned such that the staple 2230 is symmetrical in its unformed or unlaunched configuration shown in Figure 10. In various examples, the first leg 2232a is positioned distal to the second leg 2232b. Alternatively, the first leg 2232a is positioned proximal to the second leg 2232b.

[0059] A staple 2330 is shown in Figure 11. The staple 2330 comprises a base 2331, a first leg 2332a extending from the base 2331, and a second leg 2332b extending from the base 2331. The first leg 2332a comprises a straight portion 2333a connected to the base 2331 and extending along the axis. The second leg 2332b comprises a first portion 2333b connected to the base 2331 and a second portion 2334b extending from the first portion 2333b. The base 2331, the straight portion 2333a, and the first portion 2333b have, for example, a substantially V-shape. In various examples, the second portion 2334b extends inward from the first portion 2333b at the joint 2335b. The base 2331, the first leg 2332a, and the second leg 2332b can be configured and positioned such that the staple 2330 is asymmetrical in its unformed or unlaunched configuration as shown in Figure 11. In various examples, the first leg 2332a is positioned distal to the second leg 2332b. Alternatively, the first leg 2332a is positioned proximal to the second leg 2332b.

[0060] A staple 2430 is shown in Figure 12. The staple 2430 comprises a base 2431, a first leg 2432a extending from the base 2431, and a second leg 2432b extending from the base 2431. The first leg 2432a comprises a first portion 2433a connected to the base 2431 and a second portion 2434a extending from the first portion 2433a. The second leg 2432b comprises a first portion 2433b connected to the base 2431 and a second portion 2434b extending from the first portion 2433b. The base 2431, the first portion 2433a, and the first portion 2433b have, for example, a substantially V-shape. In various examples, the second portion 2434a extends inward from the first portion 2433a at a first angle at the joint 2435a, and similarly, the second portion 2434b extends inward from the first portion 2433b at a second angle at the joint 2435b. The first and second angles can be different. The base 2431, the first leg 2432a, and the second leg 2432b can be configured and positioned such that the staple 2430 is asymmetrical in its unformed or unlaunched configuration shown in Figure 12. In various examples, the first leg 2432a is positioned distal to the second leg 2432b. Alternatively, the first leg 2432a is positioned proximal to the second leg 2432b.

[0061] A staple 2530 is shown in Figure 13. The staple 2530 comprises a base 2531, a first leg 2532a extending from the base 2531, and a second leg 2532b extending from the base 2531. The first leg 2532a comprises a first portion 2533a connected to the base 2531 and a second portion 2534a extending from the first portion 2533a. The second leg 2532b comprises a first portion 2533b connected to the base 2531 and a second portion 2534b extending from the first portion 2533b. The base 2531, the first portion 2533a, and the first portion 2533b have, for example, a substantially V-shape. In various examples, the second portion 2534a extends inward from the first portion 2533a at a first angle at the joint 2535a, and similarly, the second portion 2534b extends inward from the first portion 2533b at a second angle at the joint 2535b. The first and second angles can be different. The base 2531, the first leg 2532a, and the second leg 2532b are configured and arranged such that the staple 2530 is asymmetrical in its unformed or unfired configuration shown in Figure 13. The staple 2530 is similar in many respects to the staple 2430, and in at least one example, it may include a base 2531 that is wider than the base 2431. In certain examples, if the staple legs 2532a and / or 2532b extend in a direction closer to the vertical, a wider staple base may be accommodated within a given staple cavity. In various examples, the first leg 2532a is positioned distal to the second leg 2532b. Alternatively, the first leg 2532a is positioned proximal to the second leg 2532b. Further details can be found in U.S. Patent Application No. 14 / 318,996, published October 22, 2015, as U.S. Patent Application Publication No. 2015 / 0297228, the entire disclosure of which is incorporated herein by reference.

[0062] In various embodiments, referring to FIGS. 14 and 15, the end effector of the surgical instrument can include at least one implantable assistive material, such as a piece of battless material “B” releasably attached thereto. In at least one embodiment, the end effector is configured to engage and clamp tissue “T”, deploy staples into the tissue, and cut the tissue and the piece of battless material. In such an embodiment, the end effector can then be removed from the tissue, leaving the staples and the pieces of battless material attached to the tissue on both sides of the incision “I”. Further details regarding the battless material “B” can be found in U.S. Patent Application No. 12 / 032,002, issued Feb. 12, 2013 as U.S. Patent No. 8,371,491, the entire disclosure of which is incorporated herein by reference in its entirety.

[0063] The staples of the staple cartridge can be composed of any suitable material so as to provide the desired biodegradation time frame of the staples. In many cases, this amount of time may desirably be within one year of the surgical procedure, and in some cases within six months. In other examples, this amount of time may desirably be about three to four months and / or any other suitable amount of time. In various embodiments, the staples can be composed of, for example, magnesium, iron, zinc, and / or alloys thereof. In addition to or instead of the above, the staples of the staple cartridge can include one or more coatings, and / or at least partial coatings, that can increase and / or otherwise control the rate at which the staples biodegrade after being implanted into the patient's tissue. In various embodiments, the staple cartridge can include an implantable assistive material or layer that is implanted into the patient's tissue by the staples and that increases and / or otherwise controls the rate at which the implanted staples biodegrade.

[0064] In various embodiments, as described above, the staples of the staple cartridge are made of a metallic material that, after being implanted in the patient's tissue, bio-corrosive or decomposes through bio-absorption of the staples. Also, as described above, it is desirable that the staples decompose within a specific time frame. For example, it is desirable that the staples maintain sufficient strength while the tissue heals so that they do not release the tissue before it has fully healed. In many cases, the tissue healing period is about 30 days, depending on the type of tissue, such as lung tissue, colon tissue, and / or stomach tissue. Furthermore, it is desirable that the staples release the tissue after it has healed so that the tissue recovers its flexibility, or at least a substantial portion of its flexibility, after being stapled. Thus, as a result, the tissue healing period is a factor that can be used to define both ends of a desired bio-corrosion time frame.

[0065] In addition to the above, many metallic materials have their own inherent biological corrosion rates. As will be discussed in more detail below, this biological corrosion rate can be affected by the presence of other metals and / or impurities in the base metal material. For example, the biological corrosion rate of magnesium can vary by orders of magnitude due to the presence of other metals in the magnesium. Therefore, base metals can be alloyed to adjust the decomposition properties of the base metal and control the biological corrosion timeframe of the staples. As will be explained in more detail below, magnesium can be alloyed with, for example, lithium, zinc, iron, tin, aluminum, silver, zirconium, strontium, and / or calcium to adjust the decomposition rate of magnesium. In another example, magnesium can be alloyed with other metals such as zinc to adjust the decomposition rate of zinc.

[0066] In various examples, the electrode potential of pure magnesium or high-purity magnesium (HP-Mg) can be reduced by introducing one or more other elements to increase the decomposition rate of magnesium. In at least one example, the presence of another element in magnesium can create a two-phase microstructure that establishes a microgalvanic cell within the alloy. The presence of these other elements can generate a secondary phase within the magnesium, which acts as the cathode and accelerates the anodic dissolution or biological corrosion of magnesium. For example, microgalvanic corrosion can be employed by alloying magnesium with iron. For instance, more than 170 ppm of iron in high-purity magnesium significantly increases the corrosion rate of magnesium compared to high-purity magnesium. As a result, the decomposition properties of magnesium-based absorbent staples can be tuned by the galvanic effect produced by the secondary iron phase within the primary magnesium phase using magnesium alloys and / or the addition of small amounts of iron to pure magnesium. In at least one embodiment, the staples may be composed of, for example, a Mg-Al-Fe alloy. In at least one such embodiment, the aluminum is 3-8 wt% and the iron is 5-7 wt%. In at least one embodiment, the staples are made of a magnesium-iron alloy such as Mg-0.1Fe and / or Mg-0.5Fe. In at least one embodiment, the staples of the staple cartridge are made of a magnesium-iron alloy containing 1% by weight or less of iron. In at least one embodiment, the staples of the staple cartridge are made of a magnesium-iron alloy containing 1% by weight of iron. In at least one embodiment, the staples of the staple cartridge are made of a magnesium-iron alloy containing 0.5% by weight of iron. In at least one embodiment, the staples of the staple cartridge are made of a magnesium-iron alloy containing 0.1% by weight of iron. In some embodiments, annealing the magnesium-iron alloy can increase the presence of iron precipitates in the magnesium and thus increase the rate of staple decomposition.Furthermore, annealing can be used to control the particle size within the magnesium-iron staple alloy, thereby controlling the corrosion rate of the staples.

[0067] In various embodiments, microgalvanic corrosion can be employed to alloy magnesium with lithium. In certain embodiments, the lithium-containing magnesium alloy may include a two-phase structure of α-Mg and β-Li phases that establish a galvanic cell. In at least one embodiment, the staples of the staple cartridge are composed of a magnesium-lithium alloy containing, for example, 1% to 11% by weight of lithium. In at least one embodiment, the staples of the staple cartridge are composed of Mg-9Li. In at least one embodiment, the staples of the staple cartridge are composed of a magnesium-lithium alloy containing, for example, 8% to 14% by weight of lithium. Lithium-containing magnesium alloys with more than 11% by weight of lithium may have excellent mechanical properties. However, such alloys may corrode more slowly than magnesium-lithium alloys containing less than 6% by weight of lithium, which may be due to the pH effect. In at least one embodiment, the staples of the staple cartridge are composed of a magnesium-lithium alloy consisting of 2% by weight of lithium. That said, alloys can be selected to satisfy many parameters, including but not limited to the decomposition rate, ductility, and creep resistance of the staples. Furthermore, alloying magnesium with lithium can lower the electrode potential of the alloy, in addition to generating microgalvanic corrosion within the staples. In at least one embodiment, the staples of the staple cartridge are made of a magnesium-lithium alloy containing aluminum, such as Mg-14Li-1Al. In at least one embodiment, the staples of the staple cartridge are made of an alloy such as LA141.

[0068] In various embodiments, microgalvanic corrosion can be employed by alloying magnesium with zinc. In various embodiments, zinc in a magnesium alloy containing more than 6.5 wt% zinc provides an accelerating effect on corrosion. That said, magnesium alloys containing less than 6.5 wt% zinc, for example 3 wt% zinc, can have a desired decomposition rate. In at least one embodiment, the staple is made of a magnesium alloy containing 6 wt% to 10 wt% zinc, such as Mg-6Zn. In at least one embodiment, the staple is made of a magnesium alloy containing 5 wt% to 15 wt% zinc, such as Mg-14Zn. In at least one embodiment, the staple is made of a magnesium-zinc-zirconium alloy, such as Mg-6Zn-0.1Zr and / or Mg-3Zn-0.6Zr. In at least one such embodiment, zirconium is added to the magnesium-zinc alloy at 1 wt% or less for grain refinement, which in various examples can increase the decomposition rate of the magnesium-zinc alloy. In at least one embodiment, the staples of the staple cartridge are made of, for example, a ZK30 alloy. The addition of zirconium can also increase the resistivity of the magnesium alloy, which can have various other advantages, which will be further described below. In at least one embodiment, the staples are made of a magnesium-zinc-zirconium-iron alloy such as, for example, Mg-6Zn-0.1Zr-0.1Fe. As mentioned above, the addition of iron to the magnesium alloy can increase the decomposition rate of the alloy. In various embodiments, the staples of the staple cartridge are made of a magnesium-zinc-zirconium alloy containing, for example, 3% by weight of zinc and less than 1% by weight of zirconium.

[0069] In various embodiments, the staples of the staple cartridge are made of a magnesium-manganese alloy, such as Mg-1Mn. In at least one embodiment, a magnesium alloy containing 1% by weight or less of manganese has a desirable decomposition rate and ductility. In at least one embodiment, the staples of the staple cartridge are made of a magnesium-manganese alloy containing 1% by weight of manganese. In at least one embodiment, the staples of the staple cartridge are made of, for example, Mg-1Zn-0.3Ca-0.15Mn. In at least one embodiment, the staples of the staple cartridge are made of a magnesium-manganese alloy containing 0.15% by weight of manganese. That being said, the staples can be made of a magnesium-manganese alloy having more than 1% by weight of manganese.

[0070] In various examples, in addition to the above, the magnesium alloy may also include aluminum. In at least one embodiment, the staples of the staple cartridge are made of, for example, Mg-2Al-1Zn, which has a high decomposition rate. In at least one embodiment, the staples of the staple cartridge are made of, for example, Mg-3Al-1Zn, which also has a high decomposition rate.

[0071] In various embodiments, the staples are made of a magnesium-zinc-calcium alloy. In at least one such embodiment, calcium is added to the magnesium-zinc alloy at a concentration of 1% by weight or more, which can provide grain refinement and increase the decomposition rate of the magnesium-zinc alloy. In various embodiments, calcium is added to the magnesium-zinc alloy at a concentration of, for example, 0.1% to 2% by weight. In at least one embodiment, the staples of the staple cartridge are made of, for example, Mg-1.34Ca-3Zn. In at least one embodiment, the staples of the staple cartridge are made of, for example, a ZX10 alloy. In at least one embodiment, the staples of the staple cartridge are made of, for example, a ZX20 alloy. In at least one embodiment, the staples of the staple cartridge are made of, for example, a ZX50 alloy. In at least one embodiment, the staples of the staple cartridge are made of Mg-1.0Zn-0.3Ca. In at least one embodiment, the staples of the staple cartridge are composed of Mg-1.5Zn-0.25Ca. In at least one embodiment, the staples of the staple cartridge are composed of Mg-5Zn-0.3Ca.

[0072] In various cases, staples implanted in a patient are exposed to electrical energy during surgical procedures. In at least one such case, a unipolar instrument can contact the staple and transmit electricity to it. Such electricity can heat the staple, and depending on how hot the metal constituting the staple and the staple itself become, the staple can be ignited. By adding calcium to magnesium and / or magnesium alloys, the ignition temperature can be increased, preventing the staple from igniting. Furthermore, calcium contains a less noble secondary phase within the magnesium that causes galvanic corrosion. In at least one embodiment, the staples in a staple cartridge are composed of, for example, Mg-0.8Ca. In various embodiments, calcium is added to the magnesium, for example, in amounts from 0.1% to 2% by weight. In at least one embodiment, the staples in a staple cartridge are composed of a magnesium-calcium alloy containing 1% or more by weight of calcium. Furthermore, for example, adding tin, aluminum, and / or zinc to magnesium and / or magnesium alloys can increase its resistivity, thereby increasing the time until the staples can ignite, and thus preventing the staples from igniting.

[0073] As mentioned above, staples can be made of zinc. In at least one embodiment, staples can be made of, for example, cast zinc. In various embodiments, microgalvanic corrosion can be employed in zinc staples, for example, by alloying zinc with magnesium. The difference in nobility between zinc and magnesium in a zinc-magnesium alloy can create an anode-cathode relationship between the two elements. In at least one embodiment, the magnesium in a zinc-magnesium alloy can be, for example, 0.1% by weight or more. In at least one embodiment, the magnesium in a zinc-magnesium alloy can be, for example, 0.1% by weight to 1% by weight. In at least one embodiment, the magnesium in a zinc-magnesium alloy is, for example, 1% by weight. Zinc-magnesium alloys containing less than 0.1% by weight of magnesium are also conceivable, but such alloys may or may not have sufficient ductility for all applications. That said, manganese can be alloyed with zinc and magnesium alloys to improve the ductility of the zinc-magnesium alloy. In at least one embodiment, the zinc-magnesium staple alloy contains, for example, 1% by weight of magnesium. In a particular embodiment, the zinc-magnesium staple alloy contains, for example, 0.1% to 5% by weight of magnesium. In various embodiments, the decomposition rate of zinc can be increased, for example, by alloying zinc with calcium, strontium, and / or iron. In at least one embodiment, the zinc-iron staple alloy contains 1% by weight or less of iron. In at least one embodiment, the zinc-iron staple alloy contains 1% by weight of iron. In at least one embodiment, the zinc-iron staple alloy contains 0.5% by weight of iron. In at least one embodiment, the zinc-iron staple alloy contains 0.1% by weight of iron. In at least one embodiment, the zinc-strontium staple alloy contains, for example, 1% by weight of strontium. In a particular embodiment, the zinc-strontium staple alloy contains, for example, 0.1% to 5% by weight of strontium. In at least one embodiment, the zinc-calcium staple alloy contains, for example, 1% by weight of calcium.In certain embodiments, the zinc-calcium staple alloy contains, for example, 0.1% to 5% by weight of calcium. In at least one embodiment, the staple is composed of, for example, Zn-Mg-0.1Ca. In at least one embodiment, the staple is composed of a zinc-calcium alloy containing 0.1% by weight of calcium. In various embodiments, the decomposition rate of zinc can be increased, for example, by alloying zinc with aluminum. Such embodiments can produce staples with excellent ductility.

