Stabilization system for medical procedures that maintains sterility of an articulating arm above a sterile barrier

Abstract

Disclosed herein is a stabilization system that includes a base for securing the stabilization system to a patient table by inserting the base between the patient table and a mattress on the patient table. The stabilization system also includes a connector that connects a lockable articulating arm to the base. The base protrudes slightly from under the mattress to provide a robust and predictable surface for attaching the articulating arm of the stabilization system. The base can then be used to support a lockable articulating arm that has a clamp at its distal end for holding an access sheath or delivery system. The connector attaches the articulating arm to the base such that the articulating arm is above a sterile surgical drape to maintain sterility of the articulating arm. The stabilization system is advantageous in cervical access procedures.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 317,944, filed March 8, 2022, which is incorporated by reference herein in its entirety for all purposes.

[0002] The present disclosure relates to the field of stabilization systems for use with medical devices and procedures. 2. Description of Related Art [Background technology]

[0003] Various medical procedures involve the introduction of transcatheter medical devices into a patient, requiring controlled use of the catheter. It is advantageous to immobilize the medical device during the procedure in a manner that allows the device to be held stationary during parts of the procedure and adjusted during other parts of the procedure. This can be accomplished using a stabilization system.

[0004] These medical procedures may be performed in specialized labs, such as catheter insertion labs. These specialized labs may include a bed or table on which the patient lies during the procedure. Typically, there is a lot of equipment and many people present during these procedures, and space may be at a premium around the table. A stabilization system may be positioned on the table to allow the stabilization system to secure the medical equipment close to the patient. Summary of the Invention

[0005] Described herein is one or more systems, or devices, for holding a medical device (e.g., a catheter) during a medical procedure in a manner that maintains the sterility of the articulating arm above a sterile barrier. The systems and devices include a base having a connector interface that allows the connector to be connected to the base with a sterile barrier (e.g., a sterile surgical drape) imposed between the connector and the base. This allows the sterility of the connector to be maintained during connection of the connector to the base.

[0006] In some implementations, the sterile barrier forms a non-sterile region including the base and a sterile region including the connector, hi some implementations, the articulating arm can be coupled to the connector such that the articulating arm is within the sterile region.

[0007] In some implementations, the technology described herein relates to a stabilization system for use in a medical procedure to stabilize an access sheath or delivery device. The stabilization system includes a base configured to be positioned between a patient table and a pad on the patient table. The stabilization system also includes an articulating arm. The stabilization system also includes a connector configured to secure the articulating arm to a portion of the base that protrudes from under the pad. The stabilization system also includes a holder at a distal end of the articulating arm, the holder configured to interface with the access sheath or delivery device. The connector is configured to connect to the base in a manner that maintains sterility of the articulating arm above a sterile barrier during connection of the connector to the base.

[0008] In some implementations, the technology described herein relates to a stabilization system, where a base includes a stabilizing portion and a protruding portion separated by a wall extending perpendicularly from the base.

[0009] In some implementations, the technology described herein relates to a stabilization system in which a portion of the base that protrudes from under the mattress or pad forms a base attachment portion that mates with a connector.

[0010] In some implementations, the technology described herein relates to a stabilization system, where the connector includes an arm mating pin configured to mate with an articulating arm.

[0011] In some implementations, the technology described herein relates to a stabilization system, where the connector includes a shaft, a tapered clamping plate, and a bottom clamping plate.

[0012] In some implementations, the technology described herein relates to a stabilization system, where the tapered clamping plate has an elliptical cross-section.

[0013] In some implementations, the technology described herein relates to a stabilization system, where a base forms a base mounting portion having an elliptical shape complementary to an elliptical cross-section of a tapered clamping plate.

[0014] In some implementations, the technology described herein relates to a stabilization system, where the base forms a base mounting portion that is tapered to be complementary to the taper of a tapered clamping plate.

[0015] In some implementations, the technology described herein relates to a stabilization system, where the connector further includes an internally threaded knob that mates with the threaded portion of the shaft, and where the tapered clamp plate is secured to the internally threaded knob.

[0016] In some implementations, the technology described herein relates to a stabilization system in which a bottom clamp plate is axially locked to a shaft and is free to rotate around the shaft.

[0017] In some implementations, the technology described herein relates to a stabilization system in which a connector connects to a base by applying a clamping force to the base between a tapered clamping plate and a bottom clamping plate.

[0018] In some implementations, the technology described herein relates to a stabilization system in which a portion of a shaft has an elliptical cross-section and a tapered clamping plate is internally keyed to the elliptical cross-section of the portion of the shaft.

[0019] In some implementations, the technology described herein relates to a stabilization system, where a base forms a base attachment portion on a portion of the base that protrudes from beneath a mattress or pad.

[0020] In some implementations, the technology described herein relates to a stabilization system, where a surgical drape is configured to be positioned between the base attachment portion and the connector when the connector is connected to the base.

[0021] In some implementations, the technology described herein relates to a stabilization system, where the base attachment portion comprises a different material than the remainder of the base.

[0022] In some implementations, the technology described herein relates to a stabilization system, where the base is radiolucent.

[0023] In some implementations, the technology described herein relates to a stabilization system, where a holder includes a lever-actuated clamp with a pre-tensioned spring, forming a two-stage clamping mechanism.

[0024] In some implementations, the technology described herein relates to a stabilization system, where an articulating arm includes a vertical post that is stably held perpendicular to a connector during a medical procedure.

[0025] In some implementations, the technology described herein relates to a stabilization system, where a holder is removably attached to an articulating arm.

[0026] In some implementations, the technology described herein relates to a stabilization system, where an articulating arm is removably attached to a connector.

[0027] In some implementations, the technology described herein relates to a stabilization system including a base including a stabilizing portion and a protruding portion, the stabilizing portion configured to be inserted between a mattress and a table whereby the protruding portion extends outward from between the mattress and the table and forms a base mounting portion; and a connector including a shaft, a top plate, and a bottom plate, the top plate and the bottom plate configured to approach each other along an axial direction of the shaft, the connector configured to mate with the base mounting portion to secure the connector to the base with a surgical drape pressed between the connector and the base, and the top plate and the bottom plate configured to apply a clamping force against the base mounting portion to secure the connector to the base.

[0028] In some implementations, the technology described herein relates to a stabilization system that further includes a knob coupled to the top plate, where rotation of the knob axially approximates the top plate and the bottom plate.

[0029] In some implementations, the technology described herein relates to a stabilization system, where the connector further includes a grooved ring assembly for securing the knob to the top plate such that rotation of the knob translates the top plate axially along the shaft toward the bottom plate.

[0030] In some implementations, the technology described herein relates to a stabilization system in which the top plate is internally keyed to a cross section of the shaft to prevent rotation of the top plate relative to the shaft.

