SURGICAL IMPLANTS INCLUDING SENSING FIBERS
A monitoring system includes a surgical implant configured for implantation in vivo and having at least one sensing fiber configured to measure a preselected physiological parameter, and a receiving unit in wireless communication with the at least one sensing fiber and configured to receive measurements of the preselected physiological parameter. A surgical system includes an end effector having a plurality of fasteners, and a surgical implant securable to tissue via the plurality of fasteners. The surgical implant includes at least one sensing fiber configured to measure a preselected physiological parameter.
This application is a divisional of U.S. patent application Ser. No. 15/892,551, filed on Feb. 9, 2018 (now U.S. Pat. No. 11,096,610), which claims the benefit of, and priority to, U.S. Provisional Patent Application Ser. No. 62/599,232, filed on Dec. 15, 2017 and U.S. Provisional Patent Application Ser. No. 62/477,458, filed on Mar. 28, 2017, the entire content of each of which is hereby incorporated by reference herein.
BACKGROUND Technical FieldThe present disclosure relates to surgical implants including sensing fibers for post-operative monitoring. Embodiments of the present disclosure relate to surgical buttresses that are releasably attached to a surgical stapling apparatus, and in particular, to a surgical buttress including sensing fibers for detecting tissue conditions along a staple line and transmitting the tissue conditions to a remote device. Embodiments of the present disclosure relate to a surgical mesh including sensing fibers for detecting tissue conditions at a soft tissue repair site and transmitting the tissue conditions to a remote device.
Background of Related ArtSurgical stapling apparatus are employed by surgeons to sequentially or simultaneously apply one or more rows of fasteners, e.g., staples or two-part fasteners, to body tissue for the purpose of joining segments of body tissue together and/or attaching a surgical implant to body tissue. Such apparatus generally include a pair of jaws or finger-like structures between which the body tissue to be joined is placed. When the stapling apparatus is actuated, or “fired”, longitudinally moving firing bars contact staple drive members in one of the jaws. The staple drive members push the surgical staples through the body tissue and into an anvil in the opposite jaw which forms the staples. If tissue is to be removed or separated, a knife blade can be provided in the jaws of the apparatus to cut the tissue between the lines of staples.
Surgical supports, e.g., meshes or buttress materials, may be used in combination with surgical stapling apparatus to bridge, repair and/or reinforce tissue defects within a patient such as those occurring, for example, in the abdominal wall, chest wall, diaphragm, or musculo-aponeurotic areas of the body. A buttress material may reinforce a staple or suture line as well as cover the juncture of tissues to reduce leakage prior to healing. A mesh or patch may reinforce, replace, and/or augment soft tissue such as, the abdominal wall in the case of hernia repair.
For example, following surgery on the gastrointestinal system in which the bowel undergoes anastomosis, a possibility exists that an incidence may arise/develop of subsequent leakage from the bowel into the peritoneal cavity. The result of this development (e.g., impacts on morbidity and mortality) dramatically affects the patient's prognosis and largely impacts the cost of treatment. Leak detection is generally accomplished by monitoring clinical signs of infection, including white blood cell count, fever, malaise, heart rate, etc. A factor of using clinical signs is that there is a lag between the time the leak occurs and the onset of signs or symptoms. This may result in an escalation of the condition prior to its detection and the appropriate treatment being instituted.
Imaging modalities, such as fluoroscopy, may be utilized to monitor for leak detection after administering radiopaque dye orally or rectally. Imaging modalities, however, have limitations of sensitivity and specificity, and require significant resources and cost to perform. Additional leak detection attempts of measuring effluent from drains have demonstrated some success. Limitations of this approach, however, include the inconsistent use of drains due to concomitant effects (e.g., infection, clogging, migration, etc.) and identification of markers from drain fluid may be delayed significantly after the leak occurs.
