Connector system for joining suture device and medical imaging device

Abstract

This document relates to devices and methods for joining a suture device with a medical imaging device. For example, this document relates to devices and methods for joining a suture device with an endoscopic ultrasound (EUS) device so that a clinician can perform a medical procedure with the suture device under direct visualization from the EUS device.

Description

Attorney Docket No.: 07039-2331WO1 / 2023-330 CONNECTOR SYSTEM FOR JOINING SUTURE DEVICE AND MEDICAL IMAGING DEVICE TECHNICAL FIELD

[0001] This application claims the benefit of priority to U.S. Application No. 63 / 638,187,filed on April 24, 2024, the contents of which are hereby incorporated by reference. TECHNICAL FIELD

[0002] This document relates to devices and methods for joining a suture device with amedical imaging device. For example, this document relates to devices and methods for joining a suture device with an endoscopic ultrasound (EUS) device so that a clinician can perform a medical procedure with the suture device under direct visualization from the EUS device. BACKGROUND

[0003] Suturing is a technique that can be used in the gastrointestinal (GI) tract duringprocedures to close incisions, reconnect tissues, and repair injuries or defects. To perform suturing in the GI tract, a clinician can access the GI tract through minimally invasive techniques or more invasive techniques, identify a site for suturing, and perform the suturing. Suturing can involve placement of interrupted, running or locking stitches. In some cases where a treatment site is located deep within the GI tract, medical imaging can assist the clinician in performing a suturing procedure. For example, medical imaging can allow the clinician to view the suturing in real time so that the procedure is under direct visualization. SUMMARY

[0004] This document relates to devices and methods for joining a suture device with amedical imaging device. For example, this document relates to devices and methods for joining a suture device with an endoscopic ultrasound (EUS) device so that a clinician can perform a medical procedure with the suture device under direct ultrasound visualization from the EUS device, even when traditional optical endoscope visualization is not available.

[0005] In one aspect, this disclosure is directed to a medical device system comprising anendoscopic ultrasound (EUS) device configured to capture medical imaging data accordingAttorney Docket No.: 07039-2331WO1 / 2023-330 to a field of view and a suture device for performing one or more medical procedures in the gastrointestinal (GI) tract of a patient. The medical device system also includes a connector device that a clinician can use to removably attach the suture device to the EUS device so that the EUS device and the suture device can advance together to a targeted treatment site within the GI tract of the patient so that the suture device and the targeted treatment site are within the field of view of the EUS device.

[0006] In another aspect, this disclosure is directed to a method comprising capturing,using an endoscopic ultrasound (EUS) device, medical imaging data according to a field of view and simultaneously performing, using a suture device one or more medical procedures in the gastrointestinal (GI) tract of a patient under imaging (EUS) visualization even when traditional endoscope visualization is not available. The method also includes removably attaching, using a connector device, the suture device to the EUS device so that the EUS device and the suture device can advance together to a targeted treatment site within the GI tract of the patient and so that the suture device and the targeted treatment site are within the field of view of the EUS device.

[0007] Particular embodiments of the subject matter described in this document can beimplemented to realize one or more of the following advantages. In some embodiments, a connector device can secure a suture device to an EUS device so that the suture device can perform a medical procedure under direct visualization from the EUS device. The connector device can secure the suture device so that the suture device can rotate about the EUS device. By rotating the suture device about the EUS device, the clinician can maintain ultrasound visualization of a needle of the suture device throughout a procedure to place a suture using the needle. This means that the connector device can provide a system for performing suture procedures that is improved over systems that do not attach the suture device to the EUS device. In some cases, an EUS device and a suture device can each be attached to a standard endoscope so that the suture device is under visualization from both of the EUS device and the standard endoscope. In some cases, a device incorporating both an EUS device and a suture device can be attached to a standard endoscope to accomplish ultrasound-guided suture placement under direct visualization from the standard endoscope.

[0008] Unless otherwise defined, all technical and scientific terms used herein have thesame meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used to practice the invention, suitable methods and materials areAttorney Docket No.: 07039-2331WO1 / 2023-330 described herein. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

[0009] The details of one or more embodiments of the invention are set forth in theaccompanying drawings and the description herein. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1 is a first perspective view of a medical device including an endoscopicultrasound (EUS) device and a first suture device.

[0011] FIG. 2 is a second perspective view of the medical device of FIG. 1.

[0012] FIG. 3 is a first perspective view of a medical device including an endoscopicultrasound (EUS) device and a second suture device.

[0013] FIG. 4 is a perspective view of a medical device including an EUS device and athird suture device configured to wrap around a circumference of the EUS device in a spiral pattern.

[0014] FIGS. 5A-5B are perspective views of planes of visualizations of an ultrasoundtransducer.

[0015] FIG. 6 illustrates a suture device that attaches to a linear ultrasound transducer andan endoscope that is oriented in the same fashion as the linear ultrasound transducer.

[0016] FIG. 7 illustrates a medical device that includes a suture device including a suturereceptacle sheath and needle holder sheath and an imaging system including an ultrasound transducer and a standard endoscope, where components of the suture device wrap around a shaft of the standard endoscope.