[0031] In some implementations, the technology described herein relates to a stabilization system in which the upper plate has an elliptical horizontal cross-section that is complementary to the elliptical horizontal cross-section of the base mounting portion to resist rotation of the upper plate relative to the base mounting portion.

[0032] In some implementations, the technology described herein relates to a stabilization system in which the top plate has a tapered vertical cross-section that is complementary to the tapered vertical cross-section of the base mounting portion, allowing for a secure connection between the connector and the base with a surgical drape of unknown thickness between the connector and the base.

[0033] In some implementations, the technology described herein relates to a stabilization system in which a bottom plate is fixed to a shaft such that the bottom plate is axially fixed relative to the shaft but is free to rotate around the shaft.

[0034] In some implementations, the technology described herein relates to a stabilization system, where the base mounting portion forms an opening having a horseshoe shape.

[0035] In some implementations, the technology described herein relates to a stabilization system where a horizontal cross section of the top plate forms a pill shape.

[0036] In some implementations, the technology described herein relates to a stabilization system, wherein the connector further includes an arm mating pin configured to secure the articulating arm to the connector.

[0037] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features have been described. It is to be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Various embodiments are illustrated in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the present disclosure in any way. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between referenced elements. [Brief description of the drawings]

[0039] [Figure 1A] 1A, 1B, and 1C show examples of stabilization systems for use in medical procedures to secure an access sheath or delivery device. [Figure 1B] 1A, 1B, and 1C show examples of stabilization systems for use in medical procedures to secure an access sheath or delivery device. [Figure 1C] 1A, 1B, and 1C show examples of stabilization systems for use in medical procedures to secure an access sheath or delivery device. [Figure 2A] 2A, 2B, 2C, and 2D show an embodiment of connecting a connector to the base of the stabilization system of FIGS. 1A-1C. [Figure 2B] 2A, 2B, 2C, and 2D show an embodiment of connecting a connector to the base of the stabilization system of FIGS. 1A-1C. [Figure 2C] 2A, 2B, 2C, and 2D show an embodiment of connecting a connector to the base of the stabilization system of FIGS. 1A-1C. [Figure 2D]2A, 2B, 2C, and 2D show an embodiment of connecting a connector to the base of the stabilization system of FIGS. 1A-1C. [Figure 3A] 3A, 3B, 3C, and 3D show the base of the stabilization system of FIGS. 1A-1C. [Figure 3B] 3A, 3B, 3C, and 3D show the base of the stabilization system of FIGS. 1A-1C. [Figure 3C] 3A, 3B, 3C, and 3D show the base of the stabilization system of FIGS. 1A-1C. [Figure 3D] 3A, 3B, 3C, and 3D show the base of the stabilization system of FIGS. 1A-1C. [Figure 4A] 4A, 4B, 4C, 4D, and 4E show connectors of the stabilization system of FIGS. 1A-1C. [Figure 4B] 4A, 4B, 4C, 4D, and 4E show connectors of the stabilization system of FIGS. 1A-1C. [Figure 4C] 4A, 4B, 4C, 4D, and 4E show connectors of the stabilization system of FIGS. 1A-1C. [Figure 4D] 4A, 4B, 4C, 4D, and 4E show connectors of the stabilization system of FIGS. 1A-1C. [Figure 4E] 4A, 4B, 4C, 4D, and 4E show connectors of the stabilization system of FIGS. 1A-1C. [Figure 5A] 5A and 5B show an articulating arm of the stabilization system of FIGS. 1A-1C. [Figure 5B] 5A and 5B show an articulating arm of the stabilization system of FIGS. 1A-1C. [Figure 6A] 6A and 6B show a holder for the stabilization system of FIGS. 1A-1C. [Figure 6B] 6A and 6B show a holder for the stabilization system of FIGS. 1A-1C. [Figure 7A] 7A and 7B show another exemplary connector assembly. [Figure 7B] 7A and 7B show another exemplary connector assembly. [Figure 8A] 8A and 8B show another exemplary connector assembly including a connector interface including dual tapered pins and a connector including a spring-activated self-latching and locking cam lever. [Figure 8B] 8A and 8B show another exemplary connector assembly including a connector interface including dual tapered pins and a connector including a spring-activated self-latching and locking cam lever. [Figure 9] FIG. 9 illustrates another exemplary connector assembly including a connector interface that includes a keyed pin and a connector that includes a mating socket with a spring plunger latch / seating mechanism and a set screw locking mechanism. [Figure 10] FIG. 10 illustrates another exemplary connector assembly including a connector including a lever-actuated collet and a connector interface including a mating circular pin. [Figure 11A] 11A, 11B, 11C, and 11D show another exemplary connector assembly including a connector with a lever-actuated cam and ball-bearing locking mechanism. [Figure 11B] 11A, 11B, 11C, and 11D show another exemplary connector assembly including a connector with a lever-actuated cam and ball-bearing locking mechanism. [Figure 11C] 11A, 11B, 11C, and 11D show another exemplary connector assembly including a connector with a lever-actuated cam and ball-bearing locking mechanism. [Figure 11D] 11A, 11B, 11C, and 11D show another exemplary connector assembly including a connector with a lever-actuated cam and ball-bearing locking mechanism. [Figure 12] FIG. 12 illustrates another exemplary connector that interfaces with a ball similar to the ball of the connector assembly described herein with reference to FIGS. 7A and 7B. [Figure 13]FIG. 13 illustrates another exemplary connector assembly including a connector that includes a friction / cam lock actuated collet and a connector interface that includes a pin that is compatible with the collet. [Figure 14A] 14A and 14B show another exemplary connector assembly including a connector interface including a base slotted portion and a connector including a self-locking cam lever clamp. [Figure 14B] 14A and 14B show another exemplary connector assembly including a connector interface including a base slotted portion and a connector including a self-locking cam lever clamp. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed subject matter.The present disclosure relates to systems, devices, and methods that provide stabilization of a medical device while maintaining a sterile barrier between a base and an articulating arm that holds the medical device (e.g., an access sheath, or a delivery device such as a catheter).

[0041] Various medical procedures require the controlled use of medical devices (e.g., delivery devices such as access sheaths or catheters). Typically, during such medical procedures, a portion of the medical device must be positioned near the patient's body or near a surgical site during the medical procedure. Often, the medical device must be manipulated and repositioned during such procedures. However, inadvertent movement or unintended positioning of the medical device during delicate medical procedures is undesirable and may be dangerous to the patient, especially when there is a portion of the medical device, such as a catheter or implant, positioned within the body. Therefore, it is desirable to stabilize the medical device during the medical procedure.

