Adjusting use of a tissue appendage using smart packaging

Abstract

Generally, the systems and methods described herein include active or passive sensing mechanisms, such as sensors, that can monitor at least one exposure condition of an adjunct and any medicament held therein. In some cases, these active or passive sensing mechanisms can also track the extent of exposure (e.g., frequency, intensity, and / or duration) of the adjunct and the medicament.

Description

Technical Field

[0001] This disclosure relates in general to organizational appendages and methods of using organizational appendages. Background Technology

[0002] Surgical sutures are used in surgical procedures to close openings in tissues, blood vessels, catheters, shunts, or other objects or body parts involved in a particular surgical procedure. These openings can be naturally occurring, such as passages in blood vessels or internal organs similar to the stomach, or they can be created by a surgeon during the surgical procedure, such as by puncturing tissue or blood vessels to create bypasses or anastomoses or by cutting tissue during suturing.

[0003] Most suture devices have a handle with an elongated shaft having a pair of movable, opposing jaws formed at its end for holding and shaping staples between the jaws. The staples are typically housed in a staple cartridge that holds multiple rows of staples and is usually positioned in one of the two jaws for ejecting the staples to the surgical site. During use, the jaws are positioned such that the object to be sutured is positioned between the jaws, and the staples are ejected and shaped when the jaws are closed and the device is actuated. Some suture devices include a blade configured to travel between rows of staples in the staple cartridge to longitudinally cut and / or open sutured tissue between the rows of staples.

[0004] Despite years of improvement, surgical staplers still present several problems. One common issue is leakage that can occur when the staple penetrates tissue or other objects in which it is placed, creating a hole. Blood, air, gastrointestinal fluids, and other fluids can leak through the opening formed by the staple, even after the staple is fully formed. The treated tissue can also become inflamed due to the trauma caused by the suture.

[0005] Applying an appendage to the tissue at the surgical site can be beneficial. For example, the appendage can be used to prevent blood, air, gastrointestinal fluids, and other fluids from seeping through the opening formed by the appendage. Alternatively, the appendage may contain a medication configured to be released from the appendage after it has been applied to the tissue. The medication may be configured to provide one or more benefits for healing, such as promoting hemostasis, reducing inflammation, and stimulating cell proliferation.

[0006] The appendage can be absorbable. Absorbable appendages allow the appendage to dissolve or degrade within the patient's body, thus eliminating the need for additional surgery or other procedures to remove it. In cases where the appendage contains a drug, absorbable appendages facilitate the automatic release of the drug from the appendage when it dissolves or degrades. However, the drug and / or the materials forming the absorbable appendage can be adversely affected by any of a variety of factors between packaging and using the appendage. For example, environmental factors may reduce the effectiveness of the drug and / or may cause the appendage to begin degrading before it is implanted in the patient's body. As another example, the drug may expire before the drug-containing appendage is implanted in the patient's body.

[0007] Therefore, improvements to the appendages are still needed. Summary of the Invention

[0008] Various systems and methods are provided for using smart packaging to adjust the use of organizational appendages.

[0009] In one aspect, a surgical system is provided. In one embodiment, the surgical system includes: a bioabsorbable appendage configured to be implanted into a patient's body using a surgical suture device; a medicament releasably held by the appendage and configured to be released from the appendage into the patient's body; a packaging unit packaging the appendage and the medicament; and a sensor configured to collect data on exposure conditions of at least one of the appendage and the medicament, wherein the packaging unit packages the appendage and the medicament. The exposure conditions are conditions affecting the performance of at least one of the appendage and the medicament in the patient's body. The surgical system also includes a processor configured to: receive the data collected by the sensor; determine a recommendation for the use of the appendage and the medicament in the surgical procedure based on the received data and the requirements of the surgical procedure; and cause a notification of the recommendation to be provided to a practicing physician. The practicing physician may be a person associated with the surgical procedure.

[0010] The surgical system can have any number of variations. For example, the recommendation may include a recommended shelf life for the appendage and the drug. Alternatively, the recommendation may include recommended indications for the appendage and the drug. Another example is that the recommendation may include recommended contraindications for the appendage and the drug. Yet another example is that the recommendation may include a recommended shelf life for the appendage and the drug based at least on data collected regarding the exposure condition, and the recommendation may include at least one of recommended indications and recommended contraindications for the appendage and the drug, and the at least one of the recommended indications and recommended contraindications is based at least on the requirements of the surgical procedure. Yet another example is that the recommendation may include a recommended time after opening the packaging unit for the appendage to be implanted into the patient's body during the surgical procedure within that recommended time. Yet another example is that the requirements of the surgical procedure are specific to a threshold appendage durability for a type of surgery, and determining the recommendation may include comparing that threshold appendage durability with the durability of the appendage indicated by the collected data regarding the exposure condition. For example, the environmental conditions may include at least one of light and temperature. Alternatively, the environmental conditions may include at least one of humidity, oxygen, time, light, vibration, and atmospheric pressure. Alternatively, the packaging unit may include the sensor. Alternatively, a surgical hub external to the packaging unit may include the processor. Alternatively, the processor may be configured to set the operating parameters of the surgical stapler based on the received data.

[0011] In another aspect, a method is provided, in one embodiment, comprising: receiving, at a computer system external to the packaging unit, data collected by sensors of the packaging unit indicative of exposure conditions of the packaging unit, wherein the packaging unit contains a releasably held medication and is configured to be implanted using a surgical suture device; the exposure conditions are conditions affecting the performance of at least one of the appendage and the medication in the patient; the method further comprises: determining, at the computer system, a recommendation for the use of the appendage and the medication in the surgical procedure based on the received data indicative of the exposure conditions and the requirements of the surgical procedure; the method further comprises: providing notification of the recommendation to a practicing physician, who may be a person associated with the surgical procedure.

[0012] This method can be varied in several ways. For example, the recommendation may include a recommended shelf life for the appendage and the medication. Alternatively, the recommendation may include recommended indications for the appendage and the medication. Another example is that the recommendation may include recommended contraindications for the appendage and the medication. Yet another example is that the recommendation may include a recommended time after opening the packaging unit for the appendage to be implanted into the patient during the surgical procedure within that recommended time. Furthermore, the requirement of the surgical procedure may be specific to a threshold appendage durability for a type of surgery, and determining the recommendation may include comparing that threshold appendage durability with the durability of the appendage indicated by collected data regarding the exposure condition. Again, the requirement of the surgical procedure may be specific to at least one of the patient to whom the surgery will be performed and the surgeon performing the surgery. Finally, the method may further include: collecting the data using the sensor of the packaging unit before opening the packaging unit; and transmitting the data to be received at the computer system using the communication interface of the packaging unit. For example, the environmental conditions may include at least one of light, temperature, humidity, oxygen, time, vibration, and atmospheric pressure. Furthermore, the method may also include: the processor setting operating parameters of the surgical suture device based on the received data. Attached Figure Description

[0013] The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

[0014] Figure 1 This is a perspective view of an exemplary embodiment of a conventional surgical suturing and cutting instrument;

[0015] Figure 2 It is used with Figure 1 A top view of a staple cartridge used in conjunction with surgical suturing and cutting instruments;

[0016] Figure 3 for Figure 1 A perspective view of the firing pin of a surgical stapler, with an electron beam at its distal end;

[0017] Figure 4 This is a perspective view of another embodiment of the surgical suture device;

[0018] Figure 5 This is a perspective view of yet another implementation of the surgical suture device;

[0019] Figure 6 A longitudinal sectional view of an exemplary embodiment of a staple cartridge having an exemplary appendage attached to the top surface or platform surface of the staple cartridge;

[0020] Figure 7 It is shown Figure 6 A partial schematic diagram of an appendage in an organized deployment state;

[0021] Figure 8 This is a schematic diagram of an exemplary embodiment of a communication network, which includes a processor and a packaging unit.

[0022] Figure 9 This is a partial cross-sectional perspective view of another embodiment of the packaging unit;

[0023] Figure 10 This is a perspective view of another embodiment of a communication network, which includes another embodiment of a packaging unit, an exemplary embodiment of a surgical hub, and another embodiment of a surgical suture device;

[0024] Figure 11 This is a schematic diagram of another implementation scheme for a communication network;

[0025] Figure 12 This is a schematic diagram of an exemplary implementation of a computer system;

[0026] Figure 13 This is a schematic diagram of an exemplary implementation of a computer-based interactive surgical system;

[0027] Figure 14 This is a schematic diagram of an exemplary implementation of a surgical data network;

[0028] Figure 15 This is a logic diagram of an exemplary implementation of a control system for surgical instruments;

[0029] Figure 16 It is a graph showing the exposure conditions and shelf life over time;

[0030] Figure 17 It is a graph showing the exposure conditions, adhesion, and acceptable application over time;

[0031] Figure 18 This is a flowchart of an exemplary implementation of a method for establishing component compatibility;

[0032] Figure 19 This is a schematic diagram of another embodiment of a communication network, which includes another embodiment of a packaging unit and another embodiment of a computer system;

[0033] Figure 20 This is a schematic diagram of another embodiment of a communication network, which includes another embodiment of a packaging unit and another embodiment of a surgical hub;

[0034] Figure 21 This is a longitudinal sectional view of another embodiment of the packaging unit, wherein the lid of the packaging unit is closed;

[0035] Figure 22 yes Figure 21 A longitudinal sectional view of the packaging unit, with the lid of the packaging unit open;

[0036] Figure 23 It is a perspective view of another embodiment of an imaging system located outside the patient's body and an appendage pinned inside the patient;

[0037] Figure 24 This is a perspective view of an exemplary embodiment of a nail with attachments thereon;

[0038] Figure 25 It is applied to the tissue. Figure 24 A partial cross-sectional side view of the nail; and

[0039] Figure 26 It has a nail applied to it and multiple additional nails. Figure 25 A reduced perspective view of the organization. Detailed Implementation

[0040] Certain exemplary embodiments will now be described to provide a comprehensive understanding of the principles of the structure, function, manufacture, and use of the apparatuses and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the apparatuses and methods specifically described herein and illustrated in the drawings are non-limiting exemplary embodiments, and the scope of this disclosure is defined only by the claims. Features shown or described in conjunction with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the invention.

[0041] Furthermore, in this disclosure, components with similar names in various embodiments generally have similar features; therefore, in specific embodiments, not every feature of every component with a similar name is necessarily fully described. Additionally, the extent to which linear or circular dimensions are used in the description of the disclosed systems, devices, and methods is not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be readily determined for any geometry. The size and shape of systems and devices and their components may depend at least on the anatomy of the patient in which the system and device will be used, the size and shape of the components with which the system and device will be used, and the method and procedure in which the system and device will be used.

[0042] It should be understood that the terms "proximal" and "distal" are used in this article in relation to the user who grips the instrument handle, such as a clinician. Other spatial terms such as "anterior" and "posterior" similarly correspond to distal and proximal, respectively. It should also be understood that, for convenience and clarity, spatial terms such as "vertical" and "horizontal" are used in the illustrations. However, surgical instruments are used in many orientations and positions, and these spatial terms are not restrictive or absolute.

[0043] Various exemplary devices and methods for performing surgical procedures are provided. In some embodiments, the devices and methods are configured for open surgery, and in other embodiments, they are configured for laparoscopic, endoscopic, and other minimally invasive surgical procedures. These devices can be fired directly by a human user or remotely under the direct control of a robot or similar manipulator. However, those skilled in the art will understand that the various methods and devices disclosed herein can be used in many surgical procedures and applications. Those skilled in the art will further understand that the various instruments disclosed herein can be inserted into the body in any manner, such as through natural orifices, through incisions or perforations formed in tissue, or through an access device (such as a cannula). For example, the working portion or end effector portion of the instrument can be inserted directly into the patient's body or can be inserted through an access device having an end effector of the surgical instrument and a working channel through which an elongated shaft can be advanced.

[0044] It is anticipated that the use of one or more biomaterials and / or synthetic materials (referred to herein as “appendages”) in conjunction with surgical instruments can help improve surgical procedures. “Appendages” are also referred to herein as “appendage materials.” While a variety of different surgical end effectors can benefit from the use of appendages, in some exemplary embodiments, the end effector may be a surgical stapler. When used in conjunction with a surgical stapler, the one or more appendages may be positioned between and / or on the stapler jaws, integrated into a staple cartridge disposed within the jaws, or otherwise placed adjacent to the staple. When the staple is deployed, the one or more appendages can remain at the treatment site with the staple, thereby providing numerous benefits. For example, the one or more appendages can reinforce the tissue at the treatment site, preventing it from being torn or ripped apart by the staple. If the tissue is diseased, healing, and / or undergoing another change in tissue properties, tissue reinforcement may be required to prevent the staple from tearing the tissue. In some cases, appendages can minimize tissue movement (e.g., lung expansion, gastrointestinal distension, etc.) in and around the staple perforation site, which can occur due to tissue deformation that occurs after suturing. Those skilled in the art will recognize that the nail puncture site can act as a stress concentration point, and the size of the hole formed by the nail will increase when the surrounding tissue is under tension. Restricting the movement of the tissue around these puncture sites minimizes the size to which the hole can increase under tension. In some cases, the one or more appendages may be configured to wick or absorb beneficial fluids that further promote healing, such as sealants, blood, glue, etc., and in some cases, the one or more appendages may be configured to degrade to form gels that further promote healing, such as sealants. In some cases, the one or more appendages may be used to help seal the hole formed by the nail when it is implanted in tissue, blood vessels, and various other objects or body parts.

[0045] In other embodiments, the one or more appendages may be used with surgical instruments configured to seal tissue without the use of nails (e.g., by using energy, such as RF or ultrasound), for example, as described in U.S. Patent No. 10,172,611, the entire contents of which are incorporated herein by reference.

[0046] In some cases, the one or more appendages may be configured to compensate for changes in tissue thickness as the appendages are sutured to the tissue. In such cases, the appendage may also be referred to as a "tissue thickness compensator." The tissue thickness compensator has an uncompressed (undeformed) or pre-deployed height that is greater than the height of the staple in its shaped configuration. Additional details regarding exemplary tissue thickness compensators can be found, for example, in U.S. Patent No. 8,864,007, the entire contents of which are incorporated herein by reference. The tissue thickness compensator may be attached to and released from the staple cartridge in a variety of ways, for example, as described in U.S. Patents Nos. 9,272,406 and 10,136,890, each of which is incorporated herein by reference in its entirety.

[0047] In addition to the disclosure herein, further details relating to the one or more of these appendages and other exemplary appendages can be found, for example, in U.S. Patent Nos. 10,172,611 and 10,433,846 and U.S. Patent Application No. 17 / 009,769, filed September 1, 2020, entitled “Compressible Non-Fibrous Adjuncts,” each of which is incorporated herein by reference in its entirety.

[0048] Alternatively or additionally, the one or more appendages may be configured to promote inward tissue growth. In various cases, it is desirable to promote inward tissue growth within the implantable appendage to facilitate the healing of treated tissue (e.g., sutured tissue and / or cut tissue) and / or accelerate patient recovery. More specifically, inward tissue growth within the implantable appendage can reduce the incidence, extent, and / or duration of inflammation at the surgical site. Inward tissue growth within and / or around the implantable appendage can control the spread of infection at the surgical site, for example. Inward growth of blood vessels, particularly leukocytes, within and / or around the implantable appendage can resist infection in and / or surrounding the implantable appendage and adjacent tissues. Inward tissue growth can also facilitate the acceptance of foreign bodies (e.g., implantable appendages and nails) by the patient's body and reduce the likelihood of the patient's body rejecting the foreign body. Rejection of foreign bodies can lead to infection and / or inflammation at the surgical site.

[0049] Alternatively or additionally, one or more agents may be present on and / or therein of the one or more appendages. The one or more agents may vary depending on the desired effect of the one or more agents on the surrounding tissue. As a non-limiting example, the one or more agents may be provided to affect hemostasis, inflammation, macrophages, and / or fibroblasts. Also depending on the desired effect on the tissue, one or more agents may be mixed or combined in any combination, or a single agent may be provided. The one or more agents may be eluted from the one or more appendages in a variety of different ways. As a non-limiting example, the coating on the one or more appendages may be varied to be absorbed at different time points, thereby releasing the one or more agents at different time points; the one or more appendages may be varied to allow the one or more agents to diffuse through the one or more appendages at different rates; the one or more appendages may differ in molecular weight and / or physical properties, thereby causing the one or more agents to be released at different time points; etc. In addition to the disclosure herein, further details regarding drug-eluting appendages can be found in U.S. Patents 9,232,941 and 10,569,071, each of which is incorporated herein by reference in its entirety.

[0050] Surgical suture instruments

[0051] Various surgical instruments can be used in conjunction with one or more appendages and / or one or more agents disclosed herein. Surgical instruments may include surgical staplers. A variety of surgical staplers can be used, such as linear surgical staplers and circular staplers. Typically, linear staplers are configured to produce longitudinal staple sutures and may include elongated jaws having a magazine connected thereto to receive longitudinal staple rows. The elongated jaws may include a blade or other cutting element capable of making incisions between staple rows along tissue held within the jaws. Typically, circular staplers are configured to form annular staple sutures and may include circular jaws having a magazine receiving annular staple rows. Circular jaws may include a blade or other cutting element capable of making incisions within the staple rows to define an opening through tissue held within the jaws. Staplers can be used in a variety of different surgical procedures on a variety of tissues, such as thoracic surgery or gastric surgery.

[0052] Figure 1An example of a linear surgical stapler 10 suitable for use with one or more appendages and / or one or more agents is shown. The stapler 10 typically includes a handle assembly 12, a shaft 14 extending distally from a distal end 12d of the handle assembly 12, and an end effector 30 located at the distal end 14d of the shaft 14. The end effector 30 has opposing lower jaws and upper jaws 32, 34, but other types of end effectors may be used with the shaft 14, the handle assembly 12, and associated components. The lower jaw 32 has a staple channel 56 configured to support a staple cartridge 40, and the upper jaw 34 has an anvil surface 33 facing the lower jaw 32 and configured to operate as an anvil to aid in the deployment of staples from the staple cartridge 40. Figure 1 and Figure 2 (The central nail is obstructed). At least one of the opposing lower jaws and upper jaws 32, 34 is movable relative to the other to clamp tissue and / or other objects disposed therebetween. In some embodiments, at least one of the opposing lower jaws and upper jaws 32, 34 may be fixed or otherwise immovable. In some embodiments, both the opposing lower jaws and upper jaws 32, 34 may be movable. Components of the firing system may be configured to pass through at least a portion of the end effector 30 to eject the nail into the clamped tissue. In various embodiments, a blade 36 or other cutting element may be associated with the firing system to cut tissue during suturing.

[0053] Operation of the end effector 30 can begin with input from a user (e.g., a clinician, surgeon, etc.) at the handle assembly 12. The handle assembly 12 can have many different configurations designed to manipulate and operate the associated end effector 30. In the illustrated example, the handle assembly 12 has a pistol grip housing 18 with various mechanical and / or electronic components disposed therein to operate the instrument 10. For example, the handle assembly 12 may include a knob 26 mounted adjacent to its distal end 12d, which may facilitate rotation of the shaft 14 and / or the end effector 30 about the longitudinal axis L of the shaft 14 relative to the handle assembly 12. The handle assembly 12 may also include a clamping element as part of a clamping system actuated by a clamping trigger 22 and a firing element as part of a firing system actuated by a firing trigger 24. The clamping trigger 22 and the firing trigger 24 may be biased, for example, by a torsion spring to an open position relative to the fixed handle 20. Movement of the clamping trigger 22 toward the fixed handle 20 actuates the clamping system, as described below, which causes the jaws 32, 34 to collapse toward each other and thereby clamp the tissue between them. Movement of the firing trigger 24 actuates the firing system, as described below, which ejects the nail from the nail magazine 40 in which it is disposed and / or advances the blade 36 to cut the tissue trapped between the jaws 32, 34. Those skilled in the art will recognize that various configurations (mechanical, hydraulic, pneumatic, electromechanical, robotic, or other) of the firing system can be used to eject the nail and / or cut the tissue.

[0054] like Figure 2 As shown, the end effector 30 of the illustrated embodiment has a lower jaw 32 that serves as a cartridge assembly or carrier and an opposing upper jaw 34 that serves as an anvil. A staple cartridge 40, containing a plurality of staples, is supported in a staple tray 37, which in turn is supported within a cartridge channel of the lower jaw 32. The upper jaw 34 has a plurality of staple-forming recesses (not shown), each positioned above a corresponding staple from the plurality of staples housed within the staple cartridge 40. Although in the illustrated embodiment, the upper jaw 34 has a proximal pivoting end 34p only on its distal side of engagement with the shaft 14, which is pivotally received within the proximal end 56p of the staple channel 56, the upper jaw 34 can be connected to the lower jaw 32 in various ways. When the upper jaw 34 pivots downward, it moves the anvil surface 33 and causes the staple-forming recesses formed thereon to move toward the opposing staple cartridge 40.

