Surgical access system

Abstract

A surgical access system is disclosed. A surgical access system having a cannula may include a distal tip having one or more longitudinal channels distributed around the circumference of the distal tip and one or more circumferential channels around the distal tip. The surgical access system also includes an obturator coaxially insertable into the cannula, the obturator may include a distal tip and a retractable cutting element having an actuator. The surgical access system also includes an articulated interface. The surgical access system may also include a distal tip of the cannula, the distal tip may also include one or more bridges distributed circumferentially along the one or more circumferential channels of the distal tip. The obturator may also include an elongated tube and a slidable plunger element, the slidable plunger element being configured to control fluid flow within the elongated tube of the obturator.

Description

[0001] Related references

[0002] This international patent application claims priority to U.S. Provisional Patent Application No. 62 / 817,967, entitled “Surgical Access System,” filed on March 13, 2019. This international patent application also claims priority to U.S. Provisional Patent Application No. 62 / 827,352, entitled “Surgical Access System,” filed on April 1, 2019. The entire contents of the 62 / 817,967 and 62 / 827,352 applications are incorporated herein by reference. Technical Field

[0003] The claimed invention relates to surgical devices, and more particularly to surgical access devices or systems and methods thereof for correcting tricuspid regurgitation. Background Art

[0004] The availability of safe and effective treatments for tricuspid valve (TV) disease remains an area of ​​significant unmet clinical need. Tricuspid regurgitation (TR), or pathological leakage of blood back into the right atrium during systole, is common in cardiac patients with left-sided valvular or myocardial disease and is estimated to affect more than 1.5 million people in the United States, with an annual incidence of approximately 200,000 and more than 300,000 patients in the United States and Europe, respectively. Specific anatomical features from the TV complex may differ throughout the progression of ventricular remodeling in patients with functional TR, depending on the pathogenic mechanism (primary vs. secondary). TR is the most common functional disorder and is primarily caused by annular dilatation and tethered leaflets from right ventricular remodeling due to left-sided heart disease, atrial fibrillation, or pulmonary hypertension. Primary TR accounts for approximately 10% of TR cases and can be caused by congenital (Ebstein anomaly, prolapse) or acquired pathology (rheumatic disease, endocarditis, carcinoid, endomyocardial fibrosis, iatrogenic trauma associated with intracardiac leads or biopsy forceps). Today, TV disease is generally considered a hallmark of advanced chronic heart failure. TV is associated with a poor prognosis, with most patients receiving lifelong medical therapy until refractory right heart failure and end-organ dysfunction develop.

[0005] For treatment purposes, secondary TR is divided into three stages. In the early stages, initial dilation of the right ventricle results in dilation of the tricuspid annulus, but without significant leaflet tethering. In these first stages, TR should be easily repaired with ring-based systems. In the absence of long-term durability data for transcatheter TV treatment, rings may be preferred over suture annuloplasty, when possible, based on surgery, in order to reduce TR recurrence. In the second stage, progressive right ventricular and tricuspid annular dilation occurs, compromising leaflet coaptation. The potential for successful transcatheter tricuspid valve repair (TTVr) with annuloplasty alone is less likely in cases of progressive tethering and tricuspid annular dilatation. Finally, as the right ventricle continues to remodel, further leaflet tethering worsens, leading to lack of coaptation and massive or turbulent TR. When severe tethering occurs, any attempt at repair may be considered futile.

[0006] Figure 1A is a side cross-sectional view of a heart. In the view, the heart 10 is schematically shown with some relevant anatomical features. The tricuspid valve 16 (TV) is a complex structure with multiple anatomical features that make it unique. Figure 1A As shown, a TV device typically has three leaflets, a septal leaflet 22, a posterior leaflet 24, and an anterior leaflet 20, chordae tendineae 26, and typically three papillary muscles 28. The general location of the superior vena cava 12 and the inferior vena cava 14 are also shown.

[0007] like Figure 1B As shown, the tricuspid annulus 16 is the largest of the four heart valves and has very thin, fragile leaflets that constitute a potentially large regurgitant orifice area. The tricuspid valve 16 is surrounded by the tricuspid annulus 18, which is a saddle-shaped ellipsoid that becomes flat and rounded as it dilates primarily in the anterolateral free wall, mostly along the posterior edge in patients with left-sided heart disease in sinus rhythm, where leaflet tethering is less prominent in patients with functional TR secondary to chronic atrial fibrillation. Figure 1B Also shown are three leaflets: anterior leaflet 20, septal leaflet 22, and posterior leaflet 24. The relative positions of mitral valve 34 and mitral valve annulus 36, aortic valve 30 and aortic valve annulus 32, and pulmonary valve 38 and pulmonary valve annulus 40 are also shown for reference. There are four major anatomical structures surrounding the TV, and therefore risks in interventions for TV disease: the conduction system (atrioventricular node and right bundle of His) crosses the membranous septum 3 to 5 mm from the anterior septal commissure, the right coronary artery (surrounding the right atrioventricular groove, about 5.5 mm from the ventricular septum and posteriorly, about 7 mm from the anterior), and the non-coronary sinus of Valsalva and the coronary sinus ostium are important landmarks of the posterior septal commissure. TV devices present other challenging issues that need to be overcome: calcium deficiency, angulation associated with the superior vena cava (SVC) and inferior vena cava (IVC), a trabeculated and thin right ventricle that hinders transapical access, or the presence of existing cardiac implantable electronic devices.