[0042] Stabilization may be provided by a person. However, it may be undesirable to use additional personnel to stabilize the access sheath or delivery device, as this may increase crowding at the table where the patient is positioned. During cervical access procedures, using personnel to stabilize the access sheath and / or delivery device, in particular, may be difficult due to the lack of space available at the head of the table where the patient is positioned. Therefore, it may be desirable to reduce the number of personnel required in that space during a procedure while still providing stabilization to the medical equipment. Additionally, due to this lack of space, personnel may be exposed to increased levels of radiation if fluoroscopy is required.

[0043] Stabilization systems (e.g., mechanical stabilization) can be used to position and secure medical equipment rather than using dedicated personnel to provide the same function. The stabilization system holds the medical equipment in a fixed position relative to the patient or surgical site. This reduces the risk of inadvertent movement of the medical equipment. However, challenges arise with stabilization systems due to differences in table and equipment configurations. For example, catheter lab tables are manufactured by multiple companies and there are significant differences in the design and construction of each model. This results in a less predictable and secure attachment between the stabilization system and the table. Furthermore, for certain procedures, such as cervical access procedures, there is little available footprint or space at the head of the table for a large stabilization system. Furthermore, the stabilization system may interfere with other equipment used in the medical procedure. Also, with all of these stabilization systems, the ability to easily maintain sterility at the site of the medical procedure is a concern.

[0044] Therefore, to address these and other issues, a stabilization system is disclosed herein that includes a base for securing the stabilization system to a patient table by inserting the base between the patient table and a mattress on the patient table. This is in contrast to a stabilization system that is attached directly to the patient table. The stabilization system also includes a connector that connects an articulating arm to the base. The base is configured to protrude slightly from under the mattress to provide a robust and predictable surface for attaching the articulating arm of the stabilization system. This base can then be used to support the articulating arm. The articulating arm can have a clamp at its distal end for holding an access sheath or delivery system. The articulating arm can also be lockable. The disclosed stabilization system can be particularly advantageous in cervical access procedures. For example, the base can be positioned under the patient's neck / chest area and the articulating arm extends near the patient's head and neck to secure the medical device near the jugular vein for cervical access procedures.

[0045] In the disclosed stabilization system, the connector securely attaches the articulating arm to the base. A problem that arises with these and similar stabilization systems is how to connect the articulating arm to the base in a manner that maintains a secure connection and provides a sterile barrier. In particular, the unpredictable geometry of sterile surgical drapes that provide a sterile barrier presents particular challenges to the connection mechanism. Thus, the connector and base are configured to accommodate the various different configurations and geometries of sterile surgical drapes. The disclosed connector provides mechanical interlocking and / or locking of the articulating arm both torsionally and axially to the base while accommodating the variable thicknesses and designs of sterile surgical drapes. The disclosed connector is configured to attach the articulating arm to the base such that the articulating arm is above the sterile surgical drape and maintains the sterility of the articulating arm. Furthermore, the disclosed connector is configured to allow personnel to connect the articulating arm to the base without loss of sterility (e.g., without personnel having to resterilize). This is accomplished using a connection mechanism with a sterile portion and a non-sterile portion, where the sterile portion is configured to couple to the articulating arm and the non-sterile portion is configured to couple to the base, where the connection mechanism is configured such that the sterile portion mates with the non-sterile portion with a sterile surgical drape at least partially between the sterile and non-sterile portions.

[0046] The disclosed stabilization system is configured to attach to patient tables (e.g., catheterization lab tables) having different configurations or designs. This is possible due to the design of the base, where the majority of the base is positioned between the patient table and a mattress or pad on top of the patient table, while a small portion of the base protrudes from under the mattress to allow for the connection of an articulating arm. The weight of the patient and mattress provides stability to the stabilization system, rather than requiring a secure connection to the table itself, such as a rail on the table. The weight of the mattress (with or without the patient) and the size of the base contribute to holding the stabilization system in place during the procedure. In some embodiments, most of the base can be made radiolucent to allow for fluoroscopy, and the connector portion can include metal or other rigid and strong material.

[0047] The disclosed stabilization system may be particularly beneficial in procedures using a steerable guide sheath. For example, when using a steerable guide sheath, a physician may need to maintain both rotational and axial position once the target site is accessed. Without the stabilization system, an additional dedicated physician may need to be present during the procedure just to hold the device in place and be cleaned. This may result in one or more of the following problems: lack of stability due to fatigue, loss of anatomical placement of the guide sheath due to fatigue and human error, messy or congested space at the head of the patient table, messy interaction with inserting and removing devices into and from the guide sheath, and / or significantly increased radiation exposure for the physician holding the guide sheath.

[0048] The disclosed stabilization system provides many advantages while easily maintaining a sterile barrier when connecting the articulating arm to the base. For example, the disclosed stabilization system allows for the use of a steerable, flexible guide sheath that holds the guide sheath in place near the patient's access site. The disclosed stabilization system allows the operator to control the depth of the access device, or delivery apparatus, into the patient. The disclosed stabilization system allows the operator to control the torque and orientation of the access sheath and / or delivery apparatus. The disclosed stabilization system fixes the access sheath and / or delivery apparatus and holds it at a desired or target depth and a desired or target orientation (in some embodiments, the orientation can be controlled in six degrees of freedom).

[0049] As another example, the disclosed stabilization system advantageously reduces or completely eliminates the risk of radiation exposure for the physician who would have held the device, locks the device both axially and rotationally to maintain position, adds positive stabilization of the guide sheath to increase stability while inserting and removing other devices into the guide sheath, eliminates the need for an additional physician, and reduces clutter in the lab work area by having a small footprint of space occupied on the table for the unobtrusive portion of the stabilization.

[0050] The disclosed stabilization system advantageously occupies relatively little space on the patient table. Rather than using dedicated personnel to stabilize the access sheath or delivery device, the disclosed stabilization system provides stabilization capabilities while reducing crowding at the patient table. Additionally, the disclosed stabilization system provides little or no obstruction to other medical instruments used in the medical procedure, at least in part due to the size and configuration of the articulating arm and the holder at the distal end of the articulating arm. Additionally, the disclosed stabilization system has a relatively small footprint compared to other stabilization systems (e.g., typical stabilization systems for transfemoral procedures). Advantageously, the disclosed stabilization system provides relatively large degrees of freedom to position and orient medical instruments for a medical procedure. This beneficially accommodates, for example, anatomical differences between patients.

