Flexible endoscopic stapler

Abstract

An endoscopic stapler of the present invention allows for endoscopic approximation of tissue via stapling, avoiding invasive surgical procedures. The endoscopic stapler provides (1) flexibility compared to a traditional surgical stapler; (2) a long instrument (at least 135 cm) enabling the stapling to occur from a long distance as opposed to the short mechanism with today's surgical staplers; (3) a "bending section" allowing the device to reach to its target (often located at an angulation / corner / behind folds / or needing a retroflexed position); (4) small size to allow insertion through the upper esophageal sphincter (the size-limiting point in our field); and, (5) additional channels to facilitate endoscopic procedures including: one or more cameras, one or more accessory channels, suction port, and irrigation port. These features allow for easier and faster approximation of tissue, improve the efficacy of bariatric endoscopy procedures, increase the durability of tissue approximation, and reduce the costs of effective weight loss intervention.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to, and the benefit of, U.S. Provisional Patent Application Ser. No. 63 / 573,237, filed April 2, 2024, the disclosure of which is incorporated herein by reference. FIELD OF THE INVENTION

[0002] The present invention relates generally to medical devices. More particularly, the present invention relates to a flexible, multi-lumen endoscope having an end effector capable of dispensing staples into tissue. BACKGROUND OF THE INVENTION

[0003] According to the 2017-2020 National Health and Nutrition Examination Survey, 41.9% of US adults are obese (BMI of 30 kg / m2 or higher) and those with severe obesity, (BMI >40 kg / m2) are standing at 9.2%l-3. It is predicted that in 2030, 1 in 2 adults will have obesity in the US. Its rising prevalence is linked to critical health issues like heart disease, stroke, type 2 diabetes, and specific cancers, leading to preventable premature deaths. Today, it is recommended to combine anti-obesity medications with lifestyle interventions for individuals with obesity (BMI >30 kg / m2) or overweight individuals (BMI >27 kg / m2) who have at least one weight-related health condition. The FDA has approved several medications for this purpose, including tirzepatide, a dual agonist for glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1), and semaglutide or liraglutide, GLP-1 receptor agonists. Clinical trials demonstrate varied total body weight losses, ranging from 5% to 12% at the 12-month mark for these medications, with higher efficacy seen in recently FDA-approved semaglutide 2.4 mg (10-12%). Alternatively, bariatric surgery is indicated for patients with a BMI of >35 kg / m2, particularly when optimal medical treatment does not achieve therapeutic goals. The most common procedures are laparoscopic sleeve gastrectomy (LSG) and Roux-en-Y gastric bypass, which have robust evidence of long-term efficacy. There are also several alternatives available to treat / manage obesity for those who are not candidates for bariatric surgery but need to lose weight or prefer a less invasive alternative. Oral hydrogel therapy, for adults with a BMI of 25 kg / m2 or higher, displayed a mean weight loss of 6.4% at 24 weeks. Intragastric balloons, often removed after 6-12 months, exhibited a total body weight loss of 15% at 32 weeks compared to 3.3% with lifestyle intervention alone in recent trials. Endoscopic sleeve gastroplasty (ESG), which reduces gastric capacity by 1 infolding the greater curvature of the stomach with sutures, was reported to lead to a mean total body weight loss of 13.6% (vs 0.8% for lifestyle intervention alone) at 52 weeks in a randomized controlled trial.

[0004] Challenges in Obesity Treatment Options. Although there have been advancements in long-term effectiveness and safety in weight loss through bariatric surgery, its utilization has seen only marginal growth from 1993 to 2016, and is disproportionally low among eligible patients, potentially due to its invasive nature, high costs, limited accessibility, and associated complications, especially in this unhealthy population with significant comorbidities. Yet, most non-surgical interventions (e.g., medications and minimally invasive devices) often exhibit limited long-term efficacy. Clinical trials of anti-obesity medications have demonstrated initial weight loss benefits, but the weight loss plateaus at approximately 15% of total body mass despite continued use medications, and withdrawing the medication leads to weight regain, necessitating lifelong treatment. Recent randomized clinical trials of STEP 1 and SURMOUNT-4 demonstrated that approximately 1 year after the withdrawal of semaglutide and tirzepatide, respectively, participants experienced substantial regain of lost weight. Also, the rising prevalence of morbid obesity (BMI>40 kg / m2) highlights the need for treatments that result in more significant total body weight loss. Other concerns include medication adherence, the risk of side effects, the lifelong financial burden, poor insurance coverage for weight loss, and the absence of long-term safety data.

[0005] Bariatric endoscopy provides a minimally invasive alternative to surgical procedures as it utilizes a transoral approach and does not require any abdominal incisions; however, anti-obesity endoscopic interventions are limited. Intragastric balloons, typically removed after 6-12 months, offer temporary weight loss. ESG, an innovative adaptation of LSG, reduces stomach volume by suturing the greater curvature of the stomach using an endoscopic suturing device. Its short-term efficacy suggests that gastric volume reduction results in substantial weight loss. However, the associated risk of suture failure contributes to its suboptimal long-term effectiveness. Furthermore, the complexity of utilizing the existing endoscopic suturing device poses challenges to endoscopists’ proficiency, impeding its widespread use and scalability.

