Patent Application
20160346151
This invention relates to apparatus of the type used for the positive positioning of a body part such as, for example, hands, feet, knees, etc., for surgical procedures and other medical activities where the body part must be maintained in the selected optimum position and, more particularly, to an apparatus with tilt control and adjustable by one hand operation having improved holding strength, sterilization function.
Surgical procedures increasingly require that the joint, limb or body part to be operated upon to be precisely and predictably positioned during such surgery. Optimum positioning requires a large range of positive positioning adjustments to be easily available so that the limb or joint to be treated is initially positioned and thereafter maintained in the desired position. Not only must such selected position be maintainable but also it is very important and often necessary that the limb be released and repositioned on demand during the course of the procedure to ensure optimum access thereby to require a variety of angular relationships for effective surgery.
Medical devices, including surgical equipment for holding a body part, that have contact with body tissues or fluids are considered critical items as these items should be sterile when used because any microbial contamination could result in disease transmission. If these items are heat resistant, the recommended sterilization process is steam sterilization, because it has the largest margin of safety due to its reliability, consistency, and lethality. Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. Sterilization destroys all microorganisms on the surface of an article or in a fluid to prevent disease transmission associated with the use of that item. Sterilization refers to any process that eliminates, removes and/or kills all forms of life, including transmissible agents such as fungi, bacteria, viruses, spore forms, etc. present on a surface, which can be achieved by applying heat, chemicals, irradiation, high pressure, and filtration or combinations thereof. The concept of what constitutes “sterile” is measured as a probability of sterility for each item to be sterilized. This probability is commonly referred to as the sterility assurance level (SAL).
Sterilization facilities are separate from operating rooms to perform heat sterilization on surgical equipment in an autoclave, sometimes called a converter. If sterilization is needed in the operating room, flash sterilization methods are used, for example, should the plate become unsterile for any reason then flash sterilization methods require placing in hot liquids to remove pathogens and afterwards instruments may take longer to reach the required room-temperature after sterilization while cooling thereby delaying the surgical procedure and adding cost.
Problems in sterilizing surgical equipment for holding a body part abound Disadvantages of previous surgical equipment for holding a body part include the costs associated with sterilization, whereby nooks and folds where residues accumulate and cannot be, or require increased effort to be, dislodged. Another design problem is in use of multiple parts, whereby the entire set of complex rails, tubes and other parts of the surgical equipment and apparatus required disassembly, scrubbing, power washing and other procedures that increased the cost of the sterilization and overall procedure. In addition, parts of the surgical equipment for holding a body part could get lost or removal may void warranties. In general, such surgical equipment for holding a body part during a surgical procedure required sterilization before entering an operating room. Once the surgical procedure ends, the surgical equipment again requires sterilization.
These problems involving the sterilization of surgical equipment have existed for a long period of time without solution. The problem also involves design and construction involving multiple parts such as, for example, complex rails, tubes and other apparatus secured to an operating table. As a result, a simplified design for surgical equipment for holding a body part is desired that reduces these and other disadvantages including the cost of the sterilization and overall time and cost of the procedure.
It is an object of the apparatus, system and method of the present invention to provide a carriage for positioning an extremity holder featuring two locking points achieved by one locking mechanism that is an improvement to prior designs in functionality and holding strength.
It is an object of the apparatus, system and method of the present invention to provide a extremity holder such as for a positioning a knee for surgery utilizing a locking the ball and carriage on the fly with a one arm lock and ergonomic handle.
It is an object of the apparatus, system and method of the present invention to provide a carriage having advantages of minimum parts so as to improve use, sterilization, maintenance thereof.
It is an object of the present invention to provide an apparatus, system and method of treatment that advantageously is rugged in structure and provides support for the patient's limbs or body during the preparation for surgery, when it is necessary to have an extremity draped and available for operation.
It is an object of the apparatus, system and method of the present invention to provide a carriage with tilt control for use in surgical procedures of a larger limb (i.e. heavier), the weight of the body part.