[0051] The disclosed stabilization system advantageously provides a secure connection to a patient table while maintaining a sterile barrier. This is accomplished without the use of rails or other mounting features on the patient table. The design of the base with the articulating arm and connector allows the disclosed stabilization system to be positioned at a desired location, such as near a cervical access site, with the articulating arm near the patient table, all while maintaining a sterile barrier. The base is placed under the mattress, the base is in a non-sterile field, and provides a stable platform for secure connection of the articulating arm. The connector mates with the base in a sterile field (e.g., on a sterile surgical drape). Thus, the articulating arm can be assembled and prepared in a sterile manner and then connected to the base (using the connector) while maintaining the sterility of the articulating arm. This facilitates preparation for a medical procedure by not having to resterilize the articulating arm when connected to the base and positioned for a medical procedure. The articulating arm can be shifted and moved to shift and move a guide sheath or delivery device during a medical procedure. Example of a stabilization system

[0052] 1A, 1B, and 1C show an example of a stabilization system 100 for use in a medical procedure to secure an access sheath or delivery device. FIG. 1A shows the exemplary stabilization system 100 having a base 110, an articulating arm 120, a connector 130, and a holder 140. The base 110 provides a stable platform for the articulating arm 120. The articulating arm 120 is secured to the base 110 via the connector 130. The articulating arm 120 includes a holder 140 at a distal end of the articulating arm 120 to allow stabilization of the access sheath or delivery device 150. The articulating arm 120 and holder 140 are configured to provide freedom of movement to allow desired positioning of the delivery device 150. Further description of the base 110 is provided herein with respect to FIGS. 3A-3D. Further description of the connector 130 is provided herein with respect to FIGS. 4A-4E. Further description of the articulating arm 120 is provided herein with respect to Figures 5A and 5B. Further description of the holder 140 is provided herein with respect to Figures 6A and 6B.

[0053] 1B illustrates an exemplary stabilization system 100 with the base 110 positioned between a patient table 152 and a mattress 154. A sterile surgical drape 156 is positioned over the mattress 154 to provide a sterile barrier. The connector 130 connects the articulating arm 120 and the holder 140 in a sterile field and above the sterile surgical drape 156 while the base 110 is in a non-sterile field below the sterile surgical drape 156. The connector 130 is configured to compress or crush the sterile surgical drape 156 between the connector 130 and the base 110. In this manner, the connector 130 is configured to securely couple the articulating arm 120 to the base 110 to provide a stable mechanism for stabilizing the medical instrument in the holder 140.

[0054] FIG. 1C shows a side view of the patient table 152 and mattress 154 without the sterile surgical drape, illustrating how the base 110 is positioned between the patient table 152 and the mattress 154. A majority of the base 110 is positioned below the mattress to provide a stable platform for the articulating arm 120. A relatively small portion of the base 110 protrudes from below the mattress 154 to provide a connection platform for the connector 130. This provides a robust and predictable surface for mounting the articulating arm 120. The relatively small portion of the base 110 protruding from the patient table 152 contributes to the lack of footprint of the stabilization system 100 compared to other stabilization systems. Additionally, the base 110 can be positioned in various positions between the mattress 154 and the patient table 152 to allow for positioning of medical instruments in desired positions relative to the patient, or the patient's target anatomy, which can be adjusted from patient to patient in response to differences in patient anatomy. For a cervical access procedure, the base 110 may be positioned below the patient's neck / chest area.

[0055] Figures 2A, 2B, 2C, and 2D show an embodiment of connecting connector 130 to base 110 of stabilization system 100 of Figures 1A-1C. This embodiment is shown without a sterile drape in Figures 2A and 2B for clarity, but it should be understood that connector 130 is configured to be connected to base 110 with a sterile surgical drape between connector 130 and base 110 (as shown in Figures 2C and 2D).

[0056] 2A shows the connector 130 secured to the base 110. In particular, the connector 130 is positioned within a base mounting portion 112 (or connector interface) of the base 110. The base mounting portion 112 is configured to mate with a complementary component of the connector 130, as described in more detail herein. The articulating arm 120 is attached to the connector 130 using a mating portion, such as an arm mating pin, as described in more detail herein. In some embodiments, the base mounting portion 112 may be integral with the base 110, or may be separable, or may be otherwise fabricated separately and joined or attached to the base 110.

[0057] Figure 2B shows the connector 130 separate from the base mounting portion 112. The connector 130 is in an attached configuration that allows the connector 130 to mate with the base mounting portion 112. The connector 130 includes an arm mating pin 131 that is configured to mate with a corresponding feature on the articulating arm 120 (not shown in Figure 2B). The arm mating pin 131 allows for attachment and removal of the articulating arm 120 from the connector 130. This advantageously allows the connector 130 to be connected to the base mounting portion 112 without the articulating arm 120 being coupled to the connector 130 while the connection is made. This may make it easier to maintain sterility of the articulating arm 120 before and during a medical procedure.

[0058] The connector 130 includes a knob 132. The knob 132 is internally threaded. The internal threads of the knob 132 mate with a threaded portion 133 of a shaft 137. The connector 130 includes a tapered clamping plate 134 configured to move along the shaft 137. The tapered clamping plate 134 is captured and held on the knob 132 using a grooved ring assembly (not shown). Rotating the knob 132 translates the knob 132 relative to the shaft 137. The tapered clamping plate 134 has an elliptical, stadium-shaped, or pill-shaped cross-section when viewed from the top (e.g., horizontal cross-section) and a tapered cross-section when viewed from the side (e.g., vertical cross-section). The shape of the tapered clamping plate 134 mates with or complements the shape of the base mounting portion 112. Tapered clamping plate 134 is configured to seat within the opening formed by base mounting portion 112 in a manner that allows a surgical drape to be retained between tapered clamping plate 134 and base mounting portion 112. The taper of these components facilitates clamping or squeezing of the surgical drape between the components and accommodates different thicknesses or configurations of surgical drapes.

[0059] The connector 130 also includes a bottom clamp plate 136 coupled to a shaft 137. The bottom clamp plate 136 is axially constrained to the shaft 137 and is configured to rotate freely about a bottom 135 of the shaft 137. Rotating the knob 132 causes the tapered clamp plate 134 and the bottom clamp plate 136 to approach each other. When seated within the base mounting portion 112, the approximation of the tapered clamp plate 134 and the bottom clamp plate 136 creates a clamping force that secures the connector 130 to the base mounting portion 112.

[0060] 2C and 2D show a procedure for fastening the connector 130 to the base 110 with a surgical drape 156 over the base 110. The connector 130 sits within the base mounting portion 112 and the surgical drape 156 is between the base mounting portion 112 and the connector 130. The base 110 is positioned under the mattress 154 as described elsewhere herein. The articulating arm 120 is attached to the arm mating pin 131 of the connector 130.

[0061] 2C shows that the bottom clamp plate 136 is loosened to allow mating of the connector 130 and the base mounting portion 112. A surgical drape 156 is positioned over the base 110. The connector 130 is seated within the base mounting portion 112, sandwiching the surgical drape 156 between the connector 130 and the base 110. The connector 130 is tightened by rotating the knob 132 as shown by the dashed arrow in the figure, clamping the surgical drape 156 between the tapered clamp plate 134 and the base mounting portion 112 and securing the connector 130 to the base mounting portion 112.