[0017] FIG. 8 is a flow diagram illustrating an example technique for using a medicaldevice including an EUS device and a suture device to capture medical imaging. DETAILED DESCRIPTION

[0018] This document relates to devices and methods for joining a suture device with amedical imaging device to create a joined device for performing suturing procedures in the gastrointestinal (GI) tract as shown in FIG.1. For example, this document relates to devices and methods for joining a suture device with an endoscopic ultrasound (EUS)Attorney Docket No.: 07039-2331WO1 / 2023-330 device so that a clinician can perform a medical procedure with the suture device under direct ultrasound visualization from the EUS device.

[0019] The systems and techniques described herein are capable of providing a joinedtool for performing suturing procedures under direct visualization. These techniques can provide a system that is capable of completing suturing procedures that involve movement of a needle and suture while the needle and suture remain under direct visualization throughout the procedure. That is, parts of a suture device that suture targeted tissue of the patient remain within the field of view of an imaging device so that direct imaging visualization is available throughout the suturing procedure. This allows the clinician to verify progress of the suturing procedure in real time even in examples where standard optical visualization is not available.

[0020] One imaging modality that can provide direct visualization during GI tractprocedures is EUS. EUS is a minimally invasive procedure that combines endoscopy and ultrasound to obtain high-resolution images of GI tract and adjacent structures. In some cases, EUS involves insertion of a specialized endoscope (e.g., an EUS device) into the GI tract through the mouth to view the upper GI tract or through the anus to view the lower GI tract. The EUS device can include a flexible, tube-like shaft equipped with a light source, camera, and ultrasound transducer at a distal tip of the shaft.

[0021] In some cases, EUS can be useful for evaluating submucosal lesions, stagingcancers (e.g., esophageal, gastric, pancreatic, and rectal), and guiding fine-needle aspiration (FNA) to collect tissue or fluid samples. By providing high-resolution cross- sectional views, EUS can provide for assessment of tumor depth, lymph node involvement, and vascular invasion, which is crucial for treatment planning. EUS can guide FNA in real time enhances diagnostic accuracy for malignancies, cysts, and other abnormalities that might not be accessible via traditional imaging modalities like computed tomography (CT) or magnetic resonance imaging (MRI).

[0022] When the EUS device is positioned in the desired location within the GI tract, theultrasound component can be activated. For example, the ultrasound transducer can emit high-frequency sound waves that penetrate the surrounding tissues. These sound waves encounter different tissues or structures within the body, producing echoes. The echoes are detected by the ultrasound transducer. Based on the emitted sound waves and the detected echoes, the EUS device can create detailed medical images in real-time. The medical images show the internal layers of the GI tract, nearby organs, and surrounding structures.Attorney Docket No.: 07039-2331WO1 / 2023-330

[0023] Real-time medical images obtained using the EUS modality can provide valuableinformation to clinicians. These medical images can visualize abnormalities such as tumors, cysts, lymph nodes, or other lesions within or adjacent to the GI tract. This information can assist in making accurate diagnoses, staging cancers, assessing the extent of disease, and planning further treatment strategies. In addition to visualization, EUS allows for targeted biopsies or interventions. Fine-needle aspiration (FNA) or fine-needle biopsy (FNB) can be performed under EUS visualization to obtain tissue samples from suspicious lesions or lymph nodes. EUS-guided interventions can also include drainage of fluid collections, injection of medications, or placement of stents.

[0024] In some examples, an EUS device can be used to provide direct ultrasoundvisualization during suturing procedures within the GI tract. Direct visualization refers to the direct observation of tissues, organs, or structures within the body using visual examination techniques. In medical contexts, direct visualization is often achieved through various procedures or techniques that allow healthcare providers to directly see and assess the internal structures of the body. Suturing can be performed under direct visualization inthe GI tract to close incisions, reconnect tissues, or repair injuries or defects within thedigestive system. Precision is necessary during suturing procedures so that the correct tissue is sutured and so that adjacent tissue is not harmed by suturing. Direct visualization helps clinicians to achieve precision by giving clinicians a detailed view of the target treatment site so that clinicians are sure that the correct tissue is being sutured.

[0025] Medical device 10 includes an EUS device 20. The EUS device 20 is configuredto capture medical imaging data according to a field of view (FOV). This field of view is sometimes referred to as a “plane of visualization.” For example, the EUS device 20 can include an ultrasound transducer 22 on a distal end of a shaft of the EUS device 20. Ultrasound transducer 22 can capture ultrasound images according to a plane of visualization. This plane of visualization is linear, or 2-dimensional, meaning that ultrasound images are more focused than 3-dimensional optical images generated through traditional endoscopy. This means that it is beneficial that relevant parts of a suture device are within the plane of visualization of ultrasound transducer 22 during a suturing procedure.