As another example, post-surgical complications may arise after an abdominal wall hernia repair procedure. The performance of a hernia repair using a mesh fixed to an abdominal wall depends, in part, upon shear forces exerted upon the mesh and/or experienced at fixation points of the mesh to tissue due to, for example, changes in intra-abdominal pressure. Tearing, breakage, and/or bulging of the mesh may compromise the surgical repair of the hernia defect, or lead to mesh failure.
While devices and methods are available in attempts of identifying post-surgical complications, such as leaks and/or implant compromise, it would be advantageous to provide a real time non-invasive monitoring system for effective early detection of issues associated with a patient's health. Such a system would provide a clinician with a method of evaluating critical predictors of morbidity and mortality in patients in real time following surgery and/or tissue trauma. Acute stage detection would allow for early intervention resulting in improved patient outcomes. Additionally or alternatively, it would be advantageous to include a real time monitoring system as part of a post-operative regimen for improving patient recovery following surgical trauma and/or stress.
SUMMARYA monitoring system in accordance with aspects of the present disclosure includes a surgical implant configured for implantation in vivo and having at least one sensing fiber configured to measure a preselected physiological parameter, and a receiving unit in wireless communication with the at least one sensing fiber and configured to receive measurements of the preselected physiological parameter.
The surgical implant may include a porous layer, and the at least one sensing fiber may be disposed within the porous layer. The surgical implant may be formed from a plurality of fibers, and the at least one sensing fiber may be incorporated into the plurality of fibers. The surgical implant may include a non-porous layer, and the at least one sensing fiber may be disposed within the non-porous layer.
In some aspects, the at least one sensing fiber is an optical fiber. In certain aspects, the preselected physiological parameter measured by the at least one sensing fiber is pH, in some other aspects, the preselected physiological parameter measured by the at least one sensing fiber is a quantity of an analyte, and in yet other aspects, the preselected physiological parameter measured by the at least one sensing fiber is force.
The at least one sensing fiber may include a core and a sheath disposed over the core. The core may include a semiconducting element, a conducting element, and an insulating element. In some aspects, the core includes a semiconducting element and a plurality of conducting elements in contact with the semiconducting element. In certain aspects, the plurality of conducting elements is electrically connected in a circuit.
A surgical system in accordance with aspects of the present disclosure includes an end effector having a plurality of fasteners and a surgical implant securable to tissue via the plurality of fasteners. The surgical implant includes at least one sensing fiber configured to measure a preselected physiological parameter.
In some aspects, the at least one sensing fiber is an optical sensor. The at least one sensing fiber may include a core and a sheath disposed over the core. The core may include a semiconducting element, a conducting element, and an insulating element. In some aspects, the core includes a semiconducting element and a plurality of conducting elements in contact with the semiconducting element. In certain aspects, the plurality of conducting elements is electrically connected in a circuit.
The surgical implant may be a surgical buttress releasably attached to the end effector. The surgical implant may be a surgical mesh including a plurality of fibers.
A surgical stapling apparatus in accordance with aspects of the present disclosure includes an end effector having a staple cartridge assembly and an anvil assembly, and a surgical buttress releasably attached to the staple cartridge assembly or the anvil assembly. The surgical buttress includes at least one sensing fiber configured to measure a preselected physiological parameter.
The surgical buttress may include a porous layer in which the at least one sensing fiber is disposed and/or a non-porous layer in which the at least one sensing fiber is disposed. In some aspects, the at least one sensing fiber is an optical sensor. In certain aspects, the preselected physiological parameter measured by the at least one sensing fiber is pH.
The at least one sensing fiber of the surgical buttress may include a core and a sheath disposed over the core. The core may include a semiconducting element, a conducting element, and an insulating element. In some aspects, the core includes a semiconducting element and a plurality of conducting elements in contact with the semiconducting element. In certain aspects, the plurality of conducting elements is electrically connected in a circuit.
A monitoring system in accordance with aspects of the present disclosure includes a surgical buttress and a receiving unit. The surgical buttress is configured for implantation in vivo and includes at least one sensing fiber configured to measure a preselected physiological parameter. The receiving unit is in wireless communication with the at least one sensing fiber and configured to receive measurements of the preselected physiological parameter.
