Surgical adjuvants containing polyurethane foam

Abstract

The disclosed technology includes a surgical adjuvant 604, the surgical adjuvant 604 being a polyurethane foam, wherein the volume ratio of the polyurethane foam to the total volume of the surgical adjuvant 604 is in the range of about 0.125 to about 0.325; and at least one hydrophobic additive comprising at least one ceramic nanoparticle, at least one fatty acid, at least one ionic liquid, at least one long-chain surfactant, at least one enteric coating, at least one photocurable resin, or a combination thereof.

Description

[Technical Field]

[0001] (Cross-reference of related applications) This application claims priority to U.S. Patent Provisional Application No. 63 / 522,660, filed on 22 June 2023, and U.S. Patent Non-Provisional Application No. 18 / 485,145, filed on 11 October 2023, under Section 119 of the U.S. Patent Act, the entire contents of which are incorporated herein by reference.

[0002] (Field of invention) The present invention generally relates to compressible surgical aids, cartridges, cartridge assemblies, and methods for manufacturing aids and cartridge assemblies. [Background technology]

[0003] Surgical staplers are used in surgical procedures to close openings in tissues, blood vessels, conduits, shunts, or other objects or body parts related to a particular procedure. Openings may be naturally occurring, such as passages within blood vessels or viscera like the stomach, or they may be created by a surgeon during a surgical procedure, such as by forming a bypass or anastomosis by puncturing tissue or blood vessels, or by incising tissue during stapling.

[0004] Most staplers have a handle (some directly operated by the user, others via a robotic interface), and a slender shaft extends from the handle, with a pair of movable opposing jaws formed at one end, between which staples are held and formed. Staples are typically housed in a staple cartridge, which can hold multiple rows of staples and is often located within one of the two jaws for the release of staples to the surgical site. During use, the jaws are positioned so that the object to be stapled is placed between them, and when the jaws close and the device is activated, the staples are released and formed. Some staplers include a knife, which is configured to move between rows of staples in the staple cartridge, and between the stapled rows, to longitudinally incise and / or open the stapled tissue. [Overview of the project] [Means for solving the problem]

[0005] According to an example of the present invention, a surgical adjuvant is provided, the surgical adjuvant comprising a polyurethane foam, wherein the volume ratio of the polyurethane foam to the total volume of the surgical adjuvant is in the range of about 0.125 to about 0.325, and at least one hydrophobic additive comprising at least one ceramic nanoparticle, at least one fatty acid, at least one ionic liquid, at least one long-chain surfactant, at least one enteric coating, at least one photocurable resin, or a combination thereof.

[0006] According to an example of the present invention, a surgical aid comprising a polyurethane foam is provided, wherein the volume ratio of the polyurethane foam to the total volume of the surgical aid is in the range of approximately 0.125 to approximately 0.325. The polyurethane foam may include a hydrophobic surface pattern.

[0007] According to an example of the present invention, a surgical aid is provided comprising a polyurethane foam having a plurality of pores, wherein the plurality of pores are configured to prevent or reduce the entry of fluid into the polyurethane foam.

[0008] According to an example of the present invention, a surgical aid comprising a polyurethane foam is provided, wherein the volume ratio of the polyurethane foam to the total volume of the surgical aid is in the range of approximately 0.125 to approximately 0.325. [Brief explanation of the drawing]

[0009] The present invention will be better understood from the following detailed description in conjunction with the accompanying drawings. [Figure 1] This is a perspective view of an exemplary embodiment of a conventional surgical staple fastening and cutting instrument. [Figure 2A] Figure 1 is a top view of a staple cartridge for use with surgical staple fastening and cutting instruments. [Figure 2B] Figure 2A is a side view of the staple cartridge. [Figure 3] Figure 2A is a side view of a staple in an unfired (pre-deployed) configuration, which may be placed inside the staple cartridge of the surgical cartridge assembly. [Figure 4] Figure 1 is a perspective view of the knife and launching bar ("E-beam") of a surgical staple fastening and cutting instrument. [Figure 5] Figure 1 is a perspective view of the wedge thread of the staple cartridge for a surgical staple fastening and cutting instrument. [Figure 6A] This is a longitudinal cross-sectional view of an exemplary surgical cartridge assembly having a compressible, non-fibrous auxiliary material attached to the top or deck surface of a staple cartridge. [Figure 6B] This is a longitudinal cross-sectional view of a surgical end effector having an anvil pivotably connected to an elongated channel, and a surgical cartridge assembly (Figure 6A) positioned within and connected to the elongated channel, showing the anvil in a closed position with no tissue between it and the auxiliary material. [Figure 6C] A perspective view of an exemplary surgical end effector having a channel and a surgical cartridge having a thread and a driver. [Figure 7] A partial schematic view showing the auxiliary materials of FIGS. 6A-6B in a tissue deployment state. [Figure 8A] A perspective view of an exemplary cartridge assembly. [Figure 8B] A side view of an exemplary auxiliary material for a cartridge assembly. [Figure 8C] A top view of an exemplary auxiliary material for a cartridge assembly. [Figure 8D] A front view of an exemplary auxiliary material for a cartridge assembly. [Figure 8E] A view showing an enlarged portion of an exemplary auxiliary material having a porous structure. [Figure 8F-1] A view showing an exemplary auxiliary material for a cartridge assembly having gradient porosity. [Figure 8F-2] An exemplary surgical auxiliary material having a double gradient of pore size is shown. [Figure 8F-3] An exemplary surgical auxiliary material made from two exemplary surgical auxiliary materials each having a gradient of pore size is shown. [Figure 8G] A view showing an exemplary auxiliary material for a cartridge assembly having directional porosity. [Figure 8H] A view showing an exemplary auxiliary material for a cartridge assembly having directionality and closed-cell porosity. [Figure 8I] A view showing an exemplary auxiliary material for a cartridge assembly having closed-cell porosity and a hydrophobic film. [Figure 8J] A view showing an exemplary auxiliary material for a cartridge assembly having a hydrophobic section. [Figure 8K] A view showing an exemplary auxiliary material for a cartridge assembly having a hydrophobic matrix. [Figure 8L]FIG. showing exemplary auxiliaries for a cartridge assembly having an intertwined hydrophobic material. [Figure 8M] FIG. showing exemplary auxiliaries for a cartridge assembly having a hydrophobic coating. [Figure 8N] FIG. showing exemplary auxiliaries for a cartridge assembly having a patterned surface or portion. [Figure 9A] Side view of an exemplary auxiliary compressed in a dog bone profile. [Figure 9B] Front view of FIG. 9A. [Figure 9C] FIG. showing an exemplary auxiliary disposed transvaginally within a patient. [Figure 9D] FIG. showing an exemplary auxiliary disposed transvaginally within a patient. [Figure 9E] FIG. showing an exemplary auxiliary disposed transvaginally within a patient [Figure 10] Graph showing the glass transition temperature Tg of an exemplary auxiliary.

BEST MODE FOR CARRYING OUT THE INVENTION

[0010] The following detailed description is to be read with reference to the drawings, and like elements in different drawings are numbered the same. The drawings are not necessarily to scale, depict selected embodiments, and are not intended to limit the scope of the invention. The detailed description is illustrative, not limiting, and exemplifies the principles of the invention. This specification enables those skilled in the art to make and use the invention and describes some embodiments, adaptations, variations, alternatives, and uses of the invention, including what is currently considered to be the best mode for carrying out the invention.

