Patent Application
20250160885
The present disclosure pertains to surgical ports enabling access to the pericardial space for endoscopy and delivery of cardiac therapies.
Cardiac therapies can be delivered to the heart via percutaneous or open surgical methods. There is a need for a minimally invasive approach to accessing the pericardial space and the heart while enabling direct visualization of delivery procedures.
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 nor impliedly admitted as prior art against the present disclosure.
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.
In one embodiment, the present disclosure is related to a surgical access port, comprising an outer sheath having a tapered distal end; an inner sleeve fitting inside the outer sheath; and a cannulated core fitting inside the inner sleeve; wherein a distal opening of the outer sheath is configured to expand when the inner sleeve is inserted into the outer sheath, and wherein the cannulated core forms a first working channel and a second working channel between a first end of the cannulated core and an opposing second end of the cannulated core.
In one embodiment, the present disclosure is related to surgical access port, comprising an outer sheath having a tapered distal end; an inner sleeve fitting inside the outer sheath; and a cannulated core fitting inside the inner sleeve; wherein a distal opening of the outer sheath is configured to expand when the inner sleeve is inserted into the outer sheath, wherein the cannulated core forms a first working channel and a second working channel between a first end of the cannulated core and an opposing second end of the cannulated core, and wherein the first working channel and the second working channel form an angle of separation.
In one embodiment, the present disclosure is related to a surgical access port, comprising an outer sheath having a tapered distal end; an inner sleeve fitting inside the outer sheath; and a cannulated core fitting inside the inner sleeve; wherein a distal opening of the outer sheath is configured to expand when the inner sleeve is inserted into the outer sheath, wherein the inner sleeve is removably coupled to the outer sheath, wherein the cannulated core forms a first working channel and a second working channel between a first end of the cannulated core and an opposing second end of the cannulated core, wherein the first working channel and the second working channel form an angle of separation, and wherein an outer wall of the cannulated core forms a notch at a proximal end of the cannulated core oriented towards a proximal opening of the second working channel.
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:
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.
There are many conditions that necessitate the placement of a cardiovascular implantable electronic device (CIED) in the heart. CIEDs can include, for example, pacemakers and implantable cardioverter defibrillators, each of which include conductive leads that are placed on an exterior (epicardial) or interior (endocardial) surface of the heart to carry electric signals to the organ. CIEDs can be used to restore and/or maintain normal heart rate and rhythm or for cardiac resynchronization therapy (CRT) in patients with heart failure. Cardiac leads can be placed on or inside the heart via open chest surgery, wherein the leads are inserted into the body through a sternal or thoracic incision and sewn or screwed onto the surface of the heart. Open procedures are associated with risks such as tissue damage, infection, intrathoracic adhesions, painful recovery, and other post-operative complications. In addition, open surgery can be especially traumatic for pediatric patients or others with existing health complications.
Percutaneous implantation of CIEDs is an alternative to open chest surgery that typically involves accessing the heart via the subclavian vein in order to attach leads to endocardial tissue without a thoracotomy or similar incision. However, venous access to the heart is not possible for neonates, infants, children, and some adults with congenital heart disease due to small vasculature, potential venous obstructions, and/or other anomalies. There is therefore a need to develop a minimally invasive approach for accessing the thoracic cavity and pericardial space in order to deliver cardiac therapies for patients with varying anatomies and cardiac conditions. In addition, an approach that incorporates direct visualization of the heart via endoscopy can improve the ease and effectiveness of the procedure while eliminating the need for fluoroscopy, which can have damaging radiation effects on the body.