[0026] In some embodiments, the plane of visualization of ultrasound transducer 22 refersto a specific anatomical slice or section that the transducer displays based on the orientation of its ultrasound beam. This plane can be determined based on a shape and position of an active element of the ultrasound transducer 22 and can be axial, sagittal,Attorney Docket No.: 07039-2331WO1 / 2023-330 coronal, or transverse, depending on how the ultrasound transducer 22 is positioned relative to tissue being examined. In the context EUS, a plane of visualization can be a radial or linear view, with radial probes producing 360-degree cross-sectional images perpendicular to the scope’s axis, while linear probes provide longitudinal images parallel to a shaft of the scope, allowing for real-time needle guidance during procedures like fine- needle aspiration. The plane of visualization of ultrasound transducer 22 represents an area that is imaged by an EUS device 20. This means that for an object to be imaged, the plane of visualization must pass through the object. It is beneficial for a suturing device to ensurethat objects to be imaged are within the plane of visualization of ultrasound transducer 22so that the objects to be imaged are captured by the EUS imaging.

[0027] Stitching, including surgical and endoscopic suturing, can be done under opticalvisual control. During GI endoscopy, which relies on optical visualization, the only tissue directly visible is the inner lining of the gut (e.g., the inner lining of the stomach or colon). An EUS scope such as EUS device 20 can visualize tissues that are deeper than the inner lining of the gut (e.g., deep layers of the gut wall, and adjacent structures next to the gut). This is useful in suturing procedures because during suturing of a targeted treatment side within the GI tract, a needle must pierce deeper layers. EUS device 20 can provide ultrasound images of the tissues of interest according to a linear plane of visualization.

[0028] Ultrasound transducer 22 is a component of an ultrasound machine of EUS device20 responsible for both emitting ultrasound waves and receiving the echoes that bounce back from tissues and structures within the body. In some examples, ultrasound transducer 22 includes piezoelectric crystals comprised of quartz or lead zirconate titanate (PZT). These crystals can, in some examples, generate electrical charges when mechanical stress is applied to the crystals. In some embodiments, piezoelectric crystals of ultrasound transducer 22 vibrate mechanically when electrical current is applied to the piezoelectric crystals. This vibration phenomenon is known as the piezoelectric effect.

[0029] When an electrical current is applied to the piezoelectric crystals of the ultrasoundtransducer 22, the piezoelectric crystals can vibrate at a specific frequency (e.g., within a range from 0.1 megahertz (MHz) to 10 MHz). This vibration of the piezoelectric crystals generates ultrasound waves that propagate outward from ultrasound transducer 22 into the tissue of the patient. The ultrasound waves produced by the ultrasound transducer 22 can travel through the body tissues until the ultrasound waves encounter boundaries between tissues of different densities. At these boundaries, some of ultrasound waves are reflectedAttorney Docket No.: 07039-2331WO1 / 2023-330 back toward the ultrasound transducer 22 while other ultrasound waves continue to propagate deeper into the tissue.

[0030] As the reflected ultrasound waves return to the ultrasound transducer 22, thereflected ultrasound waves cause mechanical vibrations in the piezoelectric crystals. These vibrations cause the piezoelectric crystals to generate electrical signals that are detected by the ultrasound transducer 22. This means that ultrasound transducer 22 uses the piezoelectric effect to convert electrical energy (e.g., electrical current) into mechanical energy (e.g., vibrations of piezoelectric crystals). Electrical signals generated by the ultrasound transducer 22 based on reflected ultrasound waves can be processed to create a visual representation of the internal structures of the body. The strength and timing of the returning echoes can be used to determine a distance to different tissue interfaces, allowing EUS device 20 to generate two-dimensional (2D), three-dimensional (3D), or Doppler images.

[0031] Ultrasound provides several advantages over traditional optical imaging in thecontext of direct visualization of suturing procedures in the GI tract. While optical imaging provides a view of an outer layer of tissue facing the camera, ultrasound provides a view of inner layers of tissue and structures beyond the tissue. Since suturing involves puncturing layers of tissue, ultrasound can provide a valuable view of the tissue because deeper tissues that are not visible to a traditional endoscope are accessed to complete the suturing procedure. The ultrasound transducer 22 can provide a view of many layers of tissue, even layers that are separated from the ultrasound transducer 22 by other tissue or structures. This is because ultrasound waves can penetrate layers of tissue and interact with inner tissues and structures.

[0032] Medical device 10 including EUS device 20 configured for ultrasound imagingcan provide several benefits over systems that use traditional endoscopy. For example,medical device 10 can place fully transmural gastrointestinal sutures with confidence. Inthe context of the GI tract, “transmural” refers to a condition or process that involves the full thickness of the wall of the GI tract. The GI tract is composed of several layers of tissue, including mucosa, submucosa, muscularis propria (muscle layer), and serosa (outer covering). A transmural process affects all these layers, from the innermost mucosal layer to the outermost serosal layer. Transmural suturing can be more secure than submucosal sutures that tend to rip out. Under mere optical guidance, a clinician cannot be sure sutures are fully transmural – meaning they incorporate the entire gut wall. If sutures onlyAttorney Docket No.: 07039-2331WO1 / 2023-330 incorporate part of the gut wall into the stitch, the stitch tends to pull out later, undoing the work that was done.