[0008] Traditional isolated TV surgery typically requires a highly invasive surgical approach and cardiopulmonary bypass. As this current approach remains associated with one of the highest mortality risks of all valvular heart surgeries in contemporary practice (operative mortality of 8.8% to 9.7%), it is rarely used for the large population of untreated TR patients (only 5,005 isolated TV surgeries were performed in a large contemporary national registry in the United States over a 10-year period). Durability remains the Achilles heel of most surgical interventions targeting the TV. Many factors (e.g., right ventricular remodeling and dysfunction, progression of TV annular size, and pulmonary hypertension) may contribute to the high rates of TR recurrence observed after surgical TR correction. Surgical experience suggests that annuloplasty has a more durable profile than suture annuloplasty and that TV replacement is superior to repair. However, concerns about increased perioperative mortality for TV replacement compared with repair in contemporary series (related, in part, to the selection bias of patients with larger TV annular dilatation and more severe right ventricular dysfunction) have led to a trend over time toward TV repair rather than replacement.

[0009] Advances in modern cardiac surgery have made it possible to repair or replace heart valves using minimally invasive surgical techniques. As minimally invasive techniques have improved, surgeons have been able to operate on patients through smaller and smaller access holes, resulting in less perioperative pain and faster recovery times. While more efforts continue to be made to reduce the amount of time a patient must be on cardiopulmonary bypass (CPB), surgeons continue to push the boundaries of what is possible by striving to perform certain procedures on a beating heart without the need for CPB. It is more desirable to be able to perform certain cardiac surgical procedures on a beating heart under minimally invasive conditions. For example, it is highly desirable to be able to perform a tricuspid valve repair through a cannula placed between the patient's ribs and into the right atrium of the heart while the heart is still beating. The pressure within the right atrium is such that blood tends to partially fill such a cannula, which of course will be present in the right atrium, which, disadvantageously, will also completely obscure the surgeon's view of the tissue of the right atrium and tricuspid valve if this approach is to be taken. Even echocardiography, by itself, makes it difficult for a surgeon to orient a suture device through an area of ​​blood to perform a series of interrelated sutures. Therefore, there is a need for a minimally invasive suture placement system and method that provides access to a heart valve (e.g., the tricuspid valve) and can reliably place sutures around the heart valve even in the absence of direct and endoscopic visibility to achieve minimally invasive beating heart surgery to improve patient outcomes. Faster, more reliable cardiac surgery provides additional benefits, such as reduced fatigue of the surgical team and more efficient use of critical resources. Speeding up cardiac surgery can also improve patient outcomes. The minimally invasive surgical access system can be used in other surgical fields or surgical procedures. Summary of the invention

[0010] A surgical access system is disclosed. A surgical access system having a cannula may include a distal tip having one or more longitudinal channels distributed around the circumference of the distal tip and one or more circumferential channels around the distal tip. The surgical access system also includes an obturator coaxially insertable into the cannula, the obturator may include a distal tip and a retractable cutting element having an actuator. The surgical access system also includes an articulated interface.

[0011] The surgical access system may further include a distal tip of the cannula, which may further include one or more bridges circumferentially distributed along one or more circumferential channels. The obturator may further include an elongated tube. The obturator may further include a slidable plunger element configured to control fluid flow within the elongated tube of the obturator.

[0012] A method of accessing a surgical site is also disclosed. The method of accessing a surgical site also includes placing at least one purse-string suture in a heart wall, securing the at least one purse-string suture to a cannula, placing an obturator tip of a surgical access system having a retractable blade in contact with the heart wall, incising the wall with the retractable blade, and securing the incised wall to the cannula of the surgical access system. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1A-1B These are the side and top cross-sectional views of a human heart.

[0014] Figure 2 is an upper right perspective view of a cannula used in a surgical access system.

[0015] Figure 3 is used for Figure 2 Exploded view of the assembly steps of the cannula.

[0016] Figure 4 is a stereoscopic view of an obturator used in a surgical access system.

[0017] Figures 5A-5H , 5J-5N is used for Figure 3 A series of exploded perspective views of the assembly steps of the obturator portion of the surgical access system.

[0018] Fig. 6A is an exploded view illustrating assembly steps for a surgical access system.

[0019] Figure 6B yes Figure 5A Stereoscopic diagram of the surgical access system.

[0020] Figures 7A-7E It is used as a graphic Figure 5A Several side views of the surgical steps of the surgical access system.

[0021] Figures 8A-8F They are Figure 2 Front view, left side view, right side view, back view, top view and bottom view of the distal tip of the cannula.