In one embodiment, the present disclosure is directed towards a surgical access port providing access to structures inside the body. The surgical access port can also be referred to herein as a thoracic port and can provide access to the thoracic cavity and structures therein, including the pericardial space, the heart, and the great vessels. Alternative and additional areas of use for the surgical access port can be compatible with the present disclosure. In some embodiments, the surgical access port can be inserted into the thoracic cavity via a small incision in the inferior part of the sternum. In some embodiments, the thoracic port can be approximately 1 cm in diameter; thus, the incision can be smaller than the typical incision made for open chest surgery or larger ports. Advantageously, the surgical access port can be secured in the incision for endoscopic visualization of the thoracic cavity and delivery of cardiac therapies while minimizing exposure of internal organs to the open air. In one embodiment, the thoracic port can be configured for simultaneous insertion of one or more surgical instruments, including, but not limited to, a trocar, an imaging device (e.g., an endoscope), a guide wire, a needle, and other tools known to be used for delivering cardiac therapies while minimizing risk of clashing or crowding between the insertable tools. Advantageously, the surgical access port of the present disclosure can be a low-profile tool that can be easily operated by fewer medical professionals than are typically needed for cardiac procedures.
In one embodiment, the distal end of the outer sheath 100 can be configured to secure the outer sheath 100 in the incision when the outer sheath 100 is inserted into the body, as will be described in further detail herein. In one embodiment, the outer sheath 100 can include locking structures 120, e.g., cavities, at the proximal end of the outer sheath. The locking structures 120 can couple with corresponding structures 210 at the proximal end of the inner sleeve 200 to temporarily affix the inner sleeve 200 inside the outer sheath 100. The cannulated core 300 can include a cannulated plug 350, wherein the plug 350 can be attached to the body of the core 300 via a tether 305. The cannulated core 300 can be inserted into the inner sleeve 200 and can be secured in the inner sleeve 200 by a combination of physical and material features.
In one embodiment, the distal end of each vertical slat 115 can include a projection forming a flange 110, the flange 110 projecting outwards (away) from the central axis of the outer sheath and forming a widened rim at the distal end. The flange 110 can anchor the outer sheath 100 in the incision when the outer sheath is inserted into the body and expanded. For example, when the vertical slats 115 are expanded, the flanges can be in contact with the inner wall of the thoracic cavity where the outer sheath is inserted. The expansion of the flanges will be described in further detail herein. In one embodiment, the flanges 110 can have flat or rounded edges so as to reduce irritation to the body. In one embodiment, the flanges 110 can be coated with a biocompatible silicon or similar semi-soft material to reduce irritation to the body.
In one embodiment, the thoracic port can be a low-profile port. The port can provide access to the thoracic space without extending deep into the body. In one embodiment, the body of the outer sheath 100 can be shorter than typical trocars used to access the thoracic space. The distal flanges of the outer sheath 100 can anchor the thoracic port inside the body even with the shorter length of the thoracic port. The length of the thoracic port is advantageous in that the shallow but secure insertion of the port reduces the risk of the port crossing the diaphragm or causing injury to the heart or lungs upon insertion. In one embodiment, the outer sheath 100 can be a medical-grade, biocompatible material. As an example, the outer sheath can be a styrene material, such as medical-grade acrylonitrile butadiene styrene (ABS) or commercial analog or equivalent. In one example, the outer sheath can be a plastic such as medical polyurethane or multi-purpose polyurethane (MPU), or any known analog or equivalent such as MPU100, a commercial product. In some embodiments, the outer sheath can be sterilizable and durable with a high tensile strength (e.g., approximately equal to or greater than 38 MPa (megapascal). In some embodiments, the outer sheath can be 3D printed or injection molded with engineering-grade mechanical properties.
In one embodiment, the inner sleeve 200 can be a biocompatible polymer material, such as polyurethane. In one embodiment, the inner sleeve can be a rigid polyurethane (RPU) such as RPU70 or a similar or equivalent analog. In one embodiment, the tensile strength of the inner sleeve can be approximately equal to or greater than that of the outer sheath (e.g., 40 MPa). The outer sheath and the inner sleeve can be comparatively stiffer and/or stronger than the cannulated core of the thoracic port. In some embodiments, the inner sleeve can be sterilizable. In some embodiments, the inner sleeve can be 3D printed or injection molded with engineering-grade mechanical properties.