[0074] In various examples, staples made of zinc and / or zinc alloys may slowly loosen or creep into a partially open configuration due to the patient's natural body temperature, i.e., approximately 98 degrees Fahrenheit. In various embodiments, alloying zinc with copper can create staples that do not open or at least substantially open due to creep. Furthermore, alloying zinc with copper can induce microgalvanic corrosion within the staple and / or otherwise increase the rate of staple decomposition. In at least one embodiment, the copper in the zinc-copper alloy may be, for example, 1% by weight. In certain embodiments, the copper in the zinc-copper alloy may be, for example, 1% by weight or more. In at least one embodiment, the copper in the zinc-copper staple alloy may be, for example, 0.1% to 2% by weight. Creep of embedded staples can also be reduced by adding titanium to the zinc-copper staple alloy. In at least one embodiment, the zinc-copper-titanium alloy contains, for example, 0.1% by weight of titanium. In certain embodiments, the zinc-copper-titanium alloy contains, for example, 0.1% to 1.0% by weight of titanium. In at least one embodiment, the zinc-copper-titanium alloy contains, for example, 1% by weight of copper and 0.1% by weight of titanium. Staples can be made of, for example, Z41320 alloy and / or Z41321 alloy. In various embodiments, the zinc-copper alloy can contain, for example, titanium, manganese, and / or magnesium.

[0075] Magnesium and / or magnesium alloy staples may also experience creep after being implanted in a patient. In various embodiments, the staples may be composed of magnesium alloys containing rare earth elements, such as gadolinium. Such alloys may be resistant to creep, or at least more resistant. In at least one embodiment, the staples are composed of, for example, ZXM100 (1.07Zn-0.21Ca-0.31Mn) and / or ZXM120 (1.01Zn-1.63Ca-0.30Mn). The entire disclosure of “Biocorrosion and Mechanical Properties of ZXM100 and ZXM120 Magnesium Alloys,” published in the “International Journal of Metalcasting” on January 25, 2019, is incorporated herein by reference. The entire disclosure of the invention “MAGNESIUM-BASED ABSORBABLE ALLOYS” in International Patent Application Publication No. 2020 / 247383(A1) is incorporated herein by reference. The entire disclosure of “BIODEGRADABLE METALS” by YFZheng, XNGu, and F. Witte, published in “MATERIALS SCIENCE AND ENGINEERING R” and made available online on March 6, 2014, is incorporated herein by reference. The entire disclosure of “Magnesium Alloys as Degradable Biomaterials” by Yufeng Zheng, published in 2016 by Taylor & Francis Group LLC (Boca Raton, Florida) is incorporated herein by reference.

[0076] In various embodiments, the staples of the staple cartridge are composed of, for example, Mg-10Dy-1Nd-1Zn-0.2Zr. In certain examples, the Mg-10Dy-1Nd-1Zn-0.2Zr alloy may be further modified and / or alloyed as described herein to achieve a desired decomposition rate. The staples of the staple cartridge are composed of, for example, Mg-2.5Nd-1Y. As above, the Mg-2.5Nd-1Y alloy may be further modified and / or alloyed as described herein to achieve a desired decomposition rate. In various embodiments, the staples of the staple cartridge are composed of, for example, a magnesium alloy containing yttrium, zirconium, and / or rare earth metals. As above, such an alloy may be further modified and / or alloyed as described herein to achieve a desired decomposition rate. In various embodiments, the staples of the staple cartridge are composed of, for example, WE43. Similarly, the WE43 alloy may be further modified and / or alloyed as described herein, in particular, to achieve a desired decomposition rate.

[0077] The staple materials disclosed herein can be, for example, alloyed with silver and / or electroplated with silver. Silver has various anticorrosive properties. In at least one embodiment, magnesium is alloyed with, for example, silver. Furthermore, silver is highly soluble in magnesium, and as a result, the Mg-Ag alloy may be stronger than pure magnesium. Furthermore, by electroplating the staples, a smooth surface can be produced that can prevent or at least inhibit the deposition of minerals and / or materials on the staples. As a result, the decomposition rate or biological corrosion of the staples is not inhibited, or at least substantially inhibited, by deposited materials.

[0078] In various embodiments, a staple cartridge comprises a cartridge body and a longitudinal slot defined within the cartridge body and configured to receive a tissue cutting knife. The staple cartridge further includes longitudinal rows of staple cavities defined within the cartridge body on both sides of the longitudinal slot. For example, a staple cartridge may have three longitudinal rows of staple cavities on a first side of the longitudinal slot and three longitudinal rows of staple cavities on a second side or opposite side of the longitudinal slot. On each side of the longitudinal slot, in at least one such embodiment, the longitudinal rows of staple cavities are arranged as an inner row adjacent to the longitudinal slot, an intermediate row adjacent to the inner row, and an outer row adjacent to the intermediate row. In various embodiments, the staples arranged in the inner row, intermediate row, and outer row are made of the same material. In at least one such example, for example, all staples in the staple cartridge are made of the same magnesium alloy, for example.

[0079] In various alternative embodiments, in addition to the above, the staples in the inner row are made of a different material than the staples in the middle row and outer row. In at least one such embodiment, the staples in the inner row are made of a material that has a slower degradation rate or biodegradation rate than, for example, the staples in the middle row and outer row. In such embodiments, the staple closest to the incision may be the last staple to release the patient's tissue. As a result, the middle row and outer row of staples can release the patient's tissue before the inner row of staples, which reintroduces flexibility to the patient's tissue before the tissue at the incision margin is released by the inner row of staples. Such a configuration can provide the tissue at the incision margin with additional time to heal. In some embodiments, the staples in the middle row are made of a different material than the staples in the inner row and outer row. In at least one such embodiment, the staples in the middle row are made of a material that has a faster degradation rate than the staples in the inner row but a slower degradation rate than the staples in the outer row. In at least one such embodiment, the outer rows of staples can release patient tissue before the middle rows of staples, and similarly, the middle rows of staples can release patient tissue before the inner rows of staples. In such an example, the rows of staples can gradually release patient tissue, thereby gradually reintroducing flexibility to the patient tissue as it heals. In at least one such embodiment, the outer rows of staples are made of a different material than the inner and middle rows of staples. In at least one such embodiment, the outer rows of staples are made of a material that has a faster decomposition rate than, for example, the middle and inner rows of staples.

[0080] In various cases, in addition to the above, the patient's physiological and / or environmental responses may affect the corrosion process of staples embedded within the patient. For example, phosphates and / or carbonates may precipitate on the surface of the staple during the biocorrosion process, thereby slowing the rate at which the staple decomposes or biocorrodes. In at least one such case, the biocorrosion of magnesium staples may result in an increase in local pH, which reduces the solubility of corrosion products as well as physiological phosphates, carbonates, and / or organic matter. By preventing, or at least substantially minimizing, the deposition of such phosphates, carbonates, and / or organic matter on the staple during the healing process, the biocorrosion rate of the staple can be increased or at least maintained to meet a desired biocorrosion timeframe.

[0081] In various embodiments, in addition to the above, the staple includes a coating containing an absorbent polymer such as polylactic acid (PLA), polylactic acid-co-glycolic acid (PLGA), and / or polyglycolic acid (PGA). The absorbent polymer improves the solubility of corrosion products and minerals by generating an acid that maintains a lower local pH, thereby increasing the corrosion rate of the staple. In various embodiments, the staple includes a coating containing a calcification inhibitor such as fetuin A, a citrate, and / or a chelating agent such as phytic acid. After such a staple is embedded, the calcification inhibitor can be slowly released from the staple. The calcification inhibitor combines with calcium and phosphate ions to form calciprotein particles (CPPs). These retain ions in the solution, preventing or at least significantly reducing the degree of mineral deposition on the staple, thereby maintaining and / or increasing the corrosion rate of the staple. In various embodiments, the calcification inhibitor is embedded within the absorbent polymer. In at least one such embodiment, the calcification inhibitor is continuously released as the absorbable polymer is bioabsorbed.

[0082] In various embodiments, the staples include a coating comprising proteins that bind to magnesium ions to prevent or at least significantly reduce the formation of phosphates and carbonates thereon. Such coatings retain ions in solution and prevent or at least significantly reduce the degree of mineral deposition on the staples, thereby maintaining and / or increasing their corrosion rate.

[0083] In various embodiments, the staples of a staple cartridge include a coating that can prevent nucleation sites on them. In various embodiments, the staples include a coating containing inorganic ions, such as pyrophosphates or bisphosphonates (polyphosphates). Such inorganic ions contain potent inhibitors of calcium crystallization, binding to newly formed hydroxyapatite crystals and preventing their further growth, thereby maintaining and / or increasing the corrosion rate of the staples. In various embodiments, the staples include a coating containing an acrylic acid polymer that inhibits calcium phosphate precipitation by surface adsorption, thereby maintaining and / or increasing the corrosion rate of the staples. In various embodiments, the staples include a coating containing a polycarboxylic acid that can inhibit calcium phosphate precipitation by surface adsorption, thereby maintaining and / or increasing the corrosion rate of the staples.

[0084] In various embodiments, the staples are coated with osteopontin, which has been shown to be an inhibitor of calcification in the blood vessel walls.

[0085] In various embodiments, the staples include a coating containing inorganic ions, such as Mg2+ ions, which inhibit the formation of the most stable calcium phosphate polymorph (hydroxyapatite) and stabilize amorphous calcium phosphate polymorphs, thereby maintaining and / or increasing the corrosion rate of the staples.

[0086] In various embodiments, the staples include a coating that facilitates the migration of dissolved metal, phosphate, and carbonate ions away from the staples, making it less likely for corrosion products to form directly on the surface of the staples. In various embodiments, the staples include a coating that bypasses or facilitates the migration of corrosion products onto buttresses embedded in the patient's tissue along with the staples. When magnesium staples dissolve, magnesium ions are released to form molecules and / or combine with other elements surrounding the staples. In various embodiments, the magnesium staples are at least partially coated with a chloride ion eluting material. In such embodiments, magnesium ions from the dissolved staples and chloride ions eluting from the coating form magnesium chloride. Magnesium chloride is a salt that tends to lower the pH of the surrounding environment and is also readily absorbed by the surrounding patient tissue. Therefore, the magnesium chloride formed around the magnesium staples lowers the pH around the staples and also reduces the accumulation of scale on the staples. Often, scale can interfere with the absorption of the staples within a desired time window. However, the chloride eluting coating on the staples can reduce the effects of scale.

[0087] In various embodiments, the staples include a coating containing an acid that removes corrosion products from the staples and / or destabilizes corrosion products on the staples. For example, metal carbonates react with the acid to produce soluble products such as salts, carbon dioxide, and / or water. Furthermore, in various examples, a low pH helps dissolve some of the corrosion products deposited on the staples. As referenced above, PLA, PGLA, and / or PGA, for example, lower the pH of the environment surrounding the staples. When PLA, PGLA, and / or PGA dissolve, more specifically, they produce acids that maintain a lower local pH, thereby increasing the corrosion rate of the staples.

[0088] In certain embodiments, in addition to the above, the absorbent polymer comprises a layer or at least a partial layer on the metal staple material, and the calcification inhibitor comprises a layer or at least a partial layer on the absorbent polymer layer. In at least one such embodiment, the calcification inhibitor is released immediately or at least rapidly into the environment directly surrounding the staple. In certain embodiments, the absorbent polymer comprises a partial layer on a first portion of the staple, and the calcification inhibitor comprises a partial layer on a second or different portion of the staple. In at least one such embodiment, the calcification inhibitor can be released from the staple at a rate faster than the rate at which the absorbent polymer is bioabsorbed. In such examples, the calcification inhibitor deploys rapidly to prevent or at least inhibit calcification of the absorbent polymer and / or the underlying metal staple material.

[0089] In various embodiments, the staples include a coating that reduces the initial decomposition rate. A rapid early decomposition rate of the staples can cause dramatic changes in the local conditions surrounding the staples, generating a strong initial driving force for mineral deposition on the staples, which can slow down the decomposition rate of the staples, as discussed above. A slower basic or initial decomposition rate of the staples due to the surface coating can, in many examples, result in faster overall bioresorption of the staples. Furthermore, the surface coating can result in more uniform initial corrosion of the staples (i.e., immediately after the staples are implanted or within a few weeks after implantation). In various embodiments, the staple coating delays galvanic corrosion of the staples, and the bioresorption and / or dissolution of the coating exposes the metal structure beneath the staples to the surrounding environment, thereby initiating galvanic corrosion. In various embodiments, the coating is applied on the metal wires and / or punched metal structures of the staples. In at least one such embodiment, the coating is composed of one or more polymers, such as PGA. In various embodiments, the staple coating includes a base metal conversion coating beneath the staple. In at least one such embodiment, the outer surface of the magnesium staple is coated with, for example, fluoride ions and / or otherwise exposed to fluoride ions, thereby converting the outer surface of the magnesium staple to, for example, magnesium fluoride (MgF2). Coating the staple with a conversion coating may result in little, if any, change to, for example, the diameter of the metal wire beneath the staple.

[0090] In various embodiments, the staple cartridge may further include an implantable auxiliary material, such as a buttress, which is secured to the patient's tissue by the deployed staples. In at least one embodiment, the implantable auxiliary material includes a layer that is releasably fixed to the top surface or deck of the staple cartridge. During the staple firing stroke, the legs of the staples pass through the implantable auxiliary material and the patient's tissue, and as the staples deform against an anvil positioned on the opposite side of the staple cartridge, the staples secure the implantable auxiliary material to the patient's tissue. The implantable auxiliary material is configured to be released from the staple cartridge during the staple firing stroke and / or when the staple cartridge moves away from the stapled tissue. Once the staples are embedded, different parts of the staples come into contact with the embedded auxiliary material, and other parts of the staples come into contact with the patient's tissue. In various embodiments, the auxiliary material consists of an absorbent polymer and / or calcification inhibitor that can further reduce local pH and reduce the degree of mineral deposition on the staples.

[0091] In various embodiments, the corrosion rate of a staple can be increased by altering the physical design of the staple. In one embodiment, the corrosion rate of a staple is based on the volume / surface area ratio of the staple. In various embodiments, a staple may further include defined notches and / or recesses therein, which, for example, increase the surface area of ​​the staple and decrease its volume. In another embodiment, the geometry of the staple may influence the staple's tendency to exhibit stress corrosion cracking. In addition to the above, notches and / or recesses within a staple may include areas of stress concentration or amplification where the notches and recesses can induce failure of the staple. In at least one such embodiment, the notches and / or recesses may be present, for example, in the staple leg. In at least one embodiment, the notches and / or recesses may be present in the joint connecting the staple leg to the staple base.

[0092] In various embodiments, the staple includes a hollow portion defining a recess therein. In at least one embodiment, the staple includes a base, a first leg extending from a first end of the base, and a second leg extending from a second end of the base. In at least one such embodiment, the staple is composed of a hollow wire that has been cut to a predetermined length and then bent into its unfired form. In various embodiments, the hollow staple is formed by a hollow extrusion process, followed by a tube stretching process to reduce, for example, the wall thickness and diameter. In various embodiments, the staple is punched out from a metal sheet. In at least one such embodiment, the base of the staple is solid, i.e., the base does not include an internally defined opening, while the first staple leg and / or the second staple leg include an internally defined opening. In at least one such embodiment, the legs of the staple are punched flat and, during a secondary forming process, are rounded around a circular perimeter defining an internal opening. In various examples, the hollow staple design allows the staple to have sufficient rigidity but a lower volume / surface area ratio, thereby allowing the staple to bio-corrode and release patient tissue within a desired timeframe.

[0093] In various embodiments, in addition to the above, the staple comprises a circular wire including a metal outer periphery defining an internal opening and an inner core positioned within the internal opening. In at least one such embodiment, the wire is formed by a hollow extrusion process that co-extrudes the metal outer periphery and a polymer inset. In at least one embodiment, for example, the metal outer portion is extruded and the inner core is filled during an injection molding process. In various embodiments, the staple is formed using a polymer extrusion process that produces an insert coated with metal using, for example, at least one of an electroplating process and / or a sputtering process. In various embodiments, the hollow staple includes a filler positioned within the internal opening that is released as the staple corrodes. In various examples, the filler can be selected to mitigate and / or induce a physiological response in the patient. In at least one embodiment, the filler may include, for example, an absorbent polymer such as PLA, PLGA, and / or PGA. In at least one embodiment, the filler includes, for example, a lithium carbonate layer.

[0094] In various embodiments, the staples may include a smooth surface. In various examples, corrosion products are more likely to adhere to the rough surface of the staple, thereby reducing the corrosion rate of the staple. Maintaining a smooth staple surface on the staple promotes that corrosion products fall off the staple and / or do not adhere to the staple. In various embodiments, an electroplating process is used to produce the smoothness of the staple.