[0006] As such, there is a gap in the market for improved minimally invasive weight loss treatments that offer durable and optimal long-term efficacy, comparable to those of the surgical approaches (e.g., LSG), while also addressing the usability of the instrument needed for widespread adoption. It would be advantageous to provide a flexible endoscopic stapler device to provide more effective treatment. SUMMARY OF THE INVENTION

[0007] The foregoing needs are met, to a great extent, by the present invention, wherein one aspect is a device for endoscopic procedures that includes an elongated shaft having a proximal end and a distal end. The elongated shaft defines a luminal structure throughout the elongated shaft. The elongated shaft is configured to be flexible. The device includes a distal end effector coupled to the distal end of the elongated shaft. The device may also include one or more cameras and / or light sources for visualization, and in one embodiment a camera and / or a light source is coupled to the distal end effector. The device includes a handle coupled to the proximal end of the elongated shaft. The handle is configured for control of the distal end effector through elongated shaft.

[0008] In accordance with an aspect of the present invention, the end effector includes a section configured for bending and rotation. The device includes a replaceable staple cartridge configured to be coupled to the distal end effector.

[0009] The luminal structure includes multiple lumens extending through the elongated shaft wherein the lumens are configured for various functionality during the procedure: one or more lumens can provide suction and irrigation, one or more lumens can provide for the insertion and use of instruments (e.g. graspers), one or more lumens containing a drive shaft, and one or more lumens for a camera and / or a light source cable lumen.

[0010] The size of the device is configured to allow for introduction to and passage through an upper esophageal sphincter, esophagus, lower esophageal sphincter, stomach and into the duodenum across the pyloric sphincter. The size and length of the device are also configured to allow for introduction to and passage transanally into the rectum and more proximally into the colon. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The accompanying drawings provide visual representations, which will be used to more fully describe the representative embodiments disclosed herein and can be used by those skilled in the art to better understand them and their inherent advantages. In these drawings, like reference numerals identify corresponding elements and:

[0012] FIG. 1A illustrates a side view of an endoscopic stapler device, according to an embodiment of the present invention.

[0013] FIG. IB illustrates a perspective view of a staple cartridge, according to an embodiment of the present invention.

[0014] FIG. 2 illustrates a sectional view of a proximal handle of the endoscopic stapler device, according to an embodiment of the present invention.

[0015] FIG. 3 illustrates a side view of a flexible shaft of an endoscopic stapler device according to an embodiment of the present invention.

[0016] FIGS. 4A-4C illustrates sectional and perspective views of internal structure of the attachment region of the flexible, elongated shaft of the endoscopic stapler device to the handle / actuator, according to an embodiment of the present invention.

[0017] FIG. 5 A illustrates a perspective view of an end effector containing the stapler of the device, according to an embodiment of the present invention.

[0018] FIG. 5B illustrates a perspective view of a staple cartridge, according to an embodiment of the present invention.

[0019] FIG. 6 illustrates a sectional view of the end effector highlighting a flexible pusher bar used to actuate or fire the staples, according to an embodiment of the present invention.

[0020] FIG. 7 illustrates an end view of a distal end of the end effector which consists of a camera and one or more light sources, according to an embodiment of the present invention.

[0021] FIG. 8A illustrates a side view of an endoscopic stapler device, according to an embodiment of the present invention.

[0022] FIGS. 8B and 8C illustrate side and perspective views, respectively, of a handle of an endoscopic stapler device, according to an embodiment of the present invention.

[0023] FIGS. 9A and 9B illustrate side and sectional views, respectively, of a handle of an endoscopic stapler device, according to an embodiment of the present invention.

[0024] FIGS. 9C and 9D illustrate side and perspective views, respectively, of an attachment region of an endoscopic stapler device, according to an embodiment of the present invention.

[0025] FIGS. 10A-10C illustrate side views of a cartridge anvil assembly of an endoscopic stapler device with an anvil in various positions, according to an embodiment of the present invention.

[0026] FIGS. 10D-10F illustrate various side views of an end effector / stapling unit of an endoscopic stapler device, according to an embodiment of the present invention.

[0027] FIG. 11A illustrates a perspective view of a cartridge anvil assembly of an endoscopic stapler device with a detailed view of a camera lighting, according to an embodiment of the present invention.

[0028] FIGS. 1 IB and 1 IC illustrate side and sectional views, respectively, of an end effector / stapling unit of an endoscopic stapler device, according to an embodiment of the present invention.

[0029] FIG. 12 illustrates an exemplary system, according to an embodiment of the present invention. DETAILED DESCRIPTION

[0030] The presently disclosed subject matter now will be described more fully hereinafter with reference to the accompanying Drawings, in which some, but not all embodiments of the inventions are shown. Like numbers refer to like elements throughout. The presently disclosed subject matter may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Indeed, many modifications and other embodiments of the presently disclosed subject matter set forth herein will come to mind to one skilled in the art to which the presently disclosed subject matter pertains having the benefit of the teachings presented in the foregoing descriptions and the associated Drawings. Therefore, it is to be understood that the presently disclosed subject matter is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims.