It is an object to provide a carriage with tilt control with minimum parts so as to improve use, sterilization, maintenance thereof.
Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures unless otherwise specified.
For a better understanding of the present invention, reference will be made to the following Description of the Embodiments, which is to be read in association with the accompanying drawings, which are incorporated in and constitute a part of this specification, show certain aspects of the subject matter disclosed herein and, together with the description, help explain some of the principles associated with the disclosed implementations, wherein:
Non-limiting embodiments of the present invention will be described below with reference to the accompanying drawings, wherein like reference numerals represent like elements throughout. While the invention has been described in detail with respect to the preferred embodiments thereof, it will be appreciated that upon reading and understanding of the foregoing, certain variations to the preferred embodiments will become apparent, which variations are nonetheless within the spirit and scope of the invention.
The terms “a” or “an”, as used herein, are defined as one or as more than one. The term “plurality”, as used herein, is defined as two or as more than two. The term “another”, as used herein, is defined as at least a second or more. The terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open language). The term “coupled”, as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically.
Reference throughout this document to “some embodiments”, “one embodiment”, “certain embodiments”, and “an embodiment” or similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of such phrases or in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation.
The term “or” as used herein is to be interpreted as an inclusive or meaning any one or any combination. Therefore, “A, B or C” means any of the following: “A; B; C; A and B; A and C; B and C; A, B and C”. An exception to this definition will occur only when a combination of elements, functions, steps or acts are in some way inherently mutually exclusive.
The drawings featured in the figures are provided for the purposes of illustrating some embodiments of the present invention, and are not to be considered as limitation thereto. Term “means” preceding a present participle of an operation indicates a desired function for which there is one or more embodiments, i.e., one or more methods, devices, or apparatuses for achieving the desired function and that one skilled in the art could select from these or their equivalent in view of the disclosure herein and use of the term “means” is not intended to be limiting.
As used herein the term “body” “body part” “extremity” or “limb” refers to a body part or extremity consisting of foot, ankle, knee, leg, hand, wrist, arm and shoulder of a patient.
As used herein the term “Flash” sterilization is defined as steam sterilization of an unwrapped object at 132° C. for 3 minutes at 27-28 lbs. of pressure in a gravity displacement sterilizer 843 as pioneered by the Underwood and Perkins. Currently, the time required for flash sterilization depends on the type of sterilizer and the type of item, i.e., porous vs non-porous items. Although the wrapped method of sterilization is preferred for the reasons listed below, correctly performed flash sterilization is an effective process for the sterilization of critical medical devices. Flash sterilization is a modification of conventional steam sterilization (either gravity, pre-vacuum, or steam-flush pressure-pulse) in which the flashed item is placed in an open tray or is placed in a specially designed, covered, rigid container to allow for rapid penetration of steam.
As used herein the term “holder” or “extremity holder” refers to a device or a means for supporting the body part, or joint thereof, of a patient in the preparation for surgery or medical activity and/or during surgery to hold a body part for access to the body part. A holder can be used to position the body part such as an arm or leg for patient preparation.
As used herein the term “patient” refers to any recipient of health care services. The patient is most often ill or injured and in need of treatment by a surgeon, physician, physician assistant, advanced practice registered nurse, veterinarian, or other health care provider.
As used herein the term “medical activity” refers to the provision of medical care consisting of hospital activities, medical and dental practice activities, and “other human health activities” by a surgeon, physician, physician assistant, advanced practice registered nurse, veterinarian, or other health care provider. “Medical activity” can also include to numerous activities of medical treatment, diagnosis, preparation for surgery, or inspection of a body part so as to hold a body part for access to the body part.
As used herein the terms “surgery”, “operation” “surgical procedure” or refers an act of performing surgery such as by a surgeon, or simply to investigate and/or treat a pathological condition such as disease or injury, or to help improve bodily function or appearance using operative manual and instrumental techniques on a patient to in the medical specialty context. The adjective surgical means pertaining to surgery; e.g. surgical instruments or surgical nurse. The patient or subject on which the surgery is performed can be a person or an animal.