[0022] Fig. 9A and 9B is a front view of an alternative embodiment of an obturator for a surgical access system illustrating a rotation ramp feature. DETAILED DESCRIPTION

[0023] Figure 2 5 is an upper right perspective view of a cannula used in a surgical access system. The cannula 50 has a proximal end 50P that is oriented closest to the surgeon during use and a distal end 50D that is oriented away from the surgeon. The cannula 50 has a cannula top 58 at the proximal end 50P, which is connected to a cannula top coupler 66 and then connected to the cannula tube portion 54. In this illustrated embodiment, the cannula tube portion is a hollow elongated tube. The cannula distal tip 52 is connected to the distal end 50D of the cannula tube portion 54. The cannula 50 has a ball universal joint 56 that is slidably engaged to the cannula tube portion 54 of the cannula 50. The ball universal joint 56 defines an opening 64 and a set screw channel 62. The opening 64 is located opposite the hinge (not shown in this view). The ball joint 56 is configured so that the ball joint 56 can slide along the length of the cannula tube 54 and is set by the surgeon based on anatomical variations between patients (e.g., based on the distance between the chest wall and the right atrium of the patient's heart) or other anatomical distances inherent to a particular surgical site that one may wish to access. Once the desired position for the ball joint 56 is determined, a set screw 63 is inserted along an axis 65 and tightened to limit movement of the ball joint 56 during minimally invasive surgery. Although a set screw channel 62 is shown in this embodiment and a tension adjustment set screw 63 is described with respect to this embodiment, other means of setting, adjusting, or re-adjusting the tension of the ball joint 56 or other similar slidable joints may be apparent to those skilled in the art. The ball joint 56 may be separate from the cannula 50 or continuous with the cannula 50. The ball joint 56 or its alternative embodiments may be referred to as an articulated interface. An articulated interface for the surgical access system described herein is an interface coupled to or connected to the surgical access system that allows and is configured to provide independent motion that is repositionable in three planes. In an anatomical context, these three planes of motion may be referred to as the sagittal, coronal, and transverse planes, while in a Cartesian coordinate system, these three planes may be referred to as x, y, and z. It should be understood that these reference planes of motion are provided for context and are intended to encompass descriptions of alternative reference planes or planes of motion.

[0024] Figure 3 is used for Figure 2Exploded view of the assembly steps of the cannula. The cannula distal tip 52 further defines a circumferential purse-string suture channel 82; several longitudinal grooves 84 or longitudinal channels; a lace suture channel 86; a bridge portion 88 further defining a bridge hole 89 (not shown in this view); and a cannula tip opening 90. The lace suture channel 86 and the purse-string suture channel 82 are circumferential channels located on the cannula tip 52 and are configured to provide indentations to guide sutures or tissues or other materials within the circumferential channels. It should be understood that as used herein, the term "suture" is intended to cover any natural and / or synthetic silk, cable, wire, filament, strand, thread, yarn, gut or similar structure in a monofilament, composite filament or multifilament form (braided, knitted, twisted or otherwise fixed together), and equivalents, substitutes, combinations and plural forms of such materials and structures.

[0025] The additional functions of the various channels and other features of the distal tip 52 of the cannula will be described later. Figures 7A-7E Further described. The cannula tip 52 is placed on the distal end 54D of the cannula tube 54 along the axis 76 and is fixedly attached to the distal end 54D of the cannula tube 54. The ball joint 56 defines the set screw channel 62 and the opening 64, and also defines the flexible hinge 78 and the central channel 8. The flexible hinge is configured to allow the ball joint 56 to open slightly and allow the ball joint 56 to slide along the length of the cannula tube 54 when, for example, it is not subject to tension from the set screw. The ball joint 56 is then placed on the proximal end 54P of the cannula tube 54 along the axis 74. The ball joint 56 can be located at any point along the cannula tube 54, depending on any anatomical variations in distance related to the patient's external position relative to the internal surgical site being accessed. Finally, cannula tip 58 defining cannula tip coupler 66 is fixedly coupled to cannula tube spacer 70 along axis 68 and cannula tip 58 is fixedly attached to proximal end 54P of cannula tube 54. This step captures ball joint 56 along the length of cannula tube 54. Figure 3 The components assembled in the cannula are fixedly attached by brazing, welding, ultrasonic welding or by other coupling means known to those skilled in the art. In addition, the various components described for the assembly of the cannula may be formed in combination and may not necessarily be separate components.

[0026] Figure 4 is a perspective view of an obturator used in a surgical access system. Obturator 92 has a proximal end 92P oriented closest to the surgeon during use and a distal end 92D oriented away from the surgeon. Obturator 92 has an obturator distal tip 94 coupled to an obturator tube 96 at a distal tip 92D of obturator 92. The specific details and features of the obturator distal tip 94 will be discussed later with respect to FIG. Fig. 5F. The proximal end 92P of the obturator 92 has an obturator knob 98, a plunger knob 100, and a cutter knob 102. These knobs 98, 100, 102 can be actuated by an operator to use the features of the outer obturator 92 portion of the surgical access system described herein. The obturator knob 98 also defines a stopcock 104, which further defines a vacuum inlet 106 and a valve 108. The vacuum inlet can be connected to a source for delivering a vacuum or other fluid flow to or from the obturator distal tip 94. The amount of flow can be controlled, opened or closed by actuating the valve 108. Figures 5A-5H , 5J-5N discuss the assembly and specific features and details of the components of the obturator 92. Alternative means of fluid flow or gas flow regulation known to those skilled in the art may also be used.