[0095] In various embodiments, a staple cartridge contains staples having the same unformed height. Having the same unformed height ensures that the staples have exactly the same unformed height and / or are within the manufacturing tolerance range. In at least one embodiment, the staple has an unformed height of 3.5 mm. In at least one such embodiment, the staple is made of a wire having, for example, a wire diameter of 0.20 mm. In at least one embodiment, the staple has an unformed height of 3.8 mm. In at least one such embodiment, the staple has, for example, a wire diameter of 0.22 mm. In at least one embodiment, the staple has an unformed height of 4.1 mm. In at least one such embodiment, the staple has, for example, a wire diameter of 0.22 mm.

[0096] In addition to the above, various embodiments can be envisioned in which the staple cartridge includes staples having different unformed heights. In at least one embodiment, the staple cartridge comprises a longitudinal slot configured therein to receive a tissue cutting knife, and three longitudinal rows of staple cavities on each side of the longitudinal slot. Each side of the longitudinal slot includes an inner row adjacent to the longitudinal slot, an intermediate row adjacent to the inner row, and an outer row adjacent to the intermediate row. In at least one such embodiment, the staples in the staple cavities of the inner row include a first unformed height, the staples in the staple cavities of the intermediate row include a second unformed height higher than the first unformed height, and the staples in the staple cavities of the outer row include a third unformed height higher than the second unformed height. For example, the staples in the inner row have an unformed height of 3.5 mm, the staples in the middle row have an unformed height of 3.8 mm, and the staples in the outer row have an unformed height of 4.1 mm.

[0097] In various embodiments, in addition to the above, the staples in the staple cartridge are deformed to the same forming height. The same forming height allows the staples to have exactly the same forming height and / or within a tolerance range. In at least one embodiment, a staple with an unformed height of 3.5 mm is deformed to, for example, a forming height of 1.5 mm. In at least one embodiment, a staple with an unformed height of 3.8 mm is deformed to, for example, a forming height of 1.8 mm. In at least one embodiment, a staple with an unformed height of 4.1 mm is deformed to, for example, a forming height of 2.0 mm. As a result of different forming heights, formed staples can have different clamping pressures applied to the structure. For example, a staple formed to a forming height of 1.5 mm has about 78 kPa applied, a staple formed to 1.8 mm has about 59 kPa applied, and a staple formed to 2.0 mm has about 30 kPa applied. Such pressures can be called initial or firing clamping pressures. Such embodiments apply maximum clamping pressure to the tissue adjacent to the incised tissue edge, thereby preventing or at least reducing bleeding from that point. However, other embodiments are conceivable in which greater pressure is applied by staples further away from the tissue incision. In any case, as the staples bio-corrosion occurs, the clamping pressure they apply to the patient's tissue decreases. In other words, the staples disclosed herein gradually release the clamping pressure applied to the patient's tissue as the patient's tissue heals.

[0098] As mentioned above, the staples in a staple cartridge can be formed to one or more formation heights. Such formation heights can be called final formation heights. In other words, a staple deforms both plastically and elastically as it is deformed, and after the staple has deformed to its formation height, the height of the staple then increases from its formation height to its final formation height as a result of the release of the elastic energy stored in the staple. This process is sometimes called springback. In particular, unless other considerations exist, titanium staples have a greater springback than magnesium staples. Therefore, in various examples, titanium staples may need to be fired to a smaller firing height in order to reach the same final formation height as magnesium staples.

[0099] Many examples are disclosed in this application. Many of these examples involve one material being contained within another material in a certain percentage. For example, as provided above, calcium can be added to a magnesium-zinc alloy in some embodiments at a concentration of 0.1% to 2% by weight. That said, for all embodiments disclosed in this application as having a specific percentage of material, this application also includes embodiments having approximately that percentage of material. With respect to the previous examples, for example, this application also discloses that calcium can be added to a magnesium-zinc alloy at a concentration of approximately 0.1% to 2% by weight. The term "approximately" includes a range of 20% of a given value on both sides of the given value. Thus, a percentage of approximately 0.1% by weight includes a range of 0.08% to 0.12% by weight. Furthermore, a percentage of approximately 2% by weight includes a range of 1.6% to 2.4% by weight.

[0100] As described above, staples can be manufactured by deforming wire. Such deformation typically includes both elastic and plastic deformation. Elastic deformation of the wire generated during the manufacturing process releases itself naturally when the force applied to the wire by the manufacturing process is released. Plastic deformation of the wire during the manufacturing process does not release itself elastically. Therefore, when a wire is bent to form, for example, a substantially V-shaped staple, the staple includes a crown and two legs, each leg connected to the crown by a bend. These bends are the result of large plastic deformation and can contain high residual stress, particularly on the inner surface of the bend. The inner surface of the bend has a smaller radius than the outer surface, and in various examples, the inner surface may undergo more work hardening than the outer surface. Such work hardening can cause cracks in the wire along the inner surface of the bend, especially when the wire is made of, for example, magnesium. More specifically, the inner surface of the bend is subjected to compression during the manufacturing of the V-shaped staple, while the outer surface of the bend is subjected to tension. As a result, the inner radius bend may be more susceptible to cracking, for example, because magnesium and magnesium alloys may have lower strength in compression than in tension. This phenomenon is more common in staples with thicker wire diameters than thinner wire diameters, due to the larger moment arm between the inner surface of the curve and the center of mass.

[0101] In at least one example, in addition to the above, staples can be annealed to reduce and / or strengthen the residual stress contained within them. In at least one example, staples are heated and then slowly cooled before being loaded into a staple cartridge. In at least one other example, staples are loaded into a staple cartridge, and then the entire staple cartridge is heated to anneal the staples while they are inside. In such an example, the plastic parts of the staple cartridge are made of a high-performance plastic that can withstand high temperatures without substantially degrading, such as polyetheretherketone. After the staple cartridge is heated, it is cooled before use. In any case, the annealing process described above anneals the entire staple. In other examples, only a portion of the staple may be treated to relieve residual stress and / or improve the toughness of the portion. In at least one such process, for example, the bent portion of the staple is heated with a laser.

[0102] In various examples, in addition to the above, the wire used to form the staple has a constant cross-sectional thickness or diameter along its length. In various examples, the cross-section of the wire may be modified to reduce residual stress within the wire and / or to reduce the possibility of cracking and / or breaking of the wire at a particular location. In at least one such example, the inner surface of the bend can be flattened. For example, one or more flat spots can be punched into the wire before it is deformed into a staple, so that when the wire is deformed into a staple, the flat spots are on the inner surface of the bend. Referring to Figures 19 and 20, the staple 3400 includes a wire base including a crown portion 3410, a leg portion 3420, and a bend 3430 connecting the leg portion 3420 to the crown portion 3410. Referring to Figure 21, the wire base of the staple 3400 includes a circular cross-section present in the crown portion 3410 and the leg portion 3420, and referring to Figure 22, the bend 3430 includes a flattened cross-section with a flat spot 3435. In at least one embodiment, the portion of wire that will form the bend is processed to have a smaller cross-sectional area or diameter than the portion of wire that will form the crown and staple legs. Such a process produces a wire staple having a crown and staple legs, where these staple legs have a larger cross-section than the bend or at least a portion of the bend that connects them. As a result, the bend is less likely to crack and / or break. In at least one other embodiment, the portion of wire that will form the bend and staple legs is processed to have a smaller cross-sectional area or diameter than the portion of wire that will form the crown.

[0103] As described above, wire staples can be heated and then slowly cooled to reduce residual stress in the wire and / or strengthen the wire. In other examples, wire staples can be heated and then rapidly cooled. In at least one example, the staples are quenched in a liquid. In at least one example, the staples of a staple cartridge are made of magnesium glass containing magnesium or a magnesium alloy, the magnesium or magnesium alloy having an amorphous or at least substantially amorphous crystalline grain structure for a time such that the metal has time to form crystals or a substantial amount of crystals.

[0104] In at least one example, the staples in the staple cartridge are made of a magnesium shape memory alloy. In at least one such example, the staples are made of, for example, a magnesium-scandium alloy. The staples are bent into a substantially V-shape from a wire made of a magnesium shape memory alloy with fixed residual stress and strain. The staples are then loaded into a staple cartridge and implanted in the patient. By applying heat to the staples, the residual stress and strain within the staples are released, causing the staples to move into a closed or substantially B-shaped configuration, with the legs of the staples deflecting inward to trap the patient's tissue within the staples.

[0105] In various examples, in addition to the above, forming or closing staples ejected from a staple cartridge during the staple firing process involves pressing the legs of the staples against an anvil positioned on the opposite side of the staple cartridge. In at least one example, the staple cartridge includes a driver that is pushed upward toward the anvil by the threads moving from the proximal end of the staple cartridge toward the distal end. In any case, the anvil has forming pockets that guide the staple legs inward toward each other when the legs are deformed to create a closed or substantially B-shaped firing configuration. However, in some examples, one or both of the staple legs may be bent outward during the staple firing process. Although deformed, the staples may still be able to apply sufficient clamping pressure to the tissue. Whether formed accurately or imperfectly, the staples are subjected to a considerable amount of stress and strain during the forming process. Such stresses and strains can cause cracks and / or breakage in the bent portion of the staple between the crown and the leg, even if cracks and / or breakage did not occur during the staple manufacturing process. The following describes a staple and / or staple driver configuration that reduces the likelihood and / or severity of such cracks and / or breakage.

[0106] In at least one example, referring to Figure 16, the staple 3100 includes a crown portion 3110, a first leg portion 3120, a first bend portion 3130 connecting the first leg portion 3120 to the first end of the crown portion 3110, a second leg portion 3120, and a second bend portion 3130 connecting the second leg portion 3120 to the second end of the crown portion 3110. The first leg portion 3120, the second leg portion 3120, and the crown portion 3110 each have a straight or at least substantially straight segment. However, there are examples in which one or more of these segments are not straight. In this example, the first bend portion 3130 is defined by a constant radius of curvature. The first bend portion 3130 extends along a continuous constant radius between the crown portion 3110 and the first leg portion 3120. Similarly, the second bend 3130 is also defined by a constant radius of curvature. Like the first bend 3130, the second bend 3130 extends between the crown 3110 and the second leg 3120 along a continuous constant radius. In this example, the radius defining the first bend 3130 is the same as the radius defining the second bend 3130. Such a configuration can produce a symmetrically formed staple. See Figure 16A. However, one of the staple legs 3120 may often experience different formation mechanics than the other leg 3120 during the staple firing process. To address this, in at least one example, the staple may include a first bend defined by a first constant radius and a second bend defined by a second constant radius different from the first constant radius. The second constant radius may be larger or smaller than the first constant radius. In any case, a curved section with a certain radius reduces the possibility of cracking and / or breakage of the curved section during the staple firing process.

[0107] In at least one example, the staple has a substantially V-shaped configuration including a crown, a first leg, a first connecting portion connecting the first leg to the crown, a second leg, and a second connecting portion connecting the second leg to the crown. The staple 3100 in Figure 16 is, for example, substantially V-shaped. The first leg, the second leg, and the crown each have a straight or at least substantially straight segment. However, examples can be conceivable in which one or more of these segments are not straight. In any case, the first connecting portion comprises two bends and an intermediate portion, the first bend connecting the first leg to the intermediate portion, and the second bend connecting the intermediate portion to the crown. Each of the first and second bends within the first connecting portion provides at least one degree of freedom within the staple, allowing the first staple leg to be bent into a closed or firing configuration while reducing the possibility of cracking and / or breakage of the first connecting portion during the staple firing process. The second connection section has a similar configuration to the first connection section. However, various examples can be conceivable in which the multi-bend connection section described above may be used only to connect one of the staple legs to the crown section. Such examples may be useful when one of the staple legs is subjected to greater stress and strain than the other.

[0108] In at least one example, in addition to the above, the wire staple comprises a crown portion, a first leg portion, a first bend portion connecting the first leg portion to the crown portion, a second leg portion, and a second bend portion connecting the second leg portion to the crown portion. In at least one such example, the crown portion includes the wire diameter and extends along a line parallel to or at least substantially parallel to the deck or top surface of the staple cartridge when the staple is positioned within a staple cavity defined within the staple cartridge. The staple cartridge comprises a driver including a seat portion defined on the upper portion of the driver supporting the crown portion of the staple. The seat portion comprises a trough or recess including a first side wall extending longitudinally along the first side of the staple and a second side wall extending longitudinally along the second side of the staple. In at least one embodiment, the seat of the staple driver is configured to support the entire bottom surface of the staple when the staple is in its non-firing position, and then to push the bottom surface of the staple upward when the staple driver is driven upward toward an anvil positioned opposite the staple cartridge during the staple firing stroke. In such an example, the driving surface of the seat that contacts the bottom surface of the staple is flat and coincides with the flat bottom surface of the crown.

[0109] In various embodiments, referring to Figure 24, the staple 9800 comprises a crown portion 9810 having a downwardly extending first portion 9815 and a downwardly extending second portion 9815, connected at an intermediate vertex 9816. The first portion 9815 comprises a straight segment of the crown portion 9810 extending downward at approximately -5 degrees from the bend portion 9830, and the second portion 9815 also comprises a straight segment extending downward at approximately -5 degrees from the opposite bend portion 9830. That said, the straight segments 9815 can extend downward at any appropriate angle. In any case, the staple 9800 is driveable by a staple driver 9900. The seat portion 9910 of the staple driver 9900 comprises a driving surface that conforms to the bottom surface of the staple 9800 and inclined side walls that fully enclose the crown portion 9810 of the staple 9800, thereby restricting relative movement between the staple 9800 and the staple driver 9900. In various other examples, the downward-sloping first and second portions 9815 may be, for example, nonlinear and curved. In any case, the seat portion of the corresponding staple driver is molded to match the contour of the staple crown portion.

[0110] In at least one example, as shown in Figure 23, the staple 3500 includes a crown portion 3510, a first leg portion 3520 extending from the crown portion 3510, and a second leg portion 3520 extending from the crown portion 3510. The crown portion 3510 comprises three curved portions: a first curved portion 3512 connected to the first leg portion 3520, a second curved portion 3512 connected to the second leg portion 3520, and an intermediate curved portion 3514 located between the first and second curved portions 3512. The first and second curved portions 3512 and 3512 have a concave shape, while the intermediate curved portion 3514 has a convex shape. A staple driver 3600 used to drive the staple 3500 toward an anvil comprises a seat portion 3610 that matches or substantially matches the waveform profile of the crown portion 3510. For example, the seat portion 3610 includes first and second protrusions 3612 aligned with the first and second recesses 3512 of the staple crown portion 3510, and an intermediate recess 3614 aligned with the convex intermediate portion 3514 of the staple crown portion 3510.

[0111] In at least one example, referring to Figure 25, the wire staple 3800 includes a crown portion 3810, a first leg portion 3820 extending from the crown portion 3810, and a second leg portion 3820 extending from the crown portion 3810. The wire staple 3800 includes a bent portion 3830 connecting the leg portions 3820 to the crown portion 3810. The crown portion 3810 has a curved portion, and the first and second legs 3820 extend from the ends of the curved portion. The curved portion includes a catenary shape, but may include any suitable shape. As described above, the staple 3800 is driveable by a corresponding staple driver 3900 configured to drive the staple 3800 from a staple cartridge having a seat portion 3910 that presses against the bottom surface of the staple 3800. The driver seat portion 3910 is in complete contact with the staple crown portion 3810, so that there is no gap between the driver seat portion 3910 and the staple crown portion 3810.

[0112] In various embodiments, referring to Figure 35, the wire staple 4600 is configured to be driven by the staple driver 4700 during a staple firing stroke deflected relative to the staple driver 4700. The staple 4600 comprises a crown portion 4610, a leg portion 4620, and a bent portion 4630 connecting the leg portion 4620 to the crown portion 4610. The staple driver 4700 comprises an internally defined seat portion 4710 configured to receive the staple crown portion 4610. As shown in Figure 35, the driver seat portion 4710 does not fully contact the bottom surface of the staple crown portion 4610, at least when the driver 4700 and staple 4600 are in their non-firing positions. Rather, only the ends 4730 of the driver seat portion 4710 are in contact with, or can be in contact with, the lower driving surface of the staple 4600 while the driver 4700 and staple 4600 are in their non-firing positions. In other words, the middle portion 4715 of the driver seat 4710 does not contact the drive surface of the staple 4600 when the driver 4700 and staple 4600 are in the non-firing position. When the driver 4700 is lifted upward to fire the staple 4600, the end portion 4730 of the driver seat 4710 pushes the staple 4600 upward toward the anvil, and the middle portion 4715 of the driver seat 4710 does not contact the staple 4600 until the staple leg portion 4620 contacts the anvil. More specifically, after the staple leg portion 4620 contacts the anvil and a considerable firing force is transmitted through the staple 4600, the middle portion 4615 of the staple crown portion 4610 deflects and contacts the middle portion 4715 of the staple driver 4710. When the intermediate portion 4615 of the staple crown portion 4610 is deflected and comes into contact with the driver seat portion 4710, the entire driver seat portion 4710, or substantially the entire driver seat portion 4710, comes into contact with the staple crown portion 4610, and as a result the firing force is distributed across the crown portion 4610. Such a configuration reduces the possibility of the staple bending portion 4630 cracking and / or breaking during the staple injection process.In at least one example, the downward deflection of the staple crown 4610 causes plastic deformation within the crown 4610, resulting in the crown 4610 permanently taking on the shape of the driver seat 4710, at least partially, during the staple firing process.

