Skin base entrance

Abstract

Surgical access stabilization devices, systems, and methods are disclosed herein. For example, the devices, systems, and methods disclosed herein can be used to selectively establish, stabilize, and maintain a desired trajectory and / or positioning of a surgical access device during a surgical procedure. An exemplary surgical access stabilization device may include: a pad having a distally facing adhesive surface for bonding to an anchoring portion surface, a surgical access device coupled to the pad, and a locking mechanism that selectively locks the position of the surgical access device relative to the pad. In one embodiment, the anchoring portion surface may be the patient's skin. An exemplary surgical access device stabilization method may include: making an incision at a surgical site in a patient's body; inserting a surgical access device through the incision; bonding the pad to an anchoring portion surface, such as the patient's skin; coupling the surgical access device to the pad; and selectively locking the position of the surgical access device relative to the pad. Other exemplary devices, systems, and methods are also provided herein.

Description

Technical Field

[0001] Disclosed herein are surgical access stabilization devices and related methods, for example, for stabilizing a port or other surgical access device relative to a patient during a surgical procedure. Background Art

[0002] In many cases, it may be desirable to stabilize an instrument or object. In surgical applications, for example, it may be desirable to stabilize a surgical access device, such as a port, relative to a patient during a surgical procedure. By way of another example, it may be desirable to establish, stabilize, and maintain a desired trajectory of a surgical access device during a surgical procedure to accommodate instruments, objects (e.g., implants), etc. that are passed through the access device percutaneously to reach a surgical site. Furthermore, it may be desirable to stabilize the surgical access device in a manner that minimizes interference with the surgical procedure during surgery and allows the surgical access device to be easily and quickly adjusted to different positions, if necessary.

[0003] In current practice, surgical instruments or objects are often stabilized by being connected or linked to another instrument or object. Typically, a rigid connector is used to stabilize a surgical instrument by connecting or linking the surgical instrument to a support. For example, a robotic arm connector can be used to connect a surgical access device to a support such as an operating bed or a rigid implant column to stabilize the access device during a surgical procedure. Prior art stabilization methods and devices rely on at least one additional stationary object at or near the surgical site to be linked to the surgical access device. Such systems may be particularly cumbersome in minimally invasive surgeries where the operating area is small in size and only a limited amount of space is available for manipulation.

[0004] In addition, using a rigid mechanical arm connector to stabilize surgical access devices constrains surgery in several ways. For example, the position of a support (e.g., an operating table or a rigid implant column) determines the position of the access device based on the size and configuration of the mechanical connector. Similarly, the rigid mechanical connector of the prior art will limit the range of movement of the access device once connected to the support. Typically, surgeons expect to perform a wider range of motion in at least one preferred direction based on the anatomical structure of the operation during surgery. For example, in spinal surgery, surgeons typically want to be able to achieve greater port movement in a direction transverse to the spine. Due to the physical constraints of the connector and the accompanying support structure, the rigid connector prevents this desired movement. In addition, the flow of the surgical operation can be determined by the connector stabilization system of the prior art, rather than by the surgeon's expertise. For example, in the case of stabilizing the surgical access device by being connected to a pedicle screw or other implant column, before inserting and stabilizing the access device, the contralateral screw must first be placed in the patient's body.

[0005]

[0006] Therefore, there remains a need for devices and techniques for establishing, stabilizing and maintaining desired trajectories and positioning of surgical instruments, particularly surgical access devices, during surgical procedures in an easier, less constrained manner. Summary of the invention

[0006] The present invention generally provides devices and methods for stabilizing surgical access devices. Specifically, the devices and methods described herein can be used to stabilize a surgical access device (such as a port) relative to an anchor surface (e.g., a patient's skin) within a surgical incision. In one aspect of the present invention, a surgical access stabilization device is provided, the device comprising: a pad having a proximal-facing surface and a distal-facing adhesive surface; a surgical access device coupled to the pad; and a locking mechanism that selectively locks the position of the surgical access device relative to the pad.

[0007] The above-described surgical access stabilization device may have a variety of modifications within the scope of the present invention. For example, in some embodiments, the pad may have an opening extending therethrough to receive the locking mechanism. Further, in some embodiments, the opening may be an elongated slot. In some embodiments, the opening may be centrally located on the pad. The pad may also include an imaging feature to assist in imaging the pad. In some embodiments, the pad may include a navigation feature to assist in navigating the surgical access device. In certain embodiments, the pad may have a central portion having at least one radial finger. In some embodiments, the pad may be made of any of a flexible fabric, an elastomer, and a polymer.

[0008] In some embodiments, the locking mechanism can selectively lock translational movement of the surgical access device in a direction along the proximal-facing surface of the pad. In some embodiments, the locking mechanism can selectively lock translational movement of the surgical access device in a direction transverse to the proximal-facing surface of the pad. Still further, in some embodiments, the locking mechanism can selectively lock any of rotational movement of the surgical access device and angular movement of the surgical access device. The locking mechanisms of the present invention can take a variety of forms. For example, in some embodiments, the locking mechanism can include at least one locking ring. While in other embodiments, the locking mechanism can include any of a releasable adhesive and a hook and loop fastener.

[0009] In another aspect, a surgical access stabilization system is provided that includes a pad having a proximally facing surface and a distally facing adhesive surface; a surgical access device defining a working channel; and a connection mechanism coupled between the pad and the surgical access device to place the surgical access device at a location distal to the pad.

[0010] The surgical access stabilization system described above may have a variety of modifications within the scope of the present invention. For example, in some embodiments, the connection mechanism may include an arm that is coupled to the surgical access device at a first end and to the pad at a second end. Further, in some embodiments, the arm may be capable of bending to adjust the arrangement of the first end relative to the second end.

[0011] In another aspect, a method of stabilizing a surgical access device is provided, the method comprising: making an incision in a patient; adhering a pad to the patient; inserting the surgical access device through the incision in the patient; coupling the surgical access device to the pad; and selectively locking a position of the surgical access device relative to the pad.

[0012] The above-described surgical access stabilization method may have various modifications within the scope of the present invention. For example, in some embodiments, the method may further include positioning the surgical access device within the incision by at least one of translating, rotating, and angulating the surgical access device relative to the pad.

[0013] In other embodiments, selectively locking the position of the surgical access device can prevent further translation, rotation, or angulation of the surgical access device relative to the pad.

[0014] In some embodiments, the pad may be bonded to the patient after the incision is made. In other embodiments, the pad may be bonded to the patient before the incision is made. In certain embodiments, the pad may be bonded to the patient at a location away from the incision.

[0015] In some embodiments, coupling the surgical access device to the pad can include positioning the surgical access device within an opening of the pad. In other embodiments, coupling the surgical access device to the pad can include coupling the surgical access device to the pad using a connector arm.

[0016] In other embodiments, the surgical access device stabilization method can further include deploying at least a portion of the pad from the surgical access device after inserting the surgical access device through the incision.

[0017] Any of the above features or variations can be applied to any specific aspect or embodiment of the present disclosure in a variety of different combinations. No specific combination is explicitly described only to avoid redundancy in the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The above-described aspects and embodiments of the present invention will be more fully understood from the following detailed description in conjunction with the accompanying drawings, in which:

[0019] Figure 1 is a perspective view of one embodiment of a surgical access stabilization device having a base pad and a locking mechanism in which a surgical access device is disposed;

[0020] Figure 2 yes Figure 1 A perspective view of a surgical access stabilization device;

[0021] Figure 3 yes Figure 1 a cross-sectional view of a surgical access stabilization device having a surgical access device disposed therein;

[0022] Figure 4 yes Figure 1 A perspective view of a surgical access stabilization device having a surgical access device disposed therein;

[0023] Figure 5 yes Figure 1 A perspective view of a base pad;

[0024] Figure 6 Is has Figure 1 A perspective view of a pad engaging a base portion of a locking mechanism;

[0025] Figure 7 Is has Figure 6 An exploded view of a base engaging a base portion;

[0026] Figure 8 yes Figure 6 A perspective view of the base;

[0027] Fig. 9 yes Figure 6 Top view of the base;

[0028] Fig.10 yes Figure 1 A perspective view of a base and a pedestal, a skirt, and a split ring of a locking mechanism of a surgical access stabilization device having a surgical access device disposed therein;

[0029] Fig.11 yes Fig.10 A perspective view of a skirt;

[0030] Fig.12 yes Fig.10 A perspective view of the split ring;

[0031] Fig.13 yes Figure 1 A perspective view of a skirt of a locking mechanism and a split ring in which a surgical access device is disposed;

[0032] Fig.14 yes Figure 1 A perspective view of a base, skirt, split ring and buckle of a locking mechanism of FIG.