[0031] Surgical staplers are essential tools in various surgical procedures that are used to simultaneously resect and staple tissue and perform surgical anastomoses. The field of endoscopy has boomed in the last 10 years, mainly due to the maturation of the field of therapeutic endoscopy. This has been the direct result of investment in endoscopy and the 5 development of dedicated instruments and accessories. Therapeutic endoscopy often offers a minimally and less invasive alternative approach to counterpart surgical procedures. For example, peroral endoscopic myotomy has replaced Heller myotomy in the treatment of achalasia at most tertiary centers around the world. Despite the major advancements in the field, a flexible endoscopic stapler has yet to be introduced. The present invention provides a novel endoscopic tool able to approximate tissue via stapling. It is designed to be flexible and utilizes imaging to guide the insertion into and use within the upper and lower gastrointestinal tract. The device can be used with either a transoral or transanal approach. The innovation presents several improvements to the currently available tissue approximation tools for endoscopic procedures by delivering efficiency and improved outcomes: (1) allows for easier and faster approximation of tissue; (2) improves the efficacy of endoscopy procedures; (3) increases the durability of tissue approximation; and (4) reduces the costs of endoscopic interventions.

[0032] Because the present invention is engineered for use in the gastrointestinal tract, it aims to deliver the following benefits: (1) flexible compared to a traditional surgical stapler; (2) a long instrument (at least 135 cm) enabling the stapling to occur from a long distance as opposed to the short mechanism with today’s surgical staplers; (3) a “bending section” allowing the device end effector to reach to its target (often located at an angulation / comer / behind folds / or needing a retroflexed position); (4) small enough to insert through the upper esophageal sphincter (the size-limiting point in our field); and, (5) has additional channels to facilitate endoscopic procedures including: visualization, one or more accessory or instrument channels, one or more end effector actuation channels, suction port, and irrigation port. With this design, the endoscopic stapler of the present invention can be used for a variety of therapeutic endoscopy indications including endoscopic stapled gastroplasty for weight loss, stoma reduction, gastrointestinal leaks, perforations or fistulas. The positioning of the lumens within the flexible, elongated shaft are optimized, which allows for advancement and visualization distally during an endoscopic procedure of the instruments and end effector used during tissue approximation.

[0033] The present invention will provide a groundbreaking adaptation of the LSG, able to reduce the stomach volume by about 50-70% by stapling the greater curvature of the stomach. When comparing ESG and LSG, published data indicates that LSG demonstrates significantly superior long-term efficacy. This difference can be attributed to the distinct mechanisms of action employed by the two interventions. LSG involves the irreversible removal of a part of the gastric wall, effectively reducing gastric volume permanently. In contrast, ESG does not involve removing any part of the gastric wall and carries the possibility of suture failure, especially when combined with inadequate eating behavior by the patient. This distinction in mechanisms can significantly impact the lasting effectiveness of these procedures in managing weight over time.

[0034] FIG. 1 illustrates a side view of an endoscopic stapler device, according to an embodiment of the present invention. In one embodiment, the device is a sterile, single-use, disposable, transoral, multilumen, with an integrated camera(s) and endoluminal stapler. Three elements of the device are described, the handle / actuator 10, a flexible shaft 20, and an end effector / stapling unit 30 with a replaceable staple cartridge.

[0035] FIG. 2 illustrates a sectional view of the proximal handle / actuator of the endoscopic stapler device, according to an embodiment of the present invention. The handle assembly is made of a polymer enclosure and is sterilizable, consisting of multiple components including a handle 40, a recharging element 50, the rotation element 60, electronic motor 70, a high / low travel limit switch 80, gearbox reduction 90, as well as a shaft 100. The handle also includes access elements for instruments, potentially a chip camera and suction / irrigation 110. There is a rotational knob 120, on the handle to rotate the distal end of the assembly ±90° from the median. There is also envisioned another element on the handle to allow the device to articulate at the distal end from zero to ±45 degrees. The handle may be plugged in or coupled electronically 50, to charge a battery 130, which would be in the handle assembly. A trigger mechanism 140, is also envisioned which couples to the motor allowing the shaft to move back and forward. Limit switches 80, in the handle determine the amount of proper stroke forward and backward. Alternative modes of drive may be a manual rack mechanism or a lead screw mechanism which could be in the handle instead of a motor. While limit switches are used as an example herein, other means known to or conceivable by one of skill in the art could also be used, such as an encoder or other means of quantifying stroke length. It should be noted that the handle can include control for a number of additional functions of the endscopic stapler, including, but not limited to, suction and camera irrigation / cleaning.

[0036] FIG. 3 illustrates a side view of the elongated, flexible shaft of an endoscopic stapler device according to an embodiment of the present invention. The elongated, flexible shaft 150 is attached to the handle and end effector. It is a shaft approximately 135 centimeters in length for its intended use. It is envisioned that it can be between 90 and 180 centimeters in length. The diameter is envisioned to be 16mm for primary use. Alternate embodiments can have the elongated, flexible shaft diameter be between 8 and 20mm. The elongated, flexible shaft is bendable along its entire length and can be flexible up to and beyond 180°. The flexible shaft is also atraumatic in nature allowing for a smooth transition through the esophagus or other endoluminal structures.

