Percutaneous access kit and uses thereof

Abstract

Devices used to access the pericardial space of the heart. In particular, there is described an apparatus to enable an operator to access the pericardial space of the heart, and deliver cardiac therapies to the pericardial space, under direct visualization through a single, small incision.

Description

PERCUTANEOUS ACCESS KIT AND USES THEREOFCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Application No.63 / 615,692, filed December 28, 2024, the teachings of which are hereby incorporated by reference in its entirety for all purposes.FEDERAL FUNDING DISCLOSURE

[0002] This invention was made with government support under R41 HL 174307 awarded byNational Institute of Health. The government has certain rights in the invention.BACKGROUNDFIELD OF THE DISCLOSURE

[0003] The present disclosure relates to the field of cardiac rhythm therapy, and an apparatus for enabling access to the pericardial space under direct visualization and control for medical device delivery.DESCRIPTION OF THE RELATED ART

[0004] Cardiac pacing may be utilized to stimulate the heart. Currently, two distinct approaches to implantation of medical devices for cardiac pacing are performed: (1) transvenous access of the endocardium or (2) direct surgical access to the epicardial surfaces.When it becomes necessary to implant a cardiac pacemaker in small children or patients with congenital heart defects, however, cardiologists and surgeons are presented with a unique set of challenges. These patients are often too small for insertion of pacemaker leads through a transvenous approach and congenital anomalies of the heart or venous system may complicateor prevent transvenous lead placement. Further to small body habitus and limited venous capacitance, other contraindications to transvenous pacing may include intracardiac shunts, venous obstruction, endocarditis, mechanical tricuspid valve, and complex venous anatomy resulting in an inability to access the right heart endocardium. Moreover, patients with congenital heart disease and device-dependent primary electrical diagnoses are likely to require multiple invasive procedures over the course of a lifetime with attendant cumulative risk of venous occlusion, therefrom.

[0005] Most of the approved technologies used to implant devices for managing cardiac rhythm disease, are delivered via transvenous approach and rely on patient vasculature for navigation under intermediate exposure to fluoroscopy. For pediatric, single ventricle, and abnormal vasculature patients, however, a transvenous approach is not feasible due to anatomical restrictions in navigation. This patient population, typically subjected to either thoracotomy or equivalent procedure to expose the heart and allow direct access to the pericardium, may benefit from a minimally invasive approach to implantation of epicardial devices as described in the present disclosure. In general, a minimally invasive approach for pericardial access can be safer than typical fluoroscopic methods, which can result in heart wall perforation and excessive bleeding. Once pericardial access is obtained, therapies can be delivered, including pacing leads, defibrillation leads, ablation catheters, and stem cell / drug injections.

[0006] The foregoing “Background” description is for the purpose of generally presenting the context of the disclosure. Work of the inventors, to the extent it is described in this background section, as well as aspects of the description which may not otherwise qualify as prior art at the time of filing, are neither expressly or impliedly admitted as prior art against the present invention.SUMMARY

[0007] In one embodiment, the present disclosure relates to an apparatus for percutaneous access to a body, comprising a sheath including a proximal base and a lumen; a core configured to be concentrically inserted in the lumen of the sheath and including a first imaging sensor and a first illumination source at a distal end of the core, the core further including an insufflation channel and a working channel terminating at the distal end of the core; and an access tool configured to be concentrically inserted into the working channel of the core, the access tool including a second imaging sensor and a second illumination source at a distal end thereof, wherein the first illumination source includes one or more optical fibers extending from the proximal base of the core to the distal end of the core, and the second illumination source includes optical fibers providing illumination at the distal end of the access tool.

[0008] In one embodiment, the present disclosure relates to an apparatus for percutaneous access to a body, comprising a sheath including a proximal base and a lumen; a core configured to be concentrically inserted in the lumen of the sheath and including a first imaging sensor and a first illumination source at a distal end of the core, the core further including a working channel terminating at the distal end of the core; and an access tool configured to be concentrically inserted into the working channel of the core, the access tool including a second imaging sensor and a second illumination source at a distal end of the access tool, wherein the first illumination source and the second illumination source include one or more optical fibers.

[0009] In one embodiment, the present disclosure relates to an apparatus for percutaneous access to a body, comprising: a sheath including a proximal base and a lumen; a core configured to be concentrically inserted in the lumen of the sheath and including a first imaging sensor and a first illumination source at a distal end of the core and a workingchannel terminating at the distal end of the core; and an access tool configured to be concentrically inserted into the working channel of the core and including a second imaging sensor and a second illumination source at a distal end of the access tool.

[0010] In one embodiment, the present disclosure relates to an apparatus for percutaneous access to a body, comprising: a sheath including a base, a lumen, and an illumination source at a distal opening of the lumen; and an access tool configured to be concentrically inserted in the lumen of the sheath and including an imaging sensor at a distal end of the access tool and at least one working channel.

[0011] The foregoing paragraphs have been provided by way of general introduction, and are not intended to limit the scope of the following claims. The described embodiments, together with further advantages, will be best understood by reference to the following detailed description taken in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] A more complete appreciation of the disclosure and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:

[0013] FIG. 1 A is an illustration of an access apparatus, according to one embodiment of the present disclosure;

[0014] FIG. IB is an illustration of an access apparatus, according to one embodiment of the present disclosure;

[0015] FIG. 1C is an illustration of an access apparatus, according to one embodiment of the present disclosure;

[0016] FIG. ID is an illustration of an access apparatus, according to one embodiment of the present disclosure;

[0017] FIG. 2 is an illustration of an access apparatus, according to one embodiment of the present disclosure;

[0018] FIG. 3 A is an illustration of an access apparatus core, according to one embodiment of the present disclosure;

[0019] FIG. 3B is an illustration of an access apparatus core, according to one embodiment of the present disclosure;

[0020] FIG. 3C is an illustration of an access apparatus core, according to one embodiment of the present disclosure;

[0021] FIG. 3D is an illustration of an access apparatus core, according to one embodiment of the present disclosure;

[0022] FIG. 3E is an illustration of an access apparatus core, according to one embodiment of the present disclosure;

[0023] FIG. 4A is an illustration of an access apparatus core, according to one embodiment of the present disclosure;

[0024] FIG. 4B is an illustration of an access apparatus core, according to one embodiment of the present disclosure;