[0033] Fig.15 yes Fig.14 A cross-sectional view of a locking mechanism component;

[0034] Fig.16 yes Fig.14 Top view of the buckle;

[0035] Fig.17 yes Fig.16 A perspective view of the buckle;

[0036] Fig.18 is with Figure 1 A top view of a base of a locking mechanism engaging a buckle;

[0037] Fig.19 yes Fig.19 A cross-sectional view of

[0038] Fig. 20 yes Figure 1 A perspective view of a surgical access stabilization device having a surgical access device disposed therein;

[0039] Fig.21 yes Fig. 20 A cross-sectional view of a locking mechanism;

[0040] Fig. 22 is a perspective view of an embodiment of a first locking block;

[0041] Fig.23 is a perspective view of an embodiment of a second locking block;

[0042] Fig.24 yes Fig.23 A sectional view of a second locking block;

[0043] Fig.25 yes Fig. 22 A cross-sectional view of a second locking block engaged with the skirt portion;

[0044] Fig.26 is a representation of an exemplary surgical application of one embodiment of a surgical access stabilization device;

[0045] Fig. 27 is a representation of another exemplary surgical application of an embodiment of a surgical access stabilization device;

[0046] Fig.28 is a pictorial representation of a surgical access stabilization device of the present invention for use in spinal surgery having a rigid port tube disposed therein;

[0047] Fig.29 is a pictorial representation of a surgical access stabilization device of the present invention for use in spinal surgery having a flexible barrier port disposed therein;

[0048] Fig.30 is a representation of an exemplary surgical application of another embodiment of a surgical access stabilization device;

[0049] Fig.31 is a representation of an exemplary surgical application of another embodiment of a surgical access stabilization device;

[0050] Fig.32 is a representation of an exemplary surgical application of another embodiment of a surgical access stabilization device;

[0051] Fig.33 is a perspective view of another embodiment of a surgical access stabilization device having a surgical access device disposed therein;

[0052] Fig.34 yes Fig.33 A representation of an exemplary base pad of a surgical access stabilization device;

[0053] Fig.35 is a representation of another embodiment of a surgical access stabilization device having a surgical access device disposed therein;

[0054] Fig.36 yes Fig.35 Another view of the surgical access stabilization device;

[0055] Fig.37 yes Fig.35 A representation of another exemplary surgical application of a surgical access stabilization device;

[0056] Fig.38 yes Fig.35 A representation of another exemplary surgical application of a surgical access stabilization device is shown;

[0057] Fig.39 is an illustration of another embodiment of a surgical access device of the surgical access stabilization device of the present invention;

[0058] Fig.40 is a perspective view of another embodiment of a handle of a surgical access stabilization device of the present invention;

[0059] Fig.41 yes Fig.40 An exploded view of the handle of

[0060] Fig.42 yes Fig.40 A perspective view of the body of the handle. DETAILED DESCRIPTION

[0061] Certain exemplary embodiments will now be described to understand the principles of the structure, function, manufacture and use of the devices, systems and methods disclosed herein as a whole. One or more examples of these embodiments are shown in the accompanying drawings. It will be appreciated by those skilled in the art that the devices, systems and methods specifically described herein and shown in the accompanying drawings are non-restrictive exemplary embodiments. The features shown or described in conjunction with an exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure.

[0062] Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed devices and methods, such dimensions are not intended to limit the types of shapes that may be used in conjunction with such devices and methods. One skilled in the art will recognize that equivalent dimensions to such linear and circular dimensions may be readily determined for any geometric shape. Still further, the size and shape of the device and its components may depend at least on the anatomy of the subject in which the device will be used, the size and shape of the components with which the device will be used, and the method and procedure in which the device will be used.

[0063] Although the illustrated embodiments and the accompanying descriptions are particularly referenced to spinal surgery, and in particular, to applications in minimally invasive spinal surgery, the devices, systems, and methods described herein are not limited to these applications. Rather, the devices, systems, and methods described can be used in a variety of applications that require or benefit from stabilization of an object, and are particularly well suited for surgical applications to stabilize a surgical access device relative to a patient at one or more desired positions, trajectories, or orientations during a surgical procedure.

[0064] Figures 1 to 4 A first exemplary embodiment of a surgical access stabilization device 100 is shown. The device 100 can be used to stabilize a surgical access device, such as a port or access device 10, inserted through an incision in a patient. Preferably, the surgical access stabilization device of the present invention can be patient mounted to stabilize the surgical access device relative to the patient. The device 100 can selectively limit any of the translational movement, rotational movement, or angular movement of the port relative to the patient. In addition, the surgical access stabilization device 100 can be used to establish, stabilize, and maintain the surgical access device at a desired trajectory during a surgical procedure and can be easily adjusted as needed.

[0065] Figure 1A preferred embodiment of a surgical access stabilization device according to the present invention is shown. The surgical access stabilization device 100 is shown as having a surgical access device, such as a port or access device 10, engaged therein. The surgical access stabilization device 100 may include a base pad 102 and a locking mechanism 104 described in more detail below. The locking mechanism 104 may be configured to couple and secure the port 10 to the pad 102. The locking mechanism may further be configured to facilitate positioning and adjustment of the port 10, and may selectively lock movement of the port relative to the pad. The pad 102 may have a distally facing adhesive surface configured to contact and adhere to an anchoring portion surface. In a preferred embodiment, the anchoring portion surface may be the patient's skin, and the distally facing surface of the pad may be a patient contacting surface. The proximal facing surface of the pad may be exposed to the user and may include features for facilitating placement of the pad and adjustment of the port 10 during surgery.

[0066] Figure 2 Shows Figure 1 A surgical access stabilization device in which no surgical access device is disposed. A central opening 101 can extend through the surgical access stabilization device 100 and can be configured to receive the port 10. Figure 2 As shown, in some embodiments, the central opening 101 can extend through the locking mechanism 104 and the pad 102. The central axis A1 of the surgical access stabilization device can extend through the central opening 101 orthogonal to the proximal surface of the pad. The port 10 can be inserted distally through the central opening 101 along the axis A1 so that the port 10 is received in the surgical access stabilization device. Figure 3 Shows Figure 1 , which shows a surgical access stabilization device 100 having a port 10 inserted through a central opening 101. Here, the various components that make up one embodiment of a locking mechanism 104 can be seen in an assembled configuration. In one embodiment, the locking mechanism 104 can include a base 200, a buckle 202, a skirt 204, a split ring 206, a first locking block 208, and a second locking block 210, each of which will be described in more detail below with reference to additional figures.

[0067] The port 10 may have a proximal end 10p and a distal end 10d and an inner cavity 20 extending therebetween and having a longitudinal axis A2. When the port 10 is inserted into the surgical access stabilization device 100, the proximal end 10p of the port 10 may remain proximal to the surgical access stabilization device, while the distal end 10d of the port 10 may extend distally beyond the surgical access stabilization device through an incision in the patient's body to the surgical site. It should be understood that in Figure 1 and Figure 3In the orientation shown, the longitudinal axis A1 and the port axis A2 of the surgical access stabilization device are collinear due to the depicted orientation of the port 10 relative to the surgical access device 100. More specifically, the port 10 is shown inserted into the surgical access device 100 without any angle relative to the pad 102 such that the port axis A2 is aligned with the longitudinal axis A1 of the surgical access device 100. When the port 10 is angled relative to the surgical access device 100, the longitudinal port axis A2 may be offset or angled relative to the longitudinal axis A1 of the surgical access stabilization device. This is because movement of the port 10 relative to the pad 102 may adjust the angle between the port axis A2 and the stabilization device axis A1. For example, as may be seen in FIG. Figure 4 As can be seen in FIG. 1 , port 10 can be angled relative to pad 102 within locking mechanism 104 such that port axis A2 is displaced by angle α from longitudinal axis A1 of the surgical access stabilization device. It should be appreciated that angle α of zero degrees corresponds to a co-linear orientation of port 10 and the longitudinal axis of the surgical access stabilization device.

[0068] Return to Figure 3 , the port 10 may have a handle 12 to allow an operator to manipulate the port 10 within the surgical access stabilization device. The handle 12 may include a grip portion 14 and a port extension 16. The port extension 16 may extend axially to engage with the proximal port end 10p so that the lumen of the port extension is aligned with the port lumen 20. Extending the lumen 20 by engaging the handle 12 may facilitate easier insertion of instruments, implants, etc. through the lumen 20 of the port 10. In one embodiment, the outer surface of the port 10 may have an engagement feature 18 that is configured to mate with a complementary engagement feature of the handle 12 to secure the port in a desired longitudinal position. For example, the outer surface of the port 10 may have a plurality of longitudinally aligned grooves 18. In one embodiment, the port extension 16 of the handle 12 may have at least one inwardly extending protrusion that is configured to selectively engage with at least one of the grooves 18 of the port 10. In this way, by adjusting the engagement between the port extension and the plurality of grooves 18, the handle may be placed at a desired position on the port 10. Those skilled in the art will appreciate that alternative engagement methods may be used to engage the handle 12 with the port 10. With the handle 12 secured to the port 10, the grip 14 may be used to move the port 10 in any of a rotational, angular, or translational direction relative to the pad 102 and the axis A1. Alternatively, the proximal end 10p of the port may be manipulated directly without attaching a handle thereto to facilitate port movement.

[0069] The gripping portion 14 may extend in a direction substantially transverse to the port axis A2 and may be configured to facilitate manipulation of the port by a user. The gripping portion 14 may include any of a variety of geometric shapes. In one embodiment, as Figure 1 and Figure 3 As depicted, the grip portion 14 may have an inclined lever shape with a semicircular end. Preferably, the grip body may be inclined in the proximal direction. The grip body 14 may be shaped to facilitate easy grasping and manipulation by a user. For example, the inclined portion of the grip portion 14 may have a contour that can comfortably receive a user's hand or fingers.

