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WO2024261660A1 - Systèmes et procédés de fixation d'auxiliaires à des cartouches d'agrafes chirurgicales à l'aide d'adhésifs biocompatibles - Google Patents

Systèmes et procédés de fixation d'auxiliaires à des cartouches d'agrafes chirurgicales à l'aide d'adhésifs biocompatibles Download PDF

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Publication number
WO2024261660A1
WO2024261660A1 PCT/IB2024/055987 IB2024055987W WO2024261660A1 WO 2024261660 A1 WO2024261660 A1 WO 2024261660A1 IB 2024055987 W IB2024055987 W IB 2024055987W WO 2024261660 A1 WO2024261660 A1 WO 2024261660A1
Authority
WO
WIPO (PCT)
Prior art keywords
adjunct
staple cartridge
biocompatible adhesive
tissue
staple
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2024/055987
Other languages
English (en)
Inventor
Peyton HOPSON
Sarah SCULLY
Michael J. Vendely
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cilag GmbH International
Original Assignee
Cilag GmbH International
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/485,117 external-priority patent/US20240424745A1/en
Application filed by Cilag GmbH International filed Critical Cilag GmbH International
Priority to EP24736098.5A priority Critical patent/EP4551261A1/fr
Publication of WO2024261660A1 publication Critical patent/WO2024261660A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07292—Reinforcements for staple line, e.g. pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/52—Hydrogels or hydrocolloids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00938—Material properties hydrophobic

Definitions

  • the present invention generally relates to systems and methods for attaching adjuncts to surgical staple cartridges using biocompatible adhesives.
  • staplers have a handle (some of which are directly user operable, others of which are operable by a user via a robotic interface) with an elongate shaft extending from the handle and having a pair of movable opposed jaws formed on an end thereof for holding and forming staples therebetween.
  • the staples are typically contained in a staple cartridge, which can house multiple rows of staples and is often disposed in one of the two jaws for ejection of the staples to the surgical site.
  • the jaws are positioned so that the object to be stapled is disposed between the jaws, and staples are ejected and formed when the jaws are closed, and the device is actuated.
  • Some staplers include a knife configured to travel between rows of staples in the staple cartridge to longitudinally cut and/or open the stapled tissue between the stapled rows.
  • a method for attaching an adjunct to a surgical staple cartridge using a biocompatible adhesive may include depositing a biocompatible adhesive onto a top surface of a surgical staple cartridge.
  • the method may include attaching an adjunct to the biocompatible adhesive.
  • the biocompatible adhesive may have a component configured to reduce a sensitivity of the biocompatible adhesive to moisture and temperature.
  • the component may include a hydrophobic component.
  • FIG. 1 is a perspective view of one exemplary embodiment of a conventional surgical stapling and severing instrument.
  • FIG. 2A is a top view of a staple cartridge for use with the surgical stapling and severing instrument of FIG. 1 ;
  • FIG. 2B is a side view of the staple cartridge of FIG. 2A;
  • FIG. 3 is a side view of a staple in an unfired (pre-deployed) configuration that can be disposed within the staple cartridge of the surgical cartridge assembly of FIG. 2A;
  • FIG. 4 is a perspective view of a knife and firing bar (“E-beam”) of the surgical stapling and severing instrument of FIG. 1 ;
  • FIG. 5 is a perspective view of a wedge sled of a staple cartridge of the surgical stapling and severing instrument of FIG. 1 ;
  • FIG. 6A is a longitudinal cross-sectional view of an exemplary surgical cartridge assembly having a compressible non-fibrous adjunct attached to a top or deck surface of a staple cartridge;
  • FIG. 7 is a partial-schematic illustrating the adjunct of FIGS. 6A-6B in a tissue deployed condition
  • FIG. 9 is a flow chart showing an exemplary method for attaching an adjunct to a surgical staple cartridge using a biocompatible adhesive
  • the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ⁇ 10% of the recited value, e.g., “about 90%” may refer to the range of values from 81% to 99%.
  • polyurethane refers to a polymeric reaction product of an isocyanate and a polyol, and is not limited to those polymers which include only urethane or polyurethane linkages. It is well understood by those of ordinary skill in the art of preparing polyurethanes that the polyurethane polymers may also include linkages such as allophanate, carbodiimide, and other linkages described herein in addition to urethane linkages.
  • reaction system reactive formulation
  • reaction product reactive mixture
  • room temperature refers to temperatures of about 20°C, this means referring to temperatures in the range 18° C to 25° C. Such temperatures will include, 18° C, 19° C, 20° C, 21° C, 22° C, 23° C, 24° C and 25° C.
  • weight percentage (indicated as % wt. or wt. %) of a component in a composition refers to the weight of the component over the total weight of the composition in which it is present and is expressed as percentage.
  • Glass transition temperature and “T g ” as referred to herein refers to the temperature at which a reversible transition from a hard glass condition into a rubber-elastic condition occurs.
  • a surgical stapling assembly can include a staple cartridge having staples disposed therein and an adjunct configured to be releasably retained on the staple cartridge.
