Medical device support and method of use
Stabilization systems for medical devices address the challenge of precise control and stability in transvascular procedures by providing adjustable and sterile support for catheters, enhancing procedural efficiency and precision.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- EDWARDS LIFESCIENCES CORP
- Filing Date
- 2022-03-24
- Publication Date
- 2026-07-08
AI Technical Summary
Existing transvascular procedures for delivering and implanting medical devices, such as stents and heart valves, face challenges in maintaining precise control and stability of catheters due to the invasive nature of cardiac surgery, which can complicate the maneuvering and positioning of these devices within the vascular system.
The development of stabilization systems and devices, including bases, frames, and rail systems, that support and stabilize medical devices like catheters during procedures, allowing for adjustable positioning and secure attachment without compromising sterility, enabling precise control and maneuverability.
These stabilization systems enhance the precision and ease of catheter handling during lengthy procedures, maintaining device position and facilitating adjustments as needed, while ensuring sterility and compatibility with various device lengths and configurations.
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Abstract
Description
Technical Field
[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 301,989, filed Jan. 21, 2022, and U.S. Provisional Patent Application No. 63 / 168,204, filed Mar. 30, 2021, both entitled "Medical Device Support and Method of Use", the entire disclosures of which are incorporated herein by reference.
Background Art
[0002] Intravascular delivery systems can be used in a variety of procedures to deliver medical devices or instruments to target locations within a patient's body that are not easily accessible surgically and to target locations where access without surgery is desirable. By using the systems described herein, medical devices (stents, heart valves, grafts, clips, rings, repair devices, valve treatment devices, etc.) can be delivered to locations within a patient's body.
[0003] Access to a target location within a patient's body can be achieved by inserting and guiding a delivery system through a body internal pathway or lumen, including but not limited to, for example, a blood vessel, esophagus, trachea, any part of the digestive tract, or lymphatic vessel. Catheters are known in the art and are commonly used to reach target locations within a patient's body.
[0004] In some procedures, devices for repairing or replacing natural heart valves can be delivered using one or more catheters. Natural heart valves (i.e., aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play a vital role in ensuring forward flow for adequate blood supply through the cardiovascular system. These valves can be damaged, for example, by congenital malformations, inflammatory processes, infections, diseases, etc., which can reduce their effectiveness. Such damage to the valves can lead to serious cardiovascular complications or even death. Damaged valves can be surgically repaired or replaced during cardiac surgery. However, cardiac surgery is highly invasive and can be complicated. Transvascular techniques allow for the introduction and implantation of implantable devices or implants (e.g., implantable prostheses, artificial spacer devices, valve repair devices, valve replacement devices, etc.) in a far less invasive manner than cardiac surgery. As an example, transvascular techniques that can be used to access natural mitral and aortic valves are transseptal techniques. Transseptal techniques involve advancing a catheter into the right atrium (for example, inserting the catheter into the right femoral vein, ascending through the inferior vena cava, and advancing it into the right atrium). The septum can then be punctured, and the catheter can be passed into the left atrium. A similar transvascular technique can be used to implant an artificial device inside the tricuspid valve, in which case the procedure begins similarly to the transseptal technique, but instead of puncturing the septum, the delivery catheter is guided towards the tricuspid valve within the right atrium.
[0005] A healthy heart has an overall conical shape that tapers towards the apex and base. The heart is a four-chambered structure, containing the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The natural mitral valve in the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure from other natural heart valves. The mitral valve includes an annulus, which is the ring portion of the natural valve tissue surrounding the mitral valve opening, and a pair of leaflets or lobes that extend downward from the annulus into the left ventricle. The mitral annulus may form a "D" shape, an ellipse shape, or other non-circular cross-sectional shape with a long axis and a short axis. Because the anterior leaflet is larger than the posterior leaflet, when they close together, a roughly "C" shaped boundary may be formed between the abutting sides of the lobes.
[0006] When functioning correctly, the anterior and posterior leaflets work together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle relax (also called "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also called "ventricular systole" or "systole"), the blood pressure in the left ventricle rises, biasing the two valve leaflets to align laterally. This closes the one-way mitral valve, preventing blood from flowing back into the left atrium, and instead expelling it from the left ventricle through the aortic valve. To prevent the two valve leaflets from dislocating due to pressure or folding back towards the left atrium through the mitral annulus, several fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.
[0007] Valve regurgitation involves a valve improperly allowing some blood to flow through the valve in the wrong direction. For example, mitral regurgitation occurs when the natural mitral valve fails to properly close during systole, allowing blood to flow from the left ventricle into the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, including valve leaflet prolapse, papillary muscle dysfunction, stretching of the mitral annulus due to left ventricular dilation, or a combination of these. Mitral regurgitation in the central part of the valve leaflet can be called central jet mitral regurgitation, while mitral regurgitation closer to one of the valve leaflets (i.e., the point where the leaflets meet) can be called eccentric jet mitral regurgitation. Central jet regurgitation occurs when the valve does not close properly because the edges of the valve leaflets do not meet in the middle, resulting in regurgitation. Tricuspid valve regurgitation, while similar, can occur on the right side of the heart. [Overview of the project]
[0008] This abstract is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, no feature included in the examples in this abstract is a requirement of the claims unless the claims expressly enumerate such features. Also, the features, components, steps, concepts, etc., described in this abstract and the examples elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.
[0009] By using stabilization systems and / or devices, one or more components of a delivery system, such as a catheter assembly, can be supported and / or held in a stable position. The system may include one or more stabilization systems / devices and a delivery system / catheter assembly. Valve repair devices, replacement valves, annuloplasty rings, or other implantable devices can be coupled to the delivery system / catheter assembly.
[0010] An exemplary stabilization system and / or apparatus for a medical system includes a base, a support column, a rail, and an adjustment assembly. The base may be positioned on one or more surfaces, such as a table. The support column is mounted to the base and supports the rail. The adjustment assembly may allow the support column and / or rail to move relative to the base. The rail is movably mounted to the support column and is configured to receive the medical system.
[0011] An exemplary stabilization device for a medical system includes a frame, at least one base, a rail, and an adjustment assembly. The base can be positioned on one or more surfaces, such as a table. The frame is mounted to the base and supports the rail. The adjustment assembly can allow the frame and / or rail to move relative to the base. The rail is movably mounted to the frame and is configured to receive the medical system.
[0012] An exemplary stabilization device for a medical system includes a mount, an arm, a rail, and an adjustment assembly. The mount can be attached to one or more surfaces, such as a table. The arm is attached to the mount and supports the rail. The adjustment assembly can allow the arm and / or rail to move relative to the mount. The rail is movably attached to the arm and is configured to receive the medical system.
[0013] An exemplary stabilization device for a medical system includes a stabilization base configured as a mat having at least one channel. The mat can be placed directly on the patient's body. The channel is configured to receive the medical system.
[0014] In some implementations, exemplary systems for supporting medical devices include a stabilization base comprising multiple legs and a platform mounted to the multiple legs. The system also includes a stabilization system for receiving the medical device, the stabilization system being detachably mounted to the platform.
[0015] In some implementations, one or more of the multiple legs are adjustable to change the vertical, horizontal, and / or angular position of the platform.
[0016] In some implementations, the stabilization system is connected to the platform via a metal plate.
[0017] In some implementations, one or more of the legs include an outer portion and an inner portion that is movably positioned inside the outer portion.
[0018] In some implementations, one or more of the legs include a gas spring mechanism for adjusting the vertical position of the inner portion relative to the outer portion.
[0019] In some implementations, the stabilizing base includes a first plate and a second plate, which are parallel to each other and extend vertically downward from the platform on both sides of the platform.
[0020] In some implementations, the knob mechanism extends through at least one of the first and second plates.
[0021] In some implementations, the system includes a mechanism for controlling the length of one or more of the legs. In some implementations, the mechanism is an electromechanical mechanism. In some implementations, the mechanism is a mechanical mechanism. In some implementations, the mechanism is an electric mechanism. In some implementations, the mechanism is a hydraulic mechanism.
[0022] In some implementations, the stabilization system is a rail system for receiving a medical device, and the rail system is detachably attachable to the platform.
[0023] In some implementations, the medical device is a delivery system that can be coupled to the stabilization system, and the overall system includes the delivery system.
[0024] In some implementations, the system includes at least one retaining member for holding each of the plurality of support legs in a stowed position.
[0025] In some implementations, the retaining member is attached to the bottom cover of the platform.
[0026] In some implementations, the retaining member includes an elastomeric pad.
[0027] In some implementations, the system includes a latching mechanism for prohibiting rotation of the first pair of legs and the second pair of legs when the first pair of legs and the second pair of legs are in the stowed position and the deployed position.
[0028] In some implementations, the latching mechanism of the system includes a rotary catch member and a slide latch member. The rotary catch member extends between the support legs of the first pair of legs and the support legs of the second pair of legs. The slide latch member prohibits rotation of the rotary catch member by engaging with the rotary catch member.
[0029] In some implementations, the system includes a tightening screw that engages with an extension member of the rotary catch member.
[0030] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like members are designated with like reference numerals.
Brief Description of the Drawings
[0031] To further clarify the various aspects of implementation of this disclosure, a more detailed description of specific implementations will be provided by referring to various aspects of the accompanying drawings. It will be understood that these drawings illustrate only typical implementations of this disclosure and are therefore not intended to limit the scope of this disclosure. Furthermore, while the drawings may be shown to scale for some implementations, they are not necessarily shown to scale for all implementations. Implementations of this disclosure, as well as other features and advantages, will be described and explained with additional specificity and detail through the use of the accompanying drawings.
[0032] [Figure 1] Figure 1 shows an operating table with an exemplary stabilization base on its upper surface for supporting a medical device / system (e.g., a delivery system) that can be used to implant an implantable device. [Figure 2] Figures 2 and 3 show exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 3] Same as above. [Figure 4] Figures 4–7 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 5] Same as above. [Figure 6] Same as above. [Figure 7] Same as above. [Figure 8] Figure 8 shows an exemplary stabilization base for supporting a medical device / system (e.g., a delivery system). [Figure 9] Figures 9–12 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 10] Same as above. [Figure 11] Same as above. [Figure 12] Same as above. [Figure 13]Figures 13–16 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 14] Same as above. [Figure 15] Same as above. [Figure 16] Same as above. [Figure 17] Figures 17–20 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 18] Same as above. [Figure 19] Same as above. [Figure 20] Same as above. [Figure 21] Figures 21–25 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 22] Same as above. [Figure 23] Same as above. [Figure 24] Same as above. [Figure 25] Same as above. [Figure 26] Figure 26 shows an exemplary stabilization base for supporting a medical device / system (e.g., a delivery system). [Figure 27] Figures 27–30 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 28] Same as above. [Figure 29] Same as above. [Figure 30] Same as above. [Figure 31] Figures 31–34 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 32] Same as above. [Figure 33] Same as above. [Figure 34] Same as above. [Figure 35]Figures 35-36 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 36] Same as above. [Figure 37] Figures 37–40 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 38] Same as above. [Figure 39] Same as above. [Figure 40] Same as above. [Figure 41] Figures 41–44 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 42] Same as above. [Figure 43] Same as above. [Figure 44] Same as above. [Figure 45] Figures 45–48 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 46] Same as above. [Figure 47] Same as above. [Figure 48] Same as above. [Figure 49] Figures 49–51 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 50] Same as above. [Figure 51] Same as above. [Figure 52] Figures 52–54 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 53] Same as above. [Figure 54] Same as above. [Figure 55]Figure 55 shows an exemplary stabilization base for supporting medical devices / systems (delivery systems, etc.). [Figure 56] Figures 56–66 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 57] Same as above. [Figure 58] Same as above. [Figure 59] Same as above. [Figure 60] Same as above. [Figure 61] Same as above. [Figure 62] Same as above. [Figure 63] Same as above. [Figure 64] Same as above. [Figure 65] Same as above. [Figure 66] Same as above. [Figure 67] Figures 67–72 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 68] Same as above. [Figure 69] Same as above. [Figure 70] Same as above. [Figure 71] Same as above. [Figure 72] Same as above. [Figure 73] Figures 73–74 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 74] Same as above. [Figure 75] Figures 75–84 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems), and their components. [Figure 76] Same as above. [Figure 77] Same as above. [Figure 78] Same as above. [Figure 79]Same as above. [Figure 80] Same as above. [Figure 81] Same as above. [Figure 82] Same as above. [Figure 83] Same as above. [Figure 84] Same as above. [Figure 85] Figures 85–87 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 86] Same as above. [Figure 87] Same as above. [Figure 88] Figure 88 shows a perspective view of an exemplary stabilization base for supporting a medical device / system (e.g., a delivery system). [Figure 89] Figures 89–90 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 90] Same as above. [Figure 91] Figures 91–94 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 92] Same as above. [Figure 93] Same as above. [Figure 94] Same as above. [Figure 95] Figures 95–104 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 96] Same as above. [Figure 97] Same as above. [Figure 98] Same as above. [Figure 99] Same as above. [Figure 100] Same as above. [Figure 101] Same as above. [Figure 102] Same as above. [Figure 103]Same as above. [Figure 104] Same as above. [Figure 105] Figures 105–118 show various diagrams of exemplary stabilization bases for supporting medical devices / systems (e.g., delivery systems). [Figure 106] Same as above. [Figure 107] Same as above. [Figure 108] Same as above. [Figure 109] Same as above. [Figure 110] Same as above. [Figure 111] Same as above. [Figure 112] Same as above. [Figure 113] Same as above. [Figure 114] Same as above. [Figure 115] Same as above. [Figure 116] Same as above. [Figure 117] Same as above. [Figure 118] Same as above. [Modes for carrying out the invention]
[0033] The following description refers to the accompanying drawings illustrating specific implementations of this disclosure. Other implementations with different structures and operations do not deviate from the scope of this disclosure.
[0034] The exemplary implementations of this disclosure concern devices and systems for stabilizing medical devices and systems. It should be noted that various implementations of stabilization devices are disclosed herein, and that, unless specifically excluded, any combination of features in these implementations is possible. In other words, the individual components of the disclosed devices and systems can be combined as long as they are not mutually exclusive or physically impossible to combine.
[0035] As described herein, when one or more components are described as being connected, joined, fixed, coupled, attached, or otherwise interconnected, such interconnections can be direct, such as between components themselves, or indirect, such as through the use of one or more intermediate components. Also as described herein, references to “member,” “component,” or “part” are not limited to a single structural member, component, or element, but may include assemblies of components, members, or elements. Also as described herein, the terms “substantially” and “about” are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).
[0036] In surgical procedures involving one or more catheters, it is typically beneficial for the operator to have precise control over the catheter's movement, as the catheter needs to be guided through the patient's vascular system. This includes mechanisms to assist in maneuvering through the vascular system by allowing the catheter to bend, and mechanisms to control the deployment of implantable devices. During the procedure, the operator may control the catheter using a handle, which can provide control over extending, retracting, and bending the catheter, including when maneuvering it through the patient's vascular system to the delivery or repair site.
[0037] Transcatheter procedures can be lengthy, and it can be inconvenient for the operator to manually maintain the position of the catheter handle throughout the procedure. At some points during the procedure, it may be desirable to adjust the position of the catheter handle relative to the patient, but at other points, it may be desirable to maintain the position of the catheter handle relative to the patient, for example, to maintain the insertion depth of the catheter or to maintain the rotational position of the handle.
[0038] By using a stabilization system / device, and by using a stabilization base to support it, medical devices or medical systems, such as delivery systems for implanting implantable devices (e.g., delivery catheters, a series of catheters, catheter assemblies, handles, etc.), can be held against a patient during surgical procedures. The stabilization base can also be used as a work surface for holding other tools, instruments, materials, or similar items required for a particular procedure. An exemplary stabilization system / device supports and positions the medical device / system in a desired position so that it does not move without instructions from the device operator. The stabilization systems / devices disclosed herein can also be easily adjusted so that such movement is easily achieved when the operator requests to reconfigure or move the medical system / device (e.g., a delivery system).
[0039] The exemplary stabilization systems / devices and stabilization bases disclosed herein can also accommodate sterile barriers, such as drapes, placed between the stabilization system / device and the stabilization base. The stabilization system / device can remain adjustable relative to the base without removing the sterile barrier. This configuration offers significant advantages over prior art methods in which the stabilization system / device is fixed to the stabilization base using clamps that must be released and moved in order to adjust the position of the stabilization system / device relative to the stabilization base. To accommodate medical devices / systems of different lengths, the exemplary stabilization systems / devices disclosed herein can span multiple exemplary stabilization bases, thereby enabling an operator to configure work surfaces of different lengths using the same components.
[0040] The stabilization systems / devices described herein may include one or more rail systems. One or more rail systems may be configured to be mounted to the stabilization base with a sterile barrier between the rail system and the stabilization base. The platform of the stabilization system / device can engage with the rail system, ensuring secure attachment of the rail system to the stabilization base. Various mechanisms can be employed to facilitate adjustment of the relative positions of the components and to facilitate locking or unlocking of the components by connecting one or more rail systems and the stabilization base. Various stabilization methods for various implementations are possible and will be described in more detail below for each implementation. Additional information relating to these types, and various other types of stabilization systems, stabilization devices, stabilization methods, etc., which may be used in conjunction with the inventions herein, can be found in U.S. Provisional Application No. 63 / 073392, U.S. Patent Application No. 15 / 951830, U.S. Patent Application No. 15 / 905257, U.S. Patent Application No. 16 / 582,307, U.S. Patent Application No. 17 / 066416, and PCT Application No. PCT / US2021 / 048333, each of which is incorporated herein by reference in its entirety for all purposes.
[0041] Figure 1 shows a table, such as an operating table, having an exemplary stabilization base on its upper surface for supporting a medical device / medical system (e.g., a delivery device, a delivery system, one or more catheters, one or more handles, a catheter assembly, one or more devices, etc.) that can be used to implant an implantable device. The patient can also be positioned on the operating table, in which case the stabilization base is positioned near the patient, for example, to the side of the patient, between the patient's legs, on part of the patient, etc. Figures 2-3 also show an exemplary stabilization base 100, which may be the same as or similar to the exemplary stabilization base 100 in Figure 1, or may have one or more differences therefrom.
[0042] The stabilization base 100 in any of Figures 1 to 3 may include any features of the stabilization base disclosed herein and may be formed from any suitable material, such as metal or plastic. The stabilization base 100 has a base, such as legs, struts, or a frame, for supporting the platform so that it can be raised and lowered above a patient being treated with a medical device / system, such as a catheter assembly 114, which is stabilized by the stabilization base 100. The base may include feet (not shown) so as to further stabilize the legs and / or so as to require fewer than four legs to support the stabilization base 100 in a stable base state. The stabilization base 100 may also include various base mounting positions to reconfigure the stabilization method, such as to avoid obstacles. In some implementations, the legs are movable to different angles. In some implementations, the legs are extendable to different lengths to change the angle of the platform. In some implementations, the legs may be set to a fixed angle, but the legs may still be extendable to different lengths to change the angle of the platform.