[0062] 2D shows the connector 130 in a fixed configuration (in cross section to better illustrate the various components). In the fixed configuration, the bottom clamp plate 136 abuts against a bottom side of the base mounting portion 112 and the tapered clamp plate 134 abuts against an upper tapered portion of the base mounting portion 112. In this fixed configuration, the surgical drape 156 is pressed between the base mounting portion 112 and the tapered clamp plate 134. In some examples, the surgical drape 156 may be pressed between the bottom clamp plate 136 and the bottom of the base mounting portion 112. Rotating the knob 132 moves the shaft 137 upwardly relative to the knob 132, thereby moving the bottom clamp plate 136 upwardly toward the tapered clamp plate 134 (as shown by the arrow). As shown, the shaft 137 includes a threaded portion 133 of the shaft 137 and a bottom portion 135 of the shaft 137. The bottom 135 of the shaft 137 limits the axial movement of the bottom clamp plate 136. The arm mating pin 131 may be formed as part of the shaft 137 or may be an extension attached to the shaft 137. The movement (axial and rotational) of the arm mating pin 131 is also constrained by the shaft 137. In this view, you can see the grooved ring assembly that secures the tapered clamp plate 134 to the knob 132 (grooved ring assembly 138 is described in more detail herein with respect to Figures 4A-4E).

[0063] The horizontal cross-section of the tapered clamping plate 134 is shaped to be complementary to the horizontal cross-section of the opening in the base mounting portion 112. For example, the horizontal cross-section of the tapered clamping plate 134 may be elliptical, such as a stadium or pill shape, and the opening formed by the base mounting portion 112 may be a similar elliptical shape having a closed end and an open end, such as a horseshoe shape. For example, the horizontal cross-section of the tapered clamping plate 134 may include a rounded end that mates with a rounded portion of the opening formed by the base mounting portion 112, and the horizontal cross-section of the tapered clamping plate 134 may include a straight portion extending from the rounded end that mates with a straight edge of the opening formed by the base mounting portion 112. The complementary shapes of the tapered clamping plate 134 and the base mounting portion 112 provide stability to the articulating arm 120 and resist rotation caused by forces and / or torques on the articulating arm 120. In some implementations, the horizontal cross-section of the tapered clamping plate 134 may be any suitable regular or irregular shape that deviates from a circular cross-section, such as an ellipse, an oval, a rectangle, a rounded rectangle, a square, a pill shape, an oblong shape, etc. The deviation from a circular cross-section of the tapered clamping plate 134 is advantageous because the tapered clamping plate 134 resists rotation or twisting relative to the base mounting portion 112 when force and / or torque is applied to the articulating arm 120. The advantages of the complementary oblong shapes of the tapered clamping plate 134 and base mounting portion 112 can be realized with other configurations of the connector and base mounting portion and need not be limited to the embodiments of the connector and base mounting portion configured as described in FIGS. 2A-4E.

[0064] A typical process for preparing the stabilization system disclosed herein to maintain sterility involves placing the base 110 between the mattress 154 and the patient table 152 (under the patient) prior to preparing the other components. Once the patient and base 110 are in place, a sterile surgical drape 156 is positioned over the patient and base 110. On a separate sterile preparation table, the articulating arm 120, connector 130, and holder 140 are assembled. These sterile components are then connected to the base 110 on the surgical drape 156 to maintain the sterility of the assembled components. Thus, the base 110 is in a non-sterile area while the connector 130, articulating arm 120, and holder 140 are in a sterile area, and the sterile barrier defined by the surgical drape 156 is maintained before and after connecting the assembled articulating arm 120 to the base 110.

[0065] 3A, 3B, 3C, and 3D show the base 110 of the stabilization system 100 of FIGS. 1A-1C. FIG. 3A shows an angled view of the top of the base 110, FIG. 3B shows an angled view of the bottom of the base 110, FIG. 3C shows a top view of the base 110, and FIG. 3D shows a side view of the base 110. The base 110 includes a stabilizing portion 111 and a protruding portion 113. The stabilizing portion 111 is configured to be placed between a mattress or pad and a patient table to secure the base 110 to the patient table. With the stabilizing portion 111 of the base 110 so positioned, the protruding portion 113 extends outwardly from between the mattress and the patient table to expose the base mounting portion 112. This allows the connector 130 to be secured to the base 110 as described herein with reference to FIGS. 2A-2D.

[0066] The base 110 includes a wall 114 extending perpendicularly from the base 110. The wall 114 is configured to provide a stop for inserting the base 110 between a patient table and a mattress, thereby separating the stabilizing portion 111 from the protruding portion 113 of the base 110. In some implementations, the base 110 does not include the wall 114. The base 110 may include a handle 116 for ease of handling. In some implementations, the base 110 does not include the handle 116. Although a specific example is provided for the base 110, it should be understood that the base 110 can be any of a variety of platforms that fit between the mattress and table and support the connector while maintaining the sterility of the sterile side of the sterile barrier.

[0067] The base 110 may be radiolucent so as not to interfere with x-ray imaging and / or be transparent to fluoroscopy. In some embodiments, the base 110 is made of plastic. In certain embodiments, the base mounting portion 112 includes metal or other hard and strong material to enhance the mounting strength of the base 110.

[0068] 4A, 4B, 4C, 4D, and 4E show the connector 130 of the stabilization system 100 of FIGS. 1A-1C. FIG. 4A shows an angled view of the connector 130 from above, FIG. 4B shows an angled view of the connector 130 from below, FIG. 4C shows a side view of the connector 130, FIG. 4D shows a cross-sectional view of the connector 130, and FIG. 4E shows an exploded view of the connector 130. As described herein with reference to FIGS. 2A-2D, the connector 130 includes an arm mating pin 131 configured to couple to an articulating arm, such as the articulating arm 120 described herein. The connector 130 includes a knob 132 that is internally threaded. The internal threads of the knob 132 mate with a threaded portion 133 of a shaft 137. Rotating the knob 132 causes the knob 132 to translate axially along the shaft 137 (the shaft 137 includes a threaded portion 133 of the shaft 137, a bottom 135 of the shaft 137, and an arm mating pin 131). The connector 130 includes a tapered clamping plate 134 that is affixed or secured to the knob 132 by a grooved ring assembly 138. Thus, as the knob 132 rotates and translates axially along the shaft 137, the tapered clamping plate 134 also translates axially along the shaft 137. The connector 130 includes a bottom clamping plate 136 that moves toward the tapered clamping plate 134 in response to the rotation of the knob 132. The bottom clamping plate 136 is axially fixed relative to the bottom 135 of the shaft 137, but is free to rotate around the bottom 135 of the shaft 137.