[0033] Because ultrasound transducer 22 is able to capture ultrasound images thatindicate deeper layers of the gut and interfaces between layers of the gut, ultrasound transducer 22 provides direct visualization confirming whether suture material has crossed the entire gut wall. This also allows the clinician to avoid inadvertent puncture or suturing of adjacent structures, including blood vessels and other organs. Under traditional optical guidance, the clinician cannot be sure if the suture is penetrating structures adjacent to the gut wall that get pulled into the stitch, such as adjacent vessels, nerves and organs.

[0034] Medical device 10 can include a suture device that is connected to EUS device 20such that the suture device performs suturing procedures under direct visualization by the EUS device 20. This suture device can use a needle and suturing material to perform suturing on a targeted tissue site within or adjacent to the GI tract. Suture procedures in the GI tract can be performed during surgeries to close incisions, connect or reconnect tissues, or repair injuries or defects within the digestive system. During suturing, a needle can be passed through tissue to guide the suturing material through the tissue. The needle can guide the suturing material through material on two different sides of a wound or incision. This allows the suturing material to hold the wound or incision closed.

[0035] Suturing can be performed by a clinician such as a surgeon to close incisions thatwere made for a surgical procedure, close wounds, or any combination thereof. Since suturing involves puncturing tissue with a sharp needle, it is important that suturing is done in the correct areas and without puncturing the wrong tissue. When suturing is performed in areas that are not generally visible to the clinician’s naked eye such as areas within the GI tract, medical imaging can be used to provide direct visualization of the suturing in real time so that the clinician can complete the suturing safely without unnecessarily puncturing tissue adjacent the targeted treatment site.

[0036] In some examples, the suture device of medical device 10 includes a suturereceptacle sheath 30 having a distal end 32 and a needle holder sheath 40 having a distal end 42. A needle 48 can move slidably within the needle holder sheath 40 such that the needle 48 can slide out of the needle holder sheath 40 and / or retract within the needle holder sheath 40. The suture receptacle sheath 30 can receive suture material for use during the suture procedure. In some examples, the suture material received within the suture receptacle sheath 30 can join with needle 48 so that needle 48 can guide the suture material through tissue of the patient.Attorney Docket No.: 07039-2331WO1 / 2023-330

[0037] In some embodiments, a distal portion of suture receptacle sheath 30 can wraparound a distal end of the EUS device 20 so that the distal portion of the suture receptacle sheath 30 forms a bended “C” shape as shown in FIG.1. This may ensure that the distal end 32 of suture receptacle sheath 30 is within the plane of visualization of the ultrasound transducer 22. As seen in FIG.1, the distal end 42 of the needle holder sheath 40 extends to a distal portion of the EUS device 20 proximate to ultrasound transducer 22. This means that the distal end 42 of the needle holder sheath 40 can be within the plane of visualization of the ultrasound transducer 22. When the distal end 32 of suture receptacle sheath 30 and the distal end 42 of the needle holder sheath 40 are both within the plane of visualization of the ultrasound transducer 22, this means that there can be direct visualization of the entire suturing procedure.

[0038] Connector rings 52 and 54 can, in some embodiments, secure the suture receptaclesheath 30 and the needle holder sheath 40 to a shaft of the EUS device 20. As seen in FIG. 1, connector rings 52 and 54 can secure the suture receptacle sheath 30 to the EUS device 20 so that suture receptacle sheath 30 is flush with a surface of EUS device 20 along most of a length of suture receptacle sheath 30. However, the distal portion of suture receptacle sheath 30 can, in some examples, separate from the surface of EUS device 20 and wrap around a distal end of the EUS device 20. The medical device 10 is not limited to using two connector rings 52 and 54. In some examples, medical device 10 can include more than two connector rings or less than two connector rings. Connector rings can, in some embodiments, be spaced evenly along a length of the shaft of the EUS device 20. Medical device 10 is not limited to including two connector rings 52, 54. In some examples, medical device 10 includes a single connector ring that secures the suture receptacle sheath 30 and the needle holder sheath 40 to a shaft of the EUS device 20 or more than two connector rings that secure the suture receptacle sheath 30 and the needle holder sheath 40 to a shaft of the EUS device 20.