  • the various adjuncts provided can be configured to compensate for variations in tissue properties, such as variations in tissue thickness, and/or to promote tissue ingrowth when the adjuncts are stapled to tissue.
  • an adjunct can include a bioabsorbable material, such as a foam.
  • An exemplary stapling assembly can include a variety of features to facilitate application of a surgical staple, as described herein and illustrated in the drawings. However, a person skilled in the art will appreciate that the stapling assembly can include only some of these features and/or it can include a variety of other features known in the art. The stapling assemblies described herein are merely intended to represent certain exemplary examples. Moreover, while the adjuncts are described in connection with surgical staple cartridge assemblies, the adjuncts can be used in connection with staple reloads that are not cartridge based or any type of surgical instrument.
  • FIG. 1 illustrates an exemplary surgical stapling and severing device 100 suitable for use with an implantable adjunct.
  • the illustrated surgical stapling and severing device 100 includes end effector 106 having an anvil 102 that is pivotably coupled to an elongate channel 104.
  • the end effector 106 can move between an open position, as shown in FIG. 1, and a closed position in which the anvil 102 is positioned adjacent to the elongate channel 104 to engage tissue therebetween.
  • the end effector 106 can be attached at its proximal end to an elongate shaft 108 forming an implement portion 110.
  • the implement portion 110 can present a sufficiently small cross-section suitable for inserting the end effector 106 through a trocar. While the device 100 is configured to staple and sever tissue, surgical devices configured to staple but not sever tissue are also contemplated herein.
  • the end effector 106 can be manipulated by a handle 112 connected to the elongate shaft 108.
  • the handle 112 can include user controls such as a rotation knob 114 that rotates the elongate shaft 108 and the end effector 106 about a longitudinal axis (Ls) of the elongate shaft 108 and an articulation control 115 that can articulate the end effector 106 about an articulate axis (TA) that is substantially transverse to the longitudinal axis (Ls) of the elongate shaft 108.
  • Further controls include a closure trigger 116 which can pivot relative to a pistol grip 118 to close the end effector 106.
  • a closure release button 120 can be outwardly presented on the handle 112 when the closure trigger 116 is clamped such that the closure release button 120 can be depressed to unclamp the closure trigger 116 and open the end effector 106, for example.
  • Handle 112 may also take the form of an interface for connection to a surgical robot.
  • a firing trigger 122 which can pivot relative to the closure trigger 116, can cause the end effector 106 to simultaneously sever and staple tissue clamped therein.
  • the firing trigger 122 may be powered, require force from a user to engage, or some combination thereof.
  • a manual firing release lever 126 can allow the firing system to be retracted before full firing travel has been completed, if desired, and, in addition, the firing release lever 126 can allow a surgeon, or other clinician, to retract the firing system in the event that the firing system binds and/or fails.
  • a staple cartridge 200 can be utilized with the instrument 100. In use, the staple cartridge 200 is placed within and coupled to the elongate channel 104.
  • the staple cartridge 200 can have a variety of configurations, in this illustrated example, the staple cartridge 200, which is shown in more detail in FIGS. 2A-2B, has a proximal end 202a and a distal end 202b with a cartridge longitudinal axis (LC) extending therebetween.
  • the longitudinal axis (LC) is substantially or approximately parallel with the longitudinal axis (LS) of the elongate shaft 108.
  • the staple cartridge 200 includes a longitudinal slot 210 defined by two opposing walls 210a, 210b and configured to receive at least a portion of a firing member of a firing assembly, like firing assembly 400 in FIG.
  • the longitudinal slot 210 extends from the proximal end 202a toward the distal end 202b of the staple cartridge 200. It is also contemplated herein that in other examples, the longitudinal slot 210 can be omitted.
  • the illustrated staple cartridge 200 includes staple cavities 212, 214 defined therein, in which each staple cavity 212, 214 is configured to removably house at least a portion of a staple (not shown).
  • the number, shape, and position of the staple cavities can vary and can depend at least on the size and shape (e.g., mouth-like shape) of the staples to be removably disposed therein.
  • the staple cavities are arranged in two sets of three longitudinal rows, in which the first set of staple cavities 212 is positioned on a first side of the longitudinal slot 210 and the second set of staple cavities 214 is positioned on a second side of the longitudinal slot 210.
  • each staple cavity 212, 214 may include a maximum length SL of about 0.122 inches to about 0.124 inches and a maximum width SW of about 0.023 inches to about 0.027 inches. In addition, at least the centers of two adjacent cavities 212, 214 are spaced apart by about 0.158 inches.
  • the staples releasably stored in the staple cavities 212, 214 can have a variety of configurations.
  • An exemplary staple 300 that can be releasably stored in each of the staple cavities 212, 214 is illustrated in FIG. 3 in its unfired (pre-deployed, unformed) configuration.
  • the illustrated staple 300 includes a crown (base) 302 and two legs 304 extending from each end of the crown 302. In this example, the crown 302 extends in a linear direction and the staple legs 304 have the same unformed height.