[0025] FIG. 5 A is an illustration of an access apparatus, according to one embodiment of the present disclosure;

[0026] FIG. 5B is an illustration of an access apparatus, according to one embodiment of the present disclosure;

[0027] FIG. 6 is an illustration of an access apparatus, according to one embodiment of the present disclosure;

[0028] FIG. 7 is an illustration of an access apparatus needle, according to one embodiment of the present disclosure;

[0029] FIG. 8 is an illustration of pericardial access, according to one embodiment of the present disclosure; and

[0030] FIG. 9 is a method of accessing the pericardial space, according to one embodiment of the present disclosure.DETAILED DESCRIPTION

[0031] The terms “a” or “an”, as used herein, are defined as one or more than one. The term“plurality”, as used herein, is defined as two or more than two. The term “another”, as used herein, is defined as at least a second or more. The terms “including” and / or “having”, as used herein, are defined as comprising (i.e., open language). Reference throughout this document to "one embodiment", “certain embodiments”, "an embodiment", “an implementation”, “an example” or similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of such phrases or in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation.

[0032] In one embodiment, the present disclosure is directed to an apparatus for percutaneous access to the interior of the body, referred to herein as an access apparatus. The access apparatus can provide access to the interior of the body for direct visualization and a number of functions, including, but not limited to, administration of therapies, biopsy, insufflation, device implantation, etc. under direct visualization. In one embodiment, the access apparatus can provide illumination when inserted into the body in order to facilitate imaging of the interiorof the body during a procedure. In one embodiment, the access apparatus can be used to provide percutaneous access to the pericardial space for epicardial lead implantation. However, it can be appreciated that the devices and methods described herein are not limited to usage in the pericardial space but can be used for percutaneous access to any cavity or space in the body, and delivered therapy is not limited to cardiac pacing leads, but can refer to any therapy including but not limited to defibrillation, ablation, stem cell injection, infusions, drug injection, and biopsy.

[0033] FIG. 1 A is an illustration of an access apparatus 100 according to one embodiment. In one embodiment, the access apparatus 100 can include a sheath 110. The sheath 110 can include a proximal end base 111 that is flared, capped, or otherwise wider than a distal end of the sheath 110. The sheath 110 can include a lumen (or channel) 112 that is approximately cylindrical extending from the base 111. In one embodiment, the base 111 can include one or more protrusions, such as the two wings 113a, 113b extending from the base illustrated in FIG.1 A. The lumen 112 can be inserted into the body, while the base 111 can remain external to the body when the sheath 110 is inserted. In one embodiment, the lumen 112 of the sheath 110 can be a single channel. In one embodiment, the lumen 112 can be divided by internal walls into more than one channel.

[0034] In one embodiment, the access apparatus 100 can include a core 120 that can be concentrically inserted into the lumen of the sheath 110. The core 120 can be approximately cylindrical and can include a proximal end base 121. In one embodiment, the base 121 of the core can be removably coupled to the base 111 of the sheath. For example, the outer surface or walls of the base 121 of the core can form a circumferential press fit or snap fit with the inner surface or walls of the base 111 of the sheath. In one embodiment, a portion of the outer surface of the base 121 can form an edge or lip that fits into a corresponding edge or lip along the inner surface or walls of the base 111. In this manner, the core 120 can be secured when it is insertedinto the sheath 110. In one embodiment, the core 120 can be rotatable when it is inserted into the sheath 110. For example, the core 120 can be formed of a rigid material such that rotating the base 121 external to the body results in a rotation of the distal tip of the core 120 and any components embedded or inserted therein.

[0035] The core 120 can include one or more channels extending from the base 121 to the distal end or tip of the core 120. In one embodiment, the tip of the core 120 can be a flat face(e.g., a circular face). In one embodiment, the tip of the core 120 can be pointed or rounded. In one embodiment, the core can include at least one working channel 125 extending from the base 121 to the tip of the core 120. The working channel 125 can provide access for insertion of guidewires, devices, scopes, etc. For example, FIG. IB illustrates the access apparatus 100 wherein the core 120 is coupled to the sheath 110 and an access needle is advanced through the working channel 125. FIG. 1C illustrates the core 120 being removed from the sheath 110.When the core 120 is removed, larger devices can be inserted through the sheath 110.

[0036] FIG. ID illustrates an obturator 901 inserted into the lumen 112 for insertion of the sheath 110 into the body. The obturator 901 can include a wider base that can be removably coupled to the base 111 of the sheath to secure the obturator 901 in the sheath. The obturator can provide structural support so that the sheath does not buckle when it is inserted into the body. In one embodiment, the obturator can have a blunt tip. In one embodiment, the obturator can have a sharp tip, such as a pyramid cutting tip. In one embodiment, the sharp tip can be sharp or include a cutting edge. In one embodiment, the tip of the obturator can include a retractable tip. For example, the obturator can include a blunt tip and a retractable sharp tip(e.g. needle). The retractable needle can be advanced while the obturator is being inserted into the body and retracted once the obturator is inserted to avoid damaging internal organs. In one embodiment, the obturator can include a camera or endoscope to facilitate visualization of access inside the body. In one embodiment, the camera can be embedded in the obturator, e.g.,at the obturator tip. Once the sheath is inserted, the obturator can be removed and replaced with a core or other devices.

[0037] FIG. 2 illustrates the sheath 110 according to one embodiment wherein the lumen 112 of the sheath 110 can be expanded. In one embodiment, the wall of the sheath can be fully or partially split. For example, the wall can be split from the proximal end (the base 111) to a portion along the lumen or to the distal end. In one embodiment, the sheath 110 can be separated into two or more parts. The wall can be split along one or more parting lines running longitudinally along the sheath. In one embodiment, the wall can be split when force is applied to the base 111, e.g., to the wings 113a, 113b. For example, a torsion or twisting force can be applied to the wings to split the wall. In one embodiment, the wall can be weaker (e.g., thinner) along the parting line so that the parting line forms a natural breaking point when a force is applied to the sheath. The wall can be split to expand the lumen 112 so that larger devices can be advanced through the sheath. The wall can be split to provide wider access to the interior of the body through the distal end of the sheath. The expansion of the lumen 112 can also expand the insertion site of the sheath.