[0027] Figures 5A-5H , 5J-5N is used for Figure 4 A series of exploded views of the steps for assembling the obturator portion of a surgical access system. Figure 5A An assembly step of the obturator 92 is shown, wherein a cutter blade 116 is shown having a cutter blade edge 118 and two holes 117 inserted into a slot 112 defined by a cutting element drive rod 110 along an axis 115. The cutting element drive rod 110 also defines two holes 114 on either side of the slot 112. Figure 5B Two pins 120 are shown inserted through two holes 114 on the cutting element drive rod 110, through blade holes 117 on the cutter blade 116, and finally through two corresponding holes (not shown in this view) on the opposite side of the cutting element drive rod 110. These pins 120 secure the blades on the ends of the cutting element drive rod 110. Other embodiments may include a one-piece cutting element or similar configurations as will be apparent to those skilled in the art. Figure 5C The complete subassembly of the cutting element 122 is shown. The retractable element 122 can be actuated independently of other mechanisms in the obturator 92, such as a slidable plunger element (to be discussed later). Although the element 122 is constructed with a mechanical blade as its functional cutting element, other sharp tools capable of piercing or forming a controlled incision can be useful alternative embodiments of the cutting element, such as a scalpel, scissors, a cauterizing element, a laser element, etc. Although the cutter blade 116 in the present embodiment has a cutter blade edge 118 on the patient-facing side or distal side of the rectangular cutter blade 116, the scalpel can have a triangular cutter blade with sharp edges on one or both sides of the triangular cutter blade. The retractable cutting element can also be in the form of scissors, wherein the two blade members have relative sharp edges, and when actuated or pivoted relative to each other, the sharp edges slide relative to each other to contact with the tissue and start the cutting motion.

[0028] Figure 5D The diagram shows the Figure 4 Another assembly step of the obturator portion of the surgical access system of the present invention. The vacuum plunger 130 defines a plunger recess 134 having a diameter smaller than that of the vacuum plunger 130. The vacuum plunger 130 also defines two vacuum ports 136 and a blade slot 138, which are connected over the entire length of the vacuum plunger 130. The two vacuum ports 136 are configured to deliver fluid flow from the vacuum inlet 106 of the obturator 92 to the obturator distal tip 94 when the vacuum plunger 130 is pulled back in the proximal direction, and to cut off fluid flow from the vacuum inlet 106 of the obturator 92 to the obturator distal tip 94 when the vacuum plunger 130 is pushed forward in a more distal direction. The vacuum plunger 130 is also configured to fit tightly within the obturator tube 96, and may have a gasket or other device that seals or blocks fluid flow between the vacuum plunger 130 and the obturator tube 96. Other embodiments of the vacuum plunger 130 may have different numbers or orientations or shapes of vacuum ports than those illustrated herein. In addition, alternative methods of controlling the vacuum at the distal tip 94 of the obturator may be employed and are known to those skilled in the art. The blade slot 138 is configured to allow the cutter blade edge 118 of the cutting element 122 to pass through the length of the vacuum plunger 130 when the cutting element 122 is inserted into the blade slot 138 of the vacuum plunger 130 along the axis 128. Figure 5D The subassembly of is completed by placing a plunger drive tube 124 over the cutting element 122 along axis 126 and fixedly attaching the plunger drive tube 124 to the vacuum plunger 130. The cutting element 122 is configured to slide back and forth within the plunger drive tube 124. The plunger drive tube 124 or hollow actuator is a slidable plunger element that can be actuated independently of the actuation of the element 122. Figure 5E The diagram shows the Figure 5D The result of the assembly steps of the obturator shown. In this view the inner obturator assembly 140 is shown.

[0029] Fig. 5F The diagram shows the Figure 4Another assembly step of the obturator portion of the surgical access system of the present invention. The obturator distal tip 94 defines a cutting element slot 148, a stop ring 144, several tip ports 146 and a shaft connecting recess 142. As previously described, the cutting element slot 148 is configured to align with the blade slot 138 in the vacuum plunger 130 and allow the cutting element 122 to extend through the obturator distal tip 94 when in use. The tip port 146 is a channel through which the fluid flows, and is configured on either side of the element slot 148 so that they are not aligned with the two vacuum ports 136 on the vacuum plunger 130 when the vacuum plunger 130 is pushed distally. The present embodiment illustrates the tip ports 146 in two groups of channels, each different group being located on either side of the blade slot 138. The blade slot 138 can be considered a central channel. Typically, these channels are connected or contacted from the tip of the instrument to the opposite end or port, and when the fluid flow is opened or actuated, the fluid can be introduced at the opposite end or port. On the contrary, when the fluid flow is closed, the flow between the tip of the instrument to the opposite end or port where the fluid may be introduced is interrupted. This can be achieved by having a hollow cylindrical member therein, having a specific port in each internal component, having a solid tube or cylinder in the lumen or internal channel, or any combination thereof. In an arrangement known to those skilled in the art, there may be an alternative embodiment with more than two groups of channels. When the vacuum plunger 130 is pushed distally against the inner side of the obturator distal tip 94, the arrangement effectively cuts off the fluid flow. The obturator tube 96 is a hollow elongated tube or cylinder defining a center 150. The alternative embodiment may not be hollow, but a solid tube, and therefore may have an inner cavity or channel along the length of the tube for actuating each cutting element, plunger element or fluid flow component. The shaft rod connection recess 142 on the obturator distal tip 94 is configured to be inserted along the axis 152 until the stop ring 144 contacts the end of the obturator tube 96. The obturator distal tip 94 is then fixedly attached to the obturator tube 96, completing this assembly step. Figure 5G The diagram shows the Fig. 5F The result of the assembly steps of the obturator shown. In this view the external obturator assembly 154 is shown. Figure 5H The diagram shows the Figure 4 Another assembly step of the obturator portion of the surgical access system. Figure 5E The internal obturator assembly 140 is inserted along the axis 156 into Figure 5G In the external obturator assembly 154. Figure 5J The diagram shows the Figure 5H The result of the assembly steps of the obturator is shown. The obturator subassembly 158 is shown in this view, wherein the orientation and placement of the obturator distal tip 94, obturator tube 96, plunger drive tube 124 and cutting element drive rod 110 are shown.