The surgical buttress may include a porous layer in which the at least one sensing fiber is disposed and/or a non-porous layer in which the at least one sensing fiber is disposed. In some aspects, the at least one sensing fiber is an optical sensor. In certain aspects, the preselected physiological parameter measured by the at least one sensing fiber is pH.
The at least one sensing fiber of the surgical buttress may include a core and a sheath disposed over the core. The core may include a semiconducting element, a conducting element, and an insulating element. In some aspects, the core includes a semiconducting element and a plurality of conducting elements in contact with the semiconducting element. In certain aspects, the plurality of conducting elements is electrically connected in a circuit.
A method of in vivo monitoring of an anastomosis in real time includes: securing a surgical buttress to tissue, the surgical buttress including at least one sensing fiber configured to measure a preselected physiological parameter; and monitoring the preselected physiological parameter via data wirelessly received by a receiving unit from the at least one sensing fiber of the surgical buttress. In aspects, the method further includes: positioning a body portion of a surgical stapling device including a staple cartridge assembly adjacent a first tissue and positioning an anvil assembly of the surgical stapling device adjacent a second tissue, the staple cartridge assembly or the anvil assembly including the surgical buttress releasably retained thereon; and firing the surgical stapling device to mechanically secure the surgical buttress and the first and second tissues with staples from the staple cartridge assembly along a staple line.
Other aspects, features, and advantages will be apparent from the description, drawings, and the claims.
Various aspects of the present disclosure are described herein below with reference to the drawings, which are incorporated in and constitute a part of this specification, wherein:
The present disclosure is directed to surgical implants, systems, and methods of using the same for measuring physiological parameters in real time. The physiological parameters may be associated with acute and/or chronic tissue compromise or failure in one or multiple tissue/organ sites. The present disclosure describes embodiments of surgical implants for real time monitoring of physiological parameters, surgical stapling apparatus supporting and/or securing said surgical implants to tissue, monitoring systems including said surgical implants and a receiving unit for analysis of the physiological parameters, and exemplary corresponding methods of use in accordance with principles of the present disclosure.
The presently disclosed surgical implants may be any medical device, such as scaffolds, grafts, patches, slings, pledgets, growth matrices, drug delivery devices, wound plugs, and, in general, may be soft tissue repair devices and/or surgical prostheses. It should be understood that the surgical implants may also be utilized as topically applied medical products, such as wound dressings, coverings, and the like, that can be used in medical/surgical procedures. The principles of the present disclosure are related to monitoring of surgical and medical treatments of disease and body ailments of a patient, such as necrosis, infection, and cancer. For example, devices, systems, and methods of the present disclosure may be utilized in the detection of infection, metabolic disorder, or abnormal or non-ideal conditions of wound healing.
Embodiments of the presently disclosed surgical implants will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. Throughout this description, the term “proximal” refers to a portion of a structure, or component thereof, that is closer to a clinician, and the term “distal” refers to a portion of the structure, or component thereof, that is farther from the clinician. As used herein, the term “patient” should be understood as referring to a human subject or other animal, and the term “clinician” should be understood as referring to a doctor, nurse, or other care provider and may include support personnel.
Referring now to
The surgical implant 10 may be porous, non-porous, or combinations thereof. Suitable porous structures include, for example, fibrous structures (e.g., knitted structures, woven structures, and non-woven structures) and/or foams (e.g., open or closed cell foams). Suitable non-porous structures include, for example, films. The surgical implant 10 described herein may be a single porous or non-porous layer, or include a plurality of layers including any combination of porous and non-porous layers. For example, a surgical implant may include multiple porous and non-porous layers that are stacked in an alternating manner. In another example, a surgical implant may be formed in a “sandwich-like” manner wherein the outer layers of the surgical implant are porous and the inner layer(s) are non-porous.