[0038] FIG. 3 A is an illustration of the core 120 according to one embodiment. The core 120 can include one or more of an illumination source 122, a imager 123, and an insufflation channel 124. The core 120 can include a working channel 125. The working channel 125 can be a continuous channel along the length of the core 120 that is used to introduce devices (e.g., diagnostic devices) and / or therapies into the body. For example, FIG. 3B illustrates an access needle advanced through the working channel. In one embodiment, the working channel 125 can be parallel to the longitudinal axis of the core 120. In one embodiment, the working channel125 can be angled relative to the longitudinal axis of the core 120. In one embodiment, the longitudinal axis of the working channel 125 can be perpendicular to the working plane of the imager 123. In one embodiment, the longitudinal axis of the working channel 125 can be non-orthogonal to the working plane of the imager 123. In one embodiment, the working channel125 can have a diameter that accommodates an 18-gauge (G) needle. Larger and smaller diameters are also compatible. In one embodiment, the working channel can include a gasket at the proximal or distal opening of the working channel in order to maintain insufflation pressure of the body cavity when insufflation is administered. In one embodiment, the core 120 can include a cap at the proximal end to cap the working channel 125. In one embodiment, the distal end or face of the core 120 can include a visual feature that can be imaged by the imager123. For example, the imager 123 can capture a portion of the distal end or face of the core120. A visual feature, such as a structure or a reflective component, can indicate the orientation of the core 120 in the field of view of the imager 123.

[0039] In one embodiment, the illumination source 122 can be an LED at the distal end. In one embodiment, the illumination source 122 can include optical fibers that run longitudinally through the core and are coupled to an illuminator outside of the body. The optical fibers can transmit light from the illuminator to the distal end of the core. In one embodiment, the illuminator can include a halogen light source or a light-emitting diode (LED). The illumination can be at any wavelength, including, but not limited to, white light and near-infrared light. In one embodiment, the light emitted from the illumination source 122 can be polarized light. For example, the light can be uniformly polarized to reduce glare when the light reflects off tissue in the body cavity. In one embodiment, the illumination from the optical fibers can be adjusted, e.g., with a light box that has an adjustable output. In one embodiment, the intensity of illumination can be adjusted individually for each fiber or for a subset of fibers. In one embodiment, a number of optical fibers can be configured to not emit light. In one embodiment, the illumination source 122 can be a bundle of optical fibers that are clustered in a location on the face of the distal end, as illustrated in FIG. 3 A. In one embodiment, the optical fibers can be distributed across the face of the distal end. For example, the optical fibers can be distributedin a ring around the edge of the face of the distal end. In one embodiment, a bundle of optical fibers can be oriented at approximately 0-4° relative to the longitudinal axis of the core to further reduce glare from the bundle. In one embodiment, the illumination source 122 can be embedded in the core. In one embodiment, the optical fibers can line the inner wall of the core.In one embodiment, the illumination source 122 can be removably provided in a working channel in the core that can be used for other devices when the illumination source 122 is removed.

[0040] The imager 123 can be an imaging scope. In one embodiment, the imager 123 can include a complementary metal-oxide semiconductor (CMOS) sensor, such as a micro-CMOS sensor that can acquire video and images in real time. In one embodiment, the imager can in(wired or wireless) communication with imaging control circuitry configured to process imaging data acquired by the imager. The image processing can include, but is not limited to, exposure correction, magnification, color adjustment, glare reduction, distortion correction, contrast enhancement, etc. The image processing can be performed in real time. In one embodiment, the sensor can acquire data about wavelengths outside of the visible / color spectrum, such as near-infrared wavelengths, which can be used to image through obstructions such as thin tissues and blood. In one embodiment, the sensor can be packaged with a glass lens and surrounded by cladding for moisture protection. The imager 123 can terminate in a coaxial cable at or beyond the base 121. In one embodiment, the imager 123 can be approximately 1.6 millimeters (mm) in diameter, approximately 1 meter long, and have an approximately 5 mm working distance and 3-50 mm depth of field. In one embodiment, the imager 123 can be positioned along an axis (e.g., a diameter of the distal end) that intersects with the working channel 125. In this manner, the imager 123 can provide a field of view that is directly adjacent to the working channel 125 in one direction and that can include a device advanced through the working channel. As described above, the core 120 can be rotated in thesheath 110 to change the field of view of the imager 123. In one embodiment, the imager 123 can be rotated in the core 120.

[0041] In one embodiment, the imager 123 can include a scope in the core that includes fibers or lenses to relay light from the inside of the body to a camera that is outside of the body. In one embodiment, the imager 123 can be embedded in a channel through the core. In one embodiment, the imager 123 can be removably provided in a working channel in the core that can be used for other devices when the imager 123 is removed.

[0042] In one embodiment, the insufflation channel 124 can be used to direct gas (e.g. carbon dioxide) into the interior space. In one embodiment, the base 121 of the core can include an inlet at the insufflation channel 124 that can be coupled to an insufflation port and insufflation tubing e.g. via a Luer lock. In one embodiment, the sheath can include an inlet that can couple an insufflation port or tubing to the insufflation channel via a Luer lock. A Luer lock can have a valve (e.g. a one-way stop cock valve) that can be used to seal the insufflation channel 124 when insufflation is not occurring. In one embodiment, the insufflation channel can be a working channel of the sheath. The core can be shaped so as to not obstruct or interfere with an insufflation channel in the sheath. For example, the core can include a longitudinal trench that can fit around a working channel in the sheath. A working channel in the sheath can be used for any type of delivery or access.

[0043] FIG. 3B is an illustration of a core 120 including two imagers 123a, 123b according to one embodiment. The two imagers can be used to acquire stereo (stereoscopic) images and provide depth and perceptive and quantitative three-dimensional imaging. In one embodiment, the illumination source 122 can be adjacent to one of the imagers 123a. In one embodiment, the core 120 can include more than one illumination source 122 positioned adjacent to or in proximity to the imagers. In one embodiment, a device that is advanced through the workingchannel 125, such as an access needle, can also include an imager such as a camera, as will be discussed in further detail herein.