[0030] Figure 5K The diagram shows the Figure 4 Another step in assembling the obturator portion of the surgical access system. Figure 5J The obturator subassembly 158 of the present invention is provided. The obturator knob 98 also defines a central hole 164 and a vacuum port 162, which is configured to communicate a fluid flow from the stopcock 104 (not shown here) to the obturator distal tip 94. The obturator knob 98 is fixedly attached to the obturator tube 96 and attached to the end of the obturator tube 96 by sliding the obturator knob 98 over the cutting element drive rod 110 and the plunger drive tube 124. The plunger knob 100 defines a central hole 166 and is fixedly attached to the plunger drive tube 124 by inserting the plunger drive tube 124 into the central hole 166 of the plunger knob 100 along the axis 160. It should be noted that the plunger drive tube 124 and the attached plunger knob 100 are independent of the previously installed obturator knob 98 and move independently of the cutting element drive rod 110. The cutter knob 102 also defines a central hole. Finally, the cutting element drive rod 110 is inserted into the center hole 168 on the cutter knob 102 along the axis 160 and fixedly attached thereto. In the present embodiment, once assembled in the obturator, the obturator knob 98 will not move. The plunger knob 100 moves the plunger drive tube 124 and thus moves the vacuum plunger 130 to the distal and proximal side independently of the obturator knob 98 and the cutter knob 102. The plunger knob can also be regarded as an actuator or plunger actuator, because this feature is used to actuate or affect the movement of the vacuum plunger 130 and thus actuate so that the fluid flow through the obturator 92 is appropriately opened or closed. In addition, the cutter knob 102 moves the cutting element drive rod 110 and thus moves the cutter blade 116 to the distal and proximal side independently of the obturator knob 98 and the plunger knob 100. The cutter knob 102 may also be considered an actuator or cutting actuator because this feature is used to actuate or affect the movement of the cutting element 122. The cutting element drive rod 110 may also be considered an actuator rod or actuation drive rod because this rod or wire is used to actuate or move the cutter blade 116 into or out of the cutting element slot 148 in the obturator distal tip 94. Figure 5L The diagram shows the Figure 5K , which shows the assembled orientation and position of the obturator distal tip 94 , obturator tube 96 , obturator knob 98 , plunger knob 100 , and cutter knob 102 .

[0031] Figure 5M The diagram shows the Figure 4The final assembly step of the obturator portion of the surgical access system is shown in FIG. 1 . The vacuum port 162 defined by the obturator knob 98 is a fluid passage configured to receive the stopcock 104 by inserting the central hole 164 defined by the stopcock 104 into the vacuum port 162 along the axis 165. The vacuum port 162 is a passage that allows fluid to flow from the outside of the surgical access system to the inside of the obturator tube 96 of the obturator 92. This assembly step produces Figure 4 The occluder 92.

[0032] Figure 5N yes Figure 4 1. A side view of the obturator portion of a surgical access system of FIG. 1. The side view shows the assembled obturator 92 with additional details about the articulation of the plunger knob 100 and the cutter knob 102. Arrow 101 indicates the articulation direction of the plunger knob 100. When the plunger knob 100 moves toward the distal end 92D of the obturator 92, the plunger drive tube 124 coupled to the plunger knob 100 also moves distally and independently of the inserted cutter drive rod 110, and the fluid flow through the obturator 92 is cut off, as previously described. Conversely, when the plunger knob 100 moves toward the proximal end 92P of the obturator 92, the plunger knob 100 also moves proximally with the coupled vacuum plunger 130, and the fluid flow through the obturator 92 is opened. Arrow 103 indicates the articulation direction of the cutter knob 102. When the cutter knob 102 moves toward the distal end 92D of the obturator 92, the cutter drive rod 110 also moves independently distally in the plunger drive tube 124, and the cutter blade 116 is actuated or pushed out of the obturator tip 94, as described above. Conversely, when the cutter knob 102 moves toward the proximal end 92P of the obturator 92, the cutter drive rod 110 also moves independently proximally in the plunger drive tube 124, and the cutter blade 116 retracts into the obturator tip 94.