Porous layer(s) in the surgical implant may enhance the ability of the surgical implant to absorb fluid, reduce bleeding, and seal the wound. Also, the porous layer(s) may allow for tissue ingrowth to fix the surgical implant in place. Non-porous layer(s) in the surgical implant may enhance the ability of the surgical implant to resist tears and perforations during the manufacturing, shipping, handling, and securing (e.g., stapling) processes. Also, non-porous layer(s) may retard or prevent tissue ingrowth from surrounding tissues thereby acting as an adhesion barrier and preventing the formation of unwanted scar tissue.
As shown in
As discussed above, the surgical implant 10 may have other configurations. For example, as shown in
Referring now to
The sensing fiber 20 may be: an optical or electrical sensor for measuring characteristics such as impedance, temperature, pH, the presence and/or level of analytes, etc.; a mechanical sensor for measuring, for example, characteristics such as force, stress, strain, etc.; a conductivity or resistivity sensor for measuring, for example, ionic concentration of a compound; among other sensors within the purview of those skilled in the art for physical or chemical sensing. It should be understood that a surgical implant 10, 10a may include multiple sensing fibers 20 that measure the same or different characteristics.
With continued reference to
The core 22 includes one or more semiconducting elements 22a for measuring the physiological parameter, one or more conducting elements 22b (e.g., electrodes) connected in a circuit, and one or more insulating elements 22c disposed between and/or around the semiconducting and/or conducting elements 22a, 22b. The semiconducting element(s) 22a of the core 22 may be formed from a chalcogenide glass, the conducting element(s) 22b of the core 22 may be formed from a metal or metal alloy, and the insulating element(s) 22c of the core 22 and/or the sheath 24 may be formed, for example, from a thermoplastic polymer or copolymer such as polyetherether ketone, polyetherimide, polyether sulfone, polysulfone, polycarbonate, polyethylene, polymethyl methacrylate, or polytetrafluoroethylene.
The semiconducting, conducting, and insulating elements 22a, 22b, 22c are configured in a specific geometry (e.g., with selected material interfaces) during fabrication of the sensing fiber 20 to enable a desired sensing functionality. Accordingly, it should be understood that the core 22 of the sensing fiber 20 may have any of a variety of configurations (e.g., the core 22 can be solid or include spaces or gaps, may be symmetrical or non-symmetrical, etc.).
The sensing fiber 20 is wireless and may be powered externally via, e.g., radiofrequency or magnetic telemetry, to run continuously or be activated intermittently. The receiving unit 30 is an extracorporeal device configured to communicate with the sensing fiber 20 via a wireless (e.g., radiofrequency, optical, WiFi, Bluetooth®, LTE, etc.) connection to collect the signals from the sensing fiber 20 in real time and to process the signals into digital data. The receiving unit 30 may be a portable electronic device which may be worn by a patient (e.g., a wristwatch or transcorporeal patch), or otherwise carried by the patient (e.g., a mobile device such as a cell phone, or a unit disposed within a carrying case) to allow for patient mobility during post-surgical monitoring.
The signals/data collected by the receiving unit 30 may also be sent to a mobile device of a clinician or be transmitted to a cloud such that a clinician can access the information. The receiving unit 30 may provide a sensor alert via an indicator (e.g., a visual, audio, or other sensory indicator) to the patient and/or a clinician when a predetermined test criterion is met to allow for appropriate medical response based on the information received. The signals produced by the sensing fiber 20 contain information about a specific characteristic of the tissue and/or tissue environment which, in turn, imparts information about a condition or state of the tissue which can be utilized in determining a proper course of treatment.
With reference now to
The surgical buttresses may be used in sealing a wound by approximating the edges of wound tissue between a staple cartridge assembly and an anvil assembly of a surgical stapling apparatus which includes at least one surgical buttress having sensing fiber(s). The surgical buttress is releasably attached to the surgical stapling apparatus such that staples fired from the surgical stapling apparatus attach the surgical buttress to tissue. The sensing fibers of the surgical buttress measure a physiological parameter of the tissue and/or tissue environment and transmit the data to a receiving unit for monitoring by a clinician or the patient.