[0113] In various other embodiments, in addition to the above, the wire staple 4800 is driven by a staple driver 4900, and the staple 4800 is deflected downward toward the staple driver 4900 during the staple firing process, but the entire crown portion of the staple 4800 does not come into contact with the staple driver 4900. Referring to Figure 36, the staple 4800 comprises a crown portion 4810, a leg portion 4820, and a bent portion 4830 connecting the leg portion 4820 to the crown portion 4810. The staple driver 4900 comprises a defined seat portion 4910 therein, including a seat end portion 4930 that comes into contact with the bent portion 4830 of the staple 4800 when the staple 4800 and the driver 4900 are in a non-firing position. Notably, the center 4815 of the crown portion 4810 is not in contact with the center 4915 of the driver seat portion 4910 when the staple 4800 and driver 4900 are in the non-firing position. When the staple 4800 is lifted upward by the driver 4900 and deformed relative to the anvil, the center 4815 of the crown portion 4810 is deflected downward toward the center 4915 of the driver seat portion 4910, but does not come into contact with the driver seat portion 4910.

[0114] In at least one example, in contrast to the above, when the driver and staples are in their non-firing positions, the center of the staple crown is in contact with the center of the staple driver, while the ends of the staple crown are not in contact with the driver. As the driver is lifted upward toward the anvil, the driver seat presses against the center of the staple crown until the staple legs make contact with the anvil. In this case, the bends connecting the staple legs to the crown are pushed down until they make contact with the driver seat, resulting in the entire lower driving surface of the staple, or substantially the entire lower driving surface, being in contact with the staple driver, and the firing force transmitted through the staple being distributed across the crown. Such a configuration reduces the possibility of cracking and / or breakage of the staple bends during the staple firing process. In at least one example, the downward deflection of the staple crown causes plastic deformation within the crown, resulting in the crown at least partially permanently taking the shape of the driver seat during the staple firing process. In addition, the bends of the staple can be contoured by the driver seat as the staple deforms relative to the anvil. In at least one example, the bent portion of the staple has a large radius of curvature when the staple is loaded into the staple cartridge, and this radius of curvature decreases as the staple is deformed.

[0115] In at least one example, referring to Figures 27–32, the staple cartridge comprises a staple driver 4100, which includes a seat 4110 that releasably holds a wire staple 4000 within the driver seat 4110. The staple 4000 comprises a crown portion 4010, a leg portion 4020, and a bent portion 4030 that connects the leg portion 4020 to the crown portion 4010. In addition to the seat 4110, the staple driver 4100 further comprises a cam portion 4120 configured to engage with a thread during the staple firing stroke to lift the staple driver 4100 and the staple 4000 toward an anvil located on the opposite side of the staple cartridge. The staple driver 4100 further comprises a guide 4130 that interacts with a slot defined within the staple cartridge, which maintains the staple driver 4100 and the staple 4000 aligned with a forming pocket located on the opposite side of the staple 4000. The driver seat 4110 further comprises a first seat end for holding a first bend 4030 of the staple 4000 and a second seat end for holding a second bend 4030 of the staple 4000. The first seat end has an internal slot for receiving the first bend 4030, which is at least partially defined by side walls 4112 and 4114 that form a wedge-shaped configuration. The distance between the side walls 4112 and 4114 is equal to or slightly less than the diameter of the staple wire, such that an interference fit exists between the staple 4000 and the driver seat 4110. The second seat end has a similar configuration. As a result, the staple driver 4100 grips and holds the staple 4000, thereby limiting the relative movement between the staple 4000 and the staple driver 4100 during the staple firing process. Such a configuration reduces the possibility of the staple 4000 slipping or sliding against the staple driver 4100. The driver 4100 is removed from the staple 4000 during the staple firing process, or, in various examples, after the staple firing process, when the stapler jaws are released and the staple cartridge is moved away from the stapled tissue.In this example, the walls of the staple seat 4110 hold the staple 4000 from the sides and do not extend to any part of the staple 4000. In at least one other example, referring to Figure 34, the staple driver 4500 includes a seat 4510 that includes walls and / or a catch 4530 that extend over, for example, the crown portion 4410 of the staple 4400 and hold the staple 4400 in a releaseable manner to the staple driver 4500. In at least one such example, the catch 4530 deflects during the staple firing process to release the staple 4400 from the staple driver 4500.

[0116] In at least one example, a material is inserted into the staple cavity of a staple cartridge to hold the staples in an unfired position. In at least one example, a mixture containing sodium stearate and water is injected into the staple cavity of a staple cartridge and / or deposited in other ways. The mixture flows down over the staples and then dries. Once dry, or at least partially dry, the sodium stearate holds the staples releasably in their unfired positions, preventing, or at least inhibiting, the staples from falling out of their staple cavity. When the staple cartridge is loaded into a stapler and then inserted into a patient, the fluids within the patient may come into contact with the dried sodium stearate and soften it. Whether or not the sodium stearate has softened, as the staples are fired, they detach from the sodium stearate. In various examples, some of the sodium stearate may remain attached to the staples after they have been embedded.

[0117] In addition to the above, certain parts of the staple can undergo a hardening process, while other parts of the staple can undergo a softening process. For example, a staple comprises a crown, legs, and a bent portion connecting the legs to the crown, where the bent portion is softened, for example, through an annealing process, and the tip of the leg is hardened through a quenching process. In at least one such example, the entire staple is heated, which can then be cooled slowly, except for the tip of the staple leg, which is exposed to a cold fluid such as cold gaseous nitrogen and / or immersed in a cold hydrocarbon. In other processes, only a portion of the staple is heated. In at least one such example, only the bent portion and the staple tip are heated, and only the staple tip is actively cooled in a cooling process. Such a process can produce a staple having a staple tip hard enough to interact with a metal anvil and a bent portion that can withstand the staple firing process without cracking or fracturing.

[0118] In at least one example, the tip of the staple leg is coated with a hard lubricating material to reduce friction between the staple leg and the anvil. In at least one example, the staple is made of a magnesium or magnesium alloy wire having a staple leg that is at least partially coated with magnesium nitride. In other examples, boron nitride, for example, can be used. In at least one example, a sputtering process can be used to deposit the coating on the staple leg. In at least one example, only the tip of the staple leg is coated. In at least one such example, the uncoated portion of the staple is masked and / or coated in other ways during the coating application process. In various examples, a process such as a sputtering process can be used to apply the coating onto a metal wire substrate in a pointillist or dot pattern. In at least one example, the coating is applied to the metal wire substrate at a constant density or at least substantially constant density across the coated surface. In at least one other example, the density of the coating on a first section of the metal wire substrate has a first density, and the density of the coating on a second section of the metal wire substrate has a second density that is higher than the first density. In at least one example, the coating density is highest at the tip of the staple leg and gradually decreases as you move away from the tip of the staple leg.

[0119] In addition to, or instead of, a hard lubricating coating on the staple, the anvil may be at least partially coated with a hard lubricating coating. In at least one embodiment, the coating on the anvil is harder than the coating on the staple and harder than the metal wire substrate of the staple deformed against the anvil. In at least one example, the anvil is made of at least one of stainless steel and titanium, and at least a portion of the anvil is coated with titanium nitride. In at least one such example, for example, the anvil has a forming pocket configured to receive and deform the leg of the staple, and only the forming pocket is coated with titanium nitride, for example.

[0120] In at least one example, in addition to the above, a length of metal wire is drawn from a wire spool and cut to a certain length. As part of this cutting process, the metal is sheared such that the end of the wire has a sharp end that will become the staple tip when the wire is formed into a staple. In at least one example, the cutting process creates a laterally inclined cut within the metal wire to produce an inclined flat through surface at each staple tip. The inclined flat through surface faces outward, but in other embodiments, the inclined flat through surface faces inward. Referring to Figure 25, the staple 3800 comprises a leg portion 3825 having a tip portion 3825 with an outward-facing surface. In at least one example, the inclined flat through surface extends at an angle greater than 45 degrees from a plane extending through the tip of the staple leg portion. In at least one example, the angle is, for example, about 50 degrees. In another example, the angle is, for example, about 60 degrees. In different examples, the angle is, for example, about 70 degrees. In another example, the angle is, for example, about 80 degrees. In at least one other example, the staple tip includes a nonlinear through surface, such as a curved through surface. In at least one example, the curved through surface includes a concave through surface, and in other examples, the curved through surface includes a convex through surface. In at least one other example, each staple tip includes two straight portions defining the through surface.

[0121] Referring to Figure 26, the staple 3800' comprises a leg tip 3825' defined by two flat surfaces that intersect at a sharp point. Such embodiments are particularly useful for penetrating tough tissue when, for example, the metal constituting the base material of the staple is soft and / or brittle. Such embodiments are useful for staples made of, for example, pure magnesium, magnesium alloys, zinc, zinc alloys, iron, and / or iron alloys. In various embodiments, the leg tip 3825' is coated with a hard material, such as a nitride, to facilitate insertion of the leg tip 3825' through the patient's tissue so that the leg tip 3825' properly engages with the anvil-forming pocket during the staple firing process.

[0122] As described above, various staple cartridges comprise a cartridge body and staples removably stored within the cartridge body. In various embodiments, the cartridge body includes a proximal end, a distal end, and a deck extending between the proximal and distal ends. The deck is configured to support patient tissue clamped to the staple cartridge and includes longitudinal rows of staple cavities defined within the deck. The deck further comprises longitudinal slots extending from the proximal to the distal end and configured to receive a tissue cutting knife. The longitudinal slots extend between three longitudinal rows of staple cavities defined on one side of the longitudinal slot and three longitudinal rows of staple cavities on the opposite side of the longitudinal slot. In various embodiments, a single staple is stored in each staple cavity. The staple cartridge further includes a thread that moves from the proximal end to the distal end during the firing stroke, and the firing stroke continuously ejects staples from the staple cartridge as the thread gradually moves from the proximal end to the distal end. An anvil positioned opposite the staple cartridge has six longitudinal rows of forming pockets, each of which is aligned with a staple cavity defined within the staple cartridge such that each forming pocket deforms a single staple.

[0123] More specifically, the staples housed within the staple cartridge are configured to move from a non-firing position to a firing position during the staple firing stroke. In various examples, the tip of the staple leg is positioned below the deck of the staple cartridge when the staple is in the non-firing position. When the staple is pressed into the firing position, the tip of the staple leg emerges above the deck of the staple cartridge and punctures the patient's tissue located above the staple. The tip of the staple leg is then deformed to exit the patient's tissue, contact the anvil, and return towards the tissue. In various examples, the tip of the staple leg re-punctures the patient's tissue when the staple is deformed into a fully firing configuration. In particular, depending on the thickness of the tissue being stapled and / or the force used to deform the staple, the staple can take on a lightly tightened configuration, a highly tightened configuration, or somewhere in between. All such configurations can be referred to as B-shaped configurations. However, lightly fastened formed staples have a loose B-shape, while tightly fastened formed staples have a narrow B-shape. In a tightly fastened configuration, for example, the tip of the staple leg may approach the crown of the staple during the forming process. In many cases, it is desirable that the staple tip does not deform beyond the crown.

[0124] In various embodiments, referring to Figure 33, the staple driver 4300 is configured to drive the staple 4200 during the staple firing stroke. The staple 4200 comprises a crown portion 4210 and legs 4220 extending from the crown portion 4210, each leg 4220 having a sharp staple tip 4225. The staple driver 4300 includes a seat portion 4310 for receiving and pressing the crown portion 4210 of the staple 4200. The staple driver 4300 further includes a platform and / or lateral flange 4390 including a stop surface for the staple tip 4225 to prevent the staple 4200 from being overtightened during the staple firing process. In at least one such embodiment, the staple driver 4300 is made of a metal such as stainless steel and / or titanium, which has sufficient strength to stop further tightening of the staple 4200. In at least one embodiment, the staple driver 4300 is made of plastic plated and / or coated with metal.

[0125] In various embodiments, in addition to the above, the staple cartridge is configured to prevent the staples deployed therefrom from being excessively deformed or overtightened. In at least one embodiment, the staple cartridge includes a stopper extending upward from the distal end of the staple cartridge. The stopper is sized and configured to set a minimum gap between the staple cartridge and an anvil positioned on the opposite side of the staple cartridge, such that the staples are formed to a desired height when the staples are deformed relative to the anvil. In at least one such embodiment, the stopper is positioned distal to the entire staple cavity. In at least one such embodiment, one or more stoppers are positioned at the distal end of the staple row. In at least one embodiment, the staple cartridge includes a gap-setting element deployed during the staple firing stroke, which, when lifted, can push the anvil to a desired minimum distance away from the staple cartridge. In at least one such embodiment, the gap setting element is positioned, for example, within the staple cavity in the outermost staple row and is pushed upward toward the anvil by a thread moving distally during the staple firing stroke. In at least one such embodiment, the deployable gap setting element is made of solid plastic. In at least one such embodiment, the deployable gap setting element comprises a first component, a second component, and a spring element positioned between the first and second components, which can provide a variable gap height setting element.

[0126] In various examples, in addition to the above, the staple leg may begin to spread outward as the staple leg emerges above the deck. More specifically, the staple has a substantially V-shaped configuration before being loaded into the staple cavity, which is elastically deflected into a substantially U-shaped configuration when the staple is loaded into the staple cavity, and as a result the staple leg no longer exists and elastically spreads outward as it emerges from the constraint of the staple cavity sidewall. In most examples, the spreading staple leg still contacts the appropriate or aligned forming pocket in the anvil during the staple firing process. That said, the spreading staple leg may be further deflected by the patient's tissue and, in some cases, may dislodge the aligned forming pocket. Embodiments for limiting and / or controlling the spreading of the leg are described below.

[0127] In at least one embodiment, referring to Figure 38, the staple 5300 includes a crown portion 5310, a leg portion 5320 extending from the crown portion 5310 and including a leg tip portion 5325, and a connector 5340 positioned above the crown portion 5310 and connecting the leg portion 5320. In at least one example, the crown portion 5310 and the leg portion 5320 are made of metal wire, and the connector 5340 includes an absorbent polymer such as PGA and / or PLLA. The connector 5340 is positioned below the deck of the staple cartridge when the staple 5300 is in the non-firing position and appears above the deck when the staple 5300 is being fired or pushed upward toward the anvil by the staple driver 4100. The connector 5340 prevents, or at least substantially limits, the outward spreading of the staple leg portion 5320 until the connector 5340 contacts the patient's tissue T. In at least one example, when the connector 5340 comes into contact with the patient's tissue T, the connector 5340 slides down the staple leg 5320, allowing the staple leg to spread outward. In at least one such example, the connector 5340 is parallel to, or at least substantially parallel to, the crown portion 5310 and slides downward parallel to the crown portion 5310. In at least one other example, one end of the connector 5340 is higher than the other end. In at least one example, the connector 5340 is fragile and configured to break when it comes into contact with the patient's tissue T. In various examples, the connector 5340 completely separates from the staple leg 5320 during the staple firing process. In some examples, one or more parts of the connector 5340 remain attached to the staple leg 5320, which can slide down the staple leg 5320 when the staple 5300 is being fired.

[0128] In addition to or instead of the above, referring to Figure 37, the staple cartridge comprises a cartridge body 5000 including a deck 5030 and a staple cavity 5010 defined within the deck 5030; staples 5100 removably housed within the staple cavity 5010; and a staple driver 5200 configured to drive the staples 5100 from the staple cavity 5010. Each staple 5100 comprises a crown portion 5110 and a leg portion 5120 extending upward and outward from the crown portion 5120. The staple leg portion 5120 is in contact with the side wall 5020 of the staple cavity and elastically flexes inward by the side wall 5020. The staple cartridge comprises a staple cavity extension 5025 extending upward from the deck 5030 of the cartridge body 5000. The cartridge body 5000 further comprises a staple cavity extension 5025 that prevents or at least suppresses the outward spreading of the staple legs 5120 and / or misalignment with a forming pocket in an anvil located on the opposite side of the staple cartridge during the staple firing process. In at least one example, the staple cavity extension 5025 extends the side wall 5020 of the staple cavity 5010 over the deck 5030 such that the side wall 5020 extends in a continuous direction through the staple cavity extension 5025. In at least one other example, the side wall 5020 of the staple cavity 5010 extending through the staple cavity extension 5025 extends inward, causing the legs 5020 to curve inward during the staple firing process, providing better control over the staple legs 5020. In any case, the tip 5125 of the staple leg 5120 is positioned within and / or aligned with the staple cavity extension 5025 when the staple 5100 is in the non-firing position, as shown in Figure 37. Thus, the staple cavity extension 5125 can maintain control of the staple leg 5120 throughout the entire staple firing process, or at least until the staple 5100 is overdriven from the staple cavity 5010 on the deck 5030.