[0033] Fig. 6A is an exploded view illustrating assembly steps for a surgical access system. Fig. 6A An optional surgical instrument holder 172 is shown terminating in a clamp adapter 170 attached to its end. The clamp adapter 170 is shown opened and placed in Figure 2 Above the ball joint 56 of the cannula 50, the jaws 176 are closed and tightened by tightening the adjustment screw 178. Figure 4 The obturator 62 is inserted into the center of the cannula 50 along the axis 169. Figure 6B yes Fig. 6A Stereoscopic diagram of the surgical access system.

[0034] A surgical access system 174 is illustrated that can be used to provide access to the right atrium of a patient for minimally invasive tricuspid valve repair as previously described. Similar embodiments of the surgical access system 174 can also be used for other surgeries where minimally invasive access to the surgical site is advantageous. The surgical access system has a cannula 50, an obturator 92, and a ball and socket joint 56. The ball and socket joint is secured in a clamp adapter 170 having an adjustment screw 178 and a lever lock 180. The clamp adapter 170 is attached to a surgical instrument holder 172 that secures the surgical access system 174 in a possible initial position for minimally invasive surgery. The clamp adapter 170 has a clamp jaw 176 that secures the ball and socket joint 56 that is slidably attached to the cannula tube, as previously described. Those skilled in the art will be aware of alternative embodiments of the clamp adapter or alternative clamping elements. The ball joint 56 in combination with the clamp adapter 170 and the surgical instrument holder 172 provides multiple degrees of freedom of motion and the ability to position the surgical access system in any number of positions that facilitate a desired access to a minimally invasive surgical site. Suitable surgical instrument holders such as, but not limited to, the miniARM from LSI Solutions, Inc. (www.lsisolutions.com of Victor, New York) are also available. TM INSTRUMENT HOLDER) is intended for use in such surgical procedures.

[0035] An advantageous feature of the articulated interface in the embodiments described herein is that the ball joint 56 can first be appropriately positioned along the length of the cannula tube 54 depending on anatomical variations. This provides articulation along the axis of the cannula tube 54, thereby providing articulation in one plane. As shown, securing the substantially spherical ball joint 56 within a clamping element or clamp adapter 170 provides adjustment in the remaining two dimensions. This arrangement of the ball joint 56 and the clamp adapter 170 provides articulation in all planes and can therefore be repositioned by the surgeon to provide flexible access to a minimally invasive surgical site. Fig. 6A and 6B As shown, by attaching the clamp adapter 170 to the surgical instrument holder 172, the operator or surgeon can obtain even further adjustability and repositioning capabilities. Alternatively, a universal joint can be used in a surgical access system such as described herein. A universal joint is a connector or joint that connects multiple segments, tubes, rods or branches on a universal device. The segment axes are tilted to each other and may or may not transmit rotational motion. The connector includes a pair of hinges connected by a cross-shaped shaft rod close to each other. A universal joint configured in this arrangement allows rotational motion of a rod or segment, while the rod or segment connected by the universal joint is not oriented in a straight line.

[0036] Figures 7A-7E are several side views of the surgical steps, illustrating Figure 6B A use of a surgical access system. Fig. 7A The wall of the right atrium or right atrial wall 182 is illustrated, which is the target surgical site for a surgical access system such as described herein. In preparation for use of the surgical access system, the position of the ball joint 56 is set along the length of the cannula tube 54. A suitable right anterior access site is selected and an incision is made in the second intercostal space at the right edge of the chest wall. Subcutaneous tissue and major muscle fibers and intercostal muscle fibers are divided and separated, using blunt dissection as much as possible. A suitable access port is installed, and a retractor may be optionally used. Also optional is the use of appropriate suture management equipment. Further dissection, movement or removal of fat or other tissue is performed as needed. Additional visualization methods may be used to assist in the placement of the surgical access system 174 during subsequent steps of the surgical procedure outlined herein.

[0037] Figure 7B It is used as a graphic Figure 6B Side view of the surgical steps of the surgical access system. Figure 7B Two concentric purse-string sutures 184, 186 are shown around the right atrial wall 182 incision site so that one end of each purse-string suture enters and exits the right atrial wall 182. This can be accomplished using a suitable surgical suturing device, such as, but not limited to, the PRESTIGE TM Once the purse-string sutures 184, 186 are completed, they are both snare-trapped and each of the purse-string sutures 184, 186 is snare-trapped using a device such as, but not limited to, a purse-string suture from LSI Solutions (www.lsisolutions.com of Victor, New York). device. Figure 7B The illustration shows purse-string sutures 184, 186 entrapped and encapsulated within their respective suture tubes 188, 190. Such an arrangement is one method of using a suture snare, but other means of entrapping, organizing, and encapsulating sutures during minimally invasive surgical procedures may be known to those skilled in the art. Examples include a simple snare in a tube arrangement, wherein the suture or snare may be secured in place using common clamping methods (e.g., butterfly clamps, etc.), or a suture locking device may be used to releasably and repeatedly lock and unlock the position of the suture within the tube. The suture tubes 188, 190 are attached to a longitudinal groove 84 located on the distal tip 52 of the cannula 50. The longitudinal groove 84 or channel is configured to releasably secure the suture or suture tube so that it is secured proximate to the cannula during use. Prior to subsequent surgical steps illustrated herein, the suture tubes 188, 190 are further secured to the distal tip 52 of the cannula 50 using a tie suture 192 along the tie suture channel 86 of the cannula tip 52, as shown. Figure 7Cshown.