[0039] Connector rings 52 and 54 can secure the needle holder sheath 40 to the shaft ofthe EUS device 20 so that needle holder sheath 40 is flush with a surface of EUS device 20 along most of a length of needle holder sheath 40. In some cases, connector rings 52 and 54 can cause a distal portion of the needle holder sheath 40 to angle away from the shaft of EUS device 20 at a small angle as seen in FIG. 1. This allows needle 48 to penetrate tissue and place suture material proximate to EUS device 20 and under direct visualization of the ultrasound transducer 22.Attorney Docket No.: 07039-2331WO1 / 2023-330

[0040] For example, the plane of visualization of the ultrasound transducer 22 can extendradially outward from the outer circumference of the curved portion of ultrasound transducer 22 depicted in FIG.1. When the distal end 32 of suture receptacle sheath 30 and the needle 48 are both within the same plane and displaced from the outer circumference of the curved portion of ultrasound transducer 22, this means that ultrasound transducer 22 can emit signals according to the plane of visualization that pass through both of the distal end 32 of suture receptacle sheath 30 and the needle 48 and return to the ultrasound transducer 22. By causing the distal portion of the needle holder sheath 40 to angle away from the shaft of EUS device 20 at a small angle, the connector rings 52 and 54 can help to ensure that both of the distal end 32 of suture receptacle sheath 30 and the needle 48 are within the plane of visualization of the ultrasound transducer 22.

[0041] When the needle 48 extends out of the distal end 42 of needle holder sheath 40 atan angle with the longitudinal axis of EUS device 20, for example, this can ensure that needle 48 is able to pierce tissue in an area sufficiently displaced from the EUS device 20 that is within the plane of visualization of the ultrasound transducer 22. It can be beneficial for needle 48 to be displaced form a surface of the ultrasound transducer 22 so the needle 48 can perform the function of suturing while also being imaged by the ultrasound transducer 22.

[0042] In some examples, connector rings 52 and 54 can rotate about the shaft of EUSdevice 20 while the suture receptacle sheath 30 and the needle holder sheath 40 are connected to rings 52 and 54. This means that connector rings 52 and 54 can cause suture receptacle sheath 30 and the needle holder sheath 40 to rotate about the shaft of EUS device 20. In some examples, it may be beneficial for suture receptacle sheath 30 and the needle holder sheath 40 to rotate about the shaft of EUS device 20 to place the distal end 32 of suture receptacle sheath 30 and the distal end 42 of needle holder sheath 40 within the plane of visualization of the ultrasound transducer 22. For example, suture receptacle sheath 30 and the needle holder sheath 40 can be arranged through rotation about EUS device 20 so that a suturing of a targeted treatment site is under direct visualization throughout the suturing.

[0043] As connector rings 52 and 54 rotate about the shaft of EUS device 20, connectorrings 52 and 54 can maintain a distance of suture receptacle sheath 30 and the needle holder sheath 40 relative to EUS device 20. For example, the distal portion of suture receptacle sheath 30 may remain wrapped around the distal end of EUS device 20 as connector rings 52 and 54 rotate. Additionally, or alternatively, a distal portion of needleAttorney Docket No.: 07039-2331WO1 / 2023-330 holder sheath 40 may remain angled away from EUS device 20 as connector rings 52 and 54 rotate.

[0044] In some embodiments, connector rings 52 and 54 can rotate about the shaft ofEUS device 20 in a way that maintains suture receptacle sheath 30 and the needle holder sheath 40 together in the same plane relative to a surface of EUS device 20. In these embodiments, connector rings 52 and 54 can prevent suture receptacle sheath 30 and needle holder sheath 40 from rotating relative to each other about the body of the EUS device 20. This can ensure that both of needle 48 and the distal end 32 of suture receptacle sheath 30 remain within the plane of visualization of the ultrasound transducer 22 without one of needle 48 and the distal end 32 of suture receptacle sheath 30 exiting the plane of visualization while the other of needle 48 and the distal end 32 remains within the plane of visualization.

[0045] In some embodiments, medical device 10 can improve the outcomes of someprocedures (e.g., endoscopic sleeve gastroplasty) and perform other procedures (e.g., gastrointestinal anastomoses) that are difficult using traditional endoscopy. To perform a side-to-side gastrojejunal anastomosis, medical device 10 including EUS device 20 comprising a flexible EUS scope equipped with the EUS suture device can be passed through the mouth to the stomach. A loop of proximal jejunum adjacent to the gastric greater curvature can be visualized by ultrasound from within the stomach, using the ultrasound transducer 22 of EUS device 20. Medical device 10 can place an oval ring of stitches in stomach, with each stitch crossing the gastric lumen into the jejunal lumen. Because the procedure is performed under ultrasound visualization, the clinician can confirm that stitches are being placed correctly into the jejunum, and that the jejunum is being attached in side-to-side fashion to the stomach. Once the oval ring of stitches are in place, the clinician can create an incision in the tissue in the center of the ring, creating the anastomosis.

[0046] In some embodiments, the suture passes through a working channel of theendoscope (not illustrated). In some embodiments, the suture passes through a third sheath alongside the endoscope shaft, similar to and parallel to sheaths 30 and 40, through which the suture can be tied, cinched and / or cut.

[0047] Referring now to FIGS. 1-2, connector ring 52 can secure suture receptacle sheath30 and needle holder sheath 40 to EUS device 20 so that suture receptacle sheath 30 andneedle holder sheath 40 are on opposite sides of EUS device 20 along most of a length ofEUS device 20. This allows the distal portion of suture receptacle sheath 30 to wrapAttorney Docket No.: 07039-2331WO1 / 2023-330around the distal end of EUS device 20 so that the distal end 32 of suture receptacle sheath30 faces a distal end 42 of needle holder sheath 40. Consequently, the suture material can meet with needle 48 in a gap between the distal end 32 of suture receptacle sheath 30 and the distal end 42 of needle holder sheath 40. This gap is in the plane of visualization of the ultrasound transducer 22.