In one embodiment, the core 300 can be used as a reference to indicate an appropriate length for a cardiac procedure requiring access to the thoracic cavity. In some procedures, an incision into the thoracic cavity can typically be made a set distance from a known anatomical structure to enable access to the pericardial space. For example, an incision can be made approximately 13 mm below the xiphoid process, which can be felt at the base of the sternum. The tether 305 can include one or more reference markings, projections, or similar features along the length of the tether as a reference point for a known length. For example, the tether 305 can include a demarcation or reference feature 306 along the length of the tether 305. The demarcation can be a visual marking or a structural feature along the length of the tether. The distance between the end of the tether 305, where the cannulated plug 350 is provided, and the reference feature 306 can be a known length such as 13 mm that is used to determine where to make an incision for implantation. In some embodiments, the reference features can indicate more than one length. For example, the distance between the reference feature and the body of the cannulated core or the distance between a first reference feature and a second reference feature can be a second known length that is typically used in an implantation procedure, such as a typical incision length. During a procedure, a user can use the tether 305 to determine an incision point that is 13 mm away from the xiphoid process, thus eliminating the need for guesswork or additional measurement tools.
In one embodiment, the cannulated core 300 can be an elastic core. For example, the cannulated core 300 can be a flexible polymer material, such as ethylene vinyl acetate copolymer or a polyurethane elastomer such as EPU40. In one embodiment, the cannulated plug 350 can be a rigid polyurethane (e.g., RPU70) or a similar analog. In some embodiments, the cannulated core can be sterilizable. In some embodiments, the cannulated core can be 3D printed or injection molded with engineering-grade mechanical properties. The cannulated core 300 can be removably inserted into the inner sleeve to provide working channels for access to the thoracic cavity and structures therein. In some embodiments, the cannulated core 300 can be removed from the inner sleeve to provide a wider access port to the thoracic cavity through the opening of the inner sleeve.
The visualization channel 310 can accommodate a trocar for thoracic insufflation and an endoscope for thoracic imaging. In some embodiments, the insufflation trocar can be concentric with the endoscope. For example, an insufflation trocar can be inserted into the visualization channel 310 to inflate the thoracic cavity with a gas (e.g., carbon dioxide) for pericardial access. An endoscope, e.g., a deflectable endoscope, can be passed through the trocar and into the thoracic cavity. The endoscope can be adjusted to provide an operator with a live view of the heart and the thoracic cavity. The trocar and the endoscope can be secured in place at the insertion site by the thoracic port. In one example, the visualization channel can generate a drag force (e.g., 4N (Newtons)) on the inserted trocar such that the trocar does not become dislodged when the endoscope is inserted. The short profile of the thoracic port enables greater range of motion for the endoscope and any other instruments or devices inserted into the port. The second working channel 320 can be a working channel for insertion of a surgical instrument or device, including, but not limited to, a guide wire, a dilator, a sheath, a catheter, a cardiac lead, etc. The smaller diameter of the second working channel 320 can constrain lateral movement of an inserted instrument inside the channel so that an operator has more control over the instrument.
In one embodiment, the first working channel 310 and the second working channel 320 can be arranged within the cannulated core to reduce contact or interference within the thoracic cavity between a first instrument advanced past the distal end of the first working channel 310 and a second instrument advanced past the distal end of the second working channel 320. In one embodiment, the first working channel 310 and/or the second working channel 320 can be angled relative to the central axis of the cannulated core rather than parallel to the central axis. According to an exemplary implementation, the first working channel 310 can be angled relative to the second working channel 320 with an angle of separation of approximately 25°. The angle of separation between the first working channel and the second working channel can refer to an angle that would be formed by the channels if the channels were coplanar. Alternative angles of separation are compatible with the present disclosure. For example, the angle of separation can be greater than 25° or less than 25°. In one embodiment, the angle of separation can be an acute angle. In one example, the first working channel 310 and the second working channel 320 can be angled towards each other at the distal end of the core but can be offset (e.g., not coplanar) such that the inserted instruments do not cross.