[0038] Figure 7C It's a picture. Fig. 6A and 6B 174. The surgical steps illustrate the next steps in an exemplary surgical sequence using the surgical access system 174 described herein. Figure 7C The distal end 174D of the surgical access system 174 is shown introduced into the surgical site and moved into position with the obturator distal tip 94 in direct contact with the right atrial wall 182. The ball joint 56 has been translated to the appropriate position on the cannula 54 to account for the distance from the patient's chest wall and the right atrial wall 182. The tie suture 192 is shown threaded over the suture tubes 188, 190, through the tie suture channel 86 and into the one or more bridge holes 89 located below the one or more bridges 88 on the cannula tip 52. The tie suture 192 further secures the suture tubes 188, 190 around the circumference of the cannula 50 of the surgical access system 174. The suture tubes 188, 190 are also secured in their respective longitudinal grooves 84 with the tie suture 192 to provide additional security. It should be noted that when fixed by the tie suture 192, the movement of the purse string suture 184, 186 is not restricted in the suture tube 188, 190. The tie suture 192 can be fastened using a knot or mechanical fastener, but is not shown in this view. The suction feature of the obturator tip 94 should be activated as described above by opening the stopcock on the obturator knob and actuating the plunger knob and thus actuating the plunger drive tube and the vacuum plunger. By applying suction through the obturator distal tip 94 via the tip ports 146 grouped on either side of the blade slot 138, the activation of the vacuum flow causes the tissue of the right atrium wall 182 to abut against the obturator distal tip 94 under additional tension. The blade slot 138 is an elongated channel through which a blade element or cutting element can pass, and the blade slot 138 is separated from the channel in the obturator distal tip 94 that allows fluid to flow through the obturator distal tip 94.

[0039] Fig.7D It is a diagram showing the use of Figure 6B Side view of the surgical steps of the surgical access system. Fig.7D Actuation of the retractable blade of the surgical access system 174 is shown. When the obturator distal tip 94 is in close contact with the right atrium wall 182, the cutter knob 102 is actuated by the user at the proximal end of the obturator 92 by pushing the cutter knob 102 in a direction 194 toward the right atrium wall 182. Actuating the cutter knob 102 in turn pushes the cutting element drive rod 110 and the cutter blade edge 118 of the cutter blade 116 in a direction 194, thereby cutting the tissue of the right atrium wall 182. This leaves an incision 198 in the right atrium wall 182 tissue.

[0040] Fig. 7E It is a diagram showing the use of Figure 6B 198 is formed in the right atrial wall 182, the cutter blade 116 is quickly retracted and the cannula tip 52 is advanced into the cut right atrial wall 182 at the site of the incision 198. The cannula tip 52 is advanced until the right atrial wall 182 is positioned within the circumferential purse string suture channel 82 of the cannula tip 52 at the incision 198. The purse string sutures 184, 186 are secured using a suture lock or other device (e.g., ) fit. Proper positioning of the cannula 50 position can be reconfirmed by adjusting the ball joint 56 within the clamp adapter 170 and by repositioning the surgical instrument holder 172. At this point, suction is also turned off and discontinued. The obturator 92 portion of the surgical access system 174 is removed from the incision 198 and the minimally invasive surgical site, thereby leaving the cannula 50 in place for any additional surgical procedures.

[0041] Figures 8A-8F They are Figure 3 8. The front view, left side view, right side view, rear view, top view and bottom view of the distal tip of the cannula of the present invention are shown in more detail from various angles. These views illustrate the features of the cannula tip 52 in more detail, including a circumferential purse-string suture channel 82, a longitudinal groove 84, a lace suture channel 86, a cannula tip opening 90 and several bridges 88. As shown above, each bridge 88 defines a bridge hole 89, which accommodates the lace suture. The lace suture can extend above or below the bridge 88 and does not need to pass through the bridge hole 89. Alternative embodiments of the cannula tip may not have a bridge or hole. Alternative embodiments of the cannula tip may have a tip with different configurations or angles and may have grooves or orifices of different numbers for holding sutures, lines, guide wires or tissues.

[0042] Fig. 9A and 9B is a front view of an alternative embodiment of an obturator for a surgical access system illustrating a rotation ramp feature. Fig. 9A 200 and 210. A front view of the distal tip of the obturator is shown in a retracted position. The obturator distal tip 200, which defines several tip ports 202 and a cutting element slot 204 as previously described, also defines a ramp recess 206 located on the outer circumference of the obturator distal tip 200. The ramp recess 206 is sized and configured to accommodate the rotational movement of a rotation ramp 208, which is shown here as a partially circular element. The rotation ramp defines an outer profile having a bottom surface 210 and a ramp surface 212, and a side profile surface 214. When viewed from a front end view, as shown in FIG. Fig. 9AAs shown, the bottom surface 210 is substantially circular, and when rotated, the inclined surface 212 extends circumferentially beyond the substantially circular contour defined by the bottom surface 210. When the rotation ramp 208 is in the retracted position, the side profile surface 214 defines an arc along the outer circumferential contour of the obturator distal tip 200. The rotation ramp 208 rotates about a pivot point 216. The rotation is controlled by an actuator 218, which is shown as a lever in this embodiment and is placed near the obturator distal tip 200, such as near the obturator knob 98 described above.