  • the staple crowns 302 can be supported by staple drivers that are positioned within the staple cartridge 200 and, concurrently, the staple legs 304 can be at least partially contained within the staple cavities 212, 214. Further, the staple legs 304 can extend beyond a top surface, like top surface 206, of the staple cartridge 200 when the staples 300 are in their unfired positions. In certain instances, as shown in FIG. 3, the tips 306 of the staple legs 304 can be pointed and sharp which can incise and penetrate tissue.
  • staples 300 can be deformed from an unfired position into a fired position such that the staple legs 304 move through the staple cavities 212, 214, penetrate tissue positioned between the anvil 102 and the staple cartridge 200, and contact the anvil 102.
  • the legs 304 of each staple 300 can capture a portion of the tissue within each staple 300 and apply a compressive force to the tissue.
  • the legs 304 of each staple 300 can be deformed downwardly toward the crown 302 of the staple 300 to form a staple entrapment area in which the tissue can be captured therein.
  • the staple entrapment area can be defined between the inner surfaces of the deformed legs and the inner surface of the crown of the staple.
  • the size of the entrapment area for a staple can depend on several factors such as the length of the legs, the diameter of the legs, the width of the crown, and/or the extent in which the legs are deformed, for example.
  • all of the staples disposed within the staple cartridge 200 can have the same unfired (pre-deployed, unformed) configuration.
  • the staples can include at least two groups of staples each having a different unfired (pre-deployed, unformed) configuration, e.g., varying in height and/or shape, relative to one another, etc.
  • the staple cartridge 200 extends from a top surface or deck surface 206 to a bottom surface 208, in which the top surface 206 is configured as a tissuefacing surface and the bottom surface 208 is configured as a channel-facing surface.
  • the top surface 206 faces the anvil 102 and the bottom surface 208 (obstructed) faces the elongate channel 104.
  • a firing assembly such as, for example, firing assembly 400, can be utilized with a surgical stapling and severing device, like device 100 in FIG. 1.
  • the firing assembly 400 can be configured to advance a wedge sled 500 having wedges 502 configured to deploy staples from the staple cartridge 200 into tissue captured between an anvil, like anvil 102 in FIG. 1, and a staple cartridge, like staple cartridge 200 in FIG. 1. Furthermore, an E-beam 402 at a distal portion of the firing assembly 400 may fire the staples from the staple cartridge. During firing, the E-beam 402 can also cause the anvil to pivot towards the staple cartridge, and thus move the end effector from the open position towards a closed position.
  • the illustrated E-beam 402 includes a pair of top pins 404, a pair of middle pins 406, which may follow a portion 504 of the wedge sled 500, and a bottom pin or foot 408.
  • the E-beam 402 can also include a sharp cutting edge 410 configured to sever the captured tissue as the firing assembly 400 is advanced distally, and thus towards the distal end of the staple cartridge.
  • integrally formed and proximally projecting top guide 412 and middle guide 414 bracketing each vertical end of the cutting edge 410 may further define a tissue staging area 416 assisting in guiding tissue to the sharp cutting edge 410 prior to being severed.
  • the middle guide 414 may also serve to engage and fire the staples within the staple cartridge by abutting a stepped central member 506 of the wedge sled 500 that effects staple formation by the end effector 106.
  • the anvil 102 in FIG. 1 can be moved into a closed position by depressing the closure trigger in FIG. 1 to advance the E-beam 402 in FIG. 4.
  • the anvil 102 can position tissue against at least the top surface 206 of the staple cartridge 200 in FIGS. 2A-2B. Once the anvil has been suitably positioned, the staples 300 in FIG. 3 disposed within the staple cartridge can be deployed.
  • the sled 500 in FIG. 5 can be moved from the proximal end toward a distal end of the cartridge body, and thus, of the staple cartridge.
  • the sled can contact and lift staple drivers within the staple cartridge upwardly within the staple cavities 212, 214.
  • the sled and the staple drivers can each include one or more ramps, or inclined surfaces, which can co-operate to move the staple drivers upwardly from their unfired positions.
  • the staples are lifted upwardly within their respective staple cavities, the staples are advanced upwardly such that the staples emerge from their staple cavities and penetrate into tissue.
  • the sled can move several staples upwardly at the same time as part of a firing sequence.
  • the stapling device can be used in combination with a compressible adjunct.
  • adjuncts are shown and described below, the adjuncts disclosed herein can be used with other surgical instruments and need not be coupled to a staple cartridge as described. Further, a person skilled in the art will also appreciate that the staple cartridges need not be replaceable.
  • a surgeon is often required to select the appropriate staples having the appropriate staple height for tissue to be stapled. For example, a surgeon will utilize tall staples for use with thick tissue and short staples for use with thin tissue. In some instances, however, the tissue being stapled does not have a consistent thickness and thus, the staples cannot achieve the desired fired configuration for every section of the stapled tissue (e.g., thick and thin tissue sections). The inconsistent thickness of tissue can lead to undesirable leakage and/or tearing of tissue at the staple site when staples with the same or substantially greater height are used, particularly when the staple site is exposed to intra-pressures at the staple site and/or along the staple line.