[0129] In various embodiments, in addition to the above, the staple cavity extension at the distal end of the staple line is higher than other staple cavity extensions within the staple line. The higher staple cavity extension serves the additional purpose of setting the minimum tissue gap between the staple cartridge and the anvil.

[0130] In various embodiments, a surgical stapling device comprises an end effector including first and second jaws, a motor-driven jaw closure system, and a separate motor-driven staple launching system. The surgical stapling device further comprises a control system including a closure actuator that causes the jaw closure system to close the jaws of the end effector when activated, and a launching actuator that launches staples from a staple cartridge seated within the end effector when activated. During use, the motor-driven jaw closure system is operated until the jaws are fully closed, and then the motor-driven staple launching system is operated. However, in some cases, fully closed jaws may have a narrow gap between the jaws depending on the thickness of the tissue trapped between the jaws, resulting in the formation of excess staples during the staple launching stroke. In at least one embodiment, the control system of the surgical stapling device is configured to reverse the closure drive while the staple launching stroke is being performed to at least slightly retract or reduce the clamping pressure on the patient's tissue. By partially retracting the closing drive, the gap between the anvil and the staple cartridge is increased, thereby reducing the possibility of over-forming of staples during the staple firing stroke. In at least one example, the closing drive is retracted at the start of the staple firing stroke. In at least one example, the closing drive is retracted in the latter half of the staple firing stroke. In at least another example, the closing drive is retracted during the last quarter of the staple firing stroke. The appropriate time for selecting when to retract the closing drive can be based on previously collected data and / or real-time data collected by the control system during the staple firing stroke. In at least one such example, the control system includes a circuit configured to detect the current to the motor and, if the current exceeds a predetermined threshold, to retract the closing drive by a predetermined distance, and / or to retract the closing drive until the current to the motor falls below a predetermined threshold.

[0131] The various staples disclosed herein are made of metals or metal alloys, such as stainless steel, titanium, magnesium, and / or magnesium alloys. In various examples, staples are manufactured by cutting and shaping wires and then positioned in a staple cartridge. In other examples, staples are manufactured from sheets of cut and / or punched material and then positioned in a staple cartridge. During the manufacturing and assembly processes, staples may be exposed to water, air, oxygen, carbon dioxide, or corrosive agents, which can degrade the integrity of the raw materials and / or the staples. During use, staples are exposed to bodily fluids that can corrode them when implanted in a patient. For one or more reasons, it is advantageous to coat the staples during the staple manufacturing process, during the assembly process in which the staples are positioned in the staple cartridge, and / or after the staples are assembled in the staple cartridge.

[0132] In various embodiments, in addition to the above, an initial coating and / or lubricant is applied to the wire stock before it is cut and formed into staples. Once the wire stock is cut and formed into staples, an additional coating and / or lubricant can be applied to the staples. The additional coating and / or lubricant may be the same as, for example, the initial coating and / or lubricant, or it may be different. Furthermore, once the staples are placed in the staple cartridge, an additional coating and / or lubricant may be applied, for example, to the staples and / or parts of the staple cartridge. The coating and / or lubricant applied during assembly may be the same as, or it may be different from, the previously applied coating and / or lubricant. Taking the above into consideration, various combinations of coatings and / or lubricants may be used during the manufacture of surgical staples and / or the assembly of surgical staple cartridges.

[0133] In various embodiments, lubricants such as soap are applied to the staples at various stages of their manufacture, during their assembly into the staple cartridge, and / or during use. If there is no coating on the staples or on an absorbent coating already present on the substrate, the lubricant can be applied directly to the substrate of the staples. In various embodiments, lubricants may include, but are not limited to, magnesium stearate, sodium stearate, calcium stearate, ethyl lauroyl alginate (LAE), a solution of LAE and sodium stearate, a solution of LAE and calcium stearate, a solution of LAE and magnesium stearate, and / or combinations thereof. Ethyl lauroyl alginate (LAE) is a lubricant that acts as both an antimicrobial agent and a drying soap lubricant. Furthermore, when LAE is combined in solution with sodium stearate, calcium stearate, and / or magnesium stearate, the resulting solution may be thinner, have a more consistent drying rate, and adhere better to the staple surface to which it is applied and / or dried, compared to such a substance without LAE.

[0134] In various embodiments, the lubricant described above is applied to the staples using a soap solution which may contain water, alcohol, and / or other solvents, for example, aqueous. In such embodiments, the soap solution further contains a solute which is non-aqueous. After the lubricant or soap solution is coated onto the intended surface, the solvent eventually evaporates, leaving the solute and coating the surface covered with the soap solution. In various embodiments, for example, sodium stearate, LAE, sodium stearate and LAE, calcium stearate and LAE, magnesium stearate and LAE, and / or combinations thereof are left on the staples and / or staple cartridges. In various embodiments, the soap solution or lubricant is applied to a wire stock or sheet of material, whether pre-coated or uncoated, and dried or allowed to dry before being cut and formed into staples. In other embodiments, the lubricant remains wet when the staples are formed, which can reduce damage to the substrate and / or coating during the staple manufacturing process. In addition to or instead of the above, formed staples are coated with lubricant before they are loaded into a staple cartridge. In various applications, the lubricant remains moist when the staples are loaded into the staple cartridge, thereby facilitating their insertion into the cartridge. Alternatively, in addition to or instead of the above, the staples are coated with lubricant after they have been loaded into the staple cartridge. In such applications, the lubricant coats any exposed surfaces, facilitating the ejection of the staples from the cartridge.

[0135] Figure 68 shows a staple cartridge 10100 containing a cartridge body 10101, staples 10120 positioned in a staple cavity cavity 10110 defined within the cartridge body 10101. Staples 10120 are wire staples formed from wires that have been cut and bent to form the staples 10120. In other embodiments, staples 10120 are punched out from a sheet of material. In at least one embodiment, staples 10120 are positioned in the cavity 10110 using a staple assembly tool 10310 shown in Figure 70. The staple cavity 10110 defines an opening in the staple deck surface 10105 of the cartridge body 10101, and staples 10120 are configured to be ejected through the opening. Each staple cavity 10110 comprises a proximal end wall 10112, a distal end wall 10114, and two opposing lateral side walls 10116 that form the staple cavity 10110. When each staple 10120 is positioned within its respective staple cavity 10110, the staple legs 10122 of the staple 10120 are pressed against or elastically biased against the proximal end wall 10112 and the distal end wall 10114 to hold the staple 10120 at least partially within the staple cavity 10110. When the staple 10120 and staple driver 10130 are in the non-firing position, the staple 10120 rests on the staple driver 10130 positioned within the cartridge body 10101 of the staple cartridge 10100. The staple driver 10130 is movable from a non-firing position (Figure 68) to a firing position by a thread 10140, and ejects staples 10120 from the staple cavity 10110. Each staple 10120 has a staple leg 10122 that extends above the staple deck 10105 when the staple 10120 is in the non-firing position within the cartridge body 10101. Embodiments can also be conceivable in which the staple leg 10122 does not extend above the staple deck 10105 when the staple 10120 is in the non-firing position.Various combinations of different wire staple sizes and shapes, as well as different driver sizes and shapes, can be used to determine whether or not the staple legs 10122 extend above the deck surface 10105.

[0136] Figure 69 shows a staple cartridge 10200 comprising a cartridge body 10201 and staples 10220 positioned within a staple cavity 10210 defined within the cartridge body 10201. Staples 10120 are punched staples formed from a sheet of material that is cut and / or punched and then bent to form staples 10120. The punched staples 10220 are provided with an integrated staple driver 10221 or ramp formed thereon to facilitate the injection of staples 10220. In at least one embodiment, staples 10220 are positioned within the cavity 10210 using a staple assembly tool 10310 shown in Figure 70. In any case, the staple cavity 10210 defines a plurality of openings 10211 within the staple deck surface 10205 of the cartridge body 10201, and the staples 10220 are configured to be injected through the openings 10211. Each staple cavity 10210 comprises a proximal end wall 10212, a distal end wall 10214, and two opposing lateral side walls 10216 that form the staple cavity 10210. When each staple 10220 is inserted into its respective staple cavity 10210, the staple legs 10222 of the staple 10220 press against the proximal end wall 10212 and the distal end wall 10214, or are elastically biased against them, thereby holding the staple 10220 at least partially within the staple cavity 10210. During the staple firing stroke, the staple 10220 is ejected by the thread 10240 toward the deck 10205 of the cartridge body 10201 when the thread 10240 is moved distally and engages with the integrated driver 10221 of the staple 10220. Each staple 10220 is provided with a staple leg 10222 that extends above the staple deck 10205 when the staple 10220 is in the unfired position within the cartridge body 10201. However, other embodiments can be envisioned in which the staple leg 10222 does not extend above the deck 10205 when the staple 10220 is in the unfired position within the cartridge body 10201.Various combinations of different punched staple sizes and shapes, as well as different integrated driver sizes and shapes, can determine, for example, whether the staple legs 10222 extend above the deck surface 10205.

[0137] In addition to the above, uncoated staple tips and / or uncoated portions of staples obtained from the staple manufacturing process may be coated and / or lubricated after the staples are loaded into the staple cartridge. In various embodiments, staples 10120, 10220 shown in Figures 68 and 69 include uncoated and / or unlubricated portions resulting from the manufacturing process described above. Staples 10120, 10220 are fully seated within the staple cavities 10110, 10210 of staple cartridges 10100, 10200, with the uncoated and / or unlubricated staple tips extending above the deck surfaces 10105, 10205. In various embodiments, a second lubricant is applied to the exposed uncoated and / or unlubricated portions of staples 10120, 10220 after they have been positioned within the staple cartridges 10100, 10200. The second lubricant may be the same as, similar to, or different from, the lubricant applied before assembling the staples into the staple cartridge.

[0138] In various embodiments, the second lubricant is applied by dipping the exposed staple tips of the deck surfaces 10105, 10205 and the staples 10120, 10220 into the lubricant, and then allowing the lubricant to dry. For example, other embodiments can be envisioned in which the second lubricant is sprayed onto the uncoated portions of the deck surfaces 10105 and the staples 10120, 10220. In any case, once the second lubricant dries, the uncoated portions of the staples and the portions of the staple cartridges 10100, 10200 are coated with the second lubricant. In various examples, the staples 10120, 10220 are at least partially held in the staple cavities 10110, 10210 by the dried second lubricant.

[0139] In addition to the above, other embodiments can be conceivable in which the staples 10120, 10220 do not fully seat in the staple cavities 10110, 10210 when the second lubricant is applied to the deck surfaces 10105, 10205 and the exposed, uncoated staple tips of the staples 10120, 10220. In such configurations, the staples 10120, 10220 may be pushed down to their fully seated positions in the staple cavities 10110, 10210 before the second lubricant dries. Therefore, the second lubricant is placed between the staple legs 10122, 10222 and the staple cavity walls 10112, 10114, 10116, 10212, 10214, 10216 to at least partially hold the staples 10120, 10220 within the staple cavities 10110, 10210.

[0140] In addition to the above, other embodiments can be envisioned in which the uncoated staple tips of staples 10120 and 10220 are positioned below the deck surfaces 10105 and 10205, but are still accessible through staple cavity openings within the staple decks 10105 and 10205. In such a configuration, a second lubricant is applied to the staple deck 10105 and dripped or injected into the staple cavities 10110 and 10210 to coat the uncoated portions of staples 10120 and 10220, and once dry, to at least partially retain staples 10120 and 10220 within the staple cavities 10110 and 10210.

[0141] Other embodiments can be envisioned in which staples 10120, 10220 having uncoated and / or unlubricated portions may be fully or partially placed within a staple cartridge, and the entire staple cartridge 10100, 10200 may then be immersed or sprayed with a second lubricant. After the second lubricant is applied and before it dries, the staples 10120, 10220 are pressed down into their full seating positions. Once the second lubricant dries, it holds the staples 10120, 10220 at least partially within the staple cavities 10110, 10210.

[0142] In various embodiments, the staple cartridge, the stock used to produce the staples, and / or the staples themselves are coated with different adhesive polymers and / or lubricated with different lubricants and / or adhesive soap solutions. In one embodiment, the stock material is coated with an adhesive polymer and then lubricated with a first lubricant (e.g., the lubricants described herein) before inserting the staples into the staple cartridge. After the staples are seated in the staple cavity of the staple cartridge, a second lubricant different from the first lubricant is applied to the staples. However, other embodiments can be conceived in which the first and second lubricants are the same.

[0143] In at least one embodiment, the staple is lubricated with a first lubricant, such as one described herein, before inserting the staple into the staple cartridge. After the staple is fully seated in the staple cavity of the staple cartridge, the staple is lubricated with a second lubricant different from the first lubricant. Embodiments in which the first and second lubricants are the same are conceivable. The second lubricant is applied to the staple such that it is not positioned between the staple leg and the staple cavity wall.

[0144] In at least one embodiment, the stock material is coated with an adhesive polymer and then lubricated with a first lubricant, such as one described herein, before inserting the staples into a staple cartridge. The staples are then positioned within the staple cartridge, but not fully seated. At that point, the staples are lubricated with a second lubricant and then pressed down into a fully seated position within the stapled cartridge before the second lubricant dries. The second lubricant is different from the first lubricant. However, other embodiments in which the first and second lubricants are the same can be imagined.

[0145] In at least one embodiment, the staple is lubricated with a first lubricant, such as one described herein, before being inserted into a staple cartridge. The staple is then positioned within the staple cartridge, but not fully seated within it. The staple within the staple cartridge is then lubricated with a second lubricant and subsequently pushed down to a fully seated position within the stapled cartridge before the second lubricant dries. The second lubricant is different from the first lubricant. However, other embodiments in which the first and second lubricants are the same can be imagined.

[0146] In at least one embodiment, the stock material is coated with an adhesive polymer and then lubricated with an initial lubricant, such as the lubricant described herein. After the stock material is formed into staples, an intermediate lubricant is applied to the staples before inserting them into a staple cartridge. After the staples are positioned in the staple cavity of the staple cartridge, a final lubricant is applied to the staples and / or parts of the staple cartridge. In at least one embodiment, the initial lubricant, intermediate lubricant, and final lubricant are the same. However, other embodiments in which the initial lubricant, intermediate lubricant, and final lubricant differ can be imagined. Other embodiments in which the stock material is not coated with an adhesive polymer and is lubricated only with the initial lubricant can be imagined.

[0147] In addition to the above, the staples of the staple cartridge can be coated with the first lubricant and the second lubricant, or at least partially coated. In various embodiments, the second lubricant is a completely different type of lubricant from the first lubricant. In at least one embodiment, for example, the first lubricant is a solution of LAE and sodium stearate, and the second lubricant is a solution of LAE and calcium stearate. Other embodiments can be imagined in which the first and second lubricants are the same type of lubricant but have different concentrations. In other words, the first and second lubricant solutions consist of the same solvent(s) and solute(s) but have different concentrations. In at least one embodiment, the first lubricant is a solution of LAE and sodium stearate containing a first ratio of LAE to sodium stearate, and the second lubricant is a solution of LAE and sodium stearate containing a second ratio different from the first ratio of LAE to sodium stearate. In at least one embodiment, the first lubricant is a soap solution that is diluted more than the soap solution of the second lubricant.

[0148] In addition to the above, the stock material and / or staples are made from a high-silicone metal alloy coated with a highly hygroscopic lubricant to limit the infiltration of bodily fluids into the underlying silicone metal. An example of a lubricant that may be applied to the stock material and / or staples is magnesium stearate, among other lubricants and / or coatings described herein. In at least one embodiment, the stock material and / or staples are lubricated and dried to form a coating having, for example, a thin layer of LAE, a thin layer of LAE and sodium, and / or a thin layer of LAE and calcium stearate.

[0149] In various examples, a thin layer of coating is applied to the staples before they are loaded into the staple cartridge. Once the pre-coated staples are placed in the staple cavity of the staple cartridge, in various examples, a thicker, more robust layer of lubricant is applied to the staples. The thicker layer of lubricant is then dried, or allowed to dry, to create a thicker coating on the staples. In various examples, the thin coating applied to the staples before they are inserted into the staple cartridge is made of a different material than the thicker coating applied to the staples while they are stored in the cartridge. In some examples, the thin and thick coatings are, for example, made of the same material but at different concentrations. In any case, the thicker the lubricating layer on the staples and staple cartridge, the greater their resistance to larger amounts of water.