[0069] The tapered clamp plate 134 has an oval, or pill, shape when viewed from the top and a tapered cross-section when viewed from the side. The pill shape mates with or is complementary to a correspondingly shaped mounting portion for the base to resist torque from the articulating arm 120. The complementary tapered shape allows for a secure connection between the connector 130 and the base 110 with surgical drapes of unknown thickness (or a variety of different surgical drapes having different thicknesses) between the connector 130 and the base 110. Although a specific example is provided for the connector 130, it should be understood that the connector can be any of a variety of connectors that interface with a base, examples of which are provided herein.

[0070] The tapered clamping plate 134 may be internally keyed to the cross section of the shaft 137. For example, the tapered clamping plate 134 has an oval or pill shaped internal opening to fit the oval or pill shaped cross section of the shaft 137 (seen as part of the threaded portion 133 of the shaft 137 in FIG. 4E). The keying of the internal opening of the tapered clamping plate 134 to the shaft 137 resists or prevents rotation of the tapered clamping plate 134 relative to the shaft 137. Thus, the keying of the tapered clamping plate 134 to the shaft 137 in combination with the complementary shapes of the tapered clamping plate 134 and the base mounting portion 112 provides that the connector 130 is rigidly connected to the base 110 to resist torques and forces input to the connector 130 via the articulating arm 120. This is advantageous because the articulating arm 120 may be long relative to the size of the connector 130 and can generate substantial torques on the connector 130, and the mechanically robust connections described herein are configured to resist those torques in order to maintain stability during a medical procedure.

[0071] 5A and 5B show an articulating arm 120 of the stabilization system 100 of FIGS. 1A-1C. The articulating arm 120 includes a mating connector 121 configured to mate with an arm mating pin of the connector 130. In some embodiments, the articulating arm 120 includes another type of connection element that interfaces with another type of connector that is a variation of the connectors provided herein. The articulating arms 120 each include a rotational engagement mechanism 122 that can be tightened and loosened to disable and allow rotation of a vertical post 127 relative to the mating connector 121. The vertical post 127 extends from the mating connector 121 to a rotational hinge 123. The rotational hinge 123 can be loosened or tightened to allow rotation and disable rotation using a hinge lock 124. Extending from the rotational hinge 123 is an extension arm 128. The angle of the rotation hinge 123 controls the angle, or direction, of extension of the extension arm 128. The articulating arm 120 includes a holder rotation engagement mechanism 125 that couples the holder interface 126 to the extension arm 128. The holder rotation engagement mechanism 125 controls the orientation of the holder interface 126 (and thus the holder attached to the holder interface 126) and can be tightened and loosened to control the orientation of the holder interface 126. The articulating arm 120 may be lockable once positioned in a desired configuration. The articulating arm 120 may be removably attached to the connector 130. Although a specific example is provided for the articulating arm 120, it should be understood that the articulating arm 120 may be any of a variety of moveable, positionable articulating arms.

[0072] 6A and 6B illustrate the holder 140 of the stabilization system 100 of FIGS. 1A-1C. The holder 140 includes an arm mating pin 141, similar to the arm mating pin 131 of the connector 130, that is configured to mate with the holder interface 126 of the articulating arm 120 to secure the holder 140 to the articulating arm 120. The holder 140 includes a lever 142 that provides one-handed operation using a two-stage clamping mechanism. A medical instrument may be placed in the holder 140 between a first jaw 144 and a second jaw 145. A relatively light force is applied due to pre-tensioned springs 146, 147 in the holder 140. This force is sufficient to hold the medical instrument in place. The lever 142 is then actuated by rotating it away from the arm mating pin 141 to interact with the jaw extension 143 of the first jaw 144 to rotate the first jaw 144 towards the second jaw 145, thereby increasing the force on the medical instrument. This can be accomplished one-handed in most cases. The holder 140 may be configured to be removably attached to the articulating arm 120. Of course, while a particular embodiment of the holder 140 is provided, the holder 140 may be any of a variety of clamping or fixation mechanisms for interfacing with or holding an access sheath or delivery system during a procedure (e.g., a cervical procedure). Additional Connector Examples

[0073] As disclosed herein, a connector can be used to connect the articulating arm to the base while maintaining a sterile barrier. The connector connects to the base with a sterile drape bonded therebetween in a manner that allows the connector to be connected to the base while the base is covered by the sterile drape. The connector is configured to securely join the articulating arm to the base while also maintaining the sterility of the articulating arm. The following description and figures show examples of connectors, or connector assemblies, for a stabilization system such as stabilization system 100.

[0074] Connector assembly may be used to refer to the connector and the connector interface of the base (e.g., base mounting portion) that interfaces with the connector. The connector assembly includes two main components for mounting the base to a mating peripheral device, such as an articulating arm, on a sterile drape. The first component of the connector assembly is configured to be mounted to or integral with the base. The first component is non-sterile. The first component is configured to receive or fit into the second component of the connector. The second component of the connector is mounted to or integral with the peripheral device (e.g., articulating arm) that is mounted to the base. The second component of the connector assembly is sterile throughout the procedure and maintains sterility while attached to the first component of the connector assembly. The connector can be configured in a variety of ways, some of which are described with respect to the following figures.

[0075] 7A and 7B show another exemplary connector assembly 700. FIG. 7A shows a side view of the connector assembly 700, and FIG. 7B shows a top view of the connector assembly 700. The connector assembly 700 includes a connector 730 with a cam drive / lock ball and a base mounting interface with a hitch 712 similar to a "tow hitch" connection for vehicles. The lever 732 can be either side mounted or top mounted. The hitch 712 can protrude from the base. The hitch 712 allows for various mounting orientations of the connector 730. The lever 732 actuates a cam 734 that moves a latch 736 under the hitch 712 to secure the hitch 712 within the housing of the connector 730. The latch 736 is configured to apply an upward force to the bottom of the hitch 712, essentially pulling the hitch 712 into the housing of the connector 730 and securing the connector 730 to the hitch 712.

[0076] 8A and 8B illustrate another exemplary connector assembly 800 including a connector interface 812 including a dual tapered pin and a connector 830 including a spring-activated self-latching and locking cam lever. The dual tapered pin 812 is inserted into a conduit formed by the connector 830. A screw 832 having a head that mates with a groove 813 in the dual tapered pin 812 is inserted through a window 834 to secure the pin 812 within the connector housing.