[0055] Various clamping components can be used to open and close the jaws 32 and 34 to selectively clamp tissue between them. As shown, the pivoting end 34p of the upper jaw 34 includes a closing feature structure 34c distal to its pivot attachment to the pin channel 56. Thus, in response to the clamping trigger 22, the closing tube 46 selectively imparts an opening action to the upper jaw 34 during proximal longitudinal movement and a closing action to the upper jaw 34 during distal longitudinal movement, the distal end of which includes a horseshoe-shaped hole 46a engaging the closing feature structure 34c. As described above, in various embodiments, the opening and closing of the end effector 30 can be achieved by the relative movement of the lower jaw 32 relative to the upper jaw 34, the relative movement of the upper jaw 34 relative to the lower jaw 32, or by the movement of both jaws 32 and 34 relative to each other.

[0056] The firing mechanism shown in the specific embodiment includes, for example: Figure 3 The figure shows a firing lever 35 with an electron beam 38 at its distal end. The firing lever 35 is included within a shaft 14, for example, in a longitudinal firing lever slot 14s of the shaft 14, and is guided by a firing action from the shank 12. Actuation of the firing trigger 24 can affect the distal action of the electron beam 38 through at least a portion of the end effector 30, thereby causing the firing of a nail housed in the nail cartridge 40. As shown, a guide 39 protruding from the distal end of the electron beam 38 can engage... Figure 2 The wedge-shaped slider 47 shown in the diagram then pushes the nail driver 48 upward through the nail cavity 41 formed in the nail magazine 40. The upward movement of the nail driver 48 applies an upward force to each of the plurality of nails in the magazine 40, thereby pushing the nail upward against the anvil surface 33 of the upper jaw 34 and producing a shaped nail.

[0057] In addition to firing the nail, the electron beam 38 is also configured to facilitate the closure of jaws 32, 34, the separation of the upper jaw 34 relative to the nail cartridge 40, and / or the cutting of tissue captured between jaws 32, 34. Specifically, a pair of top pins and a pair of bottom pins can engage one or both of the upper and lower jaws 32, 34 to compress jaws 32, 34 toward each other as the firing rod 35 advances through the end effector 30. Simultaneously, a blade 36 extending between the top and bottom pins is configured to cut the tissue captured between jaws 32, 34.

[0058] In use, the surgical stapler 10 can be placed in a cannula or mouth and positioned at the surgical site. The tissue to be cut and sutured can be placed between the jaws 32, 34 of the surgical stapler 10. The characteristic structure of the stapler 10 can be manipulated by the user as needed to achieve the desired position of the jaws 32, 34 at the surgical site and the tissue relative to the jaws 32, 34. After proper positioning has been achieved, the clamping trigger 22 can be pulled toward the fixed handle 20 to actuate the clamping system. The trigger 22 actuates a component of the clamping system, causing the closing tube 46 to be advanced distally through at least a portion of the shaft 14 to cause at least one of the jaws 32, 34 to collapse toward the other to clamp the tissue positioned between them. The trigger 24 can then be pulled toward the fixed handle 20 to actuate a component of the firing system, causing the firing rod 35 and / or the electron beam 38 to be advanced distally through at least a portion of the end effector 30 to fire the staple and optionally sever the tissue trapped between the jaws 32, 34.

[0059] Another example of a surgical instrument in the form of a linear surgical suture device 50 is shown in Figure 4 In the middle. The suture device 50 can usually be used with Figure 1 The suture device 10 is similarly constructed and used. Similar to... Figure 1 The surgical instrument 10, surgical instrument 50 includes a handle assembly 52 having a shaft 54 ​​extending distally from the handle assembly and having an end effector 60 for treating tissue at the distal end of the shaft. The upper and lower jaws 64, 62 of the end effector 60 are configured to capture tissue between them, suture the tissue by firing a pin from a cartridge 66 disposed in the lower jaw 62, and / or create an incision in the tissue. In this specific embodiment, an attachment portion 67 on the proximal end of the shaft 54 ​​is configured to allow the shaft 54 ​​and the end effector 60 to be removably attached to the handle assembly 52. ​​Specifically, a mating feature structure 68 of the attachment portion 67 can mate with a complementary mating feature structure 71 of the handle assembly 52. ​​The mating features structures 68, 71 can be configured to be coupled together via, for example, snap-fit ​​couplings, bayonet couplings, etc., but any number of complementary mating features and any type of coupling can be used to removably attach the shaft 54 ​​to the handle assembly 52. While the entire shaft 54 ​​in the illustrated embodiment is configured to be detachable from the handle assembly 52, in some embodiments, the attachment portion 67 is configured to allow only the distal portion of the shaft 54 ​​to be detached. This detachable connection of the shaft 54 ​​and / or the end effector 60 allows for selective attachment of the desired end effector 60 for a specific procedure, and / or reuse of the handle assembly 52 for multiple different procedures.

[0060] The handle assembly 52 may have one or more features located thereon for manipulating and operating the end effector 60. As a non-limiting example, a knob 72 mounted on the distal end of the handle assembly 52 may facilitate rotation of the shaft 54 ​​and / or the end effector 60 relative to the handle assembly 52. ​​The handle assembly 52 may include a clamping member as part of a clamping system actuated by a movable trigger 74 and a firing member as part of a firing system also actuated by the trigger 74. Thus, in some embodiments, movement of the trigger 74 toward the fixed handle 70 through a first range of motion actuates the clamping member, causing opposing jaws 62, 64 to approach each other to a closed position. In some embodiments, only one of the opposing jaws 62, 64 may move to the closed position. The trigger 74 moves further toward the fixed handle 70 through the second action range to actuate the firing member, causing the nail to be ejected from the nail magazine 66 and / or causing the advance of a knife or other cutting element (not shown) to cut the tissue captured between the jaws 62, 64.

[0061] An example of a surgical instrument in the form of a circular surgical suture device 80 is shown in Figure 5 In the middle. The suture device 80 is typically compatible with... Figure 1 and Figure 4 The linear suture devices 10 and 50 are similarly constructed and used, but some of their features are adapted to their function as circular suture devices. Similar to surgical instruments 10 and 50, surgical instrument 80 includes a handle assembly 82 and a shaft 84 extending distally from the handle assembly, with an end effector 90 for treating tissue at the distal end of the shaft. The end effector 90 may include a cartridge assembly 92 and an anvil 94, each having a tissue contact surface that is substantially circular in shape. The cartridge assembly 92 and anvil 94 may be coupled together via a shaft 98 extending from the anvil 94 to the handle assembly 82 of the suture device 80, and an actuator 85 on the handle assembly 82 may retract and advance the shaft 98 to move the anvil 94 relative to the cartridge assembly 92. The anvil 94 and cartridge assembly 92 can perform various functions and can be configured to capture tissue between them, suture tissue by firing staples from a cartridge 96 of the cartridge assembly 92, and / or create incisions in the tissue. Generally speaking, the chamber assembly 92 can accommodate a chamber containing nails, and the nails can be deployed against the anvil 94 to form a circular nail pattern, such as nails surrounding the periphery of a tubular main organ.

[0062] In one embodiment, shaft 98 may be formed of a first portion and a second portion (not shown) configured to be releasably coupled together to allow disengagement of the anvil 94 from the storage chamber assembly 92, allowing greater flexibility in positioning the anvil 94 and storage chamber assembly 92 within the patient's body. For example, the first portion of shaft may be disposed within the storage chamber assembly 92 and extend distally beyond it, terminating in a distal mating feature. The second portion of shaft may be disposed within the anvil 94 and extend proximally beyond it, terminating in a proximal mating feature. In use, the proximal and distal mating features may be coupled together to allow movement of the anvil 94 and storage chamber assembly 92 relative to each other.

[0063] The shank assembly 82 of the stapler 80 may have various actuators disposed thereon capable of controlling the movement of the stapler. For example, the shank assembly 82 may have a knob 86 disposed thereon for positioning the end effector 90 by rotation, and / or a trigger 85 for actuating the end effector 90. Movement of the trigger 85 toward the fixed shank 87 through a first range of motion may actuate a component of the clamping system toward the jaws, for example, moving the anvil 94 toward the cartridge assembly 92. Movement of the trigger 85 toward the fixed shank 87 through a second range of motion may actuate a component of the firing system to deploy a staple from the cartridge assembly 92 and / or advance the blade to cut tissue captured between the cartridge assembly 92 and the anvil 94.

[0064] The illustrated examples of surgical suturing instruments 10, 50, and 80 are merely a few examples of many different configurations and associated methods of use that can be used in conjunction with the disclosure provided herein. While the illustrated examples are all configured for use in minimally invasive surgery, it should be understood that instruments configured for use in open surgery, such as the open linear suture device described in U.S. Patent No. 8,317,070, filed February 28, 2007, entitled “Surgical Stapling Devices That Produce Formed Staples Having Different Lengths,” can be used in conjunction with the disclosure provided herein. Further details of the examples shown, as well as additional examples of surgical suture devices, their components, and related methods of use, are provided in the following patents: U.S. Patent Publication No. 2013 / 0256377, filed February 8, 2013, entitled “Layer Comprising Deployable Attachment Members”; U.S. Patent No. 8,393,514, filed September 30, 2010, entitled “Selectively Orientable Implantable Fastener Cartridge”; U.S. Patent No. 8,317,070, filed February 28, 2007, entitled “Surgical Stapling Devices That Produce Formed Staples Having Different Lengths”; and U.S. Patent No. 7,143, filed June 21, 2005, entitled “Surgical Instrument Incorporating EAP Blocking Lockout Mechanism”.U.S. Patent No. 925, filed November 8, 2013, entitled "Sealing Materials For Use in Surgical Stapling"; U.S. Patent No. 2015 / 0134077, filed November 8, 2013, entitled "Sealing Materials for Use in Surgical Procedures"; U.S. Patent No. 2015 / 0134076, filed November 8, 2013, entitled "Hybrid Adjunct Materials for Use in Surgical Stapling"; U.S. Patent No. 2015 / 0133996, filed November 8, 2013, entitled "Positively Charged Implantable Materials and Method of Forming the Same"; and U.S. Patent No. 2015 / 0133996, filed November 8, 2013, entitled "Tissue Ingrowth Materials and Method of Using the U.S. Patent Publication No. 2015 / 0129634 entitled "Same", U.S. Patent Publication No. 2015 / 0133995 entitled "Hybrid Adjunct Materials for Use in Surgical Stapling" filed November 8, 2013, U.S. Patent Application No. 14 / 226,142 entitled "Surgical Instrument Comprising a Sensor System" filed March 26, 2014, and U.S. Patent Application No. 14 / 300,954 entitled "Adjunct Materials and Methods of Using Same in Surgical Methods for Tissue Sealing" filed June 10, 2014, are all incorporated herein by reference in their entirety.

[0065] Implantable appendages

[0066] As noted above, various implantable appendages are provided for use in conjunction with surgical suture instruments. When used in conjunction with a surgical suture device, one or more of these appendages may be positioned between and / or on the jaws of the suture device, integrated into a staple cartridge disposed within the jaws, or otherwise placed adjacent to the staples. For example, as... Figure 6 As shown, the accessory 104 is positioned against the staple cartridge 102. For simplicity, the accessory 104 is typically located at... Figure 6 The various structural configurations of the appendages are shown below, and are described in more detail below. Although in Figure 6 The center is partially obscured, but the staple cartridge 102 includes staples 106 configured to be deployed into tissue. Staples 106 may have any suitable unformed (pre-deployed) height. For example, staples 106 may have an unformed height between approximately 2 mm and 4.8 mm. Prior to deployment, the crown of the staple may be supported by a staple driver (not shown).

[0067] In the illustrated embodiments, the appendage 104 may releasably engage with at least a portion of the top surface or platform surface 108 of the staple cartridge 102. In some embodiments, the top surface 108 of the staple cartridge 102 may include one or more surface feature structures. Alternatively or additionally, one or more adhesives may be used to releasably engage the appendage with the staple cartridge 102. The one or more surface feature structures and / or the one or more adhesives may be configured to engage the appendage 104 to prevent undesired movement of the appendage 104 relative to the staple cartridge 102 and / or to prevent premature release of the appendage 104 from the staple cartridge 102. Exemplary surface feature portions are described in U.S. Patent Publication 2016 / 0106427, the entire contents of which are incorporated herein by reference. Additional details regarding adhesives and other exemplary adhesives for temporary attachment to devices can be found in U.S. Patents 9,282,962, 10,172,617, 10,172,618, 10,258,332, 10,517,592, 10,548,593, 10,568,621, and 10,588,623, each of which is incorporated herein by reference in its entirety. Additional details regarding attachment methods and other exemplary methods can be found in U.S. Patents 10,166,023 and 10,349,939 and U.S. Patent Application 17 / 022,520, filed September 16, 2020, entitled “Method of Applying Buttress to End Effector of Surgical Stapler,” each of which is incorporated herein by reference in its entirety.

[0068] In some cases, the appendage can be compressible to allow it to compress to different heights, thereby compensating for varying tissue thicknesses trapped within the deployed nail. For example, as... Figure 6 As shown, the appendage 104 has an uncompressed (undeformed) or pre-deployed height and is configured to deform to one of a plurality of compressed (deformed) or deployment heights. Therefore, the appendage 104 may have a firing height greater than that of the nail 106 disposed within the nail magazine 102 (e.g., Figure 7The uncompressed height (H) of the firing pin 106a. That is, the appendage 104 may have an undeformed state in which the maximum height of the appendage 104 is greater than the maximum height of the firing pin (e.g., a pin in a shaped configuration). In such cases, the appendage may be referred to as a "tissue thickness compensation member". In one embodiment, the uncompressed height of the appendage 104 may be about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or about 100% higher than the firing height of the pin 106. In some embodiments, for example, the uncompressed height of the appendage 104 may be more than 100% higher than the firing height of the pin 106.

[0069] The appendage can have various configurations and can be formed from a variety of materials. Typically, the appendage can be formed from one or more of the following: membranes, foams, injection-molded thermoplastics, vacuum thermoforming materials, fibrous structures, additive manufacturing materials, and mixtures thereof. The appendage may also include one or more bio-derived materials and one or more pharmaceuticals. Each of these materials is discussed in more detail below.

[0070] The appendages can be formed from foams, such as closed-cell foams, open-cell foams, or sponges. An example of how such appendages can be manufactured is from animal-derived collagen (such as porcine tendons), which can then be processed and freeze-dried into a foam structure. Examples of various foam appendages are further described in the previously mentioned U.S. Patent No. 8,393,514, entitled “Selectively Orientable Implantable Fastener Cartridge,” filed September 30, 2010, the entire contents of which are incorporated herein by reference.

[0071] The appendage may also be formed from a membrane of any suitable material or combination thereof discussed below. The membrane may comprise one or more layers, each layer having a different degradation rate. Furthermore, the membrane may have various regions formed therein, for example, reservoirs capable of releasably retaining one or more different forms of a pharmaceutical agent. One or more different coatings may be used to seal the reservoir containing at least one pharmaceutical agent; these coatings may comprise absorbable or non-absorbable polymers. The membrane may be formed in various ways, for example, it may be an extruded molding membrane or a compression molding membrane.

[0072] The appendage may also be formed from injection-molded thermoplastic or vacuum-formed materials. Examples of various molded appendages are further described in U.S. Patent Publication 2013 / 0221065, filed February 8, 2013, entitled “Fastener Cartridge Comprising A Releasably Attached Tissue Thickness Compensator,” the entire contents of which are incorporated herein by reference. The appendage may also be a fiber-based lattice, which can be woven, knitted, or nonwoven, such as a loosely woven fabric formed by meltblowing, needle punching, or thermal construction. The appendage may have multiple regions that can be formed from lattices of the same type or different types, which can be combined to form the appendage in a variety of different ways. For example, fibers may be woven, braided, knitted, or otherwise interconnected to form regular or irregular structures. Fibers may be interconnected such that the resulting appendage is relatively loose. Alternatively, the appendage may comprise tightly interconnected fibers. The appendage may be in the form of a sheet, tube, spiral, or any other structure that may include flexible portions and / or more rigid reinforcing portions. Appendages can be configured to allow for denser fibers in certain areas and lower-density fibers in other areas. Depending on the intended application of the appendage, the fiber density can vary in different directions along one or more dimensions of the appendage.

[0073] In other embodiments, the appendages may be formed using a 3D printing process compatible with the absorbable polymer. Non-limiting examples of suitable 3D printing processes include stereolithography (SLA or SL), material jetting, selective laser sintering (SLS), and filament fabrication as understood by those skilled in the art.

[0074] The appendages can also be hybrid constructs, such as laminated composites or melt-interlocked fibers. Examples of various hybrid constructs are further described in the following patents: U.S. Patent Publication 2013 / 0146643, filed February 8, 2013, entitled "Adhesive FilmLaminate," and U.S. Patent Publication 7,601,118, filed September 12, 2007, entitled "Minimally Invasive Medical Implant And Insertion Device And Method For Using The Same," which are incorporated herein by reference in their entirety.

[0075] Material

[0076] The appendages according to the technology can be formed from a variety of materials. These materials can be used in various embodiments for different purposes. These materials can be selected according to the desired treatment to be delivered to the tissue in order to facilitate tissue ingrowth. The materials described below can be used to form appendages in any desired combination.

[0077] These materials may include bioabsorbable polymers and biocompatible polymers, including homopolymers and copolymers. Non-limiting examples of homopolymers and copolymers include p-dioxane (PDO or PDS), polyglycolic acid (PGA) (e.g., Dexon and Neoveil), poly(lactic-co-glycolic acid copolymer) (PLGA), polycaprolactone (PCL), polyglycolic acid (PGL), trimethylene carbonate (TMC), polylactic acid (PLA) (e.g., Linvatec Bioscrew and Bionx Implants SmartScrew), poly(trimethylene carbonate) (PTMC), polyethylene diglycolate (PEDG), poly(propylene fumarate) (PPF), polyvinyl ether (PEE), poly(ethylene glycol) (PEG), poly(N-isopropylacrylamide), poly(amino acids), poly(epoxy carbonate), poly(propylene 2-oxide carbonate), poly(diol citrate), polymethacrylate anhydride, poly(ethoxyethylene diglycolate), poly(glycolic acid-lactic acid copolymer) (PLA / PGA) (e.g., for Vicryl, Vicryl PLA / PGA materials from Rapide, PolySorb, and Biofix, polyurethanes (such as Elastane, Biospan, Tecoflex, Bionate, and Pellethane fibers), polyorthoesters, polyanhydrides (e.g., Gliadel and Biodel polymers), polyoxyesters, polyesteramides (e.g., REVA ReZolve scaffolds), and tyrosine-based polyesteramides (e.g., TYRX). Copolymers may also include poly(lactic acid-polycaprolactone copolymer) (PLA / PCL) (e.g., hydrolyzed for 16-18 months), poly(L-lactic acid-polycaprolactone copolymer) (PLLA / PCL), poly(glycolic acid-trimethylene carbonate copolymer) (PGA / TMC) (e.g., Maxon), poly(glycolic acid-caprolactone copolymer) (PCL / PGA) (e.g., Monocryl and Capgly), PDS / PGA / TMC (e.g., Biosyn), PDS / PLA, PGA / PCL / TMC / PLA (e.g., Caprosyn), LPLA / DLPLA (e.g., Optima), PLGA-PCL (e.g., 15:85 (PCL: 50% D,L-lactide: 50% glycolide), 40:60 (PCL: 50% D,L-lactide: 50% glycolide), and 40:60 (PCL: 85%). D,L-lactide (15% glycolide), PLGA-PCL-PLGA and PLGA-PEG-PLGA.

[0078] The appendages may also include specialty polymer end groups, including (meth)acrylates and organically derived polymers. Non-limiting examples of organically derived polymers include those derived from collagen (e.g., Avitene, Endoavitene, Instat, Integran, Veritas, and microfibrillary collagen (MFC)).

[0079] The appendages may also include active agents, such as viable cell cultures (e.g., excised autologous tissue, reagents for stem cell therapy (e.g., Biosutures and Cellerix SL), hemostatic agents, and tissue healing agents). Non-limiting examples of hemostatic agents may include cellulose such as oxidized regenerated cellulose (ORC) (e.g., Surgicel and Interceed), fibrin / thrombin (e.g., Thrombin-JMI, TachoSil, Tiseel, Floseal, Evicel, TachoComb, Vivostat, and Everest), autologous platelet plasma, gelatin (e.g., Gelfilm and Gelfoam), hyaluronic acid such as microfibers (e.g., yarns and textile fabrics) or other hyaluronic acid-based structures or hyaluronic acid-based hydrogels. Hemostatic agents may also include polymeric sealants, such as, for example, bovine serum albumin and glutaraldehyde, human serum albumin and polyethylene crosslinking agents, and ethylene glycol and trimethylene carbonate. Polymer sealants may include FocalSeal surgical sealant developed by Focal Inc.