[0037] FIG. 4 illustrates sectional and perspective views of internal structure of the attachment region of the elongated, flexible shaft of the endoscopic stapler device to the handle / actuator, according to an embodiment of the present invention. Internal to the flexible shaft would be a plurality of lumens, as illustrated in FIG. 4. One or more of these lumens would be for the accelerator cable or drive mechanism 160, that would operate the distal end. This is envisioned to be an accelerator cable or a flexible component which is resistant to torque and push-pull application. Another lumen(s) 170, would be for suction / irrigation. These lumen(s) intended use is to provide for irrigation or vacuum to the distal end effector, to allow for dispersion of fluids or aspiration of fluids which may be used while the procedure is taking place. There is at least one lumen 180 to create an instrument channel for use of graspers or other tools. The intended use is to have a plurality of lumen to facilitate instrument introduction and usage. Ideally at least two instruments would be used for tissue manipulation. Another lumen(s) 190, is conceived which may allow camera introduction into the endoluminal cavity at the stapler end effector. The flexible shaft may be hermetically sealed to preclude introduction or discharge of fluids / gases between the shaft and the endoluminal tract. It should be noted that the shaft may be rotated independent of the handle control.

[0038] The luminal structure includes multiple lumens extending through the elongated shaft wherein the lumens are configured for various functionality during the procedure: one or more lumens can provide suction and irrigation, one or more lumens can provide for the insertion and use of instruments (e.g. graspers), one or more lumens containing a drive shaft, and one or more lumens for a camera cable lumen. The drive shaft lumens can specifically include at least one lumen to actuate the opening and closing (e.g. clamping) of the distal end effector and at least one lumen to actuate or fire a staple cartridge contained within the end effector. In a preferred embodiment, the lumens described have a circular cross-section. In other embodiments, the lumens can have other cross-sectional shapes known in the art including D-shape (semi-circle cross-section), crescent shaped. In a preferred embodiment a lumen diameter will be of a single diameter along the shaft length. Alternately, the lumen diameter can be variable across the shaft length (e.g. taper down, taper up).

[0039] In an alternate embodiment, the luminal structure includes multiple lumens extending through the elongated shaft wherein the lumens are configured for various functionality during the procedure: one or more lumens can provide suction and irrigation, one or more lumens can provide for the insertion and use of instruments (e.g. graspers), one or more lumens containing a drive shaft, and one or more lumens for an endoscope (standard or neonatal / small caliber). The drive shaft lumens can specifically include at least one lumen to actuate the opening and closing (e.g. clamping) of the distal end effector and at least one lumen to actuate or fire a staple cartridge contained within the end effector.

[0040] FIG. 5 illustrates a perspective view of the end effector and stapler of the endoscopic stapler device, according to an embodiment of the present invention. Coupled to the flexible shaft is the end effector comprised of the stapler, apposition device 200. This device consists of an anvil 210, a channel 220 which would hold a staple cartridge 230, containing a sled and pusher for lifting mechanical fastener / staples. The stapler length is envisioned in the preferred embodiment to be between 30 to 40 millimeters in length. It is envisioned that the overall stapler length can be between 10 and 75 millimeters. The staples are to be aligned in a pitch staggered pattern with the plurality of rows. A preferred length of the staple is 4.1 millimeters. The staple can be formed, when fired. A preferred final staple length will be approximately 2.0mm, having a closed loop / “B” formation. Alternatively, a single, post, or tack style configuration may be used for apposition. The preferred material of the staple is to be titanium, but alternate embodiments may include Nitinol, absorbable metal, or a polymer. The device includes a replaceable staple cartridge configured to be coupled to the distal end effector.

[0041] The distal end effector can also include a segment configured for bending and rotation. This section must be strategically close to anvil / channel (described below) to allow for the best clinical outcomes.

[0042] The cartridge anvil assembly 260 may be opened or closed to manipulate and / or grasp tissue. The cartridge anvil assembly can be articulated or rotated through communication 9 between the flexible shaft and the handle. Graspers 270 may be extended at the proximal side of the cartridge assembly through the instrument channels and be in opposition and be spaced 180° apart from each other. These graspers would provide tissue traction and manipulation into the staple cartridge assembly. The articulation needed is along the horizontal plane defined by opening of the anvil / cartridge.

[0043] FIG. 6 illustrates a sectional view of a flexible pusher bar of the endoscopic stapler device, according to an embodiment of the present invention. The flexible pusher bar 280 is capable of articulating. Coupled to the shaft this element provides horizontal motion to the sled to lift the staples during actuation or firing. It is envisioned that in some embodiments, this pusher bar 280 will also provide for cutting capabilities to transect tissue while staples are being formed and provide for tissue gap control. A bar 240 is present to couple the shaft / screw motion to the sled. An alternate embodiment would be a lead screw to drive the sled forward in rotational motion to advance this sled and push the staples up.

[0044] The anvil channel assembly is closed by the following means. A hoop or bar slides over the top of the anvil, forcing it toward the cartridge channel assembly for initial jaw closure. The knife / pusher bar 280 in an alternate embodiment is envisioned to have a secondary form to maintain distance between the anvil and channel to maintain optimal tissue gap- 10045] FIG. 7 illustrates an end view of a distal end of the endoscopic stapler device, according to an embodiment of the present invention. As an alternative to a camera that extends through the entire system, one embodiment is that there be chip-on-tip camera with lighting 290. The device could contain a plurality of cameras. In a preferred embodiment, the device includes, three cameras. A camera could be on the extreme distal end, to visualize insertion into the endoluminal opening through the esophagus into the stomach. There could also be lateral cameras in the area around tissue gap stops on the anvil, which would be used when tissue is being approximated or withdrawn into the annual cartridge assembly. It is anticipated that these cameras will have a cleaning mechanism / irrigation 300 associated with them. The cleaning mechanism is envisioned to either be a spritzer type configuration or mechanical wiper to maintain the optical field clarity during the surgical process.