[0043] Fig. 9B A front view of the distal tip of the obturator in the extended position is shown. The actuator 218 has moved in the direction 220, which in turn rotates the rotation ramp 208 about the pivot point 216, so that the side profile surface 214 has moved into the ramp recess 206 and the ramp 212 is now located on the circumference of the obturator distal tip 200, thereby temporarily increasing the effective circumference of the obturator distal tip 200 when the rotation ramp 208 is in the extended position. It should be noted that for the purpose of temporarily increasing the effective circumference of the obturator distal tip 200, a shape different from the shape shown can be used in the rotation ramp 208. If additional circumference or girth is needed to help advance the cannula and obturator of the surgical access system into the incised atrial wall, the rotation ramp 208 has a shape that provides a temporary increase in the effective circumference of the obturator tip 200 when rotated. The rotation ramp 208 can be actuated, extended or retracted by an actuator 218, such as a lever shown or a button, knob or other device known to those skilled in the art. The actuator may alternatively be located elsewhere on the obturator. The rotation ramp 208 is also configured within the obturator distal tip 200 such that when the obturator is fully inserted into a cannula in the surgical access system, the rotation ramp 208 extends beyond the cannula tip, thereby allowing the rotation ramp 208 to extend beyond the circumference defined by the surgical access system. Fig. 9B In the actuated or extended position shown, the rotational ramp 208 expands or pulls the tissue in an outward direction so that it helps to move the tissue over the cannula tip and into the circumferential purse-string suture channel of the cannula tip.

[0044] Various advantages of surgical access systems and methods thereof for, for example, repairing tricuspid regurgitation have been discussed above. The embodiments discussed herein have been described by way of example in this specification. It will be apparent to those skilled in the art that the foregoing detailed disclosure is intended to be presented by way of example only and not by way of limitation. Although not expressly stated herein, various substitutions, improvements, and modifications will occur and are intended to be used by those skilled in the art. These substitutions, improvements, and modifications are intended to be presented herein and are within the spirit and scope of the claimed invention. In addition, the order of the listed processing elements or sequences, or the use of numbers, letters, or other names therefor, is not intended to limit the claims to any order unless specified in the claims. Therefore, the present invention is limited only by the appended claims and their equivalent arrangements.

Claims

1. A surgical access system, comprising: A cannula comprising a proximal end and a distal end, and further comprising: a cannula tube portion extending from a proximal end to a distal end along a cannula tube portion axis, and A distal tip at the distal end of the cannula tube, the distal tip having: one or more longitudinal channels distributed around the circumference of the distal tip, wherein the one or more longitudinal channels are configured to releasably secure a suture or suture tube; and one or more circumferential channels surrounding the distal tip, wherein the one or more circumferential channels are configured to guide suture or tissue; An obturator coaxially insertable into the cannula, the obturator comprising: distal tip; and a retractable cutting element having an actuator; and A spherical universal joint having a central channel extending along the central channel axis, a portion of the cannula tube portion being accommodated in the central channel so that the central channel axis is coaxially aligned with the cannula tube portion axis, wherein the spherical universal joint can be slidably displaced along the cannula tube portion axis and can be selectively locked to a portion of the outer surface of the cannula tube portion.

2. The surgical access system according to claim 1, wherein: The distal tip of the cannula further includes one or more bridge portions distributed circumferentially along the one or more circumferential channels.

3. The surgical access system according to claim 1, wherein: The cannula also includes an elongated tube.

4. The surgical access system according to claim 3, wherein: The distal tip of the cannula is continuous with the elongated tube of the cannula.

5. The surgical access system according to claim 1, wherein: The obturator also includes an elongated tube.

6. The surgical access system according to claim 5, wherein: The obturator further includes an obturator knob having a passage communicating with the interior of the elongated tube of the obturator.

7. The surgical access system according to claim 5, wherein: The distal tip of the obturator also includes one or more channels in communication with the interior of the elongated tube of the obturator.

8. The surgical access system according to claim 7, wherein: The distal tip of the obturator also includes two groups of one or more channels separated by a central channel.

9. The surgical access system according to claim 5, wherein: The obturator further includes a slidable plunger element configured to control fluid flow within the elongated tube of the obturator.

10. The surgical access system according to claim 9, wherein: The obturator also includes a hollow actuator coupled to the slidable plunger element.

11. The surgical access system according to claim 10, wherein: The obturator also includes an actuator rod coupled to the retractable cutting element.

12. The surgical access system according to claim 11, wherein: An actuator rod coupled to the retractable cutting element is slidably engaged within a hollow actuator coupled to the slidable plunger element.

13. The surgical access system according to claim 1, wherein: The retractable cutting element is selected from the group consisting of a blade, a scalpel, and scissors.

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