[0080] The appendages described herein are capable of releasably retaining at least one pharmaceutical agent, selectable from a large number of different agents. The agents include, but are not limited to, drugs or other agents having the desired function contained within or associated with the appendages. The agents include, but are not limited to, antimicrobial agents (such as antibacterial agents and antibiotics), antifungal agents, antiviral agents, anti-inflammatory agents, growth factors, analgesics, anesthetics, tissue matrix degradation inhibitors, anticancer agents, hemostatic agents, and other agents that induce biological responses.

[0081] Non-limiting examples of antimicrobial agents include ionic silver, aminoglycosides, streptomycin, polypeptides, bacitracin, triclosan, tetracycline, doxycycline, minocycline, demeclocycline, tetracycline, oxytetracycline, chloramphenicol, nitrofurans, furazolidone, nitrofurantoin, β-lactams, penicillin, amoxicillin, amoxicillin + clavulanic acid, azlocillin, flucloxacillin, ticarcillin, piperacillin + tazobactam, tebuconazole, and Biopiper. TZ, Piperacillin, Carbapenems, Imipenem, Meropenem, Ertapenem, Donipenem, Biapenem, Panipenem / Betamilon, Quinolones, Ciprofloxacin, Enoxacin, Gatifloxacin, Gemimifloxacin, Levofloxacin, Lomefloxacin, Moxifloxacin, Naproxic Acid, Norfloxacin, Sulfonamides, Sulfamiron, Sulfaacetyl, Sulfadiazine, Silver Sulfadiazine, Sulfamethazine, Sulfamethazine, Sulfamethoxazole, Sulfasylpyridinium, Sulfamethoxazole, Compound Sulfamethoxazole, Prontocillin, Lodosin, Geldermycin, Atrazine, Fidamycin, Glycopeptides Teicoplanin, vancomycin, tervanomycin, dabazomycin, orivoxil, lincosamides, clomacromycin, lincomycin, lipopeptides, dapoxetine, macrolides, azithromycin, clarithromycin, erythromycin, roxithromycin, tebuconazole, spiramycin, oxazolidinone, linezolid, aminoglycosides, amikacin, gentamicin, kanamycin, neomycin, netilmicin, tobramycin, paromomycin, cephalosporins, cefbiprexa, cefoloza, cefixime, fluoxetine, monoclonal cyclophosphamide, aztreonam, colistin, and polymyxin B.

[0082] Non-limiting examples of antifungal agents include triclosan, polyene, amphotericin B, candidiasis, ferulic acid, haramicin, natamycin, nystatin, sclerotinib, azoles, imidazoles, triazoles, thiazoles, allylamine, amorolfine, butenafine, naftifine, terbinafine, echinococcins, anisoflurane, caspoflurane, miafungin, ciclopirox olamine, and benzoic acid.

[0083] Non-limiting examples of antiviral agents include: uncoated inhibitors, such as, for example, amantadine, rimantadine, and pleconaril; reverse transcriptase inhibitors, such as, for example, acyclovir, lamivudine, antisense, fomivirsen, morpholino compounds, ribosylase, and rifampin; and virucidal agents, such as, for example, cyanovirin-N, griffithsin, scytovirin, α-lauroyl-L-arginine ethyl ester (LAE), and ionic silver.

[0084] Non-limiting examples of anti-inflammatory agents include nonsteroidal anti-inflammatory agents (e.g., salicylates, aspirin, diflunisal, propionic acid derivatives, ibuprofen, naproxen, fenolofen, and cloxoprofen), acetic acid derivatives (e.g., tometidine, sulindac, diclofenac sodium), enolic acid derivatives (e.g., piroxicam, meloxicam, doxicoxicam, and lornoxicam), anthranilic acid derivatives (e.g., mefenamic acid, meclofenamic acid, and flufenamic acid), selective COX-2 inhibitors (e.g., celecoxib (Celebrex), parecoxib, rofecoxib (Vox), sulfonylureas, nimesulide, and clotrimazole), immunoselective anti-inflammatory derivatives, corticosteroids (e.g., dexamethasone), and iNOS inhibitors.

[0085] Non-limiting examples of growth factors include cellular signaling molecules that stimulate cell growth, healing, remodeling, proliferation, and differentiation. Exemplary growth factors can be short-range (paracrine), long-range (endocrine), or autostimulatory (autocrine). Further examples of growth factors include growth hormones (e.g., recombinant growth factor, Nutropin, Humatrope, Genotropin, Norditropin, serotonin, omeprazole, and biosynthetic growth factors), epidermal growth factor (EGF) (e.g., inhibitors, gefitinib, erlotinib, afatinib, and cetuximab), heparin-bound EGF-like growth factors (e.g., epidermal regulatory factors, β-cytokinin, bimodalin, and Epigen protein), transforming growth factor α (TGF-α), neuromodulators 1-4, fibroblast growth factor (FGF), etc. FGFs (e.g., FGF1-2, FGF2, FGF11-14, FGF18, FGF15 / 19, FGF21, FGF23, FGF7 or keratinocyte growth factor (KGF), FGF10 or KGF2 and phenytoin), insulin-like growth factor (IGFs) (e.g., IGF-1, IGF-2 and platelet-derived growth factor (PDGF)), vascular endothelial growth factor (VEGFs) (e.g., inhibitors, bevacizumab, ranibizumab, VEGF-A, VEGF-B, VEGF-C, VEGF-D and becapprenomy).

[0086] Additional non-limiting examples of growth factors include cytokines such as granulocyte-macrophage colony-stimulating factor (GM-CSF) (e.g., inhibitors that suppress inflammatory responses and GM-CSF manufactured using recombinant DNA technology and via recombinant yeast-derived sources), granulocyte colony-stimulating factor (G-CSF) (e.g., filgrastim, levofloxacin, and eubrazol), tissue growth factor β (TGF-B), leptin, and interleukins (ILs) (e.g., IL-1a, IL-1b, konnabidiol, IL-2, adelin, interking, dentine, IL-3, IL-6, IL-8, IL-10, IL-11, and olprespin). Non-limiting examples of growth factors also include erythropoietin (e.g., dabepoetin, epcept, dynepo, epmax, neorecormon, silapo, and retacrit).

[0087] Non-restrictive examples of analgesics include anesthetics, opioids, morphine, codeine, oxycodone, hydrocodone, buprenorphine, tramadol, non-anesthetics, acetaminophen, paracetamol, nonsteroidal anti-inflammatory drugs, and flupirtine.

[0088] Non-limiting examples of anesthetics include local anesthetics (e.g., lidocaine, benzocaine, and ropivacaine) and general anesthetics.

[0089] Non-limiting examples of tissue matrix degeneration inhibitors that inhibit the action of metalloproteinases (MMPs) and other proteases include MMP inhibitors (e.g., exogenous MMP inhibitors, hydroxamic acid-based MMP inhibitors, barmasta (BB-94), ilomastasta (GM6001), marimastasta (BB2516), thiols, periodat (doxycycline), squaric acid, BB-1101, hydroxyurea, hydrazine, endogenous carbamoyl phosphate, β-lactams, and tissue inhibitors of MMPs (TIMPs)).

[0090] Non-limiting examples of anticancer agents include monoclonal antibodies, bevacizumab (Avastin), cell / chemical inducers, alkylating agents (e.g., bifunctional, cyclophosphamide, dichloromethyldiethylamine, chlorambucil, melphalan, monofunctional, nitrosourea, and temozolomide), anthracyclines (e.g., doxorubicin, epirubicin, idarubicin, mitoxantrone, and pentorubicin), cytoskeleton disruptors (e.g., paclitaxel and docetaxel), epothilone agents that limit cell division by inhibiting microtubule function, inhibitors of various enzymes required to block cell division or certain cellular functions, histone deacetylase inhibitors (e.g., vorinostat and romidesin), and topoisomers. Enzyme I inhibitors (e.g., irinotecan and topotecan), topoisomerase II inhibitors (e.g., etoposide, teniposide, and tafluposide), kinase inhibitors (e.g., bortezomib, erlotinib, gefitinib, imatinib, vemurafenib, and vemodigine), nucleotide analogs (e.g., azacitidine, azathioprine, capecitabine, cytarabine, deoxyfluorouridine, fluorouracil, 5-FU, Adrucil, Carac, Efudix, Efudex, Fluoroplex, gemcitabine, hydroxyurea, mercaptopurine, and thioguanine), and peptide antibiotics that cleave DNA and disrupt DNA unwinding / entanglement (e.g., bortezomib, erlotinib, gefitinib, imatinib, vemurafen ... Platinum-based antitumor agents that inhibit DNA repair and / or synthesis of cross-linked DNA (e.g., carboplatin, cisplatin, oxaliplatin, and eloxatin), retinoids (e.g., retinoic acid, retinoic acid, and besalodin), vinblastines that inhibit mitosis and microtubule formation (e.g., vincristine, vinorelbine, vinorelbine, vinorelbine), and angiogenesis inhibitors that inhibit cell growth or cell expansion (e.g., axitinib (Inritar), bevacizumab (Avastin), cabozantinib (Cometriq), everolimus (Afinil, Zortress), lenalidomide (Lepril), pazopanib (Vitrant), and remoxicillin). Rucizumab (Cyramza), Regorafenib (Stivarga), Sorafenib (Nexavar), Sunitinib (Sutent), Thalidomide (Cilavir, Sesylvaline), Vandertanib (Caprelsa), Zib-Aflibercept (Zaltrapezil), Anti-angiogenic polysaccharides, Alpradine (Dehydrometasine B), Saponins (20(S)-Protopanaxadiol and 20(S)-Protopanaxtriol), Anti-intestinal obstruction agents, Prokinetic agents, Immunosuppressants (e.g., Tacrolimus), Blood modulators (e.g., Vasodilators, Viagra and Nifedipine), 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitors (e.g., Atorvastatin), and Anti-angiogenic agents.

[0091] Exemplary agents also include agents that passively promote wound healing, such as nutrients, oxygen-removing agents, amino acids, collagen-synthesizing agents, glutamine, insulin, butyrate, and dextran. Exemplary agents also include anti-adhesion agents, non-limiting examples of which include hyaluronic acid / carboxymethyl cellulose (seprafilm), oxidized regenerated cellulose (Interceed), and 4% icodextrin (Extraneal, Adept).

[0092] Exemplary agents also include agents that promote blood supply regeneration following coronary artery disease (CAD) (e.g., VEGF165 protein, AdVEGF165, AdVEGF121, and VEGF165 plasmid) or peripheral artery disease (PAD) (e.g., VEGF165 plasmid, AdVEGF121, SB-509 (SFP-VEGF plasmid), AdVEGF165, and Ad2-HIF1α-VP16 (WALK trial)).

[0093] Drug release

[0094] The appendage according to the technology can be associated with at least one agent in a variety of different ways to provide a desired effect, such as promoting inward growth of tissue. The at least one agent can be configured to be released from the appendage in a variety of spatial and temporal patterns to trigger a desired healing process at the treatment site. The agent can be disposed in, combined with, incorporated into, dispersed within, or otherwise associated with the appendage. For example, the appendage may have one or more regions that releasably hold one or more different agents. These regions can be different reservoirs of various sizes and shapes that hold agents in various ways, or other different or continuous regions within the appendage. In some aspects, a particular configuration of the appendage allows it to releasably hold one or more different agents.

[0095] Regardless of how the drug is disposed within the appendage, an effective amount of at least one drug can be encapsulated in a container, such as a microcapsule, a pellet in the form of microbeads, or any other container. The container may be formed from a bioabsorbable polymer.

[0096] Targeted delivery and release of at least one agent from an appendage can be accomplished in a variety of ways depending on various factors. Typically, the at least one agent can be released from the appendage material as a bolus dose, such that the agent is released substantially immediately upon delivery of the appendage material to the tissue. Alternatively, the at least one agent can be released from the appendage over a period of time, which can be minutes, hours, days, or longer. The rate of timed release and the dose of drug released can depend on various factors, such as the degradation rate of the area where the agent is released, the degradation rate of one or more coatings or other structures used to retain the agent in the appendage, environmental conditions at the treatment site, and various other factors. In some aspects, when the appendage has more than one agent disposed therein, the bolus dose release of the first agent can modulate the release of a second agent that begins to be released after the release of the first agent. The appendage may include multiple agents, each of which can influence the release of one or more other agents in any suitable manner.

[0097] The release of at least one agent, as a bolus dose or a timed release, may occur or begin substantially immediately after the adjuvant material is delivered to the tissue, or may be delayed for a predetermined time. The delay may depend on the structure and properties of the adjuvant or one or more regions thereof.

[0098] The adjuvant material can be configured to facilitate the dispensing of an effective amount of one or more agents carried within the adjuvant to provide the desired effect. For example, targeted delivery of the agent can be achieved by incorporating the agent into a patterned region (e.g., a reservoir such as a hole or other structure) within the adjuvant, the pattern allowing the agent to form a spatial distribution during delivery. The agent disposed within the reservoir can be incorporated into different containers. The reservoir can include more than one type of different agent. The one or more agents can be eluted from the adjuvant in a homogeneous or non-homogeneous spatial and / or temporal manner to deliver the desired treatment. The structure of the adjuvant and the manner in which the agent is released from it can be used to influence or control tissue regeneration. Furthermore, tissue regeneration can be promoted at certain locations at the treatment site, while not at other locations.

[0099] Exposure condition monitoring

[0100] Monitoring and / or tracking the exposure of appendages and any agents held therein to one or more exposure conditions can provide numerous benefits. Exposure conditions (also known as environmental conditions) can affect the performance of the appendage (e.g., shelf life) and / or the performance of the agent held therein (e.g., activity, shelf life, and potency). The activity of an agent generally refers to its potency, such as its ability to produce a specific effect. The shelf life of an appendage generally refers to the length of time during which the appendage can produce a specific effect, such as the ability of the appendage to degrade or dissolve in the patient's body and thereby release the agent from the appendage. The potency of an agent generally refers to the amount of agent required to produce a specific effect. From packaging to administration or as part of it, monitoring or tracking appendages and agents held therein allows for early identification of inactive appendages and inactive agents, and modifications to patient treatment, such as providing additional doses of agent to patients based on exposure monitoring or tracking to compensate for agents that have experienced exposure conditions that adversely affect their performance and / or shelf life. Therefore, monitoring and / or tracking the exposure of appendages and any medications held therein can reduce the risk of implanting appendages that have become ineffective due to exposure conditions, reduce the risk of administering medications at doses that have become ineffective due to exposure conditions, and reduce the risk of administering inactive medications to patients via appendages that hold medications therein.

[0101] Generally, the systems and methods described herein include active or passive sensing mechanisms, such as sensors, capable of monitoring at least one exposure condition of the appendage and any medication held therein. In some cases, the active or passive sensing mechanism may also track the extent (e.g., frequency, intensity, and / or duration) of the appendage and medication exposure. Therefore, information relating to the exposure condition itself and / or the extent of exposure can be used to determine the effectiveness of the appendage and any medication held therein before the appendage is implanted and / or before the appendage in which the medication is held is commercially distributed.

[0102] The systems and methods described herein that include active or passive sensing mechanisms may include a staple cartridge and an accessory releasably coupled to the staple cartridge, such as any or more of the staple cartridges and accessories discussed above. Also as discussed above, the accessory may hold one or more agents therein, and the staple cartridge may be fixedly coupled to the jaws of a surgical stapler or may be configured to be removably and alternatively coupled to the jaws of a surgical stapler. The agents may include any or more of the agents discussed above.

[0103] In an exemplary embodiment, the packaging unit for the packaging appendages and the medicine held therein includes at least one active or passive sensing mechanism. Therefore, at least one exposure condition of the appendages and the medicine held therein can be monitored along the supply chain from the time the appendages and the medicine held therein are packaged in the packaging unit until they are removed from the packaging unit.

[0104] The packaging unit may package an appendage in which at least one agent is releasably held, wherein the appendage is configured to be releasably coupled to the staple cartridge after the packaging unit is opened. Alternatively, the packaging unit may package an appendage in which at least one agent is releasably held, wherein the appendage is releasably coupled to the staple cartridge, such that the packaging unit packages the appendage, at least one agent, and the staple cartridge. In such embodiments, the staple cartridge having the appendage releasably coupled thereto may be configured to be placed in the end actuator of a surgical stapler after the packaging unit is opened, or the packaging unit may also package the surgical stapler, wherein the staple cartridge is placed in the end actuator of the stapler, or wherein the staple cartridge is placeable in the end actuator of the stapler after the packaging unit is opened. In some embodiments, the packaging unit may package multiple appendages, each having at least one agent held therein, and may optionally package multiple staple cartridges, each staple cartridge having one of the appendages releasably coupled thereto. Providing multiple attachments in the packaging unit allows for the provision of different staple cartridges, enabling surgeons or other medical professionals to select the appropriate size cartridge for a specific procedure, as staple cartridges are typically provided in different sizes for different surgical staplers and / or with different sizes of staples and / or different numbers of staples. Providing multiple attachments in the packaging unit also allows for the provision of multiple identical attachments to facilitate the reloading of a series of identical attachments to the surgical stapler during surgery. Regardless of the elements packaged in the packaging unit, in the exemplary embodiment, the packaging unit is sterile to help ensure safe use of the packaged elements by the patient.

[0105] As mentioned above, sensors can be configured to monitor or detect at least one exposure condition of an adjunct and any agent held therein. Examples of exposure conditions include geographic location (e.g., sensed by a location sensor configured to sense GPS or other locations), time (e.g., sensed by a timer or clock device such as an atomic clock), date (e.g., sensed by a timer), temperature (e.g., sensed by a temperature sensor), ultraviolet (UV) exposure (e.g., sensed by a UV sensor configured to sense UV levels), pH (e.g., sensed by a pH sensor configured to sense pH levels), humidity (e.g., sensed by a humidity sensor configured to sense humidity levels), light (e.g., sensed by a photodetector configured to sense light levels), oxygen exposure (e.g., sensed by an oxygen (O2) sensor configured to sense oxygen levels), vibration (e.g., sensed by a vibration sensor, accelerometer, etc. configured to sense vibration), and atmospheric pressure (e.g., sensed by an atmospheric pressure sensor configured to sense atmospheric pressure or an atmospheric pressure sensor configured to sense ambient air pressure). Alternatively or additionally, the sensor may be configured to track the frequency, duration, and / or intensity of adverse exposure events experienced by the appendage and any pharmaceutical agent held therein prior to implantation, such as the peak value of the exposure condition sensed during transport or storage of the appendage and any pharmaceutical agent held therein by a sensor configured to sense the exposure condition and a timer configured to provide date and timestamp data of the sensed data. One or more sensors may be used to monitor at least one exposure condition. The sensor may be configured to monitor a single exposure condition (e.g., time only, geographic location only, pH only, light only, etc.) or may be configured to sense at least two exposure conditions (e.g., temperature and humidity, time, date, and at least one other exposure condition, light and UV light, etc.). U.S. Patent Publication No. 2002 / 0014951, entitled “Remote Control For A Hospital Bed”, published on February 7, 2002, and U.S. Patent Publication No. 2007 / 0251835, entitled “Subnetwork Synchronization And Variable Transmit Synchronization Techniques For A Wireless Medical Device Network”, published on November 1, 2007, further discuss various exemplary sensors and are incorporated herein by reference in their entirety.

[0106] Temperature can adversely affect the performance of appendages. For example, temperatures above a predetermined maximum threshold temperature or below a predetermined minimum threshold temperature can cause the appendage to begin degrading before it is implanted into a patient's body, and therefore the appendage should no longer be used. Temperature can also adversely affect the performance of medications. For example, temperatures above a predetermined maximum threshold temperature or below a predetermined minimum threshold temperature (depending on the specific medication) can cause the medication to lose its potency, and therefore appendages containing the medication should no longer be used, or the medication should not be kept in the appendage before it is retained in the appendage.

[0107] UV exposure can adversely affect the performance of appendages. For example, UV levels above a predetermined maximum threshold or below a predetermined minimum threshold (depending on the material of the specific appendage) can cause the appendage to begin degrading before it is implanted into a patient, and therefore the appendage should no longer be used. UV levels can also adversely affect the performance of pharmaceuticals. For example, UV levels above a predetermined maximum threshold or below a predetermined minimum threshold (depending on the specific pharmaceutical) can cause the pharmaceutical to lose its efficacy, and therefore appendages containing the pharmaceutical should no longer be used, or the pharmaceutical should not be kept in the appendage before it is retained in the appendage.