  • adjuncts can be configured to compensate for varying thickness of tissue that is captured within fired (deployed) staples to avoid the need to take into account staple height when stapling tissue during surgery. That is, the adjuncts described herein can allow a set of staples with the same or similar heights to be used in stapling tissue of varying thickness (e.g., from thin to thick tissue) while also, in combination with the adjunct, providing adequate tissue compression within and between fired staples. Thus, the adjuncts described herein can maintain suitable compression against thin or thick tissue stapled thereto to thereby minimize leakage and/or tearing of tissue at the staple sites.
  • exemplary adjuncts described herein may be configured to be absorbed in the body over a period of 100 to 300 days depending on implanted location and tissue health.
  • the adjuncts can be configured to promote tissue ingrowth.
  • tissue ingrowth it is desirable to promote the ingrowth of tissue into an implantable adjunct, to promote the healing of the treated tissue (e.g., stapled and/or incised tissue), and/or to accelerate the patient's recovery.
  • the ingrowth of tissue into an implantable adjunct may reduce the incidence, extent, and/or duration of inflammation at the surgical site.
  • Tissue ingrowth into and/or around the implantable adjunct may, for example, manage the spread of infections at the surgical site.
  • the ingrowth of blood vessels, especially white blood cells, for example, into and/or around the implantable adjunct may fight infections in and/or around the implantable adjunct and the adjacent tissue.
  • Tissue ingrowth may also encourage the acceptance of foreign matter (e.g., the implantable adjunct and the staples) by the patient's body and may reduce the likelihood of the patient's body rejecting the foreign matter. Rejection of foreign matter may cause infection and/or inflammation at the surgical site.
  • foreign matter e.g., the implantable adjunct and the staples
  • the adjuncts provided herein are designed and positioned atop a staple cartridge, like staple cartridge 200.
  • the staples When the staples are fired (deployed) from the cartridge, the staples penetrate through the adjunct and into tissue. As the legs of the staple are deformed against the anvil that is positioned opposite the staple cartridge, the deformed legs capture a portion of the adjunct and a portion of the tissue within each staple. That is, when the staples are fired into tissue, at least a portion of the adjunct becomes positioned between the tissue and the fired staple.
  • the adjuncts described herein can be configured to be attached to a staple cartridge, it is also contemplated herein that the adjuncts can be configured to mate with other instrument components, such as an anvil of a surgical stapler.
  • the adjuncts provided herein can be used with replaceable cartridges or staple reloads that are not cartridge based.
  • FIGS. 6A-6B illustrate an exemplary example of a stapling assembly 600 that includes a staple cartridge 200 and an adjunct 604.
  • the adjunct 604 is generally illustrated in FIGS. 6A-6B, and various configurations of the adjunct are described in more detail below.
  • the adjunct 604 is positioned against the staple cartridge 200.
  • the staple cartridge 200 includes staples 300, that are configured to be deployed into tissue.
  • the staples 300 can have any suitable unformed (pre-deployed) height.
  • the adjunct 604 can be mated to at least a portion of the top surface or deck surface 206 of the staple cartridge 602.
  • the top surface 206 of the staple cartridge 200 can include one or more surface features which can be configured to engage the adjunct 604 to avoid undesirable movements of the adjunct 604 relative to the staple cartridge 200 and/or to prevent premature release of the adjunct 604 from the staple cartridge 200. Exemplary surface features are described further below and in U.S. Patent Publication No. 2016/0106427, which is incorporated by reference herein in its entirety.
  • FIG. 6B shows the stapling assembly 600 placed within and coupled to the elongate channel 610 of surgical end effector 106.
  • the anvil 102 is pivotally coupled to the elongate channel 610 and is thus moveable between open and closed positions relative to the elongate channel 610, and thus the staple cartridge 200.
  • the anvil 102 is shown in a closed position in FIG. 6B and illustrates a tissue gap TGI created between the staple cartridge 602 and the anvil 612. More specifically, the tissue gap TGI is defined by the distance between the tissue-compression surface 102a of the anvil 102 (e.g., the tissue-engaging surface between staple forming pockets in the anvil) and the tissue-contacting surface 604a of the adjunct 604.
  • both the tissue-compression surface 102a of the anvil 102 and the tissue-contacting surface 604a of the adjunct 604 is planar, or substantially planar (e.g., planar within manufacturing tolerances).
  • the tissue gap TGI is generally uniform (e.g., nominally identical within manufacturing tolerances) when no tissue is disposed therein.
  • the tissue gap TGI is generally constant (e.g., constant within manufacturing tolerances) across the end effector 106 (e.g., in the y-direction).
  • the tissue-compression surface of the anvil can include a stepped surface having longitudinal steps between adjacent longitudinal portions, and thus create a stepped profile (e.g., in the y-direction).
  • the tissue gap TGI can be varied.
  • the adjunct 604 is compressible to permit the adjunct to compress to varying heights to thereby compensate for different tissue thickness that are captured within a deployed staple.
  • the adjunct 604 has an uncompressed (undeformed), or pre-deployed, height and is configured to deform to one of a plurality of compressed (deformed), or deployed, heights.
