Patent Application
20240423618
The present invention relates generally to compressible surgical adjuncts, cartridges, cartridge assemblies and methods of making adjuncts and cartridge assemblies.
Surgical staplers are used in surgical procedures to close openings in tissue, blood vessels, ducts, shunts, or other objects or body parts involved in the particular procedure. The openings can be naturally occurring, such as passageways in blood vessels or an internal organ like the stomach, or they can be formed by the surgeon during a surgical procedure, such as by puncturing tissue or blood vessels to form a bypass or an anastomosis, or by cutting tissue during a stapling procedure.
Most 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. In use, 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.
There is provided, in accordance with an example of the present invention, a surgical adjunct includes a polyurethane foam and a film disposed on at least one surface of the polyurethane foam. A volumetric ratio of the polyurethane foam to the total volume of the surgical adjunct is in a range of about 0.125 to about 0.325.
There is provided, in accordance with an example of the present invention, a stapling assembly. The stapling assembly may include a deck of a cartridge that includes at least one post extending away from the deck. The at least one post may include a first diameter at a top of the at least one post that is greater than a second diameter at the bottom of the at least one post. The cartridge may include a first film disposed on the deck and at least partially surrounding the at least one post with a gap between the top of the at least one post and the film. The cartridge may also include a surgical adjunct disposed on the first film and at least partially surrounding the at least one post. The surgical adjunct may include a polyurethane foam with a volumetric ratio of the polyurethane foam to the total volume of the surgical adjunct is in a range of about 0.125 to about 0.325.
There is provided, in accordance with an example of the present invention, a stapling assembly. The stapling assembly includes a deck and a surgical adjunct disposed on deck. The surgical adjunct may include a polyurethane foam with a volumetric ratio of the polyurethane foam to the total volume of the surgical adjunct is in a range of about 0.125 to about 0.325.
This invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
As used herein, 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%.
Surgical stapling assemblies and methods for manufacturing and using the same are provided. In general, 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. As discussed herein, 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 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.
The use of absorbable stapling adjuncts or other dampening implants (e.g., ligament anchor surgery, tendon repair) requires a balance between the mechanical strength of the implant/adjunct, chemistry (e.g., absorbable), and deployment requirements. The strength to retain staples, sutures, screws, etc., may conflict with the requirements for endoscopic deployment (e.g., compression through trocar). As the implant strength increases, there is an increased force required to compress the implant for insertion. This may exceed the limits of the endoscopic instrument (e.g., surgical stapling and severing device 100) requiring compromises to the implant performance. While this may be mitigated through phase change materials (e.g., water swell, glass to rubber transitions), this further limit applicable chemistries given the need to have an absorbable implant or adjunct.
A facile method for improving the strength requires to retain stapes, sutures, screws, etc., without compromising the bulk mechanical properties of the implant is the inclusion of a backing material or film. Given the potential need for increase mechanical strength, the backing material may be a different material from the surgical adjunct or implant. The backing material may be incorporated in situ or adhered to the surgical adjunct or implant.
An example of the adherence during processing may include melt welding commonly used to bond thermoplastic materials. In this process, a combination of temperature, pressure, and time are controlled to have diffusion of the thermoplastics into each other. This process can be used to a lesser extent between a thermoplastic and thermoset material where the thermoplastic material flows around a geometric feature on the thermoset material and a mechanical bond is formed.
The stapling adjuncts or damping implants will likely be composed of either a thermoplastic or thermoset material. In the case of a thermoplastic material, there are limitations in retaining the desired shape with the thermal processing as the material may flow during processing. Conversely, the incorporation of a backing material with a thermoset is limited during thermal processing as the material will not flow and form an intimate bond interface.
Another limiting case for melt welding in the case of absorbable materials (e.g., a polyurethane foam) is the potential degradation during processing. Many absorbable materials, particularly faster absorbing materials, are thermally labile and thus may lose mechanical properties, generate degradant species, etc. during processing.