[0077] 9 shows another example connector assembly 900 including a connector interface 912 with keyed (e.g., hex) pins and a connector 930 with a mating socket having a spring plunger latch / seating mechanism 932 and a set screw locking mechanism 934. The set screw 934 can be a simple set screw or can have a profiled tip or a profiled plunger to increase surface area engagement.

[0078] FIG. 10 shows another exemplary connector assembly 1000 including a connector 1030 including a lever-actuated collet 1032 and a connector interface including a mating circular pin 1012. The tapered pin 1012 is configured to accommodate varying drape thicknesses. The lever-actuated collet 1032 can be placed over the pin 1012 to accommodate the thickness of the surgical drape when placed over the pin 1012. The lever 1032 can be spring loaded with a cam to be self-latching (e.g., the cam can be designed to mate and self-latch with the tapered pin 1012). Actuating the lever 1032 pushes the cup down onto the tapered pin 1012. The pitch of the taper is such that it is low enough to self-lock in terms of fragmentation against the pin 1012.

[0079] 11A-11D show other exemplary connector assemblies 1100a, 1100b including a connector 1130 with a lever actuated cam and ball bearing locking mechanism. The ball bearing can directly interact with the lock pin 1112 or can have a plunger that the ball bearing acts on to increase the mechanical interlock. The connector assembly 1100a can utilize a collet. A shaft protrudes from a base and extends through the center of the collet. The lever rotates and clamps the ball bearing around the pin 1112 using a ball bearing that sits on a raceway. The rotation of the lever causes the ball bearing to rise up a ramp drawn around a diameter, forcing the ball bearing onto the groove of the pin 1112. The connector assembly 1100b replaces the ball bearing with a profiled plunger to obtain a line contact with the pin 1112 rather than the point contact provided by the ball bearing. The connector 1130 of the connector assembly 1100b uses a geometrically driven cam to force the pin onto the shaft.

[0080] 12 shows another exemplary connector 1230 that interfaces with a ball similar to the ball of connector assembly 700 described herein with reference to FIGS. 7A and 7B. The connector 1230 includes a screw-actuated lever to achieve a ball-pitch style connection. The connector 1230 is part of a ball-and-socket joint with a fulcrum between a socket on the bottom and a screw that is used to tighten the connector 1230 onto a ball that extends from a base.

[0081] 13 shows another exemplary connector assembly 1300 including a connector 1330 that includes a friction / cam lock actuated collet and a connector interface that includes a collet-compatible pin 1312. A lever rotates and forces a threaded shaft up and down onto a tapered socket, closing a geometry around the tapered pin 1312. The connector 1330 functions similarly to a collet.

[0082] 14A and 14B show another exemplary connector assembly 1400 including a base mounting interface 1412 with a slotted portion of the base 1410 and a connector 1430 with a self-locking cam lever clamp. The base mounting interface 1412 is incorporated into the base 1410 of the stabilization system. The connector 1430 operates in a similar manner to the connector 130 of FIGS. 1A-1C, where the lever 1432 is used to press the top clamp plate 1434 downward onto the rounded bottom plate 1436 on the shaft 1437 with the base mounting interface 1412 between the two plates 1434, 1436. A sterile drape can be positioned in the gap between the top plate 1434 and the bottom plate 1436 to maintain sterility. The lever 1432 can be part of a self-locking cam lever that locks the top plate 1434 in place. It should be understood that the base mounting interface 1412 may be integral with the base 1410 or may be separable from the base 1410. Additional Features and Embodiments

[0083] Although certain preferred embodiments and examples are disclosed herein, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or applications, as well as modifications and equivalents thereof. Thus, the scope of claims that may arise from this specification is not limited by any of the specific embodiments described herein. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Although various operations may be described sequentially as multiple separate operations in a manner that may be useful for understanding a particular embodiment, the order of description should not be construed as implying that these operations are order dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein. The description of the embodiments of the present disclosure is not intended to be exhaustive or to limit the disclosure to the precise forms disclosed herein. While specific embodiments and examples have been described above for illustrative purposes, various equivalent modifications are possible within the scope of the present disclosure, as those skilled in the relevant art will recognize.

[0084] With respect to the various disclosed embodiments, certain location-related terms are used herein. While certain spatially relative terms such as "outer", "inner", "upper", "lower", "lower", "upper", "vertical", "horizontal", "top", "bottom" and similar terms are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between the element(s) / structure(s) illustrated in the drawings. The spatially relative terms are intended to encompass different orientations of the element(s) / structure(s) during use or operation in addition to the orientation depicted in the drawings. For example, an element / structure described as "above" another element / structure may represent a position below or to the side of such other element / structure with respect to the intended patient or alternative orientations of the element / structure, and vice versa.

[0085] In particular, conditional language used herein, such as "can," "could," "might," "may," "eg," and the like, unless specifically stated otherwise or understood otherwise within the context in which it is used, is intended to have its ordinary meaning and is generally intended to convey that certain embodiments include certain features, elements, and / or steps, but other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are required in any way by one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps are included or performed in any particular embodiment, with or without author input or prompting.

[0086] It should be understood that certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements, such as structures, components, operations, etc., do not necessarily indicate a priority or order of the element relative to any other elements, but rather may generally distinguish an element from other elements having similar or identical names (except for the use of sequential terms). In addition, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an operation performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited. In some contexts, descriptions of actions or events occurring or performed "based on" or "based at least in part on" a described event or condition may be construed as being triggered by or performed in response to the described event or condition.

[0087] In the above description of the embodiments, it should be understood that various features may be grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular embodiment herein may be applied to or used in conjunction with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is necessary or essential to each embodiment. Thus, it is intended that the scope of the invention herein, as disclosed and claimed below, should not be limited by the particular embodiments described above, but should be determined solely by a fair reading of the following claims.

[0088] Unless the context clearly requires otherwise, throughout the specification and claims, the words "comprise," "comprising," "have," "having," "include," "including," and the like, are to be construed in an open and inclusive sense, i.e., "including but not limited to," as opposed to a closed, exclusive, or exhaustive sense.

[0089] The term "associated with" is used herein in accordance with its broad and ordinary meaning. For example, when a first feature, element, component, device, or member is described as "associated with" a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, connected, integrated with, at least partially embedded within, or otherwise physically associated with the second feature, element, component, device, or member, whether directly or indirectly.

[0090] As generally used herein, the term "coupled" refers to two or more elements that are physically, mechanically, and / or electrically connected or may be otherwise associated, whether directly or indirectly (e.g., through one or more intermediate elements, components, and / or devices). Additionally, the terms "herein," "above," "below," and words of similar import, when used in this application, refer to this application as a whole and not to any particular portions of this disclosure, including any disclosure incorporated by reference. Where permitted by context, terms in this disclosure using singular or plural numerals may also include each, plural, or singular numeral.