[0011] Where used herein, the terms “about” or “approximately” for any number or range indicate a preferred dimensional tolerance that enables some or all of the components to function for the intended purposes described herein. More specifically, “about” or “approximately” may refer to a range of values ​​within ±10% of the enumerated values. For example, “about 90%” may refer to a range of values ​​between 81% and 99%.

[0012] Surgical staple assemblies, as well as methods for manufacturing and using the same, are provided. Generally, a surgical staple assemblies may include a staple cartridge in which staples are disposed, and auxiliary materials configured to be releasably held on the staple cartridge. As discussed herein, the various auxiliary materials provided may be configured to compensate for changes in tissue properties, such as changes in tissue thickness, and / or to promote tissue ingraftment when the auxiliary materials are stapled to the tissue.

[0013] Exemplary staple fastening assemblies, as described herein and shown in the drawings, may include various features to facilitate the application of surgical staples. However, those skilled in the art will understand that staple fastening assemblies may include only some of these features, and / or various other features known in the art. The staple fastening assemblies described herein are intended to represent specific exemplary examples only. Furthermore, while auxiliary materials are described in relation to surgical staple cartridge assemblies, auxiliary materials can be used in relation to the reloading of staples that are not cartridge bases or any type of surgical instrument.

[0014] In transmucosal procedures, particularly those involving the digestive system, there is a risk of internal fluids being drawn up through the material, potentially contaminating the body cavity. To eliminate this risk, surgical adjuvants may partially or completely block fluid flow by (i) being fabricated to be partially or completely hydrophobic, (ii) including a mechanical barrier within or in addition to the material to block fluid flow, or (iii) including a gradient, direction, and / or closed-cell (impermeable) morphology. However, completely blocking fluid flow may limit the absorption of the surgical adjuvant within the body. In other words, as hydrophobicity or fluid control increases, the associated absorption time increases. Therefore, it is crucial to select the correct material, pattern, additives, barrier, or morphology to create an adjuvant with the desired properties.

[0015] Figure 1 shows an exemplary surgical stapling and cutting device 100 suitable for use with implantable auxiliary materials. The illustrated surgical stapling and cutting device 100 includes an end effector 106 having an anvil 102 pivotally connected to an elongated channel 104. As a result, the stapling application assembly 106 can move between an open position, as shown in Figure 1, and a closed position in which the anvil 102 is positioned adjacent to the elongated channel 104 and engages tissue between them. The end effector 106 can be mounted at its proximal end on an elongated shaft 108 that forms a mounting portion 110. When the end effector 106 is closed, or at least substantially closed (for example, when the anvil 102 moves from the open position in Figure 1 toward the elongated channel), the mounting portion 110 can present a sufficiently small cross-section suitable for inserting the end effector 106 through a trocar. Device 100 is configured to staple and cut tissue, but surgical devices configured to staple tissue but not cut it are also contemplated herein.

[0016] In various cases, the end effector 106 can be operated by a handle 112 connected to an elongated shaft 108. The handle 112 includes a user control unit such as a rotary knob 114 that rotates the elongated shaft 108 and the end effector 106 around the longitudinal axis (Ls) of the elongated shaft 108, and an articulated axis (T) substantially crossing the longitudinal axis (Ls) of the elongated shaft 108. A The system may include an articulation control unit 115 that can articulate the end effector 106 around the pistol grip 118. Further control units may include a closing trigger 116 that can pivot relative to the pistol grip 118 to close the end effector 106. For example, when the closing trigger 116 is clamped, a closing release button 120 is presented on the outside of the handle 112, and pressing the closing release button 120 releases the clamp on the closing trigger 116 and opens the end effector 106. The handle 112 may also take the form of an interface for connection to a surgical robot.

[0017] In some examples, the firing trigger 122 can pivot relative to the closing trigger 116, thereby allowing the end effector 106 to simultaneously cut and staple the tissue clamped inside it. The firing trigger 122 may be powered, require user force to engage, or be any combination of these. A manual firing release lever 126 allows the firing system to be retracted before completing its full movement for firing, if desired, and further allows a surgeon or other clinician to retract the firing system if it becomes immobile and / or malfunctions.

[0018] Further details relating to the surgical stapling and cutting device 100 and other surgical stapling and cutting devices suitable for use with the present disclosure are described, for example, in U.S. Patent No. 9,332,984 and U.S. Patent Application Publication No. 2009 / 0090763, which are incorporated herein by reference in their entirety. Furthermore, the surgical stapling and cutting device does not need to include a handle and instead may have a housing configured to be coupled to a surgical robot, as described, for example, in U.S. Patent Application Publication No. 2019 / 0059889, which are incorporated herein by reference in their entirety.

[0019] As further shown in Figure 1, the staple cartridge 200 can be used with the apparatus 100. During use, the staple cartridge 200 is positioned and connected within the elongated channel 104. The staple cartridge 200 can have various configurations, but in this illustrated example, the staple cartridge 200 shown in detail in Figures 2A and 2B has a proximal end 202a and a distal end 202b, with the longitudinal axis (LC) of the cartridge extending between the proximal end 202a and the distal end 202b. As a result, when the staple cartridge 200 is inserted into the elongated channel 104 (Figure 1), the longitudinal axis (LC) is substantially or nearly parallel to the longitudinal axis (LS) of the elongated shaft 108. Furthermore, 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 launching member of a launching assembly, such as the launching assembly 400 in Figure 4, as will be discussed further below. As shown, the longitudinal slot 210 extends from the proximal end 202a to the distal end 202b of the staple cartridge 200. It is also intended herein that in other examples the longitudinal slot 210 may be omitted.

[0020] The illustrated staple cartridge 200 includes defined staple cavities 212, 214, each configured to removably accommodate at least a portion of staples (not shown). The number, shape, and position of the staple cavities can vary and depend at least on the size and shape (e.g., mouth-like shape) of the staples to be removably placed inside. In this illustrated example, the staple cavities are arranged in two sets of three longitudinal rows, with the staple cavities 212 of the first set located on the first side of the longitudinal slot 210, and the staple cavities 214 of the second set located on the second side of the longitudinal slot 210. For each side of the longitudinal slot 210, and therefore for each set of rows, the first longitudinal row of staple cavities 212a, 214a extends along the longitudinal slot 210, the second row of staple cavities 212b, 214b extends along the first row of staple cavities 212a, 214a, and the third row of staple cavities 212c, 214c extends along the second row of staple cavities 212b, 214b. Each row may be substantially parallel, and the staple cavities constituting the row may be oriented substantially parallel to the longitudinal slot 210. As shown in Figure 2A, 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. Furthermore, at least the centers of the two adjacent cavities 212 and 214 are separated by approximately 0.158 inches.

[0021] The staples, which are releasably stored within the staple cavities 212 and 214, can have various configurations. An exemplary staple 300, which can be releasably stored in each of the staple cavities 212 and 214, is shown in its un-launched (pre-deployed, unformed) configuration in Figure 3. 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 linearly, and the staple legs 304 have the same unformed height. Furthermore, before the staple 300 is deployed, the staple crown 302 may be supported by a staple driver positioned within the staple cartridge 200, and at the same time, the staple legs 304 may be at least partially housed within the staple cavities 212 and 214. Furthermore, when the staple 300 is in the un-launched position, the staple legs 304 may extend beyond an upper surface such as the upper surface 206 of the staple cartridge 200. In certain cases, as shown in Figure 3, the tip 306 of the staple leg 304 may be pointed and sharp so as to be able to cut and penetrate tissue.