[0043] In some implementations, the stabilization base includes multiple legs and a platform attached to these legs. In some implementations, the stabilization system for receiving medical devices is detachably attached to the platform. In some implementations, the stabilization system is connected to the platform via a metal plate.
[0044] In some implementations, one or more of the legs are adjustable to change the vertical, horizontal, and / or angular position of the platform. In some implementations, the length of one or more legs is adjustable. In some implementations, the angle of one or more legs is adjustable.
[0045] In some implementations, the system includes a mechanism for controlling the length of one or more of the legs. In some implementations, the mechanism is an electromechanical mechanism. In some implementations, the mechanism is a mechanical mechanism. In some implementations, the mechanism is an electric mechanism. In some implementations, the mechanism is a hydraulic mechanism.
[0046] In some implementations, one or more of the legs include an outer portion and an inner portion movably positioned inside the outer portion. In some implementations, the inner and outer portions can be extended or retracted, or otherwise moved relative to each other, in order to change the length of the leg. In some implementations, one or more of the legs include a mechanism (e.g., a hydraulic mechanism, an electromechanical mechanism, an electric mechanism, a gas spring mechanism, a mechanical mechanism, etc.) for adjusting the vertical position of the inner portion relative to the outer portion.
[0047] In some implementations, the stabilizing base includes a first plate and a second plate, which are parallel to each other and extend vertically downward from the platform on both sides of the platform. In some implementations, a knob mechanism extends through at least one of the first plate and the second plate.
[0048] In some implementations, the stabilization system is a rail system for receiving medical devices, and the rail system is detachably mounted to the platform.
[0049] In some implementations, the stabilization system includes a rail system 140. In some implementations, the rail system is movably and optionally detachably mounted on the platform of the stabilization base 100 so that the delivery system / catheter assembly 114 can move relative to the stabilization base 100 together with the rail system. Exemplary rail systems that may be used with the stabilization base of this application are disclosed in U.S. Provisional Patent Application No. 63 / 073,392, filed 1 September 2020, and / or PCT Application No. PCT / US2021 / 048333, filed 31 August 2021, which are incorporated herein by reference in their entirety for all purposes.
[0050] The stabilization base 100 can be placed on a support surface, such as a table 110, including, an operating table. Alternatively or additionally, the stabilization base 100 can be attached to the table 110 by attaching it to a bed rail on the side of the table 110 or to another component of the table. By attaching the clamp 142 to the rail system 140, a medical device / system, such as a catheter assembly 114, can be secured to the rail system 240. Exemplary clamps that may be used with the stabilization base of this application are disclosed in U.S. Provisional Patent Application No. 63 / 073,392, filed 1 September 2020, and / or PCT Application No. PCT / US2021 / 048333, filed 31 August 2021, which are incorporated herein by reference in their entirety.
[0051] A sterile barrier 112, such as a drape, can be placed on the top surface of the base 110, below the stabilizing base 100, or between parts of the stabilizing base 100. The illustrated barrier 112 can be moved between the stabilizing base 100 and the rail system 140, or additional barriers can be placed between the stabilizing base 100 and the rail system 140. The rail system 140 can be configured to be held whole or partially by the features of the stabilizing base 100 so that the rail system 140 can still be attached to the stabilizing base 100 even when the stabilizing base is covered by a sterile barrier 112 such as a drape. That is, the rail system 140 can be attached to the stabilizing base 100 without requiring any mounting means such as fixing members that would puncture or perforate the sterile barrier placed between the stabilizing base 100 and the rail system 140. In some implementations, the rail system 140 can be attached to the stabilizing base 100 using magnetic plates.
[0052] The stabilization base 100 can take on a wide variety of different forms. In the example shown in Figure 1, the stabilization base 100 may include one or more (two in the illustrated implementation) stands or bases, each having four legs. In some implementations, the stabilization base 100 includes two or three adjustable legs. The legs can be adjusted to change the height and angle of the stabilization base 100 relative to the operating table 110, for example, by changing the angle of one or more legs, by changing the length of one or more legs, and / or by a combination thereof. As shown in Figure 3, the stand in Figure 2 can be folded into a smaller configuration for transport and / or storage. In some implementations, the rail system 140 and / or clamp 142 can be housed inside the folded stabilization base.
[0053] Referring here to Figures 4–7, exemplary stabilization bases 200 for supporting medical devices / systems are shown. Stabilization bases 200 may include any of the features of stabilization bases disclosed herein and may be formed from any suitable material such as metal or plastic.
[0054] The stabilizing base 200 includes a base plate 220, a support column 230, a platform 244, and a rail system 240. The support column 230 extends vertically upward from the base plate 220 and is mounted to the platform 244. The platform 244 is detachably mounted to the rail system 240 (however, in some implementations, the platform and rail system can be formed integrally). By attaching a clamp 242 to the rail system 240, a medical device / system such as a delivery system or catheter assembly 114 can be secured to the rail system 240. In some implementations, the rail system 240 and / or clamp 242 are identical to those disclosed in U.S. Provisional Patent Application No. 63 / 073392, filed September 1, 2020, and / or PCT Application No. PCT / US2021 / 048333, filed August 31, 2021, which are incorporated herein by reference in their entirety. The stabilizing base 200 maintains stability by having a wide base plate 220 for mounting on a surface such as a patient's table.
[0055] The base plate 220 can be a substantially flat plate of any suitable shape and dimensions to provide counterbalancing and support for the medical device / system fixed to the stabilizing base 200. The base plate can be square, circular, hexagonal, and homogeneous in shape. The base plate 420 can be solid or have a void space in the center of the plate. In some implementations, the base plate 220 can be a solid rectangular plate.
[0056] The support column 230 can be joined to the base plate 220 by any suitable means, such as welding, adhesive, or similar. In some implementations, the support column 230 can be movably mounted to the base plate 220 by a hinge mechanism or the like, so that the support column 230 can pivot relative to the base plate 220. The support column 230 can be any suitable shape, such as a square, circle, or oval. In some implementations, the support column 230 has an outer portion 232 and an inner portion 234 movably positioned inside the outer portion 232. The vertical position of the inner portion 234 of the support column 230 within the outer portion 232 of the support column 230 can be adjusted via an internal gas spring mechanism (not shown) of the support column 230. The gas spring mechanism can be locked in place using an actuator 238, such as a button, tab, switch, or similar. In some implementations, the gas spring mechanism is adjusted to balance the weight of the catheter assembly 114 so that the user can easily adjust the vertical position of the support column 230.
[0057] The gas spring mechanism inside the support column 230 can be adjusted by unlocking the actuator 238 and moving the inner portion 234 of the support column 230 upward or downward within the outer portion 232 of the support column 230. The movement of the inner portion 234 within the outer portion 232 of the support column 230 changes the distance between the base plate 220 and the platform 244. By adjusting the height of the platform 244, the rail system 240 and the catheter assembly 114 fixed to the rail system 240 can be positioned at the desired height above the patient.
[0058] The platform 244 can be joined to the support column 230 by any suitable means such as welding, fasteners, and / or adhesives. In some implementations, the inner portion 234 of the support column 230 can be connected to the platform 244 via an adjustable connection such as a hinge 236 that allows the platform 244 to pivot relative to the support column 230. In some implementations, the radial position of the platform 244 relative to the support column 230 can be adjusted by unlocking the hinge 236, and further movement of the platform 244 can be prevented by locking the hinge 236 after the desired radial position has been established. In some implementations, the hinge 236 can be adjusted or selected by a spring or counterweight mechanism, which can prevent radial movement of the platform 244 unless the hinge 236 is driven by applying sufficient upward or downward force to the platform 244.
[0059] The rail system 240 can be detachably attached to or combined with the platform 244 of the stabilization base 200 by any suitable means, such as fasteners, threaded fasteners, snaps, clamps, latches, friction fits, spring clamps, hook and loop fasteners, magnets, or the like. The rail system 240 can be configured to be held whole or partially by the features of the platform 244 of the stabilization base 200 so that the rail system 240 can still be attached to the stabilization base 200 even when the stabilization base is covered by a sterile barrier (not shown), such as a drape. The illustrated barrier 112 can be placed between the stabilization base 200 and the rail system 240. The rail system 240 can be attached to the stabilization base 200 without requiring attachment means, such as fasteners, that would puncture or perforate the sterile barrier placed between the platform 244 and the rail system 240. In some implementations, the rail system can be attached to the stabilization base 200 using magnetic plates or snap connections that do not perforate the sterile barrier. In some implementations, the horizontal position of the rail system 240 can be adjusted relative to the platform 244 by sliding the rail system 240 back and forth relative to the platform 244.
[0060] The base plate 220 can be positioned flush with the plane formed by the base 110 (as shown in Figure 1), and the patient's legs can be placed on the base plate 220 such that the support columns 230 extend vertically upward between the patient's legs. The position of the delivery system / catheter assembly 114 relative to the patient can be optimized by adjusting the position of various elements of the stabilizing base 200, for example, by raising or lowering the height of the support columns 230, adjusting the pitch of the platform 244 relative to the support columns 230, and / or sliding the rail system 240 back and forth relative to the platform 244.
[0061] Referring here to Figure 8, an exemplary stabilization base 300 for supporting a medical device / system such as a catheter assembly 114 is shown. The stabilization base 300 may include any of the features of the stabilization base disclosed herein and may be formed from any suitable material such as metal or plastic.
[0062] The stabilizing base 300 includes a base plate 320, a support column 330, and a platform 344. The support column 330 includes a lower portion 331 extending vertically upward from the base plate 320 and an upper portion 333 extending vertically downward from the platform 344. The platform 344 can be detachably attached to a rail system (not shown).
[0063] The base plate 320 can be a substantially flat plate of any suitable shape and dimensions to provide counterbalancing and support for the medical device / system fixed to the stabilizing base 300. The base plate can be square, circular, hexagonal, and homogeneous in shape. The base plate 420 can be solid or have a void space in the center of the plate. In some implementations, the base plate 320 can be a solid rectangular plate.
[0064] The lower portion 331 of the support column 330 has a first slot 337A and a second slot 337B. The first slot 337A and the second slot 337B are diagonally opposite each other and are installed at a certain distance from each other. The upper portion 333 has a first peg 335A and a second peg 335B extending outward from the surface of the upper portion that is close to the lower portion 331. In this case, the first peg 335A is located inside the first slot 337A in the lower portion 331 of the support column 330, and the second peg 335B is located inside the second slot 337B in the lower portion 331 of the support column 330. The height of the platform 344 relative to the base plate 320 can be adjusted by sliding the first peg 335A and the second peg 335B within the first slot 335A and the second slot 335B. When the first peg 335A and the second peg 335B approach the lower ends of the first slot 337A and the second slot 337B, the platform 344 moves closer to the base plate 320. When the first peg 335A and the second peg 335B slide upward toward the upper ends of the first slot 337A and the second slot 337B, the platform 344 moves away from the base plate 320.
[0065] In some implementations, the first peg 335A and the second peg 335B can be secured inside the first slot 337A and the second slot 337B by any suitable method, such as frictional engagement between slots 337A and 337B and the pegs 335A and 335B, or frictional engagement between the upper portion 331 and the lower portion 333 of the post 330. In some implementations, the first peg 335A and the second peg 335B are screwed into nuts (not shown) that extend through the first peg 335A and the second peg 335B and can be tightened or loosened to increase or decrease the frictional engagement between the upper portion 331 and the lower portion 333 of the post 330, respectively.
[0066] The rail and / or clamping system (such as the rail and / or clamping system described above) can be detachably attached to the platform 344 of the stabilizing base 300 by any suitable means, such as fasteners, threaded fasteners, snaps, clamps, latches, friction fits, spring clamps, hook and loop fasteners, magnets, or the like. The rail system can be configured to be held whole or partially by the features of the platform 344 of the stabilizing base 300 so that the rail system can still be attached to the stabilizing base 300 even when the stabilizing base is covered by a sterile barrier such as a drape (not shown). That is, the rail system can be attached to the stabilizing base 300 without requiring attachment means such as fasteners that would puncture or perforate a sterile barrier placed between the platform 344 and the rail system. In some implementations, the rail system can be attached to the stabilizing base 300 using magnetic plates. Exemplary rails that can be used with the stabilization base 300 are disclosed in U.S. Provisional Patent Application No. 63 / 073,392, and / or PCT Application No. PCT / US2021 / 048333, filed on 31 August 2021.
[0067] The base plate 320 can be positioned flush with the plane formed by the platform 110 (see Figure 1), and the patient's legs can be placed on the base plate 320 such that the support columns 330 extend vertically upward between the patient's legs. The position of the delivery system / catheter assembly 114 relative to the patient can be optimized by adjusting the position of various elements of the stabilizing base 300, for example, by raising or lowering the height of the platform 344 relative to the base plate 320.
[0068] Referring here to Figures 9–12, exemplary stabilization bases 400 for supporting medical devices / systems are shown. Stabilization bases 400 may include any of the features of stabilization bases disclosed herein and may be formed from any suitable material such as metal or plastic.
[0069] The stabilizing base 400 includes a base plate 420, a support column 430, support column plates 450A and 450B, a platform 444, and a rail system 440. The support column 430 extends vertically upward from the base plate 420 and is mounted to the platform 444. The platform 444 is detachably mounted to the rail system 440 (however, in some implementations, the rail system can be integrally formed as part of the platform). By attaching clamps to the rail system 440, medical devices / systems such as catheter assemblies 114 can be secured to the rail system 440. Clamps may be any clamps in any implementation described herein, although they are not shown in Figures 9–12 for the sake of simplicity in the drawings. Any clamps, features, and / or rails, such as those disclosed in U.S. Provisional Patent Application No. 63 / 073,392, or in other applications incorporated herein, can be used on the stabilizing base 400 as shown in Figures 9 to 12.
[0070] The base plate 420 can be a substantially flat plate of any suitable shape and dimensions to provide counterbalancing and support for the medical device / system fixed to the stabilizing base 400. The base plate can be square, circular, hexagonal, and homogeneous in shape. The base plate 420 can be solid or have a void space in the center of the plate. In some implementations, the base plate 420 is a flat hexagonal frame.
[0071] The support column 430 can be joined to the base plate 420 by any suitable means, such as welding, adhesive, or similar means. The support column 430 can also be molded from the same material as the base plate 420 so that the support column 430 and the base plate 420 form a single solid member. The support column 430 can be any suitable shape, such as a square, circle, or oval. In some implementations, the support column 430 is arched so that the support column 430 extends vertically from the base plate 420 at the first and second ends.
[0072] The platform 444 can be joined to the support column 430 by any suitable means, such as welding, adhesive, or similar means. The platform 444 can also be attached to the support column 430 so as to be movable or detachable so as to be able to adjust the position of the platform 444 relative to the support column 430. In some implementations, a first support plate 450A and a second support plate 450B parallel to the first support plate 450A extend vertically downward from the platform 444 on both sides of the support column 430. The first support plate 450A and the second support plate 450B are spaced apart from each other such that the support column 430 fits tightly into the gap space between them, but the first support plate 450A and the second support plate 450B are still movable relative to the support column 430. A knob mechanism 452, located adjacent to the first plate 450A, extends through the first plate 450A and is attached to the second plate 450B by any suitable means. When the knob mechanism 452 is tightened, it reduces the distance between the first support plate 450A and the second support plate 450B, thereby increasing the frictional engagement between the support plates 450A, 450B and the support 430. When the knob mechanism 452 is loosened, the distance between the first support plate 450A and the second support plate 450B increases, thereby decreasing the frictional engagement between the support plates 450A, 450B and the support 430.
[0073] In some implementations, the rail system 440 is detachably attached to the platform 444 of the stabilization base 400 by any suitable means, such as fasteners, threaded fastener snaps, clamps, latches, friction fits, spring clamps, hook and loop fasteners, magnets, or similar. The rail system 440 can be configured to be held whole or partially by the features of the platform 444 of the stabilization base 400 so that the rail system 440 can still be attached to the stabilization base 400 even when the stabilization base is covered by a sterile barrier (not shown), such as a drape. A barrier 112 illustrated herein (see Figure 1) can be placed between the stabilization base 400 and the rail system 440. The rail system 440 can be attached to the stabilization base 400 without requiring attachment means, such as fasteners, which would puncture or perforate a sterile barrier placed between the platform 444 and the rail system 440. In some implementations, the rail system can be attached to the stabilization base 400 using magnetic plates. In some implementations, the horizontal position of the rail system 440 can be adjusted relative to the platform 444 by sliding the rail system 440 back and forth relative to the platform 444.
[0074] The base plate 420 can be positioned flush with the plane formed by the base 110 (see Figure 1), and the patient's legs can be placed on the base plate 420 such that the support columns 430 extend vertically upward between the patient's legs. In some implementations, when the knob mechanism 452 of the stabilizing base 400 is loosened, the support plates 450A and 450B can be moved freely in any direction relative to the support columns 430, including in the rotational direction, the translational direction, and the vertical direction. Thus, the position of the platform 444 can be adjusted to the optimal distance and optimal radial position relative to the patient. The knob mechanism 452 can then be tightened, thereby holding the platform 444, and thus the rail system 440 and delivery system / catheter assembly fixed to the platform 444, in the optimal position relative to the patient.
[0075] Referring here to Figures 13–16, exemplary stabilization bases 500 for supporting medical devices / systems are shown. Stabilization bases 500 may include any of the features of stabilization bases disclosed herein and may be formed from any suitable material such as metal or plastic.
[0076] The stabilizing base 500 includes a base plate 520, a support column 530, support column plates 550A and 550B, a platform 544, and a rail system 540. The support column 530 extends vertically upward from the base plate 520 and is mounted to the platform 544. The platform 544 is detachably mounted to the rail system 540 (however, in some implementations, the rail system and platform can be formed integrally). By attaching clamps to the rail system 540, medical devices / systems such as catheter assemblies 114 can be secured to the rail system 540. Clamps may be any clamps in any implementation described herein, although they are not shown in Figures 13–16 for the sake of simplicity in the drawings. Any clamps, features, and / or rails, such as those disclosed in U.S. Provisional Patent Application No. 63 / 073,392, or in other applications incorporated herein, can be used on the stabilizing base 500 as shown in Figures 13 to 16.
[0077] The base plate 520 can be a substantially flat plate of any suitable shape and dimensions to provide counterbalancing and support for the medical device / system fixed to the stabilizing base 500. The base plate can be square, circular, hexagonal, and homogeneous in shape. The base plate 520 can be solid or have a void space in the center of the plate. In some implementations, the base plate 520 is a solid, substantially rectangular plate.