It should be understood that a variety of surgical stapling apparatus may be utilized with a surgical buttress of the present disclosure. For example, linear staplers may be utilized, such as, for example those including Duet TRS™ reloads and staplers with Tri-Staple™ technology, available through Medtronic, formerly Covidien (North Haven, Conn.), as well as other anastomosis staplers, such as, for example, EEA™, CEEA™, GIA™, EndoGIA™, and TA™, also available through Medtronic. It should also be appreciated that the principles of the present disclosure are equally applicable to surgical staplers having a variety of configurations, such as, for example, end-to-end anastomosis staplers having a circular cartridge and anvil (see, e.g., commonly owned U.S. Pat. No. 5,915,616, entitled “Surgical Fastener Applying Apparatus,” the entire content of which is incorporated herein by this reference); laparoscopic staplers (see, e.g., commonly owned U.S. Pat. Nos. 6,330,965 and 6,241,139, each entitled “Surgical Stapling Apparatus,” the entire contents of each of which being incorporated herein by this reference); and transverse anastomosis staplers (see, e.g., commonly owned U.S. Pat. Nos. 5,964,394 and 7,334,717, each entitled “Surgical Fastener Applying Apparatus”, the entire contents of each of which being incorporated herein by this reference).
It is additionally appreciated that the principles of the present disclosure are equally applicable to powered handheld electromechanical surgical staplers having a variety of configurations, such as, for example, those shown and described in U.S. Patent Application Publication No. 2015/0297199, the entire content of which is incorporated herein by this reference.
Referring now to
The surgical stapling apparatus 100 further includes a trigger 112 movably mounted on the handle assembly 110. Actuation of the trigger 112 initially operates to move the anvil assembly 140 from the open position to the closed position relative to staple cartridge assembly 150 and subsequently actuates the surgical stapling apparatus 100 to apply lines of staples to tissue captured between the anvil and staple cartridge assemblies 140, 150. Specifically, a driver 116 is provided to move the anvil jaw member 142 between the open and closed positions relative to the receiving jaw member 152. The driver 116 moves between a longitudinal slot 141 formed in the anvil jaw member 142, and a knife 118 (
In order to properly orient the jaw assembly 130 relative to the tissue to be stapled, the surgical stapling apparatus 100 includes a rotation knob 114 mounted on the handle assembly 110. Rotation of the rotation knob 114 relative to the handle assembly 110 rotates the elongate tubular body portion 120 and the jaw assembly 130 relative to the handle assembly 110 so as to properly orient the jaw assembly 130 relative to the tissue to be stapled.
With continued reference to
It should be understood that while the surgical buttresses 11 are shown and described herein as being associated with both the anvil assembly 140 and the staple cartridge assembly 150, the surgical buttresses may be the same or different, or may only be associated with either the anvil assembly or the staple cartridge assembly, depending on, for example, the surgical application and/or desired placement and monitoring as should be understood by a person of ordinary skill in the art.
The surgical buttress 11 may have any shape, size, and/or dimension suitable to fit a surgical stapling apparatus. The surgical buttress is fabricated from biocompatible material(s) and may be porous, non-porous, or combinations thereof, as discussed above. The surgical buttress 10a includes at least one sensing fiber 20 (
In embodiments, the sensing fiber 20 of the surgical buttress 11 is configured to measure a physiological parameter of interest related to monitoring for anastomosis leakage about a staple line. In some embodiments, the sensing fiber 20 is an optical pH sensor adapted to measure changes in pH in the tissue environment adjacent the staple line. In some embodiments, the sensing fiber 20 is a chemical sensor adapted to detect the presence of an analyte indicative of anastomotic leakage. The analyte to be detected can be an endogenous material that would normally only be present within a patient's body (e.g., intestines, etc.) such as E. coli or blood, or an exogenous material introduced into the patient's body and that remains within the body unless leakage occurs.