  • the adjunct 604 can have an uncompressed height which is greater than the fired height of the staples 300 disposed within the staple cartridge 200 (e.g., the height (H) of the fired staple 606a in FIG. 7). That is, the adjunct 604 can have an undeformed state in which a maximum height of the adjunct 604 is greater than a maximum height of a fired staple (e.g., a staple that is in a formed configuration).
  • the surgical stapler can be actuated, e.g., as discussed above, to thereby clamp the tissue between the anvil 102 and the stapling assembly 600 (e.g., between the tissue-compression surface 102a of the anvil 102 and the tissue-contacting surface 604a of the adjunct 604) and to deploy staples from the cartridge through the adjunct and into the tissue to staple and attach the adjunct to the tissue.
  • tissue (T) and a portion of the adjunct 604 are captured by the fired (formed) staples 606a.
  • the fired staples 606a each define the entrapment area therein, as discussed above, for accommodating the captured adjunct 604 and tissue (T).
  • the entrapment area defined by a fired staple 606a is limited, at least in part, by a height (H) of the fired staple 606a.
  • At least one bridge has a length in the longitudinal direction of about 0.035 inches to about 0.046 inches.
  • the adjunct 604 has a length L of about 40 mm to about 80 mm, such as about 60 mm to about 65 mm, about 66.04 mm to about 66.3 mm, about 45 mm to about 55 mm, or about 51.12 mm to about 51.38 mm.
  • the adjunct 604 has a width W of about 8 mm to about 12 mm, such as about 9.75 mm to about 10.25 mm or about 10.025 mm to about 10.035 mm.
  • the adjunct 604 may also have a thickness or height TH of about 2.5 mm to about 3.5 mm, such as about 2.85 mm to about 3.15 mm or about 2.95 mm to about 3.05 mm.
  • the cartridge 200 has a height CH of about 6.3 mm to about 8.1 mm, a width CW of about 8.9 mm to about 14 mm, and a length CL of about 80 to about 90mm such as about 86.7 mm.
  • the method 900 used for attaching an adjunct to a surgical staple cartridge using a biocompatible adhesive may include depositing a biocompatible adhesive 216 onto a top surface 206 of a surgical staple cartridge 200 (step 902), as particularly shown in FIG. 2B, and attaching an adjunct 604 to the biocompatible adhesive 216 (step 904), as particularly shown in FIG. 6A.
  • the biocompatible adhesive may include a component configured to reduce a sensitivity of the biocompatible adhesive to moisture and temperature.
  • the biocompatible adhesive may be sensitive to temperatures above approximately 40 degrees Celsius and/or relative humidities greater than 60%.
  • the component may be a hydrophobic component, such as a high melting wax or a reactive adhesive (e.g., polyurethane).
  • a high melting wax may help to mitigate a temperature sensitivity of the biocompatible adhesive.
  • the wax may have a melting temperature of at least approximately 60 degrees Celsius.
  • the wax may be hydrophobic, which may minimize moisture sensitivity of the biocompatible adhesive.
  • the wax may include, for example, candelilla wax, microcrystalline wax, montan wax, and/or white wax.
  • the wax may have a sharp viscosity transition (e.g., solid to liquid transition within 5 degrees Celsius) as a function of temperature.
  • Various applications may be employed for using the wax to attach an adjunct to a surgical staple cartridge, such as dip coating, electrospray, ultrasonic spray coating, inkjet, direct deposition, screen printing, spin coating, etc.
  • These application technologies can be conducted via either batch processes or in situ whereby a continuous application process can be used on either an extrusion or web-based material handling operation.
  • the conformal nature of these techniques can be controlled via wax and substrate temperature control, deposition rate, substrate motion/rate, etc.
  • these application techniques can provide spatial resolution on the adjunct and/or endoscopic instrument, which may allow for differing adhesive properties based on differing surface area coverage and/or mass (e.g., balance adhesive and wax cohesive strength for failure location optimization, etc.), as well as precision to avoid critical endoscopic instrument (e.g., instrument 100) features (e.g., staple pockets, etc.).
  • differing adhesive properties based on differing surface area coverage and/or mass (e.g., balance adhesive and wax cohesive strength for failure location optimization, etc.), as well as precision to avoid critical endoscopic instrument (e.g., instrument 100) features (e.g., staple pockets, etc.).
  • the use of a high melting wax may provide an added benefit of reduced sensitivity to temperature, such as during shipment or storage, reduced sensitivity to moisture, such as during a surgical procedure, and ease of application during manufacturing.
  • a reactive adhesive such as polyurethane, epoxy, acrylate, etc.
  • a reactive adhesive can similarly be used to reduce moisture and/or temperature sensitivities of the biocompatible adhesive. This may be accomplished through specific adhesive patterning and/or surface area minimization.
  • the reactive nature of the adhesive may allow the adhesive to be applied at low viscosities (e.g., greater than or equal to approximately 5 centipoise (cP)) that may increase the fidelity of the surface application, which can help to minimize the amount of material, coverage area (e.g., placement on a low surface area to minimize interference with other endoscopic instrument features), and/or equipment complexity.