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The base 111 has surfaces of an upper surface 116, lower surface 117 and side surfaces 118. The upper surface 116 is configured with the step 112 generally located and centered along a mid-line, the hinge portion 113 is located at one end of the step 112, and the recess 114 located at another end of the step 112. The track portion 115 is located on a lower surface 117 of the base 111. The base 111 has side surface(s) 118 so as to define a rigid rectangular structure, which is non-limiting as other designs are possible. Because the base 111 is intended for use in an operating room environment, it is formed from materials that are durable, sturdy, and that can be repeatedly sterilized such as, for example, most commonly formed from stainless steel that is known to reduce bacterial and early bio-film attachment, other suitable metals and metal alloys. The base 111 has an opening 119 in a side surface 118 configured to accept a rod 132 of a clamp assembly 130 as is described herein.
The apparatus 100 of the present invention further comprises an arm 120 having a hinge portion 121 with a hole 122 adapted to receive a pin 123 to join the arm 120 to the base 111. The arm 120 is configured to fit to the base 111 adjacent the step 112 whereby the hinge portion 121 aligns with the hinge portion 112 on the base so as to be attached with pin 123, thereby opening and closing of the arm 120 by rotation around the pin 123 and hinge portions 121, 113. The hinge portions 113 and 121 can include a sleeve bearing 124 to provide smooth rotation around the point formed by the hinge portions and pin 123. The arm 120 can be a general rectangular shape and formed from a solid material. A suitable material to form the arm 120 is stainless steel yet other materials and/or metal alloys with qualities of durability, strength and that can be repeatedly sterilized to reduce bacterial attachment can be utilized.
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According to another embodiment of the present invention, the slide assembly 180 is moved along pathway 172 engaging one or more dimples 175 established for the predetermined angle 176 (i.e. setting angles of 1°, 2°, 3°, . . . or 2°, 4°, 6°, . . . or 5°, 10°, 15°, . . . etc,). In a linear trajectory 174 the dimples 175 are spaced equally. In an arcuate trajectory 174 the dimples 175 may be spaced at varying distances. The slide assembly 180 may include a ball bearing 182 and spring 183 to engage and disengage the dimples 175, as these may be formed in the pathway 172 in base 111 or pathway 173 in arm 120, as the slide assembly is slidably moved.
According to another aspect of the present invention, the parts for the tilt control assembly 170 are minimized consisting essentially of the slide assembly 180 and milled pathways 172 and 173 in the base 111 and arm 120 are easily sterilized so as to lower the cost of use of the present invention. Moreover, the parts the slide assembly 180 and milled grooved guide 189 for pathways 172, 173 as well as the insert 181 (with ball bearing 182 secured therein) and spring 183 are easily sterilized so as to lower the cost of use of the present invention.
According to another aspect of the present invention, a knurled knob 171 may be formed in tilt control assembly 170 to tighten the carriage base 111 to an operating table 106 and prevent movement in all x, y and z directions. The knurled knob 171 is configured to be inserted into a threaded hole in the base 111 so as to set location on the operating table 106 or other track. The knurled knob 171 is configured locks carriage assembly 100 base 111 anywhere on track thereby forming an “e-brake” and stopping any translational force to assist the clamp assembly 130 with additional locking so as not slide along the rail or track. These parts are again minimized for sterilization as the knurled knob 171 requires removal and the hole and knob 178 can be easily cleaned and sterilized.
While certain configurations of structures have been illustrated for the purposes of presenting the basic structures of the present invention, one of ordinary skill in the art will appreciate that other variations are possible which would still fall within the scope of the appended claims. Additional advantages and modifications will readily occur to those skilled in the art. Therefore, the invention in its broader aspects is not limited to the specific details and representative embodiments shown and described herein. Accordingly, various modifications may be made without departing from the spirit or scope of the general inventive concept as defined by the appended claims and their equivalents.