[0022] During use, the staple 300 can deform from an unfired position to a firing position so that the staple legs 304 move through the staple cavities 212, 214, penetrate the tissue positioned between the anvil 102 and the staple cartridge 200, and come into contact with the anvil 102. As the staple legs 304 deform relative to the anvil 102, the legs 304 of each staple 300 can capture a portion of the tissue within each staple 300 and apply compressive force to the tissue. Furthermore, the legs 304 of each staple 300 can deform downward toward the crown 302 of the staple 300 to form a staple capture region into which tissue can be captured. In various cases, the staple capture region may be defined between the inner surface of the deformed leg and the inner surface of the crown of the staple. The size of the staple capture region may depend on several factors, such as the length of the leg, the diameter of the leg, the width of the crown, and / or the degree of leg deformation.

[0023] In some examples, all staples placed within the staple cartridge 200 may have the same unfired (pre-deployed, unformed) configuration. In other examples, the staples may include at least two groups of staples, each having a different unfired (pre-deployed, unformed) configuration, such as differing in height and / or shape from one another.

[0024] Referring again to Figures 2A and 2B, the staple cartridge 200 extends from the top or deck surface 206 to the bottom surface 208, with the top surface 206 configured as the surface facing the tissue and the bottom surface 208 configured as the surface facing the channel. As a result, as shown in Figure 1, when the staple cartridge 200 is inserted into the elongated channel 104, the top surface 206 faces the anvil 102 and the bottom surface 208 (which is obscured) faces the elongated channel 104.

[0025] Referring to Figures 4 and 5, a launch assembly, such as launch assembly 400, can be used in conjunction with a surgical stapling and cutting device, such as device 100 in Figure 1. The launch assembly 400 may be configured to advance a wedge thread 500, which has a wedge 502 configured to deploy staples from a staple cartridge 200, into tissue trapped between an anvil, such as an anvil 102 in Figure 1, and a staple cartridge, such as the staple cartridge 200 in Figure 1. Furthermore, an E-shaped beam 402 located in the distal portion of the launch assembly 400 can launch staples from the staple cartridge. During launch, the E-shaped beam 402 can also pivot the anvil toward the staple cartridge, and thus move the end effector from an open position to a closed position. The illustrated E-shaped beam 402 includes a pair of upper pins 404, a pair of intermediate pins 406 which may follow a portion 504 of the wedge thread 500, and a lower pin or foot 408. The E-shaped beam 402 may also include a sharp cutting edge 410 configured to cut captured tissue as the firing assembly 400 advances distally, and thus toward the distal end of the staple cartridge. In addition, integrally formed, proximal projecting upper guides 412 and intermediate guides 414, flanking each vertical end of the cutting edge 410, may further define a tissue staging area 416 that assists in guiding tissue toward the sharp cutting edge 410 before cutting the tissue. The intermediate guides 414 may also function to engage with and fire staples in the staple cartridge by abutting a stepped central member 506 of the wedge thread 500, which results in staple formation by the end effector 106.

[0026] During use, the anvil 102 in Figure 1 moves to the closed position by pressing down the closing trigger in Figure 1, allowing the E-shaped beam 402 in Figure 4 to advance. The anvil 102 can position the tissue against at least the upper surface 206 of the staple cartridge 200 in Figures 2A-2B. Once the anvil is properly positioned, the staples 300 in Figure 3, which are positioned within the staple cartridge, can be deployed.

[0027] To deploy staples from the staple cartridge, as described above, the thread 500 in Figure 5 can be moved from the proximal end to the distal end of the cartridge body, and therefore from the proximal end to the distal end of the staple cartridge. As the firing assembly 400 in Figure 4 advances, the thread can contact the staple driver in the staple cartridge and lift the staple driver upward within the staple cavities 212, 214. In at least one example, the thread and staple driver may each include one or more inclined or beveled surfaces, which can work together to move the staple driver upward from its unfired position. Once the staple driver is lifted upward within its respective staple cavity, the staple advances upward, exiting the staple cavity and penetrating into the tissue. In various cases, the thread may move several staples upward simultaneously as part of the firing sequence.

[0028] As described above, the stapling device can be used in combination with a compressible auxiliary material. Although such auxiliary materials are shown and described below, those skilled in the art will understand that the auxiliary materials disclosed herein can be used with other surgical instruments and do not need to be connected to a staple cartridge as described. Furthermore, those skilled in the art will understand that the staple cartridge does not need to be replaceable.

[0029] As mentioned above, with some surgical staplers, surgeons are often required to select the appropriate staple with the appropriate staple height for the tissue being stapled. For example, surgeons use tall staples for thick tissue and short staples for thin tissue. However, in some situations, the stapled tissue does not have a consistent thickness, and therefore the staple cannot achieve the desired post-launch configuration for all parts of the stapled tissue (e.g., parts of thick tissue and parts of thin tissue). If staples of the same or substantially higher height are used due to the inconsistent thickness of the tissue, undesirable leakage and / or tearing of the tissue may occur at the staple site, especially if the staple site is exposed to internal pressure at and / or along the row of staples.

[0030] Therefore, to avoid the need to consider staple height when stapling tissue during surgery, various examples of auxiliary materials are provided that can be configured to compensate for the varying thicknesses of tissue captured within the fired (deployed) staples. That is, the auxiliary materials described herein can also be used in combination with the auxiliary material to provide sufficient tissue compression within and between fired staples, while enabling the use of sets of staples of the same or similar height when stapling tissues of varying thicknesses (e.g., from thin to thick tissues). Thus, the auxiliary materials described herein can maintain suitable compression for thin or thick tissues that are stapled, thereby minimizing leakage and / or tearing of tissue at the staple site. In addition, the exemplary auxiliary materials described herein may be configured to be essentially completely absorbed by the body over a period of 100 to 300 days, depending on the implantation site and the health of the tissue.

[0031] Alternatively or in addition, the implantable material may be configured to promote tissue endografting. In various cases, it is desirable to promote tissue endografting into the implantable material in order to promote the healing of the tissue being treated (e.g., stapled and / or incised tissue) and / or to accelerate the patient's recovery. More specifically, tissue endografting into the implantable material may reduce the incidence, severity, and / or duration of inflammation at the surgical site. Tissue endografting into and / or around the implantable material may, for example, control the spread of infection at the surgical site. For example, endografting of blood vessels, particularly leukocytes, into and / or around the implantable material may combat infection in and around the implantable material and adjacent tissue. Tissue endografting may also facilitate the acceptance of foreign bodies (e.g., implantable materials and staples) by the patient's body and reduce the likelihood of the patient's body rejecting them. Rejection of foreign bodies can lead to infection and / or inflammation at the surgical site.

[0032] Generally, the auxiliary materials provided herein are designed and positioned on top of a staple cartridge, such as a staple cartridge 200. When a staple is fired (deployed) from the cartridge, the staple penetrates the auxiliary material and enters the tissue. When the legs of the staples deform upon contact with an anvil positioned on the opposite side of the staple cartridge, the deformed legs capture a portion of the auxiliary material and a portion of the tissue within each staple. That is, when a staple is fired into the tissue, at least a portion of the auxiliary material is positioned between the tissue and the fired staple. While the auxiliary materials described herein may be configured to be attached to a staple cartridge, it is also intended herein that the auxiliary materials may be configured to mate with components of other instruments, such as an anvil for a surgical stapler. Those skilled in the art will understand that the auxiliary materials provided herein may be used for reloading staples that are not replaceable cartridges or cartridge-based.