As such, there are limitations associated with (i) utilizing thermally labile materials, (ii) an inability to spatially modulate adhesive properties, and (iii) adherence limited to mechanical encapsulation for thermoset/thermoplastic combinations. Thus, there are inefficiencies for backing material incorporation a surgical adjunct or damping implant. Therefore, alternative methods and materials are discussed herein.
Additionally, films used to attach a surgical adjunct to a staple cartridge deck may be mechanically attached to the cartridge deck along with the surgical adjunct to prevent early release of the surgical adjunct from a staple cartridge deck.
Additionally, the surgical adjunct itself can be designed of made to include a gradient or double gradient of pore diameters in order to help maintain both compressive and tensile properties needed to create a hemostatic seal and also strong enough to allow a surgeon to grasp and manipulate the tails of the cushion. Such a morphology would mimic that of bone or other materials found in nature.
In various instances, 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.
In some examples, 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 a 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.
Additional details on the surgical stapling and severing device 100 and other surgical stapling and severing devices suitable for use with the present disclosure are described, for example, in U.S. Pat. No. 9,332,984 and in U.S. Patent Publication No. 2009/0090763, the disclosures of which are incorporated herein by reference in their entireties. Further, the surgical stapling and severing device need not include a handle, but instead can have a housing that is configured to couple to a surgical robot, for example, as described in U.S. Patent Publication No. 2019/0059889, the disclosure of which is incorporated herein by reference in its entirety.
As further shown in
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. In this illustrated example, 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. On each side of the longitudinal slot 210, and thus for each set of rows, a first longitudinal row of staple cavities 212a, 214a extends alongside the longitudinal slot 210, a second row of staple cavities 212b, 214b extends alongside the first row of staple cavities 212a, 214a, and a third row of staple cavities 212c, 214c extends alongside the second row of staple cavities 212b, 214b. Each row may be approximately parallel and the staple cavities that make up the rows may be approximately parallel in orientation with the longitudinal slot 210. As shown in
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
In use, 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. As the staple legs 304 are deformed against 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. Further, 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. In various instances, 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.
In some examples, all of the staples disposed within the staple cartridge 200 can have the same unfired (pre-deployed, unformed) configuration. In other examples, 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.
Referring back to
With reference to
In use, the anvil 102 in
To deploy staples from the staple cartridge, as discussed above, the sled 500 in
As indicated above, the stapling device can be used in combination with a compressible adjunct. A person skilled in the art will appreciate that, while 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.
As discussed above, with some surgical staplers, 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.
Accordingly, various examples of adjuncts are provided that 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. In addition, exemplary adjuncts described herein may be configured to be essentially fully absorbed in the body over a period of 100 to 300 days depending on implanted location and tissue health.
Alternatively, or in addition, the adjuncts can be configured to promote tissue ingrowth. In various instances, 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. More specifically, 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.
In general, the adjuncts provided herein are designed and positioned atop a staple cartridge, like staple cartridge 200. 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. While 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. A person of ordinary skill will appreciate that the adjuncts provided herein can be used with replaceable cartridges or staple reloads that are not cartridge based.
In the illustrated example, the adjunct 604 can be mated to at least a portion of the top surface or deck surface 206 of the staple cartridge 602. In some examples, 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.
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. For example, 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 300a in
As shown in
Referring to
As shown in
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 90 mm such as about 86.7 mm.
Referring to
Referring to
In some examples, the adjunct 604 includes one or more slits 808 with two or more bridges 802 spaced apart by a bridge length BL of about 0.035 inches to about 0.045 inches such as about 0.04 inches.
