Patent Application
20160367332
1. Field of the Invention
The present invention generally relates to assistive procedural devices and, more particularly, to procedures that are performed percutaneously with one or more procedural tools or devices that can benefit from maintaining a specific percutaneous access location, orientation of said procedural tools or devices, and securement of said procedural tools or devices.
2. Description of Prior Art
In placing a medical device or instrument into a patient it is best to use precision. However, correct device placement and preservation of device position are made difficult by various patient, disease, environmental, and user factors. Moreover, there is often a need for slight adjustment of the device in one or more dimensions (e.g., depth, angle with skin). Various systems, assemblies, devices, and methods for guiding and positioning, medical tools or devices are known in the medical field. The following are examples.
U.S. Pat. No. 4,265,561 to Heckele (herein, “Heckele '561”) discloses a device for holding a medical instrument wherein the device holder is mounted to a headband worn by the user. The device includes a base mounted to the headband with a recess therein, into which a rotatable member with a through-hole fits in a ball-and-socket fashion. The through-hole in the rotatable member accommodates an arm of the medial instrument.
U.S. Pat. No. 4,693,240 to Evans (herein, “Evans '240”) discloses a bone pin clamp as depicted in Evans ‘240.’ The bone pin clamp is secured in a ball-in-socket joint wherein the ball comprises a through-hole for receiving the pin (100). The through-hole may be axially grooved for securing the pin therein.
U.S. Pat. No. 6,328,748 to Henning (herein, “Henning '748”) also discloses a device for adjusting stereotactically and endoscopically located equipment where the holder comprises a lower ring (1) for receiving a ball (2) which will form a ball joint, and an upper ring (3) for locking the ball in a specific position, where the ball (2) has a channel for insertion of medical instruments, and where the lower ring (1) has an external threaded surface (8) for direct screwing to an area of a patient's skull. The device is characterized by the fact that the ball's (2) central point, and thereby the ball joint's fulcrum is arranged for positioning on a level with the patient's cranium by way of a groove-like or curved surface (21) on the holder which forms an abutment for the ball (2), wherein the groove-like surface (21) may be screwed directly into the patient's skull.
U.S. Pat. No. 7,204,840 to Skakoon et al. discloses (herein, “Skakoon '840”) discloses devices and methods to provide accurate targeting, placement, and/or stabilization of an electrode or other instrument(s) into the brain or other body organ. In an example an embodiment of Skakoon '840, a base 104 is secured to the skull using bone screws. A pedestal or tower 3002 is secured to base 104 as illustrated or, alternatively, is secured directly to the skull. Tower 3002 includes a socket 3004 housing a ball 3006. Ball 3006 includes a center opening that receives a rotating inner barrel sleeve 3008. In this example, sleeve 3008 includes one or more lumens 3010A-C extending there through for passing and guiding instruments, sheaths, stylets, etc. An affixation device, such as thumbscrew 3012, fixes the position of ball 3006 when the desired trajectory alignment has been obtained, such as by using the MRI, CT, PET, or frameless navigational guidance techniques discussed above. Proximal portions of lumens 3010A-C include recesses for snapping into place lips on devices inserted therein, such as alignment stem (or frameless adapter) 3014 and/or Luer stem 3016.
U.S. Pat. No. 7,824,417 to Magnusson et al. (herein, “Magnusson '417”) discloses a skin-mounted gimbal-like device for guiding a puncturing needle or other medical device to a treatment site. The device comprises a series of adhesive pads (6) that are releasably secured to the patient's skin and mounted with a base (5) and ball joint (7) to allow rotatable positioning of a needle guiding member (3) over the patient's skin.