[0046] FIGS. 8-11 illustrate additional views of the device, according to an embodiment of the invention. FIG. 8 illustrates multiple perspective views of the handle and an exemplary view of a luminal structure of the device shaft. In this exemplary luminal structure, lumens (1) are for suction / irrigation, lumens (2) are for instruments / graspers, lumen (3) is for a clamping drive shaft to actuate the jaws of a stapler assembly, lumen (4) is for a staple firing drive shaft; and lumens (5) are for a camera cable lumen. FIG. 9 illustrates perspective and sectional views of the handle and attachment region of the elongated, flexible shaft of the endoscopic stapler device to the handle / actuator. FIG. 10 illustrates perspective views of an end effector configured for stapling. FIG. 11 illustrates perspective and sectional views of the end effector and camera placement, according to an embodiment of the present invention.

[0047] The present invention is designed to ensure a balance between flexibility, strength of stapling, and length of the shaft. Additionally, the device is designed to address size limitations to pass through the upper esophageal sphincter, the positioning of one or more camera(s), and accessory channels to advance instruments including grasping devices for tissue approximation under direct visualization, and maintaining cost-effectiveness in manufacturing are other potential problems.

[0048] The size of the device is configured to allow for introduction to and passage through an upper esophageal sphincter, esophagus, lower esophageal sphincter, stomach and into the duodenum across the pyloric sphincter. The size and length of the device are also configured to allow for introduction to and passage transanally into the rectum and more proximally into the colon.

[0049] The design of the present invention includes cameras to allow for navigation of small insertion paths and minimizing the device size to facilitate insertion. Moreover, to resolve the rotational dynamics of the End Effector (rotating to 90° clockwise and counterclockwise), a specialized bending section is integrated. Additionally, the incorporation of one or more camera(s) and their positioning for direct visualization during staple deployment is critical.

[0050] One exemplary use of a device of the present invention is for gastric reduction particularly in the stomach through the means of tissue apposition. Other uses include closure of gastrointestinal defects (e.g. leaks, perforation and fistulas), stoma reduction, remnant stomach reduction, and closure of post resection defects including full thickness defects in the gastrointestinal tract. Future uses may also include simultaneous resection and closure in addition to endoscopic gastroenteric or entero-enteric anastomoses.

[0051] In some embodiments, the device can take the form of a stand-alone device, i.e. one device with features of both an endoscope and a stapler. Another iteration is a flexible stapler that goes over an endoscope (standard or slim endoscope). The stapler will be guided by the endoscope camera. The suction and irrigation and traction are all provided by the endoscope. The stapler will have a sleeve where the endoscope will be placed. The endoscope will act as a monorail along which the stapler is advanced.

[0052] The present disclosure also provides various systems and computer program products or machine-readable media, as described further herein, that are useful in performing the methods disclosed herein. In some aspects, for example, the methods described herein are optionally performed or facilitated at least in part using systems, distributed computing hardware and applications (e.g., cloud computing services), electronic communication networks, communication interfaces, computer program products, machine readable media, electronic storage media, software (e.g., machine-executable code or logic instructions) and / or the like. To illustrate, FIG. 12 provides a schematic diagram of an exemplary system suitable for use with implementing at least aspects of the methods disclosed in this application. As shown, system 1200 includes at least one controller or computer, e.g., server 1202 (e.g., a search engine server), which includes processor 1204 and memory, storage device, or memory component 1206, and one or more other communication devices 1214, 1216, (e.g., client-side computer terminals, telephones, tablets, laptops, other mobile devices, etc. (e.g., for receiving data for further analysis, etc.)) positioned remote from endoscopic stapler device 1218, and in communication with the remote server 1202, through electronic communication network 1212, such as the Internet or other internetwork. Communication devices 1214, 1216 typically include an electronic display (e.g., an internet enabled computer or the like) in communication with, e.g., server 1202 computer over network 1212 in which the electronic display comprises a user interface (e.g., a graphical user interface (GUI), a web-based user interface, and / or the like) for displaying results upon implementing the methods described herein. In certain aspects, communication networks also encompass the physical transfer of data from one location to another, for example, using a hard drive, thumb drive, or other data storage mechanism. System 1200 also includes program product 1208 stored on a computer or machine readable medium, such as, for example, one or more of various types of memory, such as memory 1206 of server 1202, that 12 is readable by the server 1202, to facilitate, for example, a guided search application or other executable by one or more other communication devices, such as 1214 (schematically shown as a desktop or personal computer). In some aspects, system 1200 optionally also includes at least one database server, such as, for example, server 1210 associated with an online website having data stored thereon searchable either directly or through search engine server 1202. System 1200 optionally also includes one or more other servers positioned remotely from server 1202, each of which are optionally associated with one or more database servers 1210 located remotely or located local to each of the other servers. The other servers can beneficially provide service to geographically remote users and enhance geographically distributed operations

[0053] Control of the device of the present invention or display of visual images or data related to the device, camera feed, and procedure of the present invention can be carried out using a computer, non-transitory computer readable medium, or alternately a computing device or non-transitory computer readable medium incorporated into the robotic device or the imaging device. Visual displays may include images from associated endoscopic cameras used in conjunction with the device or image guidance of the device within the surgical field.