Referring back to
The surgical adjunct 604 may have one or more of the properties described below to enable the adjunct to be flexible when in vivo, but yet remain in a certain position attached to the cartridge when outside of the body. For example, the polyurethane may server to create an adjunct 604 that is flexible when going into the body but “sets” to its final mechanical properties as the plasticizer is absorbed in vivo. In some examples, a plasticizer may be added to the polyurethane foam to lower its glass transition temperature to be within the below described ranges as well as conform to the other listed properties. Regardless, an adjunct 604 having one or more of the below properties consistently creates a hemostatic or near hemostatic seal on tissue.
The surgical adjunct 604 may include a polyurethane foam with or without a plasticizer where the glass transition temperature of the surgical adjunct 604 is about 0° C. to about 40° C. (e.g., about 19.4° C.), such as about 7.5° C. to about 22.5° C. or about 12.5° C. to about 17.5° C. The glass transition temperature of the adjunct 604 is obtained by using a standard differential scanning calorimetry (DSC) system. Using the DSC system with its output shown in
The surgical adjunct 604 may include a volumetric ratio of the polyurethane foam to the total volume of the adjunct 604 of about 0.125 to about 0.325, such as about 0.175 to about 0.225 or about 0.19 to about 0.21. The total volume may include air (from pores of the foam) or other material beside the foam structures.
The plasticizer may include one or more of a low molecular weight glycol, polyethylene glycol, polyvinylpyrrolidone, dibutyl sebacate, glyceryl triacetate, glyceryl behenate, hexanoic acid, decanoic acid, octadecanoic acid, boric ester, and a fatty acid. In some examples, the plasticizer includes one or more fatty acids.
Referring to
In some examples, the adjunct 604 includes a polydioxanone (PDO) film disposed on one or more surfaces of the polyurethane foam. In some examples, the PDO film is adhered to at least a bottom or crown side of the adjunct 604. In some examples, the PDO film has a thickness of about 20 μm to about 100 μm, such as about 40 μm.
The adjunct 604 may have a compression strength of about 30 kPa to about 70 kPa, such as about 30 kPa to about 60 kPa (e.g., about 42 kPa), about 30 kPa to about 50 kPa, about 32.5 kPa to about 37.5 kPa. In order to test compression strengths, an adjunct 604 was placed in a humid warm environment at approximately 37° C., compressed to a first height, then a second height shorter than the first height, and then released back to the first height at which point the adjunct's compression strength was measured.
In some examples, the adjunct 604 may have a tensile strength of about 30 kPa to about 90 kPa such as about 45 kPa to about 85 kPa or about 55 kPa to about 75 kPa. In some examples, the adjunct 604 will have tensile strength of about 110 kPa to about 150 kPa.
Referring to
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Solvent welding may be used to add a film to bioabsorbable material. For example, solvents such as ethyl acetate, dichloromethane, acetone may be used. Using this process eliminated the need for thermal processing and eliminated the need for spatial arrangement of bonding parts with the film.
Reactive adhesives may be used to add a film to the bioabsorbable material. Some reactive adhesives may include polyurethanes, epoxies, acrylates, etc. The reactive adhesive may be directly deposited onto the adjunct and/or the film. This can be patterned with both surface area and mass modulate the adhesive strength along and across the bioabsorbable material. Such an application may be useful in the case where selective release of the film is designed to minimize the overall bioabsorbable material (e.g., film only were contacted with staples with the remaining staying with the endoscopic instrument. In addition to the application process, the chemistry may be used to tune the adhesive properties. The reactive adhesive may be applied using inkjet printing, direct deposition, thermal spraying, cold dynamic spraying, cold spraying, electro spraying, ultrasonic spray coating, dip coating, screen printing, and spin coating. Using adhesives is beneficial because it is possible to bond two thermoset materials (film and bioabsorbable material) where material flow is not required. Using reactive adhesives may eliminate the need for thermal processing, eliminate need to arrange bonding points between film and bioabsorbable material, and allows for the modulating of adhesive forces across the surgical adjunct to create a selective release feature if needed.