[0044] FIG. 3C is an illustration of a core 120 including a first working channel 125a and a second working channel 125b. The two working channels can be the same size or different sizes. Different tools or devices can be advanced through the working channels. For example,FIG. 3C illustrates a grasping tool advanced through the first working channel 125a and an18G access needle advanced through the second working channel 125b. A grasping tool can be used to manipulate (e.g., pull, displace, obtain a sample of) tissue. In one embodiment, a hook can be advanced through a working channel to manipulate tissue. In one embodiment, the proximal ends of the working channels can be spaced apart so that one or more users can manipulate the devices in the working channels without interference at the proximal end. In one embodiment, the working channels can be parallel to each other. In one embodiment, the proximal ends of the working channels can be angled relative to each other, e.g., angled away from each other at the proximal end. The working channels can each be parallel to or not parallel to the longitudinal axis of the core.

[0045] FIG. 3D is an illustration of a core 120 including an imager 123 and a first illumination source 122a, a second illumination source 122b, and a third illumination source 122c. In one embodiment, an illumination source 122a can include a ring of optical fibers surrounding the imager 123, as illustrated in the face of the core 120 in FIG. 3E. In one embodiment, illumination sources 122b, 122c can include optical fibers arranged to fill a shape, such as the crescent shape illustrated in FIG. 3E. In one embodiment, each illumination source can be independently controlled to output light of a certain wavelength, including visible (or colored) light, near-infrared light, etc. In one example, each illumination source can output light of different wavelengths. In one example, one or more illumination sources can output light of the same wavelength. In one embodiment, the imager can be a color camera, such as anOCHFA10 camera. In one embodiment, the imager can be configured to image an object based on a type of illumination provided by an illumination source. It can be appreciated that the number of illumination sources illustrated in FIG. 3E are provided as a non-limiting example, and that more or fewer illumination sources can also be implemented with the apparatuses described herein. In one embodiment, the core 120 can be approximately 8.5 centimeters (cm) in length.

[0046] In one embodiment, the core 120 illustrated in FIG. 3D can include a first insufflation channel 124a, a second insufflation channel 124b, and a working channel 125. The first and / or second insufflation channels 124a, 124b can be working channels for insertion of devices. In one embodiment, the working channel 125 can be larger than the insufflation channels 124a,124b. In one embodiment, one or more of the channels (e.g. the insufflation channels 124a,124b) can terminate at a proximal end in through-hole tubes, which can be used for insufflation or smaller devices.

[0047] FIG. 4A is an illustration of an access needle 300 advanced through a working channel of the core, according to one embodiment. In one embodiment, the access needle 300 can include at least one imager 310 and at least one illumination source 320. The first imager 123 at the distal end of the core and the second imager 310 at the distal end of the access needle can provide two different views of the interior of the body. The first imager 123 can provide a view of the access needle, which can be useful for maneuvering and advancing the needle into the body. The second imager 310 can provide a view at the distal end of the access needle, e.g. , where the access needle is in contact with an organ. In one embodiment, the access needle 300 can form a lumen such that a device or tool can be advanced through the access needle and / or the access needle can be advanced over a guide wire.

[0048] The imager 310 can be an imaging scope. In one embodiment, the imager 310 can include a complementary metal-oxide semiconductor (CMOS) sensor, such as a micro-CMOSsensor that can acquire video and images in real time. In one embodiment, the imager can in(wired or wireless) communication with imaging control circuitry configured to process imaging data acquired by the imager. The image processing can include, but is not limited to, exposure correction, magnification, color adjustment, glare reduction, distortion correction, contrast enhancement, etc. The image processing can be performed in real time. In one embodiment, the sensor can acquire data about wavelengths outside of the visible / color spectrum, such as near-infrared wavelengths, which can be used to image through obstructions such as thin tissues and blood. In one embodiment, the sensor can be packaged with a glass lens and surrounded by cladding for moisture protection. The imager 310 can terminate in a coaxial cable at or beyond the base 121.

[0049] In one embodiment, the imager 310 can include a scope in the access needle 300 that includes fibers or lenses to relay light from the inside of the body to a camera that is outside of the body. In one embodiment, the imager 310 can be embedded in a channel through the access needle. In one embodiment, the imager 310 can be removably provided in a working channel in the access needle that can be used for other devices when the imager 310 is removed. In one embodiment, the imager 310 can be rotatable in the access needle.

[0050] In one embodiment, the illumination source 320 in the access needle 300 can be anLED at the distal end. In one embodiment, the illumination source 320 can include optical fibers that run longitudinally through the access needle and are coupled to an illuminator outside of the body. The optical fibers can transmit light from the illuminator to the distal end of the core. In one embodiment, the illuminator can include a halogen light source or a light- emitting diode (LED). The illumination can be at any wavelength, including, but not limited to, white light and near-infrared light. In one embodiment, the light emitted from the illumination source 320 can be polarized light. For example, the light can be uniformly polarized to reduce glare when the light reflects off tissue in the body cavity. In oneembodiment, the illumination from the optical fibers can be adjusted, e.g., with a light box that has an adjustable output. In one embodiment, the intensity of illumination can be adjusted individually for each fiber or for a subset of fibers. In one embodiment, a number of optical fibers can be configured to not emit light. In one embodiment, the illumination source 320 can be a bundle of optical fibers that are clustered in a location on the face of the distal end. In one embodiment, the optical fibers can be distributed across the face of the distal end. For example, the optical fibers can be distributed in a ring around the edge of the face of the distal end. The arrangement of the optical fibers in a ring can be advantageous in providing uniform illumination while reducing the footprint of the illumination source in the limited surface area at the distal tip of the access needle. In one embodiment, a bundle of optical fibers can be oriented at approximately 0-4° relative to the longitudinal axis of the core to further reduce glare from the bundle. In one embodiment, the illumination source 320 can be embedded in the access needle. In one embodiment, the optical fibers can line the inner wall of the access needle.In one embodiment, the illumination source 320 can be removably provided in a working channel in the access needle that can be used for other devices when the illumination source320 is removed. The illumination source 320 can result in improved image quality from the imager 310, which may be reduced in size or complexity in order to fit at the distal tip of the access needle.