[0070] Figures 5 to 25 Various exemplary components of the stabilization device 100 are shown. Figure 5 An exemplary embodiment of a base pad 102 is shown. The pad may have a proximal-facing surface 102p and a distal-facing adhesive surface (not shown). The distal-facing adhesive surface may be bonded to the anchoring portion surface so that the pad 102 is fixed to the anchoring portion surface. For example, the pad 102 may be bonded to the patient's skin so that the pad 102 is firmly anchored relative to the patient. However, in other embodiments, the pad 102 may be bonded to any kind of surface. The pad 102 may preferably be made of a flexible material so that the pad can be closely contoured with the anchoring portion surface. The flexible pad 102 may allow the pad to be closely contoured with the patient's skin at any one of a variety of application locations. The side of the pad 102 facing the distal side of the adhesive may have a distal adhesive layer. For example, the adhesive layer may be a medical grade adhesive.

[0071] By way of non-limiting example, the pad 102 may be made of any of a flexible fabric, an elastomer, and a polymer. Exemplary materials may include synthetic rubber or natural rubber. In one embodiment, the pad 102 may be made of a thin polymer such as, for example, rubber, neoprene, polytetrafluoroethylene (PTFE), etc. In some embodiments, the thin polymer pad may have a thickness of 1 mm to 5 mm. In other embodiments, the thin polymer pad may have a thickness of 1.5 mm to 3.5 mm.

[0072] The pad 102 can have any of a variety of sizes and shapes and can be tailored to a particular surgical procedure or application. For example, the shape of the pad 102 can be configured to cover the entire sterile drape opening. In one embodiment, as Figure 5 As shown, the pad 102 can have a generally four-sided shape with rounded corners. Alternatively, the pad can have a low-profile shape to contour to the anatomy of a patient of short stature, such as the waist. Further, the pad 102 can be cut, trimmed, or otherwise shaped to facilitate placement for a particular application or surgical procedure. For example, the pad 102 can be cut to conform to an obstruction or object that can be placed at or near a surgical site.

[0073] The pad 102 may have an opening 106 extending through the pad from the proximal-facing surface 102p to the distal-facing surface. It should be understood that the opening 106 may have any of a variety of different shapes and sizes. In addition, the opening 106 may be placed at a variety of different locations on the pad 102. For example, the opening 106 may be generally circular and located at a central portion of the pad 102, such as Figure 5 Alternatively, the opening 106 can be positioned off-center or closer to the edge of the pad 102. The pad 102 can have a concave portion 108 surrounding the opening 106. The concave portion 108 can facilitate smoother engagement and relative movement between the locking mechanism 104 and the pad 102. In one embodiment, the concave portion 108 of the pad 102 can have a shape similar to or curved like a distal-facing portion of the locking mechanism 104, as will be discussed in more detail herein.

[0074] The pad 102 may have one or more engagement features configured to removably attach the pad to the locking mechanism. In one embodiment, one or more protrusions 110 may extend proximally from the proximal-facing surface of the pad 102. The protrusions 110 may be configured to engage with one or more complementary portions of the locking mechanism 104 to facilitate a secure connection between the pad 102 and the locking mechanism 104. In one embodiment, the protrusions 110 may be generally rectangular or oval and extend a distance above the proximal-facing surface of the pad 102. In one embodiment, the pad 102 may include a plurality of protrusions 110 spaced apart around the periphery of the opening 106. Any number of protrusions 110 may be formed on the pad 102 so that the locking mechanism 104 can be stably mated with the pad 102. Although the protrusions 110 are shown as being located around the periphery of the opening 106, the protrusions 110 may be placed in any of a variety of positions on the pad 102. One of ordinary skill in the art will recognize that other engagement features and methods may be used to secure the locking mechanism 104 to the pad 102. Non-limiting examples of engagement features include a snap-fit ​​mechanism, a lock and key mechanism, any of a variety of screws or other threaded features, and the like.

[0075] The pad may also include various features to assist or aid the user. The pad may have imaging features to facilitate imaging of the pad during positioning. For example, the pad 102 may include radiopaque markers 112 to facilitate fluoroscopic identification during positioning. The radiopaque markers may be identified by an imaging system to provide accurate feedback regarding the placement of the pad 102. In one embodiment, the markers 112 may facilitate positioning a locking mechanism engaged within the pad 102 or the opening 106 of the pad 102 at a known distance from the patient's midline. The pad 102 may include navigation features to facilitate navigation of a surgical access device coupled to the pad. For example, the pad may have reflective fiducials or markers to facilitate surgical navigation of a coupled surgical access device trajectory or axis placement.

[0076] In one embodiment, the locking mechanism 104 can be attached to the pad 102 through the opening 106 so that a portion of the opening 106 and the central opening of the locking mechanism 104 are aligned to form the central opening 101 of the surgical access stabilization device. In an exemplary embodiment, the base 200 of the locking mechanism 104 can be connected to the pad 102, such as Figure 6 As shown. The base 200 can serve as the primary contact between the locking mechanism 104 and the pad 102. The base 200 can include an opening 216 that can be aligned with at least a portion of the pad opening 106. Although the base 200 is depicted as having a generally ring shape, it should be understood that the base 200 can have any of a variety of shapes. The base 200 and the pad 102 can be preassembled as a single unit prior to surgery. Alternatively, the pad 102 and the base 200 can be constructed as two separate components that can be attached during surgery before or after the pad 102 is bonded to the anchor surface. For example, the pad 102 can be bonded to the anchor surface at a desired location. When the pad is fixed, the engagement feature of the base 200 can engage with the engagement feature of the pad 102 so that the base 200 is securely attached to the pad 102.

[0077] By way of non-limiting example, Figure 7 As shown, the engagement feature of the base 200 can be configured as a slot 209. The slot 209 can extend through the base 200 and can be configured to receive the protrusion 110 of the pad 102. The base 200 can be securely attached to the pad 102 by placing the protrusion 110 of the pad within the slot 209 of the base to form a snap fit between the base and the pad. It should be understood that alternative attachment mechanisms can be used to secure the base 200 to the pad 102. The base 200 can have a tapered portion 218 extending inwardly from an outer portion of the base 200 to the opening 216. Preferably, the tapered portion 218 can have a geometry that is complementary to the geometry of the concave portion 108 of the pad 102. When the base 200 is attached to the pad 102, the tapered portion 218 of the base 200 and the concave portion 108 of the pad 102 can be aligned to seat the base 200 within the pad 102.

[0078] Figure 8A perspective view of the base 200 is shown. A platform 220 may be formed between the tapered portion 218 and the outer rim wall 222. The outer rim 222 may extend proximally from the platform 220, thereby forming a ring around the outer edge of the base. In one embodiment, the outer rim 222 may taper from a distal end to an opposite proximal end at a junction with the platform 220. The outer rim 222 may include one or more extension segments 224 having an upper lip at the proximal end of the rim 222, the upper lip extending radially inwardly above the platform 220, so that a groove 225 is formed between the upper lip of the extension segment 224 and the surface of the platform 220. A transition portion 226 may be formed at one end of each extension segment 224. In a preferred embodiment, the transition portion 226 may be formed at the distal end of each extension segment 224, as measured in a clockwise direction along the periphery of the base 200. The transition portion 226 can be a solid portion extending distally from the upper lip to the platform 220. In other words, the transition portion 226 forms a stop in the circumferential groove 225. The transition portion 226 can also define a transition between the extension segment 224 and the recessed segment 228. The recessed segment 228 does not have any portion extending radially inward beyond the outer rim 222. As such, the transition portion 226 can have an outer edge that deflects radially outward from a radially inward position of the extension segment 224 to a position at the inner surface of the rim. The recessed segment 228 can form a recessed portion or pit area between two extension segments 224.

[0079] As from Fig. 9 As can be seen from the top view of the base 200 in FIG. 1 , one embodiment of the base 200 may include three extended segments 224 separated by three recessed segments. Preferably, one of the recessed segments may be a modified recessed segment 229. The tab portion 230 may be pushed radially outward by an object inserted into the base 200 and rotated in a clockwise direction. Once the outward force is removed, the tab portion 230 may return to the position as shown in FIG. Fig. 9The tab portion 230 may be formed by a channel 232 that extends radially inward from the outer edge of the rim 222 and continues to extend a certain distance in the circumferential direction along the platform 220. The tab portion 230 may be formed to include a stop 227 that is similar to the transition portion 226 described above and extends distally to the platform 220. As discussed below, the buckle 202 may be rotatably received in the base 200 so that the buckle can rotate between a locked state and an unlocked state. The tab 230 can fix the buckle in the locked position and prevent the buckle from being rotated back to the unlocked state undesirably. The identification feature 234 may extend from a portion of the tab 230 to assist the user in orienting and assembling the surgical access stabilization device. For example, the identification structure 234 may extend proximally from the stop 227 of the tab portion 230. In one embodiment, to return the buckle from the locked state to the unlocked state, the user may locate the tab 230 by the identification structure 234 and simultaneously push the tab 230 outward and rotate the buckle 202 to the unlocked position by applying force to the tab 230 .

[0080] Additional exemplary features of locking mechanism 104 will now be described. Fig.10 is a perspective view of several components of the pad 102 and the locking mechanism 104 that couples the port 10 to the pad. In addition to the base 200, Fig.10 The skirt 204 and the split ring 206 of the locking mechanism 104 are shown. With the base 200 coupled to the pad 102, the skirt 204 can be placed atop the proximal-facing surface of the base 200. Fig.11 and Fig.15 As best shown, the skirt 204 may preferably have a tapered surface 318. The surface 318 may have a surface taper that is complementary to the tapered surface 218 of the base 200. The skirt 204 may be positioned so that the tapered surface 318 of the skirt 204 is disposed within the tapered surface 218 of the base 200. The tapered surface 318 of the skirt 204 may extend inwardly from the outer edge of the skirt 204 toward the opening 316. In one embodiment, the tapered surface 318 may be generally annular in shape and form the body of the skirt 204. It should be understood that the skirt 204 may have any of a variety of shapes. When the skirt 204 is disposed within the base 200, the opening 316 of the skirt 204 may be aligned with the opening 216 of the base 200 and at least a portion of the opening 106 of the pad 102.