[0078] The support column 530 can be joined to the base plate 520 by any suitable means, such as welding, adhesive, or the like. The support column 530 can also be molded from the same material as the base plate 520 so that the support column 530 and the base plate 520 form a single solid member. The support column 530 can be any suitable shape, such as a square, circle, or oval. In some implementations, the support column 530 is a flat triangular member having an orifice 537 passing through the center of the support column. The orifice 537 can be any suitable shape, such as a circle, rectangle, or oval. In some implementations, the orifice 537 is circular.
[0079] The platform 544 can be joined to the column 530 by any suitable means, such as welding, adhesive, or similar means. The platform 544 can also be attached to the column 530 so as to be movable or detachable so as to be able to adjust the position of the platform 544 relative to the column 530. In some implementations, a first column plate 550A and a second column plate 550B parallel to the first column plate 550A extend vertically downward from the platform 544 on both sides of the column 530. The first column plate 550A and the second column plate 550B are spaced apart from each other such that the column 530 fits tightly into the gap space between them, but the first column plate 550A and the second column plate 550B are still movable relative to the column 530. A knob mechanism 552, positioned close to the first plate 550A, extends through the first plate 550A and further through the orifice 537 of the column 530, and is attached to the second plate 550B by any suitable means. The gap space or the edge of the orifice 537 can be formed from a high-friction material such as rubber or silicone to increase the frictional engagement between the column 530 and the first and second column plates 550A and 550B. When the knob mechanism 552 is tightened, it reduces the distance between the first and second column plates 550A and 550B, thereby increasing the frictional engagement between the column plates 550A and 550B and the column 530. When the knob mechanism 552 is loosened, the distance between the first support plate 550A and the second support plate 550B increases, thereby reducing the frictional engagement between the support plates 550A and 550B and the support column 530.
[0080] In some implementations, the rail system 540 is detachably attached to the platform 544 of the stabilization base 500 by any suitable means, such as fasteners, threaded fastener snaps, clamps, latches, friction fits, spring clamps, hook and loop fasteners, magnets, or similar. The rail system 540 can be configured to be held whole or partially by the features of the platform 544 of the stabilization base 500 so that the rail system 540 can still be attached to the stabilization base 500 even when the stabilization base is covered by a sterile barrier (not shown), such as a drape. That is, the rail system 540 can be attached to the stabilization base 500 without requiring attachment means, such as fasteners, that would puncture or perforate a sterile barrier placed between the platform 544 and the rail system 540. In some implementations, the rail system can be attached to the stabilization base 500 using magnetic plates. A barrier 112 illustrated herein (see Figure 1) can be placed between the stabilization base 500 and the rail system 540. In some implementations, the horizontal position of the rail system 540 can be adjusted relative to the platform 544 by sliding the rail system 540 back and forth relative to the platform 544.
[0081] The base plate 520 can be positioned flush with the plane formed by the base 110 (see Figure 1), and the patient's legs can be placed on the base plate 520 such that the support columns 530 extend vertically upward between the patient's legs. In some implementations, when the knob mechanism 552 of the stabilizing base 500 is loosened, the support plates 550A and 550B can be moved freely in any direction relative to the support columns 530, including in the rotational direction, the translational direction, and the vertical direction. Thus, the position of the platform 544 can be adjusted to the optimal distance and optimal radial position relative to the patient. The knob mechanism 552 can then be tightened, thereby holding the platform 544, and thus the rail system 540 and delivery system / catheter assembly fixed to the platform 544, in the optimal position relative to the patient.
[0082] Referring here to Figures 17–20, exemplary stabilization bases 600 for supporting medical devices / systems are shown. Stabilization bases 600 may include any of the features of stabilization bases disclosed herein and may be formed from any suitable material such as metal or plastic.
[0083] The stabilizing base 600 includes a base plate 620, a support column 630, a support column cover 650, a platform 644, and a rail system 640. The support column 630 extends vertically upward from the base plate 620 and is mounted to the platform 644. The platform 644 is detachably mounted to the rail system 640 (however, in some implementations, the rail system and platform can be formed integrally). By attaching clamps to the rail system 640, medical devices / systems such as catheter assemblies 114 can be secured to the rail system 640. Clamps may be any clamps in any implementation described herein, although they are not shown in Figures 17-20 for the sake of simplicity in the drawings. Any clamps, features, and / or rails, such as those disclosed in U.S. Provisional Patent Application No. 63 / 073,392, or in other applications incorporated herein, can be used on the stabilizing base 600 as shown in Figures 17 to 20.
[0084] The base plate 620 can be a substantially flat plate of any suitable shape and dimensions to provide counterbalancing and support for the medical device / system fixed to the stabilizing base 600. The base plate can be square, circular, oval, hexagonal, and homogeneous in shape. The base plate 620 can be solid or have a void space in the center of the plate. In some implementations, the base plate 620 is a solid oval plate.
[0085] The support column 630 can be joined to the base plate 620 by any suitable means, such as welding, adhesive, or the like. The support column 630 can also be molded from the same material as the base plate 620 so that the support column 630 and the base plate 620 form a single solid member. The support column 630 can be any suitable shape, such as a square, circle, or oval. In some implementations, the support column 630 is trapezoidal.
[0086] Platform 644 can be joined to the support column 630 by any suitable means, such as welding, adhesive, or similar. Platform 644 can also be mounted to the support column 630 so as to be adjustable in its position relative to the support column 630, either movable or detachable. In some implementations, a support column cover 650 extends vertically downward from platform 644 and surrounds the support column 630. The area between the support column 630 and the support column cover 650 can accommodate a mechanism (not shown) for controlling the position of platform 644 relative to the support column 630, such as an electromagnetic, electromechanical, hydraulic, pneumatic, gear-driven, and similar mechanism (not shown). The mechanism can be controlled manually and / or electronically. In some implementations, the mechanism is operated by a controller 670, such as a toggle, button, joystick, or similar. The controller 670 can be positioned at any location on the stabilization base 600, such as on the base plate 620, on the support column 630, or on the support column cover 650. In some implementations, the controller 670 is remotely attached to the stabilization base 600 via code 672. The controller 670 can also operate the mechanism wirelessly through a computer, tablet, or similar electronic device. The mechanism can control the position of the platform 644 relative to the support column 630 by raising or lowering the platform 644, moving the platform 644 back and forth, changing the pitch of the platform 644 relative to the base plate 620, or moving the platform 644 left and right.
[0087] The rail system 640 is detachably attached to the platform 644 of the stabilization base 600 by any suitable means, such as fasteners, threaded fasteners, snaps, clamps, latches, friction fits, spring clamps, hook and loop fasteners, magnets, or the like. The rail system 640 can be configured to be held whole or partially by the features of the platform 644 of the stabilization base 600 so that the rail system 640 can still be attached to the stabilization base 600 even when the stabilization base is covered by a sterile barrier (not shown), such as a drape. That is, the rail system 640 can be attached to the stabilization base 600 without requiring attachment means such as fasteners that would puncture or perforate a sterile barrier placed between the platform 644 and the rail system 640. In some implementations, the rail system can be attached to the stabilization base 600 using magnetic plates. In some implementations, the horizontal position of the rail system 640 can be adjusted relative to the platform 644 by sliding the rail system 640 back and forth relative to the platform 644. The barrier 112 illustrated herein (see Figure 1) can be placed between the stabilizing base 600 and the rail system 640.
[0088] The base plate 620 can be positioned flush with the plane formed by the platform 110 (see Figure 1), and the patient's legs can be placed on the base plate 620 such that the support column 630 extends vertically upward between the patient's legs. In some implementations, the internal mechanism of the support column 630 (not shown) can be controlled electronically or manually by the user, thereby allowing the platform 644 to be moved in any direction relative to the support column 630, such as in the rotational direction, in the translational direction, and vertically. Thus, the position of the platform 644 can be adjusted to the optimal distance and radial position relative to the patient.
[0089] Referring here to Figures 21–25, exemplary stabilization bases 800 for supporting medical devices / systems are shown. Stabilization bases 800 may include any features of the stabilization bases disclosed herein and may be formed from any suitable material such as metal or plastic.
[0090] The stabilization base 800 includes a frame 880 and a rail system 840. The rail system 840 is movably mounted to the top of the frame 880. By attaching clamps to the rail system 840, medical devices / systems such as catheter assemblies 114 can be secured to the rail system 840. The clamps may be any clamps in any implementation described herein, although they are not shown in Figures 21–25 for the sake of simplicity in the drawings. Any clamps, features, and / or rails, such as those disclosed in U.S. Provisional Patent Application Serial No. 63 / 073,392 or in other applications incorporated herein, may be used on the stabilization base 800 as shown in Figures 21–25.
[0091] The frame 880 has at least one track section 882A, 882B and at least one support member 884A, 884B. The support members 884A, 884B support and stabilize the frame 880 on a surface such as a base 110. The support members 884A, 884B can be any suitable shape and configuration, such as a column, bar, triangular or rectangular frame, and the like. The support members 884A, 884B support at least one track section 882A, 882B, which extends parallel to the surface on which the frame 880 is placed and is positioned at a sufficient height above the surface so that a patient's body can fit between the surface and at least one track section 882A, 882B. The support members 884A and 884B can be permanently attached to at least one track portion 882A and 882B by welding, adhesive, or similar means, or by any suitable means so as to allow the position of the track portion 882A and 882B to be adjusted relative to the support members 884A and 884B.
[0092] In some implementations, the frame 880 has a first support member 884A, a second support member 884B, a first track section 882A, and a second track section 882B. In some implementations, the first support member 884A and the second support member 884B are horizontal bars placed on a surface (e.g., a base 110) at both ends of the frame 880. One end of the first track section 882A is attached to one end of the first support member 884A, and one end of the second track section 882B is attached to the other end of the first support member 884A. The other end of the first track section 882A is attached to one end of the second support member 884B, and the other end of the second track section 882B is attached to the other end of the second support member 884B, thereby forming a U-shape at both ends of the frame 880.
[0093] In some implementations, the ends of the first support member 884A and the second support member 884B are recessed into the ends of the first track portion 882A and the second track portion 882B, respectively, so that the positions of the first track member 882A and the second track member 882B can be adjusted vertically with respect to the first support member 884A and the second support member 884B. Optionally, the ends of the first track portion 882A and the second track portion 882B can be recessed into the ends of the first support member 884A and the second support member 884B.
[0094] The rail system 840 can be joined to the frame 880 by any suitable means, such as welding or similar means. The rail system 840 can also be mounted to the frame 880 in a movable or detachable manner so that the position of the rail system 840 relative to the frame 880 can be adjusted. The rail system 840 can be configured to be held whole or partially by the frame 880 features of the stabilizing base 800 so that the rail system 840 can still be mounted to the stabilizing base 800 even if the stabilizing base is covered by a sterile barrier (not shown), such as a drape. That is, the rail system 840 can be mounted to the stabilizing base 800 without requiring mounting means such as fasteners that would puncture or perforate a sterile barrier placed between the frame 880 and the rail system 840. In some implementations, the rail system can be mounted to the stabilizing base 800 using magnetic plates. In some implementations, the stabilizing base 800 rests on the top of the drape 112. The barrier 112 illustrated herein (see Figure 1) can be positioned between the stabilizing base 800 and the rail system 840. In some implementations, the horizontal position of the rail system 840 can be adjusted, for example, by sliding the rail system 840 forward or backward relative to the frame 880, or by sliding the rail system 840 left or right along at least one track section 882A, 882B of the frame 880.
[0095] The first support member 884A and the second support member 884B can be positioned flush with the surface formed by the base 110 (as shown in Figure 21), and the patient's body can lie directly beneath the frame 880 of the stabilizing base 800 such that at least one track section 882A, 882B is positioned over the patient and the first support member 884A and the second support member 884B are positioned on either side of the patient. In some implementations, the position of the rail system 840 can be adjusted relative to the frame 880 of the stabilizing base 800 by sliding the rail system 840 horizontally or translationally along at least one track section 882A, 882B, or by pivoting the rail system 840 upward or downward. Thus, the position of the rail system 840 can be adjusted to the optimal distance and radial position relative to the patient.
[0096] Referring here to Figure 26, an exemplary stabilization base 900 for supporting a medical device / system is shown. The stabilization base 900 may include any of the features of the stabilization base disclosed herein and may be formed from any suitable material such as metal or plastic.
[0097] The stabilization base 900 includes a frame 980 and a rail system 940. The rail system 940 is movably mounted to the top of the frame 980. By attaching clamps to the rail system 940, medical devices / systems such as catheter assemblies 114 can be secured to the rail system 940. The clamps may be any clamps in any implementation described herein, although they are not shown in Figure 26 for the sake of simplicity in the drawings. Any clamps, features, and / or rails, such as those disclosed in U.S. Provisional Patent Application No. 63 / 073,392 or in other applications incorporated herein, may be used on the stabilization base 900 shown in Figure 26.
[0098] The frame 980 has at least one track section 982 and at least one support member 984A, 984B. The support members 984A, 984B support and stabilize the frame 980 on a surface such as a base 110. The support members 984A, 984B can be any suitable shape and configuration, such as a column, bar, triangular or rectangular frame, and the like. The support members 984A, 984B support at least one track section 982, which extends parallel to the surface on which the frame 980 is placed and is positioned at a sufficient height above the surface so that a patient's body can fit between the surface and at least one track section 982. The support members 984A and 984B can be permanently attached to at least one track portion 982 by welding, adhesive, or the like, or by any suitable means so as to allow the position of the track portion 982 to be adjusted relative to the support members 984A and 984B.
[0099] In some implementations, the frame 980 has a first support member 984A, a second support member 984B, and a track section 982. In some implementations, the first support member 984A and the second support member 984B are horizontal bars placed on a surface (e.g., a base 110) at both ends of the frame 980. One end of the track section 982 is attached to the first support member 984A, and the other end of the track section 982 is attached to the second support member 984B. In some implementations, the track section 982 is attached to the centers of the first support member 984A and the second support member 984B. In some implementations, the ends of the track section 982 are recessed into the first support member 984A and the second support member 984B so that the track section 982 can be raised and lowered relative to the first support member 984A and the second support member. In some implementations, the vertical position of the track section 982 is locked in place unless operated by the user. In some implementations, the button 986 can be operated by force, such as by pushing or pulling, thereby adjusting the position of the track portion 982. When the button 986 is released, the position of the track portion 982 is locked in place. In some implementations, a gradient 981 along at least one side of the track portion 982 indicates the height of the track portion 982 relative to the first support member 984A and the second support member 984B. In some implementations, the button 986 is located on the track portion 982 or on the first support member 984A and the second support member 984B of the frame 980. In some implementations, the radial position of the track portion 982 relative to the first support member 984A and the second support member 984B can be adjusted. In some implementations, a knob 988 located on at least one end of at least one of the track portions 984A and 984B controls the radial position of the track portion 982. When the knob 988 is operated by force such as pulling, pushing, or rotating, the track section 984 can pivot back and forth.
[0100] The rail system 940 can be joined to the frame 980 by any suitable means, such as welding or similar means. The rail system 940 can also be mounted to the frame 980 in a movable or detachable manner so that the position of the rail system 940 relative to the frame 980 can be adjusted. The rail system 940 can be configured to be held whole or partially by the features of the frame 980 so that the rail system 940 can still be mounted to the stabilizing base 900 even if the stabilizing base is covered by a sterile barrier such as a drape (the illustrated barrier 112 can be moved from between the base 110 and the stabilizing base 900 to between the stabilizing base 900 and the rail system 940, or an additional barrier can be placed between the stabilizing base 900 and the rail system 940). In other words, the rail system 940 can be mounted to the stabilizing base 900 without requiring mounting means such as fasteners that would puncture or perforate the sterile barrier placed between the frame 980 and the rail system 940. In some implementations, the stabilizing base 900 rests on the top of the drape 112. In some implementations, the rail system can be attached to the stabilizing base 900 using magnetic plates. In some implementations, the rail system 940 is attached to the track section 982 by brackets 946. In some implementations, the horizontal position of the rail system 940 can be adjusted relative to the track section 982 of the frame 980 by sliding the rail system 940 back and forth relative to brackets 946 or the frame 980, or by sliding the brackets 946 and the rail system 940 left and right along the track section 982 of the frame 980.
[0101] The first support member 984A and the second support member 984B can be positioned flush with the surface formed by the base 110 (as shown in Figure 26), and the patient's body can lie directly beneath the frame 980 of the stabilizing base 900, with the track portion 982 positioned above the patient and the first support member 984A and the second support member 984B positioned on either side of the patient. In some implementations, the position of the rail system 940 can be adjusted relative to the frame 980 of the stabilizing base 900 by sliding the rail system 940 horizontally or translationally along the track portion 982, or by pivoting the track portion 982 forward and backward relative to the support members 984A and 984B. Thus, the position of the rail system 940 can be adjusted to the optimal distance and radial position relative to the patient.
[0102] Referring here to Figures 27–30, exemplary stabilization bases 1000 for supporting medical devices / systems are shown. Stabilization bases 1000 may include any features of the stabilization bases disclosed herein and may be formed from any suitable material such as metal or plastic.
[0103] The stabilization base 1000 includes a frame 1080 and a rail system 1040. The rail system 1040 is movably mounted to the top of the frame 1080. By attaching clamps to the rail system 1040, medical devices / systems such as catheter assemblies 114 can be secured to the rail system 1040. The clamps may be any clamps in any implementation described herein, although they are not shown in Figures 27–30 for the sake of simplicity in the drawings. Any clamps, features, and / or rails, such as those disclosed in U.S. Provisional Patent Application Serial No. 63 / 073,392 or in other applications incorporated herein, may be used on the stabilization base 1000 as shown in Figures 27–30.
[0104] The frame 1080 has at least one track section 1082 and at least one support member 1084A, 1084B. The support members 1084A, 1084B support and stabilize the frame 1080 on a surface such as a table (not shown). The support members 1084A, 1084B can be any suitable shape and configuration, such as a column, bar, triangular or rectangular frame, and the like. The support members 1084A, 1084B support at least one track section 1082, which extends parallel to the surface on which the frame 1080 is placed and is positioned at a sufficient height above the surface so that a patient's body can fit between the surface and at least one track section 1082. The support members 1084A and 1084B can be attached to at least one track portion 1082 permanently by welding, adhesive, or the like, or detachably by any suitable means so that the position of the track portion 1082 can be adjusted relative to the support members 1084A and 1084B.