Direct deposition may be used to directly apply a film to the bioabsorbable material. The film itself may be distributed in a solution or be composed of a reactive mixture that is subsequently applied to the bioabsorbable material. Direct depositions method for adding the film to the bioabsorbable material may include stereolithography, lithography, holographic printing, inject printing, direction deposition, thermal spraying, cold dynamic spraying, cold spraying, electro spraying, ultrasonic spray coating, dip coating, screen printing, and spin coating. Reactive mixtures for these processes, may include polyurethane, epoxy. Photocurable formulations may be used as well. These can include a photoinitiator, a solvent, inhibitors, photocurable oligomer or monomer, light absorber, and mixtures thereof. The advantages of directly applying the film include the ability to conformally apply the film, spatial control of the film, being able to easily apply the film, and flexibility in applying the film in terms of rate, thickness, etc. for different uses.
Referring to
When using thermoset materials (e.g., polyurethane foams) for surgical adjuncts, there is a potential to incorporate the material during the adjunct fabrication process. Before the completion of curing and/or specific stochiometric imbalance, the film may be applied to the adjunct. For best results, the addition of the film should be completed after the gel point of the thermoset material to ensure that the film does not constrain the adjunct formation. After applying the film, the curing process should resume to allow for chemical bonds between the thermoset material and the film. This will especially be the case where free hydroxyl groups are present in the case of polyurethane-based adjuncts. The chemical bonds would provide strength profiles that may exceed any adhesive interaction between the film and the thermoset material. Advantages to using this method include, elimination of thermal processing, potential covalent attachment between the film and the thermoset material, and the elimination of the need for a separate adhesive.
Additionally, the film such as PDO may be overmolded on the bioabsorbable material.
Referring to
As will be appreciated by one skilled in the art, The embodiments described above are cited by way of example, and the present invention is not limited by what has been particularly shown and described hereinabove. Rather, the scope of the invention includes both combinations and sub combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.
In some examples, disclosed devices (e.g., end effector, surgical adjunct, and/or staple cartridges) and methods involving one or more disclosed devices may involve one or more of the following clauses:
Clause 1: A surgical adjunct 604, comprising: a polyurethane foam 902 comprising a volumetric ratio of the polyurethane foam 902 to the total volume of the surgical adjunct 604 is in a range of about 0.125 to about 0.325; and a film 904 disposed on at least one surface of the polyurethane foam.
Clause 2: The surgical adjunct 604 of clause 1, wherein the film 904 comprises polyurethane having a higher density than the polyurethane foam.
Clause 3: The surgical adjunct 604 of clause 1, wherein the film 904 has a thickness FT of about 0.0003 inches to about 0.010 inches and has pore diameters of about 0.0005 inches to about 0.005 inches.
Clause 4: The surgical adjunct 604 of clause 1, wherein the film 904 is laminated on the at least one surface of the polyurethane foam 902 and comprises an absorbable material selected from the group consisting of polydioxanone (PDO), poly(delta-gluconolactone) (PGL-1), poly(glycolide/l-lactide) (PGL-2), polyglycolic acid (PGA), a glycolide and epsilon caprolactone copolymer (PGCL), a glycolide and l-lactide copolymer, urethane, polycaprolactone (PCL), polyglactin 370 (PG-370), polyglactin 185 (PG-185), or combinations thereof.
Clause 5: The surgical adjunct 604 of clause 4, wherein the absorbable material comprises polyglactin 370 or polyglactin 185.
Clause 6: The surgical adjunct 604 of clause 4, wherein the absorbable material comprises poly(glycolide/l-lactide).
Clause 7: The surgical adjunct 604 of clause 4, wherein the film 904 has a thickness FT of about 0.0003 inches to about 0.003 inches.
Clause 8: The surgical adjunct 604 of clause 1, wherein the film 904 is attached to the at least one surface of the polyurethane foam 902 with an adhesive 906.
Clause 9: The surgical adjunct 604 of clause 8, wherein the adhesive 906 comprises polyvinylpyrrolidone.