[0033] How to staple tissue Figures 6A and 6B show exemplary examples of a staple fastening assembly 600 including a staple cartridge 200 and an auxiliary material 604. For simplification, the auxiliary material 604 is shown in its entirety in Figures 6A and 6B, and various configurations of the auxiliary material are described in more detail below. As shown, the auxiliary material 604 is positioned relative to the staple cartridge 200. Although partially obscured in Figures 6A and 6B, the staple cartridge 200 includes staples 300 configured to unfold within the structure. The staples 300 can have any preferred unformed (pre-unfolded) height.

[0034] In the illustrated example, the auxiliary material 604 may be fitted 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 may include one or more surface features that engage with the auxiliary material 604 and / or prevent premature release of the auxiliary material 604 from the staple cartridge 200. Exemplary surface features are described further below and are described in U.S. Patent Application Publication No. 2016 / 0106427, which is incorporated herein by reference in its entirety.

[0035] Figure 6B shows a staple fastening assembly 600 positioned within and connected to an elongated channel 610 of a surgical end effector 106. Anvil 102 is pivotally connected to the elongated channel 610 and is therefore movable between an open position and a closed position relative to the elongated channel 610, and thus to the staple cartridge 200. Anvil 102 is shown in the closed position in Figure 6B, and the interstitial gap T created between the staple cartridge 602 and anvil 612 is visible. G1 This shows that. More specifically, the interstitial space T G1The intercellular gap T is defined by the distance between the microstructure compression surface 102a of the anvil 102 (e.g., the microstructure engagement surface between staple-forming pockets in the anvil) and the microstructure contact surface 604a of the auxiliary material 604. In this illustrated example, both the microstructure compression surface 102a of the anvil 102 and the microstructure contact surface 604a of the auxiliary material 604 are planar or substantially planar (e.g., planar within manufacturing tolerances). As a result, when the anvil 102 is in the closed position, the intercellular gap T is as shown in Figure 6B. G1 When no tissue is present within it, it is generally uniform (for example, nominally identical within manufacturing tolerances). In other words, the inter-tissue gap T G1 The interstitial gap T is approximately constant across the end effector 106 (e.g., in the y-direction) (e.g., constant within manufacturing tolerances). In other examples, the microstructure compression surface of the anvil includes a stepped surface with longitudinal steps between adjacent longitudinal portions, thus creating a stepped profile (e.g., in the y-direction). In such examples, the interstitial gap T G1 It can fluctuate.

[0036] The auxiliary material 604 is compressible, and can be compressed to various heights to compensate for different tissue thicknesses captured within the deployed staple. The auxiliary material 604 has an uncompressed (undeformed) or pre-deployment height and is configured to deform to one of several compressed (deformed) or deployed heights. For example, the auxiliary material 604 may have an uncompressed height that is higher than the post-launch height of the staple 300 placed in the staple cartridge 200 (e.g., the height (H) of the launched staple 300a in Figure 7). That is, the auxiliary material 604 may have an undeformed state in which the maximum height of the auxiliary material 604 is higher than the maximum height of the launched staple (e.g., the staple in the formed configuration).

[0037] As shown in Figure 6C, the staple cartridge 200 includes a thread 614 and a plurality of drivers 612, the plurality of drivers 612 configured to drive one or more staples upward and deploy the staples when the user presses the firing trigger 122 shown in Figure 1. When the firing trigger 122 is pressed, the thread 614 moves toward the distal end 616 of the end effector 106, contacting one or more drivers 612a, 612b at a time, pushing one or more drivers 612a, 612b upward together with one or more corresponding staples 300 to form a fired staple 300a, trapping material such as tissue (T) (see Figure 7) between the anvil 104 and the fired staple 300a. The cartridge 200 may include a first row 613a of a single driver 612a corresponding to driving staples 300 located in the third rows 212c, 214c of the staple cavity, and a second row 613b of a dual driver 612b corresponding to driving staples 300 located in the first rows 212a, 214b and the third rows 212a, 212b of the staple cavity (see Figure 2A for the staple cavity).

[0038] One or more single drivers 612a may have a height SDH of approximately 0.044 inches to approximately 0.074 inches, for example, approximately 0.050 inches to approximately 0.068 inches, approximately 0.054 inches, or approximately 0.06 inches. One or more dual drivers 612b may have a height DDH of approximately 0.044 inches to approximately 0.074 inches, for example, approximately 0.050 inches to approximately 0.068 inches, approximately 0.054 inches, or approximately 0.06 inches. The thread 614 may have at least a first rail 614a corresponding to a single driver 612a positioned in a first column 613a, and a second rail 614b corresponding to a dual driver 612b positioned in a second column 613b. The first rail 614a may have a rail height SRH of approximately 0.164 inches or approximately 0.167 inches and engage with a single driver 612a. The second rail 614b may have a rail height DRH of approximately 0.140 inches to approximately 0.162 inches, for example, approximately 0.149 inches or approximately 0.152 inches, and engages with the double driver 612b. When the staple 300 is deployed, the staple 300 forms a launched staple 300a having a crush height CH of approximately 0.08 inches to approximately 0.12 inches, for example, approximately 0.97 inches or approximately 0.1 inches.

[0039] During use, when a surgical stapling and cutting device such as device 100 in Figure 1 is directed toward the surgical site, the tissue is positioned between the anvil 102 and the stapling assembly 600 so that the anvil 102 is positioned adjacent to a first side of the tissue and the stapling assembly 600 is positioned adjacent to a second side of the tissue (for example, the tissue may be positioned relative to the tissue contact surface 604a of the auxiliary material 604). Once the tissue is positioned between the anvil 102 and the stapling assembly 600, the surgical stapler is operated, for example as described above, thereby clamping the tissue between the anvil 102 and the stapling assembly 600 (for example, between the tissue compression surface 102a of the anvil 102 and the tissue contact surface 604a of the auxiliary material 604), and staples are deployed from the cartridge through the auxiliary material into the tissue, thereby stapling and attaching the auxiliary material to the tissue.

[0040] As shown in Figure 7, when the staple 300 is fired, a portion of the tissue (T) and auxiliary material 604 is captured by the fired (formed) staple 300a. Each fired staple 300a defines a capture area within itself to contain the captured auxiliary material 604 and tissue (T), as described above. The capture area defined by the fired staple 300a is at least partially limited by the height (H) of the fired staple 300a.

[0041] Figure 8A shows a perspective view of a staple cartridge assembly 600 having an auxiliary material 604 and a staple cartridge 200. The auxiliary material 604 has a tissue contact surface 604a, a proximal end 604a, and a distal end 604b. The auxiliary material 604 may include a slot / slit 808 that separates or partially separates two parallel portions of the auxiliary material 604. In one example, the auxiliary material 604 may include a slot 808 that separates two parallel portions of the auxiliary material 604, while in another example, the auxiliary material 604 may include a slit 808 that separates two parallel portions of the auxiliary material 604, and one or more bridges (e.g., five bridges) 802 that connect the two parallel portions of the auxiliary material 604. At least one bridge has a longitudinal length of about 0.035 inches to about 0.046 inches. The auxiliary material 604 has a length L of approximately 40 mm to approximately 80 mm, such as approximately 60 mm to approximately 65 mm, approximately 66.04 mm to approximately 66.3 mm, approximately 45 mm to approximately 55 mm, or approximately 51.12 mm to approximately 51.38 mm. The auxiliary material 604 has a width W of approximately 8 mm to approximately 12 mm, such as approximately 9.75 mm to approximately 10.25 mm or approximately 10.025 mm to approximately 10.035 mm. The auxiliary material 604 may also have a thickness or height TH of approximately 2.5 mm to approximately 3.5 mm, such as approximately 2.85 mm to approximately 3.15 mm, or approximately 2.95 mm to approximately 3.05 mm.