  • Various applications may be employed for using a reactive adhesive to attach an adjunct to a surgical staple cartridge, such as electrospinning, electrospray, dip coating, thermal spray, screen printing, direction deposition, etc.
  • a reactive adhesive may provide an added benefit of minimal material usage, lower surface area coverage, and ease of application during manufacturing.
  • the biocompatible adhesive may include a component configured to reduce a sensitivity of the biocompatible adhesive to moisture and temperature.
  • a hydrogel adhesive may allow for a balance of adhesive forces before and during a surgical procedure.
  • the hydrogel In the package, as well as during manufacturing, the hydrogel may be in a dehydrated state that may have significant adhesive and cohesive strength.
  • the primary mode of adhesive strength is specific chemical interactions with the stapling adjunct and endoscopic instrument (e.g., hydrogen bonding, dipole-dipole, etc.). These interactions may be significantly higher (e.g., up to approximately 20 kJ/mol) than a pressure sensitive adhesive given the significant hydrophilic nature of the hydrogel.
  • the dehydrated state can be tuned to have significant cohesive strength as well through crosslinker concentration and specific intramolecular hydrogen bonding. Once the hydrogel is rehydrated during the surgical procedure, both the cohesive and adhesive strength can be reduced allowing for release of the stapling adjunct from the endoscopic instrument.
  • hydrogels Another feature of hydrogels is the utilization of either covalent and/or ionic crosslinks.
  • Most synthetic hydrogels may include a covalently crosslinked network with irreversible bonds.
  • Another class of hydrogels utilizes ionic crosslinks which are reversible and ion dependent. These hydrogels have multivalent ions that act as crosslinks centers to increase the mechanical strength of the hydrogel. In the presence of a more electronegative ion, counterion exchange may occur. The switching between a multivalent and monovalent ion (e.g., calcium to sodium ion, etc.) can cause a reduction in mechanical strength to the point of dissolution in an aqueous environment.
  • a multivalent and monovalent ion e.g., calcium to sodium ion, etc.
  • ionic crosslinks may allow for the use of naturally occurring materials, such as carrageenan, alginate, polysaccharide-based, cellulose derivatives, etc., that may increase biocompatibility of the overall system.
  • the hydrogel In the case where the hydrogel is designed to remain attached to the stapling adjunct after the procedure, it can be used to deliver therapeutic agents (e.g., active pharmaceutical ingredients (APIs), growth factors, etc.). These could be designed for either extended or short-term therapies through different microencapsulation technologies or solubility characteristics of the agent. Additionally, the hydrogel can be used to house living cells. The inclusion of a bio ink for cell viability could facilitate the loading of the cells either before or after the stapling adjunct is opened in the surgical suite.
  • therapeutic agents e.g., active pharmaceutical ingredients (APIs), growth factors, etc.
  • APIs active pharmaceutical ingredients
  • growth factors etc.
  • the hydrogel can be used to house living cells. The inclusion of a bio ink for cell viability could facilitate the loading of the cells either before or after the stapling adjunct is opened in the surgical suite.
  • the hydrogel could be composed of a naturally occurring material or a photocurable network.
  • the photocurable formulation can include a photoinitiator, solvent, inhibitors, photocurable oligomer or monomer, light absorber, or mixtures thereof.
  • a hydrogel network may be employed for using a hydrogel network to attach an adjunct to a surgical staple cartridge, such as stereolithography/lithography, holographic printing, inkjet printing, direct deposition, thermal spraying, cold dynamic spraying, cold spraying, electro spraying, ultrasonic spray coating, dip coating, screen printing, spin coating, etc.
  • hydrogel may provide an added benefit of tailored strength, such as during shipment, packaging, or a surgical procedure, utilization of naturally sourced materials, potential to deliver therapeutic agents, reduced temperature sensitivity, utilization of lower cohesive strength stapling adjuncts, and ease of application during manufacturing.
  • the method 1000 used for attaching an adjunct to a surgical staple cartridge using a biocompatible adhesive may include depositing a biocompatible adhesive onto a top surface of a surgical staple cartridge (step 1002), and attaching an adjunct to the biocompatible adhesive (step 1004).
  • the biocompatible adhesive may include a component configured to selectively detach from the surgical staple cartridge based on a pH of an environment surrounding the adjunct.
  • the biocompatible adhesive may include a stimuli responsive material.
  • the utilization of stimuli responsive materials both to in vivo and externally applied stimuli may eliminate the balance between adhesive strength and cohesive strength of the stapling adjunct, thus increasing the range of adjunct mechanical properties that can be used.
  • the in vivo stimuli may be pH or counter ion exchange, as further discussed herein.
  • the transition from the acidic trigonal form to the basic tetrahedral form can be observed through ultraviolet (UV) absorption and thus quantified for various arylboronic acid, styrylpyrene, o-nitrobenzyl, coumarin, and polyol combinations.
  • the adhesive could be designed to have specific behavior (e.g., mechanical strength) before and after surgical implantation.