[0051] FIG. 4B is an illustration of an access needle 300 advanced through the working channel of the core 200. In one embodiment, the access needle 300 can be an 18G needle. In one embodiment, the access needle 300 (and / or any device that is advanced through the working channel) is rotatable in the working channel. The field of view of the imager 310 can change as the access needle is rotated. In one embodiment, the imager 310 can be positioned to be opposite to the bevel of the access needle to capture the bevel in its intra-luminal field of view. The image axis of the imager can be normal to the surgical field. In one embodiment, theposition and orientation of the imager can be fixed with a hemostasis valve having a Y- connector that is attached to the hub of the needle. In one embodiment, an angle between the bevel of the needle and the imager can be adjusted by rotating the valve. In one embodiment, the access needle 300 can be a straight needle. In one embodiment, the access needle 300 can have an angled or bent tip, e.g., bent at an angle of up to, at, or more than 45°. In one embodiment, the access needle 300 can be a nitinol needle with a bend in the distal tip. The bend can be set with heat, and the needle tip can be straightened for insertion through the access apparatus. The nitinol material then returns to a bent shape when the needle emerges from the distal end of the core. In one embodiment, the access needle can be longer than the core. In one embodiment, the working channel(s) of the access needle can be used for insertion of air, fluid, drugs, stem cells, guidewires, devices, etc.

[0052] FIG. 5A is an illustration of an access apparatus according to one embodiment. A dilator 500 can be advanced through the sheath. In one embodiment, the dilator 500 can include an imager 510, an illumination source 520, and a working channel 530. In one embodiment, the imager 510 and the illumination source 520 can be offset from the working channel 530.For example, FIG. 5 A illustrates a working channel extending to the distal tip of the dilator, wherein the distal opening of the dilator forms the opening of the working channel 530. FIG.5B illustrates a guidewire advanced through the working channel 530 of the dilator. The imager510 and the illumination source 520 can be located in a second channel (imaging channel, illumination channel) 540. In one embodiment, the imaging channel can terminate before the working channel 530 terminates. In one embodiment, the dilator can have a conical distal tip and the imaging channel 540 can terminate along the sidewall of the conical distal tip. In one embodiment, the conical distal tip can include a cutout or divot between the imager 510 and the distal opening of the dilator so that the imager 510 has a field of view that includes the distal opening.

[0053] The imager 510 can be an imaging scope. In one embodiment, the imager 510 can include a complementary metal-oxide semiconductor (CMOS) sensor, such as a micro-CMOS sensor that can acquire video and images in real time. In one embodiment, the imager can in(wired or wireless) communication with imaging control circuitry configured to process imaging data acquired by the imager. The image processing can include, but is not limited to, exposure correction, magnification, color adjustment, glare reduction, distortion correction, contrast enhancement, etc. The image processing can be performed in real time. In one embodiment, the sensor can acquire data about wavelengths outside of the visible / color spectrum, such as near-infrared wavelengths, which can be used to image through obstructions such as thin tissues and blood. In one embodiment, the sensor can be packaged with a glass lens and surrounded by cladding for moisture protection. The imager 510 can terminate in a coaxial cable at or beyond the base 121.

[0054] In one embodiment, the imager 510 can include a scope in the dilator 500 that includes fibers or lenses to relay light from the inside of the body to a camera that is outside of the body.In one embodiment, the imager 510 can be embedded in a channel through the dilator. In one embodiment, the imager 510 can be removably provided in a working channel in the dilator that can be used for other devices when the imager 510 is removed. In one embodiment, the imager 510 can be rotatable within the dilator.

[0055] In one embodiment, the illumination source 520 in the dilator 500 can be an LED at the distal end. In one embodiment, the illumination source 520 can include optical fibers that run longitudinally through the dilator and are coupled to an illuminator outside of the body.The optical fibers can transmit light from the illuminator to the distal end of the dilator. In one embodiment, the illuminator can include a halogen light source or a light-emitting diode (LED).The illumination can be at any wavelength, including, but not limited to, white light and near- infrared light. In one embodiment, the light emitted from the illumination source 520 can bepolarized light. For example, the light can be uniformly polarized to reduce glare when the light reflects off tissue in the body cavity. In one embodiment, the illumination from the optical fibers can be adjusted, e.g., with a light box that has an adjustable output. In one embodiment, the intensity of illumination can be adjusted individually for each fiber or for a subset of fibers.In one embodiment, a number of optical fibers can be configured to not emit light. In one embodiment, the illumination source 520 can be a bundle of optical fibers that are clustered in a location on the face of the distal end. In one embodiment, the optical fibers can be distributed across the face of the distal end. For example, the optical fibers can be distributed in a ring around the edge of the face of the distal end. The arrangement of the optic al fibers in a ring can be advantageous in providing uniform illumination while reducing the footprint of the illumination source in the limited surface area at the second channel of the dilator. In one embodiment, a bundle of optical fibers can be oriented at approximately 0-4° relative to the longitudinal axis of the dilator to further reduce glare from the bundle. In one embodiment, the illumination source 520 can be embedded in the dilator. In one embodiment, the illumination source 520 can be removably provided in the second channel 540. The illumination source 520 can result in improved image quality from the imager 510, which may be reduced in size or complexity in order to fit in the dilator.

[0056] FIG. 6 is an illustration of an access apparatus according to one embodiment. In one embodiment, the access apparatus can include a sheath 610 having an illumination source 611 at a distal end of the sheath 610. In one embodiment, the sheath 610 can include an imager at the distal end. The imager can have any of the imaging components described herein. The sheath 610 can form one or more working channels. The one or more working channels can be used for delivery of treatment, access, imaging, etc. In one embodiment, the working channel of the sheath 610 can be used as an insufflation channel. The proximal end of the sheath 610can be connected to an insufflation port and tubing, e.g., via a Luer lock. In one embodiment, the sheath 610 can include an imager at the distal end.