[0042] Cartridge 200 has a height CH of approximately 6.3 mm to approximately 8.1 mm, a width CW of approximately 8.9 mm to approximately 14 mm, and a length CL of approximately 80 mm to approximately 90 mm, for example, approximately 86.7 mm.

[0043] Referring to Figures 8B to 8D, the auxiliary material 604 has a lower surface 604d and may have a distal chamfered portion 818, a proximal chamfered portion 820, and a central portion 822. The distal chamfered portion 818 has a vertical portion 818a having a height CPH of approximately 0.009 inches to approximately 0.029 inches, such as approximately 0.019 inches. The distal chamfered portion 818 may have an inclined portion 818b proximal to the vertical portion 818a. The inclined portion 818b has a slope VA of approximately 30 degrees to approximately 60 degrees, for example, approximately 45 degrees, measured from the tissue contact surface 604a.

[0044] Referring to Figure 8C, the distal chamfered portion 818 and the central portion 822 have a total length DL of approximately 2.25 inches to approximately 2.45 inches, for example, approximately 2.35 inches. The proximal chamfered portion 820 has a beveled portion 820b with a length DCL of approximately 0.1 inches to approximately 0.3 inches. The proximal chamfered portion 820 also has a horizontal portion 820a and a beveled portion 820n. The horizontal portion 820a may have a width CW of approximately 0.27 inches to approximately 0.29 inches, for example, approximately 0.28 inches.

[0045] In some examples, the auxiliary material 604 includes one or more slits 808 having two or more bridges 802 spaced apart by a bridge length BL of approximately 0.035 inches to approximately 0.045 inches, for example, approximately 0.04 inches.

[0046] Referring again to Figure 8A, the staple cartridge 200 may include one or more raised ledges 804 along one or more sides of the auxiliary material 602 to help align the auxiliary material 604 onto the deck of the staple cartridge 200.

[0047] As mentioned above, the auxiliary material 604 is compressible. Figures 9A and 9B show the dogbone shape and dimensions that the auxiliary material 604 takes when subjected to compressibility testing to determine its material properties. As shown, the auxiliary material 604 has a compressive length CPL of approximately 9.45 mm to approximately 9.61 mm, for example, approximately 9.53 mm. The auxiliary material 604 has a compressive thickness CT of approximately 3.15 mm to approximately 3.21 mm, for example, approximately 3.18 mm. The auxiliary material 604 has a dogbone radius DBR of approximately 12.62 mm to approximately 12.78 mm, for example, approximately 12.7 degrees. The auxiliary material 604 has a dogbone height DBH of approximately 6.35 mm to approximately 12.71 mm, for example, approximately 9.53 mm. The auxiliary material 604 has a dogbone length DBL of approximately 40 mm to approximately 80 mm, for example, approximately 63.5 mm. The support material has a dogbone width (DBW) of approximately 2.5 mm to 3.5 mm, for example, approximately 3.03 mm.

[0048] Surgical adjuvants 604 may be hydrophobic or may contain hydrophobic materials to prevent the entry of fluids from organs such as the colon from contaminating the patient's body cavities. Polyurethane foams may contain hydrophobicity. For example, the polyurethane foam of surgical adjuvants 604 may contain hydrophobic chemical additives when forming the foam. Some examples of additives may include ceramic nanoparticles (e.g., calcium phosphate), fatty acids (e.g., oleic acid, decanoic acid, hexanoic acid, dodecanoic acid), ionic liquids, enteric coatings, photocurable resins, or other long-chain surfactants. Fatty acids may have pH-dependent solubility. For example, increasing the chain length from hexanoic acid to decanoic acid can be used to change solubility at low pH, along with increasing solubility under basic conditions. This may be an additional mechanism involving transient hydrophobicity in which the fatty acid is trapped within the network in the presence of acid. Retention allows for a barrier against fluid flow. In areas not exposed to acidic conditions, the fatty acid may dissolve over a specified period to allow for absorption consistent with the undiluted adjuvant material.

[0049] The mechanism of ionic liquids is based on potential counterion exchange (sodium exchange) within the body, which allows for the dissolution of liquids within the body. In association states, ionic liquids can provide increased hydrophobicity. Therefore, by including ionic liquids, transient hydrophobicity can be produced.

[0050] As shown in Figure 8M, the hydrophobic additive may be a hydrophobic coating 865 placed on the polyurethane foam. The hydrophobic coating 865 does not alter the chemical properties of the polyurethane foam and is layered on top of the foam, partially or completely blocking the flow of fluid. Although the coating is shown on the surface, it may cover one or more surfaces or parts thereof. The coating 865 may consist of multiple layers of different, similar, or the same material to promote coating adhesion that increases hydrophobicity. Furthermore, multiple layers can be used to minimize the effect on adsorption by alternating surface erosion coatings. For example, a surface erosion polyester (e.g., polypropylene fumarate) can be used as an outer coating together with the final layer of enteric coating. The generation of acid during polyester decomposition creates a localized acidic environment that eliminates water permeability while maintaining the hydrophobic surface. After the acidic environment dissipates, the enteric coating rapidly dissolves, allowing the additive to be absorbed. Examples of coating materials include at least one fatty acid (e.g., oleic acid, decanoic acid, hexanoic acid, dodecanoic acid), at least one long-chain surfactant, at least one enteric coating (e.g., a cellulose derivative or methacrylate copolymer), at least one photocurable resin, or a combination thereof. Hydrophobic coatings can be applied to polyurethane foams by inkjet printing, direct deposition, thermal spraying, cold dynamic spraying, cold spraying, electrospraying, ultrasonic spray coating, dip coating, screen printing, solution deposition, spin coating, film coating, external lamination, and lithography.

[0051] The surgical aid 604 may include several different or similar methods of application for coating the inner and other surfaces of a polyurethane foam. The surgical aid 604 may include one or more hydrophobic coatings, as well as hydrophobic chemical additives added to the foam. In some examples, the hydrophobic coatings may react with the surface of the polyurethane foam to impart hydrophobic properties to the surgical aid 604. In some examples, the hydrophobic chemical additives and / or hydrophobic properties may include additional steps (e.g., immersion in water, heating, cooling) to activate the hydrophobic properties.

[0052] Furthermore, hydrophobic coatings can be used in time-related therapeutic agents within adjuvants to aid healing, reduce inflammation, and treat diseases.

[0053] As shown in Figure 8N, the surgical aid 604 may include one or more patterns 867 having one or more hydrophobic surfaces or portions thereof. Hydrophobicity can be generated through a specific surface texture on the surface of the surgical aid 604. Such a surface pattern 867 may have one or more specific repeating patterns having a pitch smaller than the diameter of a water droplet. For example, the surface pattern may include at least one repeating pattern having a pitch of less than about 0.005 centimeters. The specific hydrophobic surface pattern 867 may be generated by interference lithography, stereolithography, selective ablation, freeze-drying, plasma etching, chemical etching, or a surface-initiated polymer brush.

[0054] The advantage of adding one or more of the hydrophobic features described above is that such surgical aids may reduce and eliminate transmucosal degradation, mitigate transmucosal risks in vivo, potentially increase the retention of the mechanical strength of the surgical aid based on physiological conditions, and potentially allow the surgical aid 604 to be used as a long-release intra-organ drug delivery mechanism.