Clause 10: The surgical adjunct 604 of clause 1, wherein the surgical adjunct 604 is attached to the deck with a bioabsorbable adhesive.
Clause 11: A method for making the surgical adjunct 604 of clause 1, comprising: providing the polyurethane foam 902; disposing at least one volatile solvent on at least a portion of at least one surface of the polyurethane foam; disposing the film 904 on the at least one volatile solvent 906; and dissolving a least a portion of the polyurethane foam and the film 904 with the at least one volatile solvent to join the polyurethane foam and the film.
Clause 12: A method for making the surgical adjunct 604 of clause 1, comprising: providing the polyurethane foam 902; disposing a reactive adhesive on at least a portion of the film 904, at least a portion of the polyurethane foam, or both; and disposing the film on the at least polyurethane foam 902 such that the reactive adhesive is sandwiched between the polyurethane foam and the film 904.
Clause 13: The method of clause 12, wherein disposing the reactive adhesive comprises applying the adhesive via at least one application process selected from the group consisting of inkjet printing, direct deposition, thermal spraying, cold dynamic spraying, cold spraying, electro spraying, ultrasonic spray coating, dip coating, screen printing, spin coating, or combinations thereof.
Clause 14: A method for making the surgical adjunct 604 of clause 1, comprising: providing a polyurethane foam precursor cured to its gel point to form a partially cured polyurethane foam; disposing the film 904 on the partially cured polyurethane foam on at least a portion of one surface; and finalize curing the partially cured polyurethane foam with the film to form the surgical adjunct 604.
Clause 15: A method for making the surgical adjunct 604 of clause 1, comprising: providing the polyurethane foam 902; applying the film to the polyurethane foam 902 via a direct deposition method to create the surgical adjunct 904.
Clause 16: The method of clause 15, wherein the direct deposition method comprises at least one process selected from the group consisting of 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, or combinations thereof.
Clause 17: A cartridge for surgical stapling, comprising: a deck 206 comprising at least one post 1104 extending away from the deck 206, wherein the at least one post having a first diameter PDT at a top 1106 of the at least one post 1104 that is greater than a second diameter PDB at the bottom 1108 of the at least one post 1104; a first film 904 disposed on the deck 206 and at least partially surrounding the at least one post with gap 1110 between the top 1106 of the at least one post and the film; and a surgical adjunct 604 disposed on the first film 904 and at least partially surrounding the at least one post 1104, the surgical adjunct 604 comprising a polyurethane foam 902 with a volumetric ratio of the polyurethane foam 902 to the total volume of the surgical adjunct 604 is in a range of about 0.125 to about 0.325.
Clause 18: The cartridge of clause 17, wherein the first film 904 comprises a perforated pattern at least partially surrounding or covering one or more staple slots 1112.
Clause 19: The cartridge of clause 17, further comprising a second film 904 disposed on polyurethane foam, wherein the first film 904 has a first melting point that is lower than a second melting point of the polyurethane foam 902.
Clause 20: A method of making the cartridge of clause 17, the method comprising: providing the deck 206 with the at least one post; disposing the film 904 on the deck and at least partially surrounding the at least one post 1104; applying heat to the at least one post 1104 to form the top 1106 with the first diameter PDT and the bottom 1108 with the second diameter PDB such that the top of the at least one post at least partially overlaps the film 904; and disposing the surgical adjunct 604 on the film to at least partially surround the at least one post 1104.
Clause 21: A stapling assembly 600 for surgical stapling, comprising: a deck 206; and a surgical adjunct 604 disposed on deck 604 and comprising a polyurethane foam 902 with a volumetric ratio of the polyurethane foam 902 to the total volume of the surgical adjunct 604 is in a range of about 0.125 to about 0.325.
Clause 22: The stapling assembly of clause 21, wherein the surgical adjunct 604 comprises a film 904 disposed on at least one surface of the polyurethane foam 902.