U.S. Pat. No. 8,425,404 to Wilson et al. (herein, “Wilson '404”) discloses a laparoscopic surgical tool positioning device comprising a plurality of arms connected by ball-and-socket joints and able to be increased and decreased in length to provide the proper position and angle of skin entry for the laparoscopic tool. Wilson '404 discloses a clamp for holding the tool, comprising a spring-loaded clamping jaw (122) for gripping medical devices of different diameters. The clamping jaw is open on one side to allow releasable attachment to the device being positioned for skin entry,
U.S. Pat. No. 5,354,283 to Bark et al. (herein, “Bark '283”) describes a trocar retention device for attachment to the skin of the patient. The device comprises a trocar-receivable rotatable spheroid frictionally retained in a stabilizing member. The base, or stabilizing member (10) is preferably a frusto-conical member molded from a material such as silicone elastomer, rubber, plastic or the like and comprising a socket (14) into which the rotatable spheroid (22) sits and is frictionally engaged. The spheroid (22) has a cylindrical bore 24 that is adapted to slidably receive a trocar 22. In one disclosed embodiment, the stabilizing member (10) and the spheroid both have a slit (34) that allows the flexible material of the stabilizing member and the spheroid to be fitted over the trocar at the surface of the patient's skin after the has been placed in the proper position. The stabilizing member comprises a groove (28) around a “neck” portion thereof which may be secured by a clamp or other means to close the slit (34) and secure the stabilizing member and spheroid around the placed trocar. Bark '283 also describes bow the interior walls 26 of the stabilizing member 10 are inclined, preferably at a 45° angle to the skin of the patient, to prevent the trocar 22 from becoming dislodged during the surgical procedure by limiting the angle of inclination of the trocar 22. The spheroid is engaged and secured to the trocar (22) by the frictional force of the clamp or tie acting on the stabilizing member and spheroid. In some embodiments, the Bark '283 device is secured to the patient by means of a plurality of suction cups 40 positioned about the bottom of the base disc 18 of the trocar retaining apparatus. The suction cups 40 secure the stabilizing member 10 to the patient. The suction cups 40 provide for short term attachment of the stabilizing member 10 during surgery, rather than long term therapy. Alternatively, double sided. medical tape or a contact medical adhesive may be used to secure the stabilizing member 10 to the skin of the patient.
U.S. Pat. No. 4,841,967 to Chang et al. (herein, “Chang '967”) discloses a device for accurate positioning of needles for percutaneous insertion comprising a base having a circular angle indicator similar to a protractor for indicating the angle of needle insertion by reference to markings thereon. As seen in Chang '967, a needle holding device may comprise a needle holder 40 having a longitudinal grooved housing adapted to receive a needle 70 (or other elongated medical instrument intended for percutaneous insertion into a body cavity) in a longitudinal groove 45 defined in the front face 43 of housing 40. The needle 70 can be removably affixed to housing 40 by means of a removable clasp 50 which can be fabricated from a material and of a size such that the inner sides 65 of clasp 50 securely grip the sides 41 of housing 40 to hold needle 70 within groove 45 and to prevent needle 70 from moving.
In accordance with the foregoing objects, the purpose of the present invention is to facilitate the performance of percutaneous procedures by stabilizing various access devices, thereby reducing trauma to the tissues (especially when the access devices have sharp tips) and enabling the user to take one hand off of the access device to perform other steps with two hands. Hence, the present invention is a device to maintain a specific percutaneous access location and orientation of access devices once said location and orientation have been identified by the user, and to secure the distal tip of said access device(s) relative to said location and orientation during said percutaneous procedure. Access devices include but are not limited to a needle, wire, trocar, dilator, and catheter (together referred to as “access devices”).