[0055] Figures 9C, 9D, and 9E are exemplary figures 950a, 950b, and 950c showing a surgical adjuvant 604 placed transwallically within a patient. For example, it can be used for biopharmaceuticals such as monoclonal antibodies, which have limited ability to be absorbed in the gastrointestinal tract. If the surgical adjuvant 604 can be used as a carrier for biopharmaceuticals, it may enable bioavailability in the body without the burden of injection or infusion.

[0056] Surgical adjuvants 604 may have one or more of the properties described below to enable them to be flexible when in vivo but to remain in a specific position attached to a cartridge when outside the body. For example, polyurethane may function to create an adjuvant 604 that is flexible when in vivo but "set" to its final mechanical properties once a plasticizer is absorbed in vivo. In some examples, a plasticizer may be added to a polyurethane foam to lower its glass transition temperature to the range described below and conform to other enumerated properties. In any case, an adjuvant 604 having one or more of the properties described below consistently produces hemostasis or near-hemostatic seal on tissue.

[0057] The surgical augment 604 may contain or not contain a plasticizer-containing polyurethane foam, and the glass transition temperature of the surgical augment 604 is approximately 0°C to approximately 40°C (e.g., approximately 19.4°C), e.g., approximately 7.5°C to approximately 22.5°C or approximately 12.5°C to approximately 17.5°C. The glass transition temperature of the augment 604 is obtained by using a standard differential scanning calorimetry (DSC) system. Using a DSC system having the output shown in Figure 13, the augment 604 is equilibrated at approximately -40°C, heated to approximately 120°C at approximately 40°C / min, held isothermally for approximately 1 minute, cooled to approximately -40°C at approximately 40°C / min, held isothermally for approximately 1 minute, and then heated to approximately 120°C at approximately 10°C / min to obtain the glass transition temperature T g The values ​​were measured and recorded using a DSC system.

[0058] The surgical aid 604 may include a volume ratio of the polyurethane foam to the total volume of the aid 604, such as from about 0.175 to about 0.225 or from about 0.19 to about 0.21, of from about 0.125 to about 0.325. The total volume may include air (from the pores of the foam) or other materials other than the foam structure.

[0059] The plasticizer may include one or more of low molecular weight glycols, polyethylene glycols, polyvinyl pyrrolidone, dibutyl sebacate, glyceryl triacetate, glyceryl behenate, hexanoic acid, decanoic acid, octadecanoic acid, borate esters, and fatty acids. In some examples, the plasticizer includes one or more fatty acids.

[0060] Referring to FIG. 8E, the surgical aid 604 may include a polyurethane foam having pores 832 with a median pore diameter of about 0.025 mm, such as about 0.022 mm 3 ~ about 0.300 mm 3 In some examples, the surgical aid 604 may have one or more struts 834 between the pores 832 that provide support and strength to the surgical aid 604. Specifically, the surgical aid 604 may include a plurality of struts 834 having a median strut thickness ST of from about 0.025 mm to about 0.300 mm, such as about 0.08 mm. 3 In some examples, the surgical aid 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 the bottom or crown side of the surgical aid 604. In some examples, the PDO film has a thickness of from about 20 μm to about 100 μm, such as about 40 μm.

[0061] [[ID=J18]]

[0062] ​The auxiliary material 604 may have compressive strengths ranging from approximately 30 kPa to approximately 70 kPa, such as approximately 30 kPa to approximately 60 kPa (e.g., approximately 42 kPa), approximately 30 kPa to approximately 50 kPa, and approximately 32.5 kPa to approximately 37.5 kPa. To test the compressive strength, the auxiliary material 604 was placed in a humid, warm environment at approximately 37°C, compressed to a first height, then compressed to a second height lower than the first height, and then released back to the first height once the compressive strength of the auxiliary material was measured.

[0063] In some examples, the auxiliary material 604 may have a tensile strength of approximately 30 kPa to 90 kPa, such as approximately 45 kPa to 85 kPa or approximately 55 kPa to 75 kPa. In some examples, the auxiliary material 604 may have a tensile strength of approximately 110 kPa to 150 kPa. The tensile strength is measured on the auxiliary material 604 having a dogbone configuration as illustrated and described with respect to Figures 9A and 9B. Specifically, the tensile strength of the auxiliary material 604 is measured after immersion in water at a temperature of approximately 37°C for less than 1 minute, followed by a tensile strength test.

[0064] Manipulating the foam morphology of surgical adjuvants 604 to prevent transmucosal pathways could significantly impact the versatility of foam applications in the medical market. Through morphological manipulation, the risk of transmucosal infection can be greatly reduced while maintaining the overall purpose and biocompatibility of surgical adjuvants 604, whether it is gradient, directional, or closed-cell / impermeable.

[0065] Referring to Figure 8F-1, the surgical aid 604 may include a polyurethane foam having a gradient porous structure 850a with pores 832 including small pores 842 located adjacent to a first end or first side 848. When placed in the patient's body, the first end 848 may be positioned adjacent to a point of transmural access from the patient's organs within the patient's body cavity. The pores 832 of the polyurethane foam may also include larger pores 846 located away from the first end 848 and accompanying a second end or second side 849. The polyurethane foam may also include transition pores 844, which are generally arranged such that smaller diameter pores are located closer to the first end 848 and larger diameter pores are located further away from the first end 848. Some of the smaller holes 842 and transition holes 844 (e.g., the smaller ones) may prevent fluid from entering the surgical aids from the rest of the patient's body from the patient's organs (e.g., organs from the digestive system), while some of the larger holes 846 and transition holes 844 (e.g., some of the larger ones) may allow fluid to enter from other parts of the body, such as blood flow, to accelerate the biodegradation of the polyurethane foam. The holes 832 have been described as increasing in size from the first end 848 as they move away from the first end 848, but the holes 832 may increase in size along any direction, such as axial 851 (Figure 8H), transverse 833b (Figure 8H), or both.

[0066] Referring to Figure 8F-2, the surgical abutment 604 may include a dual density gradient with respect to its pore diameter. For example, the surgical abutment 604 may include holes 832 having smaller diameters adjacent to a first end and a second end opposite the first end. Moving from the first or second end towards the center of the surgical abutment 604, the diameter of the holes 832 continues to increase to a larger diameter size. Referring to Figure 8F-3, the surgical abutment 604 may include two bioabsorbable materials 1002a, 1002b, each having a single gradient of pore diameter. These two bioabsorbable materials 1002a, 1002b may be joined together to form a dual density gradient. In both Figures 8F-2 and 8F-3, the surgical abutment may include a strut 834 whose thickness may increase near larger holes than near smaller holes.

[0067] Referring to Figures 8G and 8H, the surgical aid 604 may include a polyurethane foam having a directional morphology. For example, the pores 832a of the polyurethane foam may be aligned in a first direction 833a to generally control fluid flow in the first direction 833a and a second direction 833a (opposite direction arrow), which is the opposite direction to the first direction (see Figure 8G). In another example, the polyurethane foam may include directional pores 832a aligned in a first direction 833b (which is also the transverse direction), as well as small pores 832 or closed-cell pores (see Figure 8H). Both the directional pores 832a and the small pores 832 (or closed-cell pores) may prevent the fluid 843 from passing through a particular portion of the polyurethane foam, but may allow the fluid 843 to flow through a portion of the foam containing the directional pores.

[0068] Using an impermeable thin outer layer prevents fluid transport through the cushion while maintaining optimal porosity within the surgical adjuvant 604. Furthermore, by reducing the surfactant content, the foam can be manipulated to achieve a closed-cell morphology with a thin film surrounding the bubbles. This prevents water absorption through the porous structure for a predetermined period during tissue healing. After tissue healing, the membrane slowly disintegrates, allowing complete cell infiltration and tissue proliferation into the cushion for biodegradation.