The angled working channels can guide the advancement of the inserted instruments to prevent crossing, entanglement, intersection, or other interference at the distal end of the thoracic port. In some embodiments, the angled working channels can guide the inserted instruments to a region of the thoracic cavity (e.g., the heart) while maintaining the visualization of the inserted instruments. For example, a needle inserted into the second working channel 320 can be advanced towards the pericardial sac by following the angle of the second working channel. An endoscope inserted into the first working channel 310 can be advanced away from the needle, wherein the location of the endoscope in the thoracic cavity as a result of the angle of the first working channel 310 enables a field of view that includes the needle and the pericardial sac. The separation and angle of the working channels can optimize the surgical field such that all delivery tools remain visible in a captured endoscope image throughout the procedure.
In one embodiment, the outer wall of the cannulated core can form a notch 307 at a proximal end of the cannulated core oriented towards a proximal opening of the second working channel 320. The notch 307 can be a curved indentation as in
The cannulated plug 350 can be attached to the core 300 with the tether 305. The tether 305 can include one or more reference features 306 to indicate a known length of a portion of the tether. In one embodiment, the tether 305 can be secured in place at the inner and/or the outer sheath. As an example, the tether 305 can be fitted into the notch 199 of the outer sheath and the notch 299 of the inner sleeve, wherein the notch 299 of the inner sleeve sits inside or on top of the notch 199 of the outer sheath. In one embodiment, the tether 305 can remain in the notches when the cannulated plug 350 is inserted into one of the working channels in the core 300. The tether 305 can bend or fold at a point past the notch. The tether 305 thus does not interfere with access and operations through the thoracic port. In some implementations, the cannulated plug 350 can be inserted into a working channel that is not used for visualization, e.g., the second working channel 320 of
According to one use case, the plug 350 can be inserted into the second working channel 320 and a needle can be inserted through the working channel 351 and used to pierce the pericardial sac as a first step of cardiac therapy delivery. The needle can then be removed from the working channel 351 and the plug 350 can be removed from the second working channel 320. A larger instrument, such as a dilator, can then be inserted into the second working channel 320 to continue the procedure. In some embodiments, the cannulated plug 350 can prevent gas leakage from the thoracic cavity. For example, the thoracic cavity can be insufflated via a trocar inserted into the first working channel 310. If an instrument or device that is narrower than the second working channel 320 is inserted into the second working channel 320, the empty space between the instrument and the inner wall of the second working channel 320 provides a channel for gas to escape from the thoracic cavity. Gas leakage reduces the efficacy and efficiency of the insufflation. The plug 350 can fill the empty space in the second working channel 320 to prevent such leakage.
In some embodiments, the notches 199, 299 in the outer and inner sleeves can indicate the orientation of the thoracic port. For example, the thoracic port can be inserted into a subxiphoid process incision such that the notches and the tether of the cannulated core are oriented towards the head of the patient. The thoracic port can be oriented so that the angled working channels guide the inserted instruments towards designated regions in the thoracic cavity. For example, the proper orientation of the thoracic port in a subxiphoid process incision can ensure that the second working channel 320 is angled towards the heart, while the first working channel 310 is angled away from the heart. In one embodiment, the components of the thoracic port can include additional or alternative visual or structural features to indicate proper insertion orientation and usage.
In some embodiments, the thoracic port can be assembled without the cannulated core 300. For example, the thoracic port can provide access to the thoracic cavity for instruments that are larger than the working channels provided in the cannulated core. The outer sheath 100 can be inserted into an incision in the body and the inner sleeve 200 can be inserted into the outer sheath 100. The chamber formed by the inner sleeve 200 can be a surgical window, wherein instruments and devices can be inserted into the thoracic cavity directly through the surgical window. The diameter of the chamber formed by the inner sleeve 200 can be, in some embodiments, approximately 1 cm. The insertion through the inner sleeve 200 without the cannulated core 300 can be especially advantageous for delivering larger cardiac therapies. For example, the surgical window can be used to insert and attach patch epicardial leads and leadless pacemakers or to dissect pericardial adhesions in patients with prior cardiothoracic surgeries. The surgical window can provide direct visualization of the thoracic cavity through the window as well as a working channel for larger instruments.