As shown in
As shown in
The surgical stapling apparatus 100 is initially actuated by movement of the trigger 112 (
Upon full actuation of surgical stapling apparatus 100, a knife 118 defining a knife blade 119, which is carried by the driver 116, cuts the tissue “T” between the rows of now formed staples 156. Upon movement of the anvil assembly 140 to the open position spaced apart from the staple cartridge assembly 150, the surgical buttresses 11 are pulled away from the anvil and staple cartridge assemblies 140, 150.
The resulting tissue “T”, divided and stapled closed with the staples 156, is illustrated in
Referring now to
The staple cartridge assembly 250 may be fixedly connected to the distal end of the elongate tubular body portion 220 or may be configured to concentrically fit within the distal end of the elongate tubular body portion 220. The staple cartridge assembly 250 includes a staple pusher 256 including a proximal portion having a generally frusto-conical shape and a distal portion defining two concentric rings of peripherally spaced fingers (not shown), each one of which is received within a respective staple receiving slot 252.
A knife 258, substantially in the form of an open cup with the rim thereof defining a knife blade 259, is disposed within the staple cartridge assembly 250 and mounted to a distal surface of the staple pusher 256. The knife 258 is disposed radially inward of the pair of annular arrays of staples 254. Accordingly, in use, as the staple pusher 256 is advanced, the knife 258 is also advanced axially outward.
A surgical buttress 11a is releasably attached to the anvil assembly 240 and/or the staple cartridge assembly 250. As specifically shown in
Referring again to
Thereafter, a clinician maneuvers the anvil assembly 240 until the proximal end of shaft 244 is inserted into the distal end of the tubular body portion 220 of the surgical stapling apparatus 200, wherein a mounting structure (not shown) within the distal end of tubular body portion 220 engages the shaft 244 of the anvil assembly 240 to effect mounting. The anvil assembly 240 and the tubular body portion 220 are then approximated to approximate the first and second tissue sections “T1”, “T2”. The surgical stapling apparatus 200 is then fired, firing the staples 254 through the surgical buttresses 11a as well as the first and second tissue sections “T1”, “T2”, effecting stapling of the first and second tissue sections “T1”, “T2” to one another and cutting of the first and second tissue sections “T1”, “T2” by the knife 258 to complete the anastomosis. Upon movement of the anvil assembly 240 away from the staple cartridge assembly 250, the surgical buttresses 11a are pulled away from the anvil and staple cartridge assemblies 240, 250.
As described above, the surgical buttresses 11a are stapled to the first and second tissue sections “T1”, “T2” thereby sealing and reinforcing the staple lines created by the staples 254, as well as allowing a clinician to monitor properties on each side of, and through, the stapled first and second tissue sections “T1”, “T2” via the sensing fiber(s) 20 (
With reference now to
As shown in
In embodiments, the sensing fiber 20 of the surgical mesh 11b is configured to measure a physiological parameter of interest related to monitoring conditions about a soft tissue defect, e.g., herniated tissue. In some embodiments, the sensing fiber 20 is a mechanical sensor, an electrical sensor, or an optical sensor adapted to measure a physical property of the tissue or the tissue environment. For example, the sensing fiber 20 may be configured to measure a load or force (e.g., strain) related to physical activity, such as intra-abdominal pressure, on a hernia repair site. As another example, the sensing fiber 20 may be configured to measure displacement of a surgical mesh indicative of mesh migration. In certain embodiments, the sensing fiber 20 is a strain gauge (e.g., an optical strain gauge).
In some embodiments, the sensing fiber 20 of the surgical mesh 11b is an optical sensor or a chemical sensor adapted to detect and/or quantify an amount of a material or substance (e.g., a chemical, an analyte, a byproduct, a metabolite, etc.) in tissue or the tissue environment indicative of a post-surgical condition or state. Accordingly, if the sensing fiber 20 detects the material or substance to be above or below a pre-determined value or to fall within a pre-defined range, a clinician and/or the patient is alerted so that a proper course of action may be taken to accelerate or optimize healing (e.g., to correct or balance the condition). For example, the sensing fiber 20 may be configured to measure nitrogen content as a biomarker for protein loss and/or muscle wasting such that if nitrogen levels fall below a pre-determined value, a clinician may administer an hGH treatment by, e.g., subcutaneous injection, to improve nitrogen balance and to maintain and/or increase muscle mass and/or strength.