[0069] Referring to Figure 8I, the surgical adjuvant 604 may include an impermeable barrier, outer layer, or moisture barrier 845 disposed on one or more surfaces of the polyurethane foam. The polyurethane foam may contain small pores (or closed-cell pores) 832.

[0070] Referring to Figure 8J, the surgical aid 604 may include an impermeable or hydrophobic material 860b or a moisture barrier, along with one or more sections of buttress material (e.g., adhesive) 860a and polyurethane foam 605. The hydrophobic material 860b is placed between the buttress material 860 and the polyurethane foam 605. The moisture barrier may include a film containing aliphatic polyester such as polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polydioxanone (PDO), poly(trimethylene carbonate) (PTMC), or a combination of copolymers.

[0071] Referring to Figure 8K, the surgical adjuvant 604 may include a matrix 862 of a hydrophobic film or moisture barrier within a polyurethane foam 864. Referring to Figure 8L, the surgical adjuvant 604 may include a material 863 woven into the polyurethane foam 864. The material 863 may include or be hydrophobic, a hydrophobic coating. The moisture barrier may include a film containing aliphatic polyesters such as polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polydioxanone (PDO), poly(trimethylene carbonate) (PTMC), or a combination of copolymers.

[0072] As those skilled in the art will understand, the embodiments described above are by illustrative reference only, and the present invention is not limited to those specifically illustrated and described herein. Rather, the scope of the present invention includes both combinations and partial combinations thereof of the various features described herein, as well as variations and modifications thereof not disclosed in the prior art, which will be conceivable to those skilled in the art by reading the above description.

[0073] In some examples, polyurethane foam is used as the primary component of surgical adjuvant 604. Other bioabsorbable materials may and may be used.

[0074] In some cases, the disclosed devices (e.g., end effectors, surgical aids, and / or staple cartridges), and methods involving one or more of the disclosed devices, may be subject to one or more of the following provisions.

[0075] Clause 1: Surgical adjuvant 604 comprising: a polyurethane foam, wherein the volume ratio of the polyurethane foam to the total volume of the surgical adjuvant 604 is in the range of about 0.125 to about 0.325; and at least one hydrophobic additive comprising at least one ceramic nanoparticle, at least one fatty acid, at least one ionic liquid, at least one long-chain surfactant, at least one enteric coating, at least one photocurable resin, or a combination thereof.

[0076] Clause 2: Surgical adjuvant 604 as described in Clause 1, wherein at least one hydrophobic additive comprises at least one fatty acid, including oleic acid, decanoic acid, hexanoic acid, dodecanoic acid, or a combination thereof.

[0077] Clause 3: Surgical adjuvant 604 as described in Clause 2, wherein at least one fatty acid comprises oleic acid.

[0078] Clause 4: The surgical adjuvant 604 according to Clause 1, wherein at least one hydrophobic additive comprises at least one ceramic nanoparticle.

[0079] Clause 5: Surgical adjuvant 604 according to Clause 4, wherein at least one ceramic nanoparticle comprises calcium phosphate.

[0080] Clause 6: Surgical adjuvant 604 according to Clause 1, wherein at least one hydrophobic additive comprises at least one long-chain surfactant.

[0081] Clause 7: The surgical aid 604 according to Clause 1, wherein at least one hydrophobic additive is a hydrophobic coating disposed on a polyurethane foam.

[0082] Clause 8: Surgical adjuvant 604 as described in Clause 7, wherein the hydrophobic coating comprises at least one fatty acid, at least one long-chain surfactant, at least one enteric coating, at least one photocurable resin, or a combination thereof.

[0083] Clause 9: Surgical aid 604 comprising a polyurethane foam, wherein the volume ratio of the polyurethane foam to the total volume of the surgical aid 604 is in the range of about 0.125 to about 0.325, and the polyurethane foam comprises a hydrophobic surface pattern.

[0084] Clause 10: Surgical aid 604 according to Clause 9, wherein the surface pattern includes at least one repeating pattern having a pitch of less than approximately 0.005 centimeters.

[0085] Clause 11: Surgical aid 604 comprising: a polyurethane foam, wherein the volume ratio of the polyurethane foam to the total volume of the surgical aid 604 is in the range of about 0.125 to about 0.325; and a moisture barrier configured to divide the polyurethane foam into at least two sections and prevent the entry of fluid.

[0086] Clause 12: Surgical adjuvant 604 according to Clause 11, wherein the moisture barrier comprises a film containing an aliphatic polyester.

[0087] Clause 13: Surgical adjuvant 604 as described in Clause 11, wherein the moisture barrier includes a matrix that divides the polyurethane foam.

[0088] Clause 14: Surgical aid 604 as described in Clause 11, comprising a moisture barrier including a suture coated with one or more poly(p-dioxanone) woven into a polyurethane foam.

[0089] Clause 15: Surgical aid 604 comprising a polyurethane foam having a plurality of pores, wherein the plurality of pores are configured to prevent or reduce the entry of fluid into the polyurethane foam.

[0090] Clause 16: The surgical adjuvant 604 as described in Clause 15, wherein the volume ratio of polyurethane foam to the total volume of the surgical adjuvant 604 is in the range of approximately 0.125 to approximately 0.325.

[0091] Clause 17: Surgical aid 604 as described in Clause 15, wherein multiple holes form a gradient or double gradient based on the average diameter and with respect to the first side of the polyurethane foam. Clause 18: The surgical aid 604 according to Clause 15, wherein at least some of the multiple holes are aligned in a first direction to direct fluid entry into the polyurethane foam in at least the first direction and a second direction opposite to the first direction.

[0092] Clause 19: Surgical aid 604 as described in Clause 18, wherein at least some of the multiple holes are closed-cell pores configured to prevent the entry of fluid.

[0093] Clause 20: Surgical aid 604 as described in Clause 15, wherein at least some of the multiple holes are closed-cell pores configured to prevent the entry of fluid.

[0094] Clause 21: Surgical adjuvant 604 comprising a polyurethane foam, wherein the volume ratio of the polyurethane foam to the total volume of the surgical adjuvant 604 is in the range of about 0.125 to about 0.325.

[0095] Clause 22: Surgical adjuvant 604 as described in Clause 21, further comprising at least one hydrophobic additive comprising at least one ceramic nanoparticle, at least one fatty acid, at least one ionic liquid, at least one long-chain surfactant, at least one enteric coating, at least one photocurable resin, or a combination thereof.

[0096] Clause 23: Surgical adjuvant 604 as described in Clause 22, wherein at least one hydrophobic additive comprises at least one fatty acid, including oleic acid, decanoic acid, hexanoic acid, dodecanoic acid, or a combination thereof.

[0097] Clause 24: Surgical adjuvant 604 as described in Clause 23, wherein at least one fatty acid comprises oleic acid, decanoic acid, hexanoic acid, dodecanoic acid, or a combination thereof.

[0098] Clause 25: Surgical adjuvant 604 according to Clauses 22-24, wherein at least one hydrophobic additive comprises at least one ceramic nanoparticle.

[0099] Clause 26: Surgical adjuvant 604 according to Clauses 22-25, wherein at least one ceramic nanoparticle comprises calcium phosphate.