[0054] A non-transitory computer readable medium is understood to mean any article of manufacture that can be read by a computer. Such non-transitory computer readable media includes, but is not limited to, magnetic media, such as a floppy disk, flexible disk, hard disk, reel-to-reel tape, cartridge tape, cassette tape or cards, optical media such as CD-ROM, writable compact disc, magneto-optical media in disc, tape or card form, and paper media, such as punched cards and paper tape. The computing device can be a special computer designed specifically for this purpose. The computing device can be unique to the present invention and designed specifically to carry out control or displays associated with a device of the present invention. The computing device can also take the form of an operating console computer. The operating console is a non-generic computer specifically designed by the manufacturer. It is not a standard business or personal computer that can be purchased at a local store. Additionally, the console computer can carry out communications with any associated imaging modality through the execution of proprietary custom built software that is designed and written by the manufacturer for the computer hardware to specifically operate the hardware.

[0055] Some further aspects are defined in the following clauses:

[0056] Clause 1: A device for endoscopic surgery comprising: an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible; a distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector includes a fastener deployment unit; and a handle coupled to the proximal end of the elongated shaft, wherein the handle is configured for control of the elongated shaft and the distal end effector.

[0057] Clause 2: The device of Clause 1 wherein the fastener deployment unit deploys one or more staples.

[0058] Clause 3: The device of Clause 1 or Clause 2 wherein the fastener deployment unit comprises a removable staple cartridge.

[0059] Clause 4: The device of any one of Clauses 1-3 further comprising a camera and / or a light source for visualization coupled to the distal end effector.

[0060] Clause 5: The device of any one of Clauses 1-4 wherein the handle comprises one or more of a recharging element, a rotation element, a motor, a high / low travel limit switch, a gearbox reduction, and a shaft.

[0061] Clause 6: The device of any one of Clauses 1-5 wherein the distal end effector comprises a section configured for bending and rotation.

[0062] Clause 7: The device of any one of Clauses 1-6 wherein the luminal structure includes at least five lumens and up to twelve lumens extending through the elongated shaft, wherein the lumens are configured for various functionality including: one or more lumens for applying suction and irrigation, one or more lumens for insertion of instruments, one or more lumens containing a drive shaft for the distal effector, and one or more lumens for a camera and / or a light source cable.

[0063] Clause 8: The device of any one of Clauses 1-7 wherein the instruments comprise one or more graspers.

[0064] Clause 9: The device of any one of Clauses 1-8 comprising two graspers that can be extended in opposition to each other at a proximal side of the fastener deployment unit.

[0065] Clause 10: The device of any one of Clauses 1-9 wherein two of the lumens are dedicated as drive shaft lumens, one to actuate the opening and closing of the distal end effector and a second to actuate or fire a staple cartridge contained within the distal end effector.

[0066] Clause 11: The device of any one of Clauses 1-10 wherein a size of the device is configured to allow for passage through an upper esophageal sphincter.

[0067] Clause 12: The device of any one of Clauses 1-11 wherein the fastener deployment unit comprises a pusher bar that provides cutting capabilities to transect tissue while fasteners are being formed and to provide for tissue gap control.

[0068] Clause 13: The device of any one of Clauses 1-12 wherein the fastener deployment unit comprises a cartridge anvil assembly that comprises an anvil and a channel configured to hold a staple cartridge.

[0069] Clause 14: The device of any one of Clauses 1-13 wherein the cartridge anvil assembly can be opened and closed to manipulate and / or grasp tissue.

[0070] Clause 15: The device of any one of Clauses 1-14 wherein the fastener deployment unit is between 10 and 75 millimeters in length or between 30 and 40 millimeters in length.

[0071] Clause 16: The device of any one of Clauses 1-15 wherein the fastener deployment unit forms fasteners having a length of approximately 2.0 mm.

[0072] Clause 17: A kit comprising the device of any one of Clauses 1-16.

[0073] Clause 18: The kit of Clause 17 wherein the kit further comprises one or more fasteners, one or more grasper instruments, one or more light sources, and / or one or more cameras.

[0074] Clause 19: The kit of Clause 17 or Clause 18 wherein the fasteners comprise one or more staples.

[0075] Clause 20: A system comprising the device of any one of Clauses 1-16.

[0076] Clause 21: A system, comprising: a device comprising: an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible; a distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector includes a fastener deployment unit; and a handle coupled to the proximal end of the elongated shaft, wherein the handle comprises a motor and is configured for control of the elongated shaft and the distal end effector, and, a controller operably connected to the motor, which controller is configured to effect operation of the motor.

[0077] Clause 22: The system of Clause 21 further comprising a camera for visualization coupled to the distal end effector, wherein the controller is operably connected to the camera and is configured to capture one or more images via the camera.

[0078] Clause 23: The system of Clause 21 or Clause 22 wherein the fastener deployment unit deploys one or more staples.

[0079] Clause 24: The system of any one of Clauses 21-23 wherein the fastener deployment unit comprises a removable staple cartridge.