[0108] Humidity can adversely affect the performance of appendages. For example, humidity levels above a predetermined maximum threshold or below a predetermined minimum threshold (depending on the material of the specific appendage) can cause the appendage to begin degrading before it is implanted into the patient's body, and therefore the appendage should no longer be used. Humidity can also adversely affect the performance of medications. For example, humidity levels above a predetermined maximum threshold or below a predetermined minimum threshold (depending on the specific medication) can cause the medication to lose its effectiveness, and therefore appendages containing the medication should no longer be used, or the medication should not be kept in the appendage before it is retained in the appendage.

[0109] Geographic location can indicate temperature and / or humidity exposure, as the temperature and humidity at a particular location on a specific date and time can be known. Geographic location can also indicate whether an agent is approved for use in its current location; for example, whether an agent has been exposed to an inappropriate geographic location and therefore should not be used.

[0110] Light can adversely affect the performance of a drug. For example, light levels above a predetermined maximum threshold can cause a drug to lose its effectiveness, and therefore the appendage in which the drug is held should no longer be used, or the drug should not be held in the appendage before being held therein.

[0111] Oxygen can adversely affect the performance of appendages. For example, exposing an appendage to oxygen levels above a predetermined maximum threshold oxygen level can cause it to lose sterility and / or begin to degrade before implantation into a patient, and therefore the appendage should no longer be used. If the appendage is sealed in a sterile packaging unit, its oxygen exposure should not be altered until the packaging unit is opened for use. Therefore, an oxygen level above a predetermined maximum threshold oxygen level on a specific date / timestamp may indicate that the appendage has lost sterility and should no longer be used, and / or that the appendage may have begun to degrade and should no longer be used.

[0112] Vibration can adversely affect the performance of appendages. For example, exposure of an appendage to vibration above a predetermined maximum indicates that the appendage has been subjected to a force. This force can cause the appendage to be prematurely compressed, for example, before implantation, and therefore unable to compress and conform properly in the patient's body.

[0113] Atmospheric pressure can adversely affect the performance of a pharmaceutical agent. For example, exposure of a pharmaceutical agent to atmospheric pressure above a predetermined maximum threshold can cause the agent to lose its effectiveness, and therefore the adjuncts holding the agent should no longer be used.

[0114] Congestion or delays in the supply chain can impact appendages and pharmaceuticals. For example, delays in the production or storage of appendages and the pharmaceuticals held therein can adversely affect the shelf life of the appendages or pharmaceuticals.

[0115] As mentioned above, the system may include one or more sensors. The sensors may be associated with at least one appendage (and therefore any medication held therein) and / or a packaging unit for said at least one appendage (and therefore any medication held therein). As discussed above, one or more appendages in the packaging unit may be standalone components or may be releasably coupled to a staple cartridge, which may be a standalone unit within the packaging unit configured to be removably and alternatively positioned in the jaws of an end effector of a surgical stapler, or may be already coupled to an end effector of a surgical stapler within the packaging unit, such as by being fixedly positioned in the jaws of the end effector or by being removably and alternatively positioned in the jaws of the end effector.

[0116] Sensors can be used to monitor the exposure conditions of the appendage and any medication contained therein before the appendage is implanted into the patient and therefore before the medication is administered to the patient. This helps ensure that the appendage effectively releases the medication upon implantation and that each of one or more medications is active and delivered at an effective dose when the medication is administered after the appendage is implanted and / or thereafter. Furthermore, this monitoring can also help detect inactive appendages and / or inactive medications early in the supply chain. Therefore, manufacturers can recall inactive appendages (and thus any medications contained therein) at an early stage, such as before packaging and / or distribution, which can lead to reduced recall costs and avoid potential health risks to patients.

[0117] The sensor can be configured to monitor at least one exposure condition of the appendage and any medication held therein when the appendage is placed in the staple cartridge (regardless of whether the staple cartridge is placed in the jaws of the end effector). Alternatively or additionally, the sensor can be configured to monitor at least one exposure condition of the appendage and any medication held therein when the appendage and any medication held therein are within the packaging unit (e.g., regardless of whether the appendage is packaged to be attached to the staple cartridge). Thus, the sensor can be configured to monitor at least one exposure condition of the medication after the medication has been associated with the appendage, for example, after the medication has been held by the appendage but before the appendage has been implanted in the patient. Therefore, once the medication is held by the appendage, the sensor can be used as a shelf-life monitor for the appendage in which the medication is held and as a shelf-life monitor for the medication.

[0118] Data acquired by the sensors can be transmitted to the processor via a communication interface. In an exemplary embodiment, the communication interface is associated with the appendage or the staple cartridge in which the appendage is housed, and the packaging unit that packages the appendage and the medication held therein includes the communication interface, as discussed herein. The processor may be located remotely from the appendage or locally to the appendage, and thus remotely or locally to the packaging unit that packages the appendage.

[0119] In use, once the processor receives data, it can process the data and provide data output. In one example, the data output could be the expiration date of a drug held by an appendage, which can be determined by taking into account data acquired by a sensor. The processor can be configured to similarly process the data and provide data output regarding the appendage. For example, the processor can be configured to determine the expiration date by determining the amount of time elapsed since the packaged drug and appendage, as indicated by a sensor. The processor can also be configured to compare the determined amount of elapsed time with a predetermined expiration date for the drug and / or appendage, as set by the manufacturer (or other quality control authority), to determine whether the expiration date has passed. The processor can also be configured to adjust the amount of elapsed time based on data acquired by the sensor to take into account the intensity and duration of any exposure conditions to the packaged drug and appendage. The processor can be configured to access a lookup table stored in memory that stores predetermined measurements of the drug and / or appendage. A predetermined metric can associate a drug and / or appendage with each of one or more exposure conditions and indicate the effect of the exposure condition on the shelf life of the drug and / or appendage, for example by indicating how much the shelf life of the drug and / or appendage should be adjusted downward (if any) for a specific duration of the exposure condition.

[0120] In some implementations, the expiration date of the agent can be used for the batch of the agent. The processor can be configured to provide data output indicating that the batch of the agent, and therefore the batch of the agent held by the appendage, has exceeded its expiration date. For example, the data output can be in the form of a warning, such as a warning configured to be conveyed to the user via text and / or image display (e.g., via text message, email, display on a computer system screen, etc.). The expiration date of the appendage can similarly be used for the batch of the appendage.

[0121] The warnings discussed herein can be given to users of the appendage (and therefore the medication held by it) and / or to third parties, such as manufacturers of the appendage and / or medication, cloud services configured to communicate with hospitals and / or other healthcare facilities that provide the appendage to users, etc. Providing warnings to users can help prevent the appendage from being implanted, thereby helping to prevent the appendage and medication from being delivered to the patient, and thus helping to avoid adverse patient effects and / or allowing users to obtain new appendages for implantation. Providing warnings to third parties acting as cloud services can (1) facilitate automated product replacement by allowing the cloud service to automatically reorder appendages, staple cartridges attached to appendages, and / or surgical staplers attached to staple cartridges attached to appendages; (2) allow the cloud service to automatically generate complaint reports that are transmitted from the cloud service to another third party (e.g., the manufacturer of the appendage and / or medication, a medical professional intending to implant the appendage, etc.) who can use the complaint report to assess their business, take remedial action, etc.; and (3) allow the cloud service to automatically generate requests to quality control units (such as the quality control team at the appendage and / or medication manufacturer) to consult with the user, the user's healthcare provider (HCP), the appendage manufacturer, etc. The manufacturer of the medication and / or the other party should take what steps, and / or (4) associate the specific appendage (e.g., identified by a product identification code included in the warning) with a serialization traceable to a specific distribution point in the supply chain, in which the appendage and / or the medication held therein may be non-refundable or non-replaceable due to a history of known user errors if a user makes a mistake, and / or may remind the user of the proper storage conditions of the appendage, for example, by displaying a message on a computer system monitor, sending an email to the user associated with the appendage (and therefore the medication held therein), notifying the hospital or other healthcare facility of the user error so as to discuss with one or more parties responsible for the proper storage and / or transportation of the appendage at the healthcare facility, etc.

[0122] A warning may indicate that an appendage (and therefore any medicine held by it) should not be used, for example, due to adverse exposure conditions experienced by the appendage (and therefore any medicine held by it). If the appendage (and therefore any medicine held by it) is still available but has been subjected to at least one adverse exposure condition, the warning may provide a recommendation for use reflecting the adverse exposure condition, such as the period from now when the appendage should be implanted to maintain sufficient effectiveness of the appendage (and therefore any medicine held by it). Even if the appendage (and therefore any medicine held by it) has not yet been subjected to any exposure conditions that adversely affect its use in surgical procedures, a warning may be provided, such as the period from now when the appendage should be implanted to maintain sufficient effectiveness of the appendage (and therefore any medicine held by it). For example, such a recommendation may be beneficial for appendages and / or medicines adversely affected by light exposure. When the packaging unit containing the appendage and the medicine held by it is opened, the appendage and medicine are exposed to light, which may then begin the period from now when the appendage (and therefore the medicine) should be implanted before being exposed to too much light. For example, such recommendations may be beneficial for appendages and / or agents adversely affected by temperature and / or humidity exposure. The operating room may have temperature and / or humidity sensors communicating with a processor that provides warnings, such that the warnings take into account the temperature and / or humidity of the operating room to provide a timeframe from the current time during which the appendage should be implanted to maintain sufficient effectiveness of the appendage (and thus any agents held by the appendage), taking into account the appendage's current exposure to conditions within the operating room.

[0123] Another example of a processor's data output after processing data is a deviation condition state, which can be determined by considering data acquired by sensors. For example, a processor may be configured to compare data received from sensors with predetermined thresholds or ranges indicating safe exposure conditions. If the received data is outside the predetermined safe range, above the predetermined safe threshold, or below the predetermined safe threshold (depending on the specific exposure condition), the data output may be in the form of a warning indicating that the packaging unit, and therefore its appendages and any medication held by the appendages, has so far experienced at least one exposure condition during its lifespan in the supply chain, such that its performance has been adversely affected sufficiently that the packaged appendages holding the medication should not be implanted.

[0124] Figure 8An embodiment of processor 4000 is shown, configured to communicate with packaging unit 4002, which packages an accessory 4004 containing a pharmaceutical agent 4006. In this illustrated embodiment, packaging unit 4002 is in the form of a blister pack, but other types of packaging units may also be used. Sensor 4008 attached to packaging unit 4002 is configured to monitor at least one exposure condition, as discussed herein, and incorporates a communication interface, such as an RFID sensor tag, a microcontroller including a sensor, power source, and wireless transmitter, flexible circuitry including a sensor, battery, and wireless transmitter, etc., but the packaging unit may include separate sensors and communication interfaces. Sensor 4008, for example, its communication interface, is configured to wirelessly communicate data with processor 4000. The sensor 4008 can be attached to the packaging unit 4002 in any of a variety of ways, such as by embedding it in the material forming the packaging unit 4002 (e.g., polymer, reinforced cardboard, glass, etc.), by using an adhesive to adhere it to the inner or outer surface of the packaging unit 4002, by adhering it to a mark or label on the packaging unit 4002, or by using another attachment mechanism.

[0125] Figure 9 Another embodiment of a packaging unit 4010 configured to communicate with a processor (not shown) is illustrated. In this illustrated embodiment, the packaging unit 4010 is in the form of a box, but other types of packaging units can be used. In this illustrated embodiment, the packaging unit 4010 packages a pharmaceutical agent (in...) Figure 9 The packaging unit 4010 includes an accessory 4012 (which is partially obscured). A sensor 4014 attached to the packaging unit 4010 is configured to monitor at least one exposure condition, as discussed herein. The packaging unit 4010 also includes an electrical contact 1016 configured to read sensing data from the sensor 4012. The sensor 4014 and the electrical contact 1016 are housed together with the accessory 4012 within the packaging unit 4010. The sensor 1014 is positioned adjacent to the electrical contact 1016. Therefore, once the sensor 1014 is positioned near or in direct contact with the electrical contact 1016, the sensor 1014 is read by the electrical contact 1016 (e.g., a reader), and the data from the sensor 1014 can be transmitted to a processor via a communication interface of the packaging unit, as discussed herein. In this illustrated embodiment, data is wirelessly transmitted to the processor using a communication interface of the packaging unit, which in this illustrated embodiment is part of the electrical contact 1016.

[0126] The processor configured to communicate with the packaging unit can be a computer system such as Figure 10The computer system 4018 shown is a component of an embodiment of the computer system 4018. The computer system 4018 is configured to communicate with the packaging unit 4020 via a communication interface 4022, such as a QR code, RFID tag, etc. Figure 8 Packaging unit 4002, Figure 9 The packaging unit 4010 or other packaging unit communicates wirelessly. The communication interface 4022 may be part of a multifunctional component such as a sensor incorporating communication technology, a microcontroller incorporating sensing and communication technology, or a separate sensor configured to transmit collected data to the communication interface may be attached to the packaging unit 4020. In this illustrated embodiment, the packaging unit 40202 packages and holds the pharmaceutical agent (in... Figure 10 Accessories 4024 (obscured in the middle). The computer system 4018 is also configured to be able to communicate, for example, via the communication interface of the surgical instrument 4026 (in... Figure 10 The surgical instrument 4026 (which is partially obstructed) communicates wirelessly with the surgical instrument in the illustrated embodiment, which includes a linear surgical suture device but may be another type of surgical instrument as discussed herein. The computer system 4018 may have various configurations, such as... Figure 11 and Figure 12 The computer systems 4028 and 4030 shown are discussed further below. In this illustrated embodiment, computer system 4018 includes a surgical hub. The surgical hub is also discussed further below.

[0127] In some implementations, the packaging unit may package multiple other packaging units, for example, packaging Figure 9 Multiple packaging units 4010, packaging Figure 10 Multiple packaging units 4020, packaging Figure 9 Multiple packaging units 4010 and Figure 10 Multiple packaging units 4020, packaging Figure 8Multiple packaging units 4002, or multiple packaging units of a certain other combination and / or type. Such packaging units that package multiple packaging units are generally referred to herein as "bulk packaging units". Bulk packaging units may include sensors and communication interfaces as described herein, and thus serve as exposure condition monitors for all packaging units packaged in the bulk packaging unit. This configuration reduces overall cost because each packaging unit in the bulk packaging unit does not need to include sensors and communication interfaces as described herein. However, to increase reliability and / or to account for exposure after the packaging unit is removed from the bulk packaging unit, each packaging unit in the housing may include sensors and communication interfaces as described herein. Bulk packaging units that include sensors and communication interfaces can help reduce concerns such as over-pressurization of the foil bag of the packaging unit (which may compromise the sterile seal of the bag), because the foil bag will be located in the bulk packaging unit during its long journey via air travel and thus has some protection against over-pressurization. If subjected to over-pressurization, the agent may be released prematurely, so bulk packaging units also help prevent premature agent release.

[0128] Computer System

[0129] As mentioned above, the communication interface can be associated with an accessory and / or a pharmaceutical agent held by the accessory, such as a packaging unit containing a packaging accessory including the communication interface and any pharmaceutical agent held therein. Such a communication interface can be configured to communicate with computer systems such as… Figure 11 The central computer system 4028 shown communicates. For example... Figure 11 As shown, the communication interface associated with the packaging unit 4032, which contains an appendage containing a pharmaceutical agent, is configured to communicate with a central computer system 4028 via a communication network 4034 from any number of locations, such as medical facilities 4036 (e.g., hospitals or other healthcare facilities), warehouses 4038 (e.g., distribution centers or other sites in the packaging unit's supply chain), or mobile locations 4040 (e.g., between sites along the packaging unit's supply chain)). The communication interface may be configured to access the computer system 4028 via a wired and / or wireless connection to the network 4034. In an exemplary embodiment, the communication interface is configured to wirelessly access the computer system 4028, for example, via a Wi-Fi connection, which facilitates the accessibility of the computer system 4034 from virtually any location in the world.

[0130] Those skilled in the art will understand that computer system 4034 may include security features that allow aspects of computer system 4034 available to any particular node to be determined based on, for example, the identity of the node and / or the location from which the node accesses the system. For this purpose, each node may have a unique key, username, password, and / or other security credentials to facilitate access to computer system 4034. The received security parameter information may be examined against a database of authorized nodes to determine whether a node is authorized and the extent to which a node is allowed to interact with computer system 4034, view information stored in computer system 4034, etc.

[0131] As discussed herein, one or more aspects or features of the subject matter described herein, such as components and sensors of the central computer system 4034, may be implemented in digital electronic circuits, integrated circuits, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), computer hardware, firmware, software, and / or combinations thereof. These different aspects or features may include specific implementations in one or more computer programs that are executable and / or interpretable on a programmable system including at least one programmable processor, which may be specialized or general-purpose, coupled to receive and transmit data and instructions from a storage system, at least one input device, and at least one output device. The programmable system or computer system may include clients and servers. Clients and servers are typically geographically separated and typically interact via communication networks such as the Internet, wireless wide area networks, local area networks, wide area networks, or wired networks. The client-server relationship is established by means of computer programs running on their respective computers that have a client-server relationship with each other.

[0132] These computer programs (also referred to as programs, software, software applications, components, or code) include machine instructions for a programmable processor and can be implemented in high-level programming languages, object-oriented programming languages, functional programming languages, logic programming languages, and / or assembly / machine languages. As used herein, the term "machine-readable medium" means any computer program product, device, and / or apparatus (e.g., disk, optical disk, memory, programmable logic device (PLD)) used to provide machine instructions and / or data to a programmable processor, including machine-readable media that receive machine instructions as machine-readable signals. The term "machine-readable signal" means any signal used to provide machine instructions and / or data to a programmable processor. Machine-readable media may store such machine instructions non-transitory, such as non-transitory solid-state memory or magnetic hard disk drives or any equivalent storage medium. Alternatively or otherwise, machine-readable media may store such machine instructions transiently, such as processor caches or other random access memory associated with one or more physical processor cores.

[0133] To provide interaction with the user, one or more aspects or features of the subject matter described herein can be implemented on a computer having a display screen for displaying information to the user, such as, for example, a cathode ray tube (CRT), liquid crystal display (LCD), or light-emitting diode (LED) monitor. The display screen may allow direct (e.g., as a touchscreen) or indirect (e.g., via an input device, such as a keypad or voice recognition hardware and software) input. Other types of devices may also be used to provide interaction with the user. For example, feedback provided to the user can be any form of sensory feedback (e.g., visual, auditory, or tactile feedback); and input from the user can be received in any form, including but not limited to sound, speech, or tactile input. As discussed herein, this feedback may be provided as a warning.

[0134] Figure 12 An exemplary embodiment of a computer system 4028, depicted as computer system 4030, is shown. The computer system includes one or more processors 4042 configured to control the operation of computer system 4030. Processor 4042 may include any type of microprocessor or central processing unit (CPU), including programmable general-purpose or special-purpose microprocessors and / or any of a variety of proprietary or commercially available single-processor or multi-processor systems. Computer system 4030 also includes one or more memories 4044 configured to provide temporary storage for code to be executed by processor 4042 or for data retrieved from one or more users, storage devices, and / or databases. Memory 4044 may include read-only memory (ROM), flash memory, one or more random access memories (RAM) (e.g., static RAM (SRAM), dynamic RAM (DRAM), or synchronous DRAM (SDRAM)) and / or a combination of memory technologies.

[0135] Various components of the computer system are connected to bus system 4046. Bus system 4046 is an abstract concept representing any one or more individual physical buses, communication lines / interfaces, and / or multipoint or point-to-point connections connected via appropriate bridges, adapters, and / or controllers. Computer system 4030 also includes one or more network interfaces 4048 (also referred to herein as communication interfaces), one or more input / output (I / O) interfaces 4050, and one or more storage devices 4052.

[0136] Communication interface 4048 is configured to enable the computer system to communicate with remote devices (e.g., other communication interfaces or other computer systems) via a network, and may be, for example, a remote desktop connection interface, an Ethernet adapter, and / or other local area network (LAN) adapters. I / O interface 4050 includes one or more interface components for connecting computer system 4030 to other electronic equipment. For example, I / O interface 4050 may include high-speed data ports such as a Universal Serial Bus (USB) port, a 1394 port, Wi-Fi, Bluetooth, etc. In addition, computer system 4030 may be accessible to a human user, and therefore I / O interface 4050 may include a display, speakers, a keyboard, pointing devices, and / or various other video, audio, or alphanumeric interfaces. Storage device 4052, which can be classified as memory, includes any conventional medium for storing data in a non-volatile and / or non-transient manner. Therefore, storage device 4052 is configured to retain data and / or instructions in a persistent state, in which values ​​are preserved even during power outages of the computer system. Storage device 4052 may include one or more hard disk drives, flash drives, USB drives, optical disc drives, various media cards, disks, optical discs, and / or any combination thereof, and may be directly connected to a computer system or remotely (such as via a network) connected to the computer system. In an exemplary embodiment, storage device 4052 includes tangible or non-transitory computer-readable media configured to store data, such as hard disk drives, flash drives, USB drives, optical disc drives, media cards, disks, or optical discs.