[0081] The skirt 204 can have an extension 320 extending proximally from the surface 318 to define the opening 316. In one embodiment, the inner surface 324 of the extension 320 defining the opening 316 can be a preferably smooth surface that tapers from the proximal end of the opening to the distal end of the opening. As will be described below, the smooth tapered surface 324 can facilitate rotation and angular movement of the split ring 206 and the surgical access device received therein relative to the skirt 204. The extension 320 can include an engagement feature that is configured to engage with another portion of the locking mechanism 104, and preferably engage with a locking block of the locking mechanism 104. In one embodiment, the engagement feature can be an external thread 322 formed on the outer surface of the extension 320. Other means for engaging the skirt 204 to the locking block of the locking mechanism 104 are also considered to be within the scope of the present invention.

[0082] The skirt 204 may preferably be made of a polymer or other flexible material. The skirt 204 is configured such that the skirt can translate in accordance with the translational movement of the surgical access device received by the surgical access stabilization device 100. The thickness of the skirt 204 may preferably be slightly less than the height of the cavity formed between the base 200 and the buckle 202. As will be described in detail below, the outer portion of the skirt 204 may be slidably received in the cavity such that the skirt 204 can translate in any radial direction along the base 200.

[0083] Fig.12 A split ring 206 is shown that can be received within the opening 316 of the skirt 204 to facilitate coupling a surgical access device to the pad 102 via the locking mechanism 104. The split ring 206 can have an opening 416 configured to receive a surgical access device. The opening 416 can be defined by a peripheral wall 400 having an outer surface 402 and an inner surface 404. In one embodiment, the outer surface 402 and the inner surface 404 can have different shapes such that the peripheral wall 400 has a non-uniform thickness. By way of non-limiting example, the outer surface 402 can be generally circular and the inner surface 404 can be oval or egg-shaped. In a preferred embodiment, the inner surface can have a perimeter corresponding to the shape of a surgical access device to be received therein. The outer surface 402 of the split ring 206 can have a curved profile, while the inner surface 404 can have a linear profile. The curved profile of the outer surface 402 can allow the split ring 206 to move more easily relative to the skirt opening 316. In this manner, the split ring 206 can be rotated or angled relative to the skirt and the longitudinal axis A1 of the surgical access stabilization device. Fig.13 The skirt 204 is shown with the split ring 206 receiving the port 10 through the opening 416 of the split ring. As can be seen, the port has an egg-shaped outer surface that is mirrored by the shape of the inner surface 404 of the split ring 206.

[0084] Return to Fig.12 , a channel 410 extending through the peripheral wall 400 may be formed. The channel 410 may provide flexibility to the split ring 206 so that the split ring can be expanded to accommodate a greater number of surgical access devices within the opening 416. The split ring 206 may have one or more engagement features configured to facilitate selective longitudinal positioning of the surgical access device 10 received in the opening 416. In one embodiment, at least one inwardly protruding protrusion 408 may be formed on the inner surface 404 to engage with a complementary feature (such as a plurality of grooves 18) formed on the outer surface of the surgical access device. When the surgical access device is passed distally through the opening 416, the interaction between the split ring engagement feature and the complementary feature formed on the outer surface of the surgical access device may allow the surgical access device to be more easily aligned and longitudinally adjusted relative to the inner ring. The engagement features of the split ring 206 with the inserted surgical access device may provide a secure connection between the two components so that the split ring 206 may move according to the force applied to the surgical access device. Additionally, the complementary engagement features of the split ring and the surgical access device can provide beneficial tactile feedback to the user regarding alignment and engagement of the surgical access device with the inner ring.

[0085] Fig.14 A perspective view of a locking mechanism is shown, including the assembled base 200, skirt 204, split ring 206, and buckle 202. As shown, the opening 416 of the split ring 206 may extend through the various components of the assembled locking mechanism. Fig.15 The cross-sectional view of shows how the various components of the locking mechanism 104 can be assembled relative to each other. The skirt 204 can be placed so that the outer portion of the skirt can be slidably received in the cavity 212 formed between the proximal-facing surface of the base 200 and the buckle 202. The skirt 204 can thus be translated within the cavity 212 using a force applied by a user. The split ring 206 can be placed within the opening defined by the extension 320 of the skirt 204. As discussed above, the outer curved surface 402 of the split ring 206 can be rotatably received by the inner surface 324 of the extension 320. The split ring 206 can thus be angled or rotated throughout a full range of motion within the opening 316 of the skirt 204.

[0086] Now refer to Figures 15 to 19 The buckle 202 is described in more detail. Fig.16A top view of one embodiment of a buckle of the present invention is shown. In one embodiment, the buckle 202 may have an annular body 500 having a rim 504 having at least one radially extending protrusion 502. The buckle 202 may be configured so that the buckle can be placed and fixed in the base 200. In one embodiment, the radially extending protrusion can engage with a feature of the base 200 to securely place the buckle in the base 200. The body 500 may define an opening 516, at least a portion of which may be aligned with other components of the locking mechanism to form a central through opening 101. The buckle 202 may be sized so that the buckle fits in the base. In addition, the buckle body 500 may extend radially inward at a distance removed from the surface of the base 200, thereby forming a circumferential cavity 212 between the base 200 and the body 500, which is configured to slidably receive the skirt 204. In one embodiment, the opening 516 may be generally circular and formed at a central location of the buckle 202. Preferably, the opening 516 may have a diameter greater than the diameter of the opening 216 of the base 200 and greater than the diameter of the opening 316 of the skirt 204.

[0087] The body 500 may have a generally stepped profile formed by an outer edge 504, a proximally extending portion 506, and a lateral extending portion 510. The proximally extending portion 506 may extend proximally from the edge 504. Fig.15 As best seen in the figure, the proximally extending portion 506 can form an outer circumferential ring of the body 500 having a radial thickness that is less than the radial thickness of the body 500. The lateral extension 510 can extend radially inward from the proximal end of the proximal extension 508 toward the opening 516. Specifically, the lateral extension 510 can be elevated a distance from the distal end of the proximal extension 508 such that the cavity 212 is formed below the lateral extension 510 from the inner radial point of the body 500 radially outward to the inwardly facing surface of the proximal extension 506.

[0088] In other words, the body 500 may have a solid wall circumference (i.e., the proximal extension 508) and an overhang (i.e., the lateral extension 510) that does not extend the entire distal length of the solid wall circumference, but rather creates a radial void at the distal portion of the retaining ring 202. The lateral extension 510 may have a tapered profile such that the height of the lateral extension 510 increases in the radially inward direction. Preferably, the taper of the lateral extension 510 may be complementary to the tapered portion 218 of the base 200. In this way, the radial cavity 212 formed between the distally facing surface of the lateral extension 510 and the proximally facing surface of the base 200 (specifically, the proximally facing surface of the tapered portion 218 of the base 200) may maintain a consistent height in the radial direction. Placing the retaining ring 202 within the base 200 creates the radial cavity 212. The components of the locking mechanism 104 may be sized such that the skirt 204 may slidably fit within the cavity 212 .

[0089] The radially inward surface of the lateral extension 510 may have threads 512 configured to engage with another component of the locking mechanism 104. As will be described in detail below, the threads 512 may preferably engage with threads of the first locking block 208. It should be understood that alternative engagement mechanisms between the retaining ring 202 and the first locking block 208 are possible, so long as the first locking block 208 can be selectively tightened or locked relative to the retaining ring 202.

[0090] refer to Fig.17 , radially extending protrusions 502 extend radially outward from the edge 504 and may be configured to engage with the grooves 225 of the base 200. Inserting the retaining ring 202 into the base 200 may include aligning the radially extending protrusions 502 with the recessed portion 228 of the base 200 so that the protrusions 502 are aligned with the grooves 225. Once inserted, the retaining ring 202 can be secured within the base 200 by rotating the retaining ring 202 so that the leading edge 518 of the radially extending protrusions 502 abuts the edge of the transition portion 226 of the base 200. The proximal-facing surface of the main lateral extension 510 may have at least one protrusion 514 to assist the user in grasping the retaining ring 202 and rotating it from the proximal-facing surface. In this way, the protrusions 502 may be received within the extension 224. Fig.18 As can be seen, the leading edge 518 and the transition portion 226 can have complementary geometries such that the leading edge 518 mates with the transition portion 226. With the leading edge 518 abutting the transition portion 226, the extension portion 224 of the base 200 extends over the radially extending protrusion 502, thereby restricting movement of the retaining ring 202 in the longitudinal direction relative to the base 200. In a preferred embodiment, the extension portion 224 of the base 200 can extend inwardly a radial distance such that a small gap 240 can be formed between the inwardly facing surface of the extension portion 224 and the outwardly facing surface of the body 500.

[0091] Fig.19 yes Fig.18 , which shows the buckle 202 engaged with the base 200 and rotated so that the protrusions 502 are aligned with the extension segments 224. In this locked position, the leading edge 518 of each protrusion 502 can be seen abutting the transition portion 226 of the base 200. The cavity 212 configured to slidably receive the skirt 204 can be seen between the inner surface of the lateral extension 510 and the base 200.