[0080] Clause 25: The system of any one of Clauses 21-24 wherein the handle comprises one or more of a recharging element, a rotation element, a high / low travel limit switch, a gearbox reduction, and a shaft.

[0081] Clause 26: The system of any one of Clauses 21-25 wherein the luminal structure includes at least five lumens and up to twelve lumens extending through the elongated shaft, wherein the lumens are configured for various functionality including: one or more lumens for applying suction and irrigation, one or more lumens for insertion of instruments, one or more lumens containing a drive shaft for the distal effector, and one or more lumens for a camera and / or a light source cable.

[0082] Clause 27: The system of any one of Clauses 21-26 wherein the instruments comprise graspers.

[0083] Clause 28: The system of any one of Clauses 21-27 comprising two graspers that can be extended in opposition to each other at a proximal side of the fastener deployment unit.

[0084] Clause 29: The system of any one of Clauses 21-28 wherein two of the lumens are dedicated as drive shaft lumens, one to actuate the opening and closing of the distal end effector and a second to actuate or fire a staple cartridge contained within the distal end effector.

[0085] Clause 30: The system of any one of Clauses 21-29 wherein a size of the device is configured to allow for passage through an upper esophageal sphincter.

[0086] Clause 31: The system of any one of Clauses 21-30 wherein the fastener deployment unit comprises a pusher bar that provides cutting capabilities to transect tissue while fasteners are being formed and to provide for tissue gap control.

[0087] Clause 32: The system of any one of Clauses 21-31 wherein the fastener deployment unit comprises a cartridge anvil assembly that comprises an anvil and a channel configured to hold a staple cartridge.

[0088] Clause 33: The system of any one of Clauses 21-32 wherein the cartridge anvil assembly can be opened and closed to manipulate and / or grasp tissue.

[0089] Clause 34: The system of any one of Clauses 21-33 wherein the fastener deployment unit is between 10 and 75 millimeters in length or between 30 and 40 millimeters in length.

[0090] Clause 35: The system of any one of Clauses 21-34 wherein the fastener deployment unit forms fasteners having a length of approximately 2.0 mm.

[0091] Clause 36: A method of approximating tissue in a patient, the method comprising: positioning a distal end effector of a device at least proximal to the tissue in the patient, wherein the device comprises: an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible; the distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector includes a fastener deployment unit; and a handle coupled to the proximal end of the elongated shaft, wherein the handle is configured for control of the elongated shaft and the distal end effector; and, fastening the tissue using the fastener deployment unit, thereby approximating the tissue in the patient.

[0092] Clause 37: The method of Clause 36 wherein the fastener deployment unit deploys one or more staples and wherein the fastening step comprising stapling the tissue using the fastener deployment unit.

[0093] Clause 38: The method of Clause 36 or Clause 37 wherein the fastener deployment unit comprises a removable staple cartridge.

[0094] Clause 39: A method of assembling a device, the method comprising coupling a removable fastener deployment unit to a distal end effector of a device, wherein the device comprises: an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible; the distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector is configured to couple the fastener deployment unit; and a handle coupled to the proximal end of the elongated shaft, wherein the handle is configured for control of the elongated shaft and the distal end effector, thereby assembling the device.

[0095] Clause 40: The method of Clause 39 wherein the fastener deployment unit deploys one or more staples.

[0096] Clause 41: The method of Clause 39 or Clause 40 wherein the fastener deployment unit comprises a removable staple cartridge.

[0097] Clause 42: A method of manufacturing a device, the method comprising forming a device comprising: an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible; a distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector includes a fastener deployment unit; and a handle coupled to the proximal end of the elongated shaft, wherein the handle is configured for control of the elongated shaft and the distal end effector, thereby manufacturing the device.

[0098] Clause 43: The method of Clause 42 wherein the fastener deployment unit deploys one or more staples.

[0099] Clause 44: The method of Clause 42 or Clause 43 wherein the fastener deployment unit comprises a removable staple cartridge.

[00100] The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

Claims

1. A device for endoscopic surgery comprising:an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible;a distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector includes a fastener deployment unit; anda handle coupled to the proximal end of the elongated shaft, wherein the handle is configured for control of the elongated shaft and the distal end effector.

2. The device of claim 1 wherein the fastener deployment unit deploys one or more staples.

3. The device of claim 1 wherein the fastener deployment unit comprises a removable staple cartridge.

4. The device of claim 1 further comprising a camera and / or a light source for visualization coupled to the distal end effector.

5. The device of claim 1 wherein the handle comprises one or more of a recharging element, a rotation element, a motor, a high / low travel limit switch, a gearbox reduction, and a shaft.

6. The device of claim 1 wherein the distal end effector comprises a section configured for bending and rotation.

7. The device of claim 1 wherein the luminal structure includes at least five lumens and up to twelve lumens extending through the elongated shaft, wherein the lumens are configured for various functionality including: one or more lumens for applying suction and irrigation, one or more lumens for insertion of instruments, one or more lumens containing a drive shaft for the distal effector, and one or more lumens for a camera and / or a light source cable.

8. The device of claim 7 wherein the instruments comprise one or more graspers.

9. The device of claim 8 comprising two graspers that can be extended in opposition toeach other at a proximal side of the fastener deployment unit.