[0105] In some implementations, the frame 1080 has a first support member 1084A, a second support member 1084B, and a track portion 1082. In some implementations, the first support member 1084A and the second support member 1084B are triangular frames placed on a surface (e.g., the base 110 in Figure 1) at both ends of the frame 1080. One end of the track portion 1082 is attached to the first support member 1084A, and the other end of the track portion 1082 is attached to the second support member 1084B. In some implementations, the track portion 1082 is attached to the center of the first support member 1084A and the second support member 1084B. In some implementations, the ends of the first support member 1084A and the second support member 1084B are recessed relative to each end of the track portion 1082 so that the track portion 1082 can be raised and lowered relative to the first support member 1084A and the second support member. In some implementations, the vertical position of the track portion 1082 is locked in place unless operated by the user. In some implementations, the button 1086 can be operated by force, such as by pushing or pulling, thereby adjusting the position of the track portion 1082. When the button 1086 is released, the position of the track portion 1082 is locked in place. In some implementations, an optional gradient or marking along the first support member 1084A and / or the second support member 1084B can indicate the height of the track portion 1082 relative to the first support member 1084A and the second support member 1084B. In some implementations, the button 1086 is located on the track portion 1082 or on the first support member 1084A and the second support member 1084B of the frame 1080.
[0106] The rail system 1040 can be joined to the frame 1080 by any suitable means, such as welding or similar means. The rail system 1040 can also be mounted to the frame 1080 in a movable or detachable manner so that the position of the rail system 1040 relative to the frame 1080 can be adjusted. The rail system 1040 can be configured to be held whole or partially by the features of the frame 1080 of the stabilizing base 1000 so that the rail system 1040 can still be mounted to the stabilizing base 1000 even if the stabilizing base is covered by a sterile barrier (not shown), such as a drape. In some implementations, the rail system can be mounted to the stabilizing base 1000 using magnetic plates. That is, the rail system 1040 can be mounted to the stabilizing base 1000 without requiring mounting means such as fasteners that would puncture or perforate a sterile barrier placed between the frame 1080 and the rail system 1040. A barrier 112 (see Figure 1) can be positioned between the stabilizing base 1000 and the rail system 1040. In some implementations, the stabilizing base 1000 rests on the top of a drape (not shown). In some implementations, the rail system 1040 is attached to the track section 1082 by a bracket 1046. In some implementations, the radial position of the rail system 1040 relative to the track section 1082 can be adjusted. In some implementations, a hinge 1048 of the bracket 1046 controls the radial position of the rail system 1040. In some implementations, the hinge 1048 can be locked in place by a pin or the like, or biased toward a specific radial position, unless operated by an external force. In some implementations, when the hinge 1048 is operated by force or when the pin is removed, the track section 1082 can pivot forward and backward.
[0107] In some implementations, the horizontal position of the rail system 1040 can be adjusted relative to the track portion 1082 of the frame 1080 by sliding the rail system 1040 back and forth relative to the bracket 1046 or the frame 1080, or by sliding the bracket 1046 and the rail system 1040 left and right along the track portion 1082 of the frame 1080.
[0108] The first support member 1084A and the second support member 1084B can be positioned flush with the surface formed by the base 110 (as shown in Figure 1), and the patient's body can lie directly beneath the frame 1080 of the stabilizing base 1000, with the track portion 1082 positioned above the patient and the first support member 1084A and the second support member 1084B positioned on either side of the patient. In some implementations, the position of the rail system 1040 can be adjusted relative to the frame 1080 of the stabilizing base 1000 by sliding the rail system 1040 horizontally or translationally along the track portion 1082, or by pivoting the rail system 1040 forward and backward relative to the support members 1084A and 1084B. Thus, the position of the rail system 1040 can be adjusted to the optimal distance and radial position relative to the patient.
[0109] Referring here to Figures 31–34, exemplary stabilization bases 1100 for supporting medical devices / systems are shown. Stabilization bases 1100 may include any features of the stabilization bases disclosed herein and may be formed from any suitable material such as metal or plastic.
[0110] The stabilizing base 1100 includes a base 1120, a frame 1180, and a rail system 1140. The rail system 1140 is movably mounted to the frame 1180, and the frame 1180 is movably mounted to the base 1120. By attaching clamps (not shown) to the rail system 1140, medical devices / systems such as catheter assemblies 114 (not shown) can be secured to the rail system 1140. Clamps may be any clamps in any implementation described herein, although they are not shown in Figures 31–34 for the sake of simplicity in the drawings. Any clamps, features, and / or rails, such as those disclosed in U.S. Provisional Patent Application No. 63 / 073,392 or in other applications incorporated herein, may be used on the stabilizing base 1100 as shown in Figures 31–34.
[0111] The base 1120 can be a substantially flat plate of any suitable shape and dimensions to provide counterbalancing and support for a medical device / system fixed to the stabilizing base 1100. The base 1120 can be square, circular, hexagonal, and homogeneous in shape. The base 1120 can be solid or have a void space in the center of the plate. In some implementations, the base 1120 is a substantially flat plate with first walls 1125A and second walls 1125B at both ends of the base 1120. In some implementations, the first walls 1125A and second walls 1125B are attached to the frame 1180 of the stabilizing base 1100. The first wall 1125A and the second wall 1125B can be permanently attached to the frame 1180 by welding, adhesive, or similar means, or by any suitable means so as to allow adjustment of the position of the frame 1180 relative to the first wall 1125A and the second wall 1125B of the base 1120. In some implementations, the ends of the first wall 1125A and the second wall 1125B are contained within the void space of the frame 1180 so that the frame 1180 can move relative to the base 1120. In some implementations, the ends of the first wall 1125A and the second wall 1125B are spherical, and the void space inside the frame 1180 is spherical so that the frame 1180 can slide back and forth along the spherical edges of the first wall 1125A and the second wall 1125B. In some implementations, the translational position of the frame 1180 relative to the base 1120 can be locked or unlocked using at least one actuator 1189, such as a button, switch, tab, or pin. When at least one actuator 1189 is engaged by the user, the frame 1180 slides freely against the first wall 1125A and the second wall 1125B of the frame 1180. In some implementations, multiple actuators 1189 must be engaged simultaneously to release the frame 1180. After the actuators 1189 are released, the position of the frame 1180 is locked in place relative to the base 1120.
[0112] In some implementations, the frame 1180 has at least one track section 1182, a first arm 1183A, and a second arm 1183B. The first arm 1183A and the second arm 1183B support and stabilize the frame 1180 by being attached to the base 1120. The first arm 1183A and the second arm 1183B can be any suitable shape and configuration, such as a column, bar, triangular or rectangular frame, and the like. The first arm 1183A and the second arm 1183B support at least one track section 1182, which extends parallel to the base 1120 and is positioned at a sufficient height above the base 1120 so that a patient's body can be placed between the base 1120 and the at least one track section 1182. The first arm 1183A and the second arm 1183B can be permanently attached to at least one track portion 1182 by welding, adhesive, or similar means, or detachably attached to the track portion 1182 in a manner that allows adjustment of its position relative to the first arm 1183A and the second arm 1183B, by any suitable means.
[0113] In some implementations, the first arm 1183A and the second arm 1183B of the frame 1180 are mounted to the base 1120 in an extendable manner (vertical adjustment) and / or in a sliding manner (longitudinal adjustment). In the illustrated implementation, the heights of the first arm 1183A and the second arm 1183B are adjustable. The arms 1183A and 1183B are adjustable by any suitable means, such as a hydraulic mechanism, a gas spring mechanism, a pin, a button, or the like. In some implementations, at least one of the first arm 1183A and the second arm 1183B has various orifices 1181 that are vertically aligned on one side and correspond to incremental heights. A pin 1187 can be inserted into one of the various orifices 1181 in at least one of the first arm 1183A and the second arm 1183B to lock the height of the frame 1180 in place. In some implementations, the track portion 1182 is also adjustable relative to the first arm 1183A and the second arm 1183B. The track portion 1182 is adjustable by any suitable means such as a hydraulic mechanism, a gas spring mechanism, a pin, a button, or the like. In some implementations, the radial position of the track portion 1182 can be adjusted using various orifices 1185 in at least one of the first arm 1183A and the second arm 1183B.
[0114] The position of the rail system 1140 can be adjusted relative to the track section 1182 of the frame 1180 by translating the rail system 1140 forward and backward relative to the track section 1182. The translational position of the rail system 1140 can be adjusted by various means such as springs, pins, screws, and similar devices. In some implementations, the rail system 1140 may have multiple orifices 1145 that are incrementally aligned along the length of the rail system 1140. The rail system 1140 can be held in place at a specific translational position by positioning a pin 1147 in one of the multiple orifices 1145. To move the rail system 1140 forward and backward, the pin 1147 can be removed from one orifice 1145 and positioned in another orifice 1145.
[0115] Referring here to Figures 35-36, an exemplary stabilization base 1200 for supporting a medical device / system is shown. The stabilization base 1200 may include any of the features of the stabilization base disclosed herein and may be formed from any suitable material such as metal or plastic.
[0116] The stabilization base 1200 includes an arm 1290 and a rail system 1240. The rail system 1240 is mounted to the top of the arm 1290. By attaching a clamp (not shown) to the rail system 1240, a medical device / system such as a catheter assembly 114 can be secured to the rail system 1240. The clamp may be any clamp in any implementation described herein, although it is not shown in Figures 35-36 for the sake of simplicity in the drawings. Any clamp, feature, and / or rail, such as those disclosed in U.S. Provisional Patent Application Serial No. 63 / 073,392 or in other applications incorporated herein, may be used on the stabilization base 1200 as shown in Figures 35-36.
[0117] The arm 1290 has at least one segment, preferably three or more segments, in which case the segments are movably mounted relative to each other. Optionally, the segments can be mounted relative to each other by any suitable method, such as welding, screws, or similar. The segments of the arm 1290 can be mounted relative to each other by any suitable method, such as hinged connections, ball joint connections, or telescopic connections, in which case the end of one segment is inserted into the end of another segment. The arm 1290 can be fixed to the base 110 by various means, such as by attaching the arm 1290 to the side of the base 110 using the mount 116, or by inserting a portion of the stabilizing base 1200 directly beneath a portion of the base 110.
[0118] The rail system 1240 can be joined to the arm 1290 by any suitable means, such as welding or similar means. The rail system 1240 can also be mounted to the arm 1290 so as to be adjustable in its position relative to the arm 1290, either movably or detachably. The rail system 1240 can be configured to be held whole or partially by the features of the arm 1290 on the stabilizing base 1200, so as to be able to still be mounted to the stabilizing base 1200 even if the stabilizing base is covered by a sterile barrier (not shown), such as a drape. That is, the rail system 1240 can be mounted to the stabilizing base 1200 without requiring mounting means, such as fasteners, which would puncture or perforate a sterile barrier placed between the arm 1290 and the rail system 1240. A barrier 112 illustrated herein (see Figure 1) can be placed between the stabilizing base 1200 and the rail system 1240. In some implementations, the stabilizing base 1200 extends above the drape (not shown). In some implementations, the rail system 1240 is attached to the arm 1290 by a bracket 1246. In some implementations, the radial position of the rail system 1240 relative to the arm 1290 is adjustable. In some implementations, the translational position of the rail system 1240 is adjustable relative to the arm 1290, for example, by sliding the rail system 1240 back and forth relative to the bracket 1246. Additionally, the bracket 1246 and the rail system 1240 can slide left and right along the arm 1290.
[0119] The patient's body can lie substantially directly beneath the arm 1290 of the stabilizing base 1200, such that the rail system 1240 extends over the patient. In some implementations, the position of the rail system 1240 can be adjusted relative to the patient and the plane formed by the base 110 by means of translating the rail system 1240 within the bracket 1246, sliding the rail system 1240 from side to side along the arm 1290, or pivoting the rail system 1240 forward and backward. The position of the stabilizing base 1200 can be adjusted relative to the base 110 by raising or lowering the height of the arm 1290, or by translating the stabilizing base 1200 forward and backward using a mount 116 attached to the base 110. Thus, the position of the rail system 1240 can be adjusted to the optimal distance and optimal radial position relative to the patient.
[0120] Referring here to Figures 37–40, exemplary stabilization bases 1300 for supporting medical devices / systems are shown. Stabilization bases 1300 may include any of the features of stabilization bases disclosed herein and may be formed from any suitable material such as metal or plastic.
[0121] The stabilization base 1300 includes an arm 1390 and a rail system 1340. The rail system 1340 is mounted to the top of the arm 1390. By attaching a clamp to the rail system 1340, a medical device / system such as a catheter assembly 114 can be secured to the rail system 1340. The clamp may be any clamp in any implementation described herein, although it is not shown in Figures 37–40 for the sake of simplicity in the drawings. Any clamp, feature, and / or rail, such as those disclosed in U.S. Provisional Patent Application Serial No. 63 / 073,392 or in other applications incorporated herein, may be used on the stabilization base 1200 as shown in Figures 37–40.
[0122] The arm 1390 has at least one segment, preferably three or more segments, in which case the segments are movably mounted relative to each other. Optionally, the segments can be mounted relative to each other by any suitable method, such as welding, screws, or similar. The segments of the arm 1390 can be mounted relative to each other by any suitable method, such as hinged connections, ball joint connections, or telescopic connections, in which case the end of one segment is inserted into the end of another segment. The arm 1390 can be fixed to a base (not shown) by various means, such as by attaching the arm 1390 to the side of the base using a mount (not shown), or by inserting a portion of the stabilizing base 1300 directly beneath a portion of the base. In some implementations, the arm 1390 includes a vertical segment 1394, a horizontal segment 1392, and an articulated segment 1395. The segments can be of any suitable shape or size, such as a circular, square, or oval column. In some implementations, the horizontal segment 1392 and the vertical segment 1394 are hollow cylindrical supports. The articulated segment 1395 is substantially L-shaped, having a vertical portion and a horizontal portion. The vertical segment 1394 can be extended and retractably connected to the vertical portion of the articulated segment 1395 so that the articulated segment 1395 is received into the end of the vertical segment 1394. The horizontal segment 1392 can be extended and retractably connected to the horizontal portion of the articulated segment 1395 so that the articulated segment 1395 is received into the end of the horizontal segment 1392. In some implementations, the height of the rail system 1340 relative to a base (not shown) can be adjusted by moving the articulated portion 1395 up and down within the vertical portion 1394. In some implementations, the horizontal position of the rail system 1340 relative to a base (not shown) can be adjusted by moving the articulated portion 1395 in and out within the horizontal portion 1392.In yet another exemplary implementation, the vertical segment 1394, the articulated segment 1395, and the horizontal segment 1392 are permanently attached to each other by any suitable means such as screws, welds, adhesives, or similar. In such an implementation, the position of the rail system 1340 relative to a base (not shown) can be adjusted using an actuator 1396 attached to the vertical segment 1394 of the arm 1390. The actuator 1396 can be a button, a pull member, a knob, or similar. In some implementations, the actuator 1396 is a knob, in which case, when the knob is twisted in a certain direction, such as clockwise, the frictional engagement between the actuator 1396 and the arm 1390 increases, preventing the arm 1390 from moving relative to the actuator 1396. When the actuator 1396 is twisted in the opposite direction, such as counterclockwise, the frictional engagement between the arm 1390 and the actuator 1396 decreases, allowing the arm 1390 to move freely up and down relative to the actuator 1396.
[0123] The rail system 1340 can be joined to the arm 1390 by any suitable means, such as welding or similar means. The rail system 1340 can also be mounted to the arm 1390 so as to be adjustable in its position relative to the arm 1390, either movably or detachably. The rail system 1340 can be configured to be held whole or partially by the features of the arm 1390 on the stabilizing base 1300, so as to be able to still be mounted to the stabilizing base 1300 even if the stabilizing base is covered by a sterile barrier (not shown), such as a drape. That is, the rail system 1340 can be mounted to the stabilizing base 1300 without requiring mounting means, such as fasteners, which would puncture or perforate a sterile barrier placed between the arm 1390 and the rail system 1340. A barrier 112 illustrated herein (see Figure 1) can be placed between the stabilizing base 1300 and the rail system 1340. In some implementations, the stabilizing base 1300 extends above a drape (not shown). In some implementations, the rail system 1340 is attached to the arm 1390 by a bracket 1346. In some implementations, the radial position of the rail system 1340 relative to the arm 1390 is adjustable. In some implementations, the translational position of the rail system 1340 is adjustable relative to the arm 1390, for example, by sliding the rail system 1340 back and forth relative to the bracket 1346. Additionally, the bracket 1346 and the rail system 1340 can slide left and right along the arm 1390. In some implementations, the position of the bracket 1346 can be locked or unlocked using an actuator 1396. The actuator 1396 can be a button, a pull member, a knob, or the like.In some implementations, the actuator 1396 is a knob, in which case, when the knob is twisted in a certain direction, such as clockwise, the frictional engagement between the bracket 1346 and the rail system 1340 increases, preventing the bracket 1346 from moving relative to the rail system 1340. When the actuator 1396 is twisted in the opposite direction, such as counterclockwise, the frictional engagement between the bracket 1346 and the rail system 1340 decreases, allowing the bracket 1346 to move freely from side to side relative to the rail system 1340.
[0124] The patient's body can lie substantially directly beneath the arm 1390 of the stabilizing base 1300, such that the rail system 1340 extends over the patient. In some implementations, the position of the rail system 1340 can be adjusted relative to the patient and the plane formed by the platform (not shown) by means of translating the rail system 1340 within the bracket 1346, by sliding the rail system 1340 from side to side along the arm 1390, and / or by pivoting the rail system 1340 forward and backward. The position of the stabilizing base 1300 can be adjusted relative to the platform (not shown) by raising or lowering the height of the arm 1390, or by translating the stabilizing base 1300 forward and backward along the platform. Thus, the position of the rail system 1340 can be adjusted to the optimal distance and optimal radial position relative to the patient.
[0125] Referring here to Figures 41–44, exemplary stabilization bases 1400 for supporting medical devices / systems are shown. Stabilization bases 1400 may include any of the features of stabilization bases disclosed herein and may be formed from any suitable material such as metal or plastic.
[0126] The stabilization base 1400 includes an arm 1490 and a rail system 1440. The rail system 1440 is mounted to the top of the arm 1490. By attaching a clamp to the rail system 1440, a medical device / system such as a catheter assembly 114 can be secured to the rail system 1440. The clamp may be any clamp in any implementation described herein, although it is not shown in Figures 41–44 for the sake of simplicity in the drawings. Any clamp, feature, and / or rail, such as those disclosed in U.S. Provisional Patent Application Serial No. 63 / 073,392 or in other applications incorporated herein, may be used on the stabilization base 1400 as shown in Figures 41–44.