  • the stimuli responsive material may be applied externally, such as via light mediation, such that bonds are configurable based on exposure to differing wavelengths of light (e.g., between approximately 300 to 475 nanometers (nm)).
  • Activation of these systems for adhesive control could be conducted using a transmittable wavelength through the tissue or an endoscopic procedure for activation, such as photoreversible cycloaddition of styrylpyrene.
  • Stimuli responsive materials may also be used to design an architecture transformable polymer via dynamic covalent chemistries that can be split between redox-, photo-, and mechano- responsive chemistries. Sufficient molecular mobility may allow the transition from linear to complex architectures resulting in dimensional changes within a system.
  • the stimuli responsive adhesives may be applied by one or more of the application techniques described herein.
  • a stimuli responsive adhesive may provide an added benefit of maintaining full mechanical strength for a predetermined timeframe (e.g., induction period per external excitation), mitigating moisture and thermal sensitivities, potential inclusion of a controlled API, and balance of adhesive and stapling adjunct cohesive properties.
  • disclosed devices e.g., end effector, surgical adjunct, and/or staple cartridges
  • methods involving one or more disclosed devices may involve one or more of the following clauses:
  • Clause 1 A method of attaching an adjunct to a surgical staple cartridge using a biocompatible adhesive, the method comprising: depositing a biocompatible adhesive onto a top surface of a surgical staple cartridge; and attaching an adjunct to the biocompatible adhesive, wherein the biocompatible adhesive comprises a hydrophobic component configured to reduce a sensitivity of the biocompatible adhesive to moisture and temperature.
  • Clause 2 The method of clause 1, wherein the hydrophobic component comprises a wax having a melting temperature of at least approximately 60 degrees Celsius.
  • Clause 3 The method of clause 2, wherein the wax comprises candelilla wax, microcrystalline wax, montan wax, white wax, or combinations thereof.
  • Clause 4 The method of clause 1, wherein the hydrophobic component comprises polyurethane.
  • Clause 5 The method of clause 1, wherein depositing the biocompatible adhesive onto the top surface of the surgical staple cartridge is conducted via at least one of direct deposition, spray coating, spin coating, dip coating, ultrasonic spray coating, screen printing, electrospinning, electrospray, thermal spray, or combinations thereof.
  • a method of attaching an adjunct to a surgical staple cartridge using a biocompatible adhesive comprising: depositing a biocompatible adhesive onto a top surface of a surgical staple cartridge; and attaching an adjunct to the biocompatible adhesive, wherein the biocompatible adhesive is configured to selectively detach from the surgical staple cartridge based on a pH of an environment surrounding the adjunct.
  • Clause 7 The method of clause 6, wherein the biocompatible adhesive comprises an enteric material.
  • Clause 8 The method of clause 7, wherein the enteric material comprises at least one of a cellulose derivative or a methacrylate copolymer.
  • Clause 9 The method of clause 7, wherein the enteric material is configured to adhere to the surgical staple cartridge when the pH of the environment is less than approximately 6.0.
  • Clause 10 The method of clause 7, wherein the enteric material is configured to detach from the surgical staple cartridge when the pH of the environment is at least approximately 6.0.
  • Clause 11 The method of clause 6, wherein the biocompatible adhesive comprises a stimuli responsive material.
  • Clause 12 The method of clause 11, wherein the stimuli responsive material comprises at least one of an arylboronic acid, a styrylpyrene, an o-nitrobenzyl, a coumarin, or a polyol.
  • Clause 13 The method of clause 11, wherein the stimuli responsive material is configured to reduce a sensitivity of the biocompatible adhesive to moisture and temperature.
  • Clause 14 The method of clause 11, wherein the biocompatible adhesive is further configured to selectively detach from the surgical staple cartridge based on exposure to one or more wavelengths of light.
  • Clause 16 The method of clause 11, wherein the stimuli responsive material comprises at least one of a redox-responsive material, a photo-responsive material, or a mechano-responsive material.
  • Clause 17 The method of clause 6, wherein depositing the biocompatible adhesive onto the top surface of the surgical staple cartridge is conducted via at least one of direct deposition, spray coating, spin coating, dip coating, ultrasonic spray coating, screen printing, electrospinning, electrospray, thermal spray, or combinations thereof.
  • Clause 18 A method of attaching an adjunct to a surgical staple cartridge using a biocompatible adhesive, the method comprising: depositing a biocompatible adhesive onto a top surface of a surgical staple cartridge; and attaching an adjunct to the biocompatible adhesive, wherein the biocompatible adhesive comprises a component configured to reduce a sensitivity of the biocompatible adhesive to moisture and temperature.
  • Clause 19 The method of clause 18, wherein the component comprises a hydrogel network configured to exhibit an adhesive strength based on one or more chemical interactions.
  • Clause 20 The method of clause 19, wherein the one or more chemical interactions comprise at least one of hydrogen bonding or dipole-dipole interactions.
  • Clause 21 A method of attaching an adjunct to a surgical staple cartridge using a biocompatible adhesive, the method comprising: depositing a biocompatible adhesive onto a top surface of a surgical staple cartridge; and attaching an adjunct to the biocompatible adhesive, wherein the biocompatible adhesive comprises a component configured to reduce a sensitivity of the biocompatible adhesive to moisture and temperature.