[0057] In one embodiment, the illumination source 611 in the sheath can be an LED at the distal end. In one embodiment, the illumination source 611 can include optical fibers that run longitudinally through the sheath and are coupled to a medical illuminator outside of the body.The optical fibers can transmit light from the illuminator to the distal end of the core. In one embodiment, the illuminator can include a halogen light source or a light-emitting diode (LED).The illumination can be at any wavelength, including, but not limited to, white light and nearinfrared light. In one embodiment, the light emitted from the illumination source 611 can be polarized light. For example, the light can be uniformly polarized to reduce glare when the light reflects off tissue in the body cavity. In one embodiment, the illumination from the optical fibers can be adjusted, e.g., with a light box that has an adjustable output. In one embodiment, the intensity of illumination can be adjusted individually for each fiber or for a subset of fibers.In one embodiment, a number of optical fibers can be configured to not emit light. In one embodiment, the illumination source 611 can be a bundle of optical fibers that are clustered in a location on the face of the distal end. In one embodiment, the optical fibers can be distributed across the face of the distal end. For example, the optical fibers can be distributed in a ring around the edge of the face of the distal end. The arrangement of the optical fibers in a ring can be advantageous in providing uniform illumination while reducing the footprint of the illumination source in the limited surface area at the distal end of the sheath 610. In one embodiment, a bundle of optical fibers can be oriented at approximately 0-4° relative to the longitudinal axis of the sheath to further reduce glare from the bundle. In one embodiment, the illumination source 611 can be embedded in the sheath. In one embodiment, the optical fibers can line the inner wall of the sheath. In one embodiment, the illumination source 611 can be removably provided in a working channel in the sheath that can be used for other devices whenthe illumination source 611 is removed. The illumination source 611 can result in improved image quality from imagers that are inserted through a working channel of the sheath.

[0058] FIG. 7 is an illustration of an access needle 620 according to one embodiment. In one embodiment, the access needle 620 can be advanced through a working channel of the sheath610. In one embodiment, the access needle can include an imager 621 at a distal tip of the access needle. The imager 621 can be an imaging scope. In one embodiment, the imager 621 can include a complementary metal-oxide semiconductor (CMOS) sensor, such as a micro¬CMOS sensor that can acquire video and images in real time. In one embodiment, the imager can in (wired or wireless) communication with imaging control circuitry configured to process imaging data acquired by the imager. The image processing can include, but is not limited to, exposure correction, magnification, color adjustment, glare reduction, distortion correction, contrast enhancement, etc. The image processing can be performed in real time. In one embodiment, the sensor can acquire data about wavelengths outside of the visible / color spectrum, such as near-infrared wavelengths, which can be used to image through obstructions such as thin tissues and blood. In one embodiment, the sensor can be packaged with a glass lens and surrounded by cladding for moisture protection.

[0059] In one embodiment, the imager 621 can include a scope in the access needle 620 that includes fibers or lenses to relay light from the inside of the body to a camera that is outside of the body. In one embodiment, the imager 621 can be embedded in a channel through the access needle. In one embodiment, the imager 621 can be removably provided in a working channel in the access needle that can be used for other devices when the imager 621 is removed.

[0060] In one embodiment, the access needle 620 can be an 18G needle. In one embodiment, the access needle 620 can be a 14G needle with a sharpened 30° lancet tip. In one embodiment, the access needle 620 (and / or any device that is advanced through the working channel) is rotatable in the working channel. The field of view of the imager 621 can change as the accessneedle is rotated. In one embodiment, the imager 621 can be positioned to be opposite to the bevel of the access needle to capture the bevel in its intra-luminal field of view. The image axis of the imager can be normal to the surgical field. In one embodiment, the position and orientation of the imager can be fixed with a hemostasis valve having a Y-connector that is attached to the hub of the needle. In one embodiment, an angle between the bevel of the needle and the imager can be adjusted by rotating the valve. In one embodiment, the access needle620 can be a straight needle. In one embodiment, the access needle 620 can have an angled or bent tip, e.g., bent at an angle of up to, at, or more than 45°. In one embodiment, the access needle 620 can be a nitinol needle with a bend in the distal tip. The bend can be set with heat, and the needle tip can be straightened for insertion through the access apparatus. The nitinol material then returns to a bent shape when the needle emerges from the distal end of the core.In one embodiment, the access needle can be longer than the core. In one embodiment, the working channel(s) of the access needle can be used for insertion of air, fluid, drugs, stem cells, guidewires, devices, etc.

[0061] In one embodiment, an access tool can be inserted into the sheath with an imager scope.For example, a dilator can include a lengthwise groove or trench to accommodate an imager scope that can be inserted in parallel with the dilator. In one embodiment, a pacing lead and an imager scope can be inserted through the sheath simultaneously to provide direct visualization of lead attachment. The pacing lead and the imager scope can be inserted via a splitter to split the lumen.

[0062] FIG. 8 is an illustration of a surgical workflow for accessing the pericardial space using an access apparatus according to one embodiment. The access apparatus can be used to obtain access to the pericardial space under direct visualization of cameras in the sheath, core, and / or devices (e.g. access needle). In one embodiment, an incision in the subxiphoid region can be made with a scalpel. The incision can be small, e.g. a nick made with a scalpel. In oneembodiment, a sheath can be inserted through the incision with a needle advanced through the working channel of the sheath. As an example, the needle can be a Veress needle as illustrated in step (b) of FIG. 8. In one embodiment, insufflation can be administered through the sheath once it is inserted into the body. In step (c), the Veress needle can be removed from the sheath and replaced with an access needle having an imager. In step (d), the pericardial space can then be accessed under direct visualization via the imager. The sheath can provide illumination to the space to aid in visualization. In one embodiment, after pericardial access is achieved, a guidewire can be advanced through the access needle and into the pericardial space. After the guidewire is inserted, the access needle can be removed and additional devices such as an introducer or a catheter can be advanced over the guidewire through the working channel of the sheath.

[0063] FIG. 9 is a method 900 of a surgical workflow for accessing the pericardial space using an access apparatus according to one embodiment. In one embodiment, the access apparatus used in the method of FIG. 9 can be the access apparatus 100. In step 910, an incision can be made in the subxiphoid region. The incision can be a small nick made with a scalpel to reduce external trauma or damage to the body. The components of the access apparatus enable access to the pericardial space through the small incision. In step 920, an obturator can be inserted into the sheath and the combined assembly of the obturator and the sheath can be inserted through the incision into the thoracic cavity. Once the assembly of the obturator and the sheath is inserted, the obturator can be removed and the sheath can remain in the thoracic cavity. In step 930, the obturator can be replaced with the core. The core can be used to visualize the thoracic space via the imager and illumination source. In one embodiment, insufflation can be provided through the insufflation channel of the core. When the core is positioned with the desired organ (e.g. the heart) in view, an access needle can be advanced through a working channel of the core in step 940. The access needle can include an imager and / or illuminationsource to provide additional imaging of the space. In one embodiment, imaging data from the imager of the core and imaging data from the imager of the access needle can be displayed to provide two different views of the space and devices inserted therein. As an example, the imaging data from the core can be overlaid with imaging data from the access needle as a picture-in-picture format. In one embodiment, the images from the access needle and the core can be corrected for distortion. In one embodiment, automatic gain adjustment can be applied to the imagers to maintain constant image brightness independent of lighting conditions.