The thoracic port can be expanded when in use in order to secure the outer sheath of the port to the body and lock the inner sleeve to the outer sheath. When the thoracic port is in an expanded state, each component can be secured in the incision and a user can focus on inserting and operating instruments through the port rather than holding the port in place. The thoracic port can be engaged in the expanded state when the inner sleeve is fully inserted into the outer sheath. The inner sleeve can be reversibly coupled to the outer sheath when fully inserted and can be locked in place. The thoracic port of the present disclosure can include a number of physical features and/or material properties to be secured to the body in the expanded state.
In one embodiment, the insertion of the inner sleeve 200 into the outer sheath 100 can result in the flexing of the vertical slats 115 of the outer sheath 100 and the expansion of the chamber formed by the outer sheath 10. The distal end and the outer wall of the inner sleeve 200 can push against the inner walls of the vertical slats 115 until the vertical slats 115 are straight rather than curved inward. When the vertical slats 115 are straightened, the flanges 110 at the distal ends of the slats can also extend outwards (away) from the central axis of the outer sheath. The flexing of the vertical slats 115 with the flanges 110 can result in a widening of the distal opening of the outer sheath such that the distal end of the outer sheath is wider than the incision. The extended flanges 110 can prevent movement of the outer sheath 100 in the incision, especially upward vertical movement of the outer sheath 100 out of the body. In one embodiment, the extended flanges 110 can be in contact with the inner wall of the thoracic cavity. The outer sheath 100 can thus be fixed in place by the extended flanges 110 when the inner sleeve 200 is fully inserted into the outer sheath 100. In some embodiments, the outer sheath 100 can remain in place during insufflation and can withstand pressures within and outside of the thoracic cavity in the expanded state.
In one embodiment, the inner sleeve 200 can be removed from the outer sheath 100 by applying a force to uncouple the inner sleeve 200 from the outer sheath 100. In one embodiment, the force can be applied to the inner sleeve 200. For example, a force can be applied to the clips 210 of the inner sleeve 200. The force can be a compressive (inward) force to push the clips 210 closer to each other. The inward force can cause the projection extending downwards from the inner sleeve to deform or curve and can result in the uncoupling of the projection from the cavity. In one embodiment, a combination of forces can be applied to the inner sleeve 200 and the outer sheath 100 to uncouple the inner sleeve 200 from the outer sheath 100. For example, a pushing force can be applied to the wings 120 of the outer sheath. The pushing force on the wings can distort the cavity in the outer sheath, e.g., widen the cavity, so that the projections of the inner sleeve can be released and removed from the cavity.
The inner sleeve 200 can be removed from the outer sheath 100 after being uncoupled from the outer sheath 100. In one embodiment, the removal of the inner sleeve 200 can result in the vertical slats 115 of the outer sheath 100 returning to their curved, tapered position. The outer sheath 100 can thus return to its retracted state, wherein the distal end of the sheath is narrower than the body of the sheath. The outer sheath 100 can be more easily removed from the body in the retracted state without causing irritation or trauma to the internal wall or the area surrounding the incision. In one embodiment, the outer sheath 100 can be removed from the incision by pulling on the wings 120 of the outer sheath. The wings 120 can provide a grip for handling the outer sheath 100 without contacting or blocking the chamber formed by the outer sheath 100.