[0137] Figure 12 The components shown may be some or all of the components of a single physical machine. In addition, not all the components shown need to be located on or within the same physical machine.

[0138] Computer system 4030 may include a web browser for retrieving web pages or other markup language streams, presenting these pages and / or streams (visually, audibly, or otherwise), executing scripts, controls, and other code on these pages / streams, accepting user input about these pages / streams (e.g., for completing input fields), issuing Hypertext Transfer Protocol (HTTP) requests about these pages / streams or other aspects (e.g., for submitting server information from completed input fields), etc. Web pages or other markup languages ​​may be Hypertext Markup Language (HTML) or other traditional forms, including embedded Extensible Markup Language (XML), scripts, controls, etc. Computer system 4030 may also include a web server for generating web pages and / or delivering web pages to client computer systems.

[0139] like Figure 11 As shown, as described above Figure 12 The computer system 4030 may form a component of the central computer system 4028 that communicates with one or more communication interfaces, each communication interface being associated with at least one packaging unit. Data may be exchanged between the central computer system 4030 and the one or more communication interfaces. The computer system 4030 may also be configured to communicate with one or more additional computer systems.

[0140] In an exemplary implementation, the computer system 4030 may be a single unit, such as a single server, a single desktop computer, a single laptop computer, a single mobile phone, a single tablet computer, a single smartwatch, a single tower, etc. The single unit may be modular, allowing its various aspects to be swapped in and out as needed, such as for upgrades, replacements, maintenance, etc., without interrupting the functionality of any other aspect of the system. Therefore, the single unit may also be scalable, having the ability to be added as an add-on module and / or the expectation and / or improvement of additional functionality on existing modules.

[0141] Computer system 4030 may also include any of a variety of other software and / or hardware components, including, for example, an operating system and a database management system. Although exemplary computer systems are depicted and described herein, it should be understood that this is for reasons of generality and convenience. In other embodiments, the architecture and operation of the computer system may differ from those shown and described herein. For example, memory 4044 and storage device 4052 may be integrated together, or sensors may be included within computer system 4030.

[0142] In an exemplary embodiment, a computer system comprising a surgical hub includes data such as data acquired by sensors associated with the appendage and / or data about a medicine held by the appendage. Exemplary embodiments of surgical hubs configured to receive, analyze, and output data, and methods of using such surgical hubs, are described in U.S. Patent Publication No. 2019 / 0200844, filed December 4, 2018, entitled "Method Of Hub Communication, Processing, Storage And Display"; U.S. Patent Publication No. 2019 / 0200981, filed December 4, 2018, entitled "Method Of Compressing TissueWithin A Stapling Device And Simultaneously Displaying The Location Of The Tissue Within The Jaws"; U.S. Patent Publication No. 2019 / 0206004, filed March 29, 2018, entitled "Interactive Surgical Systems With Condition Handling Of Devices And Data Capabilities"; and U.S. Patent Publication No. 2019 / 0206004, filed March 29, 2018, entitled "Surgical Hub Situational...". The “Awareness” is further described in U.S. Patent Publication No. 2019 / 0201140 and U.S. Patent Application No. 17 / 068,857, filed on October 13, 2020, entitled “Adaptive Responses From Smart Packaging Of Drug Delivery Absorbable Adjuncts,” the full text of which is incorporated herein by reference.

[0143] Generally, a surgical hub can be a component of an integrated digital health system spanning multiple medical facilities and configured to provide comprehensive and improved medical care to a large number of patients. This integrated digital health system includes a cloud-based medical analytics system configured to interconnect with multiple surgical hubs located across many different medical facilities. Surgical hubs are configured to interconnect with one or more components, such as surgical devices for patient procedures, sensors configured to monitor exposure conditions, etc. Surgical hubs provide a wide range of functionalities to improve the outcomes of medical procedures. Data about patients and medical procedures generated by various surgical devices, sensors, and surgical hubs can be transmitted to the cloud-based medical analytics system. This data can then be aggregated with similar data collected from many other surgical hubs, sensors, and surgical devices located in other medical facilities. The collected data can be analyzed by the cloud-based analytics system to discover various patterns and correlations. As a result, improvements can be generated in the technologies used to generate the data, and these improvements can then be propagated to various surgical hubs and surgical devices. Improvements in medical procedures and practices can be discovered because of the interconnection of all the aforementioned components; otherwise, these improvements might not have been discovered if many components were not interconnected in this way.Various examples of the structure and function of these components are found in the previously mentioned U.S. Patent Publication No. 2019 / 0200844, filed December 4, 2018, entitled "Method Of Hub Communication, Processing, Storage and Display"; U.S. Patent Publication No. 2019 / 0200981, filed December 4, 2018, entitled "Method Of Compressing Tissue Within A Stapling Device And Simultaneously Displaying The Location Of The Tissue Within The Jaws"; U.S. Patent Publication No. 2019 / 0206004, filed March 29, 2018, entitled "Interactive Surgical Systems With Condition Handling Of Devices And Data Capabilities"; U.S. Patent Publication No. 2019 / 0201140, filed March 29, 2018, entitled "Surgical Hub Situational Awareness"; and U.S. Patent Publication No. 2019 / 0201140, filed October 13, 2020, entitled "Adaptive Responses from Smart Packaging Of Drug". The description of “Delivery Absorbable Adjuncts” is more detailed in U.S. Patent Application No. 17 / 068,857.

[0144] Figure 13 An embodiment of a computer-implemented interactive surgical system 4100 is shown, which includes one or more surgical systems 4102 and a cloud-based system (e.g., a cloud 4104 that may include a remote computer system 4114 (a server in the illustrated embodiment) connected to a storage device 4116). Each surgical system 4102 includes at least one surgical hub 4106 communicating with the cloud 4104. In one example, as... Figure 13As shown, the surgical system 4102 includes a visualization system 4108, a robotic system 4110, intelligent surgical instruments 4112, and packaging units 4118 (e.g., packaging an appendage containing medication), which are configured to communicate with each other and / or with a hub 4106. As discussed herein, in an exemplary embodiment, the packaging unit 4118 is configured to communicate with the surgical hub 4106, which can communicate with each of the visualization system 4108, the robotic system 4110, the intelligent surgical instruments 4112, and the packaging unit 4118. The surgical system 4102 may include M hubs 4106, N visualization systems 4108, O robotic systems 4110, P4 intelligent surgical instruments 4112, and Q packaging units 4118, where M, N, O, P, and Q are integers greater than or equal to one, and these integers may be equal to or not equal to any one or more of each other. Various exemplary examples of suitable robotic systems, visualization systems, cloud-based analytics, and intelligent surgical instruments that can be used in computer-implemented interactive surgical systems are provided in the previously mentioned submission dated December 4, 2018, entitled "Method Of TM The following U.S. patents describe this in more detail: U.S. Patent Publication No. 2019 / 0200844, entitled "Hub Communication, Processing, Storage and Display"; U.S. Patent Publication No. 2019 / 0200981, entitled "Method Of Compressing Tissue Within A Stapling Device And Simultaneously Displaying The Location Of The Tissue Within The Jaws", filed December 4, 2018; U.S. Patent Publication No. 2019 / 0206004, entitled "Interactive Surgical Systems With Condition Handling Of Devices And Data Capabilities", filed March 29, 2018; U.S. Patent Publication No. 2019 / 0201140, entitled "Surgical Hub Situational Awareness", filed March 29, 2018; and U.S. Patent Application No. 17 / 068,857, entitled "Adaptive Responses from Smart Packaging Of Drug Delivery Absorbable Adjuncts", filed October 13, 2020.

[0145] The surgical instrument 4112 in system 4100 can be of various types of tools. In an exemplary embodiment, the surgical instrument 4112 includes a surgical suture configured to deliver an appendage to tissue, such as the various surgical sutures and appendages discussed above. Thus, exposure conditions associated with the appendage and the medication held therein can be communicated from the packaging unit 4118 to their associated hub 4106, and from the hub 4106 to the cloud 4104, such as through communication interfaces of the packaging unit 4118, each communication interface being configured to communicate sensed exposure condition data to its associated hub in the hub 4106. The packaging unit 4118 may also each be configured to communicate additional data to its associated hub in the hub 4106. Other data may include, for example, identification data that uniquely identifies the packaging unit 4118 and / or any of the components packaged in and / or attached to the packaging unit. Identifying data can facilitate the analysis of various useful metrics, such as surgical outcomes, records of drug delivery to patients, and records of adnexal delivery to patients. Data analysis can be further processed using outcome analysis, and the use of standardized methods can provide beneficial feedback to confirm the effectiveness of surgical treatment and adnexals and / or drugs, or to suggest modifications to surgical treatment, surgeon behavior, adnexals, and / or drugs. For example, as discussed above, monitoring and tracking the exposure conditions experienced by adnexals and any drugs held within them can be beneficial for analyzing how the exposure conditions experienced by adnexals and / or drugs held by adnexals affect surgical outcomes, such as longer or shorter healing times, premature or delayed drug release from adnexals, etc. These analyses can be used for future assessments of modifications to postoperative patient care and / or modifications to exposure conditions to help address postoperative adverse effects observed due to exposure conditions in the future, for example, by changing the threshold of exposure conditions.

[0146] Figure 14An example of a surgical data network 4120 is shown, including a modular communication hub 4122 (e.g., hub 4106) configured to connect modular devices located in one or more operating rooms within a medical facility, or any room within a medical facility specifically equipped for surgical procedures, to a cloud-based system having a cloud 4124 including a remote server connected to a storage device, for example, a cloud 4104 including a remote server 4114 connected to a storage device 4116. The modular communication hub 4122 includes a network hub 4126 and / or a network switch 4128 communicating with a network router 4130. The network hub 4126, network switch 4128, and network router 4130 define the communication interface of the communication hub. The modular communication hub 4122 can also be coupled to a local computer system 4132 to provide local computer processing and data manipulation. The surgical data network 4120 can be configured as passive, intelligent, or switched. The passive surgical data network acts as a conduit for data, enabling its transfer from one device (or segment) to another and cloud computing resources. The intelligent surgical data network includes additional features to enable monitoring of traffic through the surgical data network and configuration of each port in the network hub 4126 or network switch 4128. The “intelligent surgical data network” can be referred to as a “managed hub” or a “managed switch.” The hub reads the destination address of each packet and then forwards the packet to the correct port.

[0147] Module Unit 1 located in the operating room a -l n (e.g., any number of packaging units, such as) Figure 8 Packaging unit 4002, Figure 9 The packaging unit 4010 or other packaging units can be connected to the module communication hub 4122. The network hub 4126 and / or network switch 4128 can be connected to the network router 4130 to connect unit 1. a -l n Connect to cloud 4124 or local computer system 4132. (With unit 1) a -l n The associated data can be transmitted via router 4130 to a cloud-based computer, such as cloud 4124, for remote data processing and manipulation. (Compared to Unit 1) a -l n The associated data can also be transmitted to the local computer system 4132 for local data processing and manipulation. Modular unit 2 is located in the same operating room. a -2 mIt can also be connected to network switch 4128. Network switch 4128 can be connected to network hub 4126 and / or network router 4130 to connect unit 2. a -2 m Connected to cloud 4124. (With unit 2) a -2 n The associated data can be transmitted to the cloud 4124 via network router 4130 for data processing and manipulation. (Compared to Unit 2) a -2 m The associated data can also be transmitted to the local computer system 4132 for local data processing and manipulation. Unit 1 a -l n / 2 a -2 m The quantities n and m can be the same or different from each other.

[0148] Those skilled in the art will understand that the surgical data network 4120 can be extended by interconnecting multiple network hubs 4126 and / or multiple network switches 4128 with multiple network routers 4130. A modular communication hub 4122 can be housed in a modular control tower configured to accommodate multiple units 1. a -l n / 2 a -2 m The local computer system 4132 can also be housed in a modular control tower. A modular communication hub 4122 is connected to a display 4134, which is configured to display, for example, information generated by unit 1 during surgical procedures. a -l n / 2 a -2 m Data obtained by at least some of the units in the cloud 4124 and / or such data (and / or other data) analyzed by the cloud 4124 and / or the local computer system 4132.

[0149] Surgical data network 4120 may include unit 1 a -l n / 2 a -2 m A combination of network hubs, network switches, and network routers connected to cloud 4124. Unit 1 connected to network hub 4126 or network switch 4128. a -l n / 2 a -2 m Any one or all of the units can collect data in real time and transmit the data to a cloud computer for data processing and manipulation. Alternatively or otherwise, for example, once unit 1 a -l n / 2a -2 m One or all units are operatively connected to the cloud 4126 via a communication hub 4122, and unit 1 is connected to the network hub 4126 or network switch 4128. a -l n / 2 a -2 m Any one or all of the units in the cloud can transmit previously collected data, such as exposure condition data, to the cloud computer for data processing and manipulation. Those skilled in the art will understand that cloud computing relies on shared computing resources, rather than using local servers or personal devices to process software applications. The term "cloud" can be used as a metaphor for "the Internet," although the term is not limited thereto. Therefore, the term "cloud computing" may be used herein to refer to "a type of Internet-based computing" in which different services (such as servers, storage devices, and applications) are delivered to a modular communication hub 4122 and / or computer system 4132 located in a surgical room (e.g., a fixed, mobile, temporary, or on-site operating room or space), and to devices connected to the modular communication hub 4122 and / or computer system 4132 via the Internet. The cloud infrastructure may be maintained by a cloud service provider. In this context, the cloud service provider may be a coordinator of units 1 located in one or more operating rooms. a -l n / 2 a -2 m The entity that uses and controls the cloud computing service. Cloud computing services can perform extensive computations based on data collected by packaging units, robots, and other computerized devices located in the operating room. Central hardware enables multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage. For unit 1... a -l n / 2 a -2 m The collected data is processed using cloud computing technology, and the surgical data network can provide improved surgical outcomes, reduced costs, and / or improved patient satisfaction.

[0150] Operating room device 1 a -l n According to Unit 1 a -l n The network hub 4126 is configured to connect to the modular communication hub 4122 via a wired or wireless channel, although, as mentioned above, wireless communication is used with the packaging unit in the exemplary embodiment. The network hub 4126 can be implemented as a local network broadcasting device operating at the physical layer of the Open Systems Interconnection (OSI) model. The network hub 4126 provides connectivity with unit 1 located in the same operating room network. a -l nThe network hub 4126 collects data in packets and sends them to the router 4130 in half-duplex mode. The network hub 4126 does not store any Media Access Control / Internet Protocol (MAC / IP) data used for transmission. Unit 1 only. a -l n One of the units can send data through network hub 4126. Network hub 4126 does not have a routing table or intelligence regarding where to send information and broadcast all network data across each connection, or broadcast all network data to a remote server via cloud 4124. Network hub 4126 can detect basic network errors such as collisions, but broadcasting all information to multiple ports can introduce security risks and cause bottlenecks.

[0151] Unit 2 a -2 m The device can be connected to the network switch 4128 via a wired or wireless channel, although, as mentioned above, wireless communication is used with the packaging unit in the exemplary embodiment. The network switch 4128 operates at the data link layer of the OSI model. The network switch 4128 is used to connect unit 2 located in the same operating room. a Up to 2 m A multicast device connected to the network. Network switch 4128 sends data to network router 4130 in frames and operates in full-duplex mode. Multiple units 2 a -2 m Data can be sent simultaneously via network switch 4128. Network switch 4128 can store and use unit 2. a -2 m The MAC address is used to transmit data.

[0152] Network hub 4126 and / or network switch 4128 are connected to network router 4130 to connect to cloud 4124. Network router 4130 operates at the network layer of the OSI model. Network router 4130 generates routes for transmitting data packets received from network hub 4126 and / or network switch 4128 to cloud-based computing resources for further processing and manipulation by unit 1. a -1 n / 2 a -2 m Data collected by any one or all units within the cloud. A network router 4130 can be used to connect two or more different networks located in different locations, such as different operating rooms within the same medical facility or different networks in different operating rooms within different medical facilities. The network router 4130 sends data to the cloud 4124 in packet form and operates in full-duplex mode. Multiple units can send data simultaneously. The network router 4130 uses IP addresses to transmit data.

[0153] In one example, network hub 4126 can be implemented as a USB hub, allowing multiple USB devices to connect to a host computer. A USB hub can extend a single USB port to multiple tiers, so that more ports are available for connecting the unit to the host system computer. Network hub 4126 may include wired or wireless capabilities for receiving information via wired or wireless channels. For unit 1 located in an operating room... a -1 n and Unit 2 a -2 m Communication between them can be achieved using a short-range, high-bandwidth wireless radio communication protocol via USB.

[0154] In other examples, Unit 1 a -1 n / 2 a -2 m It can communicate with the modular communication hub 4122 via the Bluetooth wireless technology standard for exchanging data from fixed and mobile devices over short distances (using short-wavelength UHF radio waves in the ISM band from 2.4 GHz to 2.485 GHz) and for building personal area networks (PANs). In other aspects, Unit 1... a -1 n / 2 a -2 m It can communicate with the modular communication hub 203 via various wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, LTE and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as any other wireless and wired protocols specified as 3G, 4G, 5G and above. The computing module may include multiple communication modules. For example, a first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to long-range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.

[0155] Modular communication hub 4122 can serve as operating room unit 1 a -1 n / 2 a -2 m One or all of the central connections are used, and a data type called a frame is processed. A frame carries data from unit 1. a -1 n / 2a -2 m The generated data. When the modular communication hub 4122 receives a frame, the frame is amplified and transmitted to the network router 4130, which transmits the data to cloud computing resources using various wireless or wired communication standards or protocols as described herein.

[0156] The modular communication hub 4122 can be used as a standalone unit or connected to compatible network hubs and network switches to form a larger network. The modular communication hub 4122 is generally easy to install, configure, and maintain, making it a suitable addition to unit 1. a -1 n / 2 a -2 m A good option for connecting to the internet.

[0157] Figure 15 An embodiment of a control system 4136 for a surgical instrument or tool (e.g., a surgical suture as described herein) is illustrated. The control system 4136 includes control circuitry. The control circuitry includes a controller, which in this illustrated embodiment includes a microcontroller 4138, comprising a processor 4140 and a memory 4142. The microcontroller 4138 can be any single-core or multi-core processor, such as those commercially available under the name ARM Cortex from Texas Instruments. A motor 4144, driven by a motor driver 4146, is operatively coupled to a longitudinally movable displacement member, such as a closing tube, firing lever, E-beam, and / or blade, to fire a pin, close jaws, and / or cut tissue, as discussed above. A tracking system 4148 is configured to determine the position of the longitudinally movable displacement member. Position information is provided to the processor 4140, which can be programmed or configured to determine the position of the longitudinally movable displacement member. An additional motor may be located at a tool driver interface to control firing, closing tube travel, shaft rotation, and joint movement. Display 4150 displays various operating conditions of the instrument and may include touchscreen functionality for data input. Information displayed on display 4150 may be overlaid with images acquired via an endoscopic imaging module.

[0158] The microcontroller 4138 can be programmed to perform various functions, such as precise control of the speed and position of the joint motion system of the tool and end effector. The microcontroller 4138 can be configured to calculate the response in the software of the microcontroller 4138. The calculated response is compared with the measured response of the actual system to obtain the "observed" response, which is used for actual feedback decisions. The observed response is a favorable tuning value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect external influences on the system.

[0159] Motor 4144 may be a brushed direct current (DC) motor having a gearbox and a mechanical link to the articulated motion or cutting system. Motor driver 4146 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers can be readily substituted for use in tracking system 4148, which includes an absolute positioning system. Further description of the absolute positioning system is provided in U.S. Patent Publication 2017 / 0296213, entitled “Systems And Methods For Controlling A Surgical Stapling And Cutting Instrument,” published October 19, 2017, the entire contents of which are incorporated herein by reference.

[0160] Motor 4144 can be controlled by motor driver 4146 and can be employed by the firing system of a surgical instrument or tool. In various forms, motor 4144 can be a brushed DC drive motor with a maximum rotational speed of approximately 25,000 RPM. In other arrangements, motor 4144 can include a brushless motor, cordless motor, synchronous motor, stepper motor, or any other suitable electric motor. Motor driver 4146 can include, for example, an H-bridge driver including field-effect transistors (FETs). Motor 4144 can be powered by a power assembly releasably mounted to the handle assembly or tool housing for supplying control power to the surgical instrument. The power assembly can include a battery comprising multiple battery cells connected in series and used as a power source to power the surgical instrument. In some cases, the battery cells of the power assembly can be replaceable and / or rechargeable. For example, the battery cells can be lithium-ion batteries that can be coupled to and decoupled from the power assembly. Motor driver 4146 can be, for example, an A3941 available from Allegro Microsystems.