[0048] Perspective view shown in FIG. 2 shows that connector ring 52 extends fullyaround a shaft of EUS device 20. In some examples, suture receptacle sheath 30 andneedle holder sheath 40 are secured to connector ring 52 such that suture receptacle sheath30 and needle holder sheath 40 remain on opposite sides of EUS device 20 as ring 52rotates about EUS device 20. It may be beneficial for suture receptacle sheath 30 andneedle holder sheath 40 to be on opposite sides of EUS device 20 so that suture receptaclesheath 30 and needle holder sheath 40 are arranged to perform one or more suturing procedures.

[0049] Referring now to FIG. 3, medical device 10 is not limited to examples whereneedle holder sheath 40 extends to a location proximal to a distal end of EUS device 20and suture receptacle sheath 30 wraps around the distal end of EUS device 20 to form a“C” pattern. In some embodiments, as shown in FIG.3, connector rings 52 and 54 securesuture receptacle sheath 30 and needle holder sheath 40 to EUS device 20 such that suturereceptacle sheath 30 extends to a location proximal to a distal end of EUS device 20 andneedle holder sheath 40 wraps around the distal end of EUS device 20 to form a “C”pattern. Needle 48 can extend from distal end 42 of needle holder sheath 40 and / or retractwithin needle holder sheath 40.

[0050] In use, medical device 10 as illustrated in FIG. 3 can pass suture material throughsuture receptacle sheath 30 to a distal end of EUS device 20. Since needle holder sheath 40is curved around the distal end of EUS device 20, needle 48 can extend from the distal end42 of needle holder sheath 40 towards the distal end 32 of suture receptacle sheath 30while under direct visualization by ultrasound transducer 22. As shown in FIG. 3, thesuture receptacle sheath 30 can be angled slightly away from the shaft of EUS device 20.This can allow medical device 10 to perform deeper suture placement as compared with tools where the needle holder sheath and the suture receptacle sheath are not angled slightly away from a main tool shaft. This is because the slight angle allows the needle and the suture to enter tissue at a slight angle, promoting depth.

[0051] In some embodiments, the suture receptable sheath 30 and / or the needle holdersheath 40 can be actuated away from the shaft of the EUS device 20 by an actuator whenAttorney Docket No.: 07039-2331WO1 / 2023-330 the EUS device 20 has been introduced into the GI tract, enabling deeper suture placement. For example, the actuator can increase an angle between the suture receptable sheath 30 and / or the needle holder sheath 40 and the EUS device 20. In some examples, this actuator can be located on the suture receptable sheath 30 and / or the needle holder sheath 40. For example, an actuator for angling the suture receptable sheath 30 away from the shaft of the EUS device 20 can be located on the suture receptable sheath 30. Additionally, or alternatively, an actuator for angling the needle holder sheath 40 away from the shaft of the EUS device 20 can be located on the needle holder sheath 40.

[0052] Referring now to FIG. 4, medical device 10 can be arranged so that suturereceptacle sheath 30 and needle holder sheath 40 wrap around the circumference of theshaft of EUS device 20 in a spiral pattern for some or all of the length of the shaft of theEUS device. As seen in FIG. 4, suture receptacle sheath 30 can wrap around acircumference of EUS device 20 in a spiral pattern along a length of EUS device 20. Thedistal portion of the suture receptacle sheath 30 can wrap around the distal end of EUSdevice 20 to form a “C” pattern. In the example of FIG. 4, the needle holder sheath 40 alsowraps around the circumference of the shaft of EUS device 20 in a spiral pattern for mostof a length of EUS device 20.

[0053] Since needle holder sheath 40 also wraps around the circumference of the shaft ofEUS device 20 in a spiral pattern, a distal portion of needle holder sheath 40 is angledacross EUS device 20 such that the distal portion of needle holder sheath 40 forms anangle with a longitudinal axis of EUS device 20. This means that when needle 48 extendsoutward from distal end 42 of needle holder sheath 40, needle 48 extends outward at anangle with the longitudinal axis of EUS device 20. This angle allows needle 48 topenetrate deep into tissue adjacent to EUS device 20 when EUS device 20 is insertedwithin the GI tract. Needle 48 can deliver suture material from suture receptacle sheath 30to perform a transmural suturing procedure under direct visualization from the ultrasoundtransducer 22 of EUS device 20.