[0150] As discussed herein in relation to various embodiments, staples used in surgical procedures are metallic. In various embodiments, the stock material used to produce the staples is impregnated or alloyed to enhance the hydrophobicity of the staples, for example, to slow or reduce the degradation of the staples when exposed to bodily fluids and / or other corrosive substances. In certain embodiments, polyether ether ketone (PEEK), polylactic acid (PLA), polyglycolide (PGA), and / or tamoxifen citrate (TMC) are used to impregnate the particulate structure of the staple material to help seal the pores in the material. In various embodiments, magnesium or magnesium alloys are impregnated with PEEK, PLA, PGA, TMC, and / or combinations thereof to produce more hydrophobic staples that degrade less or more slowly when exposed to bodily fluids and / or other corrosive elements. In various examples, the stock material is impregnated before the staples are produced, and / or the staples are impregnated after they are formed from the stock material. In addition to the above, impregnated staples may be coated with one or more coatings or lubricants before the staples are loaded into the staple cartridge, and / or after the staples are loaded into the staple cartridge.

[0151] To reduce or slow the degradation of metal or metal alloy staples, in various embodiments, a metal less noble than the staple metal is placed in contact with the staples via a conductive solution and / or lubricant and acts as a sacrificial anode. In at least one embodiment, the sacrificial anode prevents or limits the corrosion of, for example, magnesium or magnesium alloy staples. The sacrificial anode, containing the less noble metal, may be part of a staple cartridge or staple loading device in the form of a conductive solution in contact with the magnesium or magnesium alloy staples. In at least one embodiment, a solution of the less noble metal is used to lubricate the staples before insertion into the staple cartridge. In at least one embodiment, a solution of the less noble metal in lubricant form is injected into a cavity containing the staples and dried. Once dried, the less noble material in the lubricant solution acts as a sacrificial anode to reduce the corrosion of the nobler staple material placed in the staple cavity. In various embodiments, the staples are magnesium alloys, and a lubricating solution of magnesium or magnesium stearate is injected into the staple cavity to seal the magnesium alloy staples. When the lubricating solution dries, it acts as a sacrificial anode to limit corrosion of the magnesium alloy staples. Other embodiments have been conceived in which a sodium (Na) and / or potassium (K) solution is used to form the lubricant, which can be dried on the staples before they are loaded into the staple cartridge and / or in the staple cavity after the staples are loaded into the staple cartridge to generate a sacrificial anode.

[0152] In various embodiments, a lubricant is poured into or over a portion of a staple cartridge containing staples, and then freeze-dried to hold the lubricant and / or staples in place. Such a configuration allows the staples to be held within the staple cavity together with, for example, the freeze-dried solution or lubricant around the staples. In other embodiments, the lubricant is freeze-dried within the staple cavity before the staples are inserted into the staple cavity. In such embodiments, the staples are inserted into the freeze-dried lubricant to seal the staples within the lubricant and hold them within the staple cavity.

[0153] In various embodiments, a conductive lubricant is positioned around the staples in the staple cavity of a staple cartridge, which may have an applied voltage, to prevent corrosion of the staples while the voltage is applied to the conductive lubricant. By removing the voltage from the conductive lubricant, corrosion of the staples can be allowed to proceed. In at least one embodiment, the conductive lubricant is flowed over the staples before the staples are loaded into the staple cartridge. The conductive lubricant may have a voltage applied from a power source such as a battery, for example, via a wire connection, an electrical conduit, and / or any suitable electrical connection. In any case, the voltage prevents, or at least reduces, oxidation and / or corrosion of the staples until the staples are loaded into the staple cartridge and then ready to be packaged. In various examples, once the staples are loaded into the staple cartridge, the conductive lubricant may flow over the staple cartridge and over the staples placed therein. In at least one such example, a power source such as a battery is electrically in communication with the conductive lubricant via one or more conductive paths within the staple cartridge. In at least one example, the staple cartridge does not have a power source. Instead, the power source is located within the staple cartridge packaging, which is positioned to electrically communicate with the conductive paths within the staple cartridge when the staple cartridge is loaded into the packaging. In any case, depending on the availability of a power source, voltage is supplied from the power source to the conductive paths within the staple cartridge and the conductive lubricant coating on the staples to prevent the staples from degrading until the staple cartridge is loaded into the stapler, and / or while the staple cartridge is loaded into the stapler.

[0154] In various embodiments, in addition to the above, the staples immersed in the conductive coating are made of a magnesium alloy, and the conductive coating contains, for example, a high concentration of magnesium ions. In at least one embodiment, the voltage applied to the conductive coating is based on the half-cell potential related to the Pourbet diagram of magnesium.

[0155] In various embodiments, once staples are inserted into a staple cartridge, a lubricant containing a high concentration of magnesium ions is applied to the stock material before the staples, staples, and / or staple cartridge and staples are formed. In various embodiments, the staple material is magnesium or a magnesium alloy, and the lubricant contains a high concentration of magnesium ions, particularly magnesium stearate and / or magnesium lauryl sulfate. The lubricant provides sufficient magnesium ions to reduce or inhibit further corrosion of the magnesium staples once the lubricant is applied to and / or dried on the magnesium or magnesium alloy staple material. This is based, for example, on the Nernst formula.

[0156] Figure 70 shows a surgical system 10300 comprising a staple assembly tool 10310 configured to insert internally stored staples 10320 into a staple cartridge 10330. The staple cartridge 10330 may be identical or similar to, for example, the staple cartridges 10100 and / or staple cartridges 10200 described above. The staple cartridge 10330 comprises a body portion 10332, a cartridge pan 10333, and a plurality of staple cavities 10334 defined within the body portion 10332. Each staple cavity 10334 defines an opening 10336 on the cartridge deck surface 10338 of the body portion 10332. The staple cavity 10334 is configured to receive staples 10320, and the cartridge pan 10333 is configured to prevent staples 10320 and staple drivers (if present) from falling out from the bottom of the staple cartridge 10330. The staples 10320 are configured to be placed into the staple cartridge 10330 by a staple assembly tool 10310, as will be described in more detail below.

[0157] The staple assembly tool 10310 comprises a staple magazine 10312 that houses a plurality of staples 10320 internally, and a reciprocating staple stitcher 10314. The staples 10320 may be identical or similar to, for example, the staples 10120 and / or staples 10220 described above. The staples 10320 are spring-loaded into the magazine 10312 so that they are biased toward an opening 10313 within the staple magazine 10312. When the opening 10313 is away from the staple stitcher 10314, the staples 10320 are biased toward the opening 10313 and are held in place due to the spring-loaded nature of the magazine 10312. The staple stitcher 10314 is displaceable toward the staple cartridge 10330 from a first position to a second position (Figure 70). Next, the stapler 10314 is retracted from the second position toward the first position toward the staple magazine 10312. In the illustrated embodiment, the stapler 10314 is manually operable between the first and second positions, for example, by the user of the staple assembly tool 10310. However, other embodiments can be conceivable in which the reciprocating stapler 10314 of the staple assembly tool 10310 is operated using an electric motor, a solenoid, and / or any other suitable actuation means.

[0158] When in use, the staple assembly tool 10310 is positioned above the staple cartridge 10330 so that the opening 10313 and the staple stitcher 10314 are aligned with one of the staple cavities 10334. The staple stitcher 10314 is then moved from the first position to the second position, inserting the staple 10320 positioned in the opening 10313 into one of the staple cavities 10334 of the staple cartridge 10330. The staple stitcher 10314 is then retracted towards the first position, and as the opening 10313 moves away from the staple stitcher 10314, another staple 10320 is forced into the opening 10313. Next, the staple assembly tool 10310 is moved to another location above the staple cartridge 10330 so that the opening 10313 and the staple stitcher 10314 are aligned with different staple cavities 10334. The staple stitcher 10314 is then operated again from the first position to the second position, placing another staple 10320 into the different staple cavity 10334. This process can be repeated, for example, until all of the staple cavities 10334 are filled with staples 10320.

[0159] In various embodiments, in addition to the above, the staple cartridge includes a cover or staple retainer that is removably attached to the cartridge body, the cover or staple retainer extending over the deck of the cartridge body, and preventing, or at least restraining, staples from falling out of the staple cavity while the staple retainer is attached to the cartridge body. When in use, the staple retainer is removed from the staple cartridge after the staple cartridge has seated in the surgical stapler but before the surgical stapler is inserted into the patient. In at least one embodiment, the staple retainer includes a projection extending downward into the staple cavity, the projection not only prevents staples from falling out of the staple cavity but also holds the staples in an un-launched position until at least the staple retainer is removed from the staple cartridge. In at least one such embodiment, the staple retainer includes a plastic portion extending over the deck and a metal portion attached to and / or embedded in the plastic portion, which includes a projection extending downward. The metal portion prevents, or at least inhibits, staples from becoming jammed inside the staple retainer and being removed from the staple cartridge when the staple retainer is removed.

[0160] Various embodiments are disclosed herein, in which the geometric shape, material, and / or material properties of staples stored in a staple cartridge are adjusted to provide desired performance when implanted in a patient. Often, it is desirable to delay the biodegradation of the staples, or at least specific staples, for a certain period of time. As described below, this period may include the healing period required for the patient's tissue to heal after being stapled and cut. In certain examples, as described in more detail below, it is desirable to delay the biodegradation of the staples, or at least specific staples, so that the staples cease to function and / or dissolve completely within a desired time.

[0161] The staples disclosed herein include a chemical composition that provides absorption of the staple at an appropriate rate during the tissue healing period. Absorbable staples are composed of materials that complement and support the natural wound healing process of tissue. Furthermore, the staples complement the natural wound healing process and are absorbed at an absorption rate consistent with it.

[0162] The various absorbable staples disclosed herein involve three stages of absorption / degradation. The first stage includes staples that are structurally complete and have not yet initiated the absorption / degradation process. The second stage includes staples that have initiated the absorption / degradation process but are still structurally present in the wound healing site. By the third and final stage, the staples are completely absorbed by the body in the wound healing site. Absorbable staples, whether metal-based or polymer-based, include sub-elements that do not toxicize the wound healing site as a result of excessive oxidation of the staple material. Sub-elements of absorbable staples also include absorption / degradation rates that are consistent with the natural wound healing schedule, as will be discussed in more detail below. In many cases, absorbable staples support healing tissue until the organ tissue becomes self-supporting as a result of the wound healing process. The staples are configured to be completely absorbed within the wound healing site once the tissue has become self-supporting.

[0163] Embodiments of absorbable staples may, in some examples, include zinc and magnesium. Furthermore, embodiments may include staples made from various alloys containing zinc, magnesium, and / or other trace elements. Both zinc and magnesium affect electrolyte levels in the body and wound healing. Other trace elements may also affect the wound healing process. Slightly elevated levels of zinc and magnesium are beneficial and may have a beneficial effect on wound healing. However, dramatically high and dramatically low levels of zinc and magnesium have adverse effects on the wound healing process. As background, zinc is an essential micronutrient for human health. Zinc plays a major role in regulating all stages of the wound healing process, namely, stages from membrane repair, oxidative stress, coagulation, inflammation and immune defense, tissue re-epithelialization, and angiogenesis to fibrosis / scar formation. The stages of the physiological wound healing process are described in more detail below. Furthermore, zinc supplementation has proven overwhelmingly successful in managing delayed postoperative wound healing, which remains a primary concern for surgeons. However, both excess and deficiency of zinc can hinder the elimination of microorganisms and negatively affect wound healing. Signs of excessive zinc levels include nausea, vomiting, loss of appetite, stomach cramps, diarrhea, and headaches. Long-term excess zinc in the body can lead to problems such as low copper levels, a weakened immune system, and low levels of HDL cholesterol.

[0164] Magnesium is a mineral that the body uses as an electrolyte, meaning that when dissolved in the blood, it carries electrical charges around the body. Magnesium levels affect bone health, cardiovascular function, and neurotransmission, among other functions. Most magnesium is stored in the bones. Hypermagnesemia develops when there is an excess level of magnesium in the body. Patients with symptomatic hypermagnesemia may show different clinical signs depending on the level and time at which the electrolyte imbalance occurred. The most frequent symptoms and signs may include weakness, nausea, dizziness, and confusion.

[0165] Referring now to Figure 39, the four stages of physiological wound healing are shown. Hemostasis is the first stage of wound healing, occurring immediately or very soon after body tissue is injured. Hemostasis involves the use of clotting factors to prevent further blood loss and lay the foundation for tissue formation during the healing process. Fibrin and platelets play a crucial role in forming a blood clot during the hemostasis stage. Platelets gather at the site of injury during hemostasis and adhere to the site of injury within the damaged blood vessels. During hemostasis, activated platelets form fibrin on their surface, which forms a reticular structure across the site of injury.

[0166] Inflammation is the second stage of physiological wound healing. The inflammatory stage can partially overlap with the hemostatic stage, as illustrated in Figures 39 and 40. Proteoglycans play a crucial role in the inflammatory stage. Proteoglycans contain protein chain components called glycosaminoglycans in the extracellular matrix of tissues. Glycosaminoglycan chains provide hydration and swelling in tissues during the inflammatory stage by attracting water into the extracellular matrix. Tissue swelling allows tissues to withstand compressive forces.

[0167] Proliferation is the third stage of physiological wound healing. The proliferative stage may partially overlap with the inflammatory stage, as shown in Figures 39 and 40. The proliferative stage corresponds to the formation of granulation tissue and angiogenesis, or angiogenesis. Granulation tissue is new connective tissue and microscopic blood vessels that form on the surface of the wound. The proliferative stage also involves the production of fibroblasts, the most prominent type of cell found in connective tissue. Fibroblasts help maintain the structural framework of the tissue by secreting collagen proteins.

[0168] Phagocytes such as neutrophils can destroy intracellular pathogens via reactive oxygen species (ROS). Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase is a key enzyme in the production of ROS precursors and the elimination of bacteria. Neutrophils play an essential role in the body's immune response during the inflammatory and proliferative phases by acting as a barrier between the tissue healing site and any microbial infection or pathogen. Neutrophils eliminate all microbial infections and / or pathogens through phagocytosis. Excessive levels of zinc can suppress the production of NADPH oxidase.

[0169] Similarly, macrophages play more than two roles at this stage of the wound healing process. Macrophages enhance host immune defenses and remove dead cells to promote tissue recovery during the inflammatory and proliferative phases. Lymphocytes are white blood cells that are part of the body's immune response. There are two types of lymphocytes: B cells and T cells. B cells produce antibodies, while T cells directly fight foreign invaders and produce cytokines that activate other parts of the immune system.

[0170] Figures 40 and 41 generally show increases in specific cell types at various stages during the physiological wound healing process. For example, neutrophil production appears to peak around day 2 of the wound healing process. Macrophages appear to peak around day 3 of the wound healing process. Fibroblasts appear to peak around days 5-6 of the wound healing process. Lymphocytes also appear to peak around day 6 of the wound healing process. Similarly, Figure 40 also shows how different levels of neutrophils, macrophages, fibroblasts, and lymphocytes correspond to the sequential stages of the wound healing process. Figure 42 shows the interactions between the various cell types described above at different stages during the wound healing process.

[0171] In various embodiments, the biodegradation rate of staples located within a tissue environment can be altered. In one embodiment, the biodegradation rate of staples can be altered by introducing secondary materials that cause acceleration or deceleration of the biodegradation rate of staples. In some embodiments, the introduction of one or more other elements or materials can establish microgalvanic cells within the staple material, thereby altering their electrode potential and causing an increase or decrease in the biodegradation rate. Other embodiments relating to the introduction of secondary materials or elements for altering the biodegradation rate of staples in a tissue environment are described elsewhere in this specification.

[0172] In various embodiments, the staple includes a coating that separates body fluids from the surface of the staple and inhibits the initiation of oxidation thereon. In various embodiments, the coating includes MgF2. In various embodiments, the coating includes a polymer coating. In various embodiments, the coating includes an organic-inorganic hybrid coating. In various embodiments, the coating includes a protective layer of naturally formed magnesium hydroxide. In various embodiments, the coating includes a protective layer of naturally formed magnesium carbonate. In various embodiments, the coating includes a protective layer of naturally formed magnesium hydroxycarbonate. In various embodiments, the coating includes a protective layer of naturally formed magnesium phosphate. In various embodiments, the coating includes one of magnesium hydroxide, magnesium carbonate, magnesium hydroxycarbonate, or magnesium phosphate, either alone or with CO3 -2 and PO4 -3 It can be combined with the presence of [another component]. In various embodiments, the staple includes a coating that traps deposits on it.

[0173] In another embodiment, the biological corrosion rate of the staple can be altered by changing the pH level or ionic configuration of the local fluid in the tissue environment, thereby altering the biological corrosion rate of the staple. In one embodiment, the pH level or ionic configuration of the local fluid can be altered by altering the staple. In one embodiment, an active element is applied to the staple and then left for a predetermined amount of time. After the predetermined amount of time, a neutralizing or stabilizing element is added to the staple.

[0174] In one embodiment, the biodegradation rate of staples can be altered by incorporating an auxiliary material along with the staples into the tissue environment. In various embodiments, a system is provided comprising a first staple cartridge and a second staple cartridge. The first staple cartridge comprises a first staple made of staple material and a first auxiliary material made of a first auxiliary material. The second staple cartridge comprises a second staple made of staple material and a second auxiliary material made of a second auxiliary material different from the first auxiliary material. When the first auxiliary material is embedded in the tissue environment, it biodegrades the first staple at a first rate. When the second auxiliary material is embedded in the tissue environment, it biodegrades the second staple at a second rate different from the first rate. Thus, the system provides clinicians with the ability to select between staple cartridges that contain staples made of the same material but biodegrade at different rates based on the auxiliary material provided with the staple cartridge.