[0064] In one embodiment, the access needle can be guided to the pericardial sac under direct visualization and can be used to pierce the pericardial sac. In step 950, a guidewire can be advanced through the access needle. In one embodiment, the imager of the access needle can be removed, and the guidewire can be advanced through the working channel that previously held the imager to the pericardial space. In one embodiment, the guidewire can be advanced through a separate working channel of the access needle. Advantageously, the imager of the core can remain in the cavity to provide visualization of the position of the access needle and any devices inserted through the access needle. In step 960, when the guidewire is inserted, the access needle can be removed from the working channel of the core, leaving the guidewire in place. In one embodiment, the core can then be removed from the sheath after the access needle is removed. The guidewire remains in the lumen of the sheath.

[0065] In step 970, a dilator can be inserted into the sheath and pericardial space with the guidewire in the lumen of the dilator. In one embodiment, the dilator can include an imager and illumination source as described herein. The dilator can be used to guide the sheath to the pericardial space by following the guidewire. The position of the sheath can be confirmed by visualization via the dilator imager. In step 980, the dilator and guidewire can be removed such that the entire lumen of the sheath is then made available for insertion of devices directly into the pericardial space. For example, an ablation catheter, a defibrillation lead, a miniaturepacemaker, drugs, stem cells, therapies, etc. can be inserted directly into the pericardial space through the sheath. In one embodiment, the walls of the sheath can be split as described herein to allow insertion of larger devices directly into the pericardial space.

[0066] The access apparatus described herein can enable access to the pericardial space and other cavities under direct visualization and illumination. In one in vivo example, the access apparatus was used to access the thoracic cavity and visualize the heart in 66.83 ± 32.86 seconds and access the pericardial space under direct visualization in an additional 136.67 ±80.63 seconds without ventricular perforation. In one example, a median elapsed time from skin nick to sheath access of the pericardium was 9.5 min with an interquartile range (IQR) of8-11 minutes. The median total procedure time for percutaneous implantation of an epicardial pacemaker lead was 16 minutes (IQR 14-19 minutes). The access time was shortened compared to conventional access techniques and devices. The access could be performed with a shortened incision length of approximately 4 mm, which is desirable as the incision can be easily closed without the need for sutures. The percutaneous access can be obtained from multiple trajectories rather than requiring a fixed angle of approach.

[0067] Obviously, numerous modifications and variations are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the disclosure may be practiced otherwise than as specifically described herein.

[0068] Embodiments of the present disclosure may also be as set forth in the following parentheticals.

[0069] (1) An apparatus for percutaneous access to a body, comprising: a sheath including a proximal base and a lumen; a core configured to be concentrically inserted in the lumen of the sheath and including a first imaging sensor and a first illumination source at a distal end of the core, the core further including an insufflation channel and a working channel terminating at the distal end of the core; and an access tool configured to be concentrically inserted into theworking channel of the core, the access tool including a second imaging sensor and a second illumination source at a distal end thereof, wherein the first illumination source includes one or more optical fibers extending from the proximal base of the core to the distal end of the core, and the second illumination source includes optical fibers providing illumination at the distal end of the access tool.

[0070] (2) The apparatus of (1), further comprising a third imaging sensor at the distal end of the core.

[0071] (3) The apparatus of (1) to (2), wherein a wall of the sheath is configured to be longitudinally splitable.

[0072] (4) The apparatus of (1) to (3), wherein the first imaging sensor is removably disposed in an imaging channel of the core.

[0073] (5) The apparatus of (1) to (4), wherein the first illumination source is removably disposed in an illumination channel of the core.

[0074] (6) The apparatus of (1) to (5), wherein the access tool further comprises a second working channel.

[0075] (7) The apparatus of (1) to (6), wherein the access tool further comprises a second working channel and a third working channel where the second working channel is offset from the third working channel.

[0076] (8) The apparatus of (1) to (7), wherein the second imaging sensor is removably disposed in a second working channel of the access tool.

[0077] (9) The apparatus of (1) to (8), wherein a proximal base of the core is configured to be removably coupled to the proximal base of the sheath.

[0078] (10) The apparatus of ( 1 ) to (9), wherein the second illumination source includes optical fibers providing illumination as a ring at the distal end of the access tool.

[0079] (11) The apparatus of (1) to (10), wherein the access tool is an access needle.

[0080] (12) An apparatus for percutaneous access to a body, comprising: a sheath including a proximal base and a lumen; a core configured to be concentrically inserted in the lumen of the sheath and including a first imaging sensor and a first illumination source at a distal end of the core, the core further including a working channel terminating at the distal end of the core; and an access tool configured to be concentrically inserted into the working channel of the core, the access tool including a second imaging sensor and a second illumination source at a distal end of the access tool, wherein the first illumination source and the second illumination source include one or more optical fibers.

[0081] (13) The apparatus of (12), further comprising a third imaging sensor at the distal end of the core.

[0082] (14) The apparatus of (12) to (13), wherein a wall of the sheath is configured to be longitudinally splitable.

[0083] (15) The apparatus of (12) to (14), wherein the first imaging sensor is removably disposed in an imaging channel of the core.

[0084] (16) The apparatus of (12) to (15), wherein the first illumination source is removably disposed in an illumination channel of the core.

[0085] (17) The apparatus of (12) to (16), wherein the access tool further comprises a second working channel.

[0086] (18) The apparatus of (12) to (17), wherein the second imaging sensor is removably disposed in a second working channel of the access tool.

[0087] (19) The apparatus of (12) to (18), wherein a proximal base of the core is configured to be removably coupled to the proximal base of the sheath.

[0088] (20) An apparatus for percutaneous access to a body, comprising: a sheath including a proximal base and a lumen; a core configured to be concentrically inserted in the lumen of the sheath and including a first imaging sensor and a first illumination source at a distal end of thecore and a working channel terminating at the distal end of the core; and an access tool configured to be concentrically inserted into the working channel of the core and including a second imaging sensor and a second illumination source at a distal end of the access tool.