  • Clause 22 The method of clause 21, wherein the component comprises a hydrophobic component.
  • Clause 23 The method of any of clauses 21-22, wherein the component comprises a wax having a melting temperature of at least approximately 60 degrees Celsius.
  • Clause 24 The method of clause 23, wherein the wax comprises candelilla wax, microcrystalline wax, montan wax, white wax, or combinations thereof.
  • Clause 25 The method of any of clauses 21-22, wherein the component comprises polyurethane.
  • Clause 26 The method of clause 21, wherein the biocompatible adhesive is configured to selectively detach from the surgical staple cartridge based on a pH of an environment surrounding the adjunct.
  • Clause 27 The method of any of clauses 21 and 26, wherein the biocompatible adhesive comprises an enteric material.
  • Clause 28 The method of clause 27, wherein the enteric material comprises at least one of a cellulose derivative or a methacrylate copolymer.
  • Clause 29 The method of any of clauses 27-28, wherein the enteric material is configured to adhere to the surgical staple cartridge when the pH of the environment is less than approximately 6.0.
  • Clause 30 The method of any of clauses 27-29, wherein the enteric material is configured to detach from the surgical staple cartridge when the pH of the environment is at least approximately 6.0.
  • Clause 31 The method of any of clauses 21 and 26, wherein the biocompatible adhesive comprises a stimuli responsive material.
  • Clause 32 The method of clause 31, wherein the stimuli responsive material comprises at least one of an arylboronic acid, a styrylpyrene, an o-nitrobenzyl, a coumarin, or a polyol.
  • Clause 33 The method of any of clauses 31-32, wherein the biocompatible adhesive is further configured to selectively detach from the surgical staple cartridge based on exposure to one or more wavelengths of light.
  • Clause 34 The method of clause 33, wherein the one or more wavelengths are between approximately 300 to 475 nm.
  • Clause 35 The method of any of clauses 31-34, wherein the stimuli responsive material comprises at least one of a redox-responsive material, a photo-responsive material, or a mechano- responsive material.
  • Clause 36 The method of clause 21, wherein the component comprises a hydrogel network configured to exhibit an adhesive strength based on one or more chemical interactions.
  • Clause 37 The method of claim 36, wherein the one or more chemical interactions comprise at least one of hydrogen bonding, or dipole-dipole interactions.
  • Clause 38 The method of any of claims 36-37, wherein the hydrogel network utilizes at least one of covalent or ionic crosslinks.
  • Clause 39 The method of any of clauses 36-38, wherein the hydrogel network causes the biocompatible adhesive to be released into an environment surrounding the adjunct based on at least one of water swelling or counterion exchange.
  • Clause 40 The method of any of claims 36-39, wherein the hydrogel network comprises at least one of carrageenan, alginate, a polysaccharide, or cellulose.
  • Clause 41 The method of any of claims 36-40, wherein the hydrogel network is configured to deliver one or more therapeutic agents into an environment surrounding the adjunct.
  • Clause 42 The method of any of clauses 21-41, wherein depositing the biocompatible adhesive onto the top surface of the surgical staple cartridge is conducted via at least one of direct deposition, spray coating, spin coating, dip coating, ultrasonic spray coating, screen printing, electrospinning, electrospray, thermal spray, or combinations thereof.

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  • Animal Behavior & Ethology (AREA)
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  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dermatology (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
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  • Surgical Instruments (AREA)

Abstract

La technologie de l'invention comprend un procédé de fixation d'un auxiliaire à une cartouche d'agrafes chirurgicales à l'aide d'un adhésif biocompatible. Le procédé peut comprendre le dépôt d'un adhésif biocompatible sur une surface supérieure d'une cartouche d'agrafes chirurgicales, et la fixation d'un auxiliaire à l'adhésif biocompatible. L'adhésif biocompatible peut avoir un composant conçu pour réduire une sensibilité de l'adhésif biocompatible à l'humidité et à la température.
PCT/IB2024/055987 2023-06-22 2024-06-19 Systèmes et procédés de fixation d'auxiliaires à des cartouches d'agrafes chirurgicales à l'aide d'adhésifs biocompatibles Pending WO2024261660A1 (fr)

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EP24736098.5A EP4551261A1 (fr) 2023-06-22 2024-06-19 Systèmes et procédés de fixation d'auxiliaires à des cartouches d'agrafes chirurgicales à l'aide d'adhésifs biocompatibles

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US202363522660P 2023-06-22 2023-06-22
US63/522,660 2023-06-22
US18/485,117 US20240424745A1 (en) 2023-06-22 2023-10-11 Systems and methods for attaching adjuncts to surgical staple cartridges using biocompatible adhesives
US18/485,117 2023-10-11
US18/485,210 2023-10-11
US18/485,210 US20240423620A1 (en) 2023-06-22 2023-10-11 Compressible surgical adjuncts, cartridges, and cartridge assemblies and methods of making surgical adjuncts

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