10. The device of claim 7 wherein two of the lumens are dedicated as drive shaft lumens, one to actuate the opening and closing of the distal end effector and a second to actuate or fire a staple cartridge contained within the distal end effector.

11. The device of claim 1 wherein a size of the device is configured to allow for passage through an upper esophageal sphincter.

12. The device of claim 1 wherein the fastener deployment unit comprises a pusher bar that provides cutting capabilities to transect tissue while fasteners are being formed and to provide for tissue gap control.

13. The device of claim 1 wherein the fastener deployment unit comprises a cartridge anvil assembly that comprises an anvil and a channel configured to hold a staple cartridge.

14. The device of claim 13 wherein the cartridge anvil assembly can be opened and closed to manipulate and / or grasp tissue.

15. The device of claim 1 wherein the fastener deployment unit is between 10 and 75 millimeters in length or between 30 and 40 millimeters in length.

16. The device of claim 1 wherein the fastener deployment unit forms fasteners having a length of approximately 2.0 mm.

17. A kit comprising the device of claim 1.

18. The kit of claim 17 wherein the kit further comprises one or more fasteners, one or more grasper instruments, one or more light sources, and / or one or more cameras.

19. The kit of claim 18 wherein the fasteners comprise one or more staples.

20. A system comprising the device of claim 1.

21. A system, comprising:a device comprising:an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible;a distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector includes a fastener deployment unit; anda handle coupled to the proximal end of the elongated shaft, wherein the handle comprises a motor and is configured for control of the elongated shaft and the distal end effector, and,a controller operably connected to the motor, which controller is configured to effect operation of the motor.

22. The system of claim 21 further comprising a camera for visualization coupled to the distal end effector, wherein the controller is operably connected to the camera and is configured to capture one or more images via the camera.

23. The system of claim 21 wherein the fastener deployment unit deploys one or more staples.

24. The system of claim 21 wherein the fastener deployment unit comprises a removable staple cartridge.

25. The system of claim 21 wherein the handle comprises one or more of a recharging element, a rotation element, a high / low travel limit switch, a gearbox reduction, and a shaft.

26. The system of claim 21 wherein the luminal structure includes at least five lumens and up to twelve lumens extending through the elongated shaft, wherein the lumens areconfigured for various functionality including: one or more lumens for applying suction and irrigation, one or more lumens for insertion of instruments, one or more lumens containing a drive shaft for the distal effector, and one or more lumens for a camera and / or a light source cable.

27. The system of claim 26 wherein the instruments comprise graspers.

28. The system of claim 27 comprising two graspers that can be extended in opposition toeach other at a proximal side of the fastener deployment unit.

29. The system of claim 21 wherein two of the lumens are dedicated as drive shaft lumens, one to actuate the opening and closing of the distal end effector and a second to actuate or fire a staple cartridge contained within the distal end effector.

30. The system of claim 21 wherein a size of the device is configured to allow for passage through an upper esophageal sphincter.

31. The system of claim 21 wherein the fastener deployment unit comprises a pusher bar that provides cutting capabilities to transect tissue while fasteners are being formed and to provide for tissue gap control.

32. The system of claim 21 wherein the fastener deployment unit comprises a cartridge anvil assembly that comprises an anvil and a channel configured to hold a staple cartridge.

33. The system of claim 32 wherein the cartridge anvil assembly can be opened and closed to manipulate and / or grasp tissue.

34. The system of claim 21 wherein the fastener deployment unit is between 10 and 75 millimeters in length or between 30 and 40 millimeters in length.

35. The system of claim 21 wherein the fastener deployment unit forms fasteners having a length of approximately 2.0 mm.

36. A method of approximating tissue in a patient, the method comprising: positioning a distal end effector of a device at least proximal to the tissue in the patient, wherein the device comprises:an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible;the distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector includes a fastener deployment unit; anda handle coupled to the proximal end of the elongated shaft, wherein the handle is configured for control of the elongated shaft and the distal end effector; and, fastening the tissue using the fastener deployment unit, thereby approximating the tissue in the patient.

37. The method of claim 36 wherein the fastener deployment unit deploys one or more staples and wherein the fastening step comprising stapling the tissue using the fastener deployment unit.

38. The method of claim 36 wherein the fastener deployment unit comprises a removable staple cartridge.

39. A method of assembling a device, the method comprising coupling a removable fastener deployment unit to a distal end effector of a device, wherein the device comprises: an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible;the distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector is configured to couple the fastener deployment unit; anda handle coupled to the proximal end of the elongated shaft, wherein the handle is configured for control of the elongated shaft and the distal end effector, thereby assembling the device.

40. The method of claim 39 wherein the fastener deployment unit deploys one or more staples.

41. The method of claim 39 wherein the fastener deployment unit comprises a removable staple cartridge.

42. A method of manufacturing a device, the method comprising forming a device comprising:an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible;a distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector includes a fastener deployment unit; anda handle coupled to the proximal end of the elongated shaft, wherein the handle is configured for control of the elongated shaft and the distal end effector, thereby manufacturing the device.

43. The method of claim 42 wherein the fastener deployment unit deploys one or more staples.

44. The method of claim 42 wherein the fastener deployment unit comprises a removable staple cartridge.

Images