[0054] Connector ring 52 can rotate about a shaft of EUS device 20 such that suturereceptacle sheath 30 and needle holder sheath 40 also rotate about EUS device 20 whilemaintaining spiral patterns about a circumference of EUS device 20. In some examples, connector ring 52 is not the only connector ring along EUS device 20. For example, connector rings can be spaced along the shaft of EUS device 20 at regular intervals. In anycase, connector ring 52 can rotatably attach suture receptacle sheath 30 and needle holdersheath 40 to EUS device 20.Attorney Docket No.: 07039-2331WO1 / 2023-330

[0055] Referring now to FIGS. 5A and 5B ultrasound transducer 22 of EUS device 20 canhave linear planes of visualization. For example, FIG.5A illustrates a plane of visualization 62 extending along a longitudinal axis of EUS device 20. In some examples,suture receptacle sheath 30 and needle holder sheath 40 can rotate about EUS device 20such that suturing unfolds partially or wholly within the plane of visualization 62 corresponding to ultrasound transducer 22. FIG.5B illustrates the plane of visualization 62 extending perpendicular to a longitudinal axis of EUS device 20. As seen in FIGS.5A-5B, plane of visualization 62 is a two-dimensional plane that provides depth of visualization. Ultrasound is different from camera imaging in that camera imaging captures the first layer of tissue in front of the camera, whereas ultrasound captures deeper layers.

[0056] FIG. 6 illustrates a medical device 70 including suture device that attaches to alinear ultrasound transducer and an endoscope that is oriented in the same fashion as thelinear ultrasound transducer. Medical device 70 includes a suture device including a suturereceptacle sheath and a needle holder sheath that are connected to the linear ultrasoundtransducer and the endoscope. Medical device 70 provides direct visualization both by the linear ultrasound transducer and the endoscope. This direct visualization can feature a needle of the suture device throughout a procedure to deliver a suture to targeted tissue of the patient. This means that the clinician can view a position of the needle relative to tissue to confirm that the needle is puncturing the correct tissue.

[0057] FIG. 7 illustrates a medical device 80 that includes a suture device including asuture receptacle sheath and needle holder sheath and an imaging system including an ultrasound transducer and a standard endoscope, where components of the suture device wrap around a shaft of the standard endoscope. In this embodiment, an ultrasound transducer scanning at an oblique or perpendicular angle relative to the long axis of the endoscope is incorporated into the attachment. The scanner plane can be curved to match the arc of the suturing needle. Additionally, or alternatively, a single rotating transducer can be used. The needle holder sheath and the suture receptacle sheath can curve around the tip of the scope, allowing deployment of a curved or angulated needle.

[0058] FIG. 8 is a flow diagram illustrating an example technique for using a medicaldevice including an EUS device 20 and a suture device to capture medical imaging. For example, an EUS device 20 can capture medical imaging data according to a field of view (102). In some examples, EUS device 20 includes an endoscope shaft and an ultrasound transducer 22 placed on a distal end of the endoscope shaft. The ultrasound transducer 22 can, in some examples, capture the medical imaging data. In some embodiments, the EUSAttorney Docket No.: 07039-2331WO1 / 2023-330 device 20 can output the medical imaging data for display by a display device in real time so that the suture device and the targeted treatment site are under direct visualization.

[0059] In some examples, the suture device comprises a suture receptacle sheath 30configured to receive a suture material. In some examples, the suture device includes a needle holder sheath 40 configured to receive a needle 48 configured to slidably move along the needle holder sheath 40. That is, the needle 48 can be advanced distally out of a distal end 42 of the needle holder sheath 40 and retracted proximally within the distal end 42 of the needle holder sheath 40. In some cases, a clinician can control a movement of the needle 48 within the needle holder sheath 40 (e.g., control needle 48 to extend or withdraw). In some cases, needle 48 is configured to thread the suture material through tissue at the targeted treatment site to perform a medical procedure while the needle 48 is within a field of view of the EUS device 20.

[0060] In some examples, the suture device can perform one or more medical proceduresin the gastrointestinal (GI) tract of a patient (104). For example, the suture device can perform one or more suturing procedures that involve making stitches in the walls of the GI tract. These procedures can involve piercing layers of the GI tract that are deeper than an inner lining of the stomach or colon. This means an imaging modality that images these deeper layers is beneficial so that the suturing of the deeper layers is visible in medical imaging.

[0061] EUS device 20 can removably attach, using a connector device, the suture deviceto the EUS device 20 so that the EUS device 20 and the suture device can advance together to a targeted treatment site within the field of view of the EUS device 20 (106). In some examples, the connector device is configured to connect the needle holder sheath 40 to an endoscope shaft of the EUS device 20 so that the needle holder sheath 40 forms an angle with the endoscope shaft. This angle can cause a distal end of the needle holder sheath to point outwards from a longitudinal axis of the endoscope shaft. The connector device can, for example, connect the suture receptacle sheath 30 to the endoscope shaft so that a distal end of the suture receptacle sheath 30 wraps around a distal end of the endoscope shaft. In some embodiments, the connector device is configured to connect the needle holder sheath 40 to an endoscope shaft of the EUS device 20 so that the needle holder sheath 40 wraps around the endoscope shaft in a spiral pattern. In these embodiments, the connector device can connect the suture receptacle sheath 30 to the endoscope shaft so that the suture receptacle sheath 30 wraps around the endoscope shaft in a spiral pattern and a distal end of the suture receptacle sheath 30 wraps around a distal end of the endoscope shaft.Attorney Docket No.: 07039-2331WO1 / 2023-330

[0062] The connector device includes, in some examples, one or more connector rings 52,54 configured to rotatably connect the suture device to an endoscope shaft of the EUS device 20. Each connector ring of the one or more connector rings is configured to rotate about the endoscope shaft so that the suture device rotates about the endoscope shaft. In some examples, the suture device and the targeted treatment site remain within the field of view of the EUS device as the suture device rotates about the endoscope shaft.