[0161] One or more of the sensors 4152, 4154, 4156, and 4158 of the control system may be configured to provide real-time feedback to the processor 4140. At least one of the sensors 4152, 4154, 4156, and 4158 may be configured to monitor at least one operating parameter related to the operation of surgical instruments during surgical procedures.

[0162] An example of a sensor configured to monitor operating parameters includes a position sensor configured to provide a unique position signal corresponding to the position of a displacement member, such as one configured to measure linear displacement. Linear displacement sensors may include contact or non-contact displacement sensors. Examples of linear displacement sensors include linearly variable differential transformers (LVDTs), differentially variable magnetoresistive transducers (DVRTs), sliding potentiometers, magnetic sensing systems comprising a movable magnet and a series of linearly arranged Hall effect sensors, magnetic sensing systems comprising a fixed magnet and a series of movable linearly arranged Hall effect sensors, optical sensing systems comprising a movable light source and a series of linearly arranged photodiodes or photodetectors, optical sensing systems comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, and any combination thereof.

[0163] Another example of a sensor configured to monitor operating parameters is a strain gauge or microstrain gauge configured to measure one or more parameters of the end effector of a surgical instrument. The measured strain is converted into a digital signal and provided to the processor 4140. For example, a strain gauge or microstrain gauge may be configured to measure the amplitude of the strain applied to the anvil of the surgical instrument during clamping operations, which may indicate the closing force applied to the anvil and indicate tissue compression. For example, a strain gauge or microstrain gauge may be configured to measure the force applied to the tissue by the end effector of the surgical instrument.

[0164] Another example of a sensor configured to monitor operating parameters is a load sensor, which is configured to measure the closing force applied to the anvil by the closing drive system of a surgical instrument. The load sensor may also be configured to measure the firing force applied to the E-beam (or I-beam) during the firing stroke of the surgical instrument.

[0165] Another example of a sensor configured to monitor operating parameters is a load sensor, which is configured to measure the force of a cutting element (e.g., a knife) used to operate a surgical instrument that cuts tissue captured between the jaws of an end effector.

[0166] Another example of a sensor configured to monitor operating parameters is a magnetic field sensor configured to measure the thickness of tissue trapped between the jaws of an end effector. The measurement results from the magnetic field sensor can be converted into a digital signal and provided to the processor 4140.

[0167] Another example of a sensor configured to monitor operating parameters is a current sensor 4158 configured to measure the current consumed by motor 4144. The force required to propel the firing member may correspond to, for example, the current consumed by motor 4144. The measured force is converted into a digital signal and provided to processor 4140.

[0168] The microcontroller 4138 can use measurements of tissue compression, tissue thickness, and / or the force required by the end effector on the closed tissue to characterize the selected position of the firing member, the corresponding value of the firing member's velocity, and / or the motor power level. For example, the memory 4142 can store techniques, formulas, and / or lookup tables that can be used by the microcontroller 4138 in the evaluation.

[0169] The use of sensors configured to sense operational parameters and the data measured by those sensors, including the use of robotic surgical systems to control the operation of surgical instruments, is mentioned in the previously mentioned U.S. Patent Publication No. 2019 / 0200844, filed December 4, 2018, entitled "Method of Hub Communication, Processing, Storage and Display"; U.S. Patent Publication No. 2019 / 0200981, filed December 4, 2018, entitled "Method of Compressing Tissue Within Astapling Device And Simultaneously Displaying The Location Of The TissueWithin The Jaws"; U.S. Patent Publication No. 2019 / 0206004, filed March 29, 2018, entitled "Interactive Surgical Systems With Condition Handling Of Devices And Data Capabilities"; and U.S. Patent Publication No. 2019 / 0206004, filed March 29, 2018, entitled "Surgical Hub Situational...". The concept of “Awareness” is described in more detail in U.S. Patent Publication No. 2019 / 0201140 and U.S. Patent Application No. 17 / 068,857, filed on October 13, 2020, entitled “Adaptive Responses from Smart Packaging Of Drug Delivery Absorbable Adjuncts”.

[0170] The control system 4136 for surgical instruments may include components configured to communicate with a modular communication hub, such as Figure 14The modular communication hub 4122 provides wired or wireless communication interfaces.

[0171] Analysis of exposure conditions

[0172] As discussed above, one or more exposure conditions of the appendage and any pharmaceuticals therein can be monitored, for example, by using one or more sensors in the packaging unit, and a processor, such as a surgical hub or other computer system, can be configured to receive data about one or more exposure conditions collected by one or more sensors. Also as discussed above, the processor can operatively communicate with a memory configured to store data therein. The stored data may include predetermined thresholds for each of the one or more exposure conditions about which the processor can receive data from a data module. Each of the predetermined thresholds may be associated with a specific pharmaceutical agent (or a related series of pharmaceutical agents) and / or a specific appendage (or a related series of appendages, such as appendages made entirely of the same material). The processor can be configured to compare the received exposure condition data with the predetermined thresholds for the corresponding exposure condition and element (pharmaceutical and / or appendage) and provide data output.

[0173] Figure 16 An embodiment of exposure condition data and processor analysis is illustrated. In this illustrated embodiment, the processor is configured to determine the shelf-life degradation rate of appendages packaged by the packaging unit based on measurements of temperature, humidity, and light. As discussed above, the appendages contain at least one agent held therein, and the packaging unit may contain other components, such as at least one container body, one or more additional appendages, etc. Figure 16 As shown, the sensor of the packaging unit (e.g.) Figure 8 Sensor 4008, Figure 9 Sensor 4014, Figure 10 Sensors (such as 4022) can be configured to track temperature exposure, humidity exposure, and light exposure over nine different time intervals t1, t2, t3, t4, t5, t6, t7, t8, and t9. As mentioned above, the sensor can be a single sensor configured to monitor multiple exposure conditions, or it can be multiple sensors, each configured to sense at least one of the exposure conditions. The following discussion also applies to other exposure conditions, such as ultraviolet radiation and pressure.

[0174] The memory operatively coupled to the processor has predetermined thresholds for each of temperature, light, and humidity stored therein. For temperature, the predetermined thresholds include a minimum low temperature value T. MaxLow Low temperature T Low High temperature T High and the maximum temperature TMax Low temperature T Low and high temperature T High The temperature range between these values ​​represents the acceptable temperature range for the accessory, within which temperature will not adversely affect shelf life. Below low temperature T Low and / or below the maximum temperature T MaxLow Temperature will adversely affect shelf life. Temperatures below the maximum value T MaxLow The temperature indicates that the accessory has been exposed to a temperature sufficiently unfavorable to render it unusable. Above a high temperature T High and / or above the maximum temperature T Max Temperature will adversely affect shelf life. Temperatures above the maximum temperature T... Max The temperature indicator shows that the accessory has been exposed to a temperature sufficiently unfavorable to render it unusable. For example... Figure 16 As shown, from time zero to time t1, between time t2 and time t3, and between time t7 and time t8, the temperature was sensed as being within an acceptable range; between time t1 and time t2, between time t3 and time t7, and between time t8 and time t9, the temperature was sensed as being above the high temperature T. High And below the maximum temperature T Max Furthermore, after time t9, the temperature was sensed to be higher than the maximum high-temperature value T. Max .

[0175] For humidity, the predetermined thresholds include high humidity H High and maximum humidity H Max Higher than high humidity H High and / or above the maximum humidity H Max Humidity levels will adversely affect shelf life. Humidity levels above the maximum allowed humidity (H) will further impact shelf life. Max The humidity indicator shows that the accessory has been exposed to humidity levels that are sufficiently unfavorable to render it unusable. For example... Figure 16 As shown, from time 0 to time t4 and after time t7, humidity was sensed as being below the high humidity H. High Within acceptable limits, and from time t4 to time t7, humidity was sensed as being above the high humidity H. High And below the maximum humidity H Max .

[0176] For light, the predetermined threshold includes high light L High Maximum light value L Max Zero light indicates darkness (no light exposure). Above high light (L) High and / or above the maximum light value L Max Light exposure will adversely affect shelf life. Light levels above the maximum value L... MaxThe light indicates that the accessory has been exposed to light that is sufficiently detrimental to its use. For example... Figure 16 As shown, from time zero to time t5 and after time t6, light is sensed as being below the high light level L. High Within the acceptable range, and from time t5 to time t6, the light was sensed as being above the high light level L. High And below the maximum light value L Max .

[0177] Generally, the shelf life of an accessory is adversely affected at a first rate when only one of the exposure conditions is simultaneously outside the acceptable range, at a second rate greater than the first rate when two of the three exposure conditions are simultaneously outside the acceptable range, and at a third rate greater than the second rate when all three exposure conditions are simultaneously outside the acceptable range. For example, as... Figure 16 As shown, when the owners of temperature, humidity, and light are sensed to be within their respective acceptable ranges from time 0 to time t1, from time t2 to time t3, and from time t7 to time t8, the shelf life of the appendage decreases at a first very low rate Q1. The passage of time illustrates the first rate Q1 of shelf life reduction. When only temperature is sensed to be outside the acceptable temperature range from time t1 to time t2, from time t3 to time t4, and after time t8, the shelf life of the appendage decreases at a second rate Q2 greater than the first rate Q1. When each of temperature and humidity is sensed to be outside their respective acceptable ranges and light is sensed to be within its acceptable range from time t4 to time t5, the shelf life of the appendage decreases at a third rate Q3 greater than the second rate Q2. In this illustrated embodiment where the adverse exposure conditions are temperature and humidity, the third rate Q3 is approximately three times the first rate Q1. When the owners of temperature, humidity, and light are sensed to be outside their respective acceptable ranges from time t5 to time t6, the shelf life of the appendage decreases at a fourth rate Q4, which is greater than the third rate Q3. In this illustrated embodiment where the adverse exposure conditions are temperature, light, and humidity, the fourth rate Q4 is approximately five times the first rate Q1.

[0178] When the shelf life reaches 0%, the processor determines that the appendage is no longer suitable for use. If the appendage experiences a severe exposure event before reaching 0% shelf life, the processor determines that the appendage is no longer suitable for use. In the illustrated embodiment, this is determined by the temperature being sensed at time t9 as being above the maximum high temperature value T. MaxThe adhesiotherapy device experiences a severe exposure event before its shelf life reaches 0%. Therefore, the processor determines that the adhesiotherapy device is no longer suitable for use after t9. In some implementations, instead of waiting until the shelf life reaches 0% to determine that the adhesiotherapy device is no longer suitable, this unsuitability determination percentage threshold can be a percentage higher than zero, such as 15%, 10%, 5%, 8%, 3%, 2%, etc. A unsuitability threshold percentage higher than 0% reflects that even if the adhesiotherapy device has some remaining shelf life, its lifespan is low enough that an adhesiotherapy device with a longer shelf life should be used to help ensure the effectiveness of the adhesiotherapy device in patients.

[0179] If the processor determines that the appendage is unsuitable for use, for example, by having a shelf life of 0% (or other predetermined threshold of inactivity), or by any one or more of the exposure conditions being sensed as being at a severe level (above the maximum temperature T0). Max Temperature, above the maximum humidity H Max Humidity, above the maximum light value L Max If the processor is configured to transmit data output characterizing that determination, such that a warning not to use the accessory can be provided (e.g., email warning, visual warning on a display, audible warning, tactile warning, etc.), as discussed herein, and / or data output resulting in such a warning can be transmitted. The processor can similarly be configured to transmit data output indicating the current determined shelf life of the accessory, which can assist surgeons or other medical professionals in deciding whether to use the accessory. The processor can similarly be configured to transmit data output indicating any time the accessory has experienced an adverse exposure event and the indication for that exposure event, which can assist manufacturers, distributors, or other providers in assessing storage conditions and / or shipping options for their packaging units.

[0180] Figure 17 Another embodiment of exposure condition data and processor analysis is illustrated. In this illustrated embodiment, the processor is configured to determine the indications and contraindications of the appendage packaged by the packaging unit based on measurements of temperature and light. As discussed above, the appendage has at least one pharmaceutical agent held therein, and the packaging unit may package other components therein, such as at least one container body, one or more additional appendages, etc. Figure 17 As shown, the sensor of the packaging unit (e.g.) Figure 8 Sensor 4008, Figure 9 Sensor 4014, Figure 10 Sensors such as 4022 can be configured to operate at fifteen different time intervals (time from zero to t). 15) tracking the temperature exposure and light exposure therein. As mentioned above, the sensor may be a single sensor configured to monitor multiple exposure conditions, or may be a plurality of sensors each configured to sense at least one of the exposure conditions. The following discussion also applies to other exposure conditions, such as ultraviolet rays, pressure, humidity, etc.

[0181] Similar to the above regarding Figure 16 discussed, the memory operably coupled to the processor has predetermined thresholds for each of temperature and light stored therein. In the illustrated embodiment, for temperature, the predetermined thresholds include a medium temperature F med , a high temperature F high and a maximum high temperature F max . The temperature range below the medium temperature F med is an acceptable temperature range for the accessory, within which the temperature will not adversely affect the indications or contraindications of the accessory. Temperatures above the medium temperature F med and below the high temperature F high will degrade the accessory at a first moderate degradation level. Temperatures above the high temperature F and below the maximum high temperature Fmax will degrade the accessory at a second high degradation level that is greater than the first degradation level. Temperatures above the maximum high temperature F max indicate that the accessory has been exposed to a temperature sufficiently adverse that the accessory has become contraindicated and should not be used.

[0182] For light, the predetermined thresholds include a low light J low , a medium light J med and a high light J high . The light range below the low light J low is an acceptable light range for the accessory, within which light will not adversely affect the indications or contraindications of the accessory. Light above the low light J low and below the medium light J med will degrade the accessory at a first low degradation level. Light above the medium light J med and below the high light J high will degrade the accessory at a second moderate degradation level that is greater than the first degradation level. Light above the high light J high indicates that the accessory has been exposed to light sufficiently adverse that the accessory has become contraindicated and should not be used. In the illustrated embodiment, the light range below the low light J low corresponds to darkness (no light exposure), and light above the low light J low and below the medium light J med corresponds to indoor light exposure, light above the medium light J med and below the high light J high corresponds to indirect sunlight exposure, and light above the high light J highThe light corresponds to direct exposure to sunlight.

[0183] Generally speaking, Figure 17 The degradation of the adhesive used to attach the appendage and its relationship to the surgical procedure in which it is planned to be used are illustrated. The processor adjusts the appendage's durability threshold and compares this threshold to predetermined durability requirements for the surgical procedure. This comparison produces data output from the processor, including the appendage's usage status, surgical indications, or recommended or modified procedures for appendage use.

[0184] In the illustrated embodiment, the processor determines that, up to time t4, the appendage is acceptable for use in lung applications, gastric applications, low-risk surgeries, and very low-risk surgeries. Therefore, the processor's data output for the use of the appendage will be "acceptable." At time t4, the appendage has experienced temperatures above medium F since time t2. med And below the high temperature F high The temperature and temperature of the appendages, and since time t3, they have undergone indoor light exposure. Therefore, the adhesiveness of the appendages has decreased from 100% at time t2 to 90% at time t4. 90% adhesiveness is acceptable for gastric applications, low-risk procedures, and very low-risk procedures, but problematic for pulmonary applications, where adhesiveness is of greater importance due to the particular importance of any leakage in the lungs caused by the adverse effects of leakage on respiration. Therefore, the processor's data output is "acceptable" for the use of the appendages in gastric applications, low-risk procedures, and very low-risk procedures, but "recommended with caution" for use in pulmonary applications. These indications and contraindications remain until time t7, at which time, the exposure of the appendages to light and temperature has reduced the adhesiveness of the appendages to 60%. 60% to 90% adhesiveness is acceptable for gastric applications, low-risk procedures, and very low-risk procedures, but problematic for pulmonary applications. Below 60% adhesiveness is unacceptable for pulmonary applications. Therefore, the processor's data output will be "unacceptable" for the use of the appendages in pulmonary applications. A reduction in adhesiveness to 60% will not alter the effectiveness of the adjuvant in low-risk or very low-risk procedures, but it will indeed change its effectiveness in gastric applications. In gastric applications, where the adjuvant is implanted in the patient, the adhesiveness may begin to decrease to a level that adversely affects normal gastric function. Therefore, the processor's output for the use of the adjuvant in low-risk and very low-risk procedures will be "acceptable," while its use in gastric applications is "recommended with caution." These indications and contraindications remain in effect until time t. 10Up to this point, exposure to light and temperature has reduced the adhesiveness of the appendage to 40%. Adhesiveness below 40% is unacceptable for gastric applications. Therefore, the processor's data output will be "unacceptable" for the use of the appendage in gastric applications (and in pulmonary applications, as described above). A reduction in adhesiveness to 40% does not alter the effectiveness of the appendage for low-risk or very low-risk procedures. Therefore, the processor's output will be "acceptable" for the use of the appendage in low-risk and very low-risk procedures. These indications and contraindications remain in effect until time t. 14 Up to this point, exposure to light and temperature had reduced the adhesiveness of the appendage to 25%. A 25% reduction in adhesiveness does not alter the appendage's effectiveness in very low-risk procedures, but it does alter its effectiveness in low-risk procedures. Therefore, the processor's output for the use of the appendage in very low-risk procedures would be "acceptable," while its use in low-risk procedures is "recommended with caution." These indications and contraindications remain in effect until time t. 15 Up to this point, the appendages were exposed to temperatures above the maximum temperature F. max The temperature. Therefore, the accessories are considered unsuitable for use in any application. Thus, the processor's output would be "unacceptable" for all procedures.

[0185] Figure 16 and Figure 17 The effects of exposure conditions on the appendages have been discussed, but the exposure conditions of the agent can be treated similarly, in addition to or in lieu of the exposure conditions of the appendages. Therefore, the unsuitability of an appendage for use can be determined based on the exposure of the appendage to one or more unfavorable exposure conditions and / or the exposure of the agent to one or more unfavorable exposure conditions.

[0186] Accessories, staple cartridges, and stitcher compatibility

[0187] In some cases, the appendages and the agents contained therein may not have undergone any exposure conditions that adversely affect their performance, but may still be unsuitable for use. Compatibility can be determined in addition to the exposure condition monitoring and analysis discussed above, or it can be determined without any exposure condition monitoring and analysis. Determining compatibility without any exposure condition monitoring and analysis allows for lower packaging unit costs and / or easier manufacturing, as sensing capabilities are not required.

[0188] In embodiments where the staple cartridge is configured to be removably and interchangeably coupled to the end actuator of a surgical stapler, the staple can only be properly and / or safely fired from the cartridge if it is compatible with the surgical stapler. Staple cartridges come in various sizes, therefore a staple cartridge removably and interchangeably coupled to the end actuator should have a size compatible with the specific end actuator to which it is coupled. Some surgical staplers may be incompatible with staple cartridges having appendages releasably coupled thereto, for reasons such as the appendages preventing proper closure of the stapler jaws, preventing proper firing of the staple, the stapler not providing sufficient force to drive the staple through the appendages, the cartridge being used for a different type of stapler (e.g., linear to circular), and / or the stapler blade not having sufficient sharpness and / or strength to cut the appendages. Therefore, establishing compatibility between the surgical stapler and the staple cartridge with appendages releasably coupled thereto is important.

[0189] Establishing compatibility between a surgical stapler and a cartridge with releasably attached appendages typically involves determining whether the stapler, cartridge, and appendages are pre-determined to be suitable for use with each other. Establishing compatibility before attempting to fire the staples from the stapler can help ensure that the stapler and appendages function appropriately and / or help ensure that the patient is not injured or otherwise harmed by using a stapler that includes a cartridge and / or appendages that are incompatible with it and should not be used with the stapler. In an exemplary embodiment, compatibility is established before the cartridge is attached to the stapler, for example, before the stapler cartridge is placed in the end actuator of the stapler, so that it is necessarily established before the stapler attempts to fire the staples from the cartridge.

[0190] In an exemplary embodiment, a method for establishing compatibility between a surgical suture device and a staple cartridge having an appendage releasably attached thereto includes: a processor, for example, a surgical hub or other computer system, acquiring component data associated with the appendage releasably attached thereto from a packaging unit containing the appendage, and comparing the component data with acceptable component data. The component data can be transmitted from the packaging unit using a communication interface as discussed above, for example, a communication interface that transmits stored data to an external device. In response to a mismatch between the component data and acceptable component data, the processor can cause a warning indicating incompatibility to be provided. Thus, a user may be warned against using incompatible components before attempting to use those components. In response to a match between the component data and acceptable component data, a confirmation notification indicating compatibility can be provided. In some embodiments, the packaging unit packages the appendage even before it is releasably attached to the staple cartridge, regardless of whether the packaging unit also packages the appendage. In other embodiments, the packaging unit packages the appendage even when it is releasably attached to the staple cartridge, wherein the packaging unit does not package the surgical suture device, because packaging the staple cartridge and suture device together would indicate compatibility without component data comparison.