[0127] The arm 1490 has at least one segment, preferably three or more segments, in which case the segments are movably mounted relative to each other. Optionally, the segments can be mounted relative to each other by any suitable method, such as welding, screws, or similar. The segments of the arm 1490 can be mounted relative to each other by any suitable method, such as hinged connections, ball joint connections, or telescopic connections, in which case the end of one segment is inserted into the end of another segment. The arm 1490 can be fixed to the base by various means, such as by mounting the arm 1490 to the side of the base using a mount, or by inserting a portion of the stabilizing base 1400 directly beneath a portion of the base. In some implementations, the arm 1490 includes a vertical segment 1494, a horizontal segment 1492, and an articulated segment 1495. The segments can be of any suitable shape or size, such as a circular, square, or oval column. In some implementations, the horizontal segment 1492 and the vertical segment 1494 are hollow oval supports. The articulated segment 1495 is substantially L-shaped, having a vertical portion and a horizontal portion. The vertical segment 1494 can be extended and retractably connected to the vertical portion of the articulated segment 1495 so that the articulated segment 1495 is received into the end of the vertical segment 1494. The horizontal segment 1492 can be extended and retractably connected to the horizontal portion of the articulated segment 1495 so that the articulated segment 1495 is received into the end of the horizontal segment 1492. In some implementations, the height of the rail system 1440 relative to a base (not shown) can be adjusted by moving the articulated portion 1495 up and down within the vertical segment 1494. In some implementations, the horizontal position of the rail system 1440 relative to a base (not shown) can be adjusted by moving the articulated portion 1495 in and out within the horizontal portion 1492.In some implementations, the position of the vertical segment 1494 and the position of the horizontal segment 1492 relative to the joint segment 1495 can be indicated by using a gradient 1428 that is incrementally marked along one or more segments.
[0128] The rail system 1440 can be joined to the arm 1490 by any suitable means, such as welding or similar means. The rail system 1440 can also be mounted movably or detachably to the arm 1490 so that the position of the rail system 1440 relative to the arm 1490 can be adjusted. The rail system 1440 can be configured to be held whole or partially by the features of the arm 1490 on the stabilizing base 1400 so that the rail system 1440 can still be mounted to the stabilizing base 1400 even if the stabilizing base is covered by a sterile barrier (not shown), such as a drape. That is, the rail system 1440 can be mounted to the stabilizing base 1400 without requiring mounting means, such as fasteners, which would puncture or perforate a sterile barrier placed between the arm 1490 and the rail system 1440. A barrier 112 illustrated herein (see Figure 1) can be placed between the stabilizing base 1400 and the rail system 1440. In some implementations, the stabilizing base 1400 extends above a drape (not shown). In some implementations, the rail system 1440 is attached to the arm 1490 by a bracket 1446. In some implementations, the radial position of the rail system 1440 relative to the arm 1490 can be adjusted. In some implementations, the bracket 1446 has a hinge portion 1448 that allows the position of the rail system 1440 to move radially forward or backward. In some implementations, the radial position of the rail system 1440 relative to the arm 1490 can be adjusted by unlocking the hinge 1448, and after the desired radial position is established, further movement of the rail system 1440 can be prevented by locking the hinge 1448. In some implementations, the hinge 1448 can be adjusted or selected by a spring or counterweight mechanism, etc., unless the hinge 1448 is operated by applying a sufficient upward or downward force to the rail system 1440, thereby preventing radial movement of the rail system 1440.
[0129] In some implementations, the translational position of the rail system 1440 can be adjusted relative to the arm 1490 by sliding the rail system 1440 back and forth relative to the bracket 1446. Additionally, the bracket 1446 and the rail system 1440 can slide left and right along the arm 1490. In some implementations, the position of the bracket 1446 can be locked or unlocked using an actuator (not shown). The actuator may be a button, a pull member, a knob, or the like.
[0130] The patient's body can lie substantially directly beneath the arm 1490 of the stabilizing base 1400, such that the rail system 1440 extends over the patient. In some implementations, the position of the rail system 1440 can be adjusted relative to the patient and the plane formed by the platform 110 by means of translating the rail system 1440 within the bracket 1446, by sliding the rail system 1440 from side to side along the arm 1490, and / or by pivoting the rail system 1440 forward and backward. The position of the stabilizing base 1400 can be adjusted relative to the platform 110 by raising or lowering the height of the arm 1490, or by translating the stabilizing base 1400 forward and backward along the platform. Thus, the position of the rail system 1440 can be adjusted to the optimal distance and optimal radial position relative to the patient.
[0131] Referring here to Figures 45–48, an exemplary stabilization base 1500 for supporting a medical device / system is shown. The stabilization base 1500 may include any of the features of the stabilization base disclosed herein and may be formed from any suitable material such as metal or plastic.
[0132] The stabilization base 1500 includes an arm 1590 and a rail system 1540. The rail system 1540 is mounted to the top of the arm 1590. By attaching a clamp to the rail system 1540, a medical device / system such as a catheter assembly 114 can be secured to the rail system 1540. The clamp may be any clamp in any implementation described herein, although it is not shown in Figures 45–48 for the sake of simplicity in the drawings. Any clamp, feature, and / or rail, such as those disclosed in U.S. Provisional Patent Application Serial No. 63 / 073,392 or in other applications incorporated herein, may be used on the stabilization base 1500 as shown in Figures 45–48.
[0133] The arm 1590 has at least one segment, preferably three or more segments, in which case the segments are movably mounted relative to one another. The segments can be mounted relative to one another by any suitable method, such as welding, screws, or similar. Additionally, the segments of the arm 1590 can be mounted relative to one another by any suitable method, such as hinged connections, ball joint connections, or telescopic connections, in which case the end of one segment is inserted into the end of another segment. The arm 1590 can be fixed to the base 110 by various means, such as mounting the arm 1590 to the side of the base using a mount 116, or by inserting the stabilizing portion 118 of the stabilizing base 1500 directly beneath a part of the base 110. In some implementations, the arm 1590 includes a vertical segment 1594, a horizontal segment 1592, and an articulated segment 1595.
[0134] The segments can be any suitable shape or size, such as circular, square, or oval columns. In some implementations, the horizontal segment 1592 and the vertical segment 1594 are solid square columns. The articulated segment 1595 is substantially L-shaped, having a vertical portion and a horizontal portion. The vertical segment 1594 can be extended and retractably connected to the vertical portion of the articulated segment 1595 so that the articulated segment 1595 receives the end of the vertical segment 1594. The horizontal segment 1592 can be extended and retractably connected to the horizontal portion of the articulated segment 1595 so that the articulated segment 1595 receives the end of the horizontal segment 1592.
[0135] In some implementations, the height of the rail system 1540 relative to a base (not shown) can be adjusted by moving the vertical segment 1594 up and down within the articulated segment 1595. In some implementations, the horizontal position of the rail system 1540 relative to a base 110 can be adjusted by moving the horizontal segment 1592 in and out within the articulated segment 1595. In some implementations, the position of the vertical segment 1594 and the horizontal segment 1592 relative to the articulated segment 1595 can be indicated by using a gradient 1528 incrementally marked along one or more segments. The vertical and horizontal positions of the arm segments can be controlled by various means such as springs, gas springs, hydraulics, and similar mechanisms.
[0136] The arm 1590 can house a mechanism (not shown). The mechanism can be controlled manually and / or electronically. In some implementations, the mechanism is operated by a control member 1591, such as a toggle, button, joystick, or similar. The control member 1591 can be positioned at any location on the stabilizing base 1500, such as on the arm 1590. In some implementations, the control member 1591 is remotely attached to the stabilizing base 1500 via code 1572. The control member 1591 can also operate the mechanism wirelessly via a computer, tablet, or similar electronic device. The mechanism can control the position of the vertical segment 1594 and horizontal segment 1592 of the arm 1590 relative to the articulated segment 1595 by raising and lowering the articulated segment 1595 and moving the horizontal segment 1592 inward and outward. The mechanism can also change the pitch of the rail system 1540 relative to the arm 1590, or move the rail system 1540 forward or backward.
[0137] The rail system 1540 can be joined to the arm 1590 by any suitable means, such as welding or similar. The rail system 1540 can also be mounted movably or detachably to the arm 1590 so that the position of the rail system 1540 relative to the arm 1590 can be adjusted. The rail system 1540 can be configured to be held whole or partially by the features of the arm 1590 of the stabilizing base 1500 so that the rail system 1540 can still be mounted to the stabilizing base 1500 even if the stabilizing base is covered by a sterile barrier 112 such as a drape. That is, the rail system 1540 can be mounted to the stabilizing base 1500 without requiring mounting means such as fasteners that would puncture or perforate a sterile barrier placed between the arm 1590 and the rail system 1540. The barrier 112 illustrated herein (see Figure 1) can be placed between the stabilizing base 1500 and the rail system 1540. In some implementations, the stabilizing base 1500 extends above the drape 112. In some implementations, the rail system 1540 is attached to the arm 1590 by a bracket 1546. In some implementations, the radial position of the rail system 1540 relative to the arm 1590 can be adjusted. In some implementations, the bracket 1546 has a hinge portion that allows the position of the rail system 1540 to move radially forward and backward. In some implementations, the hinge can be adjusted or selected by a spring or counterweight mechanism, etc., unless the hinge is operated by applying a sufficient upward or downward force to the rail system 1540, thereby preventing radial movement of the rail system 1540.
[0138] In some implementations, the translational position of the rail system 1540 can be adjusted relative to the arm 1590 by sliding the rail system 1540 back and forth relative to the bracket 1546. Additionally, the bracket 1546 and the rail system 1540 can slide left and right along the arm 1590. In some implementations, the position of the bracket 1546 can be locked or unlocked using an actuator. The actuator can be a button, a pull member, a knob, or something similar.
[0139] In some implementations, the stabilization base 1500 may include interchangeable base portions or mounting devices, which allow the stabilization base 1500 to be fixed to or onto a surface, such as a table 110, in various ways. Figure 46 shows a stabilization base 1500 having an optional stabilizing member 118, which can be positioned between surfaces, such as between the upper and lower portions of the table 110. The combination of the weight of the upper portion of the table 110 and the weight of the patient lying on the table generates a downward force sufficient to fix the stabilization base 1500 in place.
[0140] Figure 47 shows a stabilization base 1500 having a mount 116 as illustrated in Figure 51 and described above. Figure 48 shows a stabilization base 1500 having a first support member 1584A and a second support member 1584B. The first support member 1584A can be detachably attached to the vertical segment 1594 of the arm 1590, and the second support member 1584B can be detachably attached to the horizontal segment 1592 of the arm 1590. In this implementation, the stabilization base 1500 can be placed on the surface formed by the base 110.
[0141] The patient's body can lie substantially directly beneath the arm 1590 of the stabilizing base 1500, such that the rail system 1540 extends over the patient. In some implementations, the position of the rail system 1540 can be adjusted relative to the patient and the plane formed by the base 110 by means of translating the rail system 1540 within the bracket 1546, by sliding the rail system 1540 from side to side along the arm 1590, and / or by pivoting the rail system 1540 forward and backward. The position of the stabilizing base 1500 can be adjusted relative to the base 110 by raising or lowering the height of the arm 1590, or by translating the stabilizing base 1500 forward and backward along the base 110. Thus, the position of the rail system 1540 can be adjusted to the optimal distance from the patient and to the optimal radial position.
[0142] Referring here to Figures 49–51, exemplary stabilization bases 1600 for supporting medical devices / systems are shown. Stabilization bases 1600 may include any of the features of stabilization bases disclosed herein and may be formed from any suitable material such as metal, plastic, or silicon.
[0143] The stabilization base 1600 includes a mat 1660. Medical devices / systems, such as a catheter assembly 114, can be placed directly on the top of the mat 1660, or they can be secured by some other means, such as a rail system (not shown) attached to the mat 1660. In some implementations, the mat 1660 has a distal end 1666 and a proximal end 1668, with the proximal end 1668 being closest to the point of entry into the patient. The mat 1660 can be tapered or angled such that the thickness of the distal end 1666 is greater than the thickness of the proximal end 1668. Thus, when the delivery system / catheter assembly 114 engages with the mat 1660 of the stabilization base 1600, the delivery system / catheter assembly 114 is angled toward the point of entry into the patient.
[0144] In some implementations, the surface of the mat 1660 can have features such as recesses, ridges, valleys, and similar features to fix the position of the catheter assembly 114 relative to the stabilizing base 1600. In some implementations, the mat 1660 has several ridges 1662A, 1662B, 1662C that extend parallel to each other from the proximal end 1668 to the distal end 1666 of the mat 1660. The ridges 1662A, 1662B, 1662C form at least one valley 1664A, 1664B between them. The catheter assembly 114 can be positioned inside the valley 1664A, 1664B between two of the ridges 1662A, 1662B, 1662C, and the ridges 1662A, 1662B, 1662C prevent the catheter assembly 114 from moving from side to side relative to the stabilizing base 1600.
[0145] The mat 1660 can be formed from any suitable material such as plastic, rubber, or silicone. As shown in Figure 60, in some implementations, the mat is formed from a flexible material such as silicone that can be bent and rolled to easily store and position on various different shaped surfaces and on the patient. The material of the mat 1660, such as silicone, can also increase the frictional engagement between the catheter assembly 114 and the stabilizing base 1600, thereby preventing the catheter assembly 114 from moving back and forth relative to the stabilizing base due to the frictional engagement.
[0146] Referring here to Figures 52–54, exemplary stabilization bases 1700 for supporting medical devices / systems are shown. Stabilization bases 1700 may include any features of the stabilization bases disclosed herein and may be formed from any suitable material such as metal, plastic, or silicon.
[0147] The stabilization base 1700 includes a mat 1760. Medical devices / systems, such as a catheter assembly 114, can be placed directly on the top of the mat 1760, or they can be secured by some other means, such as a rail system 1740 attached to the mat 1760. In some implementations, the mat 1760 has a distal end 1766 and a proximal end 1768, with the proximal end 1768 being closest to the point of entry into the patient. The mat 1760 can be tapered or angled such that the thickness of the distal end 1766 is greater than the thickness of the proximal end 1768. Thus, when the delivery system / catheter assembly 114 engages with the mat 1760 of the stabilization base 1700, the delivery system / catheter assembly 114 is angled toward the point of entry into the patient.
[0148] In some implementations, the surface of the mat 1760 may have features such as recesses, ridges, valleys, and similar features to fix the position of the catheter assembly 114 relative to the stabilizing base 1700. In some implementations, the mat 1760 has a valley 1764 extending from the proximal end 1768 to the distal end 1766. In some implementations, the catheter assembly 114 can be placed directly inside the valley 1764, thereby preventing the catheter assembly 114 from moving laterally relative to the stabilizing base 1700. Optionally, a rail system 1740 can be inserted into the valley 1764, and the catheter assembly 114 can be fixed to the rail system 1740 by any suitable means, such as a clamp. The clamp may be any clamp in any implementation described herein, although it is not shown in Figures 52 and 53 to 48 for the sake of simplicity in the drawings. Any clamps, features, and / or rails, such as those disclosed in U.S. Provisional Patent Application No. 63 / 073,392, or in other applications incorporated herein, can be used on the stabilizing base 1700 as shown in Figures 52–54.
[0149] The mat 1760 can be formed from any suitable material such as plastic, rubber, or silicone. As shown in Figure 54, in some implementations, the mat is formed from a flexible material such as silicone that can be bent and rolled to easily store and position on various different shaped surfaces and on the patient. The material of the mat 1760, such as silicone, can also increase the frictional engagement between the catheter assembly 114 and the stabilizing base 1700, thereby preventing the catheter assembly 114 from moving back and forth relative to the stabilizing base due to the frictional engagement.
[0150] Referring here to Figure 55, an exemplary stabilization base 1800 for supporting a medical device / system is shown. The stabilization base 1800 may include any of the features of the stabilization base disclosed herein and may be formed from any suitable material such as metal, plastic, or silicon.
[0151] The stabilization base 1800 includes a mat 1860. Medical devices / systems, such as a catheter assembly 114, can be placed directly on top of the mat 1860, or secured by some means to a rail system (not shown) attached to the mat 1860, or by a handle mount 1867. The illustrated handle mount is sized and shaped to hold the handle of a delivery system / catheter assembly in place, but can also be used to position the handle (e.g., move it forward, backward, rotate it). After the handle is released again, the handle mount 1867 maintains the handle's new position.
[0152] In some implementations, the mat 1860 has a distal end 1866 and a proximal end 1868, with the proximal end 1868 being the closest to the point of entry into the patient. The mat 1860 may also have a ridge 1861 along the bottom surface 1863 extending from the distal end 1866 to the proximal end 1868. The ridge 1861 may be positioned between the patient's legs to hold the mat 1860 in place relative to the patient. The mat 1860 may be solid or may have an outer material and an inner material. The inner material may be flexible, such as filled beads, air, liquid, or a semi-solid material, thereby allowing the mat to conform to various surfaces and patients. The outer surface of the mat 1860 may be formed from silicone, rubber, or other flexible material. In some implementations, the mat 1860 may have a rigid top 1869 to better support the delivery system / catheter assembly 114 fixed on its upper surface.
[0153] In some implementations, the delivery system or catheter assembly 114 is secured to the mat 1860 using a handle mount 1867. The handle mount 1867 can be formed from any suitable material, such as metal, rubber, silicone, plastic, or similar. The handle mount 1867 can be a clasp, bracket, or similar configuration. In some implementations, the handle mount 1867 has a semi-annular shape with a gap or opening for receiving a portion of the catheter assembly 114, such as the body of the handle. The handle of the catheter assembly 114 can rotate within the handle mount 1867 and can also be translated in directions moving closer to and further away from the patient, both proximal and distal. Optionally, the handle mount 1867 can be moved relative to the mat 1860 so that the handle mount 1867 can rotate forward and backward, left and right, and laterally relative to the mat 1860. Thus, the position of the catheter assembly 114 can be adjusted to the optimal distance from the patient and to the optimal radial position.
[0154] Referring here to Figures 56–66, exemplary stabilization bases 1900 for supporting medical devices / systems are shown. Stabilization bases 1900 may include any features of the stabilization bases disclosed herein and may be formed from any suitable material such as metal or plastic. Stabilization bases 1900 include a platform 1910 that is hinged to a frame 1920. Support legs 1930 extend downward from the frame 1920 to an operating table (not shown), raising the platform 1910 above a patient lying on the operating table. In some implementations, a rail system (not shown) is attached to the platform 1910 (or, in some implementations, integrally formed on or as part of the platform) and may receive clamps (not shown) for securing medical devices or systems, such as a delivery system or catheter assembly 114, to the rail system. The rail system can be attached to or combined with the platform 1910 in any suitable manner, for example, using fasteners, threaded fasteners, snaps, clamps, latches, friction fits, spring clamps, hook and loop fasteners, magnets, or the like. In some implementations, the rail system and / or clamps are the same as those disclosed in U.S. Provisional Patent Application No. 63 / 073392 filed 1 September 2020 and / or PCT Application No. PCT / US2021 / 048333 filed 31 August 2021, which are incorporated herein by reference in their entirety. The stabilizing base 1900 maintains stability by having a broad base with respect to each support leg 1930 that is placed on a surface such as a patient's table.