Clause 23: The stapling assembly of clause 22, wherein the film 904 comprises polyurethane 902 having a higher density than the polyurethane foam 902.
Clause 24: The stapling assembly of clause 22, wherein the film 904 has a thickness FT of about 0.0003 inches to about 0.010 inches and has pore diameters of about 0.0005 inches to about 0.005 inches.
Clause 25: The stapling assembly of clause 22, wherein the film 904 is laminated on the at least one surface of the polyurethane foam and comprises an absorbable material selected from the group consisting of polydioxanone (PDO), poly(delta-gluconolactone) (PGL-1), poly(glycolide/l-lactide) (PGL-2), polyglycolic acid (PGA), a glycolide and epsilon caprolactone copolymer (PGCL), a glycolide and l-lactide copolymer, urethane, polycaprolactone (PCL), polyglactin 370 (PG-370), polyglactin 185 (PG-185), or combinations thereof.
Clause 26: The stapling assembly of clause 25, wherein the film 904 has a thickness FT of about 0.0003 inches to about 0.003 inches.
Clause 27: The stapling assembly of clause 25 or 26, wherein the film 904 is attached to the at least one surface of the polyurethane foam with an adhesive.
Clause 28: The stapling assembly of clause 21, wherein the absorbable material comprises polyglactin 370.
Clause 29: The stapling assembly of clause 21, wherein the surgical adjunct 604 further comprises an additional polyurethane foam 902 attached to the polyurethane foam 902, wherein the polyurethane foam has a first density gradient and the additional polyurethane foam 902 has a second density gradient that is approximately opposite of the first density gradient.
Clause 30: The stapling assembly of clause 21, wherein: the deck 206 comprises a surface and at least one post 1104 extending away from the surface, the at least one post 1104 having a top 1106 with a first diameter PDT and a bottom 1108 with a second diameter PDB that is less than the first diameter PDT, the film 904 is disposed on the surface and at least partially surrounds the at least one post 1104 with a gap 1110 between the top 1106 of the at least one post 1104 and the film 904; and the surgical adjunct 604 is disposed on the film 904 and at least partially surrounding the at least one post.
Clause 31: The stapling assembly of clause 30, wherein the film 904 comprises a perforated pattern surrounding one or more staple slots 1112.
Clause 32: A method for making a surgical tool 200, comprising: providing a polyurethane foam 902 comprising a volumetric ratio of the polyurethane foam 902 to the total volume of the surgical adjunct 604 is in a range of about 0.125 to about 0.325; and disposing or forming a film 904 on the polyurethane foam 902.
Clause 33: The method of clause 32, comprising: disposing at least one volatile solvent 906 on at least a portion of at least one surface of the polyurethane foam 902; disposing the film 904 on the at least one volatile solvent 906; and dissolving a least a portion of the polyurethane foam 902 and the film 904 with the at least one volatile solvent to join the polyurethane foam 902 and the film 904.
Clause 34. The method of clause 32, comprising: providing the polyurethane foam 902; disposing a reactive adhesive 906 on at least a portion of the film 904, at least a portion of the polyurethane foam 902, or both; and disposing the film on the at least polyurethane foam 902 such that the reactive adhesive 906 is sandwiched between the polyurethane foam 902 and the film 904.
Clause 35: The method of clause 32, comprising: providing a cartridge 200 comprising a deck with at least one post extending from the deck; disposing the film 904 on the deck and at least partially surrounding the at least one post 1104; applying heat to the at least one post 1104 to form the top 1106 with the first diameter PDT and the bottom 1108 with the second diameter PDB such that the top of the at least one post at least partially overlaps the film 904; and disposing the surgical adjunct 604 on the film 904 to at least partially surround the at least one post 1104.
This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 63/522,660, filed Jun. 22, 2023, the entire contents of which are fully incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63522660 | Jun 2023 | US |