[0191] Establishing compatibility between surgical staplers and staple cartridges with releasably attached appendages ensures that the stapler utilizes the correct staple cartridge and appendages. This reduces the risk of inadvertent use of inappropriate components, which can lead to malfunction of the stapler, cartridge, and / or appendages, improper or nonexistent staple deployment, and / or incorrect implantation of the appendages, each of which can be dangerous to the patient.

[0192] When the suture device operates according to stored control parameters, establishing component compatibility ensures compatibility with those parameters. For example, if the suture device has control parameters indicating the maximum cutting element speed, establishing component compatibility ensures that the components are compatible with the cutting element speed and ensures, for example, that attachments will be cut properly and will not be accidentally torn or otherwise unintentionally damaged in response to the movement of the cutting element through it. Control parameters can be stored in the memory of the suture device or an external device, and comparisons of these parameters with respect to whether component data is suitable or needs to be changed can be performed by a processor.

[0193] This method can establish compatibility between the suture device and only one of the staple cartridges and accessories releasably attached to the accessory, or it can establish compatibility between the suture device and each of the staple cartridges and accessories releasably attached to the accessory. A suture device compatible with only one of the staple cartridges and accessories releasably attached to the accessory can indicate that the other of the staple cartridges and accessories releasably attached to the accessory is compatible with the suture device, for example, because only certain sizes of accessories can be used with certain sizes of staple cartridges, because only certain accessories can be used with certain staple cartridges, and so on.

[0194] Comparing component data with acceptable component data may include comparing component parameters (e.g., numbers, codes, text, etc.) of the component data with acceptable parameters (e.g., numbers, codes, text, etc.) of the acceptable component data stored at an external device including a processor and / or stored in memory located outside the external device but accessible to the external device. This comparison includes determining whether each component parameter in one or more component parameters in the component data matches a corresponding parameter in the acceptable component data, where a match indicates compatibility and a non-match indicates incompatibility. Acceptable component data may be stored, for example, in the form of a lookup table, in which each possible component data receivable from the packaging unit is associated with an acceptable suture and / or cartridge. Alternatively, an acceptable component table may be stored as a lookup table that associates usable attachments and / or cartridges with a specific surgical suture to allow finding received component data in the table (indicating compatibility) or not finding received component data in the table (indicating incompatibility).

[0195] Acceptable component data can be updatable. Therefore, the suitability of the suture device with various compartments and accessories can be updated based on developments regarding compartments and accessories, as well as the suture device itself. For example, lookup tables stored in the memory of a surgical hub or other external device can be periodically updated with acceptable component data. Similarly, electronic instruction manuals (eIFUs) stored in the memory of a surgical hub or other external device can be periodically updated to include acceptable component data.

[0196] The component data stored at the packaging unit may include one or more component parameters. Examples of component parameters include accessory manufacturer, accessory model, accessory serial number, accessory material, accessory thickness, compartment manufacturer, compartment model, compartment serial number, and other parameters.

[0197] Component data may include indications of compatible firing parameters. In this way, the first component data may indicate which one or more firing settings (e.g., motor speed, cutting element speed, tissue clamping force, etc.) are suitable for operation with the component.

[0198] In addition to assessing component compatibility, other methods can be used to ensure the use of only compatible devices. For example, the size and shape of the physical interfaces between components are set to limit physical compatibility to components known to be compatible, such as the jaws of a staple cartridge and an end effector with complementary mating features. In this way, the number of staple cartridges that can be attached to the stapler and thus the number of accessories that can be releasably attached to the staple cartridges is limited, thereby reducing the likelihood of using incompatible components.

[0199] In addition to component data, the packaging unit may be configured to transmit expiration date data to an external device, indicating the expiration date of the appendage and / or the medication held by the appendage. If the expiration date has passed based on a comparison with the current date, the processor may cause a warning to be provided, indicating that the appendage and / or medication has expired and therefore should not be used.

[0200] In addition to component data, the packaging unit can be configured to transmit sub-component data to external devices, indicating batch information for each packaged component (e.g., each accessory, each agent, each stapler cartridge, each component portion of the stapler cartridge, etc.). If any sub-component data indicates a faulty specific sub-component, the processor can cause a warning to be provided based on a comparison with stored data on known faulty sub-components, indicating that the accessory, stapler cartridge, stapler, and / or agent should not be used and / or should be returned for maintenance or replacement. If a batch of sub-components is found to be faulty, but only some of these sub-components are incorporated into a small portion of a batch of final products (e.g., faulty staples used with only some staplers in a batch, faulty cutting blades used with only some staplers in a batch, faulty agents used with only some accessories in a batch, etc.), comparing the sub-component data may be useful, and a recall can be targeted only at devices containing the faulty sub-components. Thus, the processor can perform checks to ensure that all components and sub-components originate from good batches.

[0201] In some embodiments, the packaging unit is configured to transmit sub-component data but not component data. In some embodiments, the packaging unit is configured to transmit expiration date data but not component data. In some embodiments, the packaging unit is configured to transmit both expiration date data and sub-component data but not component data. In some embodiments, the packaging unit is configured to transmit both expiration date data and component data but not sub-component data. In some embodiments, the packaging unit is configured to transmit both component data and sub-component data but not expiration date data.

[0202] Figure 18An implementation scheme for establishing component compatibility is illustrated. As shown, component data is acquired at 4200. As noted herein, acquisition can occur by transmitting component data from the packaging unit to an external device. The component data is then compared with acceptable component data at 4202. As noted herein, this comparison can be performed using a processor (e.g., a processor for a surgical hub or other external device). Acceptable component data can be stored in memory associated with the processor, and the processor can compare the acquired component data with the acceptable component data stored in memory. Based on this comparison, the processor determines at 4204 whether the component data corresponds to the acceptable component data. If the component data is determined at 4204 to correspond to the acceptable component data, the processor may not take further action at 4206 because no incompatibility has been detected. Therefore, the relevant component can be used for nail and accessory delivery. However, the processor can provide a notification of compatibility. If the component data is determined at 4204 not to correspond to the acceptable component data, the processor causes at 4208 to provide a warning, as discussed herein, indicating incompatibility.

[0203] Figure 19 An embodiment of a verification system including an external device 4210 is shown. In this embodiment, the external device 4210 is in the form of a mobile phone, which is configured to interact with the packaging unit 4212 (e.g., Figure 8 Packaging unit 4002, Figure 9 The packaging unit 4202 wirelessly interacts with the packaging unit 4010 or other packaging units. In this illustrated embodiment, the packaging unit 4202 packages the staple cartridge 4214, the appendix 4216, and the agent 4218 releasably held by the appendix 4216. The staple cartridge 4214 may be packaged together with the appendix 4216, which is already releasably attached thereto. The external device 4210 is configured to acquire component data, sub-component data, and / or expiration date data from the packaging unit 4202 as discussed herein, and also to analyze the received data as discussed herein.

[0204] Packaging unit power

[0205] In some implementations, the packaging unit can operate in a single-power mode, regardless of its location in the supply chain or whether it has been opened. The packaging unit's sensors can thus be "on" to collect data throughout the unit's entire shelf life, and the unit's communication interface always has sufficient power to transmit data to external devices. Therefore, data collection and transmission are guaranteed at all relevant times.

[0206] In other embodiments, the packaging unit may be configured to operate in both a low-power mode and a high-power mode. In low-power mode, the packaging unit's sensors receive sufficient power from an onboard power source to monitor data, as discussed herein, and the packaging unit's communication interface does not have sufficient power to transmit data to an external device. In high-power mode, both the sensors and the communication interface receive sufficient power. Less power is required from the power source for data collection compared to for both data acquisition and data transmission; therefore, low-power mode helps conserve power and thus helps ensure that the power source has sufficient power throughout data transmission in high-power mode. In an exemplary embodiment, opening the packaging unit is configured to move the packaging unit from a low-power mode to a high-power mode. Until the packaging unit is opened, it remains potentially exposed to adverse conditions; therefore, waiting until the packaging unit is opened to allow data communication helps ensure that all relevant data is transmitted to an external device for analysis.

[0207] To facilitate transition from a low-power mode to a high-power mode, the packaging unit may include a tab configured to move automatically in response to opening the packaging unit. Removing the tab fully "wakes up" the power source of the packaging unit, thus providing power to the sensor to collect data (as in low-power mode) and to the communication interface to allow data communication. For example, the tab may be attached across the top box seam of the packaging unit and configured to move and / or break automatically when the top of the box is opened. Alternatively, the tab may be attached to a sealed opening of the foil pouch of the packaging unit and configured to move and / or break automatically when the sealed opening is opened. The power source may include a first power source configured to provide power to the sensor in both low-power and high-power modes and a second power source configured to provide power to the communication interface only in high-power mode. The tab may act as an insulator, preventing the second power source from providing power to the communication interface until the tab is removed, for example, in response to opening the packaging unit and causing the tab to move. In other words, the tab can be configured to prevent circuitry from being completed until the tab is removed. In some embodiments, the tab may include conductive traces configured to facilitate and prevent circuitry completion. Exemplary embodiments of tabs configured to be movable to cause movement from a low-power mode to a high-power mode are further described in International Patent Application No. PCT / IB2020 / 060710, filed November 13, 2020, entitled “Drug Delivery Device Sensing Modules,” which is incorporated herein by reference in its entirety.

[0208] Instead of including tabs, the packaging unit may include a light sensor configured to facilitate movement of the packaging unit from a low-power mode to a high-power mode. The light sensor may be disposed within the packaging unit and not exposed to light when the packaging unit is not opened. When the packaging unit is opened, the light sensor is exposed to light. Exposure of the light sensor to light can trigger a power source of the packaging unit to begin supplying power to the communication interface of the packaging unit.

[0209] In some embodiments, the packaging unit may be configured to move from a no-power mode to a power-on mode. In the no-power mode, the communication interface of the packaging unit is not powered. In the power-on mode, the communication interface is powered. The packaging unit is configured to be in a no-power mode when the packaging unit is in an unopened closed state and in a power-on mode when the packaging unit is in an open state. Therefore, the packaging unit is configured to automatically move from the no-power mode to the power-on mode in response to the packaging unit being opened (e.g., moving from a closed state to an open state). The packaging unit includes a power source configured to facilitate the movement of the packaging unit from the no-power mode to the power-on mode. The power source is photosensitive. When the packaging unit is in the closed state, the power source is dormant and not powered. The opened packaging unit is configured to activate the power source by exposing it to light. Therefore, the packaging unit is made of a material configured to prevent light from passing through it to the power source inside the packaging unit. The packaging unit is thus passive and unpowered until the packaging unit is opened. By excluding active power sources such as batteries, packaged units can be disposed of in a safer and / or more environmentally friendly manner than packaged units that include active power sources.

[0210] In an exemplary embodiment, a packaging unit configured to move from a power-free mode to a power-on mode includes a degradable element configured to degrade in response to exposure to environmental conditions such as humidity, temperature, oxygen, or radiation. In power-on mode, a communication interface is configured to transmit data indicating the state of the degradable element to a surgical hub or other computer system, as discussed herein. The state of the degradable element corresponds to its exposure to environmental conditions, thereby providing the surgical hub or other computer system with exposure condition information that can be used as discussed herein.

[0211] Figure 20 Embodiments of package units 4300, 4300' configured to move from a power-free mode to a power-on mode are shown. The power-free mode is the initial default mode. In the illustrated embodiment, package units 4300, 4300' are shown as communicating wirelessly with surgical hub 4302 4304, 4304', but as discussed herein, they can communicate with another external device.

[0212] Packaging units 4300, 4300' include degradable elements 4306, 4306', which are configured to degrade in response to exposure to environmental conditions such as humidity (including moisture or water level), temperature, oxygen, or radiation. Therefore, degradable element 4306 is typically configured as a sensor capable of monitoring exposure conditions. In a no-power mode, degradable element 4306 is intact. In other words, when packaging unit 4300 is in a closed state, the initial state of degradable element 4306 is undegraded. Circuitry 4308, including degradable element 4306, is therefore closed in the no-power mode.

[0213] In power-on mode, the degradable element is either intact (undegraded) or degraded. Figure 20 The packaging unit shown on the left, designated as packaging unit 4300, is in power-on mode, with the biodegradable element 4306 intact. Circuit 4308 is therefore closed in power-on mode, where the biodegradable element 4306 is not degraded. Figure 20 The packaging unit shown on the right, designated as packaging unit 4300' (with hash labels used for the same elements corresponding to those in the other shown packaging unit 4300), is shown in a power-on mode, where the degradable element 4306' is degraded. Circuit 4308' is thus disconnected in the power-on mode, where the degradable element 4306' has degraded.

[0214] When the packaging unit 4300 is in a no-power mode, if the degradable element 4306 has been exposed to environmental conditions for a sufficient amount of time, for example, because the packaging unit 4300 has been in a high-temperature environment long enough to degrade the degradable element 4306, because the packaging unit 4300 has been in a high-humidity environment long enough to degrade the degradable element 4306, because the packaging unit 4300 has been in a high-radiation environment long enough to degrade the degradable element 4306, because the packaging unit 4300 has been exposed to oxygen long enough to degrade the degradable element 4306, etc., then the degradable element moves from intact (degradable element 4306) to degraded (degradable element 4306'), thereby moving the circuit from closed (circuit 4308) to open (circuit 4308').

[0215] The biodegradable elements 4306, 4306' are made of an environmentally sensitive material. In an exemplary embodiment, the biodegradable elements 4306, 4306' are conductive. The conductivity of the biodegradable elements 4306, 4306' allows the circuit 4308 to close when the biodegradable element 4306 is intact. The biodegradable elements 4306, 4306' may be infused with or made of absorbable polymers configured to degrade in the presence of environmental conditions they are set to monitor and doped with conductive particles. When energized, the conductivity of the biodegradable elements 4306, 4306' is proportional to the exposure experienced by the packaging units 4300, 4300'. The biodegradable elements 4306, 4306' may be infused with or made of polymers that degrade at a rate as fast as or faster than the monitored appendage (e.g., appendages packaged by packaging units 4300, 4300'). In an exemplary embodiment, such as Figure 20 As shown, the biodegradable elements 4306, 4306' include filaments (single filament or multiple filaments) forming part of the circuits 4308, 4308'.

[0216] The biodegradable elements 4306, 4306' may be selected based on the appendages and / or agents packaged by the packaging units 4300, 4300', such that the susceptibility of the biodegradable element to one or more environmental conditions corresponds to or is more sensitive than the susceptibility of the appendages and / or agents to one or more environmental conditions. The susceptibility of the biodegradable element corresponding to the susceptibility of the appendages and / or agents allows the degradation of the biodegradable element to correspond to the effectiveness of the appendages and / or agents. In this way, degradation of the biodegradable element to the point of no longer being intact may indicate that the appendage and / or agent should not be used. The susceptibility of the biodegradable element being more sensitive than the susceptibility of the appendages and / or agents allows the degradation of the biodegradable element to occur faster than the decrease in the effectiveness of the appendages and / or agents. The degradation of the biodegradable element may therefore lead to a decrease in effectiveness, which helps ensure that ineffective appendages and / or agents are not used.

[0217] Packaging units 4300 and 4300' also include photosensitive elements 4310 and 4310' in circuits 4308 and 4308'. Photosensitive elements 4310 and 4310' are connected in series with biodegradable elements 4306 and 4306'. When packaging units 4300 and 4300' are in power-on mode (where biodegradable elements 4306 and 4306' are degraded or not), photosensitive elements 4310 and 4310' are configured to provide power to the controllers 4312 and 4312' of packaging units 4300 and 4300', the communication interfaces 4314 and 4314' of packaging units 4300 and 4300', and the lamps 4316 and 4316' of packaging units 4300. Therefore, photosensitive elements 4310 and 4310' function as power sources. In no-power mode, the photosensitive element 4310 does not provide power to any of the controller 4312, the communication interface 4314, and the light 4316.

[0218] Photosensitive elements 4310, 4310' are configured to initiate power supply to controllers 4312, 4312', communication interfaces 4314, 4314', and lamps 4316, 4316' in response to exposure to light. Therefore, opening of packaging units 4300, 4300' (e.g., moving from a closed state to an open state) is configured to activate photosensitive elements 4310, 4310' by allowing them to be exposed to light (artificial light, sunlight, or both) in the room where the packaging unit is open. In an exemplary embodiment, photosensitive elements 4310, 4310' include solar cells (a single solar cell or multiple solar cells).

[0219] In the illustrated embodiment, communication interfaces 4314, 4314' include a wireless transmitter and are configured to communicate wirelessly with the surgical hub 4302 when the communication interface 4314' is powered by the photosensitive element 4314. Data transmitted to the surgical hub 4302 using the communication interface 4314' relates to the state of the biodegradable element 4306'. When the biodegradable element 4306' is conductive, its conductivity is proportional to the amount of degradation of the biodegradable element 4306'; for example, the resistance of the conductive biodegradable element 4306' varies based on its degradation. The data transmitted by the communication interface 4314' can therefore include the amount of degradation of the biodegradable element 4306'. When the packaging unit 4300 is in a no-power mode, the communication interface 4314 is not wirelessly communicating with the surgical hub 4302 (or anything else). Controllers 4312 and 4312' are configured to control communication interfaces 4314 and 4314' based on the sensed conditions of circuits 4308 and 4308'. When circuit 4308 is closed, controller 4312 is configured to cause communication interface 4314' to communicate to surgical hub 4302 that packaging unit 4300 and therefore its packaged components meet quality standards, for example, because packaging unit 4300 has not experienced adverse environmental conditions indicating invalid appendages and / or ineffective medications. When circuit 4308' is open, controller 4312' is configured to cause communication interface 4314' to communicate to surgical hub 4302 that packaging unit 4300' and therefore its packaged components do not meet quality standards, for example, because packaging unit 4300' has experienced adverse environmental conditions indicating invalid appendages and / or ineffective medications. This communication of unmet quality standards can cause surgical hub 4302 to provide a warning, as discussed herein.

[0220] In the illustrated embodiment, lamps 4316, 4316' comprise a single LED, but may include another type of lamp and / or multiple lamps. In no-power mode, lamp 4316 is off (unlit). In power-on mode, lamps 4316, 4316' are on (lit). Therefore, the on of lamps 4316, 4316' provides a visual indication that packaging units 4300, 4300' are on and in power-on mode. The illumination color of the light in power-on mode depends on whether the biodegradable element is degraded (biodegradable element 4306') or intact (biodegradable element 4306). In the illustrated embodiment, lamp 4316 illuminates green when biodegradable element 4306 is intact, and lamp 4316' illuminates red when biodegradable element 4306' is degraded, but other colors may also be used. In other embodiments, instead of different colors, lamp 4316' may illuminate continuously when the biodegradable element (biodegradable element 4306) degrades, and lamp 4316 may flash when the biodegradable element (biodegradable element 4306) is not degraded. Alternatively, lamp 4316' may flash when the biodegradable element (biodegradable element 4306) degrades, and lamp 4316 may illuminate continuously when the biodegradable element (biodegradable element 4306) is not degraded.

[0221] Controllers 4312 and 4312' are configured to sense whether the circuit is closed (circuit 4308, degradable element 4306 is not degraded) or open (circuit 4308', degradable element 4306' is degraded). Controllers 4312 and 4312' are configured to control lamps 4316 and 4316' based on the sensed state of circuits 4308 and 4308'. For example, as shown in the illustrated embodiment, controllers 4312 and 4312' cause lamp 4316 to illuminate green when circuit 4308 is closed, and cause lamp 4316 to illuminate red when circuit 4308' is open.

[0222] As shown in the embodiment, packaging units 4300, 4300' may include force elements 4318, 4318', such as helical springs, elastic filaments, or other force elements configured to provide force to the biodegradable element 4306 when the packaging unit 4300 is in a no-power mode. Force elements 4318, 4318' are configured to facilitate the breakage of the intact biodegradable element 4306 that has been weakened by exposure to environmental conditions. Therefore, the force elements help ensure that the circuit 4308' disconnects in the event of degradation of the biodegradable element 4306'. Force elements 4318, 4318' are non-conductive, for example, by being formed of a non-conductive material and / or having an insulating coating, so as not to form part of the circuit 4308, 4308'.

[0223] Figure 21 and Figure 22 Another embodiment of the package unit 4320, configured to move from a no-power mode to a power-on mode, is shown. The package unit 4320 is generally similar to that discussed above. Figure 20 The packaging units 4300 and 4300' are similarly constructed and used, for example, including biodegradable elements (in... Figure 21 and Figure 22 (obstructed in the middle), circuit (in) Figure 21 and Figure 22 (obstructed in the middle), photosensitive element 4322, controller (in Figure 21 and Figure 22 (obstructed), communication interface 4322, lamp 4324 and force element (in) Figure 21 and Figure 22 (The middle is obscured). For example Figure 21 and Figure 22 As shown, in this embodiment, the photosensitive element and the communication interface are integrated together. In this illustrated embodiment, the photosensitive element 4322 includes a solar cell (a single solar cell or multiple solar cells). In this illustrated embodiment, the communication interface 4322 includes a wireless transmitter.