[0092] Fig. 20 A surgical access stabilization device 100 is shown having a locking mechanism 104 having a first locking block 208 and a second locking block 210. In the illustrated embodiment, the locking mechanism 104 may include a first locking block and a second locking block to selectively lock the position of the surgical access device relative to the base pad. In a preferred embodiment, the first locking block and the second locking block (e.g., 208 and 210) may be locking rings. In other embodiments, the locking mechanism 104 may include, for example, at least one releasable adhesive site, a threaded locking knob, or a lever-action tightening wheel. It should be understood that it is contemplated that any of the locking components disclosed herein are used alone or in combination to selectively lock the movement of the surgical access device relative to the pad. In an exemplary embodiment, as Fig.21 As shown in the cross-sectional view of FIG. 2 , first locking block 208 can be a locking ring configured to engage with retaining ring 202 to selectively lock the translational movement of an inserted surgical access device (such as port 10). Second locking block 210 can be a locking ring configured to engage with skirt 204 to selectively lock the rotational movement, angular movement, and translational movement of a surgical access device (such as port 10) inserted into open ring 206.

[0093] Fig. 22 A perspective view of an embodiment of the first locking block 208 is shown. Preferably, in one embodiment, the first locking block can be generally annular, having a wall 602 and an opening 608. The outer diameter of the first locking block can preferably be substantially equal to or slightly less than the inner diameter of the buckle 202. The outer surface of the wall 602 can have an engagement feature 604 that is configured to engage with a complementary engagement feature of the buckle 202. Preferably, the engagement feature can be a thread 604 formed on the outer surface of the wall 602. A tab 606 can extend radially from an upper portion of the wall 602 to facilitate rotating or otherwise moving the first locking block 208. In one embodiment, the tab 606 can be sized and shaped to facilitate a user grasping the tab 606 and rotating the first locking block 208.

[0094] Fig.21A cross-sectional view of a first locking block 208 and a second locking block 210 engaged with the retaining ring 202 and the skirt 204, respectively, is shown. The base 200 and the split ring 206 are also shown. The first locking block 208 can be rotated in a first direction relative to the retaining ring 202 to move the first locking block 208 distally toward the base 200. The first locking block 208 can be rotated in a second direction relative to the retaining ring 202 to move the first locking block 208 proximally away from the base 200. When the first locking block 208 moves distally toward the base 200, the skirt 204 placed in the cavity 212 can be clamped between the base 200 and the first locking block 208, so that the translational movement of the skirt 204 is limited. On the other hand, when the first locking block 208 is rotated in the second direction and moves proximally away from the base 200 along the inner circumference of the buckle 202, the compressive force on the skirt 204 can be released, thereby allowing the skirt 204 to translate in any radial direction relative to the base 200. More specifically, the surgeon or user can apply a force to the skirt 204 so that when the skirt 204 is not clamped by the first locking block 208, the outer portion of the skirt 204 can move within the cavity 212. In this configuration, the movement of the skirt 204 is limited by the radial depth of the cavity 212 and the size of the skirt 204.

[0095] Fig.23 An exemplary embodiment of a second locking block 210 configured as a locking ring formed by a wall 702 having a central opening 706 is shown. The outer surface of the wall 702 may be shaped to have a curved lower portion and a tapered upper portion. Fig.24 , the wall 702 can have a radially inwardly extending upper portion 708 that forms a cap over the inner surface 704 of the second locking block 210. The opening 706 can be defined at the proximal end by the inner surface of the upper portion 708 and the inner surface 704 at the distal end. As such, the opening 706 can have a first diameter at the proximal end that is smaller than a second diameter of the opening 706 at the distal end. As will be described in detail below, the larger diameter opening in the distal end of the opening 706 can allow radial movement of an object engaged with the second locking block (i.e., the extension 320 of the skirt 204) to selectively limit movement of a surgical access device received within the surgical access stabilization device 100.

[0096] Preferably, the inner surface 704 may have an engagement feature 712 configured to engage with a complementary engagement feature of the skirt 204. In one embodiment, the second locking block may have an internal thread 712 formed along the inner surface 704, which is configured to engage with the thread 322 on the outer surface of the skirt extension 320. The second locking block 210 can be rotated relative to the skirt 204 in a first direction so that the second locking block 210 moves distally relative to the skirt 204. The second locking block 210 can be rotated relative to the skirt 204 in a second direction so that the second locking block 210 moves proximally relative to the skirt 204. The tab 710 can extend proximally from the outer surface of the wall 702. Similar to the tab 606 of the first locking block, the tab 710 can help a user rotate or move the second locking block 210. Preferably, the size and shape of the tab 710 can be set to facilitate the user to grasp the tab 710.

[0097] Fig.25 A cross-sectional view of one embodiment of the second locking block 210 engaged with the skirt 204 is shown. As can be seen, the internal threads 712 of the second locking block 210 can engage with the external threads 322 of the extension 320 of the skirt 204. When the second locking block 210 is rotated in a first direction, thereby causing the second locking block 210 to move in a distal direction relative to the skirt 204, the second locking block 210 can apply a compressive force in a radially inward direction, so that the extension 320 of the skirt 204 is pushed radially inward. On the other hand, when the second locking block 210 is rotated in a second direction, the second locking block moves proximally relative to the skirt, thereby reducing any inward compressive force applied by the second locking block on the skirt 204. In this way, when the surgical access device is received in the opening formed by the skirt 204, the second locking block can selectively limit the movement between the surgical access device and the skirt by selectively applying and removing the inward compressive force on the skirt extension 320. As shown from Fig.25 It can be seen that the tapered inner surface 324 defining the opening of the skirt 204 tapers so that the radially inward compressive force can cause the upper portion of the tapered surface 324 to move radially inward toward a more linear profile and abut against the outer surface of the instrument or object received therein. In an exemplary embodiment, and returning to reference Fig.21 , the split ring 206 can be retained within the tapered surface 324 to receive a surgical access device. The radial compressive force applied by the second locking block 210 on the skirt extension 320 can cause the extension 320 to compress inwardly against the split ring 206. This inward compression can limit the movement of the split ring 206 relative to the skirt 204, and thus constrain the movement of the received surgical access device.

[0098] Fig.26 A first exemplary surgical application of the surgical access stabilization device 100 of the present invention is shown. Fig.26The surgical stabilization device 100 is shown fully assembled with the port 10 received therein. The distally facing surface of the pad 102 is bonded to the patient's skin. In this embodiment, the pad 102 is formed as a complete patch having a generally oval or egg shape.

[0099] Fig. 27 A portion of an exemplary method of using the surgical access stabilization device 100 is shown. Fig. 27 , the pad 102 is shown attached to the anchor surface (e.g., the patient's skin) at a certain position so that the surgical incision 120 is located within the opening 106 of the pad 102. The base 200 is shown fixed to the pad 102. In one embodiment, the pad 102 can be attached to the anchor surface as a separate component. Once attached, the base 200 can then be fixed by the user to the proximal surface of the pad 102. For example, the surgeon can first select, cut or otherwise manipulate the pad 102 to the desired shape and size for a specific surgical application. Then, the side of the pad 102 facing the distal side of the adhesive can be placed at the desired position on the patient's skin. With the pad firmly attached, the base 200 can be moved distally onto the pad 102 and can be fixed to the pad 102 by engaging the complementary engagement features of the base and the pad. For example, the narrow slot 209 of the base 200 can be aligned with the protrusion 110 of the pad 102. Then, the base can be fixed to the pad 102 with a snap fit.

[0100] Alternatively, the base 200 can be secured to the pad 102 prior to bonding the pad 102 to the anchor surface. In one embodiment, the pad and base can be preassembled as a single, integral component for use during surgery. Alternatively, the pad and base can be constructed as two separate components that are attached prior to surgery. In this way, the pad and base can be placed as a single assembled unit during surgery.

[0101] like Fig. 27 As shown, with the pad 102 secured to the engagement surface and the base 200 attached to the pad 102, the surgeon manipulates tissue (e.g., navigates to the surgical site, dilates the incision 120, etc.) using instruments 15 inserted through the incision 120. It should be understood that the incision 120 can be formed before or after the pad 102 is secured to the anchor surface. In addition, the incision 120 can be dilated to accommodate multiple instruments before or after the pad 102 has been secured to the engagement surface and before or after the base 200 has been attached to the pad 102. Once the incision has been dilated to accommodate a surgical access device (e.g., port 10), the port can be inserted through the incision. Likewise, the insertion of the surgical access device can occur before or after the pad 102 has been secured to the engagement surface, and can occur before or after the base 200 or any other component of the locking mechanism 104 has been attached.

[0102] In an exemplary method, the incision 120 can be formed at a desired location on the patient. The pad 102 can then be fixed to the patient's skin by placing the adhesive distal surface of the pad 102 against the skin surface, the size and shape of the pad previously set to meet the requirements of a specific surgical procedure or application. In other embodiments, a pad of standard size and shape can be cut or otherwise manipulated during surgery to meet the requirements of a specific surgical procedure or application. The pad 102 can be preassembled with a base 200 attached thereto. Alternatively, once the pad 102 is fixed to the patient's skin, the base 200 can be attached to the pad 102. In a preferred embodiment, the pad 102 can be aligned so that the incision 120 is centrally located within the opening 106 of the pad 102. With the pad and base surrounding the incision 120, the incision 120 can be prepared to receive the port 10. For example, a set of dilation tubes can be used to dilate the incision 120 to achieve the desired incision opening. Alternatively, other methods known in the art can be used to prepare the incision 120 for receiving a surgical access device. The port 10 may then be inserted into the incision 120 using common surgical techniques.