In step 720, a trocar can be inserted into the first working channel (e.g., the larger working channel) of the cannulated core to insufflate the thoracic cavity. In step 725, an endoscope can be passed through the trocar and maneuvered to provide visualization of the heart. The cannulated plug can be inserted into the second working channel (e.g., the smaller working channel) of the cannulated core to reduce the diameter of the working channel and limit leakage of insufflation gas in step 730. The cannulated plug can be inserted by folding the tether. In step 735, a needle can be passed through the working channel of the cannulated plug and into the thoracic cavity to pierce the pericardial sac. In step 740, the needle can be removed from the working channel and a sheath with a dilator can be inserted into the working channel and advanced into the pericardial space. In some implementations, the sheath with the dilator can be inserted into the pericardial space over a guide wire that has been inserted into the working channel. In step 745, one or more cardiac leads can be inserted through the sheath and fixed to the epicardium. The endoscope in the first working channel can provide a continuous view of the heart and the surrounding space throughout the steps of the method 700 so that the operator can properly advance the instruments through the second working channel and to the heart.
The structures of the thoracic port described herein can provide many advantages and eliminate common failure points in delivering cardiac therapies. In some embodiments, the performance of the thoracic port under typical clinical forces (e.g., insertion force, deployment force, operating forces, drag forces, torque) can be validated using a combination of finite element analysis (FEA) and mechanical testing. For example, the retention of the thoracic port during usage can be tested to ensure that the thoracic port is not dislodged from the incision during regular operations. The thoracic port can be fixed to the body after insertion via the expansion of the outer sheath and the contact between the distal flanges and the inner wall of the thoracic cavity. The material composition of the thoracic port, including the exemplary materials listed herein, and the distal flanges of the thoracic port can withstand typical lateral and torsion forces and be retained in the incision. In some embodiments, portions of the thoracic port can be ductile and can bend or flex under stress without breaking or otherwise failing. For example, the distal flanges of the outer sheaths can be deformable to allow the thoracic port to be twisted while inserted into the body and in the expanded state. The twisting force can bend the flanges or cause the flanges to slip rather than shear. For example, 90° rotations applied to the thoracic port can result in a torque with a maximum magnitude of approximately 0.007±0.001 Nm (Newton-meters) and no fracture.
The thoracic port according to certain embodiments can withstand an insertion stress of approximately 2.21 MPa with a minimum factor of safety (FOS) of 6.78. A downward axial force of 10 N within the outer sheath can generate a maximum stress of approximately 11.49 MPa and a minimum FOS of 1.31, indicating that the thoracic port can withstand a force applied to expand the outer sheath and couple the inner sleeve to the outer sheath. A combination of upward (e.g., 10 N) and downward (e.g., 1 N) force applied to the thoracic port to simulate attempted dislodgment of the thoracic port can result in a maximum stress of approximately 6.34 MPa and a minimum FOS of 2.37. In some embodiments, the thoracic port can withstand an attempted dislodgment force of approximately 22 N. In some embodiments, the thoracic port can withstand torque of approximately 0.012 Nm, which is greater than typical torque forces applied during operation. For example, an applied torque of 0.01 Nm can generate a maximum stress of approximately 12.32 MPa with a minimum FOS of 1.32.
In some embodiments, the forces required to insert, couple, and otherwise use the components of the thoracic port can be measured to ensure that the necessary forces are within an expected range that could be manually applied in a clinical setting. In some implementations, the material properties of the thoracic port can affect the applied forces needed to operate the port. For example, the materials of the cannulated core and the inner sleeve can create a friction force between the cannulated core and the inner sleeve that can be overcome by an average user (e.g., a clinician) inserting the core into the inner sleeve. In one embodiment, the thoracic port can be operated under lubrication and sterilization conditions typically used in surgeries. In some embodiments, the thoracic port can slip and deform in order to withstand fracturing even when excess force is applied, minimizing risk of component breakage within the body.
According to some examples, a maximum force needed to push the thoracic port through skin can be approximately 0.78±0.19 N. A force applied overcome sliding friction of the inner sleeve against the outer sheath can be approximately 3.86±0.80 N. A force applied to lock the inner sleeve to the outer sheath and deploy the flanges in an expanded state can be approximately 9.06±1.55 N. In some embodiments, an average peak force of 11.51±1.85 N can be used to remove the thoracic port from an incision without disengaging the inner sleeve.