[0155] The support legs 1930 are spaced apart from each other, allowing the stabilizing base 1900 to straddle the patient's right leg, thereby aligning the rail and delivery system with the patient's right inner thigh and right femoral artery. The platform 1910 extends further beyond the frame 1920 and support legs 1930 on one side, allowing the delivery system to be repositioned with respect to the patient's left femoral artery without the need to reposition the stabilizing base 1900. This is useful when the drape is mounted on the stabilizing base 1900 and repositioning the stabilizing base 1900 is not easy or possible. An opening 1912 within the platform 1910 is located near the support legs 1930, further inward from the edge of the platform 1910, thus allowing the user access to the height adjustment mechanism of the support legs 1930, which will be described in detail below.
[0156] In some implementations, the platform 1910 is hinged to the frame 1920 by a hinge 1922 mounted near one edge of the platform 1910, thereby allowing the platform 1910 to tilt upward to approximately 10 degrees, 15 degrees, or 20 degrees above the frame 1920. By positioning the hinge 1922 near the front edge of the platform 1910, the platform 1910 can be tilted upward without reducing the height between the platform 1910 and the patient. A pair of struts 1924 are hinged to the platform 1910 at their upper ends and slidably mounted to the frame 1920 at their lower ends. A locking member or knob 1926 holds the platform 1910 in the tilted position at the desired angle relative to the frame 1920 by fixing the sliding ends of the struts 1924 in the desired position within the slot 1928.
[0157] Referring here to Figures 60 to 63, the internal mechanism for adjusting the height of the support legs 1930 is shown in cross-sectional and enlarged detail views in several implementations. Each support leg 1930 includes an extendable support 1932 attached to the frame 1920 and a fixed support 1934 attached to a base or foot 1936 configured to rest on the platform 110. The fixed support 1934 includes a number of vertically spaced holes 1938 for receiving the latch pin 1940 of the extendable support 1932. The height of the platform 1910 can be adjusted by moving the latch pin 1940 to the unlocked position, raising the platform 1910, and further moving the latch pin 1940 to the latched position in a new pair of holes 1938 at the desired height.
[0158] The extendable support column 1932 includes a handle 1942 at the upper end of each support leg 1930, and pressing the handle 1942 allows the latch pin 1940 to be moved between a latched position and an unlocked position. The handle 1942 is connected to a latch rail 1944, which includes an inclined slot 1946 for engaging with and moving a projection 1948 of the latch pin 1940, so that when the latch rail 1944 is driven up and down in the vertical direction, the latch pin 1940 is moved laterally outward (to unlock) or inward (to latch). In order to unlock and raise or lower the platform 1910, the user must press both handles 1942.
[0159] As can be seen in Figures 60-61, the latch rail 1944 is in the lowered position when the handle 1942 is not engaged by the user, which drives the projection 1948 of the latch pin 1940 to the uppermost and innermost end of the inclined slot 1946, thereby inserting the latch pin 1940 through a pair of latch holes 1938 in the fixed post 1934. The handle 1942 can be biased to the lowered or disengaged position by the handle biasing member 1950, thereby preventing accidental release of the latch pin 1940. That is, the latch rail 1944 is in the lowered position when the handle 1942 is not engaged by the user, which drives the projection 1948 of the latch pin 1940 to the uppermost and innermost end of the inclined slot 1946, thereby inserting the latch pin 1940 through a latch hole 1938 in the fixed post 1934.
[0160] As shown in Figures 62-63, when the user presses and lifts the handle 1942, the latch rail 1944 moves upward, causing the inclined slot 1946 to engage with the projection 1948 of the latch pin 1940, moving the latch pin 1940 outward and disengaging it from the latch hole 1938 of the fixed support column 1934. This allows the user to move the extendable support column 1932 and the platform 1910 vertically. A main biasing member 1952, such as a spring as shown in Figures 60-63, reduces the force required to move the platform 1910 to the desired height by supporting or balancing the weight of the platform 1910, the frame 1920, and any attached rails or delivery systems. In some implementations, the main biasing member 1952 is configured to provide an upward biasing force that must overcome to push the platform 1910 downward, thereby ensuring that the platform 1910 moves downward only when intended by the user and that it does not fall even if the user loses grip on the platform 1910.
[0161] Referring here to Figures 64-66, the stabilizing base 1900 is shown having the same mechanism for raising and lowering the platform 1910, although it is shown with a different appearance. The platform 1910 can be tilted at the front edge, as shown in Figure 65, allowing the user to adjust the tilt angle of the platform 1910 to a desired tilt, or it can be pivoted at the central pivot point 1956, which may include a button 1958 for unlocking or locking the pivot point 1956. In the implementation shown in Figure 66, the frame can be made optional by allowing the support legs 1930 to be hinged directly to the platform 1910.
[0162] Referring here to Figures 67–72, exemplary stabilization bases 2000 for supporting medical devices / systems are shown. Stabilization bases 2000 may include any features of the stabilization bases disclosed herein and may be formed from any suitable material such as metal or plastic. Stabilization bases 2000 include a platform 2010 hinged to a frame 2020. Support legs 2030 extend downward from the frame 2020 to an operating table (not shown), raising the platform 2010 above a patient lying on the operating table. In some implementations, a rail system (not shown) may be attached to the platform 2010 (or, in some implementations, integrally formed on the platform or integrally formed as part of the platform) and may receive clamps (not shown) for securing medical devices or systems, such as delivery systems or catheter assemblies (not shown), to the rail system. In some implementations, the rail system can be attached to the platform 2010 in any suitable manner using, for example, fasteners, threaded fasteners, snaps, clamps, latches, friction fits, spring-loaded clamps, hook and loop fasteners, magnets, or the like. In some implementations, the rail system and / or clamps are the same as those disclosed in U.S. Provisional Patent Application No. 63 / 073392, filed September 1, 2020, and / or PCT Application No. PCT / US2021 / 048333, filed August 31, 2021, which are incorporated herein by reference in their entirety. The stabilizing base 2000 maintains stability by having a broad base with respect to each support leg 2030 that is placed on a surface such as a patient's table. The support legs 2030 are spaced apart from each other, which allows the stabilizing base 2000 to straddle the patient's right leg, thereby enabling the rail and delivery system to be aligned with the patient's right inner thigh and right femoral artery.
[0163] In some implementations, the platform 2010 is hinged to the frame 2020 by a hinge 2022 mounted near one edge of the platform 2010, allowing the platform 2010 to tilt upward above the frame 2020 by approximately 10 degrees, 15 degrees, or 20 degrees, from the flat position shown in Figures 67–69, as seen in Figures 70–72. By positioning the hinge 2022 near the front edge of the platform 2010, the platform 2010 can be tilted upward without reducing the height between the platform 2010 and the patient. A pair of cams 2024 can be rotated from a retracted position to an extended position by rotating a knob 2026 located on the side of the frame 2020. The cams 2024 engage with the platform 2010, lifting the platform 2010 from the flat position to the tilted position. In some implementations, the cam 2024 can be locked in a predetermined intermediate position between the retracted and deployed positions, thereby providing additional finesse to the tilted position of the platform 2010.
[0164] Each support leg 2030 includes an extendable support 2032 attached to the frame 2020 and a fixed support 2034 attached to a base or foot 2036 configured to rest on the platform 110. The fixed support 2034 includes a number of vertically spaced holes 2038 for receiving fastening members 2040 inserted through holes 2038 in the fixed support 2034 and positioning holes 2042 in the extendable support 2032. The height of the platform 2010 can be adjusted by removing the fastening members 2040 in each support leg 2030, repositioning the movable support 2032, and reattaching the fastening members 2040 through different holes 2038.
[0165] Referring here to Figures 73-74, an exemplary stabilization base 2100 for supporting a medical device / system is shown. The stabilization base 2100 may include any features of the stabilization base disclosed herein and may be formed from any suitable material such as metal or plastic. The stabilization base 2100 includes a platform 2110, a support column 2120, and a base plate 2130. The platform 2110 is supported above the base plate 2130 by the support column 2120, which extends vertically between the platform 2110 and the base plate 2130. In some implementations, a rail system 2140 may be attached to the platform 2110 (or, in some implementations, integrally formed on or as part of the platform) and may receive clamps 2142 for securing a medical device or system, such as a delivery system or catheter assembly 114, to the rail system 2140. The rail system 2140 can be attached to the platform 2110 in any suitable manner using, for example, fasteners, threaded fasteners, snaps, clamps, latches, friction fits, spring clamps, hook and loop fasteners, magnets, and the like. In some implementations, the rail system 2140 and / or clamp 2142 are the same as those disclosed in U.S. Provisional Patent Application No. 63 / 073392 filed 1 September 2020 and / or PCT Application No. PCT / US2021 / 048333 filed 31 August 2021, which are incorporated herein by reference in their entirety. The stabilizing base 2100 maintains stability by having a wide base plate 2130 for placement on a surface such as a patient's table.
[0166] The base plate 2130 can be a substantially flat plate of any suitable shape and dimensions to provide counterbalancing and support for the medical device / system fixed to the stabilizing base 2100. The base plate can be square, circular, hexagonal, and homogeneous in shape. The base plate 2130 can be solid or have a void space in the center of the plate. In some implementations, the base plate 2130 can be a solid rectangular plate. The base plate 2130 can be positioned flush with the plane formed by the platform 110 as shown in Figure 1. The patient's legs can be placed on the top of the base plate 2130 such that the support column 2120 extends vertically upward between the patient's legs. The position of the delivery system / catheter assembly 114 relative to the patient can be optimized by adjusting the height of the platform 2110.
[0167] The platform 2110, to which the rail system 2140 and / or delivery system 114 are attached, is supported vertically above the base plate 2130 by the support column 2120. The platform 2110 can be attached to the support column 2120 by any suitable means, such as welding, fasteners, and / or adhesives, or similar. The platform 2110 is attached to the support column 2120 at a fixed angle that is desirable for deploying the portable device relative to the base plate 2130.
[0168] In some implementations, the support column 2120 includes a fixed portion 2122 and a movable portion 2124, and can be any suitable shape, such as a square, circular, or oval. The fixed portion 2122 of the support column 2120 is fixedly attached to the base plate 2130 by any suitable means, such as welding, adhesive, fasteners, clamps, or the like. The movable portion 2124 slides vertically in an expandable manner within the fixed portion 2122, thereby enabling the platform 2110 to be vertically translated to a desired height. When the platform 2110 is raised or lowered to the desired height, the clamp 2126 on the fixed portion 2122 of the support column 2120 is tightened, pressing the end of the fixed portion 2122 against the movable portion 2124, thereby preventing further movement of the movable portion 2124 when the stabilizing base 2100 is in use. By using an optional mechanical spring mechanism or gas spring mechanism (not shown) inside the support column 2120, the weight of the delivery system 114 and the platform 2110 can be balanced, thereby allowing the user to more easily adjust the height of the platform 2110.
[0169] The rail system 2140 can be configured to be held whole or partially by the features of the platform 2110 of the stabilizing base 2100, so that the rail system 2140 can still be attached to the stabilizing base 2100 even when the stabilizing base 2100 is covered by a sterile barrier (not shown), such as a drape. The barrier 112 shown in Figure 1 can be placed between the stabilizing base 2100 and the rail system 2140. The rail system 2140 can be attached to the stabilizing base 2100 without requiring attachment means such as fasteners that would puncture or perforate the sterile barrier placed between the platform 2110 and the rail system 2140. In some implementations, the rail system 2140 can be attached to the stabilizing base 2100 using magnetic plates or snap connections that do not perforate the sterile barrier. In some implementations, the horizontal position of the rail system 2140 can be adjusted relative to the platform 2110, for example, by sliding the rail system 2140 back and forth relative to the platform 2110.
[0170] Referring here to Figures 75–84, an exemplary stabilization base 2200 for supporting a medical device / system is shown. The stabilization base 2200 may include any features of the stabilization base disclosed herein and may be formed from any suitable material such as metal or plastic. The stabilization base 2200 includes a platform 2210, a support column 2220, and a base plate 2230. The platform 2210 is supported above the base plate 2230 by the support column 2220, which extends vertically between the platform 2210 and the base plate 2230. In some implementations, a rail system 2240 is attached to the platform 2210 (or, in some implementations, integrally formed on the platform or integrally formed as part of the platform) and may receive clamps 2242 for securing a medical device or system, such as a delivery system or catheter assembly, to the rail system 2240. The rail system 2240 can be attached to the platform 2210 in any suitable manner, for example, using fasteners, threaded fasteners, snaps, clamps, latches, friction fits, spring clamps, hook and loop fasteners, magnets, or the like. In some implementations, the rail system 2240 and / or clamp 2242 are the same as those disclosed in U.S. Provisional Patent Application No. 63 / 073392 filed 1 September 2020 and / or PCT Application No. PCT / US2021 / 048333 filed 31 August 2021, which are incorporated herein by reference in their entirety. The stabilizing base 2200 maintains stability by having a wide base plate 2230 for placement on a surface such as a patient's table.
[0171] The base plate 2230 can be a substantially flat plate of any suitable shape and dimensions to provide counterbalance and support for the medical device / system fixed to the stabilizing base 2200. The base plate can be square, circular, hexagonal, and homogeneous in shape. The base plate 2230 can be solid or have a void space in the center of the plate. In some implementations, the base plate 2230 can be a solid rectangular plate. The base plate 2230 can be positioned flush with the plane formed by the platform 110 as shown in Figure 1. The patient's legs can be placed on the top of the base plate 2230 such that the support column 2220 extends vertically upward between the patient's legs. The position of the delivery system / catheter assembly relative to the patient can be optimized by adjusting the height of the platform 2210.
[0172] The platform 2210, to which the rail system 2240 and / or delivery system 114 are attached, is supported vertically above the base plate 2230 by the support column 2220. In some implementations, the platform 2210 is hinged to the movable portion 2224 of the support column 2220 so that the user can pivot the platform 2210 between a flat position and an inclined position. The hinge assembly 2250 connecting the platform 2210 to the support column 2220 is shown in the inclined position in Figures 79–81 and in the flat position in Figures 82–84. The hinge assembly 2250 includes a pivot bracket 2252 that is pivotably connected to a fixed bracket 2254 by a pivot member 2256. The pivot bracket 2252 is connected to the platform 2210, and the fixed bracket 2254 is connected to the movable portion 2224 of the support column 2220. The pivot member 2256 can be any suitable member or mechanism that allows the pivot bracket 2252 to tilt relative to the fixed bracket 2254, such as a shouldered screw, shaft, pin, hinge, or similar as shown in Figures 81 and 84. The pivot bracket 2252 and the fixed bracket 2254 may include corresponding inclined surfaces 2253, 2255, respectively, that provide clearance for the pivot bracket 2252 to rotate. The inclined surfaces 2253, 2255 may also function to prevent the platform 2210 from tilting further beyond a predetermined inclination angle.
[0173] The pivot bracket 2252 can be locked in an inclined or flat position, and can be pivoted by pulling the release lever 2258 to release the pivot bracket 2252, thereby allowing the platform 2210 to be tilted. The first locking pin 2260 and the second locking pin 2262 extend through the pivot bracket 2252 into the corresponding first locking holes 2264 and second locking holes 2266, respectively, thereby locking the position of the pivot bracket 2252 relative to the fixed bracket 2254. By pulling the release lever 2258, the first locking pin 2260 and the second locking pin 2262 are released from their engagement with the first locking holes 2264 and second locking holes 2266. The first locking hole 2264 is positioned such that the first locking pin 2260 aligns with and engages with the first locking hole 2264 when the platform 2210 is in a flat position. The second locking hole 2266 is positioned lower than the first locking hole 2264 so that the second locking pin 2262 aligns with and engages with the second locking hole 2266 when the platform 2210 is in an inclined position. Because the locking holes 2264 and 2266 are at different heights, only one of the two locking pins 2260 and 2262 engages at a time.
[0174] In some implementations, the support column 2220 includes a fixed portion 2222 and a movable portion 2224, and can be any suitable shape such as a square, circle, or oval. The fixed portion 2222 of the support column 2220 is detachably attached to the base plate 2230 by a clamp 2232 which is fixedly attached to the base plate 2230 by any suitable means. The clamp 2232 is released to receive the fixed portion 2222 of the support column 2220 and then tightened, thereby fixing the support column 2220 to the base plate 2230. The movable portion 2224 of the support column 2220 slides vertically in an extendable manner within the fixed portion 2222, thereby enabling the platform 2210 to be vertically translated to a desired height. The locking pin 2226 is retracted so that the movable part 2224 can move, and the locking pin 2226 is inserted into the locking hole 2228 of the movable part 2224 to hold the movable part 2224 at the desired height. The locking pin 2226 can be biased toward the locking direction, thereby preventing accidental disengagement of the locking pin 2226 that could cause the movable part 2224 to fall. By using an optional mechanical spring mechanism or gas spring mechanism (not shown) inside the support column 2220, the weight of the delivery system 114 and the platform 2210 can be balanced, thereby allowing the user to more easily adjust the height of the platform 2210 and preventing the platform 2210 from descending unintentionally.
[0175] In some implementations, the rail system 2240 can be configured to be held whole or partially by the features of the platform 2210 of the stabilizing base 2200, so that the rail system 2240 can still be attached to the stabilizing base 2200 even if the stabilizing base 2200 is covered by a sterile barrier (not shown), such as a drape. The barrier 112 shown in Figure 1 can be placed between the stabilizing base 2200 and the rail system 2240. The rail system 2240 can be attached to the stabilizing base 2200 without requiring attachment means such as fasteners that would puncture or perforate the sterile barrier placed between the platform 2210 and the rail system 2240. For example, the rail system 2240 may include fixed jaws 2244 and movable jaws 2246 for gripping the platform 2210. The movable jaw 2246 can be retracted to allow the rail system 2240 to be mounted to the platform 2210, and then it can be tightened to the platform 2210 via any suitable clamping mechanism, such as the illustrated screw clamp. In some implementations, the rail system 2240 can be mounted to the stabilizing base 2200 using magnetic plates or snap connections that do not perforate the sterile barrier. In some implementations, the horizontal position of the rail system 2240 can be adjusted relative to the platform 2210, for example, by sliding the rail system 2240 laterally relative to the platform 2210.
[0176] Referring here to Figures 85–87, an exemplary stabilization base 2300 for supporting a medical device / system is shown. The stabilization base 2300 may include any features of the stabilization base disclosed herein and may be formed from any suitable material such as metal or plastic. The stabilization base 2300 is configured to be mounted to the side rails of the operating table 110 and includes a platform 2310, a vertical support 2320, and a horizontal arm 2330. The platform 2310 is supported above the table 110 by the vertically extending support 2320 between the horizontal arm 2330 and the side rails of the table 110.