[0103] With the port 10 inserted and the base 200 secured to the pad 102, the locking mechanism 104 may be placed in the base 200. The locking mechanism 104 may be comprised of a buckle 202, a skirt 204, a split ring 206, a first locking block 208 configured to engage with the buckle 202, and a second locking block 210 configured to engage with the skirt 204. The port 10 may be positioned at the opening 416 of the split ring 206, and the locking mechanism 104 may be moved distally along the port 10 until a distally facing surface of the locking mechanism 104 contacts a proximally facing surface of the base 200. In one embodiment, the distally facing surface of the skirt 204 may contact a proximally facing surface of the base 200, and the buckle 202 may be aligned with the base 200 in an unlocked position. To secure the locking mechanism 104, the buckle 202 may be rotated from the unlocked position to the locked position. In the unlocked position, the radially extending protrusion 502 of the buckle can be aligned with the recessed segment 228 of the base, as described above. Then, the buckle 202 can be rotated in a first direction so that the protrusion 502 rotates to engage with the transition portion 226 of the base extension segment 224. The tab portion 530 of the base 200 can be pushed radially outward by the buckle protrusion 502 and can be maintained in the outward position when the protrusion 502 fully enters the extension segment 224. The buckle 202 and the base 200 can be configured so that in the locked position, that is, when the leading edge of the protrusion 502 engages with the transition portion 226, the protrusion 502 jumps over the tab portion 230, so that the tab 230 is no longer pushed radially outward and can return to its neutral configuration. In this way, the tab portion 230 can act as a fixing mechanism to prevent the buckle 202 from rotating out of the locked position during surgical application, because the tab 230 and the transition portion 226 are placed at either end of the protrusion 502 in the locked position. The user can grip the feature 514 to facilitate smooth and easy rotation of the buckle relative to the base. Although the above description is provided in conjunction with the assembly of various components (such as the locking mechanism 104) after insertion into the port, it should be understood that in some embodiments, the port can be inserted through the already assembled locking mechanism when it is in the unlocked configuration.

[0104] With the locking mechanism 104 placed within the base and the port 10 extending therethrough, the port 10 can be adjusted to a desired trajectory, orientation, and position. The port 10 can be adjusted relative to the pad 102 in multiple degrees of freedom. For example, the port 10 can be translated in any radial direction relative to the pad 102. In one embodiment, the surgeon can apply a translational force to the proximal portion of the port 10 by grasping and moving the proximal portion of the port 10 or a handle attached thereto. The skirt 204 can move according to the translational force applied to the port 10. The skirt 204 can translate or slide within the cavity 212 between the base 200 and the buckle 202. After achieving the desired positioning of the port 10, the first locking block 208 can be rotated in a first direction to clamp the skirt 204 at a desired position within the cavity 212, thereby limiting further translational movement of the skirt and thus the attached port 10 in the radial direction. Rotating the first locking block 208 in the second direction may move the first locking block proximally from the base and thereby release the clamped skirt 204 , thereby allowing translational movement of the skirt and, therefore, the attachment port 10 .

[0105] The port 10 can also be angled, rotated, or longitudinally translated relative to the pad 102. For example, the port 10 can be rotated 360 degrees by grasping the proximal portion of the port 10 and rotating the port. The split ring 206 having a rounded outer edge 402 can be rotated 360 degrees within the tapered inner surface 324 of the opening 316 of the skirt 204. In addition, the port 10 can be angled to a variety of desired orientations by grasping the proximal portion of the port 10 and angling the port relative to the pad 102. Likewise, the rounded outer edge 402 of the split ring 206 can be angled relative to the tapered inner surface 324 of the opening 316 of the skirt 204.

[0106] The port 10 can also be translated in the longitudinal direction relative to the pad 102 by applying a force to the proximal end of the port 10 in the proximal direction or the distal direction so as to translate the port 10 in the proximal direction or the distal direction relative to the pad 102. Once the desired orientation and positioning of the port 10 relative to the pad 102 is achieved, the second locking block can be rotated in the first direction to restrict further rotational movement, angular movement, or translational movement. In one embodiment, when the second locking block is rotated in the first direction, the second locking block moves distally and applies an inward compressive force to the skirt extension 320. When the skirt extension 320 is compressed radially inward, the skirt extension is compressed onto the split ring 206 in which the port 10 is placed. After rotating the second locking block by a first amount, the compressive force applied by the second locking block restricts the translational movement of the port in the longitudinal direction. After further rotating the second locking block to a second amount, the compressive force applied by the second locking block can constrain the rotational movement of the port relative to the pad by restricting the ability of the inner ring 206 to rotate relative to the inner extension 320 of the skirt 204. When the second locking block is further rotated to a third amount, the compressive force applied by the second locking block can constrain the angular movement of the port relative to the pad by limiting the ability of the split ring 206 to angle relative to the extension 320 of the skirt 204. Rotating the second locking block in the second direction moves the second locking mechanism proximally relative to the inner extension 320 of the skirt 304 and reduces the inward compressive force on the skirt 204 and, therefore, the split ring 206 and the port 10 received therein. When the second locking block is rotated in the second direction, the port 10 can be moved relative to the pad 102. In this way, the second locking block can be used to selectively limit the translational movement, rotational movement, and angular movement of the port relative to the pad. The locking mechanism 104 can be unlocked during a surgical procedure to allow adjustment of the port 10 and, if necessary, relocked to secure the port in a different position or trajectory.

[0107] With the port 10 established and stabilized at the desired location and trajectory, various instruments, implants, etc. can be passed through the port 10 percutaneously to the surgical site. Fig.28 As shown, the surgical access device can be a port tube 30 for accessing a surgical site located at a spinal region 32. An instrument 34 can be inserted through the port tube 30. The instrument 34 can be any type of instrument, such as a camera or an implant. In one embodiment, the port tube 30 can be a 15 mm rigid port that is sized to accommodate a variety of objects, including, for example, larger implants. The lumen of the port tube 30 can be sized to facilitate the insertion of a variety of instruments, implants, etc. having various shapes. Therefore, a non-circular inner lumen geometry can be preferred.

[0108] Fig.29 An exemplary application of a surgical access stabilization device 100 configured to receive a soft mesh port 40 is shown. Fig.29In an embodiment, the locking mechanism 104 may be adapted to receive a flexible port or other surgical access device by including a cap member 44 to fix and selectively close the opening of the surgical access device. The cap member 44 may be removed from the proximal end of the surgical access device so that instruments, implants, etc. may be delivered to the surgical site 42 via the skin. In some surgeries, it may be desirable to use a flexure port to minimize trauma to surrounding tissue. In one embodiment, the flexure port may be a 5mm flexible port, the size and configuration of which is configured to receive, among other things, visualization instruments, optical trocars, and medium-sized implants. In another embodiment, the flexure port may be a 4mm flexure port, the size and configuration of which is configured to receive, among other things, smaller expansion implants, optical trocars, and visualization instruments.

[0109] Variations may be made to the above methods and devices and are considered to be within the scope of the present invention. For example, before the port 10 is inserted into the incision 120, the locking mechanism 104 may be placed in the base 200 and fixed therein. In such embodiments, the port 10 may be inserted into the incision 120 by moving the port distally through the central opening 101 of the surgical access device. In another example, the first and second locking blocks may take forms other than locking rings, and selectively locking the port relative to the pad may be achieved by operating the first and second locking mechanisms, rather than by means of rotation. In a non-limiting example, the locking mechanism of the present invention may include any number of removable adhesive adjustment locations, threaded locking knobs, or lever-action tightening wheels. In addition, as described above, the locking mechanism 104 need not have separate first and second locking blocks. In one embodiment, a single locking block may be used to selectively limit the movement of the port 10 relative to the pad 102. Regardless of the configuration used, the locking mechanism 104 is configured to couple and selectively lock the surgical access device relative to the pad.

[0110] In the surgical access stabilization device of the present invention, the base pad can have a variety of shapes and sizes depending on the geometry of the application area or the needs of the user. In surgical applications, the specific shape and size of the pad can depend on a variety of factors, including the size of the patient, the location of the surgical site, the size of the incision, the size of the area to be treated, the range of motion required by the surgeon to complete the surgery, etc. Fig.30One embodiment of a surgical access stabilization device 1000 is shown, which includes a pad 1002 and a locking mechanism 1014 placed on a central portion (not shown) of the pad 1002. The pad 1002 can have at least one radial finger 1004 extending from the central portion. A navigation marker 1008 can be included on one of the at least one radial finger 1004. In the illustrated embodiment, the pad 1002 has eight radial fingers 1004. The size and shape of each radial finger 1004 can be set as needed or as required for a particular application.