[0100] Clause 27: Surgical adjuvant 604 according to Clauses 22-26, wherein at least one hydrophobic additive is a hydrophobic coating disposed on a polyurethane foam, the hydrophobic coating comprising at least one fatty acid, at least one long-chain surfactant, at least one enteric coating, at least one photocurable resin, or a combination thereof.

[0101] Clause 28: Surgical adjuvant 604 according to Clauses 21-27, wherein the polyurethane foam has a hydrophobic surface pattern.

[0102] Clause 29: Surgical aid 604 as described in Clause 28, wherein the surface pattern includes at least one repeating pattern having a pitch of less than approximately 0.005 centimeters.

[0103] Clause 30: Surgical aid 604 according to Clauses 21-29, further comprising a polyurethane foam divided into at least two sections and a moisture barrier configured to prevent the entry of fluids.

[0104] Clause 31: Surgical adjuvant 604 according to Clause 30, wherein the moisture barrier comprises a film containing an aliphatic polyester.

[0105] Clause 32: Surgical adjuvant 604 according to Clause 30 or 31, wherein the moisture barrier includes a matrix that divides the polyurethane foam.

[0106] Clause 33: Surgical aid 604 according to Clauses 30-32, comprising a moisture barrier, a suture coated with one or more poly(p-dioxanone) woven into a polyurethane foam.

[0107] Clause 34: Surgical aid 604 according to Clauses 21-33, wherein the polyurethane foam comprises a plurality of pores configured to prevent or reduce the entry of fluid into the polyurethane foam.

[0108] Clause 35: Surgical aid 604 according to Clause 34, wherein the plurality of pores (i) have an average diameter of the plurality of pores that form a gradient or double gradient with respect to a first side of the polyurethane foam, (ii) are aligned in one direction to direct the entry of fluid into the polyurethane foam, and (iii) include closed-cell pores, or a combination thereof.

[0109] [Implementation Method] (1) Surgical auxiliary material 604, A surgical aid 604 comprising a polyurethane foam, wherein the volume ratio of the polyurethane foam to the total volume of the surgical aid 604 is in the range of approximately 0.125 to approximately 0.325. (2) The surgical aid 604 according to Embodiment 1, further comprising at least one hydrophobic additive comprising at least one ceramic nanoparticle, at least one fatty acid, at least one ionic liquid, at least one long-chain surfactant, at least one enteric coating, at least one photocurable resin, or a combination thereof. (3) The surgical adjuvant 604 according to Embodiment 2, wherein the at least one hydrophobic additive comprises the at least one fatty acid, which includes oleic acid, decanoic acid, hexanoic acid, dodecanoic acid, or a combination thereof. (4) The surgical adjuvant 604 according to Embodiment 3, wherein the at least one fatty acid comprises oleic acid, decanoic acid, hexanoic acid, dodecanoic acid, or a combination thereof. (5) The surgical aid 604 according to embodiments 2 to 4, wherein the at least one hydrophobic additive comprises the at least one ceramic nanoparticle.

[0110] (6) The surgical aid 604 according to embodiments 2 to 5, wherein the at least one ceramic nanoparticle comprises calcium phosphate. (7) The surgical adjuvant 604 according to embodiments 2 to 6, wherein the at least one hydrophobic additive is a hydrophobic coating disposed on the polyurethane foam, the hydrophobic coating comprises the at least one fatty acid, the at least one long-chain surfactant, the at least one enteric coating, the at least one photocurable resin, or a combination thereof. (8) The surgical aid 604 according to Embodiments 1 to 7, wherein the polyurethane foam includes a hydrophobic surface pattern. (9) The surgical aid 604 according to Embodiment 8, wherein the surface pattern includes at least one repeating pattern having a pitch of less than about 0.005 centimeters. (10) The surgical aid 604 according to embodiments 1 to 9, further comprising a moisture barrier configured to prevent the entry of fluid, wherein the polyurethane foam is divided into at least two sections.

[0111] (11) The surgical aid 604 according to Embodiment 10, wherein the moisture barrier comprises a film containing an aliphatic polyester. (12) The surgical aid 604 according to embodiment 10 or 11, wherein the moisture barrier includes a matrix that divides the polyurethane foam. (13) The surgical aid 604 according to embodiments 10 to 12, wherein the moisture barrier includes a suture coated with one or more poly(p-dioxanone) woven into the polyurethane foam. (14) The surgical aid 604 according to embodiments 1 to 13, wherein the polyurethane foam comprises a plurality of holes configured to prevent or reduce the entry of fluid into the polyurethane foam. (15) The surgical aid 604 according to Embodiment 14, wherein the plurality of holes (i) have an average diameter of the plurality of holes that forms a gradient or double gradient with respect to a first side of the polyurethane foam, (ii) are aligned in one direction to direct the entry of fluid into the polyurethane foam, and (iii) include closed-cell pores, or a combination thereof.

Claims

1. Surgical aid 604, A surgical aid 604 comprising a polyurethane foam, wherein the volume ratio of the polyurethane foam to the total volume of the surgical aid 604 is in the range of approximately 0.125 to approximately 0.

325.

2. The surgical aid 604 according to claim 1, further comprising at least one hydrophobic additive comprising at least one ceramic nanoparticle, at least one fatty acid, at least one ionic liquid, at least one long-chain surfactant, at least one enteric coating, at least one photocurable resin, or a combination thereof.

3. The surgical adjuvant 604 according to claim 2, wherein the at least one hydrophobic additive comprises at least one fatty acid including oleic acid, decanoic acid, hexanoic acid, dodecanoic acid, or a combination thereof.

4. The surgical adjuvant 604 according to claim 3, wherein the at least one fatty acid comprises oleic acid, decanoic acid, hexanoic acid, dodecanoic acid, or a combination thereof.

5. The surgical aid 604 according to claims 2 to 4, wherein the at least one hydrophobic additive comprises the at least one ceramic nanoparticle.

6. The surgical aid 604 according to claims 2 to 4, wherein the at least one ceramic nanoparticle comprises calcium phosphate.

7. The surgical aid 604 according to claims 2 to 4, wherein the at least one hydrophobic additive is a hydrophobic coating disposed on the polyurethane foam, and the hydrophobic coating comprises the at least one fatty acid, the at least one long-chain surfactant, the at least one enteric coating, the at least one photocurable resin, or a combination thereof.

8. The surgical aid 604 according to claims 1 to 4, wherein the polyurethane foam includes a hydrophobic surface pattern.

9. The surgical aid 604 according to claim 8, wherein the surface pattern includes at least one repeating pattern having a pitch of less than approximately 0.005 centimeters.

10. The surgical aid 604 according to claims 1 to 4, further comprising a moisture barrier configured to prevent the entry of fluids by dividing the polyurethane foam into at least two sections.

11. The surgical aid 604 according to claim 10, wherein the moisture barrier comprises a film containing an aliphatic polyester.

12. The surgical aid 604 according to claim 10, wherein the moisture barrier includes a matrix that divides the polyurethane foam.

13. The surgical aid 604 according to claim 10, wherein the moisture barrier includes a suture coated with one or more poly(p-dioxanone) woven into the polyurethane foam.

14. The surgical aid 604 according to claims 1 to 3, wherein the polyurethane foam comprises a plurality of holes configured to prevent or reduce the entry of fluid into the polyurethane foam.

15. The surgical aid 604 according to claim 14, wherein the plurality of holes include (i) having an average diameter of the plurality of holes that forms a gradient or double gradient with respect to a first side of the polyurethane foam, (ii) being aligned in one direction to direct the entry of fluid into the polyurethane foam, and (iii) closed-cell pores, or a combination thereof.

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