The surgical mesh 11b may be introduced through a mesh deployment device and placed over damaged tissue (e.g., a tissue defect). Suitable devices include those shown and described, for example, in commonly owned U.S. Pat. No. 5,370,650, entitled “Articulating Mesh Deployment Apparatus,” U.S. Pat. No. 8,317,808, entitled “Device and Method for Rolling and Inserting a Prosthetic Patch into a Body Cavity,” U.S. Pat. No. 8,906,045, entitled “Articulating Patch Deployment Device and Method of Use,” U.S. Pat. No. 9,107,726, entitled “Device and Method for Deploying and Attaching an Implant to a Biological Tissue,” and U.S. Pat. No. 9,655,709, entitled “Mesh Deployment Devices and Kits,” the entire contents of each of which is incorporated herein by this reference.
The surgical mesh 11b is secured to healthy tissue “A”, such as an abdominal wall, surrounding a tissue defect “D” (shown in phantom) by fasteners “S” to anchor the surgical mesh 11b to the tissue “A”. The fasteners “S” may be staples, sutures, tacks, anchors, among other fixation devices within the purview of those skilled in the art. The fasteners “S” may be retained within an end effector of a surgical fastener delivery device and deployed therefrom to secure the surgical mesh 11b to the tissue “A.” Suitable fasteners and surgical fastener delivery devices include those shown and described, for example, in commonly owned U.S. Pat. No. 7,229,452, entitled “Tack and Tack Applier,” U.S. Pat. No. 7,866,526, entitled “Apparatus for Applying Surgical Fasteners to Body Tissue,” U.S. Pat. No. 8,216,272, entitled “Absorbable Anchor for Hernia Mesh Fixation,” the entire contents of each of which is incorporated herein by this reference.
The surgical mesh 11b is secured to the tissue “A” to reinforce the tissue defect “D”, as well as to allow a clinician to monitor properties around the tissue defect “D” via the sensing fiber(s) 20 of the surgical mesh 11b. As discussed above, the sensing fibers 20 transmit information to the clinician such that if a specific test criterion is met, a course of treatment may be selected, for example, to minimize or reduce patient morbidity and/or to detect or prevent post-operative repair failure.
Surgical instruments, such as the surgical staplers the mesh deployment devices, and the surgical fastener delivery devices, and the surgical implants usable therewith, described herein, may also be configured to work with robotic surgical systems and what is commonly referred to as “Telesurgery.” Such systems employ various robotic elements to assist the surgeon and allow remote operation (or partial remote operation) of surgical instrumentation. Various robotic arms, gears, cams, pulleys, electric and mechanical motors, etc. may be employed for this purpose and may be designed with a robotic surgical system to assist the surgeon during the course of an operation or treatment. Such robotic systems may include remotely steerable systems, automatically flexible surgical systems, remotely flexible surgical systems, remotely articulating surgical systems, wireless surgical systems, modular or selectively configurable remotely operated surgical systems, etc.
The robotic surgical systems may be employed with one or more consoles that are next to the operating theater or located in a remote location. In this instance, one team of surgeons or nurses may prep the patient for surgery and configure the robotic surgical system with one or more of the instruments disclosed herein while another surgeon (or group of surgeons) remotely controls the instruments via the robotic surgical system. As can be appreciated, a highly skilled surgeon may perform multiple operations in multiple locations without leaving his/her remote console which can be both economically advantageous and a benefit to the patient or a series of patients.