[0111] exist Fig.31 In another exemplary embodiment shown, a surgical access device 1020 can include a pad 1022 formed of a thin polymer having an adhesive surface facing distally. In one embodiment, the thin polymer pad can be rubber, neoprene, PTFE, etc. The pad 1022 can have a thickness between about 1 mm and about 5 mm, and in some embodiments, a thickness between about 1.5 mm and about 3.5 mm. Fig.31 In the illustrated embodiment, at least a portion of the locking mechanism 1024 can be placed between the anchor surface (i.e., the patient's skin) and the distally facing adhesive surface of the pad 1022. For example, the base 1026 of the locking mechanism 1024 can be placed so that the distal surface of the base 1026 contacts the anchor surface. The pad 1022 can then be placed over the anchor surface and the base 1026 so that the base 1026 remains fixed to the anchor surface by the pad 1022. The locking mechanism 1024 can be attached to the base 1026 in the manner described above.

[0112] Fig.32 Yet another exemplary embodiment of a surgical stabilization device 1030 of the present invention is shown. The surgical access stabilization device 1030 includes a pad 1032 configured as a complete patch having a generally rectangular shape. A locking mechanism 1034 is shown at a central location of the pad 1032. Alternatively, the locking mechanism 1034 may be received at any location on the pad 1032. The pad 1032 may include navigational markings, such as marking 1036, to aid in alignment and placement of the pad 1032 relative to a surgical or anatomical structure.

[0113] Fig.33 and Fig.34 A second exemplary embodiment of the surgical access stabilization device of the present invention is shown. Fig.33As shown, the surgical access stabilization device 1100 may include a pad 1102 configured to receive a surgical access device (e.g., port 1110). A locking mechanism may couple the port 1110 to the pad 1102 and selectively lock movement therebetween. The pad 1102 may have a distally facing adhesive surface configured to contact an anchor surface. In a preferred embodiment, the distally facing adhesive surface of the pad 1102 may include a medical grade adhesive contact layer that contacts the patient's skin.

[0114] Pad 1102 can have an opening 1106 configured to receive a surgical access device. In a preferred embodiment, opening 1106 can be an elongated slot extending along pad 1102. For example, referring to Fig.34 , the pad 1102 may have an opening 1106 extending along the longitudinal axis of the pad. In one embodiment, the pad 1102 may be generally rectangular in shape. Fig.34 As shown, opening 1106 may have a shape that is similar or complementary to the shape of pad 1102. Alternatively, opening 1106 may have a shape that is different from the shape of pad 1102. One of ordinary skill in the art will appreciate that pad 1102 and opening 1106 may have any of a variety of shapes.

[0115] The elongated slot opening 1106 can advantageously facilitate adjustment of the surgical access device in the transverse plane during a surgical procedure. Such adjustment allows for gross changes in the angulation of the surgical access device. For example, in spinal surgical applications, it may be desirable to move the surgical access device in a transverse direction. Thus, the pad 1102 can be positioned so that the elongated opening 1106 extends in the transverse plane (e.g., extends mesially and laterally). In this way, the port can be adjusted to allow for gross changes in angulation. For example, the port can be positioned for 25 degree TLIF access or 45 degree Kambin access to a spinal surgical site.

[0116] The base 1108 can be configured to receive the port 1110 through a central opening of the base. Alternatively, the base 1108 can be integrally formed with the port 1110 in the form of a flange extending from the proximal end of the port 1110. Further, the base 1108 can be a single component, such as Fig.33 As shown, or the base 1108 can be multiple parts. For example, the base 1108 can be configured similar to the skirt 104 described above, and the split ring is similar to the inner split ring 106 described above to receive the port 1110.

[0117] The locking mechanism can be configured to selectively limit the movement of the port 1110 relative to the pad 1102. In one embodiment, the locking mechanism 1104 can be a removable adhesive. By way of non-limiting example, the locking mechanism can be a hook-eye closure. For example, one side of the hook-eye closure can be placed on the proximal-facing surface of the pad 1102, near at least a portion of the opening 1106. The corresponding side of the hook-eye closure can be placed on the distal-facing surface of the base 1108. In this way, the base 1108 can be removably fixed to the pad 1102 by engaging the two corresponding parts of the hook-eye closure. The base 1108 with the insertion port 1110 can be repeatedly placed and removed at multiple locations along the opening 1106 as needed. It should be understood that any other form of removable adhesive can be used in a similar manner.

[0118] In some embodiments, at least one additional locking block 1112 can be used to further selectively restrict the movement of the port 1110 relative to the pad 1102. In one embodiment, the locking block 1112 can be a locking ring having external threads 1114 configured to engage with corresponding threads on the inner surface of the base 1108. A grip 1116 can extend proximally from the locking block 1112 to assist a user in rotating the locking block to selectively restrict rotational, angular, and longitudinal translational movement of the port relative to the pad 1102. It should be understood that the locking block 1112 can be configured similarly to one of the first locking block and the second locking block as previously described herein.

[0119] Fig.34 An exemplary positioning of a surgical access stabilization device of a second embodiment is shown. Pad 1102 may be positioned such that pad 1102 extends laterally along the transverse axis of the patient. In one application involving a spinal surgical site, pad 1102 may be positioned laterally in the lumbar region of the patient. Opening 1106 may extend laterally along pad 1102 such that a base 1108 having a port received therein may be selectively moved and adjusted along a transverse plane. In this manner, a surgeon may achieve a gross change in port angulation during surgery without having to remove the stabilization device or create additional incisions.

[0120] Another exemplary embodiment of a surgical access stabilization device according to the present invention is Fig.35 and Fig.36 In some applications, it may not be desirable to place an adhesive pad near a surgical site or an incision used to access the surgical site. For such situations, the surgical access stabilization device of the present invention can be used to couple a surgical access device to a remotely located base pad to place the surgical access device at a distance from the pad.

[0121] The surgical access stabilization device 1200 can have a connection mechanism 1204 configured to connect a surgical access device (e.g., port 1210) to a pad 1202. In one embodiment, the connection mechanism 1204 can include an arm 1206 having a connector 1208 and an attachment member 1214. The attachment member 1214 can have a central opening to receive the surgical access device 1210. The connector 1208 can be located at a first end of the arm 1206 and can be configured to engage a portion of the attachment member 1214. The second end of the arm 1206 can be attached to the pad 1202 such that the arm 1206 couples the surgical access device to the pad.

[0122] like Fig.36 As shown, pad 1202 can be similar to the pads described above. In one embodiment, pad 1202 can be an expandable flexible pad having a distally facing adhesive surface. Pad 1202 can have an attachment portion 1212 configured to couple with a portion of connection mechanism 1204, as will be described below. Pad 1202 and arm 1206 can be integrally formed as one component, or can be configured to be connected via one or more connection features. In one embodiment, opening 1216 can be formed in attachment portion 1212 and can be configured to receive fastener 1218 of arm 1206. It should be understood that pad 1202 and opening 1216 can take any of a variety of shapes and sizes as desired for a particular application. Pad 1202 can be connected to arm 1206 by any number of known connection methods. In one embodiment, as Fig.36 As shown, fastener 1218 may be a threaded screw fastener. Fastener 1218 may be placed within opening 1216 and engaged therein using a screw feature of fastener 1218. Non-limiting examples of alternative fasteners include snap-fit ​​mechanisms, complementary male and female interference fits, screws, threaded fasteners, and the like.

[0123] Arm 1206 can be made of a ductile material so that the arm can be bent to adjust the positioning of the first end relative to the second end. In this way, a surgical access device connected to the first end of the arm can be placed in a desired position relative to a pad connected to the second end of the arm by bending the arm into a desired configuration. In one embodiment, connector 1208 can be located on the first end of arm 1206 to engage with attachment 1214 so as to connect port 1210 to the first end of the arm. Connector 1208 can engage attachment 1214 by any connection means known in the art. For example, in one embodiment, connector 1208 can be a ball joint connector and an extension of attachment 1214 can be received in a recessed portion of the ball joint connector to secure attachment 1214 to arm 1206.

[0124] The handle 1220 can be associated with the port 1210 and facilitate movement of the port, such as rotational movement. In one embodiment, the port 1210 can be inserted through an opening in the handle 1220. The handle can have a gripping portion 1222 extending radially outward from the opening. The gripping member 1222 can include features that facilitate rotational movement of the port 1210. For example, the gripping member can have a slot for an instrument or a tab for a user to grasp. The rotational movement of the gripping member can be converted into an incidental rotational movement of the insertion port.

[0125] Fig.37 and Fig.38 An exemplary use of the port once placed in a stable position using the surgical access stabilization device of the present invention is shown. Fig.37 and Fig.38 A surgical access stabilization device is shown with an embodiment of a bendable arm connected to a port, but it should be understood that any of the embodiments described herein may be used to stabilize a port. Fig.37 and Fig.38 The port is shown to be usable for delivering any of a variety of instruments, implants, or objects percutaneously through the stable port to the target surgical site. Fig.37 As shown, port 1310 can be secured by surgical access stabilization device 1300. With port 1310 stabilized, an elongated tool or other instrument with navigation array 1350 can be inserted through port 1310 percutaneously to a target site. By way of another non-limiting example, Fig.38 Port 1410 is shown secured by surgical access stabilization device 1400. With port 1410 secured, a protective mesh 1450 can be inserted through the port to the target site to reduce trauma to surrounding tissue. Additional instruments (such as needle 1460) or other objects can then be passed through the port 1410 and mesh 1450 percutaneously.