[0177] In some implementations, the rail system 2340 is mounted to the platform 2310 (or, in some implementations, integrally formed on or as part of the platform) and may receive clamps (not shown) for securing medical devices or systems, such as a delivery system or catheter assembly 114, to the rail system 2340. Clamps may be any clamps in any implementation described herein, although they are not shown in Figures 85–87 for the sake of simplicity in the drawings. The rail system 2340 can be mounted to the platform 2310 in any suitable manner using, for example, fasteners, threaded fasteners, snaps, clamps, latches, friction fits, spring clamps, hook and loop fasteners, magnets, and the like. In some implementations, the rail system 2340 and / or clamps are identical to those disclosed in U.S. Provisional Patent Application No. 63 / 07339, filed September 1, 2020, and / or PCT Application No. PCT / US2021 / 048333, filed August 31, 2021, which are incorporated herein by reference in their entirety. The stabilizing base 2300 maintains stability based on the rigidity of the vertical support 2320 and horizontal arm 2330 mounted to the operating table 110.
[0178] The platform 2310, to which the rail system 2340 and delivery system 114 are attached, is supported vertically above the base 110 by a vertical support column 2320 and a horizontal arm 2330. In some implementations, the platform 2310 is hinged to a carriage 2332 that slides along the horizontal arm 2330 via a hinge 2312. The platform 2310 can be tilted forward and backward via the hinge 2312, thereby tilting the platform 2310, as well as the attached rail system 2340 and delivery system 114. The carriage 2332 can slide the platform 2310 laterally along the horizontal arm 2330, thereby positioning the delivery system 114 laterally, for example, relative to the right femoral artery of a patient. The hinge 2312 and carriage 2332 may include a locking device (not shown), such as a set screw or similar, to lock the tilted position of the platform 2310 relative to the top surface of the operating table 110. The lateral position of the carriage 2332 along the horizontal rail 2330 can be locked using the clamp 2334.
[0179] The vertical support column 2320 includes a fixed portion 2322 and a movable portion 2324, and can be any suitable shape such as a square, circle, or oval. The movable portion 2324 slides vertically in an extendable manner within the fixed portion 2322, thereby enabling the horizontal arm 2330 and platform 2310 to be vertically translated to a desired height above the base 110. When the platform 2310 is raised or lowered to the desired height, the clamp 2326 on the fixed portion 2322 of the support column 2320 engages the movable portion 2324, preventing further movement of the movable portion 2324 when the stabilizing base 2300 is in use. By using an optional mechanical spring mechanism or gas spring mechanism (not shown) inside the support column 2320, the weight of the delivery system 114, platform 2310, and horizontal arm 2330 can be balanced, thereby allowing the user to more easily adjust the height of the platform 2310. The fixed portion 2322 of the vertical support column 2320 is detachably attached to the side rail of the operating table 110 by a clamp 2328, thereby allowing the user to move the stabilizing base 2300 along the length of the table 110.
[0180] In some implementations, the rail system 2340 can be configured to be held whole or partially by the features of the platform 2310 of the stabilization base 2300, so that the rail system 2340 can still be attached to the stabilization base 2300 even if the stabilization base 2300 is covered by a sterile barrier (not shown), such as a drape. The illustrated barrier 112 can be placed between the stabilization base 2300 and the rail system 2340. The rail system 2340 can be attached to the stabilization base 2300 without requiring attachment means such as fasteners that would puncture or perforate the sterile barrier placed between the platform 2310 and the rail system 2340. In some implementations, the rail system 2340 can be attached to the stabilization base 2300 using magnetic plates or snap connections that do not perforate the sterile barrier. In some implementations, the horizontal position of the rail system 2340 can be adjusted relative to the platform 2310, for example, by sliding the rail system 2340 relative to the platform 2310.
[0181] Referring here to Figure 88, an exemplary stabilization base 2400 for supporting a medical device / system is shown. The stabilization base 2400 may include any features of the stabilization base disclosed herein and may be formed from any suitable material such as metal or plastic. The stabilization base 2400 is configured to be mounted to both side rails of the operating table 110, although similar to the implementation shown in Figures 35-36. The stabilization base 2400 includes a carriage 2410, two support columns 2420, and a horizontal arm 2430. The carriage 2410 is supported above the table 110 by the columns 2420, which extend from the side rails of the table 110 to the horizontal arm 2430.
[0182] In some implementations, the rail system 2440 is slidably mounted to the carriage 2410 and may receive clamps (see Figure 89) for securing medical devices or systems, such as a delivery system or catheter assembly 114, to the rail system 2440. The clamps may be those in any implementation described herein, although they are not shown in Figure 88 for the sake of simplicity in the drawings. In some implementations, the rail system 2440 and / or the clamps are the same as those disclosed in U.S. Provisional Patent Application No. 63 / 073392, filed 1 September 2020, and / or PCT Application No. PCT / US2021 / 048333, filed 31 August 2021, which are incorporated herein by reference in their entirety. The stabilizing base 2400 maintains stability based on the rigidity of the support columns 2420 and horizontal arms 2430 mounted to the side rails of the operating table 110.
[0183] The carriage 2410, to which the rail system 2440 and delivery system 114 are attached, is supported vertically above the table 110 by support columns 2420 and horizontal arms 2430. In some implementations, the carriage 2410 is aligned, for example, with respect to the patient's right femoral artery, by sliding along the horizontal arms 2430 to laterally position the delivery system 114. The carriage 2410 may include a locking device (not shown), such as a set screw or similar, to lock the lateral position of the carriage 2410 along the horizontal rails 2430. The carriage 2410 is tilted or sloped at a fixed angle based on the inclination angle or pitch angle of the horizontal rails 2430 relative to the top surface of the operating table 110.
[0184] In some implementations, each support column 2420 includes a vertical portion 2422 and an inclined or angled portion 2424, and can be any suitable shape such as a square, circular, or oval. The vertical portion 2422 and the inclined portion 2424 can be formed integrally from a single piece, or they can be connected in any suitable manner using, for example, fasteners, welding, adhesive, mortise and tenon joints, pin joints, or similar. The vertical portion 2422 of the support column is slidably mounted to a clamp 2426. The clamp 2426 can be mounted to a mount attached to the side rails of the operating table 110, or can be part of such a mount. The clamp 2426 can be loosened, thereby allowing the horizontal arm 2430 and carriage 2410 to be vertically translated to a desired height above the table 110. When the carriage 2410 is raised or lowered to the desired height, the support column 2420 is engaged by tightening the clamp 2426, preventing further movement of the support column 2420 when the stabilization base 2400 is in use. The mount and accompanying clamp 2428 can be slidably attached to the side rails of the operating table 110, thereby allowing the user to move the stabilization base 2400 along the length of the operating table 110.
[0185] In some implementations, the rail system 2440 can be configured to be held whole or partially by the features of the carriage 2410 of the stabilization base 2400, so that the rail system 2440 can still be attached to the stabilization base 2400 even when the stabilization base 2400 is covered by a sterile barrier (not shown), such as a drape. The barrier 112 shown in Figure 1 can be placed between the stabilization base 2400 and the rail system 2440. The rail system 2440 can be attached to the stabilization base 2400 without requiring attachment means such as fasteners that would puncture or perforate the sterile barrier placed between the carriage 2410 and the rail system 2440. In some implementations, the rail system 2440 can be attached to the stabilization base 2400 using magnetic plates or snap connections that do not perforate the sterile barrier. In some implementations, the horizontal position of the rail system 2440 can be adjusted relative to the platform 2410, for example, by sliding the rail system 2440 back and forth relative to the platform 2410.
[0186] Referring here to Figures 89–90, an exemplary stabilization base 2500 for supporting a medical device / system is shown. The stabilization base 2500 may include any features of the stabilization base disclosed herein and may be formed from any suitable material such as metal or plastic. Similar to the stabilization base 2400 described above, the stabilization base 2500 is configured to be mounted to both side rails of the operating table 110. The stabilization base 2500 includes a platform 2510, two support columns 2520, and a horizontal arm 2530. The platform 2510 is supported above the table 110 by the columns 2520, which extend from the side rails of the table 110 to the horizontal arm 2530.
[0187] In some implementations, the rail system 2540 is slidably mounted to the platform 2510 and can receive clamps 2542 for securing a medical device or system, such as a delivery system or catheter assembly 114, to the rail system 2540. In some implementations, the rail system 2540 and / or clamps are identical to those disclosed in U.S. Provisional Patent Application No. 63 / 073392, filed September 1, 2020, and / or PCT Application No. PCT / US2021 / 048333, filed August 31, 2021, which are incorporated herein by reference in their entirety. The stabilizing base 2500 maintains stability based on the rigidity of the support columns 2520 and horizontal arms 2530 mounted to the side rails of the operating table 110.
[0188] The platform 2510, to which the rail system 2540 and delivery system 114 are mounted, is supported vertically above the base 110 by support columns 2520 and horizontal arms 2530. In some implementations, the platform 2510 is rotatably mounted to a carriage 2512 that is slidably mounted to the horizontal arms 2530 and can slide along the horizontal arms 2530, thereby allowing the delivery system 114 to be positioned laterally, for example, to be aligned with the right femoral artery of a patient. The carriage 2512 may include a locking device (not shown), such as a set screw or similar, to lock the lateral position of the carriage 2512 and the platform 2510 along the horizontal rails 2530.
[0189] The support columns 2520 can be any suitable shape, such as a square, circle, or oval, and each support column 2520 includes a vertical portion 2522 and a movable or pivotal portion 2524 attached to the fixed portion 2522 by a hinge 2526. In some implementations, the hinge 2526 includes a locking member 2528 that can be driven to lock the position of the hinge 2526. When the locking member 2528 is disengaged, the movable portion 2524 can pivot relative to the fixed portion 2522, thereby changing the orientation of the horizontal arm 2530, and consequently the orientation of the platform 2510 and the accompanying rail system 2540. That is, the pitch or inclination of the delivery system 114 relative to the top surface of the base 110 can be changed by pivoting the movable portion 2524 of the support column 2520.
[0190] In some implementations, the vertical portion 2522 of the support column is slidably mounted to a clamp 2532. The clamp 2532 can be mounted to a mount coupled to the side rails of the operating table 110, or can be part of such a mount. The clamp 2532 can be loosened, thereby allowing the horizontal arm 2530 and platform 2510 to be vertically translated to a desired height above the table 110. When the platform 2510 has been raised or lowered to the desired height, tightening the clamp 2532 engages the support column 2520, preventing further movement of the support column 2520 when the stabilization base 2500 is in use. The mount and the accompanying clamp 2532 can be slidably mounted to the side rails of the operating table 110, thereby allowing the user to move the stabilization base 2500 along the length of the operating table 110.
[0191] In some implementations, the rail system 2540 can be configured to be held whole or partially by the features of the carriage 2510 of the stabilization base 2500, so that the rail system 2540 can still be attached to the stabilization base 2500 even when the stabilization base 2500 is covered by a sterile barrier (not shown), such as a drape. The barrier 112 shown in Figure 1 can be placed between the stabilization base 2500 and the rail system 2540. The rail system 2540 can be attached to the stabilization base 2500 without requiring attachment means such as fasteners that would puncture or perforate the sterile barrier placed between the platform 2510 and the rail system 2540. In some implementations, the rail system 2540 can be attached to the stabilization base 2500 using magnetic plates or snap connections that do not perforate the sterile barrier. In some implementations, the position of the rail system 2540 can be adjusted relative to the platform 2510, for example, by sliding the rail system 2540 back and forth relative to the platform 2510.
[0192] Referring here to Figures 91-94, an exemplary stabilization base 2600 for supporting a medical device / system is shown. The stabilization base 2600 may include any features of the stabilization base disclosed herein and may be formed from any suitable material such as metal or plastic. The stabilization base 2600 includes a platform 2610, a support frame 2620, and a base plate 2630. The platform 2610 is supported above the base plate 2630 by the support frame 2620, which extends vertically between the platform 2610 and the base plate 2630. In some implementations, a rail system (not shown) is attached to the platform 2610 (or, in some implementations, integrally formed on the platform or integrally formed as part of the platform) and may receive clamps (not shown) for securing a medical device or system, such as a delivery system or catheter assembly, to the rail system. The rail system can be attached to the platform 2610 in any suitable manner, for example, using fasteners, threaded fasteners, snaps, clamps, latches, friction fits, spring clamps, hook and loop fasteners, magnets, and the like. In some implementations, the rail system and / or clamps are the same as those disclosed in U.S. Provisional Patent Application No. 63 / 073392 filed September 1, and / or PCT Application No. PCT / US2021 / 048333 filed August 31, 2021, which are incorporated herein by reference in their entirety. The stabilizing base 2600 maintains stability by having a wide base plate 2630 for placement on a surface such as a patient's table.
[0193] The base plate 2630 can be a substantially flat plate of any suitable shape and dimensions to provide counterbalance and support for the medical device / system fixed to the stabilizing base 2600. The base plate can be square, circular, hexagonal, and homogeneous in shape. The base plate 2630 can be solid or have a void space in the center of the plate. In some implementations, the base plate 2630 can be a solid rectangular plate. The base plate 2630 can be positioned flush with the plane formed by the platform 110 as shown in Figure 1. The patient's legs can be placed on the top of the base plate 2630 such that the support frame 2620 extends vertically upward between the patient's legs. The position of the delivery system / catheter assembly relative to the patient can be optimized by adjusting the height of the platform 2610.
[0194] Platform 2610, to which the rail system and delivery system are mounted, is supported vertically above base plate 2630 by support frame 2620. In some implementations, support frame 2620 includes first support struts 2622 and second support struts 2624. The first and second support struts 2622 and 2624 are pivotally mounted to platform 2610 by upper brackets 2612. The first support strut 2622 is detachably and pivotally mounted to base plate 2630 at one of a pair of first lower brackets 2632. The second support strut 2622 is detachably and pivotally mounted to base plate 2630 at one of a pair of second lower brackets 2634. Each of the first and second support struts 2622 and 2624 includes a slot 2626 through which a pivot connecting member 2628 extends. The movable pivot connecting member 2628 can be any suitable connecting member, such as a through bolt with a knob at one end, as shown in Figure 94, between the two slots 2626 of the first support strut 2622 and the second support strut 2624, such that the position of the pivot connecting member 2628 is adjustable and it can be locked at any position along the length of the slot 2626.
[0195] In some implementations, the height and tilt angle of the platform 2610 can be changed by swapping the angles of one or both of the first support strut 2622 and the second support strut 2624 with the lower brackets 2632, 2634 to which the first support strut 2622 or the second support strut 2624 is attached. The first support strut 2622 and the second support strut 2624 can be moved by loosening a movable pivot connector 2628, which allows the movable pivot connector to slide along the slots 2626 within each of the first support strut 2622 and the second support strut 2624. When the desired orientation and height of the platform 2610 are achieved, the pivot connector 2628 is tightened, preventing further movement of the pivot connector 2628 with the first support strut 2622 and the second support strut 2624.
[0196] As can be seen in Figure 92, in some implementations, the platform 2610 is flat, i.e., substantially parallel to the base plate 2630, when each of the first support struts 2622 and the second support strut 2624 is connected to the lower brackets 2632, 2634, which are equidistant from the pivot connecting member 2628. The height of the platform 2610 is highest when each of the first support struts 2622 and the second support strut 2624 is mounted to the innermost lower brackets 2632, 2634, as shown in Figure 92, and can be lowered by moving the first support struts 2622 and the second support strut 2624 to more spaced brackets, such as the second lower bracket 2632 or the third lower bracket 2634. The platform 2610 can be tilted or pivoted from a horizontal or planar orientation when the first support strut 2622 and the second support strut 2624 are attached to the lower brackets 2632 and 2634, which are positioned unevenly apart from the pivot connecting member 2628. For example, as can be seen in Figures 93 and 94, when the first support strut 2622 is attached to the outermost first lower bracket 2632 and the second support strut 2624 is attached to the central second lower bracket 2634, the platform 2610 tilts in one direction.
[0197] In some implementations, the rail system (not shown) can be configured to be held whole or partially by the features of the platform 2610 of the stabilizing base 2600 so that the rail system can still be attached to the stabilizing base 2600 even when the stabilizing base 2600 is covered by a sterile barrier (not shown), such as a drape. The illustrated barrier 112 can be placed between the stabilizing base 2600 and the rail system. The rail system can be attached to the stabilizing base 2600 without requiring attachment means such as fasteners that would puncture or perforate the sterile barrier placed between the platform 2610 and the rail system. In some implementations, the rail system can be attached to the stabilizing base 2600 using magnetic plates or snap connections that do not perforate the sterile barrier. In some implementations, the horizontal position of the rail system can be adjusted relative to the platform 2610, for example, by sliding the rail system back and forth relative to the platform 2610.
[0198] Referring here to Figures 95–104, an exemplary stabilization base 2700 for supporting a medical device / system is shown. The stabilization base 2700 may include any features of the stabilization base disclosed herein and may be formed from any suitable material such as metal or plastic. The stabilization base 2700 includes a platform 2710 hinged to extendable support legs 2720. The support legs 2720 extend downward from the platform 2710 to an operating table (not shown), thereby raising the platform 2710 above a patient lying on the operating table. In some implementations, a rail system (not shown) may be attached to the platform 2710 (or, in some implementations, integrally formed on or as part of the platform) and may receive clamps (not shown) for securing a medical device or system, such as a delivery system or catheter assembly 114, to the rail system. The rail system can be attached to the platform 2710 in any suitable manner, for example, using fasteners, threaded fasteners, snaps, clamps, latches, friction fits, spring clamps, hook and loop fasteners, magnets, and the like. In some implementations, the rail system and / or clamps are the same as those disclosed in U.S. Provisional Patent Application No. 63 / 073392, filed September 1, 2020, and / or PCT Application No. PCT / US2021 / 048333, filed August 31, 2021, which are incorporated herein by reference in their entirety. In the illustrated implementation, the platform 2710 has a rectangular shape, and the support legs 2720 are positioned at the corners of the platform 2710, thereby spacing out the support points relative to the platform 2710 and providing stability to the stabilizing base 2700.By separating the support legs 2720, the stabilizing base 2700 can straddle the patient's right or left leg, thereby aligning the rail and delivery system with the patient's right or left inner thigh and femoral artery.