In typical procedures, multiple operators are needed to control a trocar, a scope, and any implantation instruments. The trocar and the scope must be constantly monitored and maneuvered to prevent the devices from interfering with the working path(s) of implantation instruments. The angled working channels of the surgical access port as described herein can reduce interference between inserted instruments and reduce the need for additional user assistance in accessing and visualizing the thoracic cavity. In one embodiment, the visualization channel can be designed to minimize slippage or lateral movement of an inserted instrument, while the second working channel can be designed to allow an inserted instrument to slide easily through the channel. For example, the dimensions and materials of the visualization channel can result in a drag force that minimizes unwanted movement, especially vertical movement, of a trocar and endoscope. In one implementation, the visualization channel can generate a drag force of approximately 3.97±1.65 N on an inserted tool, which represents a force needed to overcome static friction for insertion of the tool. The general sliding friction of the tool in the visualization channel can be approximately 0.91±0.48 N. The second working channel can generate a drag force of approximately 0.23±0.03 N on an inserted tool for easier movement within the second working channel. It can be appreciated that any of the foregoing measurements and quantities are included as exemplary features rather than as limitations or requirements for the design of the surgical access port presented herein.
The first working channel can be angled away from the second working channel such that the path of the trocar and the endoscope does not interfere with the path of the instruments advanced through the second working channel for implantation. In one embodiment, the angle of the working channels can direct the inserted devices and instruments towards target areas or structures in the thoracic cavity. For example, the second working channel can be angled towards the heart when the surgical access port is inserted into the thoracic cavity such that an inserted sheath can naturally be advanced towards the heart without being bent or kinked. The angled working channels can enable direct visualization while minimizing tool clashing and risk of heart perforation or damage to coronary vasculature. In some implementations, the surgical access port was determined to decrease physical demand, temporal demand, and frustration of cardiac therapy delivery.
The surgical access port of the present disclosure can provide a number of working channels of varying dimensions for use in different procedures requiring access to the thoracic cavity. According to one example, the thoracic port can include a first working channel and a second working channel in the cannulated core, as has been described herein. A cannulated plug can be inserted into the second working channel to further provide a third working channel for needles or similarly narrow instruments. In some embodiments, the cannulated core can be removed from the inner sleeve such that the chamber formed by the inner sleeve can be a large working channel or window to the thoracic cavity. Each of these working channels can be utilized in a procedure by inserting or removing the necessary components of a single thoracic port. In addition, the establishment of one working channel (e.g., the narrow working channel of the cannulated plug) can be reversed (e.g., by removing the cannulated plug from the working channel of the cannulated core) for further use. The flexible outer sheath of the thoracic port and the distal flanges can secure the thoracic port in place as the working channels are modified and used.
While this specification contains many specific implementation details, these should not be construed as limitations on the scope of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments.
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 above 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.
Similarly, while operations are depicted in the drawings in a particular order, this should 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. Moreover, the separation of various system modules and components in the embodiments described above 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 component or packaged into multiple components.
Particular embodiments of the subject matter have been described. Other embodiments 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 some cases, multitasking and parallel processing may be advantageous.
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, embodiments of the present disclosure may be practiced otherwise than as specifically described herein.
Embodiments of the present disclosure may also be as set forth in the following parentheticals:
Thus, the foregoing discussion discloses and describes merely exemplary embodiments of the present disclosure. As will be understood by those skilled in the art, the present disclosure may be embodied in other specific forms without departing from the spirit thereof. Accordingly, the disclosure of the present disclosure is intended to be illustrative, but not limiting of the scope of the disclosure, 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.
The present application claims priority to U.S. Provisional Application No. 63/308,224, filed Feb. 9, 2022, which is incorporated herein by reference in its entirety for all purposes.
This disclosure was made with government support under Grant Number 1R43HL144352-01 awarded by the National Institutes of Health. The government has certain rights to the disclosure.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2023/012657 | 2/9/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63308224 | Feb 2022 | US |