[0063] While this specification contains many specific implementation details, theseshould not be construed as limitations on the scope of any invention or of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments of particular inventions. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub combination. Moreover, although features may be described herein as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub combination or variation of a sub combination.

[0064] Similarly, while operations are depicted in the drawings in a particular order, thisshould not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system modules and components in the embodiments described herein should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single product or packaged into multiple products.

[0065] Particular embodiments of the subject matter have been described. Otherembodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results. As one example, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous.

Claims

Attorney Docket No.: 07039-2331WO1 / 2023-330 CLAIMS What is claimed is:

1. A medical device system comprising:an endoscopic ultrasound (EUS) device configured to capture medical imaging data according to a field of view; a suture device for performing one or more medical procedures in the gastrointestinal (GI) tract of a patient; and a connector device that a clinician can use to removably attach the suture device tothe EUS device so that the EUS device and the suture device can advance together to atargeted treatment site within the GI tract of the patient and so that the suture device and the targeted treatment site are within the field of view of the EUS device.

2. The medical device system of claim 1, wherein the EUS device comprises:an endoscope shaft; and an ultrasound transducer placed on a distal end of the endoscope shaft, wherein the ultrasound transducer is configured to capture the medical imaging data.

3. The medical device system of any of claims 1-2, wherein the EUS device isconfigured to output the medical imaging data for display by a display device in real time so that the suture device and the targeted treatment site are under direct visualization.

4. The medical device system of any of claims 1-3, wherein the suture devicecomprises: asuture receptacle sheath configured to receive a suture material; anda needle holder sheath configured to receive a needle configured to slidably move along the needle holder sheath, wherein the needle is configured to thread the suture material through tissue at the targeted treatment site to perform a medical procedure while the needle is within the field of view of the EUS device.

5. The medical device system of claim 4, wherein the connector device is configuredto:Attorney Docket No.: 07039-2331WO1 / 2023-330 connect the needle holder sheath to an endoscope shaft of the EUS device so that the needle holder sheath forms an angle with the endoscope shaft, wherein the angle causes a distal end of the needle holder sheath to point outwards from a longitudinal axis of the endoscope shaft; and connect the suture receptacle sheath to the endoscope shaft so that a distal end of the suture receptacle sheath wraps around a distal end of the endoscope shaft.

6. The medical device system of any of claims 4-5, wherein the connector device isconfigured to: connect the suture receptacle sheath to an endoscope shaft of the EUS device so that the suture receptacle sheath forms an angle with the endoscope shaft, wherein the angle causes a distal end of the suture receptacle sheath to point outwards from a longitudinal axis of the endoscope shaft; and connect the needle holder to the endoscope shaft so that a distal end of the suture needle holder sheath wraps around a distal end of the endoscope shaft.

7. The medical device system of any of claims 4-6, wherein the connector device isconfigured to: connect the needle holder sheath to an endoscope shaft of the EUS device so that the needle holder sheath wraps around the endoscope shaft in a spiral pattern; and connect the suture receptacle sheath to the endoscope shaft so that the suture receptacle sheath wraps around the endoscope shaft in a spiral pattern and a distal end of the suture receptacle sheath wraps around a distal end of the endoscope shaft.

8. The medical device of any of claims 4-7, further comprising an actuator configuredto advance the needle through the needle holder sheath, wherein the needle is within the field of view of the EUS device as the needle advances out of the needle holder sheath.

9. The medical device of any of claims 4-8, wherein the needle holder sheath is curvedin two perpendicular planes.

10. The medical device system of any of claims 1-9, wherein the connector devicecomprises: one or more connector rings configured to rotatably connect the suture device to anAttorney Docket No.: 07039-2331WO1 / 2023-330 endoscope shaft of the EUS device, wherein each connector ring of the one or more connector rings is configured to rotate about the endoscope shaft so that the suture device rotates about the endoscope shaft, and wherein the suture device and the targeted treatment site remain within the field of view of the EUS device as the suture device rotates about the endoscope shaft.

11. A method comprising:capturing, using an endoscopic ultrasound (EUS) device, medical imaging data according to a field of view; performing, using a suture device one or more medical procedures in the gastrointestinal (GI) tract of a patient; and removably attaching, using a connector device, the suture device to the EUS device so that the EUS device and the suture device can advance together to a targeted treatment site within the GI tract of the patient and so that the suture device and the targeted treatment site are within the field of view of the EUS device.

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