[0126] In another possible variation of the above methods and devices, the surgical access device can have a pad attached to the proximal portion of the surgical access device such that the pad can be deployed to adhere to the anchor surface. Fig.39 As shown, the surgical access device port 1510 can have an adhesive pad 1520 attached to the proximal end 1512 of the port. The adhesive pad 1520 can be attached to the proximal portion 1512 of the port so that after the port is inserted into an incision in a patient, the pad can be deployed from the proximal portion of the port to adhere to an anchor surface, such as the patient's skin. The adhesive pad 1520 can be any of the pads described above. For example, in one embodiment, the pad 1520 can be a continuous pad that can cover the entire sterile drape opening in the deployed state of the pad. In other embodiments, the adhesive pad can include one or more extensions, fingers, or tethers that can be arranged in an deployed state or a non-deployed state.

[0127] In the non-expanded state or the inserted state, the adhesive pad can be arranged in a compact manner and can be attached or fixed to the proximal portion of the port when the port is inserted through the incision. Alternatively, after the port has been inserted into the incision, the pad can be attached or fixed to the proximal portion of the port in the non-expanded state. For example, before or after the port is inserted into the incision, the pad can be snapped onto the proximal portion of the port in the non-expanded state. The pad can then be unfolded so that the adhesive surface of the pad facing the distal side can be bonded to the anchor surface. In one embodiment, the pad can be unfolded by rolling or moving the pad or a portion of the pad toward the distal side toward the anchor surface. Alternatively, the engagement mechanism between the pad and the port can be released so that the pad or a portion of the pad is no longer fixed to the port, and can be manipulated by the surgeon to fix the adhesive side of the pad facing the distal side to the anchor surface. In a non-limiting example, the engagement mechanism can be a snap, a screw, a lever, a tensioning member, or other engagement mechanisms as known in the art.

[0128] Figure 40 to Figure 42 Another embodiment of a handle 1600 of the surgical access stabilization device of the present invention is shown. For example, Figure 40 to Figure 42 The handle can be associated with a surgical access device, similar to how it is combined with Figure 35 to Figure 36 The handle 1220 is shown and described with reference to the port 1210 of FIG. The handle 1600 may include a main body portion 1610 having an extension 1620 and a lever 1630. In one embodiment, the extension 1620 may be generally cylindrical and extend distally from the main body 1610 of the handle. The extension 1620 may define a through hole 1640 through which a surgical access device (such as, for example, a port) may be inserted. It should be understood that the through hole 1640 may have any of a variety of geometric structures so that a desired surgical access device can be passed therethrough. As shown in FIG. Fig.42As best seen in the , handle 1600 can include a locking portion 1650 that can engage with a feature of a surgical access device to selectively maintain relative positioning between the surgical access device and handle 1600. In one embodiment, locking portion 1650 can be a zip tie or ratchet / pawl-style snap lever having one or more teeth 1652 that can engage with a feature on an outer surface of the surgical access device. For example, in one embodiment, when the surgical access device is disposed within through hole 1640, one or more teeth 1652 of locking portion 1650 can selectively engage with one or more grooves formed on an outer surface of the surgical access device. In some embodiments, locking portion 1650 can include a tab or lever that is biased to engage with the surgical access device without user interaction. Moreover, in some embodiments, one or more teeth 1652 can be configured to allow movement in a first direction while preventing movement in a second direction (e.g., allowing the surgical access device to be advanced distally through through hole 1640 while preventing proximal retraction).

[0129] Fig.41 Shows Fig.40 1600. The lever 1630 can selectively engage the locking portion 1650 to move the locking portion out of engagement with the surgical access device within the through hole 1640 of the handle 1600, thereby acting as a release to allow adjustment of the surgical access device relative to the handle. In one embodiment, the lever 1630 can be a generally planar element having at least one engagement feature extending from its distally facing surface. Fig.41 In the illustrated embodiment, the first post 1632 may extend from the distally facing surface of the first planar portion 1636 and may be received within the slot 1612 in the body 1610. The second post 1634 may extend from the distally facing surface of the second planar portion 1638 and may be received within the slot 1614 in the body. In order to insert the lever 1630 into the body 1610, the lever engagement features such as the posts 1632, 1634 may be moved into the body receiving features such as the slot 1612 and the hole 1614. In one embodiment, the engagement features of the lever may snap into the receiving features of the body. The slot 1612 of the body may have a first end 1616 and a second end 1618. The first end 1616 of the slot 1612 may be located closer to the edge of the body 1610 than the second end 1618 of the slot. In other words, the slot 1612 may extend laterally inward from a position close to the edge of the body 1610 toward the center of the body. It should be understood that although Fig.41 The illustrated embodiment of the handle 1600 has two engagement features and corresponding receiving features, but the lever and body of the handle may have any number of engagement features and receiving features.

[0130] For example, in Fig.40 1610, a user can engage the lever so that the lever moves the locking portion 1650 to selectively engage a surgical access device disposed in the through hole 1640. For example, a force can be applied to the lever 1630 such that the first post 1632 translates within the slot 1612. The second post 1634 of the lever can remain fixed within the hole 1614 of the body such that the lever can pivot about the second post as the first post 1632 translates within the slot 1612 in the body 1610. In one embodiment, the user can depress the lever by applying a force to the first planar portion 1636 of the lever in an inward direction (i.e., toward the centerline of the body 1610), thereby causing the first post 1632 to translate within the slot 1612 and causing the lever to pivot about the second post 1634. With the lever depressed, the second planar portion 1638 of the lever can engage the locking portion 1650 of the body 1610 to deflect the locking portion to a position where one or more teeth 1652 disengage from one or more grooves formed on the surgical access device disposed in the through hole 1640. In one embodiment, when the user releases the force, the lever 1630 can return to the position in which the locking portion 1650 is deflected. Fig.40 That is, lever 1630 can pivot about post 1634 such that first planar portion 1636 moves radially outward. This movement allows locking portion 1650 to move back to a position where one or more teeth 1652 engage one or more grooves or other features formed on a surgical access device disposed in through hole 1640 (e.g., via a biasing force, etc.).

[0131] It should be understood that Figure 40 to Figure 42 The handle 1600 and its various components may be associated with the port in a variety of different ways within the scope of the present invention. For example, a zip tie or ratchet / pawl snap lever may be used as a component of the locking mechanism of the present invention in place of a split ring to selectively limit axial movement of the surgical access device. By way of another example, the handle 1600 may be used in any of the various embodiments described herein. In addition, the engaging features of the lever and the receiving features of the body may be formed as any complementary features such that the lever may be coupled to the body of the handle and may be moved between an open position in which the locking portion of the handle is not engaged and a closed position in which the locking portion of the handle is engaged.

[0132] The above exemplary embodiments describe spinal surgery applications. Although this is a contemplated use, the methods and devices of the present invention may be equally applicable to other areas of the patient's body. Thus, the devices described herein may be formed into a variety of sizes and materials suitable for use in various areas of the patient's body.

[0133] Based on the above embodiments, those skilled in the art will appreciate additional features and advantages. Therefore, the present disclosure is not limited by what has been specifically shown and described. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Claims

1. A surgical access stabilization system comprising: a pad having a proximally facing surface and a distally facing adhesive surface; a surgical access device coupled to the pad; and a locking mechanism configured to selectively lock a position of the surgical access device relative to the pad, Wherein the locking mechanism includes an attachment member and an arm, the attachment member having an opening to receive the access device therethrough, wherein a first end of the arm is configured to be polyaxially coupled to the attachment member and a second end of the arm is configured to be coupled to the pad.

2. The system according to claim 1, wherein: The pad includes imaging features to facilitate imaging the pad.

3. A system according to claim 1 or claim 2, wherein: The pad includes navigation features to facilitate navigation of the surgical access device.

4. A system according to claim 1 or claim 2, wherein: The pad has a central portion with at least one radial finger.

5. The system according to claim 1 or claim 2, wherein: The pad is made of any of flexible fabrics, elastomers, and polymers.

6. The system of claim 1 or claim 2, wherein: The locking mechanism is configured to selectively lock translational movement of the surgical access device in a direction along the proximal-facing surface of the pad.

7. The system of claim 1 or claim 2, wherein: The locking mechanism can be configured to selectively lock translational movement of the surgical access device in a direction transverse to the proximal-facing surface of the pad.

8. The system of claim 1 or claim 2, wherein: The locking mechanism can selectively lock any one of rotational movement of the surgical access device and angular movement of the surgical access device.

9. The system of claim 1 or claim 2, wherein: The pad is positioned distally from the surgical access device.

10. The system of claim 1 or claim 2, wherein: The surgical access device is placed a distance away from the pad such that the arm separates the surgical access device from the pad.

11. The system of claim 1 or claim 2, wherein: The pad has no central opening formed therethrough.

12. The system of claim 1 or claim 2, wherein: The first end of the arm includes a ball joint configured to engage the attachment feature.

13. A surgical access stabilization system comprising: a pad having a proximally facing surface and a distally facing adhesive surface; a surgical access device defining a working channel; a connection mechanism coupled between the pad and the surgical access device to position the surgical access device at a location remote from the pad; and an attachment member having an opening to receive the surgical access device therethrough, wherein the connection mechanism further comprises an arm coupled to the surgical access device at a first end and coupled to the pad at a second end; and Wherein, the first end of the arm is pivotally coupled to the attachment member.

14. The system according to claim 13, wherein: The arm is bendable to adjust the arrangement of the first end relative to the second end.

15. The system of claim 13, wherein: The arm includes a first end, a second end, and a body extending longitudinally between the first end and the second end such that the body of the arm extends longitudinally between the surgical access device and the pad.

16. The system of claim 13, wherein: The first end of the arm includes a ball joint configured to engage the attachment feature.

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