[0224] In this illustrated embodiment, packaging unit 4320 includes a foil bag with a lid 4326. The lid 4326 is configured to be manually (completely or partially) removed from a housing 4328 of packaging unit 4320, which houses the packaged elements within its cavity 4330. The packaged elements are not in… Figure 21 and Figure 22 As shown herein, but may include elements as discussed herein, such as appendages releasably holding a drug therein, multiple appendages each releasably holding a drug therein, staple cartridges having appendages releasably attached thereto (where the appendages releasably hold a drug therein), multiple staple cartridges each having appendages releasably attached thereto (where the appendages releasably hold a drug therein), etc. As discussed herein, packaging unit 4320 may be packaged in and removed from a bulk packaging unit for use.

[0225] like Figure 21 and Figure 22 As shown, the photosensitive element 4322, communication interface 4322, and lamp 4324 can be embedded in the housing 4328. Similarly, biodegradable elements, circuits, controllers, and force elements that are shielded are embedded in the housing 4328. Embedding these elements in the housing 4328 helps protect them from damage as the packaging unit moves through the supply chain.

[0226] Figure 21The packaging unit 4320 is shown in a power-free mode. Therefore, the cover 4326 is closed, preventing the photosensitive element 4322 from being exposed to light. The lamp 4324 is off. The degradable element is subjected to environmental conditions in the power-free mode and is therefore capable of degradation (if desired).

[0227] Figure 22 The packaging unit 4320 is shown in power-on mode. Therefore, the cover 4326 is open, exposing the photosensitive element 4322 to light. The lamp 4324 is on. As discussed above, the color of the illumination light 4324 (and / or flashing / continuous illumination state) depends on whether the biodegradable element is degraded or intact. Now, with the packaging unit 4320 receiving power from the photosensitive element 4322 in power-on mode, the communication interface 4322 is shown as transmitting data 4332 regarding the state of the biodegradable element to a surgical hub or other computer system, as discussed above.

[0228] In some implementations, instead of a packaging unit configured to move from a power-free mode to a power-on mode, a photosensitive element configured to supply power to the components of the packaging unit may be included. The packaging unit may include a magnetically powered element such as an RFID tag or other passive magnetically powered element. The magnetically powered element is configured to be powered only in the presence of a magnetic field. Therefore, when exposed to a magnetic field, such as that provided by an RFID reader or other device, the magnetically powered element allows the packaging unit's communication interface to transmit data, as discussed above.

[0229] Post-implantation adnexal monitoring

[0230] As discussed above, the appendage can be absorbable. Therefore, the appendage can be configured to degrade within the patient's body. The absorbable configuration of the appendage can be used to aid in monitoring the patient's healing. Monitoring the breakdown of the appendage in the patient's body after its implantation (generally referred to herein as appendage "degradation") can be used as a means of monitoring patient healing. Appendage degradation typically corresponds to patient healing because tissue heals over time and because any medication releasably held by the appendage is released over time after the appendage has been implanted in the patient's body. Therefore, monitoring appendage degradation allows for the assessment of the patient's healing.

[0231] Monitoring of the appendages can be performed non-invasively from outside the patient's body. Therefore, no surgical intervention is required to assess the absorption status of the appendages and the patient's healing after implantation.

[0232] The degradation of implanted appendages can be monitored in various ways. For example, monitoring may include imaging the appendage to visualize radiopaque markers that can be released from the appendage into the patient's body. As another example, monitoring may include tracking waste byproducts of the appendage that can be released from the implanted appendage into the patient's body. As yet another example, monitoring may include monitoring patient waste. As yet another example, in embodiments using a surgical suture device to deliver the appendage, monitoring may include tracking a traceable element delivered from the surgical suture device that sutures the appendage into the patient. Each of these examples will be discussed further below.

[0233] Information collected regarding the degradation of the implanted appendage can be transmitted to a surgical hub or other computer system, such as via a communication interface of a device that collects images, tracks material data, etc., as discussed further below. The surgical hub or other computer system can be configured to provide the patient's surgeon or other healthcare professional with notifications of appendage monitoring, similar to those discussed above regarding notifications of compatibility, to facilitate patient care.

[0234] In some embodiments, monitoring the degradation of the implanted appendage in the patient's body may include imaging the appendage to visualize a radiopaque marker that can be released from the appendage into the patient's body. In such embodiments, the radiopaque marker is retained by the appendage when it is implanted, similar to what is discussed herein with respect to releasably retaining agents of the appendage when it is implanted. As the appendage degrades and is bioresorbed, the radiopaque marker moves from its original implantation site where the appendage was sutured or otherwise attached to the patient. This allows for monitoring of the appendage's degradation and, consequently, patient healing.

[0235] Patients can be imaged at multiple different times, such as consecutively and / or at intervals of one or more days, to visualize radiopaque markers. Thus, degradation of the appendages can be monitored over time, with each subsequent image providing an updated indication of patient healing. Therefore, comparing each of these images provides an indication of the movement of radiopaque markers in the patient's body over time, and consequently, an indication of appendage degradation and patient healing over time.

[0236] In embodiments where the appendages are compressible (e.g., as tissue thickness compensation), comparison of images taken over time can show whether the appendages are decomposing, causing radiopaque markers to move closer together as the appendages degrade, or to move apart from each other as the appendages that keep the radiopaque markers bound degrade, and the radiopaque markers to migrate freely.

[0237] Radiopaque markers can be formed from any of a variety of biocompatible radiopaque materials and can be releasably retained by the appendage in a variety of ways. For example, in an embodiment where the appendage is formed of foam, the radiopaque marker can be embedded throughout the foam such that the radiopaque marker is released as the foam degrades. Any agent releasably retained by a foam appendage can be similarly released, as discussed herein. As another example, in an embodiment where the appendage is formed of a fibrous structure, the radiopaque marker can be trapped between the fibers forming the fibrous structure such that the radiopaque marker is released as the fibrous structure degrades. Any agent releasably retained by a fibrous structure appendage can be similarly released, as discussed herein.

[0238] In an exemplary embodiment, the radiopaque marker is an element of a surgical suture device that facilitates the delivery of the appendage and the agent held by the appendage to the tissue, such as the application of the staple and the appendage. Therefore, no modification to existing appendages and agents is required for use with the radiopaque marker discussed herein, nor is special design required for future appendages or agents.

[0239] Figure 23 An embodiment of an appendage 4400 is shown that releasably retains agent 4402 and a plurality of radiopaque markers 4404. The appendage 4400 retains a single agent 4402, but can retain multiple agents as discussed herein. In this illustrated embodiment, the appendage 4400 is configured to change its configuration.

[0240] Figure 23An appendage 4400 is shown implanted at the edge of a patient's tissue 4406 via the deployment of a nail 4408 into the tissue 4406. With the appendage 4400 implanted in the patient, the patient can be imaged using an imaging system 4410 (such as a fluorescence examination system, X-ray system, or other system), which is configured to provide images that allow visualization of the radiopaque marker 4404. The imaging system 4410 is located at the exterior 4412 of the patient's body, and the appendage 4400, the agent 4402, and the radiopaque marker 4404 are located at the interior 4414 of the patient's body. Therefore, the imaging system 4410 is configured to image the patient from the exterior 4410 of the patient's body. The patient's external surface is schematically represented by dashed lines 4416. Each image taken using the imaging system 4410 may be taken at a known location where the appendage 4400 is implanted, which in this illustrated embodiment is at the edge of the tissue 4406, or multiple images may be taken at two or more different locations using the imaging system 4410. One or more of two or more locations may include the location where the known appendage 4400 is implanted. Taking at least one image at the location where the known appendage 4400 is implanted allows monitoring of the healing of tissue 4406 at that location. Taking at least one image excluding the location where the known appendage 4400 is implanted allows monitoring of healing away from the location where the known appendage 4400 is implanted (at tissue 4406 or other locations). Healing away from the location where the known appendage 4400 is implanted may be caused by the movement of agent 4402 within the patient's body. Taking at least one image excluding the location where the known appendage 4400 is implanted allows monitoring of how the degraded appendage 4400 and / or released agent 4402 move within the patient's body, which may help facilitate postoperative analysis useful to the patient and / or future patients receiving similar appendages and / or similar agents.

[0241] Figure 24 and Figure 25 Another embodiment of an appendage 4420 is shown that releasably retains the agent 4422 and releasably retains a plurality of radiopaque markers 4424. Figure 24 Pre-implantation appendage 4420 is shown. Figure 25An appendage 4420 is shown implanted in a patient's body, sutured to the patient's tissue 4426. In this illustrated embodiment, the surgical staple 4428 includes the appendage 4420 disposed on two legs of the staple 4428 configured to deliver the appendage 4420 to the tissue 4426. Thus, in this illustrated embodiment, the appendage 4420 is a two-part appendage, wherein each part of the appendage 4420 releasably retains an agent 4422 and a radiopaque marker 4424. In other embodiments, one part of the appendage 4420 may releasably retain the agent 442, and the other part of the appendage 4420 may releasably retain the radiopaque marker 4424. In some embodiments, only one staple leg may have an appendage thereon, or one or two staple legs may have more than one appendage thereon.

[0242] like Figure 25 As shown, the medication 4422 and the radiopaque marker 4424 are configured to be released from the appendage 4420 when the staple 4428 deforms after it has been deployed into the patient's tissue 4426, such as the intestine, lung, etc. Some of the medication 4422 and / or some of the radiopaque marker 4424 may remain in the appendage 4420 during suturing and be released from the appendage 4420 as it degrades. Figure 26 The diagram shows nail 4428 and a plurality of additional similar nails, each of which also has an appendage disposed thereon, similar to the arrangement of appendage 4420 on nail 4428. Figure 26 Side-to-side anastomosis is shown, but staple 4428 can be used for other surgical procedures. Drug 4222 and / or radiopaque marker 4424 can be released from the appendage 4420 into a pathway 4430 extending through the tissue 4426. Therefore, imaging of the pathway at and / or away from the appendage implantation site in the tissue 4426 allows visualization of the radiopaque marker 4424.

[0243] In some embodiments, monitoring the degradation of the implanted appendage in the patient's body may include tracking waste byproducts of the appendage that can be released from the implanted appendage into the patient's body. In such embodiments, the appendage includes waste byproducts that can be released from the implanted appendage into the patient's body. Similar to what has been discussed above regarding radiopaque markers that can be released from the appendage, the waste byproducts migrate from the original implantation site of the appendage, which was sutured or otherwise attached to the patient, as the appendage degrades and is bioresorbed. This allows for monitoring of appendage degradation and, consequently, patient healing.

[0244] Waste byproducts can be formed from any of a variety of biocompatible materials. For example, appendages can be formed from absorbable and non-absorbable materials. Non-absorbable materials, such as non-absorbable polymers, can define waste byproducts. As the absorbable material of the appendage decomposes in the patient's body, waste byproducts are released from the appendage to allow for monitoring of waste byproducts. Appendages can be formed from absorbable and non-absorbable materials in various ways, such as by forming an appendage from a fibrous structure comprising a variety of absorbable and non-absorbable fibers, by forming an appendage from at least one absorbable membrane attached to at least one non-absorbable membrane, or other appendage configurations. As another example, waste byproducts may include iron-containing materials configured to be detectable by a metal detector. Appendages may include iron-containing materials, similar to those discussed above regarding appendages including radiopaque markers. As another example, waste byproducts may include radioactive materials configured to be detectable by a radiation detector. Appendages may include radioactive materials, similar to those discussed above regarding appendages including radiopaque markers. Radioactive materials are mildly radioactive to achieve safe levels. As another example, waste byproducts may include physiological secondary products. For example, waste byproducts may include metabolic markers or degradation products. As mentioned above, byproducts may be formed from absorbable polymers. Absorbable polymers tend to break down into sub-components, including components metabolized by the body and other components that are not metabolized and released from the body as waste. Unmetabolized components can be waste byproducts. As an example, for PLGA, metabolites may include substances that act as sugars and waste byproducts including lactic acid and glycolic acid excreted by the kidneys. As another example, for PLA, metabolites may include substances that act as sugars and waste byproducts including lactic acid excreted by the kidneys.

[0245] Monitoring devices can be used to locally monitor waste byproducts. These devices can be configured to monitor the concentration and location of waste products within the patient's body. The monitoring devices are located externally to the patient's body, similar to the methods described above. Figure 23 The imaging system 4410 discussed here has a monitoring device configured to monitor material released from an implanted appendage. In an exemplary embodiment, the monitoring device is a wearable monitor that allows for easy and non-invasive monitoring of a patient.

[0246] In some embodiments, the waste byproducts may include iron-containing material, and the monitoring device may include a metal detector configured to monitor the concentration and location of the iron-containing material in the patient's body. At time zero, when the appendage releasably retains the iron-containing material implanted in the patient's body, the concentration of the iron-containing material will be known. The monitoring device can then track any changes in this concentration or dispersion of the iron-containing material away from the implantation site.

[0247] In some embodiments, waste byproducts may include radioactive material, and the monitoring device may include a radiation detector configured to monitor the concentration and location of the radioactive material in the patient's body. At time zero, when the appendage releasably retains the radioactive material implanted in the patient's body, the concentration of the radioactive material will be known. The monitoring device can then track any changes in this concentration or dispersion of the radioactive material away from the implantation site.

[0248] In some implementations, monitoring the degradation of the implanted appendage in the patient's body may include monitoring the patient's waste products. The appendage may be implanted at multiple locations in the patient, such as the lungs, gastrointestinal tract, or liver. In cases where the appendage is implanted in the gastrointestinal tract, such as the colon, the location of the appendage can be used to facilitate monitoring its degradation in the patient's body. In such cases, waste products of the appendage may be released into the gastrointestinal pathway, similar to the above description. Figure 26 The release of the radiopaque marker 4424 from the appendage 4420 into the pathway 4430 is discussed.

[0249] Monitoring patient waste may include tracking waste byproducts of the appendage that may be released from the implanted appendage into the patient's body and released with the waste. In such embodiments, waste byproducts may be systematically monitored after they have left the patient as waste. Therefore, waste byproducts can be monitored from outside the patient's body. Waste byproducts monitored after their release from the patient's body may include metabolic markers or degradation products.

[0250] The toilet may include a smart computer system monitor, similar to a urinal deodorizer, configured to track metabolic markers or degradation products. The smart monitor may be configured to notify the patient's surgeon or other healthcare professional about the monitoring of the appendage, or it may be configured to transmit data collected by it to a surgical hub or other computer system configured to provide such notification.

[0251] In addition to or as an alternative to using smart monitors, patient stool samples can be collected for the detection of waste byproducts in the stool. Waste byproducts can be detected in stool in a variety of ways, such as by the presence of a dye in the waste, which would be visually observable if present in the waste. Alternatively, waste byproducts may include a reactive chemical that, if present in the waste, will react with a reagent such as litmus paper or an activating chemical applied to the stool. Therefore, pH can be used to detect waste byproducts. Bacterial loads or other mineral reagents can also be used.

[0252] In some implementations, monitoring the degradation of the implanted appendage in the patient's body may include tracking a traceable element delivered to the patient from the surgical suture device that stitches the appendage into the patient. In cases where the appendage is implanted in the gastrointestinal tract, such as the colon, the location of the appendage can be used to facilitate monitoring its degradation in the patient's body. In such cases, the traceable element may be released into the gastrointestinal pathway, similar to the above description. Figure 26 The release of radiopaque marker 4424 from appendage 4420 into pathway 4430 is discussed. Trackable elements can be configured to interact with the microbiota in the gastrointestinal tract, such as the colon. The release values ​​of the tracked element can be used as a means of analyzing the balance of the gut microbiome and / or the healing response over time. Parameters within the colon that can be used as interactive measurements linked to microbiota balance or healing include pH, O2, and CO2. CO2 concentration causes a pH shift in organic structures. If an increased pH is detected, additional tests can be performed to determine the source of the pH change; these additional tests can lead to O2 / CO2 balance measurements. Different bacteria use O2 and CO2 in different ways, and some bacteria secrete both O2 and CO2. Balance measurements can indicate the bacterial load in the gut and thus elucidate the balance between good and bad bacteria in the microbiota.

[0253] In an exemplary embodiment, the trackable element and the appendage are delivered to the patient separately. Each of the trackable element and the appendage can be delivered to the patient using the same device, such as a surgical suture as discussed herein, but can be delivered separately from the device. Therefore, no modification to the appendage is required for use with the trackable element.

[0254] Those skilled in the art will understand that the present invention has been applied to conventional minimally invasive and open surgical instruments, as well as robot-assisted surgical procedures.

[0255] The device disclosed herein may be designed for single-use disposal or for multiple-use applications. However, in either case, the device can be repaired and reused after at least one use. Repair may include any combination of disassembling the device, subsequently cleaning or replacing specific parts, and subsequent reassembly steps. Specifically, the device is detachable, and any number of specific parts or components of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing specific parts, the device can be reassembled for subsequent use at a repair facility or by a surgical team just before surgery. Those skilled in the art will understand that various techniques can be used for disassembly, cleaning / replacement, and reassembly of the device. The use of such techniques and the resulting repaired device are within the scope of this application.

[0256] Based on the above embodiments, those skilled in the art will recognize further features and advantages of the present invention. Therefore, the present invention should not be limited to what has been specifically shown and described, unless indicated by the appended claims. All publications and references cited herein are expressly incorporated by reference in their entirety.

Claims

1. A surgical system comprising: A bioabsorbable appendage configured to be implanted into a patient's body using a surgical suture device; A medicine, said medicine being releasably held by said appendage and configured to be released from said appendage into said body of the patient; A packaging unit that packages the appendage and the medication, the packaging unit including a sensor configured to collect data on exposure conditions of at least one of the appendage and the medication, the exposure conditions being conditions that affect the performance of at least one of the appendage and the medication in the patient's body; as well as A processor configured to receive the data collected by the sensor. Its features are, The processor is also configured to determine, based on received data and a comparison of appendage durability thresholds for each of a variety of different specific surgical procedures with appendage durability indicated by collected data regarding the exposure conditions, whether the appendage and the agent are acceptable for use in each of the variety of different specific surgical procedures. The physician will be provided with a notification regarding whether the use of this technique in one of the many different specific surgical procedures is acceptable.

2. The system according to claim 1, wherein, The determination includes determining the recommended shelf life of the appendages and the pharmaceutical agent.

3. The system according to claim 1, wherein, The determination includes determining the recommended indications for the appendage and the drug.

4. The system according to claim 1, wherein, The determination includes determining recommended contraindications for the appendix and the drug.

5. The system according to claim 1, wherein, The determination includes determining the recommended shelf life of the appendage and the agent based at least on the collected data on the exposure conditions.

6. The system according to claim 1, wherein, The determination includes determining a recommended time after opening the packaging unit, during which the appendage should be implanted into the patient's body within the recommended time during the specific surgical procedure.

7. The system according to claim 1, wherein, The exposure conditions include at least one of light and temperature.

8. The system according to claim 1, wherein, The exposure conditions include at least one of humidity, oxygen, time, light, vibration, and atmospheric pressure.

9. The system according to claim 1, wherein, The surgical hub outside the packaging unit includes the processor.

10. A method for operating a surgical system, comprising: Data indicative of exposure conditions of the packaging unit, collected by sensors of the packaging unit and packaged therein to releasably hold a drug and configured to be implanted using a surgical suture device, is received from a computer system outside the packaging unit via a communication interface of the packaging unit. The exposure conditions are conditions that affect the performance of at least one of the appendage and the drug in the patient. The computer system determines, based on the following criteria, whether the appendage and the agent are acceptable for use in each of a variety of different specific surgical procedures: The received data indicating the exposure conditions; as well as A comparison of specific appendage durability thresholds for each of the various specific surgical procedures with appendage durability indicated by collected data on the exposure conditions; as well as Provide practicing physicians with information on whether it is acceptable to use in one of the many different specific surgical procedures.

11. The method according to claim 10, wherein, The determination includes determining the recommended shelf life of the appendages and the pharmaceutical agent.

12. The method according to claim 10, wherein, The determination includes determining the recommended indications for the appendage and the drug.

13. The method according to claim 10, wherein, The determination includes determining recommended contraindications for the appendix and the drug.

14. The method of claim 10, wherein, The determination includes determining a recommended time after opening the packaging unit, during which the appendage should be implanted into the patient's body within the recommended time during the specific surgical procedure.

15. The method of claim 10, further comprising: The data is collected using the sensors of the packaging unit before the packaging unit is opened; The data to be received at the computer system is transmitted using the communication interface of the packaging unit.

16. The method of claim 10, wherein, The exposure conditions include at least one of light, temperature, humidity, oxygen, time, vibration, and atmospheric pressure.

Images