[0175] In various embodiments, the material of the auxiliary material can be selected to increase or decrease the absorption rate of the staples, depending on the specific application. In one embodiment, the auxiliary material consists of a material that adjusts the pH level of the tissue environment in which the staples are located, and therefore increases or decreases the bioabsorption rate of the staples. In one embodiment, the auxiliary material consists of a material that can lower the local pH of the tissue environment, making the tissue environment more acidic, and therefore increases or decreases the biodegradation rate of the staples. In one embodiment, the auxiliary material consists of a material that can raise the local pH of the tissue environment, making the tissue environment more basic, and therefore increases or decreases the biodegradation rate of the staples.

[0176] In one embodiment, the auxiliary material is composed of pure magnesium that acts as an anode in the tissue environment, thereby increasing or decreasing the absorption rate of the staples. In another embodiment, the auxiliary material is composed of a material such as zinc or iron that decomposes magnesium-based staples at a faster rate.

[0177] In one embodiment, the staple includes an interrupter, such as a coating, surface treatment, surrounding material, or a combination thereof. The interrupter prevents substances, such as bodily fluids in the tissue environment, from coming into direct contact with the staple. In some embodiments, the interrupter inhibits the initiation of local oxidation and increases the rate of biological corrosion of the staple. In some embodiments, the interrupter captures ions that drive oxidation and corrosion, thereby increasing or decreasing the rate of biological corrosion of the staple. In some embodiments, the interrupter includes a catalyst that causes a change in the local tissue environment, thereby increasing or decreasing the rate of biological corrosion of the staple.

[0178] In various embodiments, the staple includes a coating that increases or decreases the rate of biological corrosion of the staple based on a mechanism of action. In one embodiment, the mechanism of action may include oxidation. In one embodiment, the mechanism of action may include hydrolysis. In one embodiment, the mechanism of action may include galvanic corrosion, as described elsewhere in this specification. In one embodiment, the mechanism of action may include a single substitution reaction between magnesium and hydrochloric acid. In one embodiment, the mechanism of action may include stress corrosion.

[0179] In various embodiments, staples are coated with a coating during manufacturing. In various embodiments, staples are coated with a coating after they have been embedded in the tissue environment. In one embodiment, staples are sprayed with a coating after they have been embedded in the tissue environment. In some embodiments, staples are coated after they have left the manufacturing facility but before they have been embedded in the tissue environment. In one embodiment, staples are coated while the staple cartridge is in the operating room. In various embodiments, the coating is applied in situ through an auxiliary material. In various embodiments, staples are partially coated with a coating during manufacturing and partially coated with a coating after they have been embedded in the tissue environment. In various embodiments, staples are coated with a coating made of a first material during manufacturing and then coated with a coating made of a second material different from the first material after they have been embedded in the tissue environment.

[0180] In the first experiment, pure magnesium (HP-Mg) and five alloys (AZ31, Mg-0.8Ca, Mg-1Zn, Mg-1Mn, Mg-1.34Ca-3Zn) were implanted in vivo into the subcutaneous environment of Lewis rats. After 21 days, the materials were removed, and corrosion due to weight loss was evaluated to determine the weight loss rate of each material, as shown below.

[0181] [Table 1]

[0182] Further information regarding the experiment can be found in Walker, Jemimah et al., "Magnesium alloys: predicting in vivo corrosion with in vitro immersion testing," Journal of Biomedical Materials Research Part B: Applied Biomaterials 100.4(2012):1134-1141, which is incorporated herein by reference in its entirety.

[0183] Taking into account the results of the experiment, an embodiment is disclosed in which a system comprising multiple staple cartridges is provided to a user such as a clinician. The multiple staple cartridges comprise a first staple cartridge containing first staples that decompose at a first rate in a tissue environment, and a second staple cartridge containing second staples that decompose at a second rate different from the first rate in a tissue environment. In various other embodiments, the system may comprise additional staple cartridges containing staples that decompose at different rates in a tissue environment. In various embodiments, the system may comprise six staple cartridges containing staples composed of one of the aforementioned materials listed in Table 1. Other embodiments are conceivable in which the system comprises any number of staple cartridges containing staples composed of any of the materials disclosed herein.

[0184] In various embodiments, the staple cartridges are positioned within their respective packaging, which includes markings to inform the clinician of the staple degradation rate of each cartridge. Therefore, when determining which staple cartridge to use for a particular stapling operation, the clinician can decide how quickly or slowly they want the staples to degrade. Based on this decision, the clinician can select a staple cartridge from among several according to the estimated degradation rate. For example, if the clinician determines that they want the staples to remain in the tissue environment for a longer period, the system provides the clinician with the ability to select a staple cartridge with a slower degradation rate compared to other staple cartridges in the system with a faster degradation rate.

[0185] In various embodiments, the markings on the packaging may include, for example, numbers, letters, words, symbols, and / or colors corresponding to the rate of staple degradation of a staple cartridge placed within the packaging. These markings provide a clinician with a quick way to determine the rate of staple degradation when selecting which staple cartridge to use for stapling operations. In one embodiment, the markings may include markings that inform the clinician of the rate of staple degradation relative to other staple cartridges provided in the system, as will be described in more detail below.

[0186] In various embodiments, the system may include a first package having a green mark indicating that the staple cartridge in the package contains the fastest-degrading staple among all staple cartridges in the system. The system may further include a second package having a yellow mark indicating that the staple cartridge in the package contains a staple that degrades more slowly than the green-packaged staple cartridge. In addition, the system may include a third package having a red mark indicating that the staple cartridge in the package contains the slowest-degrading staple among all staple cartridges in the system. In various embodiments, the color-based markings may be based on a green-to-red transition, as referenced above, where green is fastest and red is slowest, and green-to-red transition shading such as orange and yellow may be used to order the intermediate degradation rates. In various embodiments, the color-based markings may be based on a natural light wavelength bandwidth where red is fastest and purple is slowest, and intermediate colors and hues such as orange, yellow and green may be used to order the intermediate degradation rates. Any suitable color-based markings are contemplated by this disclosure to indicate the relative rates of degradation to a clinician.

[0187] In various embodiments, the system may include a first packaging having a first symbol, such as a rabbit, indicating that the staple cartridge in the packaging contains the fastest-decomposing staple among all staple cartridges in the system. The system may also include a second packaging having a second symbol, such as a turtle, indicating that the staple cartridge in the packaging contains the slowest-decomposing staple among all staple cartridges in the system. In various embodiments, the packaging may include a speedometer symbol, and the speedometer dial may indicate the relative decomposition rate of the staple. Any suitable symbol-based marking is contemplated by this disclosure for indicating the relative decomposition rate to a clinician.

[0188] In various embodiments, the system may include a first packaging having a first letter, such as "A," indicating that the staple cartridge in the packaging contains the fastest-decomposing staple among all staple cartridges in the system. The system may further include a second packaging having a second letter, such as "C," indicating that the staple cartridge in the packaging contains a staple that decomposes more slowly than the staple cartridge in the "A" packaging. The system may also include a third packaging having a third letter, such as "F," indicating that the staple cartridge in the packaging contains the slowest-decomposing staple among all staple cartridges in the system. In various embodiments, the letter-based markings may be based on a transition from A to F, as referenced above, where A is fastest and F is slowest, and intermediate letters such as B, C, and D (further including + or - such as B+ or B- as an example) may be used to order intermediate speeds. In various embodiments, the letter-based markings may be based on a transition from A to Z. Any suitable number-based markings are contemplated by this disclosure to indicate the relative rates of decomposition to the clinician.

[0189] In one embodiment, a staple located in a tissue environment may be in one of three states: functional, non-functional, or dissolved. The functional state is when the staple performs its intended function, such as clamping tissue to an acceptable level. For example, a staple may be functional immediately after being implanted in a patient within the tissue environment. The non-functional state is when the staple no longer adequately performs its intended function but remains embedded in the tissue environment. For example, a staple may transition from functional to non-functional after a period defined as a functional time frame has elapsed.

[0190] In one embodiment, the functional time frame can be defined as the amount of time it takes for a staple to break or at least partially break and lose its ability to fasten the stapled tissue. In various embodiments, the functional time frame can be the time it takes for one of the staple legs to break. In various embodiments, the functional time frame can be the time it takes for the base of the staple to break. In various embodiments, the functional time frame can be the time it takes for the staple leg to break away from the base of the staple. In various embodiments, the functional time frame may be the time it takes for any part of the staple to break, which results in a reduction in the clamping pressure the staple provides to the tissue. Therefore, when selecting a particular staple cartridge to use for a particular stapling operation, the functional time frame of a staple can be estimated and provided to the clinician using an estimated weight loss rate, such as those provided in Table 1. This allows the clinician to select a staple cartridge containing staples that will function in the tissue environment over the estimated time period.

[0191] In one embodiment, the functional time frame can be correlated with the tissue healing period. In various embodiments, a clinician can select a staple cartridge such that the functional time frame of the staple reaches or exceeds the tissue healing period. However, in various embodiments, a clinician can select a staple cartridge such that the functional time frame of the staple reaches or exceeds the healing period, but does not significantly exceed the healing period, and as a result, the staple is not embedded in the tissue for longer than necessary.

[0192] In one embodiment, the functional time frame can be defined as the amount of time it takes for a staple to lose a specific percentage of its weight due to biological corrosion in the tissue environment. Therefore, when selecting a specific staple cartridge to be used for a particular stapling operation, the functional time frame of the staple can be determined and provided to the clinician using an estimated weight loss rate, such as that provided in Table 1. This allows the clinician to select a staple cartridge containing staples that will function over the estimated time frame in the stapled tissue. In various embodiments, the estimated time frame is approximately 30 days. In various embodiments, the estimated time frame is approximately 60 days. In various embodiments, the estimated time frame is approximately 180 days. In various embodiments, the estimated time frame is less than one year, such as approximately 6 months or approximately 9 months, for example.

[0193] In one embodiment, the percentage of weight lost during the functional timeframe is approximately 25%. In one embodiment, the percentage of weight lost during the functional timeframe is approximately 50%. In one embodiment, the percentage of weight lost during the functional timeframe is less than approximately 25%, such as approximately 5%, 10%, 15%, or 20%. In one embodiment, the percentage of weight lost during the functional timeframe is between approximately 25% and approximately 50%, such as approximately 30%, 35%, 40%, or 45%. In one embodiment, the percentage of weight lost during the functional timeframe is approximately 75%. In one embodiment, the percentage of weight lost during the functional timeframe is between approximately 50% and approximately 75%, such as approximately 55%, 60%, 65%, or 70%.

[0194] Following the above, the dissolved state may be a state in which all, or at least a substantial amount of, the staple has been bioabsorbed by the patient. In various embodiments, a substantial amount means that less than approximately 10% of the staple's structure remains. As an example, a staple may transition from a non-functional state to a dissolved state after a period defined as a non-functional time frame has elapsed. In one embodiment, the non-functional time frame may be defined as the amount of time it takes for all, or at least a substantial amount of, the staple to bio-corrode in the tissue environment after the staple has reached a non-functional state. Therefore, when selecting a particular staple cartridge to be used for a particular stapling operation, the non-functional time frame of the staple can be estimated and provided to the clinician using an estimated weight loss rate, such as that provided in Table 1. This allows the clinician to select a staple cartridge containing staples that are present in the tissue environment but are non-functional for the estimated time.

[0195] In one embodiment, a staple can transition from a functional state to a dissolved state after a period defined as a lifetime time frame has elapsed. The lifetime time frame may, for example, be the sum of the functional time frame and the non-functional time frame described above. In one embodiment, the lifetime time frame may be defined as the amount of time required for a staple to be completely bio-corroded, or at least substantially bio-corroded, in the tissue environment. Therefore, using known weight loss rates, such as those provided in Table 1, the lifetime time frame of a staple can be estimated and provided to the clinician when selecting a particular staple cartridge to be used for stapling operations. This allows the clinician to select a staple cartridge containing staples that will be lost, or at least substantially lost, from the stapled tissue within the estimated time.

[0196] In one embodiment, the lifespan can be defined as the amount of time it takes for a staple to lose a specific percentage of its weight due to biological corrosion in the tissue environment. Thus, using known weight loss rates, such as those provided in Table 1, the lifespan of a staple can be determined and provided to the clinician when selecting a specific staple cartridge to be used for stapling operations. This allows the clinician to select a staple cartridge containing staples that will be lost, or at least substantially lost, from the stapled tissue within a known time.

[0197] In one embodiment, the percentage of weight lost during the lifespan is approximately 50%. In one embodiment, the percentage of weight lost during the lifespan is approximately 75%. In one embodiment, the percentage of weight lost during the lifespan is approximately 50% to approximately 75%, such as approximately 55%, 60%, 65%, or 70%. In one embodiment, the percentage of weight lost during the lifespan is approximately 100%. In one embodiment, the percentage of weight lost during the functional lifespan is approximately 75% to approximately 100%, such as approximately 80%, 85%, 90%, or 95%.

[0198] In various embodiments, the system may include a first packaging having a first table containing any of the functional time frame, non-functional time frame, and life time frame of staples arranged in a first staple cartridge within the first packaging. The system may further include a second packaging having a second table containing any of the functional time frame, non-functional time frame, and life time frame of staples arranged in a second staple cartridge within the second packaging, wherein the functional time frame, non-functional time frame, and life time frame of the first staple cartridge and the second staple cartridge are different. These varying time frames between staple cartridges provide clinicians with the ability to select staple cartridges from a plurality of staple cartridges provided by the system based on the desired decomposition characteristics of the staples.

[0199] A second experiment was conducted in which pure magnesium (HP-Mg) and five alloys (AZ31, Mg-0.8Ca, Mg-1Zn, Mg-1Mn, Mg-1.34Ca-3Zn) were immersed in either Earl's equilibrium salt solution ("EBSS"), minimal essential medium ("MEM"), or MEM containing 40 g / L bovine serum albumin ("MEMp"). After 21 days, the materials were removed, and corrosion was evaluated by weight loss to determine the weight loss rate of each material, as shown below.

[0200] [Table 2]

[0201] Further information regarding the experiment can be found in Walker, Jemimah et al., "Magnesium alloys: predicting in vivo corrosion with in vitro immersion testing," Journal of Biomedical Materials Research Part B: Applied Biomaterials 100.4(2012):1134-1141, which is incorporated herein by reference in its entirety.

[0202] Considering the experimental results, it is found that staples behave differently in different environments. For example, staples biodegrade at a first rate in a first tissue environment and at a second rate different from the first rate in a second tissue environment. Accordingly, embodiments are disclosed in which a system comprising multiple staple cartridges is provided to a user such as a clinician. In various embodiments, the staple cartridges are positioned within their respective packaging, which may include markings such as tables, graphs, grids, or sequences, to inform the clinician of the rate of staple degradation of each staple cartridge in multiple tissue environments.

[0203] In various embodiments, the packaging may have markings including a first column listing tissue environments such as gastric tissue, lung tissue, and liver tissue, and a second column listing the respective biological degradation rates for each tissue environment. Thus, when determining which staple cartridge to use for a particular stapling operation, a clinician can determine how quickly or slowly they want the staple to decompose in a particular tissue environment. Based on this determination, the clinician can select a staple cartridge from among several staple cartridges according to their estimated degradation rates in multiple tissue environments. In one embodiment, a clinician intending to staple gastric tissue may determine that they want the staple to remain in the tissue environment for a specific period of time. Thus, the system provides the clinician with the ability to know the approximate degradation rate of the staple in the gastric tissue environment and select a staple cartridge from among several staple cartridges.

[0204] A third experiment was conducted in which pure magnesium (HP-Mg) and two alloys (Mg2Ag and Mg10Gd) were implanted in vivo into rat femurs, or immersed in vitro in high-glucose Dulbecco's modified Eagle medium ("DMEM") + 10% fetal bovine serum ("FBS"). Corrosion due to weight loss was evaluated after 1 week and 4 weeks, and the weight loss rate of each material was determined as shown below.

[0205] [Table 3]

[0206] Further information regarding the experiment can be found in Myrissa, Anastasia et al., “In vitro and in vivo comparison of binary Mg alloys and pure Mg,” Materials Science and Engineering:C 61(2016):865-874, which is incorporated herein by reference in its entirety.

[0207] Considering the experimental results, it is evident that the rate of biodegradation of staples changes over time in different environments. For example, a staple may biodegrade at a first rate over a first period in a first tissue environment, and then at a second rate different from the first rate over a subsequent period in the first tissue environment. Accordingly, embodiments are disclosed in which a system comprising multiple staple cartridges is provided to a user such as a clinician. In various embodiments, the staple cartridges are positioned within their respective packaging, which may include markings such as tables, graphs, grids, or sequences, to inform the clinician of the rate of staple degradation of each staple cartridge over various periods in multiple tissue environments.