Other objects, features, and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiments and certain modifications thereof when taken together with the accompanying drawings in which:
For purpose of the present disclosure, the term “percutaneous” means via needle-puncture of the skin, and “percutaneous access device” means any medical device that employs a percutaneous access modality for a medical procedure. Percutaneous access and procedures frequently refer to catheter procedures such as cardiac catheterization, percutaneous transluminal angioplasty (PTA) ballooning, stent delivery, filter delivery, cardiac ablation, and peripheral vascular or neurovascular catheter procedures. Also included are procedures for percutaneous access of other body cavities such as parts of the gastrointestinal track, peritoneal cavity, pleural cavity, airway, abscesses, and other fluid- or air-containing cavities. Moreover, procedures that employ the Seldinger approach to access a space in the body generally fit into the category of percutaneous procedures. Other percutaneous procedures serve to access bone including intraosseous vascular access, vertebroplasty, and bone marrow biopsy. Still other percutaneous procedures are used to biopsy tissues. The procedures listed above are meant to serve as examples and are not an exhaustive list. The core functions of the device of the present invention are to provide the following:
(1) a securement mechanism for percutaneous access devices, wherein a component of the subject invention holds the access devices in place relative to the base and adjustment components, accommodates access devices of different sizes and diameters, maintains at least three positions (fully open, partially open, fully closed), enables the user's hand to come off of the access device, skin and/or procedural location, and does not materially limit amount of access device available for the procedure;
(2) an adjustment mechanism to maintain the location and orientation of the access device(s), wherein a component of the subject invention moves about at least one axis relative to the base, may lock to hold the position identified by the user, and may be rotated to align with the base so as to easily remove the device from the patient; and
(3) a base component designed to conform to the skin at varying locations (e.g., on flat, curved, indented or otherwise irregular surfaces), which may include adhesive, may serve as part of a sterile and/or antimicrobial dressing, may be easily replaceable, is easily removable from the skin (e.g., at the end of the procedure), has a small footprint, and accommodates the concurrent use of other procedural tools, including but not limited to scalpel, hook or retractor, ultrasound probe. Multiple techniques and/or approaches may be used to accomplish each of the functions. The detailed discussion and figures below describe limited embodiments of the device.
The device 1 features at least one axis of orientation adjustment relative to the identified procedure location on the patient, though the device preferably accommodates multiple axes of adjustment. This is herein accomplished by the adjustment mechanism 40 which articulates relative to base 10.
The base 10 of the device 1 is configured to facilitate percutaneous access at acute angles of the access device(s) relative to the patient's skin (e.g., insertion angle approaching parallel to skin). The acute angles may range from nearly perpendicular as shown in
A passageway 43 traverses the spherical shaped body 41 of adjustment mechanism 40, and exits through a collar 42 that protrudes from the spherical body 41 on one side. The percutaneous access device(s) are inserted through passageway 43 and collar 42, and so the orientation of the access device is intended to be substantially coaxial to the collar 42 and passageway 43 through adjustment mechanism 40.
The adjustment mechanism 40 of the procedural assist device 1 is additionally fitted with securement mechanism 70 for holding the access device(s) in place relative to the base 10 and adjustment mechanism 40, as was shown in
Note that the back side of the plug 72 component also contains a slot-following feature 80, here being of a dovetail tongue-in-groove design, though this is not meant to be limiting. In a standard cord lock device, the shell component and plug component both make complete circles for other complete constraining shapes) such that the object passing therethrough can only pass through in that direction, e.g. O-shaped. The similar components of the present invention feature C-shaped jaws 74 and 75, as described, with the specific purpose of allowing the objects passing there through to exit the side unimpeded. This being the case, there is a tendency for the bottom of the C-shaped jaw 74 of plug 72 to protrude from the 75 of shell 71. To prevent this occurrence, the back side of the plug 72 has a guide feature 80 that interfaces with a companion guide feature 81 on the same side of the shell 71 to constrain the plug 72 motion to remain only up and down within the shell 71.
In the preferred embodiment, the adjustment mechanism 40 can be rotated a certain way to fit in the opening 16 of base 10 for assembly. As pictured in
Having now fully set forth the preferred embodiment and certain modifications of the concept underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with said underlying concept. It is to be understood, therefore, that the invention may be practiced otherwise than as specifically set forth in the appended claims.
The present application derives priority from U.S. Provisional Application Ser. No. 62/182,221 filed 19 Jun. 2015.
| Number | Date | Country | |
|---|---|---|---|
| 62182221 | Jun 2015 | US |