[0089] (21) The apparatus of (20), further comprising a third imaging sensor at the distal end of the core.

[0090] (22) The apparatus of (20) to (21), wherein the second illumination source is disposed in a ring at the distal end of the access tool.

[0091] (23) The apparatus of (20) to (22), wherein the access tool further comprises a second working channel.

[0092] (24) An apparatus for percutaneous access to a body, comprising: a sheath including a base, a lumen, and an illumination source at a distal opening of the lumen; and an access tool configured to be concentrically inserted in the lumen of the sheath and including an imaging sensor at a distal end of the access tool and at least one working channel.

[0093] (25) The apparatus of (24), wherein the illumination source includes optical fibers arranged in a ring at the distal opening of the lumen.

[0094] (26) The apparatus of (24) to (25), wherein the imaging sensor is removably disposed in the working channel of the access tool.

[0095] (27) The apparatus of (24) to (26), wherein the access tool is an access needle.

[0096] (28) The apparatus of (24) to (27), wherein the sheath further comprises a second imaging sensor at the distal opening of the lumen.

[0097] (29) The apparatus of (24) to (28), wherein the access tool further comprises a second illumination source at the distal end of the access tool.

[0098] (30) The apparatus of (24) to (29), wherein the second illumination source includes one or more optical fibers.

[0099] (31) The apparatus of (24) to (30), wherein the sheath further comprises an insufflation port at the base of the sheath.

[0100] Thus, the foregoing discussion discloses and describes merely exemplary embodiments of the present invention. As will be understood by those skilled in the art, the present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. Accordingly, the disclosure of the present invention is intended to be illustrative, but not limiting of the scope of the invention, as well as other claims.The disclosure, including any readily discernible variants of the teachings herein, defines, in part, the scope of the foregoing claim terminology such that no inventive subject matter is dedicated to the public.

Claims

CLAIMS1. An apparatus for percutaneous access to a body, comprising: a sheath including a proximal base and a lumen; a core configured to be concentrically inserted in the lumen of the sheath and including a first imaging sensor and a first illumination source at a distal end of the core, the core further including an insufflation channel and a working channel terminating at the distal end of the core; and an access tool configured to be concentrically inserted into the working channel of the core, the access tool including a second imaging sensor and a second illumination source at a distal end thereof, wherein the first illumination source includes one or more optical fibers extending from the proximal base of the core to the distal end of the core, and the second illumination source includes optical fibers providing illumination at the distal end of the access tool.

2. The apparatus of claim 1 , further comprising a third imaging sensor at the distal end of the core.

3. The apparatus of claim 1, wherein a wall of the sheath is configured to be longitudinally splitable.

4. The apparatus of claim 1, wherein the first imaging sensor is removably disposed in an imaging channel of the core.

5. The apparatus of claim 1 , wherein the first illumination source is removably disposed in an illumination channel of the core.

6. The apparatus of claim 1, wherein the access tool further comprises a second working channel.

7. The apparatus of claim 1, wherein the access tool further comprises a second working channel and a third working channel where the second working channel is offset from the third working channel.

8. The apparatus of claim 1, wherein the second imaging sensor is removably disposed in a second working channel of the access tool.

9. The apparatus of claim 1, wherein a proximal base of the core is configured to be removably coupled to the proximal base of the sheath.

10. The apparatus of claim 1, wherein the second illumination source includes optical fibers providing illumination as a ring at the distal end of the access tool.

11. The apparatus of claim 1, wherein the access tool is an access needle.

12. An apparatus for percutaneous access to a body, comprising: a sheath including a proximal base and a lumen;a core configured to be concentrically inserted in the lumen of the sheath and including a first imaging sensor and a first illumination source at a distal end of the core, the core further including a working channel terminating at the distal end of the core; and an access tool configured to be concentrically inserted into the working channel of the core, the access tool including a second imaging sensor and a second illumination source at a distal end of the access tool, wherein the first illumination source and the second illumination source include one or more optical fibers.

13. The apparatus of claim 12, further comprising a third imaging sensor at the distal end of the core.

14. The apparatus of claim 12, wherein a wall of the sheath is configured to be longitudinally splitable.

15. The apparatus of claim 12, wherein the first imaging sensor is removably disposed in an imaging channel of the core.

16. The apparatus of claim 12, wherein the first illumination source is removably disposed in an illumination channel of the core.

17. The apparatus of claim 12, wherein the access tool further comprises a second working channel.

18. The apparatus of claim 12, wherein the second imaging sensor is removably disposed in a second working channel of the access tool.

19. The apparatus of claim 12, wherein a proximal base of the core is configured to be removably coupled to the proximal base of the sheath.

20. An apparatus for percutaneous access to a body, comprising: a sheath including a proximal base and a lumen; a core configured to be concentrically inserted in the lumen of the sheath and including a first imaging sensor and a first illumination source at a distal end of the core and a working channel terminating at the distal end of the core; and an access tool configured to be concentrically inserted into the working channel of the core and including a second imaging sensor and a second illumination source at a distal end of the access tool.

21. The apparatus of claim 20, further comprising a third imaging sensor at the distal end of the core.

22. The apparatus of claim 20, wherein the second illumination source is disposed in a ring at the distal end of the access tool.

23. The apparatus of claim 20, wherein the access tool further comprises a second working channel.

24. An apparatus for percutaneous access to a body, comprising:a sheath including a base, a lumen, and an illumination source at a distal opening of the lumen; and an access tool configured to be concentrically inserted in the lumen of the sheath and including an imaging sensor at a distal end of the access tool and at least one working channel.

25. The apparatus of claim 24, wherein the illumination source includes optical fibers arranged in a ring at the distal opening of the lumen.

26. The apparatus of claim 24, wherein the imaging sensor is removably disposed in the working channel of the access tool.

27. The apparatus of claim 24, wherein the access tool is an access needle.

28. The apparatus of claim 24, wherein the sheath further comprises a second imaging sensor at the distal opening of the lumen.

29. The apparatus of claim 24, wherein the access tool further comprises a second illumination source at the distal end of the access tool.

30. The apparatus of claim 29, wherein the second illumination source includes one or more optical fibers.

31. The apparatus of claim 24, wherein the sheath further comprises an insufflation port at the base of the sheath.

Images