[0208] In various embodiments, the packaging may have markings including a first column listing tissue environments such as stomach tissue, lung tissue, and liver tissue; a second column listing the respective biodegradation rates in each tissue environment over a first period, such as about one week, about two weeks, about one month, or about three months; and a third column listing the respective biodegradation rates in each tissue environment over a period after the first period, such as about one week, about two weeks, about one month, or about three months. Thus, when determining which staple cartridge to use for a particular stapling operation, a clinician can determine how quickly or slowly they want the staples to degrade over a certain period in a particular tissue environment. Based on this determination, the clinician can select a staple cartridge from among several staple cartridges according to the estimated degradation rate of the staple cartridge over a specific period in multiple tissue environments. It should be understood that the markings provided above, having various biodegradation rates, may include three or more columns of biodegradation rates to inform the clinician of the various biodegradation rates of the staples over a lifetime timeframe.

[0209] A fourth experiment was conducted in which pure magnesium (HP-Mg) and two alloys (Mg2Ag and Mg10Gd) were implanted in vivo into rat femurs, or immersed in vitro in phosphate-buffered saline ("PBS"), Hanks equilibrium salt solution ("HBSS"), or Dulbecco's modified Eagle medium ("DMEM"). The weight loss and hydrogen evolution used to calculate the decomposition rate of each material were evaluated as shown below.

[0210] [Table 4]

[0211] Further information regarding the experiment can be found in Marco Pelegrin, Inigo, “Degradation Testing of Magnesium and its Alloys aiming at Biodegradable Implant Applications,” (2016) (PhD Thesis), which is incorporated herein by reference in its entirety.

[0212] Considering the experimental results, it is evident that the mass loss and H2 generation in staples vary in different environments. For example, a staple biodegrades at a first rate, generating a first amount of H2 in a first tissue environment, and then biodegrades at a second rate, generating a second amount of H2 in a second tissue environment. Accordingly, embodiments are disclosed in which a system comprising multiple staple cartridges is provided to users such as clinicians. In various embodiments, the staple cartridges are positioned within their respective packaging, which may include markings such as tables, graphs, grids, or sequences, to inform the clinician of the degradation rate and H2 generation rate of the staples within the staple cartridge in relation to multiple tissue environments.

[0213] Referring to Figure 44, the corrosion rate (mg / cm³) of magnesium alloys with respect to alloying element (weight %) is shown. 2A graph showing the corrosion rate (per day) is provided. As can be seen from Figure 44, an increase in the weight percentage of alloying elements affects the corrosion rate of magnesium alloys. For example, an increase in the weight percentage of alloying elements from the first group (Fe, Ni, Co, Cu, and Sr) results in a significant increase in the corrosion rate. On the other hand, an increase in the weight percentage of alloying elements from the second group (Zr, Na, Si, Mn, Ca, Ag, Ce, Nd, La, Pb, Sn, Zn, Cd, Y, Gd, and Al) results in a stable, not dramatic increase in the corrosion rate. In some cases, an increase in the weight percentage of alloying elements from the third group (As and Ge) results in a decrease in the corrosion rate of the staples.

[0214] In light of this data, a system comprising multiple staple cartridges, including staple cartridges of a first group and staple cartridges of a second group, is provided to users such as clinicians. The staple cartridges of the first group contain staples made of a magnesium alloy alloyed with a first alloying element. The first staple cartridge within the staple cartridges of the first group contains staples alloyed with a first weight percent of the first alloying element, and the second staple cartridge within the staple cartridges of the first group contains staples alloyed with a second weight percent of the first alloying element, which is different from the first weight percent of the first alloying element.

[0215] The staple cartridges of the second group include staples made of a magnesium alloy alloyed with a second alloying element different from the first alloying element. The first staple cartridges within the second group include staples alloyed with a first weight percent of the second alloying element, and the second staple cartridges within the second group include staples alloyed with a second weight percent of the second alloying element different from the first weight percent of the first alloying element.

[0216] In various embodiments, each staple cartridge within the first and second groups of staple cartridges is positioned within its respective packaging, which includes markings to inform the clinician of the staple alloy element, the weight percentage of the alloy element, and the corrosion rate of the staples within that packaging. Thus, the system provides the clinician with the ability to select a staple cartridge from among multiple staple cartridges based on the known alloy element, the weight percentage of the alloy element, and the corrosion rate of the staples in the staple cartridge. This allows the clinician to select between cartridges with staples composed of different alloys, such as selecting a cartridge with staples composed of a first alloy, as opposed to a cartridge with staples composed of a second alloy, which may be more suitable for a particular tissue environment.

[0217] In one embodiment, for a particular stapling procedure, a clinician may determine that it is more appropriate to select a staple cartridge from a first group of staple cartridges, where the staples are alloyed with a first alloying element, rather than a staple cartridge from a second group, where the staples are alloyed with a second alloying element. The clinician's determination may be based on various factors, such as the tissue environment, the patient's medical records, or the alloy conductivity if the electrosurgery is also performed in the tissue environment. Once the clinician has selected which group of staple cartridges to use, they can then select a staple cartridge from the group according to the estimated corrosion rate based on the weight percentage of the alloying element, giving the clinician the ability to control the approximate length the staples remain in the tissue environment.

[0218] Referring to Figure 43, a graph is provided showing the elongation at break (%) against the yield stress (MPa) for pure zinc and various zinc-based alloys. As seen in Figure 43, pure zinc can have low strength and plasticity, depending on how it is processed. Zn-Mg provides good strength, but ductility decreases beyond about 0.1% Mg. Mn strengthens zinc while maintaining or improving ductility. Ca, Sr, and Fe provide low levels of strength and decrease ductility. Zn-Al offers excellent properties that can be enhanced by processing. Cu improves tensile creep strength while maintaining ductility. Li exhibits very high strength (which can be further increased) with reduced ductility. However, ductility can be improved by adding Mn. Ag increases strength without decreasing ductility due to its high solubility in Mg. Ti can be used to improve room temperature creep, particularly in Zn-Cu alloys.

[0219] In light of this data, a system comprising multiple staple cartridges is provided to users such as clinicians. The multiple staple cartridges include a first staple cartridge containing staples made of a first zinc-based alloy having a first stress-strain profile. The multiple staple cartridges further include a second staple cartridge containing staples made of a second zinc-based alloy having a second stress-strain profile different from the first stress-strain profile. In various embodiments, the first and second staple cartridges are located in their respective packaging, which includes markings that inform the clinician of the staple alloy element and its associated stress-strain profile. Thus, the system provides clinicians with the ability to select staple cartridges from among the multiple staple cartridges based on known alloy elements and their stress-strain profiles. This allows clinicians to select between cartridges with staples made of different alloys, such as selecting a cartridge with staples made of a first alloy, as opposed to a cartridge with staples made of a second alloy, which may be more suitable for a particular tissue environment.

[0220] In one embodiment, for a particular stapling procedure, a clinician may determine that it is more appropriate to select a staple cartridge having staples alloyed with a first alloying element, rather than a staple cartridge having staples alloyed with a second alloying element. The clinician's decision may be based on various factors, such as the stress the staples are expected to experience in the tissue environment. Thus, by markings indicating the stress-strain profile of the staples, the clinician can gain greater confidence that the selected staple cartridge is suitable for a particular tissue environment. The clinician's decision may also be based on other factors (e.g., the patient's medical records or the alloy conductivity in events where electrosurgery is also performed in a tissue environment). In various embodiments, the markings may indicate, along with the stress-strain profile, the preferred tissue environment in which the staples are best used, along with the tissue environment in which the staples should be avoided.

[0221] In various embodiments, in addition to the above, the biological corrosion rate of the staples can be adjusted by using staples made of zinc alloy. Zinc alloys have improved mechanical properties compared to magnesium alloys, and the diameter of the staples can be smaller compared to magnesium alloy staples. In some embodiments, the diameter of zinc alloy staples may be similar to that of conventional titanium staples. In addition, the elastic modulus of zinc alloys is considerably higher than that of magnesium alloys and closer to that of titanium.

[0222] In various embodiments, the staples are made of a 3AL-2V titanium alloy, defined by the following composition: titanium (remainder), vanadium (approximately 2.0 wt% to approximately 3.0 wt%), aluminum (approximately 2.5 wt% to approximately 3.5 wt%), hydrogen (maximum approximately 0.015 wt%), nitrogen (maximum approximately 0.03 wt%), carbon (maximum approximately 0.10%), and iron (maximum approximately 0.25 wt%), having an ultimate strength of 76,900 to 200,000 psi (530 to 1378 MPa) and an elastic modulus of 1450 ksi.

[0223] In one embodiment, relatively stiff wires, such as wires made of zinc alloy, provide the loads for staple deployment or rupture release, forces for forming and deforming staples (i.e., staple line burst strength, release of partially formed staples), and staple tip penetration loads (i.e., penetrating the bronchi and trachea rather than collapsing the staple legs). In various embodiments, stiffer wires, such as wires made of zinc alloy, allow for improved guidance of the staple legs by the staple cartridge and driver mechanism to better align the staple legs with the target tissue and resist rotation during staple deployment from the staple cartridge. In one embodiment, stiffer wire staples, such as staples made of zinc alloy, have better resistance to forces that can cause displacement during staple deployment, such as forces from tissue flow, torsional forces of auxiliary materials, or forces resulting from the displacement of inclined closing jaws on the staple trajectory.

[0224] In one embodiment, the material properties of the staple, such as yield strength, will control the force required to form and deform the staple when it is loaded by sealing the microstructure layers. In another embodiment, the material properties of the staple, such as hardness and ductility, will control the magnitude of cracking, fracture, or breakage of the material or the staple. These harnesses help the yield strength by making the staple harder, but make the material more brittle and crack-sensitive. In another embodiment, the lower tensile properties of magnesium and zinc cause higher work hardening, making the staple more brittle. Therefore, as described above, the closer the material properties of the staple are to those of titanium, such as 3AL-2V titanium alloy, the better the balance between ductility and hardness.

[0225] As discussed herein, in many cases, it is desirable that the embedded staples dissolve rapidly within the patient, or at least faster than, for example, titanium and / or stainless steel staples can dissolve. In various examples, the rapidly dissolving staples are made of metals that are not as strong as titanium and / or stainless steel, and as a result, such rapidly dissolving staples may release the patient's tissue faster than stronger and slower dissolving staples. In at least one example, the innermost row of staples, i.e., the row of staples closest to the longitudinal knife slot, contains staples made of titanium, titanium alloys, and / or stainless steel in each staple cavity, while the outermost row of staples and the intermediate row of staples, i.e., the row of staples between the innermost and outermost rows, have staples made of magnesium and / or magnesium alloys in each staple cavity. In such examples, the outermost and intermediate rows of staples may release the patient's tissue before the innermost row of staples.

[0226] In at least one example, in addition to the above, the innermost staple row of the staple cartridge contains staples made of titanium, titanium alloy, and / or stainless steel in each staple cavity, while the outermost and intermediate staple rows have staples made of zinc and / or zinc alloy in each staple cavity. In at least one other example, the intermediate and outermost staple rows have staples made of iron and / or iron alloy in each staple cavity. In any of these examples, the outermost and intermediate staple rows may release patient tissue before the innermost staple row.

[0227] In at least one example, in addition to the above, the innermost staple row of the staple cartridge contains staples made of a first magnesium alloy in each staple cavity, the intermediate staple row contains staples made of a second magnesium alloy different from the first magnesium alloy in each staple cavity, and the outermost staple row contains staples made of a third magnesium alloy different from the first and second magnesium alloys in each staple cavity. The first, second, and third magnesium alloys are selected so that the outermost staple row frees patient tissue before the intermediate and innermost staple rows. Similarly, the intermediate staple row frees patient tissue before the innermost staple row. This same technique approach can be used for zinc alloys in various staple cartridges. This approach can also be used with iron alloys in various staple cartridges. In various embodiments, the first, second, and third magnesium alloys are selected so that the innermost staple row frees patient tissue before the intermediate and outermost staple rows. Similarly, intermediate staple rows release patient tissue before the innermost staple rows. This same technique can be used with zinc alloys in various staple cartridges. This approach can also be used with iron alloys in various staple cartridges.

[0228] In at least one example, the innermost staple row of a staple cartridge contains staples made of pure magnesium, while the intermediate and outermost staple rows contain staples made of magnesium alloy. However, in other examples, pure magnesium staples can be placed in any suitable staple row within the staple cartridge. In any case, once embedded, the staples are part of the patient's staple line, where the pure magnesium staples degrade before the magnesium alloy staples. The early degradation of the pure magnesium staples can increase the pH of the environment surrounding the staple line, slowing down the degradation of the magnesium alloy staples. Furthermore, the pure magnesium staples can act as an anode, at least temporarily, attracting, redirecting, or concentrating the oxidation and absorption of the staple line toward the pure magnesium staples and away from the magnesium alloy staples. Such a configuration allows the magnesium alloy staples to continue functioning for a desired period. In various other examples, all staple rows in a staple cartridge contain magnesium alloy staples, but also include pure magnesium staples that are interdistributed throughout the staple rows. In at least one example, the staple cartridge includes one or more staple rows composed of iron staples and / or iron staples interdistributed throughout the entire staple row. In such an example, the iron staples concentrate oxidation and absorption away from the magnesium alloy staples. Also in at least one example, the staple cartridge includes one or more staple rows composed of zinc staples and / or zinc staples interdistributed throughout the entire staple row. In such an example, the zinc staples concentrate oxidation and absorption away from the magnesium alloy staples.

[0229] As described above, one or more staples deployed within a staple line can produce an anodic effect relative to other staples within the staple line. In various embodiments, non-staple implants can be implanted in the patient to produce an anodic effect that concentrates oxidation and absorption at least partially and at least temporarily on the non-staple implants. In various examples, the non-staple implants are composed of, for example, lithium, sodium, and / or potassium. In at least one embodiment, the staple line is composed of pure magnesium staples and / or magnesium alloy staples, and the non-staple implants include anodes that allow the magnesium staples and magnesium alloy staples to continue functioning over a desired period of time. In at least one such embodiment, the non-staple implants are composed of a material no more noble than magnesium. Referring to Figure 75A, the staple pattern includes a longitudinal row of staples 7000 implanted in the patient's tissue T along the incision I. Non-staple implants 7100 are also present within the staple pattern. As can be seen in Figures 75A to 75D, the non-staple implant 7100 is bioabsorbed and dissolved before the staple 7000.

[0230] In various embodiments, in addition to or instead of the above, a powder containing sacrificial anode material is introduced onto the staple line and / or onto the patient tissue surrounding the staple line. In at least one embodiment, the powder contains magnesium particles. In at least one such embodiment, the magnesium particles are mixed in dry, or at least substantially dry, sodium stearate. In at least one embodiment, the staple cartridge is coated with at least one such powder so that at least a portion of the powder is transferred to the patient tissue when the patient tissue is clamped against the staple cartridge. In at least one embodiment, the powder is contained within a staple cavity defined within the staple cartridge so that it is ejected from the staple cartridge by a staple driver during the staple firing stroke. In various examples, the powder is filled into one or more staple cavities, one of which also contains staples. In other examples, the powder is filled into one or more staple cavities, one or more of which do not contain staples. In at least one such example, such staple cavities are located in the outermost staple row. In various embodiments, the powder is contained in and / or on embedded auxiliary material attached to the deck of the staple cartridge so that the powder is embedded together with the auxiliary material during the staple firing stroke. In at least one embodiment, the sacrificial anode material is contained in and / or present on tape adhered to the staple cartridge. In at least one embodiment, the sacrificial anode material is suspended in, for example, a gel on the staple cartridge.

[0231] In various cases, the sacrificial anode ma...

Claims

1. It is a staple cartridge, The deck and A long, narrow slot, A staple cavity defined within the aforementioned deck, A staple positioned within the staple cavity, configured to be deployed within a tissue environment, and made of a magnesium alloy, wherein the magnesium alloy is selected to cause the staple to bio-corrode within the tissue environment within a predetermined time frame, comprises: A staple cartridge comprising a coating, wherein the coating is configured to adjust the biological corrosion rate of the staple to meet the predetermined time frame by offsetting the increase in biological corrosion rate due to magnesium alloy and the decrease in biological corrosion rate due to calcification, based on a mechanism of action.

2. The staple cartridge according to claim 1, wherein the staple includes a coating applied during manufacturing.

3. The staple cartridge according to claim 1, wherein the staple includes a coating configured to capture ions.

4. The staple cartridge according to claim 1, wherein the staple includes a coating configured to suppress the initiation of oxidation.

5. The staple cartridge according to claim 1, wherein the staple includes a coating configured to bypass deposits from there.

6. The staple cartridge according to claim 1, wherein the staple includes a coating configured to capture deposits thereon.

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