[0091] The term "or" when referring to a list of two or more items covers all interpretations of the term: any of the items in the list, all of the items in the list, and any combination of the items in the list. Furthermore, as used herein, the term "and / or" used between elements (e.g., between the last two of a list of elements) means any one or more of the referenced / related elements. For example, the phrase "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0092] As may be used herein, the terms "substantially" and "approximately" provide an industry accepted tolerance for its corresponding term and / or relativity between items. For some industries, the industry accepted tolerance may be less than 1 percent, while for other industries, the industry accepted tolerance may be 10 percent or more. Other examples of industry accepted tolerances range from less than 1 percent to 50 percent. Industry accepted tolerances correspond to, but are not limited to, component values, integrated circuit process variations, temperature variations, rise and fall times, thermal noise, dimensions, signaling errors, dropped packets, temperature, pressure, material composition, and / or performance metrics. Within an industry, the tolerance variance of an acceptable tolerance may be greater or smaller than the percentage level (e.g., less than approximately ±1% dimensional tolerance). Some relativities between items may range from less than a percentage level of difference to several percent. Other relativities between items may range from a few percent difference to a magnitude of difference.

[0093] One or more embodiments are used herein to describe one or more aspects, one or more features, one or more concepts, and / or one or more examples. A physical embodiment of an apparatus, article of manufacture, machine, and / or process may include one or more of the aspects, features, concepts, examples, etc. described with reference to one or more of the embodiments discussed herein. Additionally, from figure to figure, the embodiments may incorporate the same or similarly named features, steps, modules, etc., which may use the same, related, or unrelated reference numbers. Related features, elements, functions, operations, modules, etc. may be of the same or similar functionality, or may be unrelated.

Claims

1. 1. A stabilization system for use in a medical procedure for stabilizing an access sheath or delivery device, the stabilization system comprising: a base configured to be positioned between a patient table and a pad on the patient table; An articulated arm; a connector configured to secure the articulating arm to a portion of the base that projects from below the pad; a holder at a distal end of the articulating arm, the holder configured to interface with the access sheath or delivery device; A stabilization system wherein the connector is configured to connect to the base in a manner that maintains sterility of the articulating arm above a sterile barrier during connection of the connector to the base.

2. The stabilization system of claim 1 , wherein the base includes a stabilizing portion and a protruding portion separated by a wall extending perpendicularly from the base.

3. A stabilization system as described in any of claims 1 to 2, wherein the portion of the base that protrudes from under the mattress or pad forms a base mounting portion that mates with the connector.

4. The stabilization system of claim 1 , wherein the connector comprises an arm mating pin configured to mate with the articulating arm.

5. The stabilization system of claim 1 , wherein the connector comprises a shaft, a tapered clamping plate, and a bottom clamping plate.

6. The stabilization system of claim 5 , wherein the tapered clamping plate has an elliptical cross section.

7. The stabilization system of claim 6 , wherein the base defines a base mounting portion having an elliptical shape complementary to the elliptical cross-section of the tapered clamping plate.

8. The stabilization system of claim 5 , wherein the base defines a base mounting portion that is tapered to complement the taper of the tapered clamping plate.

9. The stabilization system of claim 5 , wherein the connector further comprises an internally threaded knob that mates with the threaded portion of the shaft, the tapered clamping plate being secured to the internally threaded knob.

10. The stabilization system of claim 5 , wherein the bottom clamp plate is axially locked to the shaft and is free to rotate about the shaft.

11. The stabilization system of claim 5 , wherein the connector connects to the base by applying a clamping force to the base between the tapered clamping plate and the bottom clamping plate.

12. The stabilization system of claim 5 , wherein the portion of the shaft has an elliptical cross section, and the tapered clamping plate is internally keyed to the elliptical cross section of the portion of the shaft.

13. The stabilization system of claim 1 , wherein the base defines a base mounting portion on the portion of the base that protrudes from under a mattress or pad.

14. The stabilization system of claim 13 , wherein a surgical drape is configured to be positioned between the base mounting portion and the connector when the connector is connected to the base.

15. The stabilization system of claim 13 , wherein the base mounting portion comprises a different material than the remainder of the base.

16. The stabilization system of claim 1 , wherein the base is radiolucent.

17. The stabilization system of claim 1 , wherein the holder comprises a lever-actuated clamp with a pre-tensioned spring to form a two-stage clamping mechanism.

18. The stabilization system of claim 1 , wherein the articulating arm comprises a vertical post that is stably held vertically relative to the connector during a medical procedure.

19. The stabilization system of claim 1 , wherein the holder is removably attached to the articulating arm.

20. The stabilization system of claim 1 , wherein the articulating arm is removably attached to the connector.

21. 1. A stabilization system comprising: a base including a stabilizing portion and a protruding portion, the stabilizing portion configured to be inserted between a mattress and a table, whereby the protruding portion extends outward from between the mattress and the table, the protruding portion forming a base mounting portion; a connector including a shaft, a top plate, and a bottom plate, the top plate and the bottom plate being configured to approach each other along an axial direction of the shaft; a stabilization system, wherein the connector is configured to mate with the base mounting portion to secure the connector to the base with a surgical drape pressed between the connector and the base, and the top plate and the bottom plate are configured to apply a clamping force to the base mounting portion to secure the connector to the base.

22. 22. The stabilization system of claim 21, further comprising a knob coupled to the top plate, wherein rotation of the knob axially approximates the top plate and the bottom plate.

23. 23. The stabilization system of claim 22, wherein the connector further includes a grooved ring assembly for securing the knob to the top plate such that rotation of the knob causes the top plate to translate axially along the shaft toward the bottom plate.

24. 22. The stabilization system of claim 21, wherein the upper plate is internally keyed to a cross section of the shaft to prevent rotation of the upper plate relative to the shaft.

25. 22. The stabilization system of claim 21, wherein the top plate has an elliptical horizontal cross-section complementary to an elliptical horizontal cross-section of the base mounting portion to resist rotation of the top plate relative to the base mounting portion.

26. 22. The stabilization system of claim 21, wherein the top plate has a tapered vertical cross-section that is complementary to the tapered vertical cross-section of the base mounting portion, allowing for a secure connection between the connector and the base with a surgical drape of unknown thickness between the connector and the base.

27. 22. The stabilization system of claim 21, wherein the bottom plate is fixed to the shaft such that the bottom plate is axially fixed relative to the shaft but is free to rotate around the shaft.

28. 22. The stabilization system of claim 21, wherein the base mounting portion defines an opening having a horseshoe shape.

29. 30. The stabilization system of claim 28, wherein a horizontal cross section of the top plate forms a pill shape.

30. 22. The stabilization system of claim 21, wherein the connector further comprises an arm mating pin configured to secure an articulating arm to the connector.

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