The robotic arms of the surgical system are typically coupled to a pair of master handles by a controller. The handles can be moved by the surgeon to produce a corresponding movement of the working ends of any type of surgical instrument (e.g., end effectors, graspers, knifes, scissors, etc.) which may complement the use of one or more of the embodiments described herein. The movement of the master handles may be scaled so that the working ends have a corresponding movement that is different, smaller or larger, than the movement performed by the operating hands of the surgeon. The scale factor or gearing ratio may be adjustable so that the operator can control the resolution of the working ends of the surgical instrument(s).
The master handles may include various sensors to provide feedback to the surgeon relating to various tissue parameters or conditions, e.g., tissue resistance due to manipulation, cutting or otherwise treating, pressure by the instrument onto the tissue, tissue temperature, tissue impedance, etc. As can be appreciated, such sensors provide the surgeon with enhanced tactile feedback simulating actual operating conditions. The master handles may also include a variety of different actuators for delicate tissue manipulation or treatment further enhancing the surgeon's ability to mimic actual operating conditions.
Reference is made herein to U.S. Pat. No. 8,828,023 entitled “Medical Workstation,” the entire content of which is incorporated herein by reference, for a more detailed discussion of the construction and operation of an exemplary robotic surgical system.
Persons skilled in the art will understand that the devices, systems, and methods specifically described herein and illustrated in the accompanying figures are non-limiting exemplary embodiments, and that the description, disclosure, and figures should be construed merely exemplary of particular embodiments. It is to be understood, therefore, that the present disclosure is not limited to the precise embodiments described, and that various other changes and modifications may be effected by one skilled in the art without departing from the scope or spirit of the disclosure. Additionally, it is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another exemplary embodiment without departing from the scope of the present disclosure, and that such modifications and variations are also intended to be included within the scope of the present disclosure. Accordingly, the subject matter of the present disclosure is not to be limited by what has been particularly shown and described.
Claims
1. A monitoring system comprising:
- a surgical implant configured for implantation in vivo and including at least one sensing fiber configured to measure a preselected physiological parameter; and
- a receiving unit in wireless communication with the at least one sensing fiber and configured to receive measurements of the preselected physiological parameter.
2. The monitoring system according to claim 1, wherein the surgical implant includes a porous layer, and the at least one sensing fiber is disposed within the porous layer.
3. The monitoring system according to claim 1, wherein the surgical implant is formed from a plurality of fibers, and the at least one sensing fiber is incorporated into the plurality of fibers.
4. The monitoring system according to claim 1, wherein the surgical implant includes a non-porous layer, and the at least one sensing fiber is disposed within the non-porous layer.
5. The monitoring system according to claim 1, wherein the at least one sensing fiber is an optical fiber.
6. The monitoring system according to claim 1, wherein the preselected physiological parameter measured by the at least one sensing fiber is pH.
7. The monitoring system according to claim 1, wherein the preselected physiological parameter measured by the at least one sensing fiber is a quantity of an analyte.
8. The monitoring system according to claim 1, wherein the preselected physiological parameter measured by the at least one sensing fiber is force.
9. The monitoring system according to claim 1, wherein the at least one sensing fiber includes a core and a sheath disposed over the core.
10. The monitoring system according to claim 9, wherein the core includes a semiconducting element, a conducting element, and an insulating element.
11. The monitoring system according to claim 9, wherein the core includes a semiconducting element and a plurality of conducting elements in contact with the semiconducting element.
12. The monitoring system according to claim 11, wherein the plurality of conducting elements are electrically connected in a circuit.
13-20. (canceled)
21. The monitoring system according to claim 11, wherein the plurality of conducting elements are electrodes.
22. The monitoring system according to claim 1, wherein the surgical implant is a surgical buttress.
23. The monitoring system according to claim 1, wherein the surgical implant is a surgical mesh.
Type: Application
Filed: Aug 23, 2021
Publication Date: Dec 9, 2021
Inventors: Clifford L. Emmons (Dennis, MA), Seok Joo Chang (Seoul), Hoon Cho (Seoul)
Application Number: 17/408,934