[0199] In some implementations, each of the support legs 2720 can pivot relative to the platform 2710 between an extended position (e.g., Figures 95-96) and a retracted position (Figures 99-100). The support legs 2720 are locked in the extended position by struts 2722 and released from the locked extended position by driving release buttons 2724 associated with a pair of support legs 2720. In the retracted position, the support legs 2720 are folded relative to the platform 2710, and the platform 2710 may include optional rims 2712 that extend at or beyond the support legs 2720 to conceal the support legs 2720 in the retracted position. As can be seen in Figure 99, the support legs 2720 in the folded position, i.e., the retracted position, are aligned from end to end. Alternatively, the support legs 2720 can be offset from each other so that they overlap when folded to the storage or folded position, with the support legs 2720 mounted on the opposite side of the platform 2710. Referring to Figures 97-98, pressing one of the release buttons 2724 disengages the slidable end 2726 of one of the struts 2722 from the mounting plate 2714 of the platform 2710, allowing the slidable end 2726 to slide laterally within the groove 2716 of the mounting plate 2714 (see Figure 98), thereby allowing the pair of support legs 2720 to which the struts 2722 are attached to be folded upward toward the platform 2710 to the storage or folded position shown in Figures 99 and 100.
[0200] In some implementations, the height of the support legs 2720 can be adjusted by rotating either a first height adjustment knob 2728 or a second height adjustment knob 2730 located on the side of the platform 2710. In the illustrated implementation, the first pair 2732 of the support legs 2720 are extended or retracted by using the first height adjustment knob 2728, and the second pair 2734 of the support legs are extended or retracted by using the second height adjustment knob 2730. That is, by rotating the first height adjustment knob 2728, both support legs 2720 forming the first pair 2732 of the support legs 2720 are extended or retracted, and by rotating the second height adjustment knob 2730, both support legs 2720 forming the second pair 2734 of the support legs 2720 are extended or retracted. The support legs 2720 are extended or retracted by extending or retracting the extendable portion 2736 which terminates at the pivot foot 2738. In other words, the extendable portion 2736 can be moved between a retracted position and an extended position by rotating the first height adjustment knob 2728 or the second height adjustment knob 2730. The first height adjustment knob 2728 and the second height adjustment knob 2730 may optionally include a locking device (not shown) for locking the position of the first height adjustment knob 2728 or the second height adjustment knob 2730, thereby preventing unintended adjustments to the height of the support leg 2720.
[0201] Referring here to Figure 102, in some implementations, the first height adjustment knob 2728 and the second height adjustment knob 2730 are connected to a drive shaft 2740 that extends through both of the first pair of support legs 2720 corresponding to the first height adjustment knob 2728, or through both of the second pair of support legs 2734 corresponding to the second height adjustment knob 2730. The drive shaft 2740 extends through a drive gear 2742 located within the platform 2710, which engages with a driven gear 2744 located at the upper end of each support leg 2720. The driven gear 2744 is connected to a threaded extension shaft 2746 that extends axially through each support leg 2720. An extension nut 2748 is screwed onto the threaded extension shaft 2746 and attached to the extendable portion 2738 of the support leg 2720. The drive gear 2724 and driven gear 2744 can be bevel gears or any other gears or any other mechanism for transferring the rotational motion of the drive shaft 2740 to the rotational motion of the threaded extension shaft 2746 via an angle of approximately 90 degrees between the drive shaft 2740 and the threaded extension shaft 2746. Note that the drive shaft 2740 is aligned with the rotation axis or pivot axis of the support leg 2720 so that the support leg 2720 can be rotated between the extended and retracted positions without affecting the extension of the support leg 2720.
[0202] Referring here to Figures 103 and 104, in some implementations, the first pair 2732 and the second pair 2734 of the support legs 2720 can be extended or retracted, thereby changing the height and / or tilt of the platform 2710. That is, both the first pair 2732 and the second pair 2734 of the support legs 2720 can be extended or retracted by the same amount as raising or lowering the platform 2710 while keeping it substantially parallel to the plane on which the stabilizing base 2700 is positioned. The platform 2710 can be tilted by adjusting the length of the first pair 2732 of the support legs 2720 to a different length from the length of the second pair 2734 of the support legs 2720. As can be seen in Figure 104, the platform 2710 can be tilted toward the shortened support legs 2720 by shortening the first pair 2732 of the support legs 2720. Because the threaded extension shaft 2746 of the support leg 2720 is oriented nearly perpendicular to the drive shaft 2740, forces applied to the support leg 2720 tend not to rotate the drive gear 2742 or the driven gear 2744. The height of the support leg 2720 tends to remain fixed until it is adjusted by rotating either the first height adjustment knob 2728 or the second height adjustment knob 2730, based on the configuration of the threaded extension shaft 2746 and the drive shaft 2740.
[0203] Referring here to Figures 105–118, exemplary stabilization bases 2800 for supporting medical devices / systems are shown. Stabilization bases 2800 may include any features of the stabilization bases disclosed herein and may be formed from any suitable material such as metal or plastic. Stabilization bases 2800 are similar to stabilization bases 2700 and may include any features of stabilization bases 2700 described above. Stabilization bases 2800 include a platform 2810 hinged to extendable support legs 2820. The support legs 2820 extend downward from the platform 2810 to an operating table (not shown), thereby raising the platform 2810 above a patient lying on the operating table. In some implementations, a rail system (not shown) is attached to the platform 2810 (or, in some implementations, integrally formed on or as part of the platform) and may receive clamps (not shown) for securing medical devices or systems, such as a delivery system or catheter assembly 114, to the rail system. The rail system can be attached to the platform 2810 in any suitable manner, for example, using fasteners, threaded fasteners, snaps, clamps, latches, friction fits, spring clamps, hook and loop fasteners, magnets, and the like. In some implementations, the rail system and / or clamps are the same as those disclosed in U.S. Provisional Patent Application No. 63 / 073392 filed 1 September 2020 and / or PCT Application No. PCT / US2021 / 048333 filed 31 August 2021, which are incorporated herein by reference in their entirety. In the illustrated implementation, the platform 2810 has a rectangular shape, and the support legs 2820 are positioned at the corners of the platform 2810, thereby spacing out the support points relative to the platform 2810 and providing stability to the stabilizing base 2800.By separating the support legs 2820, the stabilizing base 2800 can straddle the patient's right or left leg, thereby aligning the rail and delivery system with the patient's right or left inner thigh and femoral artery.
[0204] In some implementations, each of the support legs 2820 can pivot relative to the platform 2810 between an extended position (e.g., Figures 105-106) and a retracted position (Figures 115-118). A bottom cover 2812 mounted to the bottom surface of the platform 2810 includes an opening 2814 that provides access to a slide latch member 2816 which can be driven to pivot the support legs 2820. The bottom cover 2812 can be formed from any suitable material, such as molded or additively manufactured plastic, cast metal or machined metal, and the like, and can be formed as a single unit, multiple units, and / or multiple layers of various materials. A retaining member 2848 (Figures 106, 109, 116, and 118) is provided between the bottom cover 2812 and each support leg 2820 to hold the support legs 2820 in the retracted position. The retaining member or pad 2848 is sized to form an interference fit or interference fit between the bottom cover 2812 and the support leg 2820 so that friction between the retaining member 2848 and the support leg 2820 prevents undesirable rotation of the support leg 2820. The retaining member 2848 can be attached to the bottom cover 2812 in a wide variety of ways, for example, by insertion into a slot in the bottom cover 2812, by adhesive, by one or more fasteners, by induction welding, or similar means. The retaining member 2848 can also be formed by one or more protrusions from the bottom cover 2812, which may be made of the same material as the bottom cover 2812, or by being coated with an elastomer coating to provide additional friction against the support leg 2820. The retaining member 2848 can take a wide variety of forms, such as a strap, latch, ball detent, or similar.
[0205] Referring here to Figures 109 (showing an enlarged detail view of area 108A in Figure 108) and 110 (showing an enlarged detail view of area 108B in Figure 108), the mechanism for locking and unlocking the rotation of the support legs 2820 is shown. The rotation catch member 2822 extends between the support legs 2820 in the first pair 2828 and the second pair 2830 of the support legs and is connected to those support legs 2820. The rotation catch member 2822 includes a recess 2824 corresponding to the engaging end 2818 of the slide latch member 2816. An extension member 2826 of the rotation catch member 2822 is captured between the slide latch member 2816 and the bottom cover 2812, thereby preventing the rotation of the support legs 2820. When the slide latch member 2816 is retracted in the retraction direction 2844 so as to move away from the rotation catch member 2822, the extension member 2826 of the rotation catch member 2822 is free from the engaging end 2818 of the slide latch member 2816. As a result, the support leg 2820 and the rotation catch member 2822 can rotate from the deployed position to the retracted position, in the retraction direction 2846. The tightening screw 2850 is shown in Figures 111 and 112.
[0206] Referring here to Figures 111-112, a cross-sectional view of an exemplary stabilization base 2800 is shown to illustrate the tightening screw 2850. Extending through the bottom cover 2812, the tightening screw 2850 engages with the extension member 2826 of the rotation catch member 2822 to eliminate any slack or gap between the extension member 2826, the bottom cover 2812, and the slide latch member 2816. During the manufacture of the stabilization base 2800, the tightening screw 2850 is tightened when the support legs 2820 are in the open or extended position, thereby preventing undesirable rotation of the support legs 2820 that could cause the stabilization base 2800 to wobble or move. The extension member 2826 moves away from the tightening screw 2850 as the support legs 2820 are rotated to the closed or retracted position. When the support leg 2820 is extended again, the tightening screw 2850 stops the rotation of the extension member 2826 at a previously determined position. Thus, the tightening screw 2850 also acts as a calibration mechanism for calibrating the outermost limit of the rotation of the support leg 2820. In some implementations, a portion of the bottom cover 2812 covering the rotational extension mechanism of the support leg 2820 has greater rigidity than the rest of the bottom cover 2812 to provide additional support, for example, to the tightening screw 2850 and the rotational catch member 2822. The additional rigidity in one or more portions of the bottom cover 2812 can be provided by adding a layer of a rigid material (e.g., a metal plate or sheet) to a relatively flexible material (e.g., injection-molded plastic). As another example, the additional rigidity at a desired position can be provided by forming a separate cover member from die-cast metal that abuts against or overlaps with a portion of the other members of the bottom cover 2812.
[0207] In the deployed position, the height of the support legs 2820 can be adjusted by rotating either the first height adjustment knob 2828 or the second height adjustment knob 2830, which are located on the side of the platform 2810. In the illustrated implementation, the first pair 2832 of the support legs 2820 are extended or retracted by using the first height adjustment knob 2828, and the second pair 2834 of the support legs are extended or retracted by using the second height adjustment knob 2830. That is, by rotating the first height adjustment knob 2828, both support legs 2820 forming the first pair 2832 of the support legs 2820 are extended or retracted, and by rotating the second height adjustment knob 2830, both support legs 2820 forming the second pair 2834 of the support legs 2820 are extended or retracted. The support legs 2820 are extended or retracted by extending or retracting the extendable portion 2836 which terminates with a rounded foot 2838. In other words, the extendable portion 2836 can be moved between a retracted position and an extended position by rotation of the first height adjustment knob 2828 or the second height adjustment knob 2830. The first height adjustment knob 2828 and the second height adjustment knob 2830 may optionally include a locking device (not shown) for locking the position of the first height adjustment knob 2828 or the second height adjustment knob 2830, thereby preventing unintended adjustments to the height of the support leg 2820. The mechanism for operating the support leg 2820 to extend or retract is similar to the drive shaft 2740 and gears 2742, 2744 in the stabilizing base 2700 shown in Figure 102.
[0208] Referring here to Figures 113 and 114, in some implementations, the support legs 2820 forming a first pair 2832 and a second pair 2834 can be extended or retracted to change the height and / or inclination of the platform 2810. That is, both the first pair 2832 and the second pair 2834 of the support legs 2820 can be extended or retracted by the same amount to raise or lower the platform 2810 while keeping it substantially parallel to the plane on which the stabilizing base 2800 is placed. The extendable portion 2836 of the support legs 2820 may optionally include a scale 2842 (e.g., a ruler as shown in Figures 113-114), which helps the user measure the extension amount of each pair 2832, 2834 of the support legs, thereby helping to more easily reproduce the desired inclination angle or height of the platform 2810. Platform 2810 can be tilted by adjusting the length of the first pair 2832 of support legs 2820 to a length different from the length of the second pair 2834 of support legs 2820. As can be seen in Figure 114, by shortening the first pair 2832 of support legs 2820, platform 2810 can be tilted toward the shortened support legs 2820. The height of the support legs 2820 tends to remain fixed until it is adjusted by rotating either the first height adjustment knob 2828 or the second height adjustment knob 2830, based on the configuration of the threaded extension shaft (not shown) and drive shaft 2840 (see Figure 109) used to extend and retract the support legs 2820.
[0209] While various inventive viewpoints, concepts, and features of this disclosure may be described and illustrated herein as being embodied in combination in illustrated examples, these various viewpoints, concepts, and features can be used individually or in various combinations and subcombinations thereof in many alternative implementations. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of this application. Furthermore, while various alternative implementations relating to the various viewpoints, concepts, and features of this disclosure, such as alternative materials, alternative structures, alternative configurations, alternative methods, alternative devices, alternative components, alternative examples relating to form, alternative examples relating to fit, alternative examples relating to function, and similar, may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative implementations, whether currently known or to be developed later. A person skilled in the art can readily adopt one or more inventive viewpoints, concepts, or features into additional implementations and uses within the scope of this application, even if they are additional implementations not expressly disclosed herein.
[0210] In addition, even if some features, concepts, or viewpoints of this disclosure can be described herein as preferred configurations or methods, such descriptions are not intended to imply that such features are essential or indispensable unless expressly stated otherwise. Furthermore, while exemplary or representative values, and even exemplary or representative ranges, may be included to aid in understanding this application, such values and ranges are not intended to be confined to a restrictive sense, but are intended to be critical values or ranges only when expressly stated as such.
[0211] Furthermore, although various viewpoints, features, and concepts may be expressly identified herein as inventive or as forming part of the disclosure, such identification is not intended to be exclusive. Rather, there may be inventive viewpoints, concepts, and features that are fully described herein without being expressly identified as such or as part of a particular disclosure, and such disclosure is instead provided for in the appended claims. Descriptions of exemplary methods or processes are not limited to including all steps as essential in all cases, and the order in which multiple steps are presented is not to be construed as essential or indispensable unless expressly stated. Moreover, techniques, methods, operations, steps, etc. relating to procedures, as described or suggested herein, may be performed on living animals or on non-living simulations such as cadavers, cadaver hearts, simulators (e.g., in which body parts, hearts, tissues, etc. are simulated). The terms used in the claims are to have their entirely ordinary meanings and are not limited in any way by the descriptions of implementation herein.
Claims
1. A system for supporting a medical device, wherein the system is It is a stabilization base, Multiple legs, including a first pair of legs and a second pair of legs, A stabilizing base including a platform attached to the plurality of legs, A stabilization system for receiving the medical device, comprising a stabilization system that is detachably attached to the platform, One or more of the aforementioned legs are adjustable to change one or more of the vertical, horizontal, and angular positions of the platform. A system further comprising: a first height adjustment knob for adjusting the height of the first pair of legs; and a second height adjustment knob for adjusting the height of the second pair of legs.
2. The system according to claim 1, wherein one or more of the plurality of legs include an outer portion and an inner portion movably disposed inside the outer portion.
3. The system according to claim 1, further comprising a first plate and a second plate, wherein the first plate and the second plate are parallel to each other and extend vertically downward from the platform on both sides of the platform.
4. The system according to claim 3, further comprising a knob mechanism extending through at least one of the first plate and the second plate.
5. The system according to claim 1, further comprising a mechanism for controlling the height of one or more of the plurality of legs.
6. The stabilization system is a rail system for receiving the medical device, and the rail system is detachably mounted to the platform, according to claim 1.
7. The medical device is a delivery system that can be coupled to the stabilization system, and the system includes the delivery system, according to claim 1.
8. The system according to claim 1, wherein the first pair of legs and the second pair of legs are foldable between a stowed position and an unfolded position.
9. The system according to claim 8, further comprising a first strut for holding the first pair of legs in the deployed position and a second strut for holding the second pair of legs in the deployed position, wherein the first strut and the second strut are slidably mounted to the platform and are releasable to facilitate folding the first pair of legs and the second pair of legs from the deployed position to the retracted position.
10. Each of the first pair of legs and the second pair of legs is, Includes a drive shaft, a pair of drive gears, a pair of driven gears, and a pair of extension shafts, Each leg's extendable portion is attached to the extension shaft. The drive gear is fixedly mounted to the drive shaft, and the driven gear is fixedly mounted to the extension shaft. The system according to claim 1, wherein by rotating either the first height adjustment knob or the second height adjustment knob, both the extension shaft and the drive gear are rotationally driven via the drive gear and the driven gear, thereby increasing or decreasing the height of the leg.
11. The system according to claim 1, wherein the platform can be tilted by adjusting the height of the first pair of legs to a height lower than the height of the second pair of legs.
12. The system according to claim 8, further comprising a retaining member for holding each of the plurality of legs in the storage position.
13. The system according to claim 12, wherein the retaining member is attached to the bottom cover of the platform.
14. A system for supporting a medical device, wherein the system is It is a stabilization base, A pair of legs, The second pair of legs, A platform attached to the pair of legs and the second pair of legs, wherein each of the pair of legs and the second pair of legs comprises an outer portion and an inner portion movably disposed inside the outer portion, A first knob coupled to the pair of legs, configured to adjust the height of the pair of legs, A second knob, coupled to the second pair of legs, is configured to adjust the height of the second pair of legs, Equipped with, The aforementioned pair of legs are rotatable between a stowed position and an extended position. The second pair of legs is rotatable between a stowed position and an extended position. Stabilization base and A stabilization system for receiving a medical device, wherein the stabilization system is detachably attached to the platform, Equipped with, To change the vertical position, the horizontal position, and the angular position of the platform, the height of the pair of legs and the height of the second pair of legs are independently adjustable. Each of the aforementioned pair of legs and the aforementioned second pair of legs is, It comprises a drive shaft, a pair of drive gears, a pair of driven gears, and a pair of extension shafts, the extendable portion of each leg being attached to the extension shafts, The drive gear is fixedly mounted on the drive shaft, and the driven gear is fixedly mounted on the extension shaft. A system in which, by rotating either the first knob or the second knob, both the drive gear and the driven gear of the extension shaft rotate, thereby increasing or decreasing the height of the leg.
15. The apparatus further comprises a first strut for holding the pair of legs in the deployed position, and a second strut for holding the second pair of legs in the deployed position. The system according to claim 14, wherein the first strut and the second strut are slidably mounted to the platform and are releaseable to facilitate folding the pair of legs and the second pair of legs from the deployed position to the retracted position.
16. The system according to claim 14, wherein the platform can be tilted by adjusting the height of the pair of legs to be lower than